连花清瘟制剂临床用药安全的系统性评价
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国家科学自然基金面上项目(82070067)——外泌体经CHOP通路调控肺泡上皮细胞端粒酶活性的分子机制及对肺纤维化的影响


Systematic Evaluation of the Safety of Clinical Medication of Lianhuaqingwen Preparation
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    摘要:

    目的:系统评价连花清瘟制剂的临床用药安全。方法:在中国生物医学文献数据库(CBM)、中国期刊全文数据库(CJFD)、MEDLINE、EMbase中检索文献,检索时限设定为2005年1月至2020年7月,检索收录在上述数据库中与连花清瘟胶囊和连花清瘟颗粒随机对照临床试验相关的文献。结果:检索发现临床对照试验相关文献共128篇,其中连花清瘟制剂组8 411例,对照组8 031例。连花清瘟制剂组有349例不良反应,发生率为4.1%;对照组有443例不良反应,发生率为5.5%。连花清瘟制剂组与对照组不良反应发生率的相对危险度为(RR=0.76,95%CI为0.68~0.86,P<0.05)。连花清瘟制剂的不良发生率低于对照组。在亚组分析中,单用连花清瘟制剂亚组分析(RR=0.73,95%CI为0.59~0.91,P<0.05),连花清瘟制剂与其他联用亚组分析(RR=0.77,95%CI为0.66~0.91,P<0.05),连花清瘟胶囊亚组分析(RR=0.81,95%CI为0.70~0.94,P<0.05),连花清瘟颗粒亚组分析(RR=0.63,95%CI为0.49~0.82,P<0.05)。连花清瘟胶囊与连花清瘟颗粒的不良反应发生率要低于其他对照组。结论:在不同疾病的临床用药过程中,连花清瘟制剂的不良反应发生率要明显低于对照组。

    Abstract:

    To systematically evaluate the safety of Lianhuaqingwen preparations in clinical practice.Methods:We searched the Chinese Biomedical Literature Database(CBM),the Chinese Journal Full-text Database(CJFD),MEDLINE,Embase,to collect clinical literature about the randomized controlled clinical trials(RCT) of Lianhuaqingwen Capsules and Lianhuaqingwen Granules,the search time limit was set from January 2005 to July 2020.Results:The research found 128 RCTs,8411 cases in Lianhuaqingwen preparation group and 8031 cases in control group.349 cases(4.1%) in the Lianhuaqingwen preparation group,versus 443 cases(5.5%) in control group showed adverse reactions.The relative risk of adverse reaction rate between the Lianhuaqingwen preparation group and the control group was [RR=0.76,95%CI(0.68 to 0.86),P<0.05].This showed that the adverse incidence of Lianhuaqingwen preparation is lower than that of the control group.Subgroup analysis of Lianhuaqingwen preparations alone [RR=0.73,95%CI(0.59 to 0.91),P<0.05],combined use of Lianhuaqingwen preparations [RR=0.77,95%CI(0.66 to 0.91),P<0.05],Lianhuaqingwen Capsules [RR=0.81,95%CI(0.49 to 0.82),P<0.05],Lianhuaqingwen Granules [RR=0.63,95%CI(0.49 to 0.82),P<0.05].It was suggested that the incidence of adverse reactions of Lianhuaqingwen Capsules and Lianhuaqingwen Granules were lower than that of other control groups.Conclusion:In the clinical medication process of different diseases,the incidence of adverse reactions of Lianhuaqingwen preparation is significantly lower than that of the control group.

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孙伟,杨晓宇,周璇,姚云瑾,黄继汉,徐作军.连花清瘟制剂临床用药安全的系统性评价[J].世界中医药,2021,(18).

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  • 收稿日期:2021-03-08
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  • 在线发布日期: 2021-10-13
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