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動注化学療法は, 高齢・主要臓器機能低下等のlow risk症例においても諸家の報告と遜色のない効果が得られたことより, 今後更に検討に値する治療法の一つと考えられる.neoadjuvant療法としての有用性も期待できるが, 今後neoadjuvant療法の目的の一つであるmicrometastasisに対して全身化学療法を上回る有用性があるか否か等多くの課題も残されており, randomized studyによる多数症例での検討も必要と考える, The present investigation was conducted to examine the effects of intra-arterial chemotherapy (IAC) for patients with invasive bladder cancer. A total of 37 patients were treated with IAC at Nara Medical University and its affiliated hospitals between January, 1993 and August, 1997. There were 27 patients in the poor risk group. The remaining 10 patients underwent anti-tumor IAC. Thirty of the 37 patients received chemotherapeutic agents via a reservoir, and the remaining 7 patients received a one-shot injection of agents followed by transcatheter arterial embolization (TAE). In the reservoir group, there were 18 patients who received IAC in combination with radiation therapy. As a result, reduction of tumor size was noted in 53%, and the 3-year cause-specific survival rate was 54% in all cases. There was a significant difference in the 3-year survival rate between the radiation-treated group and the group without radiation. The adverse events included anemia, leukopenia, thrombocytopenia and gastrointestinal symptoms, but none of them were severe. The results of the present study indicate that IAC is useful in the treatment of invasive bladder cancer for poor risk patients.

We describe the case of a 44-year-old man with congenital adrenal hyper- plasia (CAH ; 21-hydroxylase deficiency) associated with bilateral adrenal myelolipoma. While undergoing computed tomogaraphy(CT) for the evaluation of persisting flank pain in May 1988, he was diagnosed incidentally as having a bilateral adrenal tumor. Histology of the right extirpated tumor revealed myelolipoma of the adrenal gland, and the other side of the tumor also was diagnosed as myelolipoma by the image diagnostic characteristics. The left side tumor was not extirpated. During examination of hyper-reninism, plasma renin activity (PRA) at 10.5ng/ml/h, he was diagnosed as having congenital adrenal hyperplasia due to elevation of adrenocorticotropin (ACTH), progesterone, and 17 α- hydroxyprogesterone (17 α-OHP). Hydrocortisone with dexamethasone supplemented therapy was started, and the ACTH, progesterone, and 17 α-OHP were normalized, but plasma PRA persisted at high levels. The PRA in this case did not show the degree of sodium loss. During 8 years of observation of the left side myelolipoma by CT, the tumor size did not increase. This case provides an interesting natural history of the clinical characteristics of CAH that went undiagnosed for a long period and an interesting compli- cation of bilateral adrenal myelolipoma.

膀胱皮膚瘻で尿路管理中の女性頸髄損傷患者5例の長期成績について検討した.全例で, 上部尿路は正常に保たれており, 自律神経過反射は消失した.患者のQOLも改善し, 手術に対する満足度も高かった.女性頸髄損傷患者において, 膀胱皮膚瘻は有用な尿路管理法であると考えられた, Tetraplegic women who underwent a cutaneous vesicostomy in our institutions were studied to evaluate long-term urinary complications and their quality of life (QOL). A total of 5 patients (C4, C5 and C6 injuries in one patient each and C7 injury in 2) were followed for 98 to 125 months (mean 107 months). Autonomic hyperreflexia disappeared after surgery in all patients. None of the patients showed deterioration of the upper urinary tract. Urinary tract infections were noted in 3 of 5 patients, but not severe. Bladder stones developed in 2 patients and a stomal stricture in 1. A questionnaire survey showed the patients to be satisfied with the operation, which had improved their QOL. These findings suggest that a cutaneous vesicostomy is an excellent surgical procedure for tetraplegic women.

前立腺癌の初期治療としてTAB療法は, 従来の内分泌療法と比較してほぼ同等の有効率がえられ, 副作用の出現頻度は女性ホルモン剤に比較し低かった.TAB療法中の再燃の際にはwithdrawal syndromeを考慮する必要がある, To evaluate the usefulness of total androgen blockade (TAB) therapy, we retrospectively studied 45 patients with prostate cancer who received TAB therapy as the first-line treatment. The clinical stage was A2 in 1 patient, B1 in 10, B2 in 9, C in 6, D1 in 3 and D2 in 16. Seven, 25 and 13 patients had well, moderately and poorly differentiated adenocarcinomas, respectively. The patients were placed on 1 of 3 TAB regimens: Luteinizing hormone-releasing hormone (LH-RH) agonist and flutamide (group 1), LH-RH agonist and chlormadinone acetate (group 2) and a surgical castration and flutamide (or chlormadinone acetate) (group 3). The therapeutic effect was evaluated at 12 weeks according to the response criteria in the general rules for clinical and pathological studies on prostatic cancer. The overall response was partial response (PR) in 35 patients (77.8%), no change (NC) in 6 (13.3%) and progressive disease (PD) in 4 (8.9%). PR was obtained in 81.3, 79.2 and 60% of the patients in groups 1, 2 and 3, respectively. One patient with PD responded briefly to flutamide withdrawal. None of the patients developed any severe adverse effects. In conclusion, the first-line TAB therapy is effective for prostate cancer with a lower risk than estrogens. Relapsed cases should be followed for flutamide withdrawal syndrome during TAB therapy.

1985年1月～1995年6月に, 奈良医大泌尿器科ならびに関連施設で入院治療した下部尿路損傷61例について臨床的検討を行った. 1)膀胱挫傷は保存的治療を行い, 膀胱破裂は早期の外科的治療を必要とした. 2)尿道損傷については出血, 著明な尿の溢流等がない場合, 膀胱瘻の設置にとどめ, 積極的な治療は骨盤骨析等の合併損傷の安定をみてから尿道形成を行う方が, 尿道狭窄等の合併症の発生頻度が低くなると考えられた, A total of 61 patients with lower urinary tract injuries were treated at Nara Medical University and its affiliated hospitals, between January 1985 and June 1995. There were 9 patients with bladder injuries and 52 patients with urethral injuries. The main cause of bladder injury was a traffic accident sustained in 4 patients (44.5%) and that of urethral injury was an occupational accident sustained in 27 cases (51.9%). The major associated injuries were a bone fracture seen in 45 patients (73.8%) and an intrascrotal hematoma seen in 28 patients (45.9%). Posterior urethral injuries associated with pelvic bone fractures were classified into 3 types according to the classification reported by Colapinto et al.; 8 patients (32.0%) into Type I, 8 (32.0%) into Type II and 9 (36.0%) into Type III. Of the 25 patients with posterior urethral injuries, 8 (32.0%) underwent immediate surgical treatment, 12 (48.0%) underwent initial cystostomies and delayed surgical treatment and 5 (20.0%) received indwelling of urethral catheters. Postoperative complications of urethral injury included urethral stricture in 30 patients (57.7%), incontinence in 3 (5.8%) and impotence in 3 (5.8%). A significant relationship between the duration of cystostomy and the incidence of postoperative urethral stricture was observed in our patients. Therefore at least three weeks of cystostomy will be necessary in the management of patients with complicated urethral injuries.

