中国临床药学杂志

目的通过治疗急性呼吸系统和泌尿系统细菌性感染,评价头孢地尼胶囊安全性和有效性。方法采用多中心、区组随机化、双盲双模拟、随机平行对照的试验方法。观察对象为符合入组条件的138例急性呼吸系统和泌尿系统细菌性感染的患者。试验组予试验用头孢地尼胶囊及已上市头孢地尼胶囊模拟药各1粒,po,tid。对照组予已上市头孢地尼胶囊及试验用头孢地尼胶囊模拟药各1粒,po,tid;疗程7～14d。结果本临床试验共入组138例,可进行疗效评价分析的病例共137例,试验组69例,对照组68例,2组总痊愈率分别为75.36%和77.94%,总有效率分别为92.75%和95.59%。呼吸系统试验组痊愈率和有效率分别为69.44%和91.67%,对照组分别为73.53%和94.12%;泌尿系统试验组痊愈率和有效率分别为81.82%和93.94%,对照组分别为82.35%和97.06%;2组总细菌阳性率分别为91.30%和80.88%,细菌清除率分别为88.89%和94.55%。2组比较差异均无统计学意义(P>0.05)。试验组不良事件发生率为8.70%(6/69),对照组为13.04%(9/69),主要不良反应为轻至中度的恶心、上腹不适、皮疹、ALT和AST升高等,2组比较差异均无统计学意义(P>0.05)。结论试验用头孢地尼胶囊治疗细菌引起的呼吸系统和泌尿系统感染,临床疗效明显,细菌清除率高,不良反应较少,与已上市头孢地尼胶囊疗效相当。

AIM To evaluate the efficacy and safety of cefdinir capsule in treatment of patients with acute bacterial infections of respiratory tract and urinary tract. METHODS It was a randomized,double-blind,double-dummy,parallel controlled and multiple center trial design.Patients in test group were given one capsule of tested cefdinir capsule and one capsule of placebo of listed cefdinir capsule simulation,po,tid,for 7-14 d. Patients in control group were given one capsule of listed cefdinir capsule and one capsule of placebo of tested cefdinir capsule simulation,po,tid,for 7-14 d. RESULTS One hundred and thirty-eight patients with acute bacteriaI infections of respiratory tract and urinary tract were selected. Among them,137 patients can be carried out the evaluation analysis (69 patients in test group,68 patients in control group).The total effective rates of the test group and control group were 92.75% and 95.59% ,and the recovery rates were 75.36% and 77.94%,respectively.In the infections of respiratory tract ,the recovery rate and the effective rate were 69.44%and 91.67% in test group,respectively. In the infections of urinary tract,the recovery rate and the effective rate were 81.82% and 93.94% in control group,respectively. The bacteria-positive rates of two group were 91.30% and 80.88%,respectively.The bacterial clearance rates were 88.89% and 94.55%,respectively.The adverse events rates were 8.70% (6/69) and 13.04%(9/69),respectively. The main adverse drug reactions included nausea,abdominal discomfort,phlebitis,the elevation of ALT,BUN,and so on.The two groups were similar in the efficacy and safety (P>0.05).CONCLUSION Tested cefdinir capsule is effective and safe in the treatment of patients with acute infections of respiratory tract and urinary tract.The effect is considerable as compared with the control drug listed cefdinir capsules.