国产甲磺酸左氧氟沙星与进口左氧氟沙星治疗细菌性感染323例疗效及不良反应比较

A randomized clinical and laboratory study of domestic levofloxacin mesylate versus import levofloxacin in the treatment of bacterial infective diseases

评价国产左氧氟沙星与进口左氧氟沙星治疗细菌性感染的临床有效性和安全性。采用随机开放平行对照试验。可评价疗效者３２３例，两组各为１５３例及１７０例。安全性评价３１２例，两组各为１５３例及１５９例。轻中度感染给予左氧氟沙星０．２ｇ，每日２次；重症或假单胞菌感染给予０．２ｇ，每日３次口服，疗程５～１４ｄ，两组给药方法及疗程一致。试验组与对照组细菌阳性率各为８２．４％及８７．６％。总有效率各为９５．４％及９４．７％，痊愈率各为８１．０％及８０．６％，细菌清除率各为９３．２％及８６．６％，不良反应率各为５．２％及４．４％，两组比较均无显著差异（Ｐ＞０．０５）。

To evaluate the efficacy and safety of domestic levofloxacin mesylate (MSALVLX, Lifaxing R, Double Crane Pharmceutical Co., LTD.) compared with import levofloxacin (LVLX, Cravit R, Daiichi Pharmaceutical Co., LTD.) in the treatment of bacterial infective diseases. Using randomized control led trials, 323 patients [MSALVLX (n=153), LVLX (n=170)] were evaluated for efficacy and 312 patients [MSALVLX (n=153), LVLX (n=159)] were evaluated for safety . The dosage and course of MSALVLX group were the same as those of LVLX group, 0.2g twice daily for slight and moderate infections; 0.2g three times daily for severe and pseudomonas infections; treatment course 5￣14 days. The positive rates of pathogens of MSALVLX and LVLX groups were 82.4% and 87.6%. The total clinical efficacy rates of MSALVLX and LVLX were 95.4% and 94.7% . The cure rates of MSALVLX and LVLX were 81.0% and 80.6%. The bacteriological clearance rates were 93.7% and 86.6%. The incidence of adverse drug reaction for MSALVLX and LVLX were 5.2% and 4.4%. There was no significant difference between the two groups ( P > 0.05 ). Both drugs are very effective in treating bacterial infections.