头孢克洛缓释片治疗成人急性鼻窦炎临床研究

目的 评价头孢克洛缓释片治疗成人急性鼻窦炎的疗效及安全性。方法 62例18-65岁诊断为急性鼻窦炎受试病例,连续服用头孢克洛缓释片(750 mg／次,每日两次,口服)14天,进行多中心的开放式研究。分别在治疗前后对病例进行症状和体征的评估,记录治疗期间发生的不良事件。结果 临床治愈15.5％,好转72.4％,总有效率87.9％(P<0.05)。12.9％的受试病例发生了以胃肠道事件为主的非严重性不良事件。结论 头孢克洛缓释片治疗急性鼻窦炎有良好临床疗效,并具有良好的安全性,可作为口服抗生素的一种有效选择。

The clinical study of Ceclor SR in the treatment of acute sinusitis in adult patients

JECTIVE To evaluate the therapeutic effects and safety of Ceclor SR (Sustained Release) for the treatment of acute sinusitis in adults.METHODS This is an multi - center, open label, non-comparative study, which involves patients with acute sinusitis. Totally 62 patients have been enrolled into the study, aged from 18 to 65 years. Doctors diagnosed sinusitis according to symptoms and physical examinations (symptoms of nasal obstruction with purulent nasal excretion, swelling or congestion of nasal mucosa, etc) and / or with radiographic examination (X ray or CT scan). The dosage of Ceclor was 1500 mg / day and were given orally in two divided doses. The duration of the treatment was 14 days. Patients were evaluated before, during and after therapy. RESULTS A clinical response of "cure" and "improved" was achieved by 15.5 % and 72.4 % of patients respectively. The incidence of adverse events was low (12.9 %) and the compliance rate was high (100 %).CONCLUSION This study shows that Ceclor SR is effective for the treatment of acute sinusitis in adults and provides a favorable safety profile and is well tolerated.