酸枣仁汤治疗失眠有效性和安全性的系统评价与Meta分析

Systematic Evaluation and Meta-Analysis of the Effectiveness and Safety of Suanzaoren Decoction in Treating Insomnia

摘要: 目的：系统评价酸枣仁汤(SZRD)治疗失眠的临床疗效与安全性，结合既往基础研究证据探讨其潜在作用机制。方法：系统检索中英文数据库(CNKI、万方、VIP、CBM、PubMed、Embase、Cochrane Library、Web of Science)，纳入2013年1月至2025年6月发表的随机对照试验(RCT)。由两名研究者独立完成文献筛选、数据提取与偏倚风险评估，采用RevMan 5.4.1软件进行Meta分析。结果：共纳入10项RCT，共计1004例患者。Meta分析显示，酸枣仁汤在改善失眠患者的匹兹堡睡眠质量指数(PSQI)总分方面优于对照组(MD = 2.01, 95% CI [1.17, 2.85], P < 0.00001)；在提高临床总有效率方面亦显著优于对照组(RR = 5.29, 95% CI [2.92, 9.60], P < 0.00001)。同时，酸枣仁汤组在焦虑(HAMA)、抑郁(HAMD)评分及血清5-HT、DA等神经递质水平方面均有改善，且安全性良好。结论：酸枣仁汤能显著改善失眠患者的睡眠质量及临床疗效，可能通过调节中枢神经递质和炎症因子实现作用。受限于现有研究数量与方法学质量，结论仍需更多大样本、高质量RCT验证。

Abstract: Objective: To systematically evaluate the clinical efficacy and safety of Suanzaoren Decoction (SZRD) in the treatment of insomnia and to explore its potential mechanisms in combination with previous experimental evidence. Methods: A comprehensive search of Chinese and English databases (CNKI, Wanfang, VIP, CBM, PubMed, Embase, Cochrane Library, Web of Science) was conducted to identify randomized controlled trials (RCTs) published from January 2013 to June 2025. Two reviewers independently performed study screening, data extraction, and risk-of-bias assessment. Meta-analysis was conducted using RevMan 5.4.1. Results: Ten RCTs involving 1004 patients were included. Pooled analysis showed that SZRD significantly improved Pittsburgh Sleep Quality Index (PSQI) scores compared with controls (MD = 2.01, 95% CI [1.17, 2.85], P < 0.00001), and increased overall clinical effectiveness (RR = 5.29, 95% CI [2.92, 9.60], P < 0.00001). Moreover, SZRD alleviated anxiety (HAMA) and depression (HAMD) scores, elevated serum 5-HT and DA levels, and demonstrated good safety. Conclusion: SZRD can effectively improve sleep quality and clinical outcomes in patients with insomnia, possibly through regulating neurotransmitters and inflammatory pathways. However, the evidence remains limited by small sample sizes and methodological quality, warranting further large-scale, high-quality RCTs.