论文部分内容阅读
目的评价注射用盐酸头孢唑兰治疗呼吸系统感染的疗效及安全性。方法采用多中心、随机、双盲、平行对照试验设计,随机化入选病例144例,分为试验组(头孢唑兰组)和对照组(头孢吡肟组)各72倒。均为每次1.0g,用5%葡萄糖注射液或0.9%氯化钠注射液100ml溶解稀释,每12小时1次,静脉滴注,疗程7~14d。结果试验组纳入分析数据集(FAS)和方案数据集(PPS)分析分别为71例和68例,对照组纳入FAS和PPS分析分别为72例和67例。疗程结束时试验组和对照组的临床治愈率(FAS分析)分别为91.55%(65/71)和91.67%(66/72);综合治愈率(FASM分析)分别为88.89%和89.66%。2组细菌清除率分别为88.89%和89.66%,2组间比较差异无统计学意义(P>0.05)。头孢唑兰组和头孢吡肟组的不良事件发生率分别为12.59%和13.29%,未见重度及严重不良事件。结论注射用头孢唑兰治疗呼吸系统急性细菌性感染的临床疗效确切,安全性好。
Objective To evaluate the efficacy and safety of cefazolin hydrochloride in the treatment of respiratory infections. Methods A multicentre, randomized, double-blind, parallel-controlled trial was designed and randomized into 144 cases and divided into experimental group (cefazolin group) and control group (cefepime group) with 72 cases each. Each 1.0g, with 5% glucose injection or 0.9% sodium chloride injection 100ml dissolved dilution, once every 12 hours, intravenous infusion, treatment 7 ~ 14d. Results In the experimental group, 71 cases and 68 cases were included in the analysis of data set (FAS) and program data set (PPS) respectively. The control group included 72 cases and 67 cases of PAS analysis respectively. The clinical cure rates (FAS analysis) of the test group and the control group were 91.55% (65/71) and 91.67% (66/72) respectively at the end of the course of treatment. The overall cure rates (FASM analysis) were 88.89% and 89.66%, respectively. The bacterial clearance rates of the two groups were 88.89% and 89.66% respectively, with no significant difference between the two groups (P> 0.05). The incidences of adverse events in the cefazolin and cefepime groups were 12.59% and 13.29%, respectively. No serious or serious adverse events were observed. Conclusion Cefazolin injection in the treatment of acute bacterial infections of the respiratory system has definite curative effect and good safety.