金振口服液有效性和安全性的多中心、随机对照临床研究

A prospective multicenter randomized controlled study on the efficacy and safety of Jin-Zheng oral solution

目的评价金振口服液祛痰止咳的有效性、安全性和依从性。方法采用前瞻性、多中心、随机双盲、平行对照临床研究。共4个中心参与研究,实际符合入选方案病例239例,其中试验组120例,口服金振口服液;对照组119例,口服急支糖浆;疗程均为5d。比较两组咳嗽、咳痰、喘息、肺部体征、发热、鼻塞、流涕、咽部充血等各单项症状改善率以及综合症状改善率、总有效率,观察药物不良反应和依从性。结果两组均有显效,但试验组用药后第3天、第5天除咽部充血外,其他各单项症状改善均优于对照组(P<0.0001)。试验组综合疗效改善率第3天为60.0%、第5天为90.0%,明显优于对照组;至用药后第5天,试验组总有效率为96.67%,对照组为64.71%,两组间比较差异有统计学意义(P=0.0000)。金振口服液依从性达98.33%,试验期间无不良事件发生。结论金振口服液治疗小儿由急性上呼吸道感染、气管支气管炎和轻型肺炎等引起的咳嗽、咳痰、喘息、发热鼻塞、流涕等症状有显著疗效,且安全性好、依从性高,是一种适用于儿童的祛痰止咳中成药。

Objective To evaluate the effectiveness of Jin-Zheng oral solution expectorant cough, safety and compliance. Methods A prospective muhicenter randomized double-blind, parallel-controlled clinical study. A total of four centers participated in this study, the actual number of cases in line with the program selected 239 cases, of which 120 cases trial group using Jin-Zheng oral solution, the control group of 119 cases, oral Ji-Zhi syrup, treatment both for 5 days. The improve rate of each single symptom of cough, sputum, wheezing, pulmonary symptoms, fever, stuffy nose, runny nose, throat congestion etc. and the comprehensive symptoms, the total effective rate were compared between two groups. The adverse drug reactions and compliance were assessed as well. Results The efficacy was showed in both groups but the trial group in the course of the 3 rd day and the 5 th day except pharyngeal congestion, the other symptoms improve markedly compared with the control group （P 〈 0.0001 ）. The integrated improving rate of Jin-Zheng oral solution was 60% on the 3rd day and 90% on the 5th day respectively, significantly better than the control group. The total efficiency of Jin-Zheng oral group after 5 days treatment was 96.67% and the Ji-Zhi syrup group was 64.71%, there was significant difference statistically between the two groups （P = 0.0000）. Jin-Zheng oral group had good compliance tqp to 98.33%, no adverse events during the trial period. Conclusion Jin-Zheng oral solution has significant efficacy and safety as well in children for treatment of cough, sputum, wheezing, fever, stuffy nose, runny nose etc. caused by acute upper respiratory tract infections, tracheo-bronchitis and mild pneumonia. Its compliance is high. Jin-Zheng oral solution is an expectorant cough for proprietary, Chinese medicine in children.