1995年8月迄の9年間に当大学及びその関連施設において治療した成人の精巣腫瘍148例について検討した. 1)病期別, 病理組織別に分類した結果.セミノーマ群は99例で, stage Iが90例, stage IIが7例, stage IIIが2例であった.またNSGCT群は49例で, stage Iが31例, stage IIAが3例, stage IIBが4例, stage IIIが11例であった. 2)著者等の統一した治療指針に沿わない解析除外例が, セミノーマ群で7例, SNGCT群で15例あった. 3)セミノーマ群のstage Iでは, 異常所見がなければ基本的に, surveillance policyとする, Since April 1986, a prospective clinical trial for testicular cancer has been underway by our Nara Uro-Oncology Research Group. One hundred and forty-eight cases of germ cell tumor were entered into this study between April, 1986 and August, 1995. They included 99 cases (66.9%) of seminoma and 49 cases (33.1%) of non-seminomatous germ cell tumor (NSGCT). The mean age of seminoma cases (39.7 yrs) was higher than that (30.2 yrs) of NSGCT cases. One hundred and twenty-three cases were treated according to our protocol. In the treatment group, one patient with stage I seminoma died of other diseases and one patient each with stage II and stage III seminoma died of cancer. Three patients with stage III NSGCT died of cancer. The 5-year survival rate was 100% for stage I seminoma, and stage I and stage II NSGCT, 75.0% for stage II seminoma, 0% for stage III seminoma and 66.7% for stage III NSGCT. These findings suggest that new treatment modalities should be introduced into our protocol in the future.

1)非前立腺癌泌尿器科疾患687例のうち, 泌尿器科的検査・処置によると考えられる一過性のPSA異常値は38例(5.5%)にみられた. 2)PSAが異常高値を示した例の頻度は, BPHで22.3%, 前立腺癌病期Aで65.4%, Bで83.5%, Cで95.1%, Dで96.1%と前立腺癌例で陽性率が高く, 前立腺腫瘍マーカーとして有用性は高かった. 3)前立腺癌の分化度別のPSA値は, 大半の病期において分化度が低くなるほど高かった. 4)前立腺癌の正診率の向上に, PSA測定に加えて, γ-seminoproten(GAM), 前立腺酸性フォスファターゼ(PAP)の3者同時測定を試みた.限局性前立腺癌の診断におけるGSM, PAPの陽性率はPSAより低く, 併用の有用性はみられず, PSAのみでよいとみられた, The number of cases of prostate carcinoma (PCA) is steadily inceasing in Japan. The clinical application of a reliable tumor marker, prostate specific antigen (PSA) for the diagnosis, as well as the increasing elderly population in Japan may account for this increase. The subjects were patients at the Nara Medical University and its affiliated hospitals; 1) 687 cases without PCA were evaluated for age-specific PSA and the incidence of abnormal PSA following urological manipulations, 2) 135 cases with histological proven BPH by transurethral resection of prostate (TUR-P) were examined for PSA density (PSAD) and positive PSA rate in BPH, 3) 135 cases receiving a needle biopsy with suspicion of PCA were examined for the efficacy of PSA and PSAD and other parameters, and 4) 459 PCA cases treated between 1988 and 1994, were examined for specific PSA and PSAD values by stage and degree of cell differentiation. The PSA assay used in this study was MARKIT-M PA (normal range < or = 3.6 ng/ml). The PSA was decreased gradually with age in non-PCA patients, and abnormal PSA was found in 5.5% of these patients following manipulations. The average PSA was 2.95 +/- 2.03 ng/ml in 130 BPH patients (mean age: 71.1 +/- 7.0 years old. and average prostate volume: 32.9 +/- 16.1 ml). And abnormal PSA level (more than 3.61 ng/ml) was found in 22.3%. The mean PSAD was 0.1.0 +/- 0.06, and PSAD was below 0.15 in 86.1% of these BPH cases. Among the 135 cases receiving a needle biopsy, 33 cases had PSA values between 3.61 and 10.0 ng/ml. Of these cases, PCA was found in 18.5% of the 27 cases with a PSAD below 1.5, and in 33.3% of the 6 cases with a PSAD over 1.5. PSA and PSAD were proportionally increased with stage, and a significant difference in the PSA value was observed between stage B1 and B2, and stage C and D (P < 0.05). However, PSA and PSAD values were not significantly correlated with the cell differentiation in PCA stage A2-C. In total, PSA was 18.1 ng/ml in well, 23.9 ng/ml in moderately and 35.9 ng/ml in poorly differentiated type PCA. The positive rate of PSA was 22.3, 65.4 and 83.5%, that of prostate acid phosphatase (PAP) was 10.0, 17.8 and 45.8%, and that of GSM was 25.0, 14.7 and 68.4%, in BPH, stage A PCA and stage BPCA, respectively. In conclusion, PSA is the most reliable tool in the diagnosis of localized PCA. However, the differential diagnosis of BPH and localized PCA is difficult when the PSA value is between 3.61 and 10.0 ng/ml, and accurate staging of localized PCA is difficult with PSA or PSAD alone. At present, it is necessary to use all possible tools for the early detection of localized PCA, and to perform the needle biopsy in all PCA-suspicious cases.

1994年6月からの1年間, 高血圧等の慢性疾患で通院中の102例(60歳代36例, 70歳代49例, 80歳以上17例)について, chemiluminescence法により前立腺特異抗原(PSA)を測定した.PSA 3.0ng/ml以上(正常値は2.22ng/ml)の例は36例(35.3%)で, うち20例は泌尿器科を受診して直腸内指診(DRE)と経直腸的超音波検査(TRUS)を行った.16例ではTRUS誘導前立腺生検を行ったが, PSA 10ng/ml以上の15例中7例で前立腺癌を発見した.即ち, 前立腺癌発見率は6.9%(7/102)で, 日本人についての従来の健診による発見率の約4倍と高率であった.PSAによるスクリーニングは前立腺癌早期発見に有用と思われる, Screening was performed on 102 patients aged 60 years or older who visited the Outpatient Department of Internal Medicine in Tane General Hospital between June 1994 and May 1995. Of those screened, 36 patients (35.3%) had elevated prostate specific antigen (PSA) values, and 20 of them visited the Urological Department, and underwent digital rectal examination (DRE) and transrectal ultrasonography (TRUS) for further screening. Of the 16 patients who underwent ultrasound guided biopsies of the prostate, 7 patients were found to have prostate cancer. Therefore, the cancer detection rate was 6.9%, which was about 4 times higher than that of mass-screening examinations previously reported in the Japanese literature. These findings suggested that the screening using PSA in outpatients of Internal Medicine may be useful for the early detection of prostate cancer.

We report a case of cystinuria in which the nephrotic syndrome developed during treatment with tiopronin (alpha-mercaptopropionylglycine). Light microscopy of renal biopsy specimen showed focal glomerulosclerosis. Proteinuria resolved after withdrawal of the drug and without corticosteroid administration. The pathogenesis of tiopronin-induced nephropathy and this unusual presentation of symptoms are discussed with respect to the literature.

