目的 系統(tǒng)評價棗仁安神膠囊與苯二氮類藥物對失眠癥的臨床療效及安全性。方法 檢索Pubmed、the Cochrane Library、中國生物醫(yī)學文獻數(shù)據(jù)庫（CBM）、中國學術期刊全文數(shù)據(jù)庫（CNKI）、維普中文期刊全文數(shù)據(jù)庫（VIP）和萬方數(shù)據(jù)庫中關于棗仁安神膠囊治療失眠癥的研究，檢索時間自建庫至2019年12月。根據(jù)納入排除標準篩選出符合條件的隨機對照試驗（RCTs），采用RevMan 5.0及Stata 12.0軟件進行Meta-分析。結果 共納入13篇RCTs，共計1 169例。Meta-分析結果顯示棗仁安神膠囊與苯二氮類藥物治療失眠癥的臨床總有效率組間差異不具有統(tǒng)計學意義［RR=1.01，95%CI（0.96，1.07），P=0.669］；棗仁安神膠囊相比于苯二氮類藥物可顯著降低失眠癥患者不良反應的發(fā)生風險，差異具有統(tǒng)計學意義［RR=0.19，95%CI（0.14，0.25），P=0.000］。結論 應用棗仁安神膠囊與苯二氮類藥物治療失眠癥的臨床療效相似，而棗仁安神膠囊可明顯降低不良反應的發(fā)生風險。

Objective To evaluate the difference of the efficacy and safety between Zaorenanshen Capsule and benzodiazepines in the treatment of insomnia. Methods Databases including Cochrane Library, PubMed, CBM, CNKI, VIP and Wanfang Database were searched to collect randomized controlled trials (RCTs) about Zaorenanshen Capsule treatment of insomnia from the inception to December 2019. Meta-analysis was performed by RevMan 5.0 software and Stata 12.0 software. Results A total of 13 RCTs, and 1 169 patients were included. The result of meta-analysis showed that, no significant difference was showed in the total effective rate between Zaorenanshen Capsule and benzodiazepines[RR=1.01, 95%CI(0.96, 1.07), P=0.669], while Zaorenanshen Capsule significantly reduced the risk of adverse reactions in patients with insomnia compared with benzodiazepines[RR=0.19, 95%CI (0.14, 0.25), P=0.000]. Conclusion The efficacy of Zaorenanshen Capsule and benzodiazepine was similar in the treatment of insomnia, while Zaorenanshen Capsule can significantly reduce the risk of adverse reactions.

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