连花清瘟胶囊治疗病毒性感冒的有效性和安全性的系统评价
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摘要
评价连花清瘟胶囊治疗病毒性感冒的有效性和安全性,以期指导临床用药。系统检索CNKI全文数据库,万方数据平台,维普数据库,SinoMed医学文献数据库和PubMed医学期刊数据库,搜索连花清瘟胶囊治疗病毒性感冒的随机对照实验(RCTs),对符合纳入标准的文献用Cochrane协作网提供的标准评价文献质量,并用RevMan 5.3软件进行Meta分析。共纳入8篇文献,总样本量为955例,试验组478例,对照组477例。疗效方面,连花清瘟胶囊组优于对照组,总有效率RR=1.20,95%CI[1.09,1.32],P=0.70;体温复常率RR=1.13,95%CI[1.02,1.24],P=0.001;症状改善率RR=1.18,95%CI[1.12,1.24],P=0.16。不良反应方面,对照组优于连花清瘟胶囊组,不良反应发生率RR=1.54,95%CI[0.73,3.24],P=0.93。连花清瘟胶囊治疗病毒性感冒疗效比较好,但不良反应发生率高,其安全性须引起重视。鉴于纳入文献数量较少,质量偏低,其有效性和安全性尚需更多高质量的临床研究去证实。
To evaluate the efficacy and safety of Lianhua Qingwen Capsules in the treatment of viral influenza in order to guide clinical medication. Randomized controlled trials(RCTs) regarding Lianhua Qingwen Capsules for treatment of viral influenza were searched in the CNKI, WanFang, VIP, SinoMed and PubMed. The quality of papers selected based on the inclusion criteria were assessed according to the Cochrane collaboration method and Meta-analysis was performed by using RevMan 5.3 software. A total of 8 articles were included, with a total sample size of 955 cases, including 478 cases in the treatment group, and 477 cases in the control group. In terms of the therapeutic effect, Lianhua Qingwen Capsules group was superior to the control group, with a total effective rate RR=1.20, 95%CI [1.09,1.32], P=0.70; recovery rate of body temperature RR=1.13, 95%CI [1.02,1.24], P=0.001; rate of symptom improvement RR=1.18, 95%CI [1.12,1.24], P=0.16. In terms of adverse reactions, the control group was superior to Lianhua Qingwen Capsules, with the incidence of adverse reactions RR=1.54, 95%CI [0.73,3.24], P=0.93. Lianhua Qingwen Capsules has a better therapeutic effect on viral influenza, but the incidence of adverse reactions is high, and its safety must be taken seriously. Given the small number of documents included and the low quality, the efficacy and safety of Lianhua Qingwen Capsules shall be confirmed by more high-quality clinical studies.
To evaluate the efficacy and safety of Lianhua Qingwen Capsules in the treatment of viral influenza in order to guide clinical medication. Randomized controlled trials(RCTs) regarding Lianhua Qingwen Capsules for treatment of viral influenza were searched in the CNKI, WanFang, VIP, SinoMed and PubMed. The quality of papers selected based on the inclusion criteria were assessed according to the Cochrane collaboration method and Meta-analysis was performed by using RevMan 5.3 software. A total of 8 articles were included, with a total sample size of 955 cases, including 478 cases in the treatment group, and 477 cases in the control group. In terms of the therapeutic effect, Lianhua Qingwen Capsules group was superior to the control group, with a total effective rate RR=1.20, 95%CI [1.09,1.32], P=0.70; recovery rate of body temperature RR=1.13, 95%CI [1.02,1.24], P=0.001; rate of symptom improvement RR=1.18, 95%CI [1.12,1.24], P=0.16. In terms of adverse reactions, the control group was superior to Lianhua Qingwen Capsules, with the incidence of adverse reactions RR=1.54, 95%CI [0.73,3.24], P=0.93. Lianhua Qingwen Capsules has a better therapeutic effect on viral influenza, but the incidence of adverse reactions is high, and its safety must be taken seriously. Given the small number of documents included and the low quality, the efficacy and safety of Lianhua Qingwen Capsules shall be confirmed by more high-quality clinical studies.
引文
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[13] 程春英.连花清瘟胶囊治疗病毒性感冒的疗效及安全性分析[J].北方药学,2018,15(3):163.
