国产磷酸克林霉素治疗细菌性感染安全性及有效性临床观察  

Randomized Controlled and Open Clinical Trial on Domestic Compared With Imported Clindamycin Phosphate

作　　者：高磊[1] 侯杰[1] 陈亦芳[1] 李家泰[1] 

机构地区：[1]北京医科大学临床药理研究所,北京100034

出　　处：《中国医药导刊》2000年第3期40-42,共3页Chinese Journal of Medicinal Guide

摘　　要：磷酸克林霉素是克林霉素的酯化衍生物,供静脉用药。本品为林可霉素类抗菌素,主要用于治疗革兰氏阳性菌及厌氧菌感染。本项研究用国产磷酸克林霉素与进口磷酸克林霉素随机对照及开放治疗急性细菌性感染52例,两药均每日静点2次,每次300mg,疗程7～14天。随机对照试验中,20例国产磷酸克林霉素与20例进口磷酸克林霉素总有效率分别为75.0％与80.0％,细菌清除率分别为85.7％与93.8％,不良反应发生率均为10.0％。本试验中用国产磷酸克林霉素共治疗呼吸道、皮肤软组织及外科感染32例,临床有效率81.3％,细菌清除率为92.3％,不良反应发生率为9.4％。Clindamycin phosphate is a new lincomycin antibacterial agent for injection use. A randomized controlled clinical trial on domestic compared with imported clindamycin phosphate was conducted. 52 patients with respiratory infections were randomized to receive either domestic or imported clindamycin phosphate 300mg iv bid for 7-14 days. The clinical efficacy rates of domestic clindamycin phosphate and imported clindamycin phosphate were 75.0% and 80.0%, respectively. The bacterial clearance rates of them were 85. 7% and 93. 8% respectively. The adverse drug reactions of both groups were mild with the rates of 10. 0% and 10. 0% respectively. An open trial on domestic clindamycin phosphate for 12 patients with skin and soft tissue infections was conducted. The' clinical efficacy rate and the bacterial clearance rate were 81. 3% and 92. 3% . The adverse drug reactions were mild with the rates of 9. 4% .

关 键 词：随机对照试验 磷酸克林霉素 急性细菌性感染 

分 类 号：R515[医药卫生—内科学]