盐酸纳美芬注射液治疗麻醉术后阿片类不良反应的 有效性和安全性Meta分析

摘要/Abstract

摘要： 目的：系统评估盐酸纳美芬注射液治疗麻醉术后阿片类药物不良反应的有效性和安全性。方法：检索PubMed 、EMbase、Cochrane library、中国知网、中国生物医学文摘数据库、维普数据库和万方数据库，纳入盐酸纳美芬注射液治疗阿片类不良反应的随机对照试验（RCTs），检索时限均为建库始至2021年4月30日止。试验组给予盐酸纳美芬注射液处置，对照组给予纳洛酮注射液处置。用R的Meta包对呼吸抑制、意识障碍和安全性相关指标进行Meta分析。结果：最终纳入14篇文献，共1 071例麻醉术后阿片镇痛患者。Meta分析结果表明：盐酸纳美芬注射液用于治疗阿片类不良反应在呼吸抑制[拔管时间(MD=-1.58，95% CI=-2.26~-0.90，P<0.001)，呼吸恢复时间(MD=-1.89，95% CI=-3.10~-0.71，P=0.002)]和意识障碍[睁眼时间(MD=-0.78，95% CI=-1.10~-0.46，P<0.001)，指令恢复时间(MD=-0.49，95% CI=-0.80~-0.17，P=0.002)，术后MMSE(MD=1.55，95% CI=0.74~2.36，P<0.001)]方面显著优于纳洛酮组。结论：盐酸纳美芬注射液改善阿片类药物导致的呼吸抑制和意识障碍等相关指标优于纳洛酮注射液，发生药品不良反应两者相当。

关键词: font-size:medium, ">阿片受体拮抗剂；盐酸纳美芬；盐酸纳洛酮；Meta分析；有效性；安全性

Abstract: Objective：To investigate the efficacy and safety of nalmefene hydrochloride injection in the treatment of adverse reactions of opioids after anesthesia. Methods：We searched PubMed，Embase，The Cochrane Library，CNKI，China biomedical abstracts database，VIP database and Wanfang database for retrieving randomized controlled clinical trials (RCT) about nalmefene hydrochloride injection in the treatment of adverse opioid reactions before April 2021. The experimental group was treated with nalmefene hydrochloride injection，and the control group was treated with Naloxone Hydrochloride Injection. Using the “meta” package of R language to conduct a meta-analysis of the indicators related to respiratory depression, disturbance of consciousness, and safety. Results：Fourteen RCTs were included finally having 1071 patients with opioid analgesia after anesthesia. Meta-analysis results showed that nalmefene hydrochloride injection used to treat opioid adverse reactions in respiratory depression [Extubation Time (MD=-1.58, 95% CI =-2.26 to -0.90, P<0.001), Respiratory Recovery Time (MD=-1.89, 95% CI=-3.10~-0.71, P=0.002)] and disturbance of consciousness [Eye-Opening Time (MD=-0.78, 95% CI=-1.10~-0.46, P<0.001), Command Recovery Time (MD=-0.49, 95% CI=-0.80~-0.17, P=0.002), postoperative MMSE (MD=1.55, 95% CI=0.74~2.36, P<0.001) was significantly better than naloxone Group. Conclusion：Nalmefene hydrochloride injection was better than naloxone injection in improving the respiratory depression and consciousness disturbance caused by opioid drugs, and the adverse effects of the drugs are equivalent.

Key words: Opioid receptor antagonist, Nalmefene hydrochloride injection, Naloxone Hydrochloride Injection, Meta-analysis, Effectiveness, Safety

中图分类号:

邱萍, 杨萍, 丁庆明, 王怡恒, 冯婉玉. 盐酸纳美芬注射液治疗麻醉术后阿片类不良反应的有效性和安全性Meta分析[J]. 中国药物评价, 2022, 39(3): 267-274.

QIU Ping, YANG Ping, DING Qing-ming, WANG Yi-heng, FENG Wan-yu. Meta-analysis of the Efficacy and Safety of Nalmefene Hydrochloride Injection in the Treatment of Adverse Reactions to Opioids after Anesthesia[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2022, 39(3): 267-274.

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