金花清感颗粒治疗流感样病例风热犯肺证的多中心随机双盲安慰剂对照试验

张家萌; 金在艳; 边永君; 李国勤; 刘志国; 李磊; 赵婷; 夏宏盛

doi:10.3969/j.issn.2095-6606.2023.06.001

您当前的位置：

首页 >

文章列表页 >

金花清感颗粒治疗流感样病例风热犯肺证的多中心随机双盲安慰剂对照试验

临床研究 | 更新时间：2023-12-08

- 金花清感颗粒治疗流感样病例风热犯肺证的多中心随机双盲安慰剂对照试验
- Jinhua Qinggan Granule for influenza-like illness with wind-heat invading the lung: a multi-center, randomized, double-blind, placebo-controlled trial
- 现代中医临床 2023年30卷第6期页码：1-6
- 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：
  
  张家萌，女，在读硕士生
  #夏宏盛，男，硕士，副主任医师，E-mail：pishi99@sina.com
- 基金信息：
  
  国家科技重大专项(2008ZX09312012)
- DOI：10.3969/j.issn.2095-6606.2023.06.001
  中图分类号： R254
- 纸质出版日期：2023-11-30，
  
  收稿日期：2023-05-07，
- 稿件说明：
移动端阅览
张家萌, 金在艳, 边永君, 等. 金花清感颗粒治疗流感样病例风热犯肺证的多中心随机双盲安慰剂对照试验[J]. 现代中医临床, 2023,30(6):1-6.

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, 2023,30(6):1-6.
张家萌, 金在艳, 边永君, 等. 金花清感颗粒治疗流感样病例风热犯肺证的多中心随机双盲安慰剂对照试验[J]. 现代中医临床, 2023,30(6):1-6. DOI： 10.3969/j.issn.2095-6606.2023.06.001.

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, 2023,30(6):1-6. 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

references

吕菁君，赵光举，赵宏宇，等.成人流行性感冒诊疗规范急诊专家共识(2022版)[J].中国急救医学，2022, 42(12): 1013-1026.

国家疾病预防控制局.国家卫生计生委办公厅关于印发全国流感监测方案(2017年版)的通知[EB/OL].(2017-04-01)[2023-03-18].http://www.nhc.gov.cn/jkj/s3577/201704/ed1498d9e64144738cc7f8db61a39506.shtmlhttp://www.nhc.gov.cn/jkj/s3577/201704/ed1498d9e64144738cc7f8db61a39506.shtml.

秦志强.流感样病例流行病学与诊断[J].中国临床新医学，2022, 15(1): 22-28.

卫生部流行性感冒诊断与治疗指南编辑专家组.流行性感冒诊断与治疗指南(2011年版)[J].中华结核与呼吸杂志，2011, 34(10): 725-734.

夏伟，陈庆华，马玉杰，等.544例流行性感冒样病例药物应用情况调查[J].中国疫苗和免疫，2013, 19(1): 53-56.

曹彬，李冉，刘颖梅，等.流感样疾病的病原学与治疗及预后的关系[J].中华结核和呼吸杂志，2008, 31(7): 483-487.

王成立，郑彩霞，吕伟，等.自拟羌芷解表方联合奥司他韦治疗流感样病例的临床观察[J].中国中医急症，2022, 31(5): 824-826.

李华俊，梁荣华，卢娅利，等.柴葛解肌汤加减方联合奥司他韦治疗冬季流感样病例的疗效观察[J].甘肃医药，2022, 41(2): 155-157.

杨凤，罗亚敏，付兴，等.中医外感热病的源流探析与当代思考[J].北京中医药大学学报，2022, 45(8): 770-774.

李国勤，赵静，屠志涛，等.金花清感颗粒治疗流行性感冒风热犯肺证双盲随机对照研究[J].中国中西医结合杂志，2013, 33(12): 1631-1635.

中华人民共和国卫生部.全国流感监测方案(2010年版)[J].国际呼吸杂志，2011, 31(2): 85-88.

方药中. 实用中医内科学[M].上海：上海科学技术出版社, 1985: 86-91.

郑筱萸. 中药新药临床研究指导原则(试行)[M].北京：中国医药科技出版社, 2002: 58-60.

张评浒，石宇，张雨茜，等.中医对“时行感冒”疫病的认知历程与辨证论治策略[J].实用临床医药杂志，2020, 24(12): 1-5.

苏家卉，晏振东，吴彩军，等.金花清感颗粒防治病毒性上呼吸道感染中西医之辨[J].中国急救复苏与灾害医学杂志，2022, 17(6): 701-704,722.

朱艳慧，韩德恩，陈俭双，等.金花清感颗粒中抑制中性粒细胞胞外诱捕网形成活性成分的筛选与验证[J].中国医院药学杂志，2023, 43(11): 1191-1200.

段璨，夏文广，郑婵娟，等.金花清感颗粒联合西医常规治疗方案治疗轻型新型冠状病毒肺炎的临床观察[J].中医杂志，2020, 61(17): 1473-1477.

张佳莹，李丽，汪晓军，等.金花清感颗粒治疗成人新型冠状病毒肺炎患者的多中心前瞻性队列研究[J].北京医学，2021, 43(9): 866-870.

SHAH M R，FATIMA S，KHAN S N，et al. Jinhua Qinggan granules for non-hospitalized COVID－19 patients：A double-blind，placebo-controlled，and randomized controlled trial[J/OL]. Front Med(Lausanne)，2022, 9: 928468[2023-03-18]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9376460/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9376460/.

ZHU Y，HAN Q，WANG L，et al. Jinhua Qinggan granules attenuates acute lung injury by promotion of neutrophil apoptosis and inhibition of TLR4/MyD88/NF－κB pathway[J/OL]. J Ethnopharmacol，2023, 301: 115763[2023-03-18]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9523948/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9523948/.

毛昀，苏毅馨，薛鹏，等.金花清感颗粒治疗新型冠状病毒肺炎作用机制探讨[J].中药材，2020, 43(11): 2842-2848.

浏览量

162

下载量

CSCD

文章被引用时，请邮件提醒。

提交

工具集

关联资源

暂无数据