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| 酸枣仁汤辅助治疗失眠的有效性与安全性的系统评价和Meta分析 |
| Systematic review and meta-analysis on efficacy and safety of Suanzaoren decoction adjuvant treatment of insomnia |
| 投稿时间：2021-08-17 修订日期：2021-11-05 |
| DOI： |
| 中文关键词: 酸枣仁汤 失眠 随机对照试验 系统评价 Meta分析 |
| 英文关键词: Suanzaoren decoction insomnia Randomized controlled trials Systematic review Meta-analysis |
| 基金项目:国家自然科学基金项目（面上项目，重点项目，重大项目） |
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| 中文摘要: |
| 系统评价酸枣仁汤辅助治疗失眠的有效性与安全性,以期为其临床治疗提供循证医学参考。计算机检索中国知网(CNKI)、维普(VIP)、万方(Wanfang)、中国生物医学文献数据库(CBM)、PubMed、EMbase、Cochrane Library等数据库,收集酸枣仁汤联合西药常规治疗(试验组)对比单用西药常规治疗(对照组)对失眠的疗效和安全性的随机对照试验(randomized controlled trial,RCT)。由2位研究者对符合纳入标准的临床研究进行资料提取后,使用Cochrane风险偏倚评估工具对纳入研究质量进行评价,采用RevMan 5.4软件进行Meta分析。共纳入35项研究,共3200例患者,其中试验组1604例,对照组1596例。总体上,所纳研究质量偏低。Meta分析结果显示,与西药常规治疗相比,酸枣仁汤辅助治疗失眠可以提高总有效率(RR= 1.26, 95%CI[1.21, 1.30], P<0.00001),改善匹兹堡睡眠质量指数(PSQI)评分(MD= -3.99, 95%CI[-4.59, -3.39], P<0.00001)和与睡眠状况自评量表(SRSS)评分(MD= -5.17,95%CI[-5.55, -4.79], P<0.00001),以及降低不良反应的发生率(RR= 0.35, 95%CI[0.25, 0.48], P<0.00001)。结果表明,酸枣仁汤辅助治疗失眠具有较好的疗效,且安全性良好。但该研究存在一定局限性,纳入研究总体质量较低,影响结果的可靠性,需更多高质量研究予以验证。 |
| 英文摘要: |
| To systematically analyze the efficacy and safety of Suanzaoren decoction in the treatment of insomnia, in orderto provide evidence-based medicine reference for clinical treatment. Databases of CNKI, VIP, Wanfang, CBM, PubMed, EMbase, Cochrane Library were searched from the establishment to August 2021 for randomized controlled trial about Suanzaoren decoction combined with conventional Western medicine as well as conventional Western medicine alone in the treatment of insomnia. Two researchers separately screened the liteture, extracted data according to pre-determined inclusion and exclusion crietia, then The Cochrane risk-of-bias tool was used to evaluate the methodology quality. RevMan 5.4 was used for meta-analysis. Altogether, 35 RCTs involving 3200 participants were finally included, with 1604 in the treatment group and 1596 in the control group. The overall quality of the RCTs was relatively low. Meta-analysis showed that Suanzaoren decoction combined with conventional Western medicine could improce the total efficacy rate(RR= 1.26, 95%CI[1.21, 1.30], P<0.00001), ameliorate PSQI(MD= -3.99, 95%CI[-4.59, -3.39], P<0.00001) and SRSS (MD= -5.17,95%CI[-5.55, -4.79], P<0.00001), reduce the incidence of adverse reactions(RR= 0.35, 95%CI[0.25, 0.48], P<0.00001). The results proved that Suanzaoren decoction combined with conventional Western medicine had a good effect with higher safety in the treatment of insomnia. However, this study existed certain limitations. The overall quality of included RCTs was relatively low, which effected the reliability. So the above conclusions still need more high-quality studies for confirmation. |
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