Wang Yan, Xu Baichuan, Zhang Peng, Li Suyun, Xie Yang
National Regional Traditional Chinese Medicine (Lung Disease) Diagnosis and Treatment Center, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China.
The First Clinical College of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan, China.
Front Pharmacol. 2025 Aug 8;16:1591136. doi: 10.3389/fphar.2025.1591136. eCollection 2025.
Reduning (RDN) injection is a traditional Chinese medicine (TCM) extract injection commonly used as an adjunct therapy for severe pneumonia (SP) in clinical practice in China; however, further validation is required. This study aims to systematically assess the efficacy and safety of RDN injection in treating SP.
The study was conducted using the data from CNKI, WanFang, VIP, SinoMed, PubMed, Embase, Cochrane Library, and Web of Science databases from their inception to 6 April 2024. We collected randomized controlled trials on the treatment of SP using RDN injection, and used Review Manager (version 5.3) for meta analysis. The primary outcomes was clinical efficacy. We used the Cochrane Risk of Bias Assessment Tool 2 (RoB 2) to assess the risk of bias for each study.
A total of 1,897 patients with SP from 22 studies were included. The meta-analysis results showed that the combination of RDN injection and conventional treatment or antibiotic treatment for patients with SP was superior to traditional and antibiotic treatments alone in terms of clinical efficacy [risk ratio = 1.25%; 95% confidence interval (CI) (1.20, 1.30); < 0.00001], fever reduction time [mean difference (MD) = -1.55 days; 95% CI (-1.91, -1.18); < 0.00001], cough disappearance time [MD = -1.97 days; 95% CI (-2.63, -1.31); < 0.00001], lung rales disappearance time [MD = -2.39 days; 95% CI (-3.09, -1.70); < 0.00001], chest X-ray improvement time [MD = -2.73 days; 95% CI (-2.96, -2.49); < 0.00001], and hospitalization time [MD = -3.11 days; 95% CI (-3.80, -2.41); < 0.00001]. Moreover, no significant improvement was observed in the Acute Physiology and Chronic Health Evaluation II (APACHE II) scale compared to the control group [MD = -2.45 points; 95% CI (-6.07, 1.17); = 0.19]. Lastly, not all studies reported any serious adverse events; however, some studies did report adverse reactions.
The administration of RDN injection as an adjunct therapy for SP can enhance clinical efficacy, reduce fever duration, accelerate cough resolution, shorten the time for lung rales to resolve, accelerate chest X-ray improvement, and decrease hospitalization duration. Further well-designed and standardized large sample clinical studies are needed for validation.
PROSPERO, identifier CRD42024540365.
热毒宁注射液是一种中药提取物注射液,在中国临床实践中常用于作为重症肺炎(SP)的辅助治疗;然而,尚需进一步验证。本研究旨在系统评价热毒宁注射液治疗SP的疗效和安全性。
本研究使用了中国知网、万方、维普、中国生物医学文献数据库、PubMed、Embase、Cochrane图书馆和Web of Science数据库从建库至2024年4月6日的数据。我们收集了使用热毒宁注射液治疗SP的随机对照试验,并使用Review Manager(5.3版)进行荟萃分析。主要结局是临床疗效。我们使用Cochrane偏倚风险评估工具2(RoB 2)评估每项研究的偏倚风险。
共纳入22项研究中的1897例SP患者。荟萃分析结果显示,热毒宁注射液联合常规治疗或抗生素治疗SP患者在临床疗效方面优于单纯传统治疗和抗生素治疗[风险比=1.25%;95%置信区间(CI)(1.20,1.30);P<0.00001],在退热时间方面[平均差(MD)=-1.55天;95%CI(-1.91,-1.18);P<0.00001],咳嗽消失时间方面[MD=-1.97天;(-2.63,-1.31);P<0.00001],肺部啰音消失时间方面[MD=-2.39天;95%CI(-3.09,-1.70);P<0.00001],胸部X线改善时间方面[MD=-2.73天;95%CI(-2.96,-2.49);P<0.00001],以及住院时间方面[MD=-3.11天;95%CI(-3.80,-2.41);P<0.00001]。此外,与对照组相比,急性生理与慢性健康状况评分系统II(APACHE II)量表未见显著改善[MD=-2.45分;95%CI(-6.07,1.17);P=0.19]。最后,并非所有研究都报告了任何严重不良事件;然而,一些研究确实报告了不良反应。
热毒宁注射液作为SP的辅助治疗可提高临床疗效,缩短发热持续时间,加快咳嗽缓解,缩短肺部啰音消失时间,加快胸部X线改善,并缩短住院时间。尚需进一步开展设计良好且标准化的大样本临床研究进行验证。
PROSPERO,标识符CRD42024540365。