头孢呋辛酯干混悬剂加用止咳橘红颗粒治疗小儿急性支气管炎(痰热壅肺证)的随机双盲、阳性药平行对照、多中心临床评价

Evaluation of Cefuroxime suspension combined with ZhiKe JuHong Granules in treatment of syndrome of phlegm-lung obstructing heat in children with acute bronchitis: A randomized, double-blind, parallel positive-drug control,multi-center clinical trial

目的评价在头孢呋辛酯干混悬剂基础上应用止咳橘红颗粒治疗小儿急性支气管炎(痰热壅肺证)的病情改善作用,探索其止咳对症治疗作用,同时观察临床应用的安全性。方法采用随机、双盲双模拟、阳性药平行对照、多中心、非劣效检验的方法。将236例受试者,按照1∶1的比例随机分为试验组和对照组。在两组均服用头孢呋辛酯干混悬剂的基础上,其中试验组服用止咳橘红颗粒和金振口服液模拟剂,对照组服用金振口服液和止咳橘红颗粒模拟剂。疗程5 d。以疾病疗效的总有效率为主要评价指标,以咳嗽起效时间、中医证候疗效、单项症状及体征消失率为次要评价指标。以临床不良反应发生率为安全性评价指标。结果疾病疗效总有效率,试验组96.40%,对照组94.55%,经非劣效检验,试验组不劣于对照组。次要指标,除咳嗽起效时间外,中医证候疗效、单项症状及体征消失率的组间比较,差异均无统计学意义。符合方案数据集(PPS)与全分析数据集(FAS)分析结论一致。本次试验发现仅对照组报道7例次不良事件(5.98%),其中1例经过研究者判断,与药物的关系为"可疑",视为不良反应(0.85%)。结论在头孢呋辛酯干混悬剂基础上,应用止咳橘红颗粒对小儿急性支气管炎(痰热壅肺证)的病情改善作用不劣于金振口服液,且具有更好的止咳对症治疗作用,临床应用的安全性较好。

Objective To evaluate the improvement of disease condition of Zhike Juhong Granules the treatment of pediatric acute bronchitis(syndrome of phlegm-heat obstructing lung)on the basis of cefuroxime dry suspension,and to explore the symptomatic treatment of cough,and to observe the safety of its clinical application.Methods The methods of randomized,double-blind,parallel positive-drug control,multi-center,non-inferiority test were used.A total of 236 subjects were randomly divided into experimental group and control group according to 1:1 ratio.On the basis of the Cefuroxime dry suspension,the experimental group was given Zhike Juhong Granules and the simulation of Jinzhen oral liquid,the control group was given Jinzhen Oral Liquid and the simulation of Zhike Juhong Granules.The course of treatment was 5 d.The total effective rate of disease curative effect was used as the main evaluation index,with cough effect time,Traditional Chinese Medicine(TCM)curative effect,cough symptoms integral,the disappearance of the lung's rate and the individual symptoms disappear rate for secondary evaluation index.The incidence of adverse reactions was used as the safety evaluation index.Results Main indicators analysis:the total effective rate of disease curative effect of treatment group and the control group was 96.40% and 94.55%,respectively.The results of non-inferiority test indicated that the efficacy of experimental group was not worse than that in the positive control group.Secondary index analysis:in addition to the time of onset of cough,there was no statistically significant difference in the efficacy of TCM syndromes,pulmonary rotations,and the disappearance rate of individual symptoms.The results of FAS and PPS were consistent.In this clinical trial,only the control group reported seven cases of adverse events(5.98%),including one case,which was judged by the researchers as "suspicious" and regarded as adverse reaction(0.85%).Conclusion The improvement of disease condition of Zhike Juhong Granules in the treatment of pediatric acute bronchitis(syndrome of phlegm-heat obstructing lung)on the basis of cefuroxime dry suspension is not inferior to JinZhen Oral Liquid with satisfactory safety,and it has better effect in the treatment of cough.