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We have re-evaluated the usefulness of the inflammation markers in the "essential laboratory tests" advocated by Japan Society of Clinical Pathology and analyzed for efficacious selection of these items by applying these tests to 349 new outpatients visited Comprehensive Medicine, National Defense Medical College. Among the patients with "tentative initial diagnoses" of infectious or inflammation-related diseases (133 cases), the diagnoses were confirmed in 102 patients by positive inflammation marker(s), whereas additional 22 cases with the diagnoses other than inflammation-related diseases were found to be in the inflammatory status by these tests. Elevated C-reactive protein (CRP) levels were not correlated with the leukocyte number, however, neutrophilia (neutro. > 70%) and/or left shift of the neutrophils (stab > 15%) were demonstrated in approximately 50% of the patients with elevated serum CRP levels. Increases of serum sialic acid highly accompanied with increases of CRP, alpha 1 or alpha 2 fraction of serum protein and elevation of erythrocyte sedimentation rate (ESR), indicating that serum sialic acid levels reflected more strictly inflammatory status than ESR. There is a relatively good correlation (r = 0.813) between serum sialic acid values and the total amounts of alpha 1 and alpha 2 protein fraction, while poor correlations were shown between CRP and sialic acid values (r = 0.606), or ESR and sialic acid values (r = 0.671). These results indicate that (1) simultaneous measurements of CRP, leukocyte number and leukocyte differential fraction are useful for the confirmation of early stage of inflammation and evaluation of the nature of infectious diseases; (2) measurement of serum sialic acid levels is more desirable for the evaluation of inflammatory status than ESR; and (3) serum protein profile can be substituted by sialic acid for the evaluation of acute inflammatory status alone.

We have explored the efficacious laboratory test system to be performed before the first medical contact with a physician on the basis of the patient's chief complaints and their abnormalities of the "essential laboratory tests" advocated by the Japan Society of Clinical Pathology by analyzing 2,625 complaints from 2,175 new patients visited the outpatient unit of Comprehensive Medicine, National Defense Medical College. The patients with complaints such as general fatigue, fever of unknown origin or reno-urinary symptoms showed higher abnormalities of these diagnostic tests than those in 750 patients performed these tests irrespective of the patient's chief complaints. However, complaints originated from neurological, gastro-intestinal, cardiovascular or respiratory diseases were not associated with abnormalities of these laboratory tests in the patients as compared to those in 750 patients mentioned above. These results indicate that (1) clinical usefulness of the "essential laboratory tests" are variable depending on the patients chief complaints and these tests are recommended for the patients with complaints such as general fatigue, fever of unknown origin or reno-urinary symptoms as pre-clinical ambulatory screening tests before history taking and physical examination to enable to make accurate initial diagnosis and subsequent efficacious medical approach and (2) test items should be selected depending on the patient's chief complaints.

The "essential laboratory tests" were applied to 1,026 new patients visiting the outpatient unit of Comprehensive Medicine, National Defense Medical College, to determine the usefulness of these tests in primary care medicine. The "essential laboratory tests" have contributed to the establishment of the initial diagnosis or confirmation of the "tentative initial diagnosis", and to the estimation of the nature or degree of seriousness of the disease. In addition, other diseases not related to the patient's chief complaint could be screened in 32% of the new patients examined with these tests. The "essential laboratory tests" were also found to be useful for the estimation of the presence of malignant tumors in 12 patients with various kinds of malignancies as well as the estimation or evaluation for such conditions as infection or inflammation, anemia, liver or renal dysfunction, and the ambulatory screening of metabolic diseases including hyperlipidemia, liver or urinary tract diseases. In conclusion, simultaneous performance of the "essential laboratory tests" with the history taking and the physical examination will provide important medical information in primary care medicine.

