新治君治疗呼吸系统感染的随机盲法多中心临床研究(1)
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[摘要] 目的：以注射用头孢噻肟钠配注射用舒巴坦钠(组合包装)为对照，评价新治君(注射用头孢噻肟钠舒巴坦钠)治疗呼吸系感染的有效性和安全性。方法：采用多中心、随机双盲、平行对照的试验方法，实验组和对照组均采用每次3.0 g，每日2次，疗程均为5~14 d的治疗方案。试验组和对照组的临床可评价病例均为60例，细菌学疗效评价例数分别为45和50例。结果：试验组和对照组的临床有效率分别为90.00%和85.00%；细菌清除率分别为95.56%和88.00%；药物不良反应发生率分别为4.76%和1.59%；两组均未出现严重药物不良反应。结论：新治君是治疗呼吸系中、重度感染的安全有效药物。
[关键词] 新治君；头孢噻肟钠；舒巴坦钠；细菌感染；临床研究
[中图分类号] R515 [文献标识码]A[文章编号]1674-4721(2011)08(b)-007-04
Multicenter clinical study on Xinzhijun for treatment of Respiratory tract infection
YAN Xixin1, HU Chengping2, LIU Shengming3, ZHANG Yongxiang4, WANG Tingchun5,LI Changqing6, WANG Ting6*
1.The Second Hospital of Hebei Medical University, Hebei Province, Shijiazhuang050005, China; 2.Xiangya Hospital ofCentral South University, Hunan Province, Changsha410013, China; 3.Affiliated Hospital of Ji'nan University, Guangdong Province, Guangzhou510630, China; 4.The First Hospital of Hebei Medical University, Hebei Province, Shijiazhuang050031, China; 5. Guangzhou Boji Clinical Research Center of New Drug, Guangdong Province, Guangzhou 510635, China; 6. Xiangbei Welman Pharmaceutical CO.Ltd., Hunan Province, Changsha410331, China
[Abstract] Objective: To evaluate the efficacy and safety of Xinzhijun (Cefotaxime Sodium and Sulbactam Sodium for Injection) in treatment of respiratory tract infections compared to Cefotaxime sodium for injection plus Sulbactam sodium for injection combination. Methods: A randomized, double-blind, parallel controlled, multicenter trial was conducted, and the dose of Xinzhijun (experimental group) and Cefotaxime sodium for injection plus Sulbactam sodium for injectioncombination (control group )was 3.0 g, bid for 5-14 days. The total number of final evaluated subjects was 120. The bacterial evaluated subjects were 45 for experimental group and 50 for control group. Results：Clinical efficacy rate and bacterial eradication rate for experimental group was 90 ......
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