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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 Only one patient in the 80 ing group was withdrawn due to shortness of breath.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.

Congenital ureteral valves have not been a well recognized condition for the cause of ureteral obstruction. In our first case a 21-year-old male presented with left flank pain. Intravenous urography showed left mild hydronephrosis due to upper ureteral obstruction. Partial ureteral resection and re-anastomosis was performed. Histology demonstrated mucosal folds with smooth muscle. In our second case a 12-year-old boy presented with left flank pain. Retrograde pyelogram showed a fold-like filing defect which suggested ureteral valve. Endoscopical valve resection through nephrostomy was performed. Optimal management and diagnostic difficulties were discussed.

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.

We performed enucleation on a patient with renal cell carcinoma associated with nephritis to preserve renal function. The patient was a 40-year-old man diagnosed with chronic nephritis. Ultrasonography performed during brief hospitalization for a check-up revealed a tumor in the left kidney. Enucleation was performed to treat stage 1 renal cell carcinoma. Pathological study revealed that the patient had IgA nephropathy and grade 1 clear cell carcinoma.

器質性インポテンス患者34名に対しAMSハイドロフレックスをインプラントして12週後, 1)満足度:非常に満足, 性交可能16例, 性交可能で満足13例, 性交可能でやや不満2例, 改善なし1例, 不明2例, 2)有用度:極めて有用20例, 有用11例, やや有用1例, 好ましくない1例, 判定不能1例, 3)副作用:海綿体膿瘍で抜去の1例, 平均19.2ヵ月中感染糜爛で抜去2例となった, The AMS Hydroflex penile prosthesis was implanted in 34 organic impotence patients between June 20, 1986 and Aug. 6, 1990. Patients ages ranged between 26 and 71 with an average of 50.5. The causes of impotences were; 17 cases of post-radical pelvic surgery, 7 cases of injury, 6 cases of diabetes and 4 of others. First evaluation was made after 12 weeks of implantation in terms of patient satisfaction with sexual intercourse and post operative complication. Sixteen patients (47.1%) were highly satisfied with intercourse, 13 (38.2%) satisfied with intercourse, 2 (5.9%) slightly dissatisfied even with successful intercourse, 1 (2.9%) with no improvement and 2 (5.9%) could not follow. Utility of the prosthesis, e.g. effectiveness and safety was; high utility in 20 (58.8%), good utility in 11 (32.4%), slight utility in 1 (2.9%), no favorable in 1 (2.9%) and no judgement in 1 (2.9%). The overall effectiveness and safety of the Hydroflex was demonstrated based on the above findings. Long term evaluation was made from the initial implantation of the device up to the termination of the trial with average of 19.2 months and was mentioned altogether.

TAP-144-SRの前立腺癌に対する比較対照試験をリン酸ジエチルスチルベストロールを対照薬として行った.有効性では, 前立腺癌の判定基準の適格例で, TAP群54.5%(36/66), 対照群47.1%(32/68)のPR例が得られ, 両群間に有意差はみられなかった.病巣別効果や自他覚症状に対する効果でも両群間に差はみられなかった.PAPなど腫瘍マーカーに対して対照群の方が有意に優れる効果を示した.内分泌効果では両群とも全例で血清testosteroneがcastration levelに低下した.安全性については, 副作用発現率はTAP群64.1%(41/64)に対し, 対照群は95.4%(62/65)と有意に高く, 対照群で4例が副作用のため試験が中止された.主治医判定による全般安全度では"問題あり"と判定された症例はTAP群6.3%(4/64), 対照群36.9%(24/65)であった.主治医判定による有用度では"有用"以上でみると, TAP群65.6%(42/64), 対照群52.3%(34/65)であった, A randomized controlled phase III clinical trial comparing TAP-144-SR (TAP) and diethylstilbestrol diphosphate was conducted for patients with prostatic cancer. Patients with Stage B, C, or D disease, who were previously untreated, were enrolled. TAP-144-SR 3.75 mg was administered subcutaneously at 4-week intervals for 12 weeks (a total of 3 injections) in the TAP-144-SR group, while 100 mg of diethylstilbestrol diphosphate was administered orally three times a day (before meals) for 12 weeks in the control group. A total of 141 patients were enrolled using a centralized telephone registration system. Four of these patients were ineligible, and there were 3 drop-outs who never received drugs because they withdrew their consents to participate in the trial. These 7 were excluded from the evaluation, and as a result, 134 patients (66 in the TAP group and 68 in the control group) were evaluable in safety and efficacy. Between the two groups, there were no significant differences in patient characteristics, except the age distribution. Clinical response rates (CR+PR) in evaluable patients according to the criteria of Japanese Prostatic Cancer Study Group were 54.5% in the TAP group and 47.1% in the control group. In addition, the rates according to the criteria for Evaluating the Direct Response to Chemotherapy in Solid Carcinomas and NPCP criteria were 7.6% in the TAP group and 8.8% in the control group and 18.2% in the TAP group and 20.6% in the control group, respectively. Using any of the three criteria, there were no significant differences in response rate between the two groups. The incidence of side effects was 64.1% in the TAP group and 95.4% in the control group; the incidence being significantly higher in the control group (p less than 0.001; chi 2-test). Therefore, the overall safety was significantly greater in the TAP group than in the control group (p less than 0.001; chi 2-test). On the basis of the efficacy and safety the clinical usefulness rate of TAP-144-SR was significantly higher than that of diethylstilbestrol diphosphate (p = 0.038; U-test). In conclusion, TAP-144-SR was confirmed to be more useful than diethylstilbestrol diphosphate as a standard drug for hormonal therapy of prostatic cancer.