1)登録症例は16例で, 全例が適格例であった. 2)副作用は16例中8例に認められたが, 軽度で, 臨床上特に問題はなかった.乳房圧痛, 乳房腫脹等の副作用が50mg群で1例, 80mg群で3例及び100mg群で2例に認められた. 3)有効性に関しては, 各投与群の1例ないし2例において, PR以上の抗腫瘍効果が認められた.又, 排尿困難, 排尿痛, 夜間頻尿の改善がみられた. 4)血清中ホルモンでは, LH, FSH, testosterone及びestradiol濃度の上昇が認められた, A phase I study (open trial) of bicalutamide (Casodex), a non-steroidal antiandrogen, was conducted on 16 patients with prostatic cancer (stage C to D). The patients were given 10, 30, 50, 80 or 100 mg of bicalutamide orally daily for 12 weeks. Adverse reactions were observed in 8 out of 16 patients, but almost all were mild. Breast pain, gynecomastia and hot flushes were observed in 6 patients. Adverse reactions regarding liver function tests were observed in 3 patients. These were increased glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT), alkaliphosphatase (AL-P) or gamma guanosine 5'-triphosphate (gamma-GTP). However, during or after the treatment period the elevated values were reversed to the pretreatment level. In terms of efficacy, anti-tumor effect was observed in 1 or 2 patients at each dose. Serum concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone and estradiol increased during treatment. Plasma concentrations of the R (-) enantiomer, which has antiandrogenic activity, reached the steady state 6-8 weeks after the initiation of treatment; its apparent plasma elimination half-life observed following repeated administration was 8.4 +/- 1.1 days. In conclusion, bicalutamide (10-100 mg od) is considered to be tolerated well enough to be administered to patients with prostatic cancer and has shown evidence of anti-tumor effect.

ビカルタミド1日1回50mg群, 80mg及び100mgを12週間投与する3群比較の無作為化非盲検試験を実施した. 1)登録症例は124例で, 適格例は122例であった. 2)総合効果における奏効率は50mg群, 80mg群及び100mg群でそれぞれ50.5%, 61.0%及び53.7%であった. 3)PSAに対する奏効率は50mg群, 80mg群及び100mg群でそれぞれ84.2%, 92.7%及び97.6%であった. 4)副作用発現率は3群ほぼ6割で副作用による中止例は80mg群の1例のみで, 安全度において3群間に有意差はなかった.主な副作用は乳房腫脹, 乳房圧痛等であった, To investigate the efficacy and safety of bicalutamide (Casodex(R)) with its clinically recommended dose, the randomized early phase II study was performed in 124 patients with prostatic cancer (stage C, D). The patients were given 50, 80 or 100 mg of bicalutamide orally once a day in fixed doses for 12 weeks ; 122 patients were eligible for evaluation. The overall response rate was 50.0% (20/40); 61.0% (25/41) and 53.7% (22/41) in the 50 mg, 80 mg and 100 mg groups, respectively. The response rate in prostate lesion, bone and lymph node metastases was slightly higher in the 80 mg group than in the 50 mg and 100 mg groups. The proportion of patients showing a response with regard to serum PSA (CR and PR) was 84.2, 92.7 and 97.6% in the 50, 80 and 100 mg groups, respectively. The incidence of adverse reactions was 65.0, 61.0 and 61.0% in the 50, 80 and 100 mg groups, respectively, and there was no significant difference in overall safety rating in the three groups. Frequent adverse reactions were gynecomastia and breast pain. Only one patient in the 80 ing group was withdrawn due to shortness of breath. Serum concentrations of LH, testosterone and estradiol increased significantly after treatment. Bicalutamide was concluded to be effective and well tolerated in patients with prostatic cancer, and its recommended dose was 80 mg once daily.

A case of congenital patent urachus is reported. A 12-month-old boy was referred to our outpatient clinic with the complaint of watery discharge from the navel. A cystography revealed the communication between the dome of the urinary bladder and the umbilicus. Excretion from the umbilicus of indigocarmine solution instilled into the urinary bladder was recognized. There were no complicated abnormalities in other organs. The patient underwent radical operation. Herein, we collected 164 cases of urachal disorders reported in Japan and reviewed the incidence, clinical symptoms, diagnosis and treatment. The classifications of the disease were briefly discussed.

1982年1月より1993年6月までに, 入院加療した腎外傷70例について臨床的検討を行った結果, 腎外傷の際にも基礎疾患として泌尿器科疾患の発見されることを念頭において治療を行う必要性がある。また, 受傷後の血漿レニン活性の変動において, とくに高値を維持する症例には高血圧の発症が予想されるため厳重な経過観察が必要と考えられた, A total of 70 patients with renal trauma were treated at the Department of Urology, Nara Medical University and Nara Prefectural Hospital, including Life-Saving Emergency center, from January 1982 to June 1993. They were between 3 and 79 years old (mean 30.0) and preponded to the younger generation. The main cause of injury was traffic accident in 46 cases (65.7%). According to the Classification of Renal Injury by the Japanese Association for the Surgery of Trauma in Japan, there were 31 cases (44.3%) of type I (subcapsular injury), 18 cases (25.7%) of type II (superficial injury), 15 cases (21.4%) of type III (deep injury), and 6 cases (8.6%) of type IV (pedicle injury). Surgical treatment was performed in 17 cases (24.2%). The major associated injuries were bone fracture in 32 cases (45.7%), lung injury in 17 cases (24.2%), and liver injury in 15 cases (21.4%). Furthermore, hydronephrosis and ureteral tumors were incidentally found in 4 and 1 patient during the course of treatment for renal trauma. Post-traumatic plasma renin activities (PRA) in types III and IV were significantly higher than those in types I and II. Hypertension developed in 1 case of types I and II and 4 cases of types III and IV. The mean level of PRA was significantly decreased 2 years after renal injury in both groups. We should bear in mind that renal trauma may be associated with other urological diseases such as hydronephrosis and urological malignancies, and post-traumatic PRA should be followed carefully.

進行性尿路移行上皮癌の転移症例に対する治療成績を検討した。1)転移巣に対する治療法は化学療法がおもなものであったが, その治療成績は近接効果, 長期予後ともに現時点では決して満足すべきものではなかった。2)再発・転移症例群において, CRがえられた症例のみ長期生存がえられた。3)再発・転移を予防するために, adjuvant療法の有用性が示唆された, The current status of treatments for advanced transitional cell carcinoma of the urinary tract with metastasis is reported. A total of 62 patients were treated in Nara Medical University Hospital and its affiliated hospitals between January, 1980 and June, 1993. All patients were divided into two categories; cases in which local recurrence and/or distant metastasis had developed during the followup study (group 1) (n = 32) and fresh cases with distant metastasis (group 2) (n = 30). Most of the metastatic sites were treated with chemotherapy alone or combination therapy including chemotherapy. As for clinical response of each case, CR + PR rate in group 1 (34%) was higher than that in group 2 (13%) (p < 0.1). As for prognosis, the survival rate in group 1 was significantly higher than that in group 2 (p < 0.05). In group 1, the survival of CR was significantly higher than that of the non-responders. No adjuvant therapy for invasive bladder cancer and post-operative adjuvant therapy for renal pelvic and/or ureteral cancer can be recommended to prevent local recurrence or distant metastasis. In addition, supporting therapy and dose intensified chemotherapy would lead to good prognosis in advanced urothelial cancer patients.

