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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。
Objective To evaluate the efficacy and safety of ceftizoxime injection for the treatment of lower respiratory tract and urinary tract infections. Methods A prospective, single-blind, randomized controlled trial of a new drug, ceftizoxime injection, was conducted in a multicenter clinical trial. Select lower respiratory tract and urinary tract infection patients, the experimental group using ceftizoxime injection (Chongqing Southwest Synthetic Pharmaceutical Co., Ltd. developed), the control group using Harbin Pharmaceutical Group Factory production ceftizoxime injection, the dose was 1 ~ 2g, every 8 to 12 hours intravenously 1. Treatment 7 ~ 14d. Results A total of 255 cases were enrolled in this study. 243 patients completed the trial, 122 in the trial group and 121 in the control group. The effective rates of the two groups were 95.08% and 95.87%, respectively. 49 cases of pneumonia in which the experimental group, the effective rate of 100%; control group of 49 cases, the effective rate was 97.96%. 14 cases of chronic bronchitis acute bacterial infection test group, control group, 12 cases, the effective rate was 100%. Acute pyelonephritis experimental group 40 cases, the effective rate was 97.50%; control group, 39 cases, the effective rate was 97.43%. 17 cases of complicated urinary tract infection test group, the effective rate was 76.47%; control group, 18 cases, the effective rate was 83.33%. Recurrent upper urinary tract infection in the experimental group 2 cases, 1 case of cure and relapse; control group 3 cases, 2 cases cured, 1 case markedly. No significant difference between the two groups. In this study, a total of 166 feasible microorganism evaluators were included, of which 81 were in the experimental group and 85 in the control group. The total number of pathogenic bacteria was 82 and 86. After the treatment, the bacterial clearance rate was 98.78% in the experimental group and 98.84 in the control group %, Two groups of bacteria clearance rate similar, the difference was not statistically significant. Adverse reactions in the two groups were 8.59% and 19.69%, respectively, with no significant difference. Among them, 4 cases were clinical adverse reaction test group and 10 cases were control group, which mainly manifested as drug fever and gastrointestinal reaction. 7 cases of related laboratory abnormalities test group, 15 cases of control group, including leukopenia and abnormal liver function. No serious adverse events occurred. Conclusion The antibacterial new drug ceftizoxime injection for the treatment of common lower respiratory and urinary tract infections and control drugs similar efficacy, low incidence of adverse reactions, can be used for the treatment of sensitive pathogens caused by these infections.