肤痒颗粒联合抗组胺药治疗慢性荨麻疹有效性和安全性的系统评价  

Systematic Review of Efficacy and Safety of Fuyang Granules Combined with Antihistamines in the Treatment of Chronic Urticaria

作　　者：郑子恢[1] 王洋[1] 张白歌 李文英[1] 马琳[1] 邹定[1] 金鹏飞[1] ZHENG Zihui;WANG Yang;ZHANG Baige;LI Wenying;MA Lin;ZOU Ding;JIN Pengfei(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730

出　　处：《中国医院用药评价与分析》2021年第8期973-977,980,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：中央保健专项基金项目(No.B2009B032)。

摘　　要：目的:系统评价肤痒颗粒联合抗组胺药治疗慢性荨麻疹(chronic urticaria,CU)的有效性和安全性。方法:计算机检索PubMed、the Cochrane Library、Embase、万方数据库、中国知网和中国生物医学文献数据库,收集肤痒颗粒联合抗组胺药治疗CU的随机对照试验(randomized controlled trial,RCT)(研究组的治疗方案为肤痒颗粒联合抗组胺药,对照组为单独使用抗组胺药),检索时间为从建库至2021年5月。由2名研究者选取文献、提取资料并评价纳入文献的偏倚风险后,采用RevMan 5.4软件进行荟萃分析(Meta分析)。结果:共纳入10项RCT研究,包括873例患者(研究组451例患者,对照组422例患者)。Meta分析结果显示,有效性方面,研究组患者的总有效率(OR=4.31,95%CI=2.78~6.68,P<0.00001)、显效率(OR=1.42,95%CI=1.06~1.91,P=0.02)、痊愈率(OR=2.56,95%CI=1.83~3.59,P<0.00001)和复发率(OR=0.29,95%CI=0.12~0.68,P=0.004)均显著优于对照组,差异均有统计学意义;安全性方面,研究组患者的不良反应发生率显著低于对照组,差异有统计学意义(OR=0.43,95%CI=0.26~0.71,P=0.001)。结论:现有证据表明,肤痒颗粒联合抗组胺药治疗CU安全、有效,不宜复发,较单独使用抗组胺药有明显优势。受选取的RCT数量和质量的限制,上述结论有待今后更多高质量RCT予以验证。OBJECTIVE:To systematically evaluate the efficacy and safety of Fuyang granules combined with antihistamines in the treatment of chronic urticaria(CU).METHODS:PubMed,the Cochrane Library,EMBase,Wanfang data base,CNKI and CBM database were retrieved to collect the randomized controlled trial(RCT)of Fuyang granules combined with antihistamines in the treatment of CU(the study group was given Fuyang granules combined with antihistamines,while the control group received antihistamines).The retrieval time was from the establishment of the database to May 2021.Meta-analysis was performed by using RevMan 5.4 software after selection of literature,extraction of information and evaluation of risk of bias in the included literature by two researchers.RESULTS:Totally 10 RCT were collected,including 873 patients(451 patients in the study group and 422 patients in the control group).Meta-analysis showed that the total effective rate(OR=4.31,95%CI=2.78-6.68,P<0.00001),significant effective rate(OR=1.42,95%CI=1.06-1.91,P=0.02),cure rate(OR=2.56,95%CI=1.83-3.59,P<0.00001)and recurrence rate(OR=0.29,95%CI=0.12-0.68,P=0.004)in the study group were significantly better than those in the control group,and the differences were statistically significant.The incidence of adverse drug reactions in the study group was significantly lower than that in the control group,with statistically significant difference(OR=0.43,95%CI=0.26-0.71,P=0.001).CONCLUSIONS:Existing evidence shows that Fuyang granules combined with antihistamines is safe and effective in the treatment of CU with lower recurrence rate,and has obvious advantages over the use of antihistamines alone.Limited by the quantity and quality of selected RCT,the above conclusions need to be verified by more high-quality RCT in the future.

关 键 词：肤痒颗粒 抗组胺药 慢性荨麻疹 META分析 随机对照试验 

分 类 号：R932[医药卫生—生药学]