摘要目的 评价吗啉硝唑联合阑尾切除术治疗化脓性或坏疽性阑尾炎的临床疗效及安全性.方法 采用随机、双盲、多中心、对照研究.选取化脓性和坏疽性阑尾炎共437例受试者,其中对照组219例,试验组218例.对照组给予奥硝唑治疗,试验组给予吗啉硝唑治疗,连续5～7d.评估两组患者用药结束后5～7d的临床疗效、细菌学疗效以及综合疗效,分析两组患者的不良事件及不良反应发生率.结果 用药结束后5～1Od,两组的临床治愈率、厌氧菌清除率以及痊愈率相比差异均无统计学意义(91.6％比91.6％、98.6％比98.1％、96.7％比93.8％,均P＞0.05).共140例受试者发生不良事件,总发生率为32.1％.对照组和试验组不良事件发生率分别为34.7％和29.4％,差异无统计学意义(P＞0.05).共66例受试者发生不良反应,总发生率为15.1％.试验组不良反应发生率低于对照组(11.5％比18.7％,P＜0.05).不良反应发生率前5位为:转氨酶升高、血小板升高、恶心、呕吐和心电图异常.结论 吗啉硝唑联合阑尾切除术治疗化脓性或坏疽性阑尾炎有效,疗效与奥硝唑相当,安全性优于奥硝唑.

abstractsObjective To assess the efficacy and safety of morinidazole combined with appendectomy in treating purulent or gangrenous appendicitis.Methods Double-blind randomized controlled multicenter clinical trial was designed and conducted.Totally 437 patients were included,219 in the control group and 218 in the experimental group.Cases of purulent or gangrenous appendicitis were enrolled and assigned to each of the two groups.The control group received ornidazole injection for 5 to 7 days while the experimental group received morinidazole injection.Both groups underwent appendectomy.Clinical response,micrombiological outcomes,overall response were evaluated.Adverse events and side effects were recorded.Results No significant difference was observed between the two groups regarding the clinical healing rate at 5-10 days after medicine withdrawal,anaerobia clearance and overall healing rates.Adverse events occurred in 140 patients (32.1％).Incidence of adverse events in the control group and the experimental group was 34.7％ and 29.4％,respectively (P ＞ 0.05).The overall incidence of side effects was 15.1％ (66 cases).Side effects were less seen in the experimental group compared with that in the control group (11.5％ vs.18.7％,P ＜ 0.05).The most frequent side effects were aminotransferase rising,thrombocytosis,nausea,vomiting and electrocardiographic abnormality.Conclusions The effect of morinidazole plus operation was comparable with ornidazole in treating purulent or gangrenous appendicitis.The safety of morinidazole is better than ornidazole.