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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)治疗泌尿系感染的有效性和安全性。方法用多中心、随机、盲法、平行对照的试验方法,实验组和对照组均采用每次3.0 g,2次/d,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例和53例。结果试验组和对照组的临床有效率分别为90.00%和88.33%;细菌清除率分别为90.11%和90.57%;药物不良反应发生率分别为4.92%和1.54%;两组均未出现严重药物不良反应。结论新治君是治疗泌尿系中、重度感染的安全有效药物。
Objective To evaluate the efficacy and safety of Cefotaxime sodium (with injection of cefotaxime sodium and sulbactam sodium) for the treatment of urinary tract infections by injecting cefotaxime sodium for injection and sulbactam sodium for injection (combination package) as control. Methods The method of multi-center, randomized, blinded and parallel control was adopted. The experimental group and the control group were treated with 3.0 g twice daily for 5 to 14 days. The clinical evaluable cases of the experimental group and the control group were 60 cases, bacteriological evaluation of the number of cases were 45 cases and 53 cases. Results The clinical efficacies in the experimental and control groups were 90.00% and 88.33%, respectively. The bacterial clearance rates were 90.11% and 90.57%, respectively. The incidences of ADR were 4.92% and 1.54% respectively. No serious adverse drug reactions occurred in both groups reaction. Conclusion Xinzheng Jun is a safe and effective drug for the treatment of moderate and severe urinary infections.