【作者】 吴国明； 刘百川； 孙圣华； 陈宝元； 崔社怀； 钟小宁； 解晓珍； 于浩； 徐颖； 杨红辉； 关致伟； 朱宝玉； 张健全； 康军； 林科雄； 徐智； 程国华； 李苌青； 欧阳舒婷； 夏正芳； 王霆；

【Author】 WU guoming , LIU baichuan , SUN shenghua , CHEN baoyuan , CUI shehuai , ZHONG xiaoning , XIE xiaozhen , YU hao , XU ying , YANG honghui , GUAN zhiwei , ZHU baoyu , ZHANG jianquan , KANG jun , LIN kexiong , XU zhi , CHENG guohua , LI changqing , OUYANG shuting , XIA zhengfang , WANG ting

【机构】 第三军医大学新桥医院呼吸科； 暨南大学药学院； 中南大学湘雅三医院呼吸科； 天津医科大学总医院呼吸科； 第三军医大学大坪医院呼吸科； 广西医科大学第一附属医院呼吸科； 第三军医大学新桥医院检验科； 南京医科大学流行病与卫生统计学系； 第三军医大学新桥医院GCP机构； 重庆红十字会医院； 湘北威尔曼制药有限公司；

【摘要】 [目的]客观评价克洛己新分散片治疗轻、中度呼吸道细菌性感染的临床疗效及安全性。[方法]本研究是多中心、随机、双盲双模拟、阳性药平行对照临床试验,采用复方头孢克洛胶囊为对照药。共入组经临床确诊为轻、中度受试者有呼吸系统急性细菌感染,且需进行全身抗菌药物治疗病例241例,其中A组121例,B组120例。[结果]全分析集合(FAS)分析结果:痊愈率A组41.67%,B组39.50%,组间比较差异无统计学意义(P=0.6704);有效率A组84.17%,B组84.87%,组间比较差异无统计学差异(P=0.8804)。符合方案集(PPS)分析结果:痊愈率A组46.73%,B组40.95%,组间比较差异无统计学意义(P=0.3975);有效率A组87.85%,B组87.62%,组间比较差异无统计学意义(P=0.9622)。细菌清除率A组为94.81%,B组为93.33%。与药物有关的不良事件发生率A组6.61%,B组8.33%,不良反应发生率试验A组3.31%,B组5.00%。[结论]克洛己新分散片在治疗轻、中度呼吸道细菌性感染疾病为安全、有效药物,对敏感细菌感染疗效确切,不良反应低、安全性高,病人依从性好,值得作为临床呼吸系统治疗用药。更多还原

【Abstract】 [Object] An objective evaluation on the clinical efficacy and safety of Cefaclor and Bromhexine Hydrochloride Tablets used in the treatment of mild and moderate respiratory tract bacterial infections. [Method] This study is a multi-center, randomized, double-blind, double-dummy, positive controlled clinical trial, taking Compound Cefaclor Capsules as Control medicines. The number of groups which are diagnosed with mild, moderate acute bacterial respiratory infections, and which are needed for systemic antibiotic treatment are 241 cases. Among them, Group A accounts for 121 cases, Group B 120 cases. [Result] Full Analysis Set (FAS) analysis: the cure rate Group A 41.67%, Group B 39.50%, there were no significant differences in the two groups(P=0.6704); the efficacy rate Group A 84.17%, Group B 84.87% there were no significant differences in the two groups(P=0.8804). Per-Protocol Set (PPS) analysis: the cure rate Group A 46. 73%, Group B 40.95%, there were no significant differences in the two groups (P=0.3975); the efficacy rate Group A 87.85%, Group B 87.62%, there were no significant differences in the two groups(P=0.9622). The bacterial clearance rate Group A 94.81%, Group B 93.33%.The incidence of ADR Group A 6.61%, Group B 8.33%, the incidence of AE Group A 3.311%, Group B 5.00%. [Conclusion] On the treatment of mild, moderate respiratory tract bacterial infections, Cefaclor and Bromhexine Hydrochloride Tablets are safe and effective drugs, which have curative effects on sensitive bacterial infections, low adverse reactions, high safety and good Patient compliance. On these basis, Cefaclor and Bromhexine Hydrochloride Tablets can be used as clinical therapeutic drugs on the treatment of the respiratory system.更多还原