摘要
目的评价左奥硝唑氯化钠注射液治疗口腔厌氧菌感染的安全性及疗效。方法采用多中心、随机、双盲、平行对照临床试验设计。试验样本共计132例,其中66例对照组,66例试验组。对照组静脉滴注奥硝唑氯化钠注射液,试验组静脉滴注左奥硝唑氯化钠注射液,给药剂量均为0.5 g,每日2次,3~5 d为一疗程。比较两组患者用药后的临床疗效、细菌学疗效、综合疗效和不良反应发生率。结果疗程结束时,试验组临床治愈率为95.45%（63/66）,对照组为93.94%（62/66）,两组比较差异无统计学意义（P〉0.05）;试验组厌氧菌细菌清除率为95.45%（21/22）,对照组为96.00%（24/25）,两组比较差异无统计学意义（P〉0.05）;综合疗效试验组痊愈率为95.45%（21/22）,对照组痊愈率为92.00%（23/25）,两组比较差异无统计学意义（P〉0.05）;试验组不良反应发生率为0（0/66）,对照组为15.15%（10/66）,两组比较差异有统计学意义（P〈0.05）。结论左奥硝唑氯化钠注射液治疗厌氧菌性口腔感染疗效确切,安全性明显优于奥硝唑氯化钠注射液,有较高的临床应用价值。
Objective To evaluate the clinical safety and efficacy of levornidazole and sodium chloride injection in treatment of oral anaerobic infection. Methods A multicenter randomized controlled double-blind trial was designed. One hundred and thirty-two patients with oral anaerobic infection were classified into two groups： 66 cases treated by levornidazole in the study group and the other 66 cases treated by Ornidazole in the control group. Patients in both groups were administered at a dose of 0. 5 g twice daily for 3-5 days. The rate of clinical efficacy,bacteria clearance,comprehensive curtive effect and adverse effect were recorded and compared between these two groups. Results At the endpoint,the rates of clinical efficacy were 95. 45%（ 63 /66） in the study group and 93. 94%（ 62 /66）in the control group,which did not reach significant difference（ P〉0. 05）. The rates of bacteria clearance were 95. 45%（ 21 /22） in the study group and 96. 00%（ 24 /25） in the control group,with no significant difference（ P〉0. 05）. The rates of comprehensive curtive efficacy were 95. 45%（ 21 /22） in the study group and 92. 00%（ 23 /25） in the control group（ P〉0. 05）. The rates of adverse reaction were zero（ 0 /66） in the study group,which was significantly lower than 15. 15%（ 10 /66） in the study group（ P〈0. 05）.Conclusions It is effective and safe to treat oral anaerobic infections with levornidazole and sodium chloride injection,which shows higher clinical application value.
出处
《安徽医药》
CAS
2015年第11期2179-2182,共4页
Anhui Medical and Pharmaceutical Journal
基金
国家科技重大专项基金项目(No 2008ZX09101-101)
关键词
左奥硝唑
奥硝唑
口腔
厌氧菌感染
随机对照试验
levornidazole
ornidazole
oral infection
anaerobic infection
multicenter study
