舒肝解郁胶囊辅助治疗精神分裂症伴失眠的效果与安全性Meta 分析

Meta-Analysis of the Efficacy and Safety of Shugan Jieyu Capsules as Adjuvant Treatment for Schizophrenia Complicated by Insomnia

摘要:

目的：系统评价舒肝解郁胶囊辅助治疗精神分裂症伴失眠患者的有效性和安全性。方法：由2名研究者独立检索中国知网、万方数据库、维普数据库、中国临床试验注册中心（ChiCTR）、PubMed、Embase、Cochrane Library数据库、美国临床试验注册库（ClinicalTrials.gov），收集关于舒肝解郁胶囊辅助治疗精神分裂症伴失眠的随机对照试验（RCT）。检索时限为建库至2025 年7 月22 日。通过文献筛选、数据提取，使用Cochrane偏倚风险工具和改良Jadad量表进行方法学质量评价。采用RevMan 5.4进行Meta分析。结果：共纳入5篇中文文献，包括477例精神分裂症伴失眠患者。Meta分析结果显示，治疗后，舒肝解郁胶囊组匹兹堡睡眠质量指数量表（PSQI） 总评分低于对照组［SMD=-2.06，95%CI（-2.65～-1.48），P＜0.01］，阳性和阴性症状量表（PANSS） 总评分［WMD=-13.66，95%CI （-14.96～-12.37），P＜0.01］、阳性症状评分［WMD=-4.62，95%CI（-5.24～-3.99），P＜0.01］、阴性症状评分［WMD=-3.81，95%CI（-4.40～-3.23），P＜0.01］、一般精神病理评分［WMD=-6.18，95%CI（-7.09～-5.26），P＜0.01］ 均低于对照组。2组不良事件比较，差异均无统计学意义（P＞0.05）。结论：抗精神病药联合舒肝解郁胶囊可能有助于改善精神分裂症患者的睡眠质量和精神症状，且安全性较好。

Abstract:

Abstract：Objective：To systematically evaluate the efficacy and safety of Shugan Jieyu Capsules as an adjuvant therapy for patients with schizophrenia complicated by insomnia. Methods： Two researchers independently searched China National Knowledge Infrastructure（CNKI）， Wanfang Data Knowledge Service Platform （Wanfang）， China Science and Technology Journal Database （VIP）， Chinese Clinical Trial Registry （ChiCTR）， PubMed， Embase， Cochrane Library，and ClinicalTrials.gov to collect randomized controlled trials （RCTs） on Shugan Jieyu Capsules as an adjuvant therapy for schizophrenia complicated by insomnia. The search period covered from the inception of each database to July 22，2025. Through literature screening and data extraction，the methodological quality was evaluated using the Cochrane bias risk tool and the modified Jadad Scale. Meta-analysis was performed using RevMan 5.4. Results： A total of 5 Chinese articles involving 477 patients with schizophrenia complicated by insomnia were included. Meta-analysis results showed that after treatment， the total score of the Pittsburgh Sleep Quality Index （PSQI） in the Shugan Jieyu Capsule group was lower than that in the control group [SMD=-2.06，95%CI （-2.65 to -1.48）， P＜0.01］ . The total score of the Positive and Negative Syndrome Scale （PANSS） [WMD=-13.66， 95%CI （-14.96 to -12.37），P＜0.01]，positive symptom score [WMD=-4.62，95%CI （-5.24 to -3.99），P＜0.01]， negative symptom score [WMD=-3.81，95%CI（ -4.40 to -3.23），P＜0.01]，and general psychopathology score [WMD= -6.18，95%CI （-7.09 to -5.26），P＜0.01] in the Shugan Jieyu Capsule group were all lower than those in the control group. There were no statistically significant differences in adverse events between the two groups （P＞0.05）. Conclusion： Antipsychotics combined with Shugan Jieyu Capsules may improve sleep quality and psychiatric symptoms in patients with schizophrenia，with favorable safety.