头孢妥仑匹酯细粒治疗儿童急性细菌性鼻窦炎的随机、双盲双模拟临床试验

A Randomized,Double-blind and Double-dummy Clinical Trial of CefditorenPivoxil in Treatment of Children with Acute Bacterial Sinusitis

目的评价头孢妥仑匹酯细粒治疗儿童急性细菌性鼻窦炎的有效性和安全性。方法对符合入组条件的患儿,随机分为两组、采用双盲双模拟的方法,与对照药(头孢克洛干混悬剂)比较,按照体重分剂量给药,治疗7d,并观察疗效指标。结果共计36例患儿随机分为两组,入组前两组受试者的各项人口统计学及一般背景特征、各项临床症状/体征都均衡可比(P>0.05),差异无统计学意义。揭盲后分析有效性的患者33例,其中头孢妥仑匹酯组17例、头孢克洛组16例;临床总有效率头孢妥仑匹酯组为100%(17/17),头孢克洛组为68.8%(11/16),两组差值(头孢妥仑匹酯-头孢克洛干混悬剂)及95%可信区间分别为31.3%(8.5%,54.0%)。头孢妥仑匹酯组治疗急性鼻窦炎的临床有效率高于头孢克洛组的临床有效率,P<0.05有显著性差异。两组均未发生严重不良事件。两组共4例次不良反应均自行恢复。结论头孢妥仑匹酯细粒治疗儿童急性细菌性鼻窦炎有效,安全性高。

Objective To evaluate the efficacy and safety of cefditorenpivoxil in treatment of children with acute bacterial sinusitis. Methods Children with acute bacterial sinusitis were randomly divided into two groups. With a double-blind and doub-le-dummy method, children in two groups were treated with cefditorenpivoxil and cefaclor for suspension（ control drug） according to their weight for 7 days and curative effect index were monitored. Results 36 cases of children with acute bacterial sinusitis were randomly divided into two groups. And there was no significant difference in demographic,general background characteristics,clini-cal symptoms and signs between two groups（P 〉0. 05） . Unblinding and analyzing 33 effective cases of patients,and there were 17 cases in cefditorenpivoxil group and 16 cases in cefaclor group. The total clinical efficiency of cefditoren group was 100% （17 of 17 children） while cefaclor group was 68. 8% （11 of 16 children）. The difference between the two groups was 31. 3% （95% confi-dence intervals ,8. 5% to 54% ）The clinical efficiency in cefditorenpivoxil group was higher than it in cefaclor（P 〈0. 05） . No serious adverse events occurred and 4 adverse events were self-recovered in both two groups. Conclusion Cefditorenpivoxil is effective and safe in treatment of children with acute bacterial sinusitis.