中国药物警戒 ›› 2023, Vol. 20 ›› Issue (7): 799-806.
DOI: 10.19803/j.1672-8629.20211066

• 安全与合理用药 • 上一篇    下一篇

厚朴排气合剂治疗术后早期肠麻痹有效性和安全性的Meta分析

张蕾1, 吕健2, 谢雁鸣1,*   

  1. 1中国中医科学院中医临床基础医学研究所,北京 100700;
    2中国中医科学院西苑医院药物临床试验质量管理规范中心,北京 100091
  • 收稿日期:2021-12-13 出版日期:2023-07-15 发布日期:2023-07-14
  • 通讯作者: *谢雁鸣,女,首席研究员·博导,中医临床评价方法研究。E-mail:ktzu2018@163.com
  • 作者简介:张蕾,女,本科,中医临床评价方法研究。
  • 基金资助:
    中国中医科学院科技创新工程项目（CI2021A00702）; 国家重点研发计划2018年度（2018YFC1707400）

Efficacy and safety of Houpupaiqi Mixture in the treatment of postoperative lieus: a Meta-analysis

ZHANG Lei1, LYU Jian2, XIE Yanming1,*   

  1. 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2GCP Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China
  • Received:2021-12-13 Online:2023-07-15 Published:2023-07-14

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摘要： 目的 系统评价厚朴排合剂治疗早期术后肠麻痹的有效性和安全性。方法 检索数据库中国知网、万方数据、维普网、中国生物医学文献数据库、Cochrane、PubMed、Embase、Web of Science,检索时间为自建库至2021年4月30日,汇总厚朴排气合剂医治术后早期肠麻痹的RCT试验,最后结合Cochrane5.1版评价手册的标准以RevMan 5.3版评价软件对纳入文献进行Meta分析。结果 共纳入Meta分析的13个研究共涉及患者1 836例,其中试验组患者1 199例,对照组患者637例。Meta分析显示,在缩短首次肛门排气时间方面,厚朴排气合剂联合常规治疗优于单用常规治疗[MD=-8.41, 95%CI(-10.37, -6.45), P<0.000 01];在缩短肠鸣音恢复时间方面,厚朴排气合剂联合常规治疗优于单用常规治疗[MD=-5.13, 95%CI(-6.39, -3.87), P<0.000 01];在缩短首次排便时间方面,厚朴排气合剂联合常规治疗优于单用常规治疗[MD=-11.79, 95%CI(-15.14,-8.44), P<0.000 01],厚朴排气合剂优于空白对照[MD=-5.27, 95%CI (-7.10, -3.45), P<0.000 01];在缩短术后住院时间方面,厚朴排气合剂联合常规治疗优于单用常规治疗[MD=-2.35, 95%CI（-3.08,-1.62）, P<0.000 01]。不良反应主要表现为恶心、呕吐、腹泻等症状,多数表现为恶心、呕吐的不良反应症状较轻,未作处置,症状消失。结论 基于当前可使用的数据和方法,厚朴排气合剂联合常规治疗或单用来治疗术后早期肠麻痹时,能缩短首次肛门排气时间、肠鸣音恢复时间、首次排便时间及术后住院时间,且多数不良反应症状相对较轻,并可自行消失。由于当前所纳入研究质量不高,尚不能提供高质量证据证实其临床疗效,需要更多设计良好、规模较大的多中心随机对照试验进一步加以验证。

关键词: 厚朴排气合剂, 术后早期肠麻痹, 随机对照试验, 系统评价, Meta分析, 药品不良反应

Abstract: Objective To systematically review the efficacy and safety of Houpupaiqi Mixture in the treatment of postoperative lieus. Methods Eight databases, including CNKI, Wanfang , VIP , CBM, Cochrane Library, PubMed , Embase and Web of Science, were searched for RCTs that used Houpupaiqi Mixture to treat postoperative lieus and were published from inception to April 30,2021. Meta-analysis was conducted using the Cochrane Handbook for Systematic Reviews of Interventions(Version 5.1) and Revman 5.3. Results Thirteen RCTs were included, involving 1 836 patients (1 199 in the experimental group and 637 in the control group). Meta-analysis showed that Houpupaiqi Mixture combined with conventional treatments was more effective than conventional treatments alone in shortening the first anal exhaust time[MD=-8.41, 95%CI(-10.37, -6.45), P<0.000 01], the first defecation time [MD= -11.79, 95% CI(-15.14, -8.44), P<0.000 01], and hospital stay [MD=-2.35, 95% CI(-3.08, -1.62), P<0.000 01]. And Houpupaiqi Mixture was better than the blank group in shortening the first defecation time [MD=-5.27, 95% CI(-7.10, -3.45), P<0.000 01]. The adverse reactions included nausea, vomiting and diarrhea. Symptoms of nausea and vomiting were mostly mild, and disappeared without treatment. Conclusion Houpupaiqi Mixture used alone or in combination with conventional treatments for postoperative lieus has many advantages. Most of the adverse reactions are mild and can disappear by themselves. However, due to the low quality of the studies included, our conclusions need to be confirmed by RCTs up to the international standards with a large sample size and rigorous design.

Key words: Houpupaiqi Mixture, postoperative lieus, randomized controlled trial, systematic reviews, Meta-analysis, adverse drug reaetion

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