目的:系统评价玉屏风散联合第二代抗组胺药对比第二代抗组胺药治疗慢性荨麻疹(CU)的疗效和安全性,以为CU的临床治疗提供循证参考。方法:计算机检索PubMed、Embase、The Cochrane Liarary、中国期刊全文数据库、中文科技期刊数据库、中国生物医学文献数据库,收集玉屏风散联合第二代抗组胺药(试验组)对比第二代抗组胺药(对照组)治疗CU的疗效(总有效率、痊愈率、复发率)和安全性(不良反应发生率等)的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取,并采用Cochrane系统评价员手册5.1.0进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入34项RCT,合计3 405例患者。Meta分析结果显示,试验组患者总有效率[OR=4.02,95%CI(3.03,5.34),P<0.001]、痊愈率[OR=2.25,95%CI(1.95,2.60),P<0.001]、复发率[OR=0.33,95%CI(0.26,0.42),P<0.001]均显著优于对照组,差异均有统计学意义;两组患者不良反应发生率比较,差异无统计学意义[OR=0.98,95%CI(0.71,1.37),P=0.92]。结论:玉屏风散联合第二代抗组胺药治疗CU在提高总有效率、痊愈率及降低复发率方面均优于单用第二代抗组胺药,安全性相当。
Abstract
OBJECTIVE: To evaluate the efficacy and safety of Yupingfeng powder combined with second- generation antihistamines versus second-generation antihistamines for chronic urticaria (CU) systematically, and to provide evidence-based reference for clinical treatment for CU. METHODS: Retrieved from PubMed, Embase, The Cochrane Library, CJFD, VIP and CBM, RCT about therapeutic efficacy (total response rate, cure rate, recurrence rate) and safety (the incidence of ADR) of Yupingfeng combined with second-generation antihistamines (trial group) versus second-generation antihistamines (control group) in the treatment of CU were collected. The data extraction was performed for included clinical studies, and Meta-analysis was performed by using Rev Man 5.3 statistical software after quality evaluation with Cochrane Handbook 5.1.0 evaluation criteria. RESULTS: A total of 34 RCTs were enrolled, involved 3 405 patients in total. Results of Meta-analysis showed that the total response rate [OR=4.02,95%CI(3.03,5.34),P<0.001], cure rate [OR=2.25,95%CI(1.95,2.60),P<0.001] and recurrence rate [OR=0.33,95%CI(0.26,0.42),P<0.001] of trial group were significantly better than those of control group, with statistical significance. There was no statistical significance in the incidence of ADR between 2 groups [OR=0.98,95%CI(0.71, 1.37), P=0.92]. CONCLUSIONS: For CU therapy, Yupingfeng powder combined with second-generation antihistamines is better than second-generation antihistamines alone in improving total response rate and cure rate, reducing recurrence rate, both have similar safety.