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

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(P0.05).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.