福多司坦胶囊祛痰的临床疗效和安全性分析

Analysis of clinical efficacy and safety of fudosteine capsule in the clearance of sputum

目的探讨肺部疾病患者应用福多司坦胶囊祛痰的疗效和安全性。方法 184例肺部疾病患者被随机分为观察组和对照组各92例;两组患者均接受常规内科治疗,观察组在此基础上给予福多司坦胶囊治疗,对照组给予盐酸氨溴索片治疗,疗程7 d。评价患者痰量、痰液的粘稠度、咳痰难易、咳嗽程度、啰音、临床综合疗效及不良反应。结果观察组痰量、痰液粘度、咳痰难易,咳嗽、肺啰音及临床综合疗效的有效率分别为91.2%、96.7%、96.7%、88.0%、92.4%、98.9%,对照组的分别为93.5%、97.8%、97.8%、87.0%、90.2%、97.8%,对两组各观察指标做秩和检验,两组病例在疗效分布上的差异并无统计学意义(P>0.05);观察组出现1例肝功能异常,1例皮肤瘙痒,1例失眠;对照组出现1例肝功能异常、1例皮肤瘙痒。结论福多司坦祛痰疗效确切,安全性较好,值得临床推广。

Objective To investigate the clinical efficacy and safety of fudosteine capsule in the clearance of sputum.Methods 184 patients with respiratory system diseases were randomly and evenly divided into two groups.All of the patients were received conventional medical treatment.The observation group was received fudosteine and the control group was treated with ambroxol hydrochloride,for 7 days.The main indicators were compared and analyzed,whichi included the volume and character of sputum,difficulty in expectoration,cough,rale in the lung,the clinical comprehensive effect and safety.Results The effective rate of the observation group in the volume and character of sputum,difficulty in expectoration,cough,rale in the lung,the clinical comprehensive effect was 91.2%,96.7%,96.7%,88.0%,92.4%,and 98.9% respectively,while in the control group these were 93.5%,97.8%,97.8%,87.0%,90.2%,and 97.8% respectively.There was no significant difference of curative effect between the two groups（P〉0.05）.There was 1 case of dysfunction of liver,1 case of cutaneous pruritus and 1 case of insomnia occurred in the observation group.Conclusion Fodusteine capsule has the similar efficacy and safety as ambroxol hydrochloride in sputum clearance,and it＇s worth to widely applied in clinical use.