Caoili E M, Talley R W, Smith F, Salem P, Vaitkevicius V K
Cancer Chemother Rep. 1975 Nov-Dec;59(6):1117-21.
Two dose schedules of guanazole were used in this phase I clinical study: intermittent prolonged 5-day infusion and intermittent iv bolus twice weekly. Ninety-seven treatment observations were analyzed for toxic effects resulting from the prolonged infusion and 42 from the twice-weekly bolus schedule. The main toxic effect was bone marrow suppressions, the frequency and severity of which were intensified by prior chemotherapy or radiotherapy and repetition of guanazole therapy. The leukocyte count was affected more than the platelet count. Partial responses were observed in four patients: two with lung carcinoma, one with prostate carcinoma, and one with melanoma. Further phase II clinical studies of guanazole are indicated.
在这项I期临床研究中使用了两种胍唑给药方案:间歇性延长5天输注和每周两次间歇性静脉推注。分析了97例延长输注的治疗观察结果以及42例每周两次推注方案的治疗观察结果的毒性作用。主要毒性作用是骨髓抑制,其频率和严重程度因先前的化疗或放疗以及胍唑治疗的重复而加剧。白细胞计数比血小板计数受影响更大。4例患者观察到部分缓解:2例肺癌患者、1例前列腺癌患者和1例黑色素瘤患者。表明需要对胍唑进行进一步的II期临床研究。