目的 系统评价酸枣仁汤治疗脑卒中后失眠的有效性和安全性。方法 检索PubMed、EMbase、中国知网、万方等数据库，时间均从建库至2023年9月15日，收集有关酸枣仁汤治疗脑卒中后失眠的随机对照试验(Randomized controlled trial，RCT)。由2名评价员独立筛选文献、提取数据并进行文献质量评价，应用RevMan 5。3软件进行Meta分析。结果 纳入13项RCT，涉及1002例患者。Meta分析结果示，酸枣仁汤治疗组临床治疗有效率高于对照组[OR=4。25，95%CI(2。79，6。46)，P<0。00001];酸枣仁汤治疗组(联合其他治疗)在降低匹兹堡睡眠质量指数(Pittsburgh sleep quality index，PSQI)评分方面优于对照组[MD=-2。78，95%CI(-3。24，-2。33)，P<0。00001];酸枣仁汤治疗组在降低美国国立卫生研究院卒中量表(National Institute of Health stroke scale，NIHSS)评分改善神经功能缺损方面优于对照组[MD=-1。58，95%CI(-1。95，-1。21)，P<0。00001];不良反应方面，酸枣仁汤组的不良反应发生率较西医常规治疗组更低[OR=0。38，95%CI(0。20，0。71)，P=0。003]。结论 酸枣仁汤可提高卒中后失眠患者的临床疗效、改善神经功能缺损程度，酸枣仁汤联合其他治疗可改善患者睡眠质量，且不良反应发生率更低。目前仍需更多高质量RCT研究予以进一步验证酸枣仁汤治疗卒中后失眠的有效性和安全性。
Efficacy and Safety of Suanzaoren Decoction in the Treatment for Post-Stroke Insomnia:A Systematic Review and Meta-Analysis
Objective We conduct a systematic review and meta-analysis to evaluate the efficacy and safety of Suanzaoren decoction for post-stroke insomnia.Methods We conducted a comprehensive literature search,including PubMed,EMbase,CNKI,WanFang Data and so on,from the database creating to September 15th 2023.Our systematic review only included randomized controlled trials(RCTs)concerning with Suanzaoren decoction in treating post-stroke insomnia.Two reviewers independently screened the literature,extracted the data,and assessed the risk of bias for included studies.We used RevMan 5.3 software to perform Meta-analysis.Results A total of 13 RCTs were included,involving 1002 patients.The meta-analysis results showed that the clinical effective rate of the Suanzaoren decoction group was higher than the control group(OR=4.25,95%CI 2.79 to 6.46,P<0.00001).The Suanzaoren decoction group(combined with other treatments)reduced the Pittsburgh sleep quality index(PSQI)score more significantly than the control group(MD=-2.78,95%CI-3.24 to-2.33,P<0.00001).The Suanzaoren Decoction group was better than the control group in reducing the score of the National Institute of Health Stroke Scale(NIHSS)and improving neurological impairment(MD=-1.58,95%CI-1.95 to-1.21,P<0.00001).The incidence of adverse events in Suanzaoren Decoction group was lower than that in the control group(OR=0.38,95%CI 0.20 to 0.71,P=0.003).Conclusion Suanzaoren decoction can enhance the clinical efficacy and improve the degree of neurological defect of post-stroke insomnia patients,Suanzaoren decoction(combined with other treatments)can improve the sleep quality.The incidence of adverse events is lower.However,the efficacy and safety of Suanzaoren decoction for post-stroke insomnia still need to be further verified by more high-quality RCTs.
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