替考拉宁与万古霉素随机对照多中心临床研究

Multicenter Randomized Controlled Clinical Trial On Teicoplanin Versus Vancomycin

目的:评价替考拉宁治疗下呼吸道革兰阳性菌感染的疗效和安全性。方法:给药方案为试验药替考拉宁,第一日每次400mg,qd,此后每次200mg,qd;重度感染第一日每次400mg,q12h,此后每次400mg,qd。对照药万古霉素,每次0、5g,q8h。重度感染每次1.0g,q12h。均为静脉滴注。疗程7～14d。结果:试验药组和对照药组有效率分别为87.10％（54/62）及90.32％（56/62）,痊愈率分别为74.19％（46/62）及61.29％（38/62）,细菌清除率分别为94.74％（54/57）及88.52％（54/61）,药物不良反应发生率分别为11.29％（7/62）及6.45％（4/62）。上述两组的各项结果经统计学处理,均无显著性差异（P>0.05）。结论:替考拉宁对革兰阳性菌抗菌活性强,临床疗效佳,药物不良反应轻微,对革兰阳性菌引起的中、重度感染安全有效。

OBJECTIVE: To Evaluate the efficacy and safety of teicoplanin. METHODS: The patients received teicoplanin intravenously once daily at 400mg in the first day, 200mg from the second day and the doses were double for the patients with severe infections, or vancomycin at 0.5g three times daily and 1.0g twice daily for the patients with severe infections. The treatment duration was 7-14 days. RESULTS: The effective rate and cure rate were 87.10% (54/62) and 74.19%(46/62)in teicoplanin group, while in vancomycin group were 90.32%(56/62)and 61.29%(38/62) respectively. The bacterial elimination rate was 94.74%(54/57) in teicoplanin group and 88.52%(54/61) in vancomycin group. Adverse reactions occurred in 11.29%(7/62) of patients in teicoplanin group and 6.45%(4/62) in vancomycin group. There were no statistically differences between the two groups. CONCLUSION: Teicoplanin is an effective and safe agent for treating moderate and severe gram positive bacterial infections.