2种注射用头孢唑肟治疗急性呼吸系统细菌感染的多中心临床评价

目的评价国产注射用头孢唑肟治疗中、重度呼吸系统细菌性感染的有效性和安全性。方法采用区组随机化、多中心、平行对照、单盲试验,共入选138例呼吸道感染病人。试验组予国产注射用头孢唑肟治疗,对照组予进口注射用头孢唑肟治疗,均为头孢唑肟2g加入氯化钠注射液250 mL,30～60 min内静脉滴注,q12 h,疗程均为7～14 d。评价2组临床疗效和不良反应。结果可进行安全性评价130例,可列入临床疗效评价共计125例,试验组和对照组分别为61例和64例。试验组和对照组临床有效率分别为92%(56/61)和89%(57/64),细菌清除率分别为94%(48/51)和93%(50/54),药物不良反应发生率分别为5%(3/65)和6%(4/65)。均无显著差异(P>0.05)。结论国产注射用头孢唑肟治疗中、重度呼吸系统细菌性感染疗效确切、药物不良反应少,疗效和安全性与进口注射用头孢唑肟相当。

A multicenter clinical study on self-manufactured versus imported ceftizoxime for injection in treatment of acute bacterial respiratory tract infectious

AIM To evaluate the efficacy and safety of self-manufactured cefiizoxime for injection in the treatment of patients with acute moderate and severe respiratory tract infections.METHODS One hundred and thirty-eight patients with respiratory tract infection were enrolled in the multicenter randomized,controlled, single blind clinical trial and divided into trial and control groups,having administration of 2 g of ceftizoxime drop infusion within 30-60 min twice a day for 7-14 d as a course individually to both the trial group and the control group with self-manufactured and imported ceftizoxime,respectively.Evaluation of the efficacy and adverse reactions were carried out.RESULTS One hundred and thirty patients could be undertaken safety evaluation but only 125 of them provided the information for clinical efficacy evaluation,including 61 of trial group and 64 of control group.The efficacy rates were 92 %(56/61)and 89 %(57/64);the bacterial clearance rates were 94 %(48/51)and 93 %(50/54);whereas the incidences of adverse drug reactions were 5 %(3/65)and 6 %(4/65)for the trial group and the control group,respectively;with no statistical significant difference between the two groups(P>0.05).CONCLUSION The self-manufactured ceftizoxime for injection is as effective and safe as those of imported ceftizoxime for the treatment of acute moderate and severe respiratory tract bacterial infections for injection.