中药穴位贴敷治疗原发性失眠疗效及安全性的系统评价与Meta分析
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摘要
目的研究中药穴位贴敷治疗原发性失眠的有效性和安全性。方法系统检索电子数据库PubMed、EMBASE、The Cochrane Library、中国生物医学文献数据库、中国知网、万方数据知识服务平台和维普咨询中文期刊服务平台,筛选各数据库自建库至2017年10月发表的中药穴位贴敷治疗原发性失眠的随机对照试验(RCT)文献,由两名评价者根据纳入和排除标准确认文献纳入并进行数据提取。最后采用RevMan5.3软件进行数据的整合分析并得出结论。结果检索到符合纳入标准的文献13篇,其中1篇含有2个对照组,共计为14个RCT,1 302例原发性失眠患者。Meta分析结果显示:以中药穴位贴敷为主的试验组与对照组相比能明显提高临床有效率[OR=3.33,95%CI(2.40,4.60),P<0.01],并降低匹兹堡睡眠质量指数(PSQI)评分情况[OR=-1.77,95%CI(-2.82,-0.71),P<0.01]。临床疗效与干预时间成正比,干预时间小于1个月时疗效不明显,干预时间等于1个月及干预时间大于1个月时试验组临床有效率明显优于对照组(P<0.05)。结论中药穴位贴敷治疗原发性失眠能明显提高临床有效率,降低不良反应发生率。
Objective To systematically evaluate the efficacy and safety of acupoint application of traditional Chinese medicine in the treatment of primary insomnia.Methods The randomized controlled trials(RCTs)on the acupoint sticking therapy of Chinese medicine for treating primary insomnia were retrieved from the electronic databases of PubMed,EMBASE,Cochrane Library,Sinomed,CNKI,VIP and Wanfang databases from their establishment to October 2017.Two evaluators confirmed the literature inclusion according to the inclusion and exclusion criteria.Finally,the RevMan5.3 software was used for conducting the data integration analysis and obtaining the conclusion.Results There were 13 articles that met the inclusion criteria,and one of the literatures had 2 control groups.Therefore,a total of 14 randomized controlled trials were included,and a total of 1 302 patients with primary insomnia were included.The Meta-analysis results showed that compared with the control group,the experimental group with Chinese medicine acupoint sticking as priority obviously increased the clinical effective rate[OR=3.33,95%CI(2.40,4.60),P<0.01],and reduced the Pittsburgh sleep quality index(PSQI)score[OR=-1.77,95%CI(-2.82,-0.71),P<0.01].The clinical curative effect was proportional to the intervention time,the curative effect was not obvious when the intervention time was less than 1 month,the clinical effective rate in the experimental group with the intervention time≥1 month was significantly superior to that in the control group(P<0.05).Conclusion The acupoint application of traditional Chinese medicine for treating primary insomnia could significantly improve the clinical efficacy and reduces the incidence rate of adverse reactions.
Objective To systematically evaluate the efficacy and safety of acupoint application of traditional Chinese medicine in the treatment of primary insomnia.Methods The randomized controlled trials(RCTs)on the acupoint sticking therapy of Chinese medicine for treating primary insomnia were retrieved from the electronic databases of PubMed,EMBASE,Cochrane Library,Sinomed,CNKI,VIP and Wanfang databases from their establishment to October 2017.Two evaluators confirmed the literature inclusion according to the inclusion and exclusion criteria.Finally,the RevMan5.3 software was used for conducting the data integration analysis and obtaining the conclusion.Results There were 13 articles that met the inclusion criteria,and one of the literatures had 2 control groups.Therefore,a total of 14 randomized controlled trials were included,and a total of 1 302 patients with primary insomnia were included.The Meta-analysis results showed that compared with the control group,the experimental group with Chinese medicine acupoint sticking as priority obviously increased the clinical effective rate[OR=3.33,95%CI(2.40,4.60),P<0.01],and reduced the Pittsburgh sleep quality index(PSQI)score[OR=-1.77,95%CI(-2.82,-0.71),P<0.01].The clinical curative effect was proportional to the intervention time,the curative effect was not obvious when the intervention time was less than 1 month,the clinical effective rate in the experimental group with the intervention time≥1 month was significantly superior to that in the control group(P<0.05).Conclusion The acupoint application of traditional Chinese medicine for treating primary insomnia could significantly improve the clinical efficacy and reduces the incidence rate of adverse reactions.
引文
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[20]赵璐.糖痹通膏穴位贴敷治疗糖尿病性周围神经病的临床研究[J].辽宁中医杂志,2007,34(7):925-927.
