国产注射用两性霉素B脂质体治疗深部真菌病的疗效与安全性的临床研究  

Liposomal Amphotericin B in Treating Deep Fungal Infections: A Clinical Study on the Efficacy and Safety

作　　者：殷凯生[1] 王彤[1] 廖万清[2] 洪微[2] 尹有宽[3] 章婉琴[3] 诸葛传德[4] 许蓓[4] 

机构地区：[1]南京医科大学第一附属医院,江苏南京210029 [2]第二军医大学附属长征医院,上海200003 [3]复旦大学华山医院,上海200040 [4]上海第二医科大学附属瑞金医院,上海200025

出　　处：《中华医院感染学杂志》2004年第8期850-854,共5页Chinese Journal of Nosocomiology

摘　　要：目的　评价南京药物研究所和上海先药业有限公司联合研制的新药两性霉素B脂质体 (锋克松 )注射剂 ,治疗深部真菌的临床疗效和安全性。方法　采用多中心开放阳性药随机平行对照的研究方法 ;实际入选深部真菌感染患者 116例 ,其中包括试验 (T)组 30例 (给予两性霉素B脂质体注射剂 ) ,对照 (B)组 31例 (给予两性霉素B注射剂 ) ,开放试验 (O)组 5 5例 (给予两性霉素B脂质体注射剂 )。结果　T组的痊愈率为 6 3 3% ,有效率为96 7% ,B组痊愈率为 5 0 0 % ,有效率为 86 7% ,两组差异无显著性 (P >0 0 5 ) ;中枢神经系统真菌患者中 ,T组意识障碍消失平均时间 (7 75± 2 0 6 )d ,比B组 (2 1 6 7± 10 4 1)d短 (P <0 0 5 ) ;T组和B组真菌清除率分别为93 3%和 93 5 % ,两性霉素B脂质体对临床分离出的 112株真菌的MIC50 为 0 5mg/L ,MIC90 为 1mg/L ,两性霉素B的MIC50 和MIC90 分别为 0 5mg/L和 2mg/L ;T组不良反应发生率 (6 0 0 % )显著低于B组 (83 9% ,P =0 0 5 )。结论　两性霉素B脂质体治疗深部真菌病的疗效与两性霉素B相似 ,其不良反应发生率低于两性霉素B。OBJECTIVE To evaluate the efficacy and safety of liposomal amphotericin B(LAB) in treating deep fungul infections. METHODS In this multicenter, randomized comparative open study, 30 patients (T group) and 55 patients (O group) were given liposomal amphotericin B intrevenously, 31 patients (B group) were given amphotericin B intravenously. RESULTS The cure rate (T group vs B group) was 63.3% vs 50.0%, the effective rate (T group vs B group) were 96.7% vs 86.7%, respectively, there was no ststistically significant difference between the two groups; in patients with central nervous system fungal infections; MIC 50 and MIC 90 of T group were 0.5mg/L and 1mg/L, and that of B group were 0.5mg/L and 2mg/L, respectivelly; the rate of adverse effect in T group(60.0%) was lower than that of B group. CONCLUSIONS The clinical efficacy of liposomal amphotericin B is as good as that of amphotericin B, the adverse reaction rate of liposomal amphotericin B is lower than that of amphotericin B.

关 键 词：两性霉素B 脂质体 真菌 感染 治疗 

分 类 号：R978.1[医药卫生—药品]