目的 对奥硝唑注射剂上市后临床应用情况进行集中监测,探讨其上市后在广泛人群使用中的真实世界情况,为规范和指导临床合理用药、完善使用说明书和使用方案提供依据。方法 采用前瞻性、多中心、大样本医院集中监测的方法,选取湖北省省内5家哨点医院,观察2015年7月1日~2015年10月31日入院并使用奥硝唑注射剂的住院患者为研究对象,记录患者的基本情况、药品使用和不良反应发生情况,并进行数据统计分析。结果 共观察病例4 396份,用药人群以中老年女性居多,主要用于手术前预防感染和手术后厌氧菌感染的治疗、腹部感染及盆腔感染治疗。临床使用中存在不合理用药现象,主要表现在给药频次不合理、滴速过快和使用疗程过长。监测期内共收集11例发生不良反应,药品不良反应发生率为 2.5‰,不良反应多在用药30 min内发生。结论 奥硝唑注射液的使用相对安全,不良反应发生率较低。建议生产厂家应进行滴速和质量标准相关研究,进一步完善说明书信息、规范临床使用。
Abstract
OBJECTIVE To investigate the clinical use of ornidazole injection in a wide patient population by the post-marketing hospital centralized monitoring method in order to regulate and guide its rational use, improve the drug specification, and provide a basis for the drug therapy. METHODS A prospective, multi-center, large sample hospital centralized monitoring method was adopted. Five sentinel hospitals in Hubei Province were selected, and hospitalized patients who received ornidazole injection treatment from July 1, 2015 to October 31, 2015 were observed. The basic information of the patients was recorded, as well as the drug use and adverse events, and then statistical analysis was made. RESULTS A total of 4396 cases were enrolled in this study, most of them were middle-aged female patients. Ornidazole injection was mainly used before surgeries to prevent infections and after surgeries for treatment of anaerobic infections, abdominal infections and pelvic infections. Irrational drug use existed in clinic, mainly concentrating at unreasonable dosing frequency, excessive dripping speed, and long duration of use. Eleven cases of adverse reactions were collected during the monitoring, indicating an incidence of adverse drug reactions of 2.5‰, and most of the adverse drug reactions occurred within 30 min post drug administration. CONCLUSION The manufacturers should make further investigation on the dripping speed and quality standard of ornidazole injection to further improve the information in the package insert and regulate the clinical use.
关键词
奥硝唑注射剂 /
医院集中监测 /
上市后再评价 /
临床应用 /
不良反应
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Key words
ornidazole injection /
hospital centralized monitoring /
post-marketing reassessment /
clinical use /
adverse reaction
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中图分类号：
R969.3
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参考文献
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