2019 年第 7 期 第 14 卷

香菊胶囊治疗流行性感冒的开放性多中心随机对照临床研究

An open-label, multi-center, random-control clinical study of Xiangju capsules in treatment of influenza

作者：杜小兵陈乾华肖瑶张雪芹夏静鸿刘双

英文作者：

单位：102200北京大学国际医院呼吸与危重症医学科（杜小兵）；100012北京，航空总医院呼吸与危重症医学科（陈乾华）；100029首都医科大学附属北京安贞医院呼吸与危重症医学科（肖瑶、刘双），感染科（夏静鸿）；100071北京丰台医院呼吸与危重症医学科（张雪芹）

英文单位：

关键词：流行性感冒；香菊胶囊；连花清瘟胶囊

英文关键词：

• 摘要：

• 【摘要】目的    评价香菊胶囊治疗流行性感冒的有效性和安全性。方法    入选2017年1月至2018年11月首都医科大学附属北京安贞医院、北京大学国际医院、北京丰台医院、航空总医院等门诊接诊的急性单纯性流行性感冒患者148例为研究对象，按照随机数字表法分为观察组（76例）和对照组（72例）。对照组口服连花清瘟胶囊3次/d，4粒/次，观察组口服香菊胶囊3次/d，2～4粒/次。2组均治疗5 d。比较2组治疗后临床症状改善情况、临床疗效，统计药物不良反应发生情况。结果    本研究治疗期间对照组2例脱落。2组治疗前后组间临床症状积分比较，差异均无统计学意义（均P>0.05）。治疗后，2组临床症状积分均明显低于治疗前,差异均有统计学意义（均P＜0.01）。意向性分析结果显示，对照组与观察组痊愈率和总有效率比较［63.9%（46/72）比68.4%（52/76）、83.3%（60/72）比86.8%（66/76）］，差异均无统计学意义（均P＞0.05）。2组患者治疗过程中均未发生严重不良反应。结论    香菊胶囊治疗流行性感冒安全有效。

• 【Abstract】Objective    To evaluate the efficacy and safety of Xiangju capsules in the treatment of influenza. Methods    From January 2017 to November 2018, 148 patients with acute simple influenza were enrolled in Beijing Anzhen Hospital, Capital Medical University, Peking University International Hospital, Beijing Fengtai Hospital and Aviation General Hospital. The patients were randomly divided into observation group(76 cases) and control group(72 cases). The control group took Lianhua Qingwen capsules, 4 capsules, 3 times a day; the observation group took Xiangju capsules, 2-4 capsules, 3 times a day. Both groups were treated for 5 days. Improvement of clinical symptoms, clinical efficacy and adverse drug reactions were analyzed. Results    Two patients in control group were dropped out during the study. There was no significant difference of clinical symptom scores between groups before and after treatment(all P＞0.05). After treatment, clinical symptom scores significantly reduced in both groups compared to those before treatment（both P＜0.01）. Intentional analysis showed no significant difference of the recovery rate and total effective rate between control group and observation group［63.9%(46/72) vs 68.4%(52/76), 83.3%(60/72) vs 86.8%(66/76)］(all P＞0.05). There was no serious adverse reaction during treatment in both groups. Conclusion    Xiangju capsules is safe and effective in the treatment of influenza.