宾纳福喜颗粒治疗普通感冒发热的疗效和安全性:一项多中心、随机、双盲、安慰剂对照的II期临床试验

IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE
Xuemei Liu , Jie Min , Bin She , Yan Chen , Jun Li , Lei Huang , Ju Chen , Ai Luo , Mei Yang , Ting Li , Yanqing Wu , Daohong Chen , Hongli Zhong , Wei Liu , Bing Mao , Hongli Jiang
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引用次数: 0

摘要

背景必那福喜颗粒是一种治疗普通感冒伴发热的维吾尔族传统药物。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,将普通感冒和发烧患者按1:1:1的比例随机分为高剂量组、低剂量组和安慰剂组。结果包括退烧时间、退热时间、无热患者比例、症状消失时间、症状消失率、有效率、紧急用药和安全性评估。结果共招募235名患者。其中,234项纳入完整分析集(FAS),217项纳入按方案集(PPS)。在FAS分析中,高剂量组、低剂量组和安慰剂组的中位退烧时间分别为6.00小时、5.54小时和10.65小时(P=0.31)。发热消退的中位时间分别为18.29小时、20.08小时和25.00小时(P=0.0018),无热患者的比例分别为92.4%、89.7%和71.4%(P=0.0002)。所有症状和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。结论必复喜颗粒能剂量依赖性地缩短普通感冒伴发热患者的发热病程,改善临床症状。试验注册本试验在中国临床试验注册中心(ChiCTR-IIR-17013379)注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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

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 (P = 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 (P = 0.0018), respectively, and the proportion of afebrile patients was 92.4%, 89.7% and 71.4% (P = 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).

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来源期刊
Integrative Medicine Research
Integrative Medicine Research Medicine-Complementary and Alternative Medicine
CiteScore
6.50
自引率
2.90%
发文量
65
审稿时长
12 weeks
期刊介绍: Integrative Medicine Research (IMR) is a quarterly, peer-reviewed journal focused on scientific research for integrative medicine including traditional medicine (emphasis on acupuncture and herbal medicine), complementary and alternative medicine, and systems medicine. The journal includes papers on basic research, clinical research, methodology, theory, computational analysis and modelling, topical reviews, medical history, education and policy based on physiology, pathology, diagnosis and the systems approach in the field of integrative medicine.
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