摘要
以３６例恶性肿瘤患者为观察对象，对国产一类抗癌新药盐酸博安霉素进行了Ｉ期临床研究。结果表明，主要毒副作用为发热、消化道反应、注射局部硬结，个别患者出现肌肉关节疼痛、皮疹、脱发。未见骨髓抑制作用，对心功能无影响，对肝、肾、肺功能影响较小，但可加重肾功能异常以及肺疾患、肺功能不全患者的肾、肺损伤。提出了Ⅱ期临床试用剂量，同时对６例患者进行了药代动力学研究。
From August 1993 to March 1994,36 patients were enrolled for a phase l study of Boanmycin(Bleomycin A6)a new anticancer drug to determine it toxicity and maximal dose.Of the 36 cases,16 were male and 20 female,age 20一62.Dose escalation was performed ifa minimum of threed patients were fully evaluable for toxicity(2 weeks following drug ad-ministration)and if severe or life-threatening toxicity had not occurred. Dose of Boanmycinwere escalated from 1 mg(0.5一0.7mg/m2)to 12mg(6.7一7.5mg/m2)i.m.three times ev-ery week for two weeks. Surveillance of serum concentration of Boanmycin was conducted insix cases by microbiological analysis, and the pharmacokinetics parameters were obtained.Phase l study of BOanmycin showed that Boanmycin had no myelosuppression and car-diac toxicity,and its major adverse reactions were fever,gastrointestinal reactions and hard-ening at injection(by i.m,route).Rather than dose-related,fever was individual-related.There were mild myalgia,alopecia, skin rash, pigmentation in some patients. All adversereactions resolved after discontinuation of therapy,There was no Boanmycin-related lethalcomplication,and the maximum tolerated dose was not obtainable. If patients have renal orlung disease,Boanmycin aggravate their renal and lung functions; Therefore we recommendthat dose of Boanmycin for phase Ⅱ clinical trial should be is 8一10mg(5一6mg/m2)i m or iv(iv can decrease local side effect)two-three times per week.
出处
《中国医学科学院学报》
CAS
CSCD
北大核心
1996年第2期143-146,共4页
Acta Academiae Medicinae Sinicae
关键词
博安霉素
Ⅰ期临床研究
药代动力学
boanmycin
bleomycin
pingyanmycin
phase I clinical study
pharmacokinetics
