作者：曹曦1 ，肖燕妮2 ，黄腾佳1 ，陈蕾1 ，李子滢1 ，李晟3 ，秦莉花1，4 ，曾倩如2

单位：

1.410208 湖南省长沙市，湖南中医药大学护理学院　2.410208 湖南省长沙市，湖南中医药大学中西医结合 学院　3.410208 湖南省长沙市，湖南中医药大学信息科学与工程学院　 4.410208 湖南省长沙市，中西医结合心脑疾病 防治湖南省重点实验室

Units：

1.School of Nursing, Hunan University of Chinese Medicine, Changsha 410208, China 2.School of Integrated Chinese and Western Medicine, Hunan University of Chinese Medicine, Changsha 410208, China 3.School of Informatics, Hunan University of Chinese Medicine, Changsha 410208, China 4.Hunan Province Key Laboratory of Cerebrovascular Disease Prevention and Treatment of Integrated Traditional Chinese and Western Medicine, Changsha 410208, China

关键词：

睡眠障碍；卒中；卒中相关睡眠障碍；中成药；治疗结果；网络Meta分析

Keywords：

Sleep disorders; Stroke; Stroke-related sleep disorders; Chinese patent drugs; Treatment outcome; Network meta-analysis

CLC：

R 277.7

DOI：

10.12114/j.issn.1008-5971.2024.00.045

Funds：

国家自然科学基金资助项目（82374437）；湖南省自然科学基金资助项目（2023JJ50035）；湖南省卫生健康委科研 计划课题（B202319018677）；湖南中医药大学学科建设“揭榜挂帅”项目（22JBZ041）

摘要：

　目的　通过网状Meta分析探讨口服中成药治疗卒中相关睡眠障碍（SSD）的效果。方法　使用计算机 检索中国知网、维普网、万方数据知识服务平台、中国生物医学文献服务系统、PubMed、Embase、Cochrane Library 中口服中成药治疗SSD的随机对照试验（RCT），检索时限设定为各数据库建库至2023-06-18。由2名研究员进行文献 筛选和资料提取。采用Stata 15.0软件进行数据处理及网状Meta分析，采用累积排名曲线下面积（SUCRA）分析各结局 指标中干预措施的优劣。结果　最终纳入文献40篇，总样本量为4 157例（其中试验组2 087例，对照组2 070例）。网 状Meta分析结果显示，接受养血清脑颗粒＋常规西药、百乐眠胶囊＋常规西药、乌灵胶囊＋常规西药、舒肝解郁胶囊 ＋常规西药、稳心颗粒＋常规西药治疗的SSD患者匹兹堡睡眠质量指数（PSQI）评分低于接受常规西药治疗的SSD患 者（P＜0.05）；接受养血清脑颗粒＋常规西药、百乐眠胶囊＋常规西药、乌灵胶囊＋常规西药、舒肝解郁胶囊＋常 规西药、稳心颗粒＋常规西药、甜梦口服液＋常规西药治疗的SSD患者临床总有效率高于接受常规西药治疗的SSD患 者（P＜0.05）。SUCRA分析结果显示，接受不同口服中成药/常规西药治疗的SSD患者PSQI评分的SUCRA从大到小依 次为：稳心颗粒＋常规西药（82.4%）、养血清脑颗粒＋常规西药（77.6%）、舒肝解郁胶囊＋常规西药（74.3%）、 乌灵胶囊＋常规西药（52.4%）、百乐眠胶囊＋常规西药（48.2%）、宁神补心丸＋常规西药（31.4%）、天智颗粒 ＋常规西药（29.8%）、常规西药（4.0%）；接受不同口服中成药/常规西药治疗的SSD患者临床总有效率的SUCRA 从大到小依次为：舒肝解郁胶囊＋常规西药（71.2%）、乌灵胶囊＋常规西药（69.9%）、甜梦口服液＋常规西药 （69.0%）、养血清脑颗粒＋常规西药（64.7%）、稳心颗粒＋常规西药（52.5%）、天智颗粒＋常规西药（35.6%）、 百乐眠胶囊＋常规西药（36.3%）、常规西药（0.7%）。结论　当前研究证据表明，养血清脑颗粒、百乐眠胶囊、乌 灵胶囊、舒肝解郁胶囊、稳心颗粒联合常规西药在提高SSD患者睡眠质量方面的效果优于单纯常规西药，其中稳心颗 粒最有优势；养血清脑颗粒、百乐眠胶囊、乌灵胶囊、舒肝解郁胶囊、稳心颗粒、甜梦口服液联合常规西药在提高 SSD患者临床总有效率方面的效果优于单纯常规西药，其中舒肝解郁胶囊最有优势。

