Objective: To observe the efficacy and safety of Kangbingdu granules (KBD) in the treatment of influenza. Methods: A multicenter, randomized, double-blind, double-dummy, and positive-drug parallel control trial was conducted in 27 Grade ⅢA hospitals in China and the subjects were randomly assigned to the KBD test group or the oseltamivir phosphate capsule control group at a ratio of 1∶1. 200 subjects were planned to be enrolled in each group. The experimental group was given KBD (18g each time, 3 times a day) and oseltamivir phosphate simulator orally, while the control group was given oseltamivir phosphate capsule (75 mg each time, twice a day) and KBD simulator orally for 5 days. The primary efficacy indicators included the remission time of major clinical symptoms and the time of complete defervescence. The secondary efficacy indicators included dosage of acetaminophen, the change of traditional Chinese medicine (TCM) syndrome score and the remission time of other important clinical symptoms. The efficacy of KBD in the test group and Oseltamivir phosphate control group were compared. Adverse events or adverse reactions were observed at the same time to evaluate the safety of KBD Granules. Results: A total of 393 subjects from 27 Grade ⅢA hospitals in China were enrolled. The experimental group included 195 subjects and 191 subjects (97.95%) completed the trial, While the control group included 198 subjects and 195 subjects (98.48%) completed the trial. There was no significant difference in the shedding rate and rejection rate between the two groups (P>0.05). In the Full Analysis Set (FAS), the mean age of the experimental group was (34.9±14.4) years old, with 83 males (42.78%). The mean age of the control group was (33.3±13.5) years old, with 78 males (39.59%). There were no statistically significant differences between the two groups in demographic data, physical examination, viral pathogen detection, total score of TCM syndromes and scores of each symptom at baseline (P>0.05). In the FAS, the remission time M (Q1, Q3) of major clinical symptoms was 3.0 (3.0, 4.0) days in the experimental group and 3.0 (3.0, 4.0) days in the control group, and the difference was not statistically significant (P>0.05). The time M (Q1, Q3) of complete defervescence was 34.0 (20.3, 49.0) hours in the experimental group and 36.5 (19.6, 48.8) hours in the control group, and the difference was not statistically significant (P>0.05). KBD granules had the same effect as Oseltamivir phosphate capsule (P>0.05) in terms of acetaminophen dosage, TCM syndrome effect and disappearance rate of most important clinical symptoms. Meanwhile, the disappearance rate of dizziness and chest distress on day 3 in the KBD granules group was better than that of oseltamivir phosphate capsule (P<0.05). Conclusion: KBD granules have the same efficacy as Oseltamivir Phosphate capsule in the treatment of influenza and the drug safety is good.
目的： 观察抗病毒颗粒治疗流行性感冒的有效性及安全性。 方法： 采用多中心、随机、双盲双模拟、阳性药平行对照试验设计，在中国27家三级甲等医院筛选流行性感冒患者，按1∶1随机分配至抗病毒颗粒试验组或磷酸奥司他韦胶囊对照组，每组计划入组受试者200例。试验组给予抗病毒颗粒（每次18 g，每日3次）及磷酸奥司他韦模拟剂口服，对照组给予磷酸奥司他韦胶囊（每次75 mg，每日2次）及抗病毒颗粒模拟剂口服，疗程均为5 d。主要疗效指标包括临床主要症状缓解时间和完全退热时间。次要疗效指标包括对乙酰氨基酚使用剂量、中医证候积分改变、其他重要临床症状缓解时间。对比抗病毒颗粒试验组和磷酸奥司他韦对照组疗效指标差异，同时监测不良事件或不良反应评估抗病毒颗粒的安全性。 结果： 共入组受试者393例，抗病毒颗粒试验组195例，完成试验191例（97.95%）。磷酸奥司他韦对照组198例，完成试验195例（98.48%），两组脱落率和剔除率差异无统计学意义（P>0.05）。全分析数据集（FAS）中试验组年龄（34.9±14.4）岁，男性83例（42.78%）；对照组年龄（33.3±13.5）岁，男性78例（39.59%）。两组受试者人口学资料、体格检查、病毒病原学检测、基线中医证候总分及各单项症状评分等比较差异均无统计学意义（P>0.05）。FAS中试验组临床主要症状缓解时间M（Q1，Q3）为3.0（3.0，4.0） d，对照组为3.0（3.0，4.0）d，差异无统计学意义（P>0.05）。完全退热时间M（Q1，Q3）试验组为34.0（20.3，49.0） h，对照组为36.5（19.6，48.8） h，差异无统计学意义（P>0.05）。抗病毒颗粒在对乙酰氨基酚使用剂量、中医证候疗效、多数重要临床症状消失率等方面与磷酸奥司他韦胶囊疗效相当（P>0.05），且抗病毒颗粒组第3天的头昏、胸闷症状消失率优于磷酸奥司他韦胶囊组（P<0.05）。 结论： 抗病毒颗粒治疗流行性感冒疗效与磷酸奥司他韦胶囊相当，且药物安全性良好。.
Keywords: Efficacy; Influenza, human; Kangbingdu granules; Safety.