Hastings R C, Jacobson R R, Trautman J R
Int J Lepr Other Mycobact Dis. 1976 Jul-Sep;44(3):287-93.
Fifty-one leprosy patients receiving long-term clofazimine have undergone systematic clinical laboratory testing in a search for any toxicity secondary to the drug. In approximately 220 patient-years of observation and in analyzing approximately 40,000 test results, no statistically significant changes in the direction of abnormality have been observed in SGOT, thymol turbidity, serum globulins, uric acid, alkaline phosphatase, white blood cell count or differential, hematocrit, hemoglobin, BUN, serum creatinine, serum cholesterol, serum albumin, serum potassium, serum calcium, stool for occult blood, routine urinalysis, or reticulocyte count. Statistically significant changes toward abnormality were found in fasting blood sugar and total serum bilirubin. These statistically significant changes in the direction of abnormality were of a small magnitude, were not associated with related clinical signs or symptoms, and do not seem to be of major clinical significance. Despite the accumulation of relatively massive amounts of the drug in various tissues, clofazimine appears remarkably free of serious or life-threatening toxicity clinically. Although the skin and gastrointestinal side effects of clofazimine limit its usefulness, on the evidence to date, its advantages outweigh its disadvantages in those leprosy patients for whom it is indicated.
51名接受长期氯法齐明治疗的麻风病患者接受了系统的临床实验室检查，以寻找该药物继发的任何毒性反应。在大约220患者年的观察期内，并分析了约40,000份检测结果，未观察到谷草转氨酶、麝香草酚浊度、血清球蛋白、尿酸、碱性磷酸酶、白细胞计数或分类、血细胞比容、血红蛋白、血尿素氮、血清肌酐、血清胆固醇、血清白蛋白、血清钾、血清钙、大便潜血、尿常规或网织红细胞计数在异常方向上有统计学显著变化。空腹血糖和血清总胆红素出现了向异常方向的统计学显著变化。这些在异常方向上的统计学显著变化幅度较小，与相关临床体征或症状无关，似乎也不具有重大临床意义。尽管该药物在各种组织中积累了相对大量的药物，但氯法齐明在临床上似乎明显没有严重或危及生命的毒性。尽管氯法齐明的皮肤和胃肠道副作用限制了其应用，但就目前的证据而言，在其适用的麻风病患者中，其优点超过了缺点。