The value of fine-needle aspiration cytology (FNAC) for the diagnosis of acute rejection in canine allotransplantation was determined. To reduce the surgical stress associated with repeated anesthesia and operations, the contra-lateral kidney was left intact. FANC, open biopsy and peripheral blood sampling were performed on day 0, 3, 5, postoperatively. Cytocentrifuged cell smear was prepared from each FNAC specimen, and stained with Giemsa. Specimen on day 3 had an increased number of mono-nuclear cells mainly composed of monocytes, and plasmacytes appeared, but they were not clearly identified. To exclude the contamination of peripheral blood from the specimen, we established an index, increased infiltrate score, to evaluate the percentage gap between the transplanted kidney and the normal own kidney. This score revealed that some kind of mono-nuclear cells increased on day 3, prior to the appearance of plasmacytes which were usually seen on day 5. On the other hand the specimen from the open renal biopsy on day 3 showed little change. We concluded that the FNAC is valuable in the early diagnosis of acute rejection of canine renal allotransplantation.

A 72-year-old male patient underwent antegrade percutaneous resection of a solitary and papillary tumor in the lower calyx of left kidney. He had undergone right nephroureterectomy one month previously due to right nonfunctioning kidney caused by right ureteral carcinoma. Percutaneous electroresection of the tumor was performed after puncture of a lower calyx. Pathological findings revealed a grade 2 transitional cell carcinoma. Second look biopsy was done on the 11th postoperative day, which showed no residual tumor pathologically. Continuous instillation of mitomycin-C 50 mg/50 ml saline with 40 cm H2O pressure for one hour was done through the nephrostomy catheter once a day, totally 7 days as an adjuvant therapy. No side effect was noticed. Cytological, radiographic studies were negative 24 months after the treatment. We discuss the indication and technical aspect of percutaneous approach to renal pelvic carcinoma.

Balloon dilation of the prostatic urethra was performed for the management of benign prostatic hypertrophy. The patients selected were mainly high risk patients who were poor surgical candidates for transurethral resection of the prostate. Ten patients between 61 and 87 years old with a mean age of 77.8 years were treated. Of the 10 patients 6 had urinary retention. The procedures were performed under spinal anesthesia, using 75 Fr dilation balloon for 10 minutes twice at 3 atmospheres. In a couple of months after treatments, 5 patients showed improvement in both uroflowmetry and clinical symptoms. Three patients revealed improvement of clinical symptoms only and 2 were in vain. One year after treatment, 3 out of 6 patients had persistent improvement. Balloon dilation of prostatic urethra was safe and showed promising effectiveness for high risk patients.

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.

Congenital ureteral valves have not been a well recognized condition for the cause of ureteral obstruction. In our first case a 21-year-old male presented with left flank pain. Intravenous urography showed left mild hydronephrosis due to upper ureteral obstruction. Partial ureteral resection and re-anastomosis was performed. Histology demonstrated mucosal folds with smooth muscle. In our second case a 12-year-old boy presented with left flank pain. Retrograde pyelogram showed a fold-like filing defect which suggested ureteral valve. Endoscopical valve resection through nephrostomy was performed. Optimal management and diagnostic difficulties were discussed.

