北京大学医学部机构知识库
Advanced  
IR@PKUHSC  > 北京大学第二临床医学院  > 期刊论文
学科主题: 临床医学
题名:
Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial
作者: Chen, Zhangjing1; Wu, Jufang1; Zhang, Yingyuan1; Wei, Junming2; Leng, Xisheng3; Bi, Jianwei4; Li, Rong5; Yan, Lunan6; Quan, Zhiwei7; Chen, Xiaoping8; Yu, Yunsong9; Wu, Zhiyong10; Liu, Dawei11; Ma, Xiaochun12; Maroko, Robert13; Cooper, Angel13
刊名: BMC INFECTIOUS DISEASES
发表日期: 2010-07-21
DOI: 10.1186/1471-2334-10-217
卷: 10
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Infectious Diseases
研究领域[WOS]: Infectious Diseases
关键词[WOS]: SKIN-STRUCTURE INFECTIONS ; INTENSIVE-CARE-UNIT ; IN-VITRO ACTIVITY ; BACTERIAL PATHOGENS ; VANCOMYCIN-AZTREONAM ; PHASE-3 ; PROGRAM
英文摘要:

Background: Tigecycline, a first-in-class broad-spectrum glycylcycline antibiotic, has broad-spectrum in vitro activity against bacteria commonly encountered in complicated intra-abdominal infections (cIAIs), including aerobic and facultative Gram-positive and Gram-negative bacteria and anaerobic bacteria. In the current trial, tigecycline was evaluated for safety and efficacy vs. imipenem/cilastatin in hospitalized Chinese patients with cIAIs.

Methods: In this phase 3, multicenter, open-label study, patients were randomly assigned to receive IV tigecycline or imipenem/cilastatin for <= 2 weeks. The primary efficacy endpoints were clinical response at the test-of-cure visit (12-37 days after therapy) for the microbiologic modified intent-to-treat and microbiologically evaluable populations. Because the study was not powered to demonstrate non-inferiority between tigecycline and imipenem/cilastatin, no formal statistical analysis was performed. Two-sided 95% confidence intervals (CIs) were calculated for the response rates in each treatment group and for differences between treatment groups for descriptive purposes.

Results: One hundred ninety-nine patients received >= 1 dose of study drug and comprised the modified intent-to-treat population. In the microbiologically evaluable population, 86.5% (45 of 52) of tigecycline- and 97.9% (47 of 48) of imipenem/cilastatin-treated patients were cured at the test-of-cure assessment (12-37 days after therapy); in the microbiologic modified intent-to-treat population, cure rates were 81.7% (49 of 60) and 90.9% (50 of 55), respectively. The overall incidence of treatment-emergent adverse events was 80.4% for tigecycline vs. 53.9% after imipenem/cilastatin therapy (P < 0.001), primarily due to gastrointestinal-related events, especially nausea (21.6% vs. 3.9%; P < 0.001) and vomiting (12.4% vs. 2.0%; P = 0.005).

Conclusions: Clinical cure rates for tigecycline were consistent with those found in global cIAI studies. The overall safety profile was also consistent with that observed in global studies of tigecycline for treatment of cIAI, as well as that observed in analyses of Chinese patients in those studies; no novel trends were observed.

Trial Registration: ClinicalTrials.gov NCT00136201

语种: 英语
项目资助者: Wyeth Research, Collegeville, PA, USA
WOS记录号: WOS:000283139500002
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63386
Appears in Collections:北京大学第二临床医学院_期刊论文

Files in This Item:

There are no files associated with this item.


作者单位: 1.Fudan Univ, Huashan Hosp, Shanghai 200433, Peoples R China
2.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
3.Shanghai Changhai Hosp, Shanghai, Peoples R China
4.China PLA Gen Hosp, Beijing, Peoples R China
5.Sichuan Univ, W China Hosp, Chengdu 610064, Peoples R China
6.Shanghai Xinhua Hosp, Shanghai, Peoples R China
7.Tongji Hosp, Wuhan, Peoples R China
8.Shanghai Renji Hosp, Shanghai, Peoples R China
9.Pfizer Inc, Collegeville, PA USA
10.Beijing Union Med Coll Hosp, Beijing 100730, Peoples R China
11.Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
12.Beijing Union Med Coll Hosp, Beijing, Peoples R China
13.China Med Univ, Affiliated Hosp 1, Shenyang, LiaoNing, Peoples R China

Recommended Citation:
Chen, Zhangjing,Wu, Jufang,Zhang, Yingyuan,et al. Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial[J]. BMC INFECTIOUS DISEASES,2010,10.
Service
Recommend this item
Sava as my favorate item
Show this item's statistics
Export Endnote File
Google Scholar
Similar articles in Google Scholar
[Chen, Zhangjing]'s Articles
[Wu, Jufang]'s Articles
[Zhang, Yingyuan]'s Articles
CSDL cross search
Similar articles in CSDL Cross Search
[Chen, Zhangjing]‘s Articles
[Wu, Jufang]‘s Articles
[Zhang, Yingyuan]‘s Articles
Related Copyright Policies
Null
Social Bookmarking
Add to CiteULike Add to Connotea Add to Del.icio.us Add to Digg Add to Reddit

Items in IR are protected by copyright, with all rights reserved, unless otherwise indicated.

 

 

Valid XHTML 1.0!
Copyright © 2007-2018  北京大学医学部 - Feedback
Powered by CSpace