摘要
目的:系统评价止嗽散加减联合西药治疗咳嗽变异性哮喘(Cough Variant Asthma,CVA)的疗效及安全性。方法:通过检索中国知网、维普、万方、中国生物医学文献数据库和PubMed等5个中英文数据库,获取从建库起至2022年5月关于止嗽散加减联合西药治疗CVA的临床随机对照试验。经文献筛选和信息提取后,再将符合质量要求的文献用Rev Man 5.3软件进行Meta分析,最后将研究结果根据GRADE标准进行证据质量评价。结果:共纳入21项研究,共计1814例CVA患者。Meta分析结果:与单纯西医治疗相比,联用止嗽散加减可以显著提高临床疗效总有效率[危险度(Risk Rate,RR)=1.24,95%置信区间(Confidence Interval,CI)(1.18,1.30),P<0.00001]、降低复发率[RR=0.27,95%CI(0.18,0.42),P<0.00001]、提高第1秒用力呼气容积(Forced Expiratory Volume in 1 Second,FEV1)[均数差(Mean Differences,MD)=0.28,95%CI(0.17,0.38),P<0.00001]、提高肺功能激发试验转阴率[RR=1.95,95%CI(1.35,2.82),P=0.0004]、增加用力肺活量(Forced Vital Capacity,FVC)[MD=0.26,95%CI(0.11,0.41),P=0.0007]、减少咳嗽缓解时间[MD=–4.36,95%CI(–5.93,–2.80),P<0.00001]、降低血清免疫球蛋白(Immunoglobulin,Ig)E值[MD=–62.03,95%CI(–106.10,–17.95),P=0.006],且差异均具有统计学意义;在安全性方面,与单纯西医治疗差异无统计学意义(P>0.05)。根据GRADE标准,“减少咳嗽缓解时间”“降低IgE”被评为极低质量证据;“增加FVC”“降低不良反应发生率”“提高临床疗效总有效率”“降低复发率”“增加FEV_(1)”“提高肺功能激发试验转阴率”被评为低质量证据。结论:相对于单纯西医治疗,联用止嗽散加减治疗CVA显示出更好的疗效。因本系统评价纳入的文献方法学质量低,且存在潜在的偏倚风险,尚需更多设计严谨的多中心随机对照试验增加证据强度。
Objective:To systematically evaluate the efficacy and safety of Zhisou San(止嗽散)in the treatment of cough variantasthma(CVA).Methods:By searching 5 Chinese and English databases,including CNKI,VIP,WANFANG,CBM and PubMed,the clinical randomized controlled trials(RCTs)on Zhisou San combined with Western medicine in the treatment of CVA from theestablishment of the database to May 2022 were obtained.After literature screening and information extraction,meta-analysis was performedon literature that met the quality requirements using RevMan 5.3 software,and finally,the evidence quality was evaluated according to GRADEstandards.Results:A total 21 RCTs were enrolled,including 1841 patients,meta-analysis results showed that Zhisou San combined with Westernmedicine could increase the response rate[RR=1.24,95%CI(1.18,1.30),P<0.00001]and reduce the recurrence rate[RR=0.27,95%CI(0.18,0.42).P<0.00001],increase forced expiratory volume at the end of the first second(FEV_(1))[WMD=0.28,95%CI(0.17,0.38),P<0.00001],increasenegative conversion rate of pulmonary function stimulation test[RR=1.95,95%CI(1.35,2.82),P=0.0004],increase forced vital capacity(FVC)[WMD=0.26,95%CI(0.11,0.41),P=0.0007],reduce cough remission time[MD=–4.36,95%CI(–5.93,–2.80),P<0.00001],immunoglobulin E(IgE)value was decreased[MD=–62.03,95%CI(–106.10,–17.95),P=0.006],and the differences were statistically significant.In terms of safety,there was no significant difference between the two groups(P>0.05).According to GRADE criteria,reduced cough resolution time and decreasedserum IgE were rated as very low quality evidence;Increasing FVC,reducing the incidence of adverse reactions,improving the total effectiverate of clinical efficacy,reducing the recurrence rate,increasing FEV_(1),improving the negative conversion rate of lung function stimulation testwere rated as low-quality evidence.Conclusion:Compared with Western medicine alone,Zhisou San combined with Western medicine shows abetter curative effect on cough-variant asthma.Due to the low methodological quality of the literature included in this systematic review and thepotential risk of bias,more rigorously designed multi-center RCTs are needed to increase the strength of evidence.
作者
杨云涵
闫平
YANG Yunhan;YAN Ping
出处
《中医临床研究》
2023年第21期35-43,共9页
Clinical Journal Of Chinese Medicine
基金
山东省中医药科技项目(M-2022073)。
