Jiang Jun-Jie, Xie Yan-Ming, Wang Yong-Yan, Li Yuan, Zhang Yi-Li, Sun Shuai-Ling, Wang Shuo, Zhu Yong, Qi Wen-Sheng, Chen Xun, Chen Qin
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Guanganmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing 100053, China.
Zhongguo Zhong Yao Za Zhi. 2017 Apr;42(8):1467-1473. doi: 10.19540/j.cnki.cjcmm.2017.0043.
A randomized, double-blind, active parallel controlled trial will be conducted to include patients with acute upper respiratory infection and wind-warmth lung heat disease (heat in lung-wei pattern). Patients with serious bacterial infection (white blood cell count>1.2×1010, neutrophil>80%) will be excluded.so as to further identify Jinye Baidu Granule indications of Wind-warmth lung heat disease (heat in lung-wei pattern).According to the subjects of symptoms of fever and sore throats,Patients will be divided into three blocks： fever, swelling and sore throat, combined fever and swelling and sore throat. Subjects in three blocks will be divided into treatment group and control group with stratified blocked randomization. The treatment group will be treated with Jinye Baidu Granule, and the control group will be treated with Fufang Shuanghua granule. Primary outcome measure of patients with fever will be body temperature recovery time. Primary outcome measure of patients with swelling and sore throat will be throat symptom score. Primary outcome measures of patients combined with fever and swelling and sore throat will be body temperature recovery time and throat symptom score. Before and after all of the patients in the group were collected blood and urine routine, liver and renal function, electrocardiogram (ECG) data as the safety index while observing it adverse events. A total of 623 patients were included. Compared with control group,sore throat symptoms of patients with sore throat and pharyngeal symptoms total score have significantly different. so Jinny Baidu granule have a significant advantage in the treatment of sore throat. All of the experiments showed that the safety of the drug was good. Nausea, vomiting, stomach pain, diarrhea, digestive tract symptoms may occur only occasionally. We should pay attention to the changes when using in patients with spleen deficiency cold to avoid adverse reaction.
将进行一项随机、双盲、活性平行对照试验，纳入急性上呼吸道感染和风温肺热病（卫分证）患者。排除严重细菌感染患者（白细胞计数>1.2×10¹⁰，中性粒细胞>80%），以进一步明确金叶败毒颗粒治疗风温肺热病（卫分证）的适应证。根据发热、咽痛症状将患者分为三个区组：发热、肿痛咽痛、发热兼肿痛咽痛。三个区组的受试者采用分层区组随机化方法分为治疗组和对照组。治疗组给予金叶败毒颗粒治疗，对照组给予复方双花颗粒治疗。发热患者的主要疗效指标为体温恢复时间。肿痛咽痛患者的主要疗效指标为咽喉症状评分。发热兼肿痛咽痛患者的主要疗效指标为体温恢复时间和咽喉症状评分。收集所有入组患者治疗前后血常规、尿常规、肝肾功能、心电图（ECG）数据作为安全性指标，同时观察其不良事件。共纳入623例患者。与对照组比较，咽痛患者的咽痛症状及咽部症状总分有显著差异。所以金叶败毒颗粒在治疗咽痛方面有显著优势。所有试验均表明该药安全性良好。恶心、呕吐、胃痛、腹泻等消化道症状可能仅偶尔出现。脾虚寒患者用药时应注意观察变化，避免不良反应。