Abstract：

Objective To explore the effect of oral Chinese patent medicine in the treatment of stroke-related sleep disorders (SSD) through network Meta-analysis. Methods Randomized controlled trials (RCT) of oral Chinese patent medicines for treating SSD in CNKI, VIP, Wanfang Data, SinoMeD, PubMed, Embase, and Cochrane Library were searched by computers, and the search deadline was from the establishment of the respective databases to June 18, 2023. The literature screening and data extraction were carried out by two researchers. Stata 15.0 software was used for data processing and network meta-analysis, and the surface under the cumulative ranking (SUCRA) was used to analyze the advantages and disadvantages of interventions in each outcome indicator. Results Finally, 40 articles were included, with a total sample size of 4 157 cases (including 2 087 cases in the experimental group and 2 070 cases in the control group) . The results of network meta-analysis showed that Pittsburgh Sleep Quality Index (PSQI) score in the SSD patients treated with Yangxue Qingnao granule + conventional western medicine, Bailemian capsule + conventional western medicine, Wuling capsule + conventional western medicine, Shugan Jieyu capsule + conventional western medicine, Wenxin granule + conventional western medicine was lower than that of SSD patients treated with conventional western medicine (P < 0.05) ; the total clinical effective rate of SSD patients treated with Yangxue Qingnao granule + conventional western medicine, Bailemian capsule + conventional western medicine, Wuling capsule + conventional western medicine, Shugan Jieyu capsule + conventional western medicine, Wenxin granule + conventional western medicine, Tianmeng oral liquid + conventional western medicine was higher than that of SSD patients treated with conventional western medicine (P < 0.05) . The results of SUCRA analysis showed that the SUCRA of PSQI score of SSD patients receiving different oral Chinese patent medicine/conventional western medicine treatment was as follows in order from largest to smallest: Wenxin granule + conventional western medicine (82.4%) , Yangxue Qingnao granule + conventional western medicine (77.6%) , Shugan Jieyu capsule + conventional western medicine (74.3%) , Wuling capsule + conventional western medicine (52.4%) , Bailemian capsule + conventional western medicine (48.2%) , Ningshen Buxin pill + conventional western medicine (31.4%) , Tianzhi granule + conventional western medicine (29.8%) and conventional western medicine (4.0%) ; the SUCRA of the total clinical effective rate of SSD patients receiving different oral Chinese patent medicine/conventional western medicine treatment was as follows in order from largest to smallest: Shugan Jieyu capsule + conventional western medicine (71.2%) , Wuling capsule + conventional western medicine (69.9%) , Tianmeng oral liquid + conventional western medicine (69.0%) , Yangxue Qingnao granule + conventional western medicine (64.7%) , Wenxin granule + conventional western medicine (52.5%) , Tianzhi granule + conventional western medicine (35.6 %) , Bailemian capsule + conventional western medicine (36.3%) , and conventional western medicine (0.7%) . Conclusion Current research evidence shows that Yangxue Qingnao granule, Bailemian capsule, Wuling capsule, Shugan Jieyu capsule, and Wenxin granule combined with conventional western medicine have better effects on improving the sleep quality of SSD patients than conventional western medicine alone, among which Wenxin granule has the most advantage; Yangxue Qingnao granule, Bailemian capsule, Wuling capsule, Shugan Jieyu capsule, and Tianmeng oral liquid combined with conventional western medicine have better effects on improving the total clinical effective rate of SSD patients than conventional western medicine alone, among which Shugan Jieyu capsule has the most advantage.

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