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.

A 72-year-old male patient underwent antegrade percutaneous resection of a solitary and papillary tumor in the lower calyx of left kidney. He had undergone right nephroureterectomy one month previously due to right nonfunctioning kidney caused by right ureteral carcinoma. Percutaneous electroresection of the tumor was performed after puncture of a lower calyx. Pathological findings revealed a grade 2 transitional cell carcinoma. Second look biopsy was done on the 11th postoperative day, which showed no residual tumor pathologically. Continuous instillation of mitomycin-C 50 mg/50 ml saline with 40 cm H2O pressure for one hour was done through the nephrostomy catheter once a day, totally 7 days as an adjuvant therapy. No side effect was noticed. Cytological, radiographic studies were negative 24 months after the treatment. We discuss the indication and technical aspect of percutaneous approach to renal pelvic carcinoma.

Balloon dilation of the prostatic urethra was performed for the management of benign prostatic hypertrophy. The patients selected were mainly high risk patients who were poor surgical candidates for transurethral resection of the prostate. Ten patients between 61 and 87 years old with a mean age of 77.8 years were treated. Of the 10 patients 6 had urinary retention. The procedures were performed under spinal anesthesia, using 75 Fr dilation balloon for 10 minutes twice at 3 atmospheres. In a couple of months after treatments, 5 patients showed improvement in both uroflowmetry and clinical symptoms. Three patients revealed improvement of clinical symptoms only and 2 were in vain. One year after treatment, 3 out of 6 patients had persistent improvement. Balloon dilation of prostatic urethra was safe and showed promising effectiveness for high risk patients.

The AMS Hydroflex penile prosthesis was implanted in 34 organic impotence patients between June 20, 1986 and Aug. 6, 1990. Patients ages ranged between 26 and 71 with an average of 50.5. The causes of impotences were; 17 cases of post-radical pelvic surgery, 7 cases of injury, 6 cases of diabetes and 4 of others. First evaluation was made after 12 weeks of implantation in terms of patient satisfaction with sexual intercourse and post operative complication. Sixteen patients (47.1%) were highly satisfied with intercourse, 13 (38.2%) satisfied with intercourse, 2 (5.9%) slightly dissatisfied even with successful intercourse, 1 (2.9%) with no improvement and 2 (5.9%) could not follow. Utility of the prosthesis, e.g. effectiveness and safety was; high utility in 20 (58.8%), good utility in 11 (32.4%), slight utility in 1 (2.9%), no favorable in 1 (2.9%) and no judgement in 1 (2.9%). The overall effectiveness and safety of the Hydroflex was demonstrated based on the above findings. Long term evaluation was made from the initial implantation of the device up to the termination of the trial with average of 19.2 months and was mentioned altogether.

We performed enucleation on a patient with renal cell carcinoma associated with nephritis to preserve renal function. The patient was a 40-year-old man diagnosed with chronic nephritis. Ultrasonography performed during brief hospitalization for a check-up revealed a tumor in the left kidney. Enucleation was performed to treat stage 1 renal cell carcinoma. Pathological study revealed that the patient had IgA nephropathy and grade 1 clear cell carcinoma.

A randomized controlled phase III clinical trial comparing TAP-144-SR (TAP) and diethylstilbestrol diphosphate was conducted for patients with prostatic cancer. Patients with Stage B, C, or D disease, who were previously untreated, were enrolled. TAP-144-SR 3.75 mg was administered subcutaneously at 4-week intervals for 12 weeks (a total of 3 injections) in the TAP-144-SR group, while 100 mg of diethylstilbestrol diphosphate was administered orally three times a day (before meals) for 12 weeks in the control group. A total of 141 patients were enrolled using a centralized telephone registration system. Four of these patients were ineligible, and there were 3 drop-outs who never received drugs because they withdrew their consents to participate in the trial. These 7 were excluded from the evaluation, and as a result, 134 patients (66 in the TAP group and 68 in the control group) were evaluable in safety and efficacy. Between the two groups, there were no significant differences in patient characteristics, except the age distribution. Clinical response rates (CR+PR) in evaluable patients according to the criteria of Japanese Prostatic Cancer Study Group were 54.5% in the TAP group and 47.1% in the control group. In addition, the rates according to the criteria for Evaluating the Direct Response to Chemotherapy in Solid Carcinomas and NPCP criteria were 7.6% in the TAP group and 8.8% in the control group and 18.2% in the TAP group and 20.6% in the control group, respectively. Using any of the three criteria, there were no significant differences in response rate between the two groups. The incidence of side effects was 64.1% in the TAP group and 95.4% in the control group; the incidence being significantly higher in the control group (p less than 0.001; chi 2-test). Therefore, the overall safety was significantly greater in the TAP group than in the control group (p less than 0.001; chi 2-test). On the basis of the efficacy and safety the clinical usefulness rate of TA

