引用本文:霍 丽,王慧玲,王镇山,薛 欣,马忠森,杨俊玲,李 立,侯松群.复方头孢克洛胶囊随机双盲对照治疗急性呼吸道感染性疾病临床试验[J].大连医科大学学报,2006,28(1):34-37.
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复方头孢克洛胶囊随机双盲对照治疗急性呼吸道感染性疾病临床试验
霍 丽,王慧玲,王镇山,薛 欣,马忠森,杨俊玲,李 立,侯松群
1.大连医科大学 第二临床学院 呼吸内科,辽宁 大连 116027;2.吉林大学 第二临床学院 呼吸内科,吉林 长春 130000;3.吉林大学 第三临床学院 呼吸内科,吉林 长春 130000
摘要:
[目的]研究复方头孢克洛胶囊的安全性与有效性。[方法]两组随机化平行对照双盲多中心设计,并选用头孢克洛与盐酸溴已新为对照药。急性呼吸道细菌性感染120例,分试验组60例,对照组60例。[结果]痊愈率试验组和对照组分别为71.67%、76.67%,有效率分别为93.33%、93.33%。细菌清除率分别为96.15%、97.87%;与药物有关的不良事件分别为3.33%和1.67%。[结论]复方头孢克洛胶囊治疗急性呼吸道感染有良好的临床疗效,与头孢克洛联用盐酸溴已新相同。且服用方便,为治疗急性呼吸道感染性疾病提供更为方便口服药物。
关键词:  抗感染  复方头孢克洛  头孢克洛  盐酸溴已新
DOI:10.11724/jdmu.2006.01.12
分类号:R56; R978
基金项目:
Randomized double-blind labeled controlled clinical trial on compound cefaclor in treatment of acute infections of respiratory tract
HUO Li1, WANG Hui-ling1, WANG Zhen-shang1, XUE Xin1, MA Zhong-sen2,3, YANG Jun-ling2,3, LI Li4, HOU Song-qun4
1.Department of Respirology, the Second Hospital of Dalian Medical University, Dalian 116027, China;2.Department of Respirology, the Second Hospital of Jilin University, Changchun 130000,China;3.;4.Department of Respirology, the Third Hospital of Jilin University, Changchun 130000,China
Abstract:
[Objective] In order to evaluate the safety and efficacy of Compound Cefaclor capsules in the treatment of acute infections of respiratory tract. [Methods] A randomized double-blind labeled controlled multicenter clinical trial was conducted for the treatment of 120 patients with respiratory tract infections. In the study, 60 patients were enrolled in Compound Cefaclor group while 60 patients were enrolled in Cefaclor and Bromhexine Hydrochloride group. [Results] The results showed that the cute rates were 71.67% for Compound Cefaclor group and 76.67% for Cefaclor and Bromhexine Hydrochloride group, the efficacy rates were 93.33% and 93.33%,respectively. The bacterial clearance rates were 96.15% and 97.87%,respectively. The incidence of adverse reaction was 3.33% and 1.67%, respectively. [Conclusion] Compound Cefaclor capsule and Cefaclor are both effective and convenient drugs for acute infections of respiratory tract.
Key words:  Compound Cefaclor  Cefaclor and Bromhexine Hydrochloride  anti-infection