中药（鼻安福喜颗粒）治疗感冒伴发热的疗效与安全性：一项多中心、随机、双盲、安慰剂对照的II期临床试验。

Efficacy and safety of herbal medicine (Binafuxi granules) for the common cold with fever: A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial.

作者信息

Liu Xuemei, Min Jie, She Bin, Chen Yan, Li Jun, Huang Lei, Chen Ju, Luo Ai, Yang Mei, Li Ting, Wu Yanqing, Chen Daohong, Zhong Hongli, Liu Wei, Mao Bing, Jiang Hongli

机构信息

Division of Pulmonary Medicine, Department of Internal Medicine, Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.

Department of Pulmonary Diseases, State Key Laboratory of Biotherapy of China, West China Hospital of Sichuan University, Chengdu, China.

出版信息

Integr Med Res. 2023 Sep;12(3):100956. doi: 10.1016/j.imr.2023.100956. Epub 2023 May 19.

DOI:10.1016/j.imr.2023.100956

PMID:37359288

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10285547/

Abstract

BACKGROUND

Binafuxi granules are a traditional Uighur medicine (TUM) for treating the common cold with fever. However, high-quality clinical studies supporting its efficacy and safety are lacking.

METHODS

In this multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial, patients with common cold and fever were randomly assigned to a high-dose group, low-dose group, and placebo group in a 1:1:1 ratio. Outcomes were time to fever relief, time to fever clearance, proportion of afebrile patients, time to symptom disappearance, rate of symptom disappearance, effective rate, emergency drug usage and safety assessment.

RESULTS

A total of 235 patients were recruited. Of these, 234 were included in the full analysis set (FAS), and 217 were included in the per-protocol set (PPS). In the FAS analysis, the median time to fever relief was 6.00 h, 5.54 h and 10.65 h ( = 0.31) in the high-dose group, low-dose group and placebo group, respectively. The median time to fever clearance was 18.29 h, 20.08 h and 25.00 h ( = 0.0018), respectively, and the proportion of afebrile patients was 92.4%, 89.7% and 71.4% ( = 0.0002), respectively. There was a significant difference in the disappearance time and disappearance rate of all symptoms and of individual symptoms. No serious adverse events were found.

CONCLUSIONS

Binafuxi granules can dose-dependently shorten the fever course and improve clinical symptoms in patients suffering from the common cold with fever.

TRIAL REGISTRATION

This trial was registered at Chinese Clinical Trial Registry (ChiCTR-IIR-17013379).

摘要

背景

比纳福西颗粒是一种用于治疗感冒发热的维吾尔族传统药物（TUM）。然而，缺乏支持其疗效和安全性的高质量临床研究。

方法

在这项多中心、随机、双盲、安慰剂对照的II期临床试验中，感冒发热患者按1:1:1的比例随机分为高剂量组、低剂量组和安慰剂组。观察指标包括退热时间、热退清时间、体温正常患者比例、症状消失时间、症状消失率、有效率、急救药物使用情况及安全性评估。

结果

共招募235例患者。其中，234例纳入全分析集（FAS），217例纳入符合方案集（PPS）。在FAS分析中，高剂量组、低剂量组和安慰剂组的退热中位时间分别为6.00小时、5.54小时和10.65小时（P = 0.31）。热退清中位时间分别为18.29小时、20.08小时和25.00小时（P = 0.0018），体温正常患者比例分别为92.4%、89.7%和71.4%（P = 0.0002）。所有症状及个别症状的消失时间和消失率存在显著差异。未发现严重不良事件。