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用国产与进口盐酸头孢他美酯随机对照及开放治疗急性细菌性感染,对前者进行安全性及有效性评价。共完成168例(试验组及对照组各60例,开放组48例),剂量为500mgbid,餐后1h服用,疗程5~14d,淋菌性尿道炎疗程3d。试验组、对照组与开放组不同感染病种患者的有效率分别为86.67%、90.00%与87.50%,各组间无显著性差异(P>0.05),试验组加开放组共108例,总有效率为87.04%,3组细菌产β-内酰胺酶率分别为67.92%、75.00%与75.00%,清除率分别为96.23%、96.15%与92.50%,不良反应发生率分别为6.67%、6.67%及10.42%(P>0.05),差异无显著性(P>0.05)。145株细菌对国产头孢他美纸片的高敏率为91.72%,与进口品90.34%相似,两者的MIC值亦相似。表明:国产盐酸头孢他美酯片抗菌谱广,抗菌活性强,对大部分细菌产生的β-内酰胺酶稳定,为一治疗轻、中度急性细菌性感染安全有效的口服药物。
With domestic and imported ceftazidime hydrochloride randomized controlled and open treatment of acute bacterial infections, the safety and efficacy of the former evaluation. A total of 168 cases were completed (experimental group and control group, 60 cases, open group, 48 cases), a dose of 500mgbid, 1h postprandial, treatment of 5 ~ 14d, gonococcal urethritis treatment 3d. The effective rates of the experimental group, the control group and the open group patients with different infectious diseases were 86.67%, 90.00% and 87.50%, respectively, with no significant difference between the two groups (P> 0.05) Plus open group of 108 cases, the total effective rate was 87.04%, 3 groups of bacteria producing β-lactamase were 67.92%, 75.00% and 75.00%, respectively, the clearance rate was 96.23 %, 96.15% and 92.50%, respectively. The incidences of adverse reactions were 6.67%, 6.67% and 10.42%, respectively, with no significant difference (P> 0.05 ). The high sensitivity of 145 strains to domestic ceftazidime was 91.72%, which was similar to the imported 90.34%. The MICs of the two strains were also similar. The results showed that the antibacterial spectrum of domestic ceftazidime hydrochloride tablet is broad and has strong antibacterial activity. It is stable to β-lactamase produced by most bacteria and is a safe and effective oral drug for the treatment of mild and moderate acute bacterial infections.