【摘要】 目的评价抗菌新药头孢唑肟注射剂治疗下呼吸道和尿路感染的疗效和安全性。方法采用前瞻性、单盲、随机对照方法,进行新药头孢唑肟注射剂的多中心临床试验。选择下呼吸道和尿路感染患者,试验组使用头孢唑肟注射剂(重庆西南合成制药股份有限公司研制),对照组使用哈药集团制药总厂生产的头孢唑肟注射剂,剂量均为每次1~2g,每8~12小时静脉滴注1次。疗程7~14d。结果本研究共入选病例255例,最终完成试验者243例,其中试验组122例,对照组121例,两组的有效率分别为95.08%和95.87%。其中肺炎试验组49例,有效率100%;对照组49例,有效率97.96%。慢性支气管炎急性细菌感染试验组14例,对照组12例,有效率均为100%。急性肾盂肾炎试验组40例,有效率97.50%;对照组39例,有效率97.43%。复杂性尿路感染试验组17例,有效率76.47%;对照组18例,有效率83.33%。反复发作性上尿路感染试验组2例,治愈及复发各1例;对照组3例,治愈2例,显效1例。两组疗效差异无统计学意义。本研究病例中,可行微生物评价者共166例,其中试验组81例,对照组85例,共获病原菌82株及86株,经治疗后试验组的细菌清除率为98.78%,对照组为98.84%,两组细菌清除率相仿,差异无统计学意义。研究中两组的不良反应发生率分别为8.59%和19.69%,差异无统计学意义。其中临床不良反应试验组4例,对照组10例,主要表现为药物热及胃肠道反应。相关实验室异常试验组7例,对照组15例,主要包括白细胞减少及肝功能异常。未发生严重不良事件。结论抗菌新药头孢唑肟注射剂治疗常见下呼吸道和尿路感染疗效与对照药相仿,不良反应发生率低,可用于治疗敏感病原菌所致的上述感染。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of ceftizoxime sodium for injection in the treatment of lower respiratory tract infections(LRTIs) and urinary tract infections(UTIs).Methods The trial was designed as a single-blinded,randomized and multicenter study.Patients with LRTI or UTI were randomized to receive ceftizoxime for injection or another ceftizoxime product as control.Patients in both groups received ceftizoxime 1-2g,q8-12h intravenously for 7 to 14 days.Results A total of 255 patients were enrolled in the trial and 243 subjects completed (122 in treatment group,121 in control group).The overall clinical effective rate was similar in the treatment and control groups(95.08% vs.95.87%,P>0.05).The bacterial eradication rate was 98.78% and 98.84% respectively(P>0.05).The incidence of adverse reaction was 8.59% and 19.69% respectively(P>0.05).No serious adverse reaction was reported.Conclusions The tested ceftizoxime for injection is an effective and safe therapy for treating LRTIs and UTIs as controlled agent.更多还原