1)腎の嚢胞性疾患6例9嚢胞に対して超音波ガイド下に嚢胞穿刺を行い嚢胞内容吸引後, CO2注入を試みた。2)穿刺後1ヵ月の時点において単純性腎嚢胞の5例5嚢胞に平均69%の縮小効果を認めた。3)穿刺施行前後においてvital signに変動なく特に合併症も見られなかった, Ultrasound-guided percutaneous puncture of renal cysts replaced by CO2 was performed on 9 renal cysts of 6 patients from May 1993 through September 1993. Puncture and aspiration of cysts was performed using a 5.5 Fr one-step fluid drain kit (pig tail stent) under ultrasonography inspection. Aspirated volume of cyst contents was 15-292ml (mean 115 ml), and the instilled CO2 volume was 15-150 ml (mean 73 ml). All patients were checked by CT scan. In one month, the reduction rate of cyst volume was 46-84% (mean 69%) and lumbago, their chief complaint, was improved in all patients. No complications were observed in patients treated by CO2 instillation. Although long-term followup is needed to draw a definite conclusion, this therapy may be useful for benign renal cystic lesions.

Rhodamine 123 (Rh123) is a red fluorescence dye, which is accumulated more and retained longer in the mitochondria of malignant transformed cells. In this study, the suppressive effects on the growth of cultured urogenital carcinoma cells (PC-3 and LNCaP from prostate carcinoma, T-24 from bladder cancer, and SV-HUC-1 human ureteral transitional cell transformed by SV virus in vitro, ACHN, YCR-1 and RCF213 from renal cell carcinoma) were examined. The cell growth of PC-3, LNCaP, T-24 and SV-HUC-1 was suppressed significantly in a dose dependent manner, but that of cells derived from renal cell carcinoma was not suppressed. The uptake and elimination of Rh123 in PC-3, ACHN and YCR-1 were not significantly different. When administered with verapamil and buthionine sulfoximine, which are reported to be chemical modulators of anticancer agents, Rh123 suppressed the growth of ACHN and YCR-1 significantly. Rh123 seems to have an anticancer effect against the urogenital carcinomas, and the role of Rh123 with hyperthermia, photodynamic therapy and chemotherapy requires further investigation.

二分脊椎患者32例に於いて, VUR(膀胱尿管逆流現象)を有する50尿管に対して逆流防止術を行った。1例を除き全例にCohen法の尿管膀胱新吻合術, 1例に両側Politano-Leadbetter法を行った。平均追跡期間42.5ヵ月に, 尿管の92.0%, 症例の87.5%で成功した。これらの成績は最近の文献のそれ等に匹敵した。3例ではVURが再発した。一側再植え込みを行った別の1例では対側尿管に新しく逆流が発生した。術後VURを防止する為には間欠導尿法を続ける事が重要である事を強調した, A series of 32 patients with spina bifida, representing 50 renal units with vesicoureteral reflux (VUR), was treated with antireflux operation. All but one patient underwent ureteral reimplantation with Cohen's technique. Another patient was treated with bilateral Politano-Leadbetter's technique. The overall success rates were 92.0% by renal unit and 87.5% by case, with a mean follow-up period of 42.5 months. These results were comparable to those in the recent literature. Failure included recurrence of VUR in 3 patients. Another patient who had undergone unilateral reimplantation developed new occurrence of reflux in the contralateral ureter. Possible masking of contralateral VUR should be taken into consideration in patients with unilateral high grade VUR. We also emphasize the importance of continuing clean intermittent catheterization in a proper manner to be free of VUR postoperatively.

Augmentation cystoplasty is evolving into a common method of surgical treatment for a low capacity and/or low compliance neurogenic bladder. Although an increasing number of successful results have been recently reported, the operative indication of augmentation cystoplasty is yet to be established. Herein, we report two cases of neurogenic bladder due to spina bifida which required abandonment of augmentation cystoplasty. The first case was in a 23-year-old female with a severely deformed bladder and right vesicoureteral reflux (VUR). She refused to undergo ileocystoplasty because we could not assure her of postoperative conception which she eagerly anticipated. The second case was in a 19-year-old male with a severely deformed bladder and right VUR. He experienced recurrent episodes of ventriculoperitoneal shunt (V-P shunt) difficulty which required exchanging the shunt tube each time, and each exchange proved to be very difficult or nearly impossible. Based on lengthy neurosurgical consultation, we came to the conclusion that ileocystoplasty was not a preferable treatment of choice for the correction of his disease due to the possibility of V-P shunt infection, which could be fatal. Alternatively, both cases were treated with Cohen's ureteral reimplantation, which resulted in the recurrence of VUR. These cases presented still unresolved issues concerning the operative indication of augmentation cystoplasty in spina bifida patients.

46歳男, 初診時すでに腫瘍は腎, 脾, 膵, 胃等に浸潤していたが, THP-COP化学療法により腫瘍サイズの縮小化をはかり, 2次的に外科的切除を行った。術後も残存腫瘍に対し間歇的に化学療法を維持することにより, 初期治療後33ヵ月と比較的長期生存がえられた, Extramedullary plasmacytoma (EMP) is a very rare disease and mainly arises in the head and neck area. We herein reported a case of EMP arising in the retroperitoneal space. A 46-year-old man was referred to our outpatient clinic in November 1989 with the complaint of flank pain on the left side. Radiological examinations showed a tumor formation in the retroperitoneal space, which involved the left kidney, spleen and pancreas. Immunoelectrophoresis showed an elevation of serum IgG level and a spike of M-protein was detected in the serum protein electrophoresis. No bone lesions were detected, and bone marrow aspiration showed no abnormal cells. US-guided needle biopsy of the tumor led to the histological diagnosis as plasmacytoma of the IgG-kappa type. Following three cycles of preoperative chemotherapy (a THP-COP regimen), which resulted in a size reduction of the tumor by 40%, extensive resection of the tumor including extirpation of the left kidney, spleen, and tail of pancreas was performed. Because of tumor extension into the posterior wall of the stomach, however, the surgery resulted in incomplete resection. A total of 11 cycles of postoperative chemotherapy (THP-COP) was performed periodically for the residual tumor in the stomach. Rapid tumor spreading in addition to re-elevation of the serum IgG level, however, developed after the 11th postoperative chemotherapy, which extensively involved the stomach and intestines. The patient died of the disease 33 months after the initiation of treatment.