[14] 何春华.连花清瘟胶囊在社区病毒性感冒治疗中的疗效探讨[J].大家健康:学术版,2014,8(17):261.
[15] 闫世艳,何丽云,刘保延,等.如何保持中医盲法临床试验的盲态[J].世界科学技术——中医药现代化,2014,16(12):2527.
[16] 于丹丹,谢雁鸣,张允岭,等.苦碟子注射液治疗急性脑梗死的有效性和安全性研究:随机对照试验的系统评价和Meta分析[J].中国中药杂志,2019,44(2):372.
[17] 卢鹏飞,廖星,谢雁鸣,等.建立中医药临床试验注册技术规范的必要性与可行性探讨[J].中国中西医结合杂志,2015,35(12):14.
[18] 赵君,支英杰,赵晖,等.灯盏花素注射剂治疗糖尿病性肾病的有效性和安全性:随机对照试验的系统评价和Meta分析[J].中国中药杂志,2019,44(4):833.
[19] 杨丰文,邹佳涵,王媛,等.中药注射剂治疗心力衰竭的网状Meta分析[J].中国中药杂志,2018,43(6):1247.
[2] 孙彬.连花清瘟胶囊治疗病毒性感冒的系统评价[C].郑州:第七届国际络病学大会,2011.
[3] 陈玉满,陈江,毛光明,等.藏药红景天及其复方抗缺氧有效成分研究[J].中国卫生检验杂志,2007(8):64.
[4] 莫红缨,柯昌文,郑劲平,等.连花清瘟胶囊体外抗甲型流感病毒的实验研究[J].中药新药与临床药理,2007(1):6.
[5] 杨立波,季振慧,王保鲜.连花清瘟胶囊治疗流行性感冒280例疗效观察[J].疑难病杂志,2005(5):276.
[6] 叶春娟,张帆,朱育银.莲花清瘟胶囊对流行性感冒合并支气管肺炎的作用[J].中国实验方剂学杂志,2013,19(24):329.
[7] 荀红军,杜孟旭.连花清瘟胶囊治疗病毒性感冒的疗效观察[J].中国医药指南,2011,9(19):306.
[8] 袁振京.连花清瘟胶囊治疗病毒性感冒的疗效及安全性评价[J].临床合理用药杂志,2014,7(12):137.
[9] 王以炳,张天民,杨玉梅,等.连花清瘟胶囊治疗病毒性感冒的有效性与安全性观察[J].临床肺科杂志,2008(9):1118.
[10] 李科,刘远飞.探析连花清瘟胶囊治疗病毒性感冒的临床效果[J].中国保健营养,2016(9):239.
[11] 何卫琪.连花清瘟胶囊治疗病毒性感冒的疗效及安全性分析[J].现代诊断与治疗,2015,26(17):3876.
[12] 罗翀.连花清瘟胶囊治疗病毒性感冒的临床研究[J].中国当代医药,2011,18(18):137.
[13] 程春英.连花清瘟胶囊治疗病毒性感冒的疗效及安全性分析[J].北方药学,2018,15(3):163.
[14] 何春华.连花清瘟胶囊在社区病毒性感冒治疗中的疗效探讨[J].大家健康:学术版,2014,8(17):261.
[15] 闫世艳,何丽云,刘保延,等.如何保持中医盲法临床试验的盲态[J].世界科学技术——中医药现代化,2014,16(12):2527.
[16] 于丹丹,谢雁鸣,张允岭,等.苦碟子注射液治疗急性脑梗死的有效性和安全性研究:随机对照试验的系统评价和Meta分析[J].中国中药杂志,2019,44(2):372.
[17] 卢鹏飞,廖星,谢雁鸣,等.建立中医药临床试验注册技术规范的必要性与可行性探讨[J].中国中西医结合杂志,2015,35(12):14.
[18] 赵君,支英杰,赵晖,等.灯盏花素注射剂治疗糖尿病性肾病的有效性和安全性:随机对照试验的系统评价和Meta分析[J].中国中药杂志,2019,44(4):833.
[19] 杨丰文,邹佳涵,王媛,等.中药注射剂治疗心力衰竭的网状Meta分析[J].中国中药杂志,2018,43(6):1247.