天王补心丹治疗失眠障碍的有效性：随机对照试验的Meta分析

Efficacy of Tianwang Buxin Pill as Therapy for Insomnia Disorders: Meta-Analysis of Randomized Controlled Trials

摘要: 目的： 系统评价天王补心丹单用或联合西医/针灸治疗失眠障碍的有效性，量化其改善睡眠质量的疗效，并探索联合疗法的协同作用。方法：系统检索科学网络(Web of Science)、中国知网和万方数据知识服务平台截至2025年4月发表的随机对照试验(RCT)。依据预设的纳入与排除标准，最终纳入12项RCT，共计14,412例患者。采用软件Review Manager 5.4和Python软件进行Meta分析，以标准化均数差(SMD)及其95%置信区间(CI)作为主要效应指标，对匹兹堡睡眠质量指数(PSQI)评分等关键结局进行合并分析。研究质量采用纽卡斯尔–渥太华量表进行评估。结果：Meta分析结果显示，天王补心丹单药治疗在降低PSQI评分方面显著优于常规西医干预。联合治疗方案展现出更优的疗效，包括：天王补心丹与西医(如苯二氮䓬类药物)联用，其效果显著优于单用西医；天王补心丹与针灸联合疗法的临床疗效也显著优于单纯针灸治疗。亚组分析进一步揭示，联合疗法对中医辨证属“阴虚火旺”型的失眠患者疗效尤为突出。此外，不同年龄分层分析表明，各年龄组患者均能获益。结论：本研究为天王补心丹治疗失眠障碍，无论是作为单药还是联合治疗方案，提供了积极的循证医学证据。其与西医或针灸联合应用时显示出显著的协同增效作用，体现了中药多靶点整合治疗的优势。

Abstract: Objective: To systematically evaluate the efficacy of Tianwang Buxin Dan (TWBD) used alone or in combination with Western medicine/acupuncture for insomnia disorder, quantify its effect on improving sleep quality, and explore the synergistic effects of combination therapies. Methods: Randomized controlled trials (RCTs) published up to April 2025 were systematically retrieved from the Web of Science, CNKI, and Wanfang Data Knowledge Service Platform. Based on predefined inclusion and exclusion criteria, 12 RCTs involving a total of 14,412 patients were included. Meta-analysis was performed using Review Manager 5.4 and Python software. The standardized mean difference (SMD) and its 95% confidence interval (CI) were used as the main effect measure to pool key outcomes such as the Pittsburgh Sleep Quality Index (PSQI) score. Study quality was assessed using the Newcastle-Ottawa Scale. Results: The meta-analysis showed that monotherapy with TWBD was significantly superior to conventional Western medicine interventions in reducing PSQI scores. Combination therapies demonstrated even better efficacy: the combination of TWBD with Western medicine (e.g., benzodiazepines) was significantly more effective than Western medicine alone, and the combination of TWBD with acupuncture was significantly more effective than acupuncture alone. Subgroup analysis further revealed that combination therapies were particularly effective for insomnia patients classified as “yin deficiency with effulgent fire” in traditional Chinese medicine syndrome differentiation. In addition, stratified analysis by age indicated that patients in all age groups benefited from the treatments. Conclusion: This study provides positive evidence-based medical support for the use of TWBD in treating insomnia disorder, both as monotherapy and in combination therapies. When combined with Western medicine or acupuncture, TWBD demonstrates significant synergistic effects, highlighting the advantages of multi-target integrated therapy with traditional Chinese medicine.