润燥止痒胶囊联合抗组胺药治疗慢性荨麻疹的系统评价

Systematic Review of Runzao Zhiyang Capsules Combined with Antihistamine in the Treatment of Chronic Urticaria

目的:系统评价润燥止痒胶囊联合抗组胺药治疗慢性荨麻疹(CU)的疗效及安全性。方法:检索PubMed、the Cochrane Library、Embase、Web of science、中国知网、中国生物医学文献数据库、万方数据库和维普数据库共8个数据库,并手动检索纳入文献的参考文献等进行补充检索,收集润燥止痒胶囊联合抗组胺药对比单纯使用抗组胺药治疗CU的随机对照试验,检索时限为建库至2021年6月。由2名研究人员独立完成筛选文献、提取资料和评价纳入研究的质量后,采用RevMan 5.3软件进行Meta分析,并采用Stata 15.1软件检验发表偏倚。结果:共纳入32项研究,合计3061例CU患者。Meta分析结果表明,润燥止痒胶囊联合抗组胺药的总有效率优于单纯使用抗组胺药(RR=1.16,95%CI=1.13~1.19,P<0.00001),不良反应发生率低于单纯使用抗组胺药(RR=0.49,95%CI=0.40~0.61,P<0.00001),复发率低于单纯使用抗组胺药(RR=0.42,95%CI=0.31~0.57,P<0.00001),差异均有统计学意义,但证据质量有待提高。发表偏倚检验及非参数剪补法分析结果显示,总有效率结局指标存在偏倚,但可能存在的发表偏倚未对结果造成影响。结论:基于现有证据,对比单纯使用抗组胺药,润燥止痒胶囊联合抗组胺药治疗CU的疗效肯定,不良反应发生率和复发率较低。但由于纳入研究的质量较低,存在较高偏倚风险,仍需谨慎看待上述结果。

OBJECTIVE:To systematically evaluate the efficacy and safety of Runzao Zhiyang capsules combined with antihistamine in the treatment of chronic urticaria(CU).METHODS:PubMed,the Cochrane Library,Embase,Web of Science,CNKI,CBM,Wanfang Data and VIP database were retrieved to collect the randomized controlled trial of Runzao Zhiyang capsules combined with antihistamine versus antihistamine alone in the treatment of CU,and the included references were manually searched for supplementary retrieval.The retrieval time was from the establishment of the database to Jun.2021.Two researchers independently screened the literature,extracted data and evaluated the quality of the included studies.Meta-analysis was performed by using RevMan 5.3 software,and publication bias was tested by Stata 15.1 software.RESULTS:A total of 32 studies were enrolled,including 3061 patients with CU.Meta-analysis showed that the total effective rate of Runzao Zhiyang capsules combined with antihistamine was better than that of antihistamine alone(RR=1.16,95%CI=1.13-1.19,P<0.00001),and the incidence of adverse drug reactions was lower than that of antihistamine alone(RR=0.49,95%CI=0.40-0.61,P<0.00001),the recurrence rate was lower than that of antihistamine alone(RR=0.42,95%CI=0.31-0.57,P<0.00001),the differences were statistically significant,yet the evidence quality remained to be improved.Results of publication bias test and non-parametric shear and supplement method showed that the outcome index of total effective rate was biased,but the possible publication bias did not affect the results.CONCLUSIONS:Based on the existing evidence,compared with antihistamine alone,Runzao Zhiyang capsules combined with antihistamine has significant effect in the treatment of CU,with a lower incidence of adverse drug reactions and recurrence.However,due to the low quality of the included studies and the high risk of bias,the above results need to be viewed with caution.