舍雷肽酶治疗分泌性中耳炎110例

目的观察舍雷肽酶治疗分泌性中耳炎的疗效,并与糖皮质激素类对比。方法 14周岁以上的218例分泌性中耳炎患者随机分成舍雷肽酶组和泼尼松组。在布地奈德鼻喷剂(128μg,喷鼻,bid)+克拉霉素(0.25 g,Po,bid)基础上,舍雷肽酶组予舍雷肽酶肠溶片10 mg,po,tid;泼尼松组予泼尼松片20 mg,po,qm。7 d为一个疗程,在第一疗程结束、2～3个疗程治疗结束、随访3 mo后进行疗效评定并观察不良反应。结果治疗首程后,舍雷肽酶组和泼尼松组总有效率分别为49.1%和48.3%,2组疗效无显著差异(P>0.05)。好转和无效者继续治疗1～2个疗程。治疗结束时及3 mo后,舍雷肽酶组总有效率均高于泼尼松组,2组临床疗效差异非常显著(P<0.01)。舍雷肽酶组和泼尼松组不良反应发生率分别为3.6%和3.7%,2组比较差异无显著意义(P>0.05)。结论舍雷肽酶治疗分泌性中耳炎起效及安全性与泼尼松相仿,治疗效果总体优于泼尼松。

Serrapeptase in treating 110 patients with secretory otitis media

AIM To observe the effect of serrapeptase in treating secretory otitis media,and to compare with glucocorticoid treatment.METHODS Two hundred and eighteen patients above 14 years old with secretory otitis media were divided into 2 groups randomly.Based on the budesonide nasal spray(128μg,nasal spray, bid) + clarithromycin(0.25 g,po,bid),serrapeptase enteric-coated tablets 10 mg,po,tid were added in the serrapeptase group,and prednisone tablets 20 mg,po,qrn were added in the prednisone group.Seven days as a course,and the clinical effect was assessed after the first course for the initial evaluation,the two to third course for the preliminary evaluation and follow-up 3 months for the terminal efficacy evaluation.RESULTS After the first course,the total effective rates were 49.1%and 48.3%for the serrapeptase and prednisone group,with no significant difference between the two groups(P > 0.05).The improved and ineffective patients were treated continuously for 1 or 2 courses.At the end of the treatment and follow-up 3 months,the total effective rates of serrapeptase group were higher than the prednisone group.There were significant differences in clinical efficacy between the two groups(P < 0.01).Incidences of adverse reactions for the serrapeptase and prednisone group were 3.6%and 3.7%,with no significant difference between the two groups(P > 0.05). CONCLUSION In treating secretory otitis media,serrapeptase has similar onset efficacy and safety compared with prednisone,but superior at the overall therapeutic effect.