天王补心丹加减治疗失眠疗效与安全性的Meta分析

发布时间：2018-03-25 19:07

本文选题：天王补心　切入点：失眠　出处：《湖北中医药大学》2017年硕士论文

【摘要】：目的系统评价天王补心丹治疗失眠的临床疗效与安全性。方法利用计算机检索各数据库自建库以来至2016年12月18日发表的关于天王补心丹加减治疗失眠的随机对照试验(RCT)文献,检索范围包括:PubMed、The Cochrane Library、Embase、中国知网数据库(CNKI)、重庆维普中文科技期刊数据库(VIP)、万方数据库(Wanfang Data)和中国生物医学文献数据库(CBM)。此外,对纳入的文献及相关综述的参考文献进行阅读及筛查以获取潜在的相关文献。由2名评价员按照事先制定的纳入与排除标准独立进行文献的筛选、提取、评价工作。采用RevMan 5.3软件对临床有效率、临床治愈率、中医症状积分、PSQI总积分、睡眠质量总有效率等观察指标进行合并效应量分析。由于本研究所收集的不良反应数据较少,故不进行相关的Meta分析,仅在文中作一般描述性分析。结果计算机共检索出776篇相关文献,最终纳入12篇目标文献,共计1056名患者,其中天王补心丹加减组(试验组)有555例,常规西药组(对照组)有501例患者。天王补心丹与常规西药相比,其治疗有效率更高(OR=3.35,95%CI[2.28,4.91],P0.00001),临床痊愈率更好(OR=1.62,95%CI[1.16,2.25],P=0.004)。在常规的西药治疗基础上,加用天王补心丹与单纯使用常规西药治疗相比,其临床治疗有效率更高(OR=5.05,95%CI[1.58,16.12],P=0.006),临床痊愈率更好(OR=2.81,95%CI[1.49,5.28],P=0.001)。通过对治疗后的PSQI各项指标的分析,结果显示:与常规西药组相比,天王补心丹可以缩短患者的入睡时间(WMD=-0.42,95%CI[-0.65,-0.19],P=0.0003),提高患者的日间功能(WMD=-0.50,95%CI[-0.70,-0.31],P0.00001),提高患者的整体睡眠质量(OR=4.31,95%CI[1.97,9.42],P=0.0002)。通过对中医症状积分的分析,天王补心丹在改善中医症状方面疗效要优于常规西药组(WMD=-4.24,95%CI[-5.25,-3.22],P0.00001)。但在睡眠时间(WMD=-0.23,95%CI[-0.65,0.19],P=0.28)和睡眠质量(WMD=-0.27,95%CI[-0.85,0.31],P=0.36)方面,两种治疗方法无统计学差异。本次研究所纳入的12篇文献中仅4篇对不良反应进行了报道,且其中仅3篇描述了发生不良反应的人数及症状,仅从不良反应的例数分析,天王补心丹加减相比常规西药治疗失眠,似乎其安全性更高、不良反应更少。结论1.与西药常规治疗失眠相比,天王补心丹加减治疗失眠在提高患者临床有效率、临床痊愈率、日间功能、睡眠质量总有效率,减少入睡时间,降低中医症状积分方面有明显的优势,安全性似乎更高。2.在PSQI评分中的睡眠时间和睡眠质量两个指标上,天王补心丹和西医常规治疗并未体现出明显差别。3.由于本次纳入的文献整体质量不高,一定程度上影响了研究结果的真实性和可靠性。期待今后有更多该方向的多中心、大样本、多层次的高质量随机双盲对照试验,对天王补心丹加减治疗失眠的疗效及安全性进行更科学的论证。
[Abstract]:Objective to evaluate the clinical efficacy and safety of Tianwang Buxin Dan in the treatment of insomnia. The search scope includes: the Cochrane Library Embase, CNKIN, Weipu Chinese Sci-tech Journals Database in Chongqing, Wanfang data, Wanfang data, and China Biomedical Literature Database. The literature included and references of related reviews were read and screened to obtain potential relevant documents. The literature was screened and extracted by two evaluators in accordance with the pre-established criteria for inclusion and exclusion. Evaluation work. The clinical effective rate, clinical cure rate, total score of TCM symptom and total effective rate of sleep quality were analyzed by using RevMan 5.3 software. Therefore, no Meta analysis was carried out, only a general descriptive analysis was made in the text. Results A total of 776 related articles were retrieved by computer, and 12 articles were included in the total of 1056 patients, including 555 cases in the Tianwang Buxindan plus or minus group (experimental group). There were 501 patients in the routine western medicine group (control group). The effective rate of Tianwang Bushindan was higher than that of conventional western medicine. The effective rate of treatment was higher than that of routine western medicine. The clinical recovery rate was better than that of routine western medicine. The effective rate of clinical treatment of Tianwang Buxin Dan was higher than that of routine western medicine alone. The effective rate of clinical treatment was higher than that of routine western medicine alone. The effective rate of clinical treatment was higher than that of routine western medicine. The clinical recovery rate was better than that of routine western medicine group, and the clinical recovery rate was better than that of traditional western medicine group. The results showed that compared with the conventional western medicine group, the clinical recovery rate was better than that in the control group, and the clinical recovery rate was better than that in the conventional western medicine group, and the results showed that compared with the conventional western medicine group, the effective rate of the treatment was better than that of the traditional western medicine group. Tianwang Buxin Dan can shorten the sleeping time of the patients and improve the daytime function of patients with WMD-0.5095 CI [-0.65U -0.19] P0.00001, and improve the overall sleep quality of patients with sleep quality: 4.3195CI [1.979.9.42] P0.0002.Through the analysis of TCM symptom scores, The curative effect of Tianwang Bushindan in improving TCM symptoms was better than that in the routine western medicine group (WMD-4.2495 CI [-5.25U -3.22] P0.00001, but WMD-0.23995 CI [-0.650.19] P0.28) and sleep quality (WMD-0.2795CI [-0.85U 0.31] P0.36). There was no statistical difference between the two treatments. Only 4 of the 12 articles included in this study reported adverse reactions, and only 3 of them described the number and symptoms of adverse reactions, and only analyzed the number of cases of adverse reactions. Compared with routine western medicine, Tianwang Bushindan has higher safety and fewer adverse reactions. Conclusion 1.Compared with routine western medicine, Tianwang Buxindan can improve the clinical effective rate and clinical cure rate of insomnia. The daytime function, the total effective rate of sleep quality, the reduction of sleep time, the decrease of TCM symptom score have obvious advantages, and the safety seems to be higher. 2. In the PSQI score, sleep time and sleep quality are two indexes. Tianwang Bu Xin Dan and routine western medicine treatment did not reflect a significant difference. 3.Because the overall quality of the literature included this time is not high, to some extent, it has affected the authenticity and reliability of the research results. We look forward to more multicentre in this direction in the future. Large sample, multi-level randomized, double-blind controlled trial was conducted to demonstrate the efficacy and safety of Tianwang Buxin Dan in the treatment of insomnia.
【学位授予单位】：湖北中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R256.23

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