1)125, 250, 375および500mgの用量の単回経口投与を受けた計11名の患者では副作用を認めなかった。2)375, 750, 1, 125および1, 500mg/日の用量の1日3分割経口投与を連日28日間行ったところ, 1, 500mg/日の投与を受けた4例中1例に胃部不快感, 悪心・嘔吐, 食欲不振の副作用症状を認めた。他の用量を投与された9例では副作用の訴えはなかった。3)臨床検査値の異常は375mg/日群の3例では認められなかったが, 他の用量群で9例中5例にトラスアミナーゼの上昇を認めた。特に, 1, 500mg/日群では評価可能な3例の全例に異常値を見た。4)LHの濃度の有意な上昇を認めた。5)客観的効果が各群において3例中2例に観察された。また, 疼痛, 排尿障害, PSの改善が認められた。6)投与後速やかに吸収され, 大部分が水酸化を受けたOH-フルタミドとして血液中に存在していた。また, 単回投与と比べ, 連日投与後のOH-フルタミドの半減期には大差を認めなかったがCmaxおよびAUCは増加していた。7)第2相臨床試験の試験用量としては, 375mg/日から1, 125mg/日の範囲が望ましいと結論された, A phase I study of orally administered flutamide (a pure anti-androgen) was performed in 26 patients with prostatic cancer. No side effects were observed in 11 patients receiving single doses of either 125, 250, 375 or 500 mg. However, in the daily dosing schedule of 375, 750, 1125 and 1, 500 mg/day doses, where medication was taken in three divided doses, discomfort in the stomach, nausea, vomiting and anorexia were experienced in one of the four patients receiving the highest dose of 1, 500 mg. Nine patients receiving the other doses did not complain of toxic symptoms. Laboratory values did not change in the three patients receiving the lowest 375 mg/day dose, but elevation of transaminase was observed in five of the nine patients given higher doses. This elevation was observed in all the three patients receiving 1, 500 mg/day dose. Among the serum hormone levels, significant increases of luteinizing hormone were observed. As for efficacy, objective responses were observed in two of the three patients in each of the four daily dosing groups. Improvement of pain, voiding obstruction symptoms, and performance status were also observed. Flutamide was found to be absorbed rapidly and to exist as a hydroxylated form (hydroxy-flutamide) in the plasma. The half-life of hydroxy-flutamide was similar in the single and daily administration, but the peak concentration and area under the concentration versus time curve in the daily administration became greater than those in the single administration. In conclusion, flutamide should be examined for efficacy and safety using doses of 375 to 1, 125 mg/day in the phase II study.

1)内分泌療法未治療の前立腺癌症例に対し, 375mg/日の用量で単独療法として使用しえる。この際, testosterone産生阻害療法に比し, 「生活の質」が保たれる。2)内分泌療法再燃例に対しても, ある程度その効果が期待できる。3)フルタミドと他の精巣性testosterone阻害剤との併用で, その併用効果が期待できる。4)また, LH-RHアナログの投与によるflare-up現象をフルタミドを併用することにより予防することが可能である, The phase II study of flutamide, a pure anti-androgen, was performed to estimate the clinical doses on 165 hormone untreated or treated patients with prostatic cancer. The hormone-untreated patients were given orally flutamide of 90, 375, 750 or 1, 125 mg/day in three divided doses daily for 12 weeks. Responses were not observed at the 90 mg/day dose except for improvement of clinical symptoms. However, an objective response rate of 48.8-46.7% was obtained at 375-1, 125 mg/day doses. In hormone-treated patients including cases refractory to the previous hormonal treatment, the objective response rates were 13.3 and 8.3% in 375 and 750 mg/day flutamide groups, respectively. Side effects such as gynecomastia, nausea, vomiting, diarrhea, and abnormal laboratory findings such as the elevation of hepatic transaminases were observed. The incidence increased dose-dependently. Determinations of serum hormone levels revealed an increase in testosterone levels by the use of flutamide. In conclusion 375 mg/day of flutamide is the optimal dose in monotherapy for hormone-untreated patients with prostatic cancer, where the quality of life can be maintained compared with therapies involving testosterone suppression. This dose is also expected to show some efficacy in cases refractory to hormone treatment.

1)初診時Ml症例に対しても可能なかぎり原発巣に対する手術を行うことが必要と考えられた。2)転移巣に対する有効な治療法の開発が必要である。3)有効な術後補助療法の開発も必要と考えた, The current status and controversy of the treatment for renal cell carcinoma are reported. From 1980 to 1990, a total of 283 patients with renal cell carcinoma were treated in Nara Medical University and its affiliated hospitals. All patients were divided into two groups: M0 group (n = 217) and M1 group (n = 66). In addition, the M0 group patients were divided into two groups according to the followup study: M0-->M0 group (n = 194) and M0-->M1 group (n = 23). There was a significant difference between the survival of the M0 group and that of the M1 group (p M0 group and that of the M0-->M1 group (p M1 group, no prognostic factor was seen. These findings indicated that surgical treatment for the primary site in M1 patients should be performed. In addition, development of effective treatment for metastatic sites other than the lungs and effective postoperative adjuvant treatment would be necessary.

1歳4ヵ月女児.病理組織検査にて異所性膵組織を認めたが, 本疾患の本邦報告例において異所性膵組織の頻度は高い.自験例では術前高値を示した血中アミラーゼが術後正常化しており, 異所性膵組織の関与が推測された.本疾患は泌尿器科疾患では尿膜管嚢胞との鑑別診断が必要であるが, 血中あるいは内容液中のアミラーゼ値が鑑別診断の助けになる可能性がある, A case of vitello intestinal cyst was reported. A 16-month-old girl was referred to our clinic with a complaint of a cystic mass in the region of the navel. With a diagnosis of urachal cyst, resection of the cyst was performed. Histopathologically, the cyst wall consisted of fibrous and fat tissue, and a small polypoid tumor which was found on the inner surface of the cyst was covered by intestinal epithelia. Pancreatic and gastric mucosal elements were observed in the submucosal layer. The histopathological diagnosis was vitello intestinal cyst. Serum amylase level elevated preoperatively normalized after removal of the cyst. We collected 11 cases of vitello intestinal cyst reported in Japan including the present case. Ectopic pancreatic tissue is considered a characteristic of vitello intestinal cyst and that serum or fluid amylase level may be useful for differential diagnosis of the disease.

1) T2～3の局所浸潤癌に対しては, prospective randomized studyにおいてCAP療法とradiationによるneoadjuvant療法群が近接効果および長期予後に対する効果ともに良い結果がえられた.2)術後の補助化学療法については, 新たなrandomized studyによる検討が必要である.3) T4の局所浸潤癌に対しては, M-VACを用いてneoadjuvant療法にて検討しているが, 症例数も少なく未だ満足できる成績はえられていない.4)補助化学療法における問題点として, The current status of adjuvant chemotherapy for clinically localized but invasive transitional cell carcinoma of the bladder is reported. Since 1986, a prospective randomized study has been conducted to examine the effects of neoadjuvant cyclophosphamide + doxorubicin + cisplatin (CAP) and radiation therapy for T2-3N0-3M0. A total of 47 patients were entered. However, 4 patients were excluded from the study. All eligible patients were randomized into two groups: neoadjuvant CAP plus radiation and control group. In the neoadjuvant treated-group, a 55% complete response plus partial response rate and a 88% downstaging were noted. Both the 12- and 36-month disease-free survival rates of neoadjuvant treated-group were 94.7%, and were higher than those of the control group (p less than 0.1). As for T4N0-3M0 cases, a total of 6 patients were treated with neoadjuvant methotrexate + vinblastine + doxorubicin + cisplatin (M-VAC) therapy. Favorable results were not obtained in this study at this point, because full dose M-VAC and planned recycling were not performed sufficiently. These findings suggests that neoadjuvant CAP plus radiation therapy would be useful for T2-3 invasive cancer of the bladder. Methods to administer full dose M-VAC; such as developments of new chemotherapeutic agents and of new anti-toxic agents, should be developed. In addition, a more successful regimen than M-VAC should be considered for T4 localized invasive bladder cancer.

