目的 評(píng)價(jià)在頭孢呋辛酯干混懸劑基礎(chǔ)上應(yīng)用止咳橘紅顆粒治療小兒急性支氣管炎（痰熱壅肺證）的病情改善作用，探索其止咳對(duì)癥治療作用，同時(shí)觀察臨床應(yīng)用的安全性。方法 采用隨機(jī)、雙盲雙模擬、陽(yáng)性藥平行對(duì)照、多中心、非劣效檢驗(yàn)的方法。將236例受試者，按照1：1的比例隨機(jī)分為試驗(yàn)組和對(duì)照組。在兩組均服用頭孢呋辛酯干混懸劑的基礎(chǔ)上，其中試驗(yàn)組服用止咳橘紅顆粒和金振口服液模擬劑，對(duì)照組服用金振口服液和止咳橘紅顆粒模擬劑。療程5 d。以疾病療效的總有效率為主要評(píng)價(jià)指標(biāo)，以咳嗽起效時(shí)間、中醫(yī)證候療效、單項(xiàng)癥狀及體征消失率為次要評(píng)價(jià)指標(biāo)。以臨床不良反應(yīng)發(fā)生率為安全性評(píng)價(jià)指標(biāo)。結(jié)果 疾病療效總有效率，試驗(yàn)組96.40%，對(duì)照組94.55%，經(jīng)非劣效檢驗(yàn)，試驗(yàn)組不劣于對(duì)照組。次要指標(biāo)，除咳嗽起效時(shí)間外，中醫(yī)證候療效、單項(xiàng)癥狀及體征消失率的組間比較，差異均無(wú)統(tǒng)計(jì)學(xué)意義。符合方案數(shù)據(jù)集（PPS）與全分析數(shù)據(jù)集（FAS）分析結(jié)論一致。本次試驗(yàn)發(fā)現(xiàn)僅對(duì)照組報(bào)道7例次不良事件（5.98%），其中1例經(jīng)過(guò)研究者判斷，與藥物的關(guān)系為“可疑”，視為不良反應(yīng)（0.85%）。結(jié)論 在頭孢呋辛酯干混懸劑基礎(chǔ)上，應(yīng)用止咳橘紅顆粒對(duì)小兒急性支氣管炎（痰熱壅肺證）的病情改善作用不劣于金振口服液，且具有更好的止咳對(duì)癥治療作用，臨床應(yīng)用的安全性較好。

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.