喜炎平注射液肌内注射治疗小儿急性支气管炎的疗效：一项多中心、随机、平行对照临床研究

Efficacy of intramuscular injection of Xiyanping injection for the treatment of acute bronchitis in children: a multicenter, randomized, parallel-controlled clinical study

摘要:

目的 观察喜炎平注射液肌内注射治疗小儿急性支气管炎的疗效和安全性。方法 采用多中心、随机、平行对照方法，前瞻性纳入2021年12月—2022年10月在3家医院的78例急性支气管炎患儿。按1∶1比例分为试验组（常规治疗加喜炎平注射液；n=36）和对照组（单用常规治疗；n=37）。喜炎平注射液采用0.3 mL/(kg·d)（日剂量≤8 mL），2次/d肌内注射，疗程≤4 d，观察7 d。比较两组患儿的治疗疗效和安全性。结果 试验组治疗后第3天总有效率显著高于对照组（P<0.05），两组治疗后第5天总有效率比较差异无统计学意义（P>0.05）。试验组治疗后第3天发热缓解率、咳嗽缓解率、肺啰音缓解率高于对照组（均P<0.05）；试验组治疗后第5天咳嗽缓解率高于对照组（P<0.05），两组发热缓解率、肺啰音缓解率比较差异无统计学意义（P>0.05）。试验组咳嗽缓解时间、日咳嗽缓解时间、夜咳嗽缓解时间均显著短于对照组（P<0.05）；两组热程和肺部啰音缓解时间比较差异无统计学意义（P>0.05）。两组患儿不良事件发生率的差异无统计学意义（P>0.05）。结论 常规治疗联用喜炎平注射液肌内注射治疗小儿急性支气管炎比单独常规治疗的总体疗效更佳，且未增加不良反应的发生。

Abstract:

Objective To study the efficacy and safety of Xiyanping injection through intramuscular injection for the treatment of acute bronchitis in children.Methods A prospective study was conducted from December 2021 to October 2022, including 78 children with acute bronchitis from three hospitals using a multicenter, randomized, parallel-controlled design. The participants were divided into a test group (conventional treatment plus Xiyanping injection; n=36) and a control group (conventional treatment alone; n=37) in a 1:1 ratio. Xiyanping injection was administered at a dose of 0.3 mL/(kg·d) (total daily dose ≤8 mL), twice daily via intramuscular injection, with a treatment duration of ≤4 days and a follow-up period of 7 days. The treatment efficacy and safety were compared between the two groups.Results The total effective rate on the 3rd day after treatment in the test group was significantly higher than that in the control group (P<0.05), while there was no significant difference in the total effective rate on the 5th day between the two groups (P>0.05). The rates of fever relief, cough relief, and lung rale relief in the test group on the 3rd day after treatment were higher than those in the control group (P<0.05). The cough relief rate on the 5th day after treatment in the test group was higher than that in the control group (P<0.05), while there was no significant difference in the fever relief rate and lung rale relief rate between the two groups (P>0.05). The cough relief time, daily cough relief time, and nocturnal cough relief time in the test group were significantly shorter than those in the control group (P<0.05), while there were no significant differences in the fever duration and lung rale relief time between the two groups (P>0.05). There was no significant difference in the incidence of adverse events between the two groups (P>0.05).Conclusions The overall efficacy of combined routine treatment with intramuscular injection of Xiyanping injection in the treatment of acute bronchitis in children is superior to that of routine treatment alone, without an increase in the incidence of adverse reactions.