The value of fine-needle aspiration cytology (FNAC) for the diagnosis of acute rejection in canine allotransplantation was determined. To reduce the surgical stress associated with repeated anesthesia and operations, the contra-lateral kidney was left intact. FANC, open biopsy and peripheral blood sampling were performed on day 0, 3, 5, postoperatively. Cytocentrifuged cell smear was prepared from each FNAC specimen, and stained with Giemsa. Specimen on day 3 had an increased number of mono-nuclear cells mainly composed of monocytes, and plasmacytes appeared, but they were not clearly identified. To exclude the contamination of peripheral blood from the specimen, we established an index, increased infiltrate score, to evaluate the percentage gap between the transplanted kidney and the normal own kidney. This score revealed that some kind of mono-nuclear cells increased on day 3, prior to the appearance of plasmacytes which were usually seen on day 5. On the other hand the specimen from the open renal biopsy on day 3 showed little change. We concluded that the FNAC is valuable in the early diagnosis of acute rejection of canine renal allotransplantation.

TAP-144-SR is a sustained release formulation of an LH-RH agonist, leuprorelin acetate (TAP-144), that has been newly developed in Japan. As a phase I study, a single subcutaneous dose of TAP-144-SR was given to 15 patients with prostatic cancer to investigate the safety, endocrinological effects, and serum levels of the drug. The patients were divided into four groups according to the dosage levels of 1.88 mg, 3.75mg, 7.5 mg and 15 mg. No serious side effects were noted in any of the patients treated with any dose. No patients exhibited signs of a local reaction at the site of injection. In two patients transient exacerbation of clinical symptoms owing to "flare up" was observed. Serum testosterone levels decreased to the castration level (less than 1.0 ng/ml) in all of the patients, although the time required to attain the castration level tended to be longer in the patients receiving 1.88 mg. Serum TAP-144 levels increased on the first day and gradually decreased thereafter. In the groups of patients that received 3.75 mg or more of TAP-144-SR, TAP-144 was detected in the serum up to 4 weeks after administration. Based on the results of the phase I study, 3.75 mg and 7.5 mg of TAP-144-SR were selected as the doses for the phase II study. The phase II study was carried out as a multi-center open trial. Patients with stage B-D prostatic cancer received subcutaneously either 3.75 mg (3.75 mg group) or 7.5 mg (7.5 mg group) of TAP-144-SR once every 4 weeks for a total of 3 doses over a period of 12 weeks. TAP-144-SR 3.75 mg was administered to 51 patients and 7.5 mg to 50 patients. Both of these doses were adequate to suppress serum LH and FSH levels. Serum testosterone was decreased to the castration level within 22 days after the first dose, and this suppression was maintained throughout the treatment period. Clinical response rate (CR + PR) was 21% in the 3.75 mg group and 22-24% in the 7.5 mg group according to the Criteria for Evaluating the Direct Response to C

We report the results and complications of 103 consecutive patients who underwent percutaneous removal of renal and ureteral stones. The overall clinical success rate was 80.6%. For the recent 33 cases in which UL-arm fluoroscopy was used, however, the success rate was as high as 87.9%, which was considered to be due to easier establishment of percutaneous direct access. The most common complications were bleeding (18.5%), extravasation (15.5%) and fever (9.7%). Four cases with significant bleeding required arteriography, but there were no sign of arteriovenous fistula nor pseudoaneurysms in any cases. To study renal parenchymal damage in the percutaneous procedures, plasma renin activities (PRA) were compared in 54 cases after six months. However, significant elevation of PRA did not occur in any case.