注射用头孢替坦二钠治疗急性细菌性感染的多中心随机对照临床观察

A multiple center randomized controlled clinical study of cefotetan disodium for injection in treatment of patients with acute bacterial infections

目的：评价注射用头孢替坦二钠治疗呼吸系统和泌尿系统急性细菌性感染的临床疗效和安全性。方法：采用单盲、随机、平行对照试验设计,以头孢美唑钠为对照药物。两组均为每次静脉滴注给药1.0～2.0g,bid,疗程均为5～10 d。观察和记录受试者与感染有关的症状和体征变化情况、疗效、细菌清除率和不良事件发生情况。结果：纳入全分析集（FAS）进行安全性分析254例,试验组和对照组分别为126例和128例;纳入符合方案集（PPS）进行疗效分析共251例,试验组和对照组分别为124例和127例;共分离符合FAS的临床致病菌136株。试验组和对照组总临床痊愈率分别为82.54%和84.38%,细菌清除率分别为97.10%（67/69）和98.51%（66/67）,不良反应发生率分别为5.56%（8/144）和6.94%（10/144）,组间均无显著差异（均P〉0.05）。结论：注射用头孢替坦二钠治疗呼吸系统和泌尿系统急性细菌感染,临床疗效明显,安全性较好,与头孢美唑钠相当。

OBJECTIVE To evaluate the efficacy and safety of cefotetan disodium for injection in the treatment of patients with acute bacterial infections of respiratory tract and urinary reproductive tract. METHODS A chnlcal trial by randomlzecl, single-blind, parallel control was conducted. The control drug was cefmetazole. Both groups were administered intravenously at a dose of 1.0- 2. 0 g , bid for 5- 10 d. The infection symptoms and signs of change,curative effects, bacterium clearance rates and adverse events were observed and recorded. RESULTS There were 254 patients in the full analysis set （FAS） for security analysis, 126 cases in the treatment group and 128 cases in the control group respectively; there were 251 patients in the perprotocal set （PPS） for efficacy analysis, 124 cases in the treatment group and 127 cases in the control group respectively; there were 136 strains of pathogenic bacterium separated with FAS clinical analysis. The total recovery rate was 82. 54% and 84. 38%, respectively; the bacterial clearance rate was 97.10 % （67/69） and 98. 51% （66/67） respectively, and the adverse reaction rate was 5.56% （8 / 144） and 6.94% （10 / 144） respectively. There were no significant differences between the two groups （P〉0. 05）. CONCLUSION Cefotetan disodium for injection is effective and safe in the treatment of patients with acute infec- tions of respiratory tract and urinary-reproductive tract, which is equal to cefmetazole.