摘要
目的：采用Meta分析方法对奥硝唑注射液静脉给药的不良反应进行系统分析,为奥硝唑注射液临床合理应用和上市后再评价提供参考。方法：计算机检索中文数据库CNKI、VIP、CMCI、Sino Med、万方数据库以及外文数据库Pub Med,Cochrane library、Ovid SP从建库至2014年12月31日公开发表的有关奥硝唑注射液静脉给药不良反应临床研究文献。根据纳入和排除标准提取资料,采用Rev Man 5.2软件,对奥硝唑注射液不良反应发生率按照剂量、疗程和对照药物不同进行Meta亚组分析。结果：符合标准并纳入Meta分析的文献共有18篇。Meta亚组分析结果显示：低剂量（〈500 mg）、高剂量（≥500 mg）、短疗程（≤5）、长疗程（〉5）、与甲硝唑和替硝唑比较,奥硝唑注射液不良反应发生率均低于对照组（P〈0.01）,OR（95%CI）分别为0.32[0.15,0.65]、0.41[0.30,0.58]、0.37[0.24,0.58]、0.41[0.27,0.63]、0.38[0.25,0.59]、0.41[0.26,0.62];且在剂量为250~1 000 mg,疗程为2~10 d范围内,奥硝唑注射液的不良反应发生率并未随剂量增加和疗程延长而上升。结论：奥硝唑注射液静脉注射治疗口腔厌氧菌感染及妇科厌氧菌感染性疾病,临床不良反应发生率低于甲硝唑、替硝唑;当剂量控制在1 000 mg以下及用药疗程控制在10 d内时,可表现出良好的安全性。
Objective：To evaluate the clinical safety of omidazole injection using Meta-analysis and to provide ref- erence for post-market evaluation and clinical application of omidazole injection. Methods： TriMs were identified through a computerized literature search of CNKI, VIP, CMCI, SinoMed, Wangfang, PubMed, Cechrane library and OvidSP data- bases according to inclusion and exclusion criteria. Meta-analysis was performed by the statistical software RevMan 5.2. The adverse drug reactions （ADR） of omidazole injection was analyzed by Meta subgroups according to the dosage, the course of treatment and the control drug. Results： A total of 18 studies were included. Meta subgroup analysis showed： low dose （ 〈 500 mg）, high dose（ ≥500 mg）, short course （ ≤5 d）, long course （ 〉 5 d）, and compared to metronidazole or tinidazole, the ADRs of omidazole injection was significantly lower than that of the control group（ P 〈0.01 ）, the odds ratio （OR） （ 95% CI ） were 0.32[0.15,0.65],0.41 [0.30, 0.58],0.37[0.24,0.58], 0.41 [0.27, 0.63],0,38 [0.25, 0.59], 0.41 [0.26, 0.62] ） respectively. In addition, the ADR rate of omidazole injection did not increase with the dose and duration increase at a dose of 250-1 000 mg and a course of 2-10 days. Conclusion：The ADR of oruidazole in- jection were significantly lower than the commonly used clinical drugs for anaerobic bacteria infection such as metron- idazole, tinidazole in the treatment of oral anaerobic bacteria infection and gynecology anaerobic bacteria infection diseases. It can show a good safety in the dosage below 1 000 mg or the medication within 10 days.
出处
《药物流行病学杂志》
CAS
2015年第12期725-729,共5页
Chinese Journal of Pharmacoepidemiology
