玉叶解毒颗粒治疗儿童流行性感冒临床观察

Clinical observation on the treatment of influenza in children with Yuye Jiedu Granules

关键词:  玉叶解毒颗粒  儿童流行性感冒  外部对照  倾向性评分匹配

Key words:  Yuye Jiedu Granule  childhood influenza  external control  propensity score matching

摘要:

[目的] 探索玉叶解毒颗粒治疗儿童流行性感冒的有效性和安全性。[方法] 采用前瞻性、单臂、开放、阳性药外部对照、多中心的设计方法。在临床研究数据库中，选择具有相同设计（人群相似、主要指标及测量方法相同、研究时间相近）的磷酸奥司他韦颗粒病例作为外部对照。疗程为5 d，随访2 d。以倾向性评分匹配（PSM）后的人群为主要分析集，比较两组临床痊愈率、临床痊愈时间、完全退热时间、加拿大急性呼吸道疾病和流感量表（CARIFS）总分及各维度评分、单项症状消失率、并发症发生率及不良事件发生率。[结果] 共纳入患儿334例，试验组133例，对照组201例，按照1∶1匹配后，每组69例。经PSM后，基线人口学资料、疾病及疗效相关性指标的组间比较，差异均无统计学意义，均衡性良好。PSM后，研究终点，试验组的临床痊愈率为92.75%，对照组为91.30%，组间比较差异无统计学意义（P＞0.05），两组率差为1.45%[95CI%（-8.35%，11.35%）]，经非劣效检验（Δ=-12%），试验组不劣于对照组，匹配前后的分析结论一致；采用限制性平均生存时间（RMST）估计临床痊愈平均时间，试验组为4.754 d，对照组为4.594 d，组间比较差异无统计学意义（P＞0.05）。两组完全退热时间、CARIFS总分及各维度评分较基线变化值、单项症状消失率、并发症发生率比较，差异无统计学意义（P＞0.05）。在安全性方面，两组不良事件/不良反应发生率比较，差异无统计学意义（P＞0.05）。[结论] 玉叶解毒颗粒治疗儿童流行性感冒的疗效不劣于磷酸奥司他韦颗粒，临床应用安全性较好，具有临床推广价值。

Abstract:

[Objective] Exploring the efficacy and safety of Yuye Jiedu Granules in the treatment of influenza in children. [Methods] A prospective，single-arm，open，positive drug external control，multicentre design was used. Cases of oseltamivir granules with the same design（similar population，same key indicators and measurements，and similar study duration） were selected as external controls in the clinical research database. The duration of treatment was 5 days with 2 days of follow-up. The population after propensity score matching（PSM） was used as the primary analysis set to compare the two groups in terms of clinical recovery rate，time to clinical recovery，time to complete fever reduction，Canadian Acute Respiratory Illness and Flu Scale（CARIFS） total and dimensional scores，single symptom disappearance rate，complication rate，and adverse events rate. [Results] A total of 334 cases were included， 133 cases in the test group and 201 cases in the control group，69 cases in each group after 1∶1 matching. After PSM，the between-group comparisons of baseline demographic information，disease and efficacy-related conditions were not statistically significant and well-balanced. After PSM，the study endpoints，the clinical cure rate was 92.75% in the experimental group and 91.30% in the control group，with no statistically significant difference in the between-group comparisons（P>0.05），and the difference in the rates between the two groups was 1.45%[（95CI%（-8.35%，11.35%）]，the test group was not inferior to the control group by the non-inferiority test（Δ=-12%），and the conclusions of the analysis before and after matching were consistent. The mean time to clinical recovery estimated using Restricted mean survival time（RMST） was 4.754 days in the experimental group and 4.594 days in the control group，and the difference between the groups was not statistically significant（P>0.05）. The time to complete fever reduction，the value of change from baseline in CARIFS total score and scores of each dimension，the rate of disappearance of single symptom，and the rate of complications were not statistically significant when compared between groups（P>0.05）. In terms of safety，intergroup comparisons of the incidence of adverse events/adverse reactions between the two groups showed no statistically significant differences（P>0.05）. [Conclusion] The efficacy of Yuye Jiedu Granules in the treatment of influenza in children is not inferior to that of oseltamivir phosphate granules，and the safety of clinical application is better，which has clinical promotion value.