注射用头孢美唑钠预防术后感染及治疗普外科感染的有效性与安全性评价  

The clinical efficacy and safety of intravenous cefmetazon for prevention of postoperative infections and treatment of infections in general surgery

作　　者：钟林[1] 裘正军[1] 陈国庆[1] 徐军明[1] 孙星[1] 邢同海[1] 王兆文[1] 樊军为 王书云[1] 黄力[1] 张金彦[1] 彭志海[1] 

机构地区：[1]上海交通大学附属第一人民医院普外科,200080

出　　处：《中华普通外科杂志》2012年第4期295-298,共4页Chinese Journal of General Surgery

摘　　要：目的评估注射用头孢美唑钠预防术后感染及治疗普外科感染的安全性与有效性。方法采用多中心、前瞻性、开放性临床研究。清洁污染手术患者入组1700例进行预防性研究，术前半小时给予注射用头孢美唑钠1g（静注或静滴），术后给药1g、2次／d，连续3d，根据症状体征及病原菌检查结果进行疗效判定；治疗性研究中，门急诊或住院诊断为腹膜炎、胆囊炎及胆管炎的患者897例，根据感染的程度，给予注射用头孢美唑钠2g，2次／d（静注或静滴），总疗程7～14d。治疗结束后进行临床症状和细菌学疗效评价。结果预防研究入选的1700例患者中，有251例由于不符合入选标准等原因不能进行临床疗效分析，最终符合方案的临床疗效可评价病例为1449例，100％的患者预防有效。治疗性研究入选的897例患者中，有110例由于不符合入选标准等原因不能进行临床疗效分析，最终符合方案的临床疗效可评价病例为787例，90．7％（714／787）的患者临床治疗有效；治疗前在50例患者的血液中检出各种细菌，治疗后46例（92．0％）细菌完全消失。预防性研究中有22例（1．3％，22／1700）、治疗性研究中有11例（1．2％，11／897）患者发生不良反应，主要是轻度恶心、呕吐等。结论注射用头孢美唑钠预防术后感染及治疗普外科感染有效率高，而且是安全的。Objective To evaluate the clinical efficiency and safety of cefmetazon in the prevention and or treatment of infections in general surgery. Methods A multicenter, prospective and open-labeled trial was conducted. In the prevention group, 1700 patients were enrolled in clean-infection surgery, cefmetazon was given 1 g iv half an hour before the surgery started, and 1 g iv twice daily after the surgery for 3 days. Clinical response was evaluated in terms of both cure （ disappearance of pre treatment symptoms） and pathogen. In the treatment group, 897 patients were diagnosed as peritonitis, eholecystitis and cholangitis, the patients were given cefmetazon 2 g iv twice a day for 7 - 14 days, clinical response and microbiological efficacy were assessed. Results In prophylactic group, 1449 patients were finally included. The clinical efficacy was 100% （1449/1449）. In the treatment group, a total of 897 patients were enrolled, and 110 patients failed for assessment of clinical efficacy, 787 patients were included in the PPS population, the clinical efficacy was 90. 7% （714/787）; Bacterial eradication rate was 92% （46/50）. Adverse reaction rates in prevention group and treatment group were 1.3% （22/1700） and 1.2% （11/897）, including mild nausea and vomitting. Conclusions Cefmetazon is effective and safe in prevention and treatment of postoperative infections in general surgery.

关 键 词：头孢美唑 抗生素预防 细菌感染 治疗效果 

分 类 号：R619[医药卫生—外科学]