本文選題：天王補(bǔ)心　切入點(diǎn)：失眠　出處：《湖北中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：目的系統(tǒng)評價(jià)天王補(bǔ)心丹治療失眠的臨床療效與安全性。方法利用計(jì)算機(jī)檢索各數(shù)據(jù)庫自建庫以來至2016年12月18日發(fā)表的關(guān)于天王補(bǔ)心丹加減治療失眠的隨機(jī)對照試驗(yàn)(RCT)文獻(xiàn),檢索范圍包括:PubMed、The Cochrane Library、Embase、中國知網(wǎng)數(shù)據(jù)庫(CNKI)、重慶維普中文科技期刊數(shù)據(jù)庫(VIP)、萬方數(shù)據(jù)庫(Wanfang Data)和中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBM)。此外,對納入的文獻(xiàn)及相關(guān)綜述的參考文獻(xiàn)進(jìn)行閱讀及篩查以獲取潛在的相關(guān)文獻(xiàn)。由2名評價(jià)員按照事先制定的納入與排除標(biāo)準(zhǔn)獨(dú)立進(jìn)行文獻(xiàn)的篩選、提取、評價(jià)工作。采用RevMan 5.3軟件對臨床有效率、臨床治愈率、中醫(yī)癥狀積分、PSQI總積分、睡眠質(zhì)量總有效率等觀察指標(biāo)進(jìn)行合并效應(yīng)量分析。由于本研究所收集的不良反應(yīng)數(shù)據(jù)較少,故不進(jìn)行相關(guān)的Meta分析,僅在文中作一般描述性分析。結(jié)果計(jì)算機(jī)共檢索出776篇相關(guān)文獻(xiàn),最終納入12篇目標(biāo)文獻(xiàn),共計(jì)1056名患者,其中天王補(bǔ)心丹加減組(試驗(yàn)組)有555例,常規(guī)西藥組(對照組)有501例患者。天王補(bǔ)心丹與常規(guī)西藥相比,其治療有效率更高(OR=3.35,95%CI[2.28,4.91],P0.00001),臨床痊愈率更好(OR=1.62,95%CI[1.16,2.25],P=0.004)。在常規(guī)的西藥治療基礎(chǔ)上,加用天王補(bǔ)心丹與單純使用常規(guī)西藥治療相比,其臨床治療有效率更高(OR=5.05,95%CI[1.58,16.12],P=0.006),臨床痊愈率更好(OR=2.81,95%CI[1.49,5.28],P=0.001)。通過對治療后的PSQI各項(xiàng)指標(biāo)的分析,結(jié)果顯示:與常規(guī)西藥組相比,天王補(bǔ)心丹可以縮短患者的入睡時(shí)間(WMD=-0.42,95%CI[-0.65,-0.19],P=0.0003),提高患者的日間功能(WMD=-0.50,95%CI[-0.70,-0.31],P0.00001),提高患者的整體睡眠質(zhì)量(OR=4.31,95%CI[1.97,9.42],P=0.0002)。通過對中醫(yī)癥狀積分的分析,天王補(bǔ)心丹在改善中醫(yī)癥狀方面療效要優(yōu)于常規(guī)西藥組(WMD=-4.24,95%CI[-5.25,-3.22],P0.00001)。但在睡眠時(shí)間(WMD=-0.23,95%CI[-0.65,0.19],P=0.28)和睡眠質(zhì)量(WMD=-0.27,95%CI[-0.85,0.31],P=0.36)方面,兩種治療方法無統(tǒng)計(jì)學(xué)差異。本次研究所納入的12篇文獻(xiàn)中僅4篇對不良反應(yīng)進(jìn)行了報(bào)道,且其中僅3篇描述了發(fā)生不良反應(yīng)的人數(shù)及癥狀,僅從不良反應(yīng)的例數(shù)分析,天王補(bǔ)心丹加減相比常規(guī)西藥治療失眠,似乎其安全性更高、不良反應(yīng)更少。結(jié)論1.與西藥常規(guī)治療失眠相比,天王補(bǔ)心丹加減治療失眠在提高患者臨床有效率、臨床痊愈率、日間功能、睡眠質(zhì)量總有效率,減少入睡時(shí)間,降低中醫(yī)癥狀積分方面有明顯的優(yōu)勢,安全性似乎更高。2.在PSQI評分中的睡眠時(shí)間和睡眠質(zhì)量兩個(gè)指標(biāo)上,天王補(bǔ)心丹和西醫(yī)常規(guī)治療并未體現(xiàn)出明顯差別。3.由于本次納入的文獻(xiàn)整體質(zhì)量不高,一定程度上影響了研究結(jié)果的真實(shí)性和可靠性。期待今后有更多該方向的多中心、大樣本、多層次的高質(zhì)量隨機(jī)雙盲對照試驗(yàn),對天王補(bǔ)心丹加減治療失眠的療效及安全性進(jìn)行更科學(xué)的論證。
[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.
【學(xué)位授予單位】：湖北中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R256.23

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本文編號：1664452