哌拉西林钠/舒巴坦钠与哌拉西林钠/三唑巴坦注射剂随机单盲对照治疗急性细菌性感染的临床评价  

A single-blind randomized clinical trial of piperacillin-sulbactam versus piperacillin-tazobactam in the treatment of acute bacterial infections

作　　者：刘焱斌[1] 吕晓菊[1] 刘凯[1] 杨尧[1] 宗志勇[1] 俞汝佳[1] 卢家秀[1] 

机构地区：[1]四川大学华西医院感染性疾病中心,成都610041

出　　处：《中国抗生素杂志》2005年第4期222-225,232,共5页Chinese Journal of Antibiotics

摘　　要：目的评价国产注射用哌拉西林钠/舒巴坦钠(每支2.5g)治疗中、重度急性细菌性感染的临床疗效与安全性.方法采用单盲、随机对照实验设计,以哌拉西林钠/三唑巴坦(每支2.25g)为对照药.两组的用量、用法、疗程均为2支溶解于生理盐水100ml中,Q8h静脉滴注,疗程5～10d,重症患者可延长至14d.结果本研究共纳入74例,哌拉西林钠/舒巴坦钠组和哌拉西林钠/三唑巴坦组各36例.其中哌拉西林钠/舒巴坦钠组纳入ITT分析36例,PP分析34例,哌拉西林钠/三唑巴坦组纳入ITT分析36例,纳入PP分析35例.疗程结束时哌拉西林钠/舒巴坦钠组和哌拉西林钠/三唑巴坦组的总痊愈率和有效率分别为80.6%与94.4%和75.0%与94.4%,两组细菌清除率分别为96.7%和100%.以上结果两组间比较无显著性差异(P＞0.05).哌拉西林钠/舒巴坦钠组和哌拉西林钠/三唑巴坦组的不良反应发生率分别为16.21%和8.11%,主要表现为皮疹(经对症处理好转)、嗜酸性粒细胞计数一过性增高及轻度转氨酶升高等.结论国产注射用哌拉西林钠/舒巴坦钠治疗中、重度急性细菌性感染的临床疗效确切,安全性较好.Objective To evaluate the clinical efficacy and safety of domestic piperacillin-sulbactam for injection in the treatment of moderate and severe acute bacterial infections. Methods A single-blind randomized clinical trial was conducted to compare the efficacy and safety of piperacillin-sulbactam with that of piperacillin-tazobactam. Piperacillin-sulbactam was administered intravenously at a dose of 5 gram thrice daily for 5 to 10 days. And piperacillin-tazobactam was administered intravenously at a dose of 4.5 gram thrice daily for 5 to 10 days. Results A total of 74 patients were enrolled in the study. There was 36 patients who enrolled in ITT (intention to treat analysis) and 34 in PP (per protocol) in piperacillin-sulbactam group, while 36 patients were enrolled in ITT and 35 patients were eligibled for PP in piperacillin-tazobactam group. At the end of the treatment, the cure rate and effective rate were 80.6% and 94.4% in piperacillin-sulbactam group; while 75.0% and 94.4% in piperacillin-tazobactam group. The bacterial eradication rates were 96.7% and 100.0% respectively. There was no statistical difference between the two groups ( P >0.05).Adverse reactions were observed in 16.21% and 8.11% of patients in the two groups, dominated by skin rash (1/37; 1/37), temporary acidophilia (1/37; 0/37) and mild elevated transaminases (4/37; 2/37). Conclusion Domestic piperacillin-sulbactam for injection is effective and safe for the treatment of moderate and severe acute bacterial infections.

关 键 词：哌拉西林钠/舒巴坦钠 哌拉西林钠/三唑巴坦 急性细菌性感染 随机单盲对照 

分 类 号：R978.1[医药卫生—药品]