静注氟氯西林钠治疗急性呼吸道感染的临床研究

目的评价静注氟氯西林钠(半合成青霉素类抗生素)治疗呼吸系统急性感染的有效性和安全性。方法采用前瞻、随机、盲法、对照、多中心临床试验,试验组106例注射氟氯西林钠,对照组107例注射氯唑西林钠,剂量均为每次2g,2次/日,疗程均为5~14天。本研究入选218例,可评价患者213例。结果2组的治愈率比较,氟氯西林钠优于氯唑西林钠(68.87%vs50.94%,P=0.008);2组的有效率基本相当,分别为96.23%,96.26%。2组细菌清除率均为96.34%。2组不良反应发生3例、10例(2.78%vs9.09%,P=0.049);主要为注射部位的疼痛、皮疹、恶心、肝功能异常、尿素氮升高等,程度均为轻度,呈一过性。结论氟氯西林钠对临床常见致病菌所致的急性呼吸道感染与已上市使用的氯唑西林钠具有相同或更好的抗菌活性,特别对产青霉素酶的葡萄球菌感染,效果较好,不良反应发生率较低。

Clinical trial of intravenous floxacillin sodium in the treatment of acute respiratory tract infections

Objective To evaluate the efficacy and safety of intravenous floxacillin sodium therapy for acute respiratory tract infections. Methods Patients with acute respiratory tract infections were designed to prospective, randomized, blind, parallel controlled and multi-center clinical trial and treatment with twice daily infusions of 2 gram floxacillin or cloxacillin for 5-14 days.Two hundreds eighteen patients were enrolled in this trial,213 cases finished whole study,while 106 patients in floxacillin group and 107 in cloxacillin group.Results The cure rate in floxacillin group was better than in cloxacillin group(68.87% vs 50.94%,P=0.008). The clinical effective rate were 96.23%,96.26%,respectively.The bacterial eradication rates were about 96.34% respectively both two the groups. The clinical adverse reactive rate(3/108) in floxacillin group was lower than that(10/110)in cloxacillin group(2.78% vs 9.09%,P=0.049).The majority of the adverse reactions were pain and rash in injective site, nausea, mild liver and renal dysfunction and all recovered quickly without treatment in two groups.Conclusion Parenteral floxacillin therapic efficacy as not less than parenteral cloxacillin for acute respiratory tract infections. The adverse effects are mild and transient in both groups but more frequent in cloxacillin group.