香菊胶囊治疗鼻窦炎的有效性和安全性的系统评价与Meta分析

Systematic review and Meta-analysis of efficacy and safety of Xiangju Capsules in treatment of sinusitis

对香菊胶囊治疗鼻窦炎的有效性和安全性进行系统评价。检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(CBM)、Cochrane Library、PubMed、EMbase、Web of Science,筛选香菊胶囊治疗鼻窦炎的随机对照试验(RCTs),并用RevMan 5.3软件对最终纳入的研究进行Meta分析。共纳入29项研究,总样本量4331例,试验组2196例,对照组2135例。Meta分析结果显示,常规治疗+香菊胶囊的显效率(RR=1.30,95%CI[1.15,1.47],P<0.00001)、总有效率(RR=1.19,95%CI[1.16,1.23],P<0.00001)和Lund-Mackay评分(MD=-1.23,95%CI[-1.39,-1.07],P<0.00001)优于仅使用常规治疗;常规治疗+桉柠蒎肠溶软胶囊+香菊胶囊对总有效率(RR=1.14,95%CI[1.07,1.21],P<0.0001)和VAS评分的改善优于常规治疗+桉柠蒎肠溶软胶囊(MD_(头痛)=-1.29,95%CI[-1.48,-1.10],P<0.00001;MD_(鼻塞)=-1.08,95%CI[-1.21,-0.95],P<0.00001;MD_(嗅觉障碍)=-1.05,95%CI[-1.23,-0.87],P<0.00001;MD_(面部障碍)=-1.38,95%CI[-1.49,-1.27],P<0.00001);常规治疗+克拉霉素+香菊胶囊治疗鼻窦炎的总有效率(RR=1.15,95%CI[1.08,1.21],P<0.00001)优于常规治疗+克拉霉素,但对显效率(RR=1.27,95%CI[0.98,1.65],P=0.07)的改善无差异;克拉霉素+香菊胶囊对鼻窦炎患者显效率(RR=2.16,95%CI[1.47,3.18],P<0.0001)和总有效率(RR=1.48,95%CI[1.28,1.72],P<0.00001)的提高以及CT评分(MD=-1.87,95%CI[-2.01,-1.74],P<0.00001)的改善明显优于单用克拉霉素。试验序贯分析(TSA)表明,目前主要结局指标的累计样本量已经达到期望值。不良反应主要为嗜睡、腹泻和腹痛等,均与香菊胶囊无直接关系。基于现有数据和方法,香菊胶囊联合多种治疗能够提高鼻窦炎治疗的显效率和总有效率,改善CT评分、VAS评分和Lund-Mackay评分,无严重不良反应。今后仍需采用大样本、设计严谨、符合国际规范的临床试验方案来验证香菊胶囊治疗鼻窦炎的有效性与安全性。

The present study evaluated the efficacy and safety of Xiangju Capsules in the treatment of sinusitis.CNKI,Wanfang,VIP,CBM,Cochrane Library,PubMed,EMbase,Web of Science and ClinicalTrials.gov were systematically searched for randomized controlled trials(RCTs)of Xiangju Capsules in the treatment of sinusitis,and Meta-analysis was performed on the included articles using RevMan 5.3.Twenty-nine articles were included,involving 4331 cases,including 2196 cases in the experimental group and 2135 cases in the control group.Meta-analysis results showed that the conventional therapy combined with Xiangju Capsules showed better significant efficiency(RR=1.30,95%CI[1.15,1.47],P<0.00001),total response rate(RR=1.19,95%CI[1.16,1.23],P<0.00001),and Lund-Mackay scores(MD=-1.23,95%CI[-1.39,-1.07],P<0.00001)than conventional therapy alone.The conventional therapy combined with Eucalyptol-limonene-pinene Enteric Soft Capsules and Xiangju Capsules showed better total response rate(RR=1.14,95%CI[1.07,1.21],P<0.0001)and VAS scores than conventional therapy combined with Eucalyptol-limonene-pinene Enteric Soft Capsules(MD_(headache)=-1.29,95%CI[-1.48,-1.10],P<0.00001;MD_(congestion)=-1.08,95%CI[-1.21,-0.95],P<0.00001;MD_(olfactory dysfunction)=-1.05,95%CI[-1.23,-0.87],P<0.00001;MD_(facial disorder)=-1.38,95%CI[-1.49,-1.27],P<0.00001).The conventional therapy combined with clarithromycin and Xiangju Capsules displayed a better total response rate(RR=1.15,95%CI[1.08,1.21],P<0.00001)than conventional therapy combined with clarithromycin,while no significant difference was observed in the significant efficiency(RR=1.27,95%CI[0.98,1.65],P=0.07).The significant efficiency(RR=2.16,95%CI[1.47,3.18],P<0.0001)and total effective rate(RR=1.48,95%CI[1.28,1.72],P<0.00001)of clarithromycin combined with Xiangju Capsules in patients with sinusitis and CT scores(MD=-1.87,95%CI[-2.01,-1.74],P<0.00001)was significantly better than clarithromycin alone.Trial sequential analysis(TSA)showed that the cumulative sample size of the main outcome indicators had met expectations.The main adverse reactions included drowsiness,diarrhea,and abdominal pain,which had no direct relationship with Xiangju Capsules.Based on the available data and methods,the combination of Xiangju Capsules with multiple treatments showed significant efficiency and total response rate in the treatment of sinusitis,and improved CT scores,VAS scores,and Lund-Mackay scores,without serious adverse reactions.The efficacy and safety of Xiangju Capsules in the treatment of sinusitis still need to be verified by a large-sample,well-designed,and internationally standardized clinical trial scheme.