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银花平感颗粒治疗社区获得性肺炎的有效性:一项随机双盲临床试验

Effectiveness of Yinhua Pinggan granules in community-acquired pneumonia: a randomized, double-blind clinical trial.

作者信息

Wang Jiao-Li, Hu Hao-Ran, Guo Yi-Lei, Han Jin, Wan Hai-Tong, Tong Yu-Xiao, Luo Man, Li Xian-Wen

机构信息

College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.

Department of Respiratory Medicine, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, China.

出版信息

Front Pharmacol. 2025 Mar 4;16:1446319. doi: 10.3389/fphar.2025.1446319. eCollection 2025.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Community-acquired pneumonia (CAP) is an acute inflammation of the alveoli and distal bronchi caused by bacterial, viral, or other pathogenic microbial infections. Yinhua Pinggan (YHPG) granules have demonstrated anti-inflammatory, antibacterial, and antiviral effects, suggesting their potential as a treatment option for CAP.

AIM

To assess the efficacy and safety of traditional Chinese medicine (TCM), YHPG granules, in combination with conventional pneumonia treatments.

MATERIALS AND METHODS

This randomized, double-blind, placebo-controlled clinical trial was conducted at a medical center in Hangzhou and involved 240 eligible participants. In addition to conventional pneumonia treatment, participants were randomly assigned in a 1:1 ratio to receive either YHPG granules or placebo for 10 days. The primary outcome measure was the difference in pneumonia cure rates at the end of treatment. Secondary outcomes included chest CT absorption rate, criticality score (SMART-COP score), Acute Physiology and Chronic Health Evaluation II (APACHE II) score, C-reactive protein (CRP) level, lactate (LC) level, procalcitonin (PCT) level, time for symptom recovery, length of hospital stay, and TCM syndrome scores.

RESULTS

In total, 229 participants were included in the analysis. The pneumonia cure rate in the YHPG granule group was higher than that in the placebo group (37.2% vs. 22.4%, mean difference: 14.75%, 95% CI: 3.05-26.46, < 0.05), indicating the superiority of YHPG granules. The granules significantly improved the chest CT absorption rate, pneumonia severity, and CRP and LC levels ( < 0.05). Additionally, YHPG granules resulted in a shorter recovery time from fever and lung rales, reduced hospital stay, and lowered the TCM syndrome scores than the placebo ( < 0.05). No significant differences were observed in other outcomes between the two groups ( > 0.05). Notably, the use of YHPG granules was associated with fewer adverse reactions.

CONCLUSION

YHPG granules are a promising adjunct therapeutic agent for CAP.

CLINICAL TRIAL REGISTRATION

https://www.chictr.org.cn/showproj.html?proj=127908, identifier ChiCTR2100047501.

摘要

民族药理学相关性

社区获得性肺炎(CAP)是由细菌、病毒或其他致病微生物感染引起的肺泡和远端支气管的急性炎症。银花平感(YHPG)颗粒已显示出抗炎、抗菌和抗病毒作用,表明其作为CAP治疗选择的潜力。

目的

评估中药YHPG颗粒联合传统肺炎治疗方法的疗效和安全性。

材料与方法

这项随机、双盲、安慰剂对照的临床试验在杭州的一家医疗中心进行,纳入了240名符合条件的参与者。除了传统的肺炎治疗外,参与者按1:1的比例随机分配,接受YHPG颗粒或安慰剂治疗10天。主要结局指标是治疗结束时肺炎治愈率的差异。次要结局包括胸部CT吸收率、危急评分(SMART-COP评分)、急性生理与慢性健康状况评分系统II(APACHE II评分)、C反应蛋白(CRP)水平、乳酸(LC)水平、降钙素原(PCT)水平、症状恢复时间、住院时间和中医证候评分。

结果

总共229名参与者纳入分析。YHPG颗粒组的肺炎治愈率高于安慰剂组(37.2%对22.4%,平均差异:14.75%,95%CI:3.05-26.46,P<0.05),表明YHPG颗粒的优越性。这些颗粒显著提高了胸部CT吸收率、肺炎严重程度以及CRP和LC水平(P<0.05)。此外,与安慰剂相比,YHPG颗粒使发热和肺部啰音的恢复时间缩短,住院时间缩短,中医证候评分降低(P<0.05)。两组在其他结局方面未观察到显著差异(P>0.05)。值得注意的是,使用YHPG颗粒的不良反应较少。

结论

YHPG颗粒是一种有前景的CAP辅助治疗药物。

临床试验注册

https://www.chictr.org.cn/showproj.html?proj=127908,标识符ChiCTR2100047501。

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