前立腺癌の治療成績の向上には前立腺癌の早期発見・早期根治治療に努めるとともに, 進行癌とくに低分化型腺癌に対する治療の開発が必要である.CDDPを中心とする化学療法ではPRが20/59例にみられたが, 生存率の改善はえられず, 進行前立腺癌に対するCDDPを中心とした化学療法はいまだその有用性は認められていない.しかし抗男性ホルモン療法に抵抗を示す進行前立腺癌の治療に他の有効な治療法が見いだせない現状では, 今後前立腺癌の自然史の解明と分子生物学的領域からもさらに有効な抗癌剤の開発や治療方法の向上に努力すべきである, CDDP combined chemotherapy was performed in 55 cases out of 229 prostatic cancer patients who were treated in Nara Medical University and Nara Prefectural Nara Hospital between January 1979 and August 1989. The previously untreated 33 patients received chemotherapy with anti-androgen treatment as an initial treatment, as well as 7 cases of unresponsive to antiandrogen treatment, 14 relapsing cases and one case with recurrence after total prostatectomy. The major regimens of chemotherapy were cis-diammine dichloroplatinum (CDDP) alone in 16 cases, PVB regimen (bleomycin or peplomycin + vincristine + CDDP) in 19 cases, and CAP regimen (cyclophosphamide + adriamycin + CDDP) in 16 cases. Complete response was not achieved or partial response was observed in 20 cases (34%), no change was seen in 20 cases (34%), and progression was seen in 19 cases (32%). Among each evaluable lesion, effects (CR + PR) were observed in 40% in the prostate, in 18% in the bone lesions, in 44% in the soft tissue lesions, and in 42% in the prostatic tumor marker. The 7-year survival rate of the chemotherapy group (35.6%) was better than that of the antiandrogen treatment group (26.6%) in stage D patients, but was not significant statistically When evaluated by the regimen, a partial response was observed in 56% of CDDP alone, in 21% of PVB regimen, and in 38% of the CAP regimen. However, there was no significant difference in survival rate among the regimens. As an adverse effect, myelosuppression and renal toxicity seemed to be dose limiting factors of CDDP combined chemotherapy for advanced prostatic cancer patients.

A 71-year-old male patient was referred to our department for further examination for right retroperitoneal tumor. Exploration was done through a flank approach and the tumor with right adrenal gland was removed. A pleomorphic lipoma was diagnosed histopathologically. There have been 8 reported cases of pleomorphic lipoma including our present case in Japan and we discuss the pathogenesis and treatment of this rare disease.

A 41-year-old female patient with a right retroperitoneal tumor for more than thirty years was referred to our department. Exploration was done through a transperitoneal approach and the tumor was removed. A ganglioneuroma was diagnosed histopathologically. There have been 99 reported cases with retroperitoneal ganglioneuroma including our present case in Japan and we discuss the pathogenesis and treatment of this rare disease.

We compared prostatic specific acid phosphatase (PAP), prostatic specific antigen (PA) and γ-seminoprotein (γ-SM) levels between bone marrow and serum for the purpose of assessing of the usefulness of these tumor markers in early detection of bone metastasis in cases with prostatic cancer. Thirty-three patients were entered into this study. Of the patients, 20 had prostatic cancer including 11 with bone metastasis, and 13 patients had benign prostatic hypertrophy (BPH) served as controls. It seemed unlikely that bone marrow PAP, PA and γ-SM are more useful than their serum levels for detection of bone metastasis of prostatic cancer. Because correlation between bone marrow and serum levels of each marker was observed not only in cases with prostate cancer accompanied by bone metastasis but also in metastasis-free prostatic cancer and BPH cases, it seems likely that PAP, PA and γ-SM in bone marrow circulate from peripheral blood rather than from bone metastasis of prostatic cancer.

A case of squamous cell carcinoma of the urinary bladder associated with a bladder stone in a 43-year-old man is reported. Because a 1 cm x 1 cm sized mass was found in the right lateral side of the dome at the time of vesicolithotomy, partial cystectomy was performed. The weight of the stone was 285 g and the tumor was histologically diagnosed as squamous cell carcinoma, grade 2, pT2. Radical cystectomy with ileal conduit was sandwiched by a total of 6 cycles of chemotherapy with PVB. Twelve cases of squamous cell carcinoma of the urinary bladder associated with a bladder stone(s) from the Japanese literature are reviewed, and the relationship between bladder stone, leukoplakia and squamous cell carcinoma discussed.

A 76-year-old man, who had undergone surgery for lung cancer, was referred to our department for further examination for left renal mass. Exploration was done through a transperitoneal approach and the left kidney was removed. A metastatic renal tumor originating from a pulmonary squamous cell carcinoma was diagnosed histologically. There have been 73 reported cases with metastatic renal tumor in Japanese literature and we reviewed the pathogenesis and treatment of this rare entity.

前立腺肥大症に対するCernilton(R)の有用性を検討するため, Paraprost(R)を対照薬とする多施設二重盲検群間比較試験を行った.1)総投与症例数192例中, 総合効果は159例, 総合安全度は178例, 有用度は159例について集計解析した.解析対象例と除外・脱落例の症例の構成および患者の背景因子において両群間に偏りはみられなかった.2)委員会と主治医判定による総合結果, 患者の印象のいずれにおいてもCN群の成績はPP群より高かったが, 両群間に有意差はなかった.3)自覚症状全般改善度の推移において, 4週後の委員会判定による中等度改善以上の改善率でCN群はPP群より有意に優れていた.また排尿困難の有力な指標である苒延性排尿に対する改善率でCN群はPP群より有意に優れていた.4)他覚所見の計測値の検討では, CN群は残尿量, 平均排尿量率, 最大排尿量率, 前立腺重量(Thumann計測)において投与前後の比較で有意の改善が認められた.また残尿量の段階推移においてもCN群で有意の改善が認められた.5)副作用, 臨床検査値で新たな異常値の発現のいずれもCN群にはみられなかった.6)委員会判定による有用度は, CN群はかなり有用以上で49.1%, PP群は41.2%でCN群の成績はPP群より高かったが両群間に有意差はなかった, A multiple center double blind study was performed to study the effectiveness of Cernilton (CN) on benign prostatic hypertrophy in comparison to Paraprost (PP). Among a total of 192 patients, overall effect was studied on 159 patients, overall safety rate on 178 patients and rate of effectiveness on 159 patients. There were no differences between the two groups in the selected patients, criteria for exclusion and drop out cases or background data of the patients. Impression of patients and overall effect by committee and physician judgment were slightly higher in the CN group compared to the PP group, but there was no significant difference between the two groups. For the improvement in subjective symptoms, the rate of moderate improvement or more after 4 weeks by committee judgement was higher in the CN group compared to the PP group. The rate of improvement in protracted miction, which is an effective marker of urinary disturbance, was also higher in the CN group compared to the PP group. An analysis of objective symptoms showed a significant improvement in residual urinary volume, average flow rate, maximum flow rate and prostatic weight in the CN group. A significant improvement in the phased change of residual urinary volume was also seen in the CN group. No side effects or abnormalities in clinical test levels were noted in the CN group. By committee judgement, the rate of more than moderate effectiveness was 49.1% in the CN group compared to 41.2% in the PP group, but there was no significant difference between the two groups. By physician's judgment, the rate of more than moderate effectiveness was 49.4% in the CN group compared to 46.3% in the PP group, but there was also no significant difference between the two groups. These results suggested that Cernilton was an effective drug for benign prostatic hypertrophy.