We evaluated diagnostic utility of the hematological, biochemical and serological tests comprised in the "essential laboratory tests" advocated by the Japan Society of Clinical Pathology in 1,026 new patients visiting the outpatient unit of Comprehensive Medicine, National Defense Medical College. Of 750 evaluable patients, 52 showed anemia associated with such conditions as ulcer or cancer of digestive tract, inflammatory disease, or renal failure. Leukocytosis (greater than 9,000/microliters) was found only in 25 of 112 CRP-positive (greater than 0.3 mg/dl) patients, suggesting bacterial infection. Forty-four patients showed hypoproteinemia and/or hypoalbuminemia indicating chronic conditions including liver and inflammatory disease. Elevation of serum creatinine level was found in 4 patients subsequently diagnosed with renal failure, whereas 32 patients demonstrated elevated BUN. After application of the "essential laboratory tests", 97 patients were diagnosed with hyperlipidemia (total cholesterol greater than 230 mg/dl and/or triglyceride greater than 250 mg/dl). Determination of serum enzyme activity was useful not only for the diagnosis of liver dysfunction or biliary tract disease but also for those of hematological malignancies or myogenic disorders; however, in patients with abnormal values of LDH, gamma-GT and ALP, clinical significance was not clarified in 53%, 38% and 59%, respectively. These results indicate that the "essential laboratory tests" are useful in the following aspects of primary care medicine: for (1) estimation of the degree or nature of infection or inflammatory status; (2) classification of anemia and its relation to underlying diseases; (3) evaluation of patient general condition and protein-producible function of liver; (4) evaluation of renal function; (5) ambulatory screening for metabolic diseases such as hyperlipidemia; and (6) diagnosis of liver and biliary tract diseases.

"Essential laboratory tests" advocated by Japan Society of Clinical Pathology were simultaneously performed with the history taking of the present illness and the physical examination in 1,026 new patients visited the outpatient unit of Comprehensive Medicine, National Defense Medical College. We have analyzed the usefulness of the "essential laboratory tests" for the establishment of the initial diagnosis in evaluable 750 patients by comparing the diagnosis made only by the history taking and the physical examination (tentative initial diagnosis) with that included the results of these laboratory tests. The "essential laboratory tests" had contributed to remarkably increased incidences of metabolic and endocrine diseases, liver or biliary tract diseases, renal and urinary tract diseases and anemia after the application of these tests. The initial diagnoses of 61 patients were successfully established by the addition of the "essential laboratory tests" among 157 cases of which tentative initial diagnoses remained undetermined. These tests confirmed the tentative diagnoses in 78 patients, while 78 tentative diagnoses were negated and corrected after evaluation of the results of these tests. Furthermore, the diagnostic tests such as CRP and leukocyte count were useful for the estimation of the nature or degree of seriousness of the disease in 57 patients. In addition, other diseases not related to the patient's chief complaint could be detected in 238 patients (303 total number of diseases) by these tests. These results indicate the usefulness of the "essential laboratory tests" not only for the establishment of more accurate initial diagnosis but also for the screening of the "hidden" diseases such as hyperlipidemia and liver dysfunction.

Japan Society of Clinical Pathology has formed a committee dealing with "lab. tests in primary care medicine". As the first step, they made "Essential Lab. Tests" which were composed of simple qualitative bed-side tests such as urinalysis, Complete blood count (CBC: Hb, Ht, WBC, RBC), CRP, or ESR (Erythrocyte sedimental rate), A/G ratio and biochemical tests if necessary (Table 1). We have performed "Essential Lab. Tests" on 1,026 outpatients who visited General Medicine Clinic for the first time. They consisted of 456 male (age 13-81), and 526 female (age 10-85). This report is the result of urinalysis from "Essential Lab. Tests" of 1,026 patients. 1) The result showed that overall positivity of the urinalysis was 21.3% (when more than one item of the qualitative tests was positive). 2) There was distinctive difference in the positivity of the urinalysis between the sex; i.e. protein and glucose were about twice frequently positive in male, where as occult blood and WBC (Esterase reaction) were 2-3 times more positive in female. 3) Urine protein shows positive in the individual 10-20 yrs old and more than 50 yrs old in both sexes. 4) Glucose was positive in over 40 yrs in male, and occult blood, 40-50 yrs or older in male. 5) WBC shows positive in all age groups in female and 50 yrs or older in male. 6) Positive WBC patients did not necessarily reflect urinary infection in female but nitrites roughly corresponded with urinary WBC in male of 50 yrs or older, meaning probable urinary infection associated with prostatic hypertrophy. 7) Abnormality of urinary sediment corresponded to the positive occult blood and WBC Erastase. 8) Urinalysis is an useful method of screening in primary care medicine.

We performed phase I study of FK 435, a new antiestrogen, in 30 patients with advanced breast cancer. Slight to moderate adverse reactions were noted as follows. Single-dose study: anorexia, nausea, lassitude in one patient (80 mg), decreased serum calcium in one (160 mg), redness, tenderness in one, facial flushing, hot flushes, headache in one (320 mg). Repeated-dose study: anorexia, nausea in one patient (40 mg/day), anorexia, diarrhea, increased FSH in one, increased PRL in one (80 mg/day). FK 435 was well tolerated. Tmax was 3-5 hours, T1/2 about 25 hours. Most of FK 435 was excreted into urine as glucuronide.