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目的:通过随机对照和开放试验的方法评价国产头孢他美酯的临床疗效和安全性。方法:随机对照选用进口头孢他美酯作为对照组,每组各20例,开放组10例,均按500mg Bid给药,疗程7～14天。结果:国产头孢他美酯的临床治愈率75％(15/20),有效率90％(18/20),细菌清除率100％(18/18)。对照组分别为85％(17/20),90％(18/20),100％(16/16)。试验组+开放组分别为76.7％(23/30)、90％(27/30)、100％(26/26)。国产头孢他美酯和进口头孢他美酯不良反应发生率分别为3.33％和5％。以上结果经统计学处理差异无显著性(P>0.05)。结论:国产头孢他美酯是治疗呼吸道、泌尿道感染有效、安全的抗菌药物。
Objective: To evaluate the clinical efficacy and safety of domestic ceftazidime by randomized controlled trials and open trials. Methods: Randomized controlled-entry ceftazidime was used as the control group, with 20 cases in each group and 10 cases in open group. All patients were treated with 500 mg Bid for 7 to 14 days. Results: The clinical cure rate of domestic ceftazidime was 75% (15/20), the effective rate was 90% (18/20) and the bacterial clearance rate was 100% (18/18). The control group was 85% (17/20), 90% (18/20), 100% (16/16) respectively. The test group and open group were 76.7% (23/30), 90% (27/30) and 100% (26/26), respectively. Domestic incidence of ceftazidime and imported cefetamet ester adverse reactions were 3.33% and 5%. The above results by the statistical difference was not statistically significant (P> 0.05). Conclusion: Domestic ceftazidime is an effective and safe anti-bacterial drug for the treatment of respiratory and urinary tract infections.