Since Kock et al. reported a low pressure continent reservoir using detubularized ileal segment as urinary diversion following cystectomy, continent urinary diversion including neobladder has been focused upon. On the other hand, ureterocutaneostomy, or ileal conduit as an incontinent urinary diversion is still commonly used, and especially the latter form is usually performed in many hospitals. These facts suggest that it is difficult to conclude that continent urinary diversion regarded as an excellent operation with good quality of life (QOL) is a generally acceptable method and that there are still some problems to decide the indication for urinary diversion. We discuss the problems about the postoperative complications and care of urinary diversion after cystectomy and our opinion about the selection of these operations.

In clinical trials in advanced urogenital cancer with metastasis there are cases showing a poor clinical response and poor prognosis. The cure of advanced urogenital cancer still remains a major problem in management. The present paper is a summary of 8 articles presented at the symposium on "Management of advanced urogenital cancer: Treatment of metastasis" in the 43th Annual Meeting of Center Section of Japanese Urological Association in November, 1993. The present status, problems and future conception of treatment modalities for advanced urogenital cancer were discussed.

Advanced (metastatic) renal cell carcinoma has a poor prognosis, and patients seldom survive for more than a few years despite aggressive therapy using conventional modalities. The treatment of metastatic lesions arising from renal cell carcinoma is a difficult and challenging problem. Recently, several kinds of new therapies including immunotherapy have been developed extensively for metastatic renal cell carcinoma, primarily because of the absence of an effective standard therapy. The present paper is a summary of 8 articles presented at the symposium on "Studies on new therapies in advanced renal cell carcinoma", 41st Annual Meeting of Center Section of Japanese Urological Association held in November, 1991. The present status and problems in treatment of advanced renal cell carcinoma, biological characters of this disease, immunotherapy including interferon therapy and LAK-therapy, monoclonal antibody to human renal cell carcinoma, intrinsic multidrug-resistance, and oncogenes (anti-IL-6 therapy) were discussed.

The present investigation was conducted to examine the effects of intra-arterial chemotherapy (IAC) for patients with invasive bladder cancer. A total of 37 patients were treated with IAC at Nara Medical University and its affiliated hospitals between January, 1993 and August, 1997. There were 27 patients in the poor risk group. The remaining 10 patients underwent anti-tumor IAC. Thirty of the 37 patients received chemotherapeutic agents via a reservoir, and the remaining 7 patients received a one-shot injection of agents followed by transcatheter arterial embolization (TAE). In the reservoir group, there were 18 patients who received IAC in combination with radiation therapy. As a result, reduction of tumor size was noted in 53%, and the 3-year cause-specific survival rate was 54% in all cases. There was a significant difference in the 3-year survival rate between the radiation-treated group and the group without radiation. The adverse events included anemia, leukopenia, thrombocytopenia and gastrointestinal symptoms, but none of them were severe. The results of the present study indicate that IAC is useful in the treatment of invasive bladder cancer for poor risk patients.

Tetraplegic women who underwent a cutaneous vesicostomy in our institutions were studied to evaluate long-term urinary complications and their quality of life (QOL). A total of 5 patients (C4, C5 and C6 injuries in one patient each and C7 injury in 2) were followed for 98 to 125 months (mean 107 months). Autonomic hyperreflexia disappeared after surgery in all patients. None of the patients showed deterioration of the upper urinary tract. Urinary tract infections were noted in 3 of 5 patients, but not severe. Bladder stones developed in 2 patients and a stomal stricture in 1. A questionnaire survey showed the patients to be satisfied with the operation, which had improved their QOL. These findings suggest that a cutaneous vesicostomy is an excellent surgical procedure for tetraplegic women.

To evaluate the usefulness of total androgen blockade (TAB) therapy, we retrospectively studied 45 patients with prostate cancer who received TAB therapy as the first-line treatment. The clinical stage was A2 in 1 patient, B1 in 10, B2 in 9, C in 6, D1 in 3 and D2 in 16. Seven, 25 and 13 patients had well, moderately and poorly differentiated adenocarcinomas, respectively. The patients were placed on 1 of 3 TAB regimens: Luteinizing hormone-releasing hormone (LH-RH) agonist and flutamide (group 1), LH-RH agonist and chlormadinone acetate (group 2) and a surgical castration and flutamide (or chlormadinone acetate) (group 3). The therapeutic effect was evaluated at 12 weeks according to the response criteria in the general rules for clinical and pathological studies on prostatic cancer. The overall response was partial response (PR) in 35 patients (77.8%), no change (NC) in 6 (13.3%) and progressive disease (PD) in 4 (8.9%). PR was obtained in 81.3, 79.2 and 60% of the patients in groups 1, 2 and 3, respectively. One patient with PD responded briefly to flutamide withdrawal. None of the patients developed any severe adverse effects. In conclusion, the first-line TAB therapy is effective for prostate cancer with a lower risk than estrogens. Relapsed cases should be followed for flutamide withdrawal syndrome during TAB therapy.

A total of 61 patients with lower urinary tract injuries were treated at Nara Medical University and its affiliated hospitals, between January 1985 and June 1995. There were 9 patients with bladder injuries and 52 patients with urethral injuries. The main cause of bladder injury was a traffic accident sustained in 4 patients (44.5%) and that of urethral injury was an occupational accident sustained in 27 cases (51.9%). The major associated injuries were a bone fracture seen in 45 patients (73.8%) and an intrascrotal hematoma seen in 28 patients (45.9%). Posterior urethral injuries associated with pelvic bone fractures were classified into 3 types according to the classification reported by Colapinto et al.; 8 patients (32.0%) into Type I, 8 (32.0%) into Type II and 9 (36.0%) into Type III. Of the 25 patients with posterior urethral injuries, 8 (32.0%) underwent immediate surgical treatment, 12 (48.0%) underwent initial cystostomies and delayed surgical treatment and 5 (20.0%) received indwelling of urethral catheters. Postoperative complications of urethral injury included urethral stricture in 30 patients (57.7%), incontinence in 3 (5.8%) and impotence in 3 (5.8%). A significant relationship between the duration of cystostomy and the incidence of postoperative urethral stricture was observed in our patients. Therefore at least three weeks of cystostomy will be necessary in the management of patients with complicated urethral injuries.

