Xi Jun-Yu, Lyu Jian, Xie Yan-Ming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
Zhongguo Zhong Yao Za Zhi. 2022 Jan;47(2):537-546. doi: 10.19540/j.cnki.cjcmm.20210922.501.
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 4 331 cases, including 2 196 cases in the experimental group and 2 135 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<0.000 01), total response rate(RR=1.19, 95%CI[1.16, 1.23], P<0.000 01), and Lund-Mackay scores(MD=-1.23, 95%CI[-1.39,-1.07], P<0.000 01) 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<0.000 1) 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<0.000 01; MD_(congestion)=-1.08, 95%CI[-1.21,-0.95], P<0.000 01; MD_(olfactory dysfunction)=-1.05, 95%CI[-1.23,-0.87], P<0.000 01; MD_(facial disorder)=-1.38, 95%CI[-1.49,-1.27], P<0.000 01). 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<0.000 01) 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<0.000 1) and total effective rate(RR=1.48, 95%CI[1.28, 1.72], P<0.000 01) of clarithromycin combined with Xiangju Capsules in patients with sinusitis and CT scores(MD=-1.87, 95%CI[-2.01,-1.74], P<0.000 01) 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.
本研究评估了香菊胶囊治疗鼻窦炎的疗效和安全性。通过系统检索中国知网、万方、维普、中国生物医学文献数据库、考克兰图书馆、PubMed、EMbase、Web of Science和ClinicalTrials.gov等数据库，查找香菊胶囊治疗鼻窦炎的随机对照试验（RCT），并使用RevMan 5.3对纳入的文章进行Meta分析。共纳入29篇文章，涉及4331例患者，其中试验组2196例，对照组2135例。Meta分析结果显示，与单纯常规治疗相比，常规治疗联合香菊胶囊的显效率（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）及Lund - Mackay评分（MD = -1.23，95%CI[-1.39，-1.07]，P < 0.00001）均更佳。常规治疗联合桉柠蒎肠溶软胶囊和香菊胶囊比常规治疗联合桉柠蒎肠溶软胶囊的总有效率更高（RR = 1.14，95%CI[1.07，1.21]，P < 0.0001），且在VAS评分方面也更优（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面部不适=-1.38，95%CI[-1.49，-1.27]，P < 0.00001）。常规治疗联合克拉霉素和香菊胶囊比常规治疗联合克拉霉素的总有效率更高（RR = 1.15，95%CI[1.08，1.21]，P < 0.00001），但显效率无显著差异（RR = 1.27，95%CI[0.98，1.65]，P = 0.07）。克拉霉素联合香菊胶囊治疗鼻窦炎的显效率（RR = 2.16，95%CI[1.47，3.18]，P < 0.0001）、总有效率（RR = 1.48，95%CI[1.28，1.72]，P < 0.00001）及CT评分（MD = -1.87，95%CI[-2.01，-1.74]，P < 0.00001）均显著优于单用克拉霉素。试验序贯分析（TSA）显示主要结局指标的累积样本量已达到预期。主要不良反应包括嗜睡、腹泻和腹痛，这些与香菊胶囊无直接关系。基于现有数据和方法，香菊胶囊与多种治疗方法联合应用在治疗鼻窦炎方面显示出显效率和总有效率，并改善了CT评分、VAS评分和Lund - Mackay评分，且无严重不良反应。香菊胶囊治疗鼻窦炎的疗效和安全性仍需通过大样本、设计良好且国际标准化的临床试验方案进行验证。