[21]张泽,白瑞娜,陈民,等.穴位贴敷联合西药治疗冠心病心绞痛有效性及安全性的系统评价[J].中华中医药杂志,2015,30(10):3531-3536.
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[23]仵倚,章新友,周小玲,等.中药穴位贴敷法治疗慢性乙肝有效性的系统评价[J].江西中医药,2017,48(4):64-67.
[24]董萍培.安胎Ⅰ号穴位贴敷改善肾虚型先兆流产患者症状的临床研究[D].杭州:浙江中医药大学,2016.
[25]史锁芳.冬病夏治与调养[M].南京:江苏科学技术出版社,2007:11-16
[2] MORIN C M,LEBLANC M,BELANGER L,et al.Prevalence of insomnia and its treatment in Canada[J].Can J Psychiatry,2011,56(9):540-548.
[3] OHAYON M M,REYNOLDS C F.Epidemiological and clinical relevance of insomnia diagnosis algorithms according to the DSM-Ⅳand the International Classification of Sleep Disorders(ICSD)[J].Sleep Med,2009,10(9):952-960.
[4]杜绪华,黄元和,秦秀荣.辩证论治穴位敷贴治疗失眠的临床疗效观察[J].中外健康文摘,2013(49):12-13.
[5]胡静,钟兰.神阙贴药治疗失眠症心脾两虚证临床疗效及对褪黑素的影响[J].新中医,2013,41(1):105-107.
[6]李颖哲.电针配合穴位敷贴治疗心肾不交型失眠的临床疗效观察[D].广州:广州中医药大学,2012.
[7]刘洪艳.镇静安神贴治疗心脾两虚型失眠症的临床研究[D].长春:长春中医药大学,2014.
[8]马文良,陈朝俊.三效安神贴配合中药内服治疗失眠症66例临床观察[J].新中医,2008,40(8):65-66.
[9]乔飞.景衣安神散穴位贴敷治疗失眠患者61例临床疗效观察[D].乌鲁木齐:新疆医科大学,2010.
[10]吴向东.中药穴位贴敷治疗失眠的临床效果探究[J].中国当代医药,2013,20(10):106,108.
[11]于海波,刘永锋,李志峰,等.三针组穴和醋调吴茱萸敷贴涌泉穴治疗阴虚火旺型不寐临床观察[J].辽宁中医药大学学报,2013,15(2):10-12.
[12]张彬.丹栀逍遥散穴位贴敷结合电针对肝郁化火型失眠临床观察[D].广州:广州中医药大学,2015.
[13]张茂,王丽梅,王燕,等.回医药穴位敷贴疗法治疗失眠症180例临床观察[C]//吴忠.第3届全国回医药学术论坛暨中国民族医药学会回医药分会成立大会论文集,宁夏,2013:124-125.
[14]赵仓焕,胡静.透皮控释纳米药物贴片穴位敷贴治疗失眠症的临床研究[C]//2006中国针灸学会临床分会第14届全国针灸学术研讨会论文集,桂林,2006:382-386.
[15]赵娜,杨文佳,谢晨,等.穴位敷贴治疗肝郁脾虚型慢性失眠症临床研究[J].国际中医中药杂志,2017,39(9):798-802.
[16]赵欣纪.穴位贴敷治疗失眠78例临床观察[J].光明中医,2010,25(8):1459-1460.
[17]吴震西,吴自强.中医内病外治[M].北京:人民卫生出版社,2015:39
[18]陈旭青,严道南,吴继勇,等.穴位贴敷治疗过敏性鼻炎随机对照试验的系统评价[J].辽宁中医杂志,2016,43(5):1043-1049.
[19]张莘,贾春生,石晶,等.穴位贴敷治疗小儿泄泻有效性的Meta分析[J].针刺研究,2013,38(4):319-323.
[20]赵璐.糖痹通膏穴位贴敷治疗糖尿病性周围神经病的临床研究[J].辽宁中医杂志,2007,34(7):925-927.
[21]张泽,白瑞娜,陈民,等.穴位贴敷联合西药治疗冠心病心绞痛有效性及安全性的系统评价[J].中华中医药杂志,2015,30(10):3531-3536.
[22]周贤刚,杨闯,杨丽霞,等.中药穴位贴敷治疗面瘫的Meta分析[J].中国针灸,2005,25(11):797-802.
[23]仵倚,章新友,周小玲,等.中药穴位贴敷法治疗慢性乙肝有效性的系统评价[J].江西中医药,2017,48(4):64-67.
[24]董萍培.安胎Ⅰ号穴位贴敷改善肾虚型先兆流产患者症状的临床研究[D].杭州:浙江中医药大学,2016.
[25]史锁芳.冬病夏治与调养[M].南京:江苏科学技术出版社,2007:11-16