Jinhua Qinggan Granule for influenza-like illness with wind-heat invading the lung: a multi-center, randomized, double-blind, placebo-controlled trial

ZHANG Jiameng; JIN Zaiyan; BIAN Yongjun; LI Guoqin; LIU Zhiguo; LI Lei; ZHAO Ting; XIA Hongsheng

doi:10.3969/j.issn.2095-6606.2023.06.001

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Jinhua Qinggan Granule for influenza-like illness with wind-heat invading the lung: a multi-center, randomized, double-blind, placebo-controlled trial

Clinical Research | 更新时间：2023-12-08

- Jinhua Qinggan Granule for influenza-like illness with wind-heat invading the lung: a multi-center, randomized, double-blind, placebo-controlled trial
- Modern Chinese Clinical Medicine Vol. 30, Issue 6, Pages: 1-6(2023)
- 作者机构：
  
  中国中医科学院广安门医院呼吸科　北京　100053
- 作者简介：
- 基金信息：
- DOI：10.3969/j.issn.2095-6606.2023.06.001
  CLC： R254
- Published：30 November 2023，
  
  Received：07 May 2023，
- 稿件说明：
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ZHANG Jiameng, JIN Zaiyan, BIAN Yongjun, et al. Jinhua Qinggan Granule for influenza-like illness with wind-heat invading the lung: a multi-center, randomized, double-blind, placebo-controlled trial. [J]. Modern Chinese Clinical Medicine 30(6):1-6(2023)
DOI：

ZHANG Jiameng, JIN Zaiyan, BIAN Yongjun, et al. Jinhua Qinggan Granule for influenza-like illness with wind-heat invading the lung: a multi-center, randomized, double-blind, placebo-controlled trial. [J]. Modern Chinese Clinical Medicine 30(6):1-6(2023) DOI： 10.3969/j.issn.2095-6606.2023.06.001.

摘要

目的

评价金花清感颗粒治疗流感样病例风热犯肺证的有效性及安全性。

方法

采用多中心、随机、双盲、安慰剂对照的设计方法，将480例流感样病例风热犯肺证患者分为治疗组360例、安慰剂组120例，分别给予金花清感颗粒5 g /次，3次/d；金花清感颗粒模拟剂5 g /次，3次/d。疗程均为连续服药3 d。观察2组退热时间及退热率、中医证候积分、中医证候疗效、流感主要症状/体征消失率及安全性指标。

结果

治疗组中位退热时间为25.7(24.0，28.0)h，安慰剂组中位退热时间为38.0 (34.7，47.5)h。随时间增长，2组退热率均上升，治疗组总体退热情况较安慰剂组好，差异有统计学意义(log-rank

＝10.822，

＝0.001)。中医证候积分2组治疗后较本组治疗前均下降，差异有统计学意义(

0.05)。2组治疗前后差值比较，差异有统计学意义(

0.05)，治疗组在改善中医证候积分方面优于安慰剂组。治疗后，治疗组中医证候疗效总有效率为97.2%，安慰剂组总有效率为85.7%，治疗组疗效优于安慰剂组，差异有统计学意义(

0.05)。除咽部充血、扁桃体肿大外，其他流感主要症状/体征包括发热、头痛、全身酸痛、咽痛、咳嗽等消失率，治疗组均优于安慰剂组，差异有统计学意义(

0.05)。2组均未出现严重不良事件。

结论

金花清感颗粒治疗流感样病例(风热犯肺证)有较好的临床疗效和安全性。

Abstract

Objective

To assess the effect and safety of Jinhua Qinggan Granule (JHG) on patients with influenza-like illness of the pattern of wind-heat invading the lung (WHIL).

Methods

In a multi-center

double-blind

randomized

controlled trial (RCT)

patients with influenza-like illness of WHIL were randomized by stratification into the treatment group (

=360) and the placebo control group(

=120). Patients in the treatment group were given JHG

while those in the control group received placebo at a dosage of 5 g per time

3 times per day. All medications were administered three times daily for 3 days. The fever disappearance time

the fever disappearance rate

the total score and efficacy of TCM syndrome

the disappearance rate of main symptoms and physical signs of flu

and safety indicators were assessed.

Results

The median fever disappearance time was 25.7(24.0

28.0) h (

=357) in the treatment group

38.0 (34.7

47.5) h (

=119) in the placebo control group. With the increase of time

the antipyretic rate of both groups increased

but the overall antipyretic condition of the treatment group was better than that of the control group

and the difference was statistically significant (log-rank

=10.822

= 0.001). Compared with baseline in the same group

the total scores of TCM syndrome were decreased after treatment in both groups (

0.05). There was significant difference between the two groups before and after treatment (

0.05). The treatment group was superior to the placebo group in improving the score of TCM syndrome. Three days after treatment

the total effective rate of TCM syndrome in the treatment group was 97.2%

higher than that of the placebo control group (85.7%)

with statistically significant differences between two groups (

0.05). The disappearance rates of influenza symptoms/signs including fever

headache

general soreness

sore throat

cough in the treatment group were better than that of the placebo group (

0.05)

except for pharyngeal congestion and tonsil enlargement. There were no serious adverse events in either group.

Conclusion

JHG can play a good clinical effect in the treatment of influenza-like illness of WHIL

and is of sound safety.

关键词

金花清感颗粒流感样病例风热犯肺证异病同治

Keywords

Jinhua Qinggan Granuleinfluenza-like illnesswind-heat invading the lungdifferent diseases treated in the same way

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