玉屏风散治疗小儿过敏性鼻炎：随机对照试验的系统评价与Meta分析
Yu ping feng san for pediatric allergic rhinitis: A systematic review and meta-analysis of randomized controlled trials.
作者信息
Liao Yong, Zhong Juan, Liu Shuqin, Dai Menglin, Liu Yang, Li Xinrong, Yang Yepeng, Zhang Dazheng, Lai Dan, Lu Tao, Zhang Qinxiu, Zhao Yu
机构信息
Department of Otorhinolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu.
Department of Otorhinolaryngology Head and Neck Surgery, Minda Hospital of Hubei Minzu University, Enshi.
出版信息
Medicine (Baltimore). 2021 Apr 2;100(13):e24534. doi: 10.1097/MD.0000000000024534.
BACKGROUND
The potential treatment effects and safety of Yu ping feng san (YPFS) for pediatric allergic rhinitis (PAR) patients have yet to be studied systematically.
OBJECTIVES
To assess the effects and safety of YPFS for treat pediatric patients, allergic rhinitis.
METHODS
We systematically searched PubMed, EMBASE (Excerpta Medical Database), Cochrane library, Chinese Cochrane Centre's Controlled Trials Register platform, Wanfang Chinese Digital Periodical and Conference Database, China National Knowledge Infrastructure Database, and VIP Chinese Science, from inception dates to November 1, 2019. Randomized controlled trials (RCTs) were included. The risk of bias in the trials was assessed in accordance with the Cochrane Handbook, version 5.1.0. RevMan 5.3 software was used to perform a meta-analysis. Grading of Recommendations Assessment, Development and Evaluation methodology was applied to evaluate the evidence quality for each outcome. The quality of evidence for each outcome measurement was low for 4 outcomes and very low for 5 outcomes.
RESULTS
A total of 10 RCTs involving 1069 participants (3-15 years old) fulfilled the inclusion criteria. After exclusion, 8 RCTs were pooled for efficacy assessment. The overall efficacy evaluation result did not show benefit for the experimental group (relative risk 0.32, CI 95% 0.24-0.45; P = .98;) Investigation of variation of serum IgA, immunoglobulin E, IgG in three studies in 2 groups returned no statistical significance. YPFS gave relatively better safety (relative risk 0.29, CI 95% 0.14-0.58; P = .0005; Fig. S8, http://links.lww.com/MD/F751) and lower recurrence rates than did Western medical therapy.
CONCLUSIONS
Current evidence cannot support the routine use of YPFS for treatment of PAR. This may be due to poor-quality study-design limitations of the included YPFS studies. Our data showed that the use of YPFS for PAR is relatively safe compared to Western medical therapy, but a conclusion could not be drawn because only 5 studies were analyzed. Every study suffered from some methodological limitation. Therefore, further large, rigorously-designed studies are necessary to determine conclusively the utility of YPFS in PAR.
背景
玉屏风散（YPFS）治疗小儿过敏性鼻炎（PAR）患者的潜在治疗效果和安全性尚未得到系统研究。
目的
评估玉屏风散治疗小儿过敏性鼻炎患者的疗效和安全性。
方法
我们系统检索了PubMed、EMBASE（医学文摘数据库）、Cochrane图书馆、中国Cochrane中心对照试验注册平台、万方中文数字期刊和会议数据库、中国知网数据库以及维普中文科技期刊数据库，检索时间从建库至2019年11月1日。纳入随机对照试验（RCT）。根据Cochrane手册5.1.0版评估试验中的偏倚风险。使用RevMan 5.3软件进行荟萃分析。应用推荐意见评估、制定与评价方法对每个结局的证据质量进行评价。4个结局的每个结局测量的证据质量为低，5个结局为极低。
结果
共有10项涉及1069名参与者（3至15岁）的RCT符合纳入标准。排除后，8项RCT纳入疗效评估。总体疗效评估结果未显示试验组有获益（相对危险度0.32，95%CI 0.24 - 0.45；P = 0.98）；对两组三项研究中血清IgA、免疫球蛋白E、IgG变化的调查无统计学意义。与西医治疗相比，玉屏风散安全性相对较好（相对危险度0.29，95%CI 0.14 - 0.58；P = 0.0005；图S8，http://links.lww.com/MD/F751）且复发率较低。
结论
目前的证据不能支持玉屏风散常规用于治疗小儿过敏性鼻炎。这可能是由于纳入的玉屏风散研究存在研究设计质量差的局限性。我们的数据表明，与西医治疗相比，玉屏风散用于小儿过敏性鼻炎相对安全，但由于仅分析了5项研究，无法得出结论。每项研究都存在一些方法学局限性。因此，有必要进行进一步的大型、设计严谨的研究，以最终确定玉屏风散在小儿过敏性鼻炎中的效用。
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