金花清感颗粒治疗风热犯肺型流感患者的双盲随机对照试验

[Treating influenza patients of wind-heat affecting Fei syndrome by jinhua qinggan granule: a double-blinded randomized control trial].

作者信息

Li Guo-Qin, Zhao Jing, Tu Zhi-Tao, Li Jiang-Bin, Liu Qing-Quan, Shi Li-Qing, Miao Qing, Yuan Hui-Qing, Liu Xin-Qiao, Long You-Yu, Liu Zhi-Guo, Zhao Ting, Li Lei, Tant Quan-Hong, He Ying-Chun, Bian Yong-Jun, Hu Jing-Qing

机构信息

Respiratory Department, Guang'anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.

Emergency Department, Dongzhimen Hospital Affiliated to Bejing University of Chinese Medicine, Beijing 100700, China.

出版信息

Zhongguo Zhong Xi Yi Jie He Za Zhi. 2013 Dec;33(12):1631-5.

PMID:24517059

Abstract

OBJECTIVE

To assess the effect and safety of Jinhua Qinggan Granule (JHG) in treating influenza patients of wind-heat affecting Fei syndrome (WHAFS).

METHODS

Totally 136 influenza patients of WHAFS were randomized by stratification into 3 groups, the high dose JHG group (44 cases, 10 g each time), the low dose JHG group (45 cases, 5 g JHG + 5 g placebo each time), and the placebo control group (47 cases, 10 g placebo each time). All medication was administered three times daily for 5 days. The fever disappearance time, the fever disappearance rate, efficacy of TCM syndrome, the disappearance rate of main symptoms and physical signs of flu, the negative rate of virus nucleic acid in the pharyngeal secretion, and safety indicators were assessed.

RESULTS

The median fever disappearance time was 32.8 h (95% CI: 22.5-41.0 h) in the high dose JHG group, 26.0 h (95% CI: 14.5-36.5 h) in the low dose JHG group, 39.5 h (95% CI: 29.0-46.0 h) in the placebo control group. There was statistical difference in the median fever disappearance time between the low dose JHG group and the placebo control group (P = 0.011). Three days after treatment, the markedly effective rate of TCM symptoms in the low dose JHG group was 66.7%, higher than that of the placebo control group (38.3%), and its effective rate was superior to that of the high dose JHG group (P = 0.043). Five days after treatment, the recovery rate of the low dose JHG group (42.2%) was higher than that of the high dose JHG group (25.0%, P = 0.026) and that of the placebo control group (14.9%, P = 0.002). The markedly effective rate of the low dose JHG group (86.7%) was higher than that of the placebo control group (55.3%, P = 0.001). Similar effects were obtained in the low dose JHG group and the high dose JHG group, but slightly poor in partial indicators of the high dose JHG group. There was no statistical difference in adverse reaction among these three groups (P > 0.05).

CONCLUSIONS

JHG was effective and safe in treating influenza patients of WHAFS. Routinely low dose was the optimal dosage of JHG.

摘要

目的

评价金花清感颗粒（JHG）治疗风热犯肺证流感患者的疗效及安全性。

方法

将136例风热犯肺证流感患者按分层随机分为3组，高剂量JHG组（44例，每次10 g）、低剂量JHG组（45例，每次5 g JHG + 5 g安慰剂）和安慰剂对照组（47例，每次10 g安慰剂）。所有药物均每日服用3次，共服用5天。评估发热消失时间、发热消失率、中医证候疗效、流感主要症状和体征消失率、咽部分泌物病毒核酸阴性率及安全性指标。

结果

高剂量JHG组发热消失时间中位数为32.8 h（95%CI：22.5 - 41.0 h），低剂量JHG组为26.0 h（95%CI：14.5 - 36.5 h），安慰剂对照组为39.5 h（95%CI：29.0 - 46.0 h）。低剂量JHG组与安慰剂对照组发热消失时间中位数比较，差异有统计学意义（P = 0.011）。治疗3天后，低剂量JHG组中医症状显效率为66.7%，高于安慰剂对照组（38.3%），有效率优于高剂量JHG组（P = 0.043）。治疗5天后，低剂量JHG组恢复率（42.2%）高于高剂量JHG组（25.0%，P = 0.026）和安慰剂对照组（14.9%，P = 0.002）。低剂量JHG组显效率（86.7%）高于安慰剂对照组（55.3%，P = 0.001）。低剂量JHG组与高剂量JHG组疗效相似，但高剂量JHG组部分指标稍差。三组不良反应比较，差异无统计学意义（P > 0.05）。