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  • 陈杨,修清玉,方正,岳红梅,程真顺,王金根,彭丽萍,崔丽英,秦志强,范治璐.注射用比阿培南治疗呼吸系统、泌尿系统细菌感染的随机对照多中心临床研究[J].第二军医大学学报,2014,35(4):388-393    [点击复制]
  • CHEN Yang,XIU Qing-yu,FANG Zheng,YUE Hong-mei,CHENG Zhen-shun,WANG Jin-gen,PENG Li-ping,CUI Li-ying,QIN Zhi-qiang,FAN Zhi-lu.Biapenem in treatment of respiratory and urinary bacterial infections:a multicenter, randomized, controlled clinical trial[J].Acad J Sec Mil Med Univ,2014,35(4):388-393   [点击复制]
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注射用比阿培南治疗呼吸系统、泌尿系统细菌感染的随机对照多中心临床研究
陈杨1△,修清玉1△,方正1*,岳红梅2,程真顺3,王金根4,彭丽萍5,崔丽英6,秦志强7,范治璐8
0
(1. 第二军医大学长征医院呼吸科, 上海 200003;
2. 兰州大学第一医院呼吸科, 兰州 730000;
3. 武汉大学中南医院呼吸科, 武汉 430030;
4. 江西省人民医院泌尿外科, 南昌 330006;
5. 吉林大学第一医院呼吸科, 长春 130021;
6. 内蒙古医学院附属医院呼吸科, 呼和浩特 010000;
7. 广西壮族自治区人民医院呼吸科, 南宁 530021;
8. 大连医科大学第二附属医院泌尿外科, 大连 116027
共同第一作者
*通信作者)
摘要:
目的 评价注射用比阿培南治疗呼吸系统和泌尿系统细菌感染的疗效和安全性。方法 采用多中心、随机、盲法、阳性药物平行对照试验方法,共入选288例呼吸系统和泌尿系统感染患者,随机分别接受比阿培南(试验组,144例)或美罗培南(对照组,144例)的治疗,统计两组的临床治愈率、细菌学疗效和不良反应发生率并进行比较。结果 试验组和对照组临床治愈率分别为95.10%(136/143)和92.25%(131/142),呼吸系统感染治愈率分别为93.06%(67/72)和94.29%(66/70),泌尿系统感染治愈率分别为97.18%(69/71)和90.28%(65/72);试验组和对照组细菌清除率分别为88.00%(66/75)和92.65%(63/68),呼吸系统感染细菌清除率分别为83.33%(30/36)和90.62%(29/32),泌尿系统感染细菌清除率分别为92.31%(36/39)和94.44%(34/36);两组间临床治愈率、细菌学疗效比较差异无统计学意义(P>0.05);试验组不良反应发生率为2.08%(3/144),对照组为8.33%(12/144),两组间比较差异有统计学意义(P=0.030 6)。非劣效性检验结果显示,试验组的细菌清除率和综合疗效非劣于对照组成立。结论 比阿培南治疗呼吸系统感染和泌尿系统感染的疗效与美罗培南相仿,安全性更好。
关键词:  比阿培南  美罗培南  细菌感染  呼吸系统  泌尿生殖系统  多中心研究
DOI:10.3724/SP.J.1008.2014.00388
投稿时间:2013-10-29修订日期:2014-02-21
基金项目:
Biapenem in treatment of respiratory and urinary bacterial infections:a multicenter, randomized, controlled clinical trial
CHEN Yang1△,XIU Qing-yu1△,FANG Zheng1*,YUE Hong-mei2,CHENG Zhen-shun3,WANG Jin-gen4,PENG Li-ping5,CUI Li-ying6,QIN Zhi-qiang7,FAN Zhi-lu8
(1. Department of Respiration, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China;
2. Department of Respiration, the First Affiliated Hospital of Lanzhou University, Lanzhou 730000, Gansu, China;
3. Department of Respiration, Zhongnan Hospital of Wuhan University, Wuhan 430030, Hubei, China;
4. Department of Urology, Jiangxi Provincial People's Hospital, Nanchang 330006, Jiangxi, China;
5. Department of Respiration, the First Affiliated Hospital of Jilin University, Changchun 130021, Jilin, China;
6. Department of Respiration, Affiliated Hospital of Inner Mongolia Medical College, Hohhot 010000, Inner Mongolia, China;
7. Department of Respiration, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning 530021, Guangxi, China;
8. Department of Urology, Second Affiliated Hospital of Dalian Medical University, Dalian 116027, Liaoning, China
Co-first authors.
*Corresponding author.)
Abstract:
Objective To evaluate the efficacy and safety of biapenem in treatment of bacterial infections of the respiratory and urinary systems. Methods A total of 288 patients with infections of the respiratory and urinary system were included in this multicenter, blinded, randomized, and parallel controlled trial. The patients were randomly assigned to receive biapenem(experimental group, n=144) or meropenem (control group, n=144). Results The clinical curative rates of the experimental group and control group were 95.10%(136/143) and 92.25%(131/142), respectively, with those for respiratory system infection being 93.06%(67/72) and 94.29%(66/70) and those for urinary infection being 97.18%(69/71) and 90.28%(65/72), respectively. The bacterial eradication rates in the experimental group and control group were 88.00%(66/75) and 92.65%(63/68), respectively, with those for the respiratory infection being 83.33%(30/36) and 90.62%(29/32) and those for urinary infection being 92.31%(36/39) and 94.44%(34/36), respectively. There were no significant differences between the two groups regarding the clinical curative rates or bacterial eradication rates (P>0.05).The side-effect rate was 2.08%(3/144) in the experimental group and 8.33%(12/144) in the control group, with significant differences found between the two groups (P=0.030 6). Conclusion Compared to meropenem, biapenem has similar efficacy in treatment of respiratory and urinary system infection, but with study
Key words:  biapenem  meropenem  bacterial infections  respiratory system  urogenital system  multicenter study