Since April 1986, a prospective clinical trial for testicular cancer has been underway by our Nara Uro-Oncology Research Group. One hundred and forty-eight cases of germ cell tumor were entered into this study between April, 1986 and August, 1995. They included 99 cases (66.9%) of seminoma and 49 cases (33.1%) of non-seminomatous germ cell tumor (NSGCT). The mean age of seminoma cases (39.7 yrs) was higher than that (30.2 yrs) of NSGCT cases. One hundred and twenty-three cases were treated according to our protocol. In the treatment group, one patient with stage I seminoma died of other diseases and one patient each with stage II and stage III seminoma died of cancer. Three patients with stage III NSGCT died of cancer. The 5-year survival rate was 100% for stage I seminoma, and stage I and stage II NSGCT, 75.0% for stage II seminoma, 0% for stage III seminoma and 66.7% for stage III NSGCT. These findings suggest that new treatment modalities should be introduced into our protocol in the future.

To investigate the efficacy and safety of bicalutamide (Casodex(R)) with its clinically recommended dose, the randomized early phase II study was performed in 124 patients with prostatic cancer (stage C, D). The patients were given 50, 80 or 100 mg of bicalutamide orally once a day in fixed doses for 12 weeks ; 122 patients were eligible for evaluation. The overall response rate was 50.0% (20/40); 61.0% (25/41) and 53.7% (22/41) in the 50 mg, 80 mg and 100 mg groups, respectively. The response rate in prostate lesion, bone and lymph node metastases was slightly higher in the 80 mg group than in the 50 mg and 100 mg groups. The proportion of patients showing a response with regard to serum PSA (CR and PR) was 84.2, 92.7 and 97.6% in the 50, 80 and 100 mg groups, respectively. The incidence of adverse reactions was 65.0, 61.0 and 61.0% in the 50, 80 and 100 mg groups, respectively, and there was no significant difference in overall safety rating in the three groups. Frequent adverse reactions were gynecomastia and breast pain. Only one patient in the 80 ing group was withdrawn due to shortness of breath. Serum concentrations of LH, testosterone and estradiol increased significantly after treatment. Bicalutamide was concluded to be effective and well tolerated in patients with prostatic cancer, and its recommended dose was 80 mg once daily.

A phase I study (open trial) of bicalutamide (Casodex), a non-steroidal antiandrogen, was conducted on 16 patients with prostatic cancer (stage C to D). The patients were given 10, 30, 50, 80 or 100 mg of bicalutamide orally daily for 12 weeks. Adverse reactions were observed in 8 out of 16 patients, but almost all were mild. Breast pain, gynecomastia and hot flushes were observed in 6 patients. Adverse reactions regarding liver function tests were observed in 3 patients. These were increased glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT), alkaliphosphatase (AL-P) or gamma guanosine 5'-triphosphate (gamma-GTP). However, during or after the treatment period the elevated values were reversed to the pretreatment level. In terms of efficacy, anti-tumor effect was observed in 1 or 2 patients at each dose. Serum concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone and estradiol increased during treatment. Plasma concentrations of the R (-) enantiomer, which has antiandrogenic activity, reached the steady state 6-8 weeks after the initiation of treatment; its apparent plasma elimination half-life observed following repeated administration was 8.4 +/- 1.1 days. In conclusion, bicalutamide (10-100 mg od) is considered to be tolerated well enough to be administered to patients with prostatic cancer and has shown evidence of anti-tumor effect.

Screening was performed on 102 patients aged 60 years or older who visited the Outpatient Department of Internal Medicine in Tane General Hospital between June 1994 and May 1995. Of those screened, 36 patients (35.3%) had elevated prostate specific antigen (PSA) values, and 20 of them visited the Urological Department, and underwent digital rectal examination (DRE) and transrectal ultrasonography (TRUS) for further screening. Of the 16 patients who underwent ultrasound guided biopsies of the prostate, 7 patients were found to have prostate cancer. Therefore, the cancer detection rate was 6.9%, which was about 4 times higher than that of mass-screening examinations previously reported in the Japanese literature. These findings suggested that the screening using PSA in outpatients of Internal Medicine may be useful for the early detection of prostate cancer.

The number of cases of prostate carcinoma (PCA) is steadily inceasing in Japan. The clinical application of a reliable tumor marker, prostate specific antigen (PSA) for the diagnosis, as well as the increasing elderly population in Japan may account for this increase. The subjects were patients at the Nara Medical University and its affiliated hospitals; 1) 687 cases without PCA were evaluated for age-specific PSA and the incidence of abnormal PSA following urological manipulations, 2) 135 cases with histological proven BPH by transurethral resection of prostate (TUR-P) were examined for PSA density (PSAD) and positive PSA rate in BPH, 3) 135 cases receiving a needle biopsy with suspicion of PCA were examined for the efficacy of PSA and PSAD and other parameters, and 4) 459 PCA cases treated between 1988 and 1994, were examined for specific PSA and PSAD values by stage and degree of cell differentiation. The PSA assay used in this study was MARKIT-M PA (normal range < or = 3.6 ng/ml). The PSA was decreased gradually with age in non-PCA patients, and abnormal PSA was found in 5.5% of these patients following manipulations. The average PSA was 2.95 +/- 2.03 ng/ml in 130 BPH patients (mean age: 71.1 +/- 7.0 years old. and average prostate volume: 32.9 +/- 16.1 ml). And abnormal PSA level (more than 3.61 ng/ml) was found in 22.3%. The mean PSAD was 0.1.0 +/- 0.06, and PSAD was below 0.15 in 86.1% of these BPH cases. Among the 135 cases receiving a needle biopsy, 33 cases had PSA values between 3.61 and 10.0 ng/ml. Of these cases, PCA was found in 18.5% of the 27 cases with a PSAD below 1.5, and in 33.3% of the 6 cases with a PSAD over 1.5. PSA and PSAD were proportionally increased with stage, and a significant difference in the PSA value was observed between stage B1 and B2, and stage C and D (P < 0.05). However, PSA and PSAD values were not significantly correlated with the cell differentiation in PCA stage A2-C. In total, PSA was 18.1 ng/ml in well, 23.9 ng/ml in mod

Since Kock et al. reported a low pressure continent reservoir using detubularized ileal segment as urinary diversion following cystectomy, continent urinary diversion including neobladder has been focused upon. On the other hand, ureterocutaneostomy, or ileal conduit as an incontinent urinary diversion is still commonly used, and especially the latter form is usually performed in many hospitals. These facts suggest that it is difficult to conclude that continent urinary diversion regarded as an excellent operation with good quality of life (QOL) is a generally acceptable method and that there are still some problems to decide the indication for urinary diversion. We discuss the problems about the postoperative complications and care of urinary diversion after cystectomy and our opinion about the selection of these operations.

A series of 180 patients treated with ileal conduit urinary diversion at Nara Medical University and its affiliated hospitals were reviewed. The patients ages at the time of operation ranged from 21 to 79 years old with an average of 60.9 years old and the average postoperative follow-up period was 44.2 months. Early complications occurred in 60 patients (33.3%) and 9 (5.0%) of them resulted in post-operative deaths. Late complications were noticed in 54 (31.6%) of the 171 patients. Frequent late complications included peristomal dermatitis (37.3%), ureteroileal stenosis (17.9%) and urolithiasis (11.9%), for the latter two of which endourological treatments seemed to be effective. To be emphasized is that more attentive care should be paid to the condition of the peristomal skin during follow-up.