乳酸环丙沙星注射剂临床疗效观察

A CLINICAL STUDY OF INTRAVENOUS PREPARATION OF CIPROFLOXACIN LACTATE

本文采用随机对照开放临床试验,对乳酸环丙沙星(Ciprofloxacin,CPLX)注射剂进行了临床评价,共治疗各种细菌性感染100例,其中50例与头孢噻肟钠(Cefotaxime,CTX)相对照。结果显示CPLX组与对照CTX组疗效各为91.0％和92.0％(P>0.05),无显著性差异。两组细菌清除率各为90,8％和88.6％(P>0.05),无显著性差异。不良反应分别为15％和8％。不良反应程度轻微,主要表现为注射局部反应和消化道反应,其中注射局部反应CPLX略高于CTX。体外抗菌活性表明CPLX对大多数革兰氏阴性菌和革兰氏阳性菌具有良好的抗菌活性。

The clinical efficacy and safety of intravenous Cipro-floxacin lactate (CPLX) administration were observed in a randomized open trial. 100 hospitalized patients with acute and moderate to serious lower respiratory, urinary, gastrointestinal tract and other infections were treated by CPLX. There were 50 cases in the control group (Cefotaxime, CTX). In the CPLX group, 91.0% of patients were clinically cured or improved as compared with 92.0% of the patients in the CTX group(p>0.05). The eradication rates of pathogens were 90.8% and 88.6%, respectively(p>0.05). The rates of side effects of CPLX were 15%. Compared with CTX group(8%), the rate of local erythema and pain caused by CPLX administration was somewhat higher. But both drugs were well tolerated and did not interrupt the course of the treatment. The results of this study suggest that CPLX is a safe and effective agent for the treatment of acute and serious infections caused by sensitive pathogens.