复聪汤加减治疗儿童分泌性中耳炎合并阻塞型睡眠呼吸暂停低通气综合征的临床研究

A Clinical Study of Modified Fucong Decoction in Treating Children Secretory Otitis Media with Obstructive Sleep Apnea and Hypopnea Syndrome

目的 观察复聪汤加减治疗儿童分泌性中耳炎(SOM)合并阻塞型睡眠呼吸暂停低通气综合征(OSAHS)的疗效及安全性。方法 120例患者随机分为对照组和观察组,各60例。对照组给予头孢丙烯+欧龙马+孟鲁司特钠+糠酸莫米松,观察组在对照组治疗基础上给予复聪汤加减,疗程均为60d。采用放射免疫法检测血清中谷胱甘肽过氧化物酶(GSHPx)、人表皮生长因子(hEGF)、降钙素基因相关肽(CGRP)和内皮素-1(ET-1)的含量;采用流式细胞术微球阵列法检测血清中肿瘤坏死因子-α(TNF-α)、白细胞介素-1β(IL-1β)、白细胞介素-6(IL-6)和白细胞介素-10(IL-10)的含量;连续7h监测呼吸暂停低通气指数(AHI)和阻塞型睡眠呼吸暂停低通气18项指标(OSA18)量表;观察脾虚痰湿证中医证候评分、有效率和不良反应发生率。结果 研究期间脱落4例。观察组患儿总有效率89.8%,高于对照组的75.4%(P<0.05);观察组患儿AHI、OSA-18和中医证候改善程度优于对照组(P<0.05);观察组患儿血清中GSH-Px、hEGF、CGRP和ET-1水平改善程度优于对照组(P<0.05);观察组患儿不良反应发生率1.7%,低于对照组的15.8%(P<0.05)。结论 复聪汤加减可明显改善SOM合并OSAHS患儿的临床症状,不良反应发生率低,值得临床推广应用。

OBJECTIVE To observe the efficacy and safety of modified Fucong decoction in treating children secretory otitis media (SOM) with obstructive sleep apnea and hypopnea syndrome (OSAHS). METHODS 120 patients were randomly divided into the control group and the observation group,each including 60 cases respectively. The control group was treated with Cefprozil + Olongma + Montelukast Sodium + Mometasone Furoate Nasal Spray. The observation group was treated with modified Fucong decoction on the basis of the treatment in the control group. Both of them have a 60-day-course. The contents of glutathione peroxidase (GSH-Px),human epidermal growth factor (hEGF),calcitonin gene-related peptide (CGRP) and endothelin-1 (ET-1) in serum were detected by radioimmunoassay. The project also resorted to cytometric bead array to detect the levels of tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1β),interleukin-6 (IL-6) and interleukin-10 (IL-10) in serum. The apnea hyponea index (AHI) and 18 indexes of obstructive sleep apnea (OSA-18) were monitored for 7 consecutive hours. The project observed TCM syndrome grades of spleen deficiency phlegm-dampness syndrome,as well as the effective rate and adverse reaction rates of the two groups. RESULTS There were 4 cases of abscission. The total effective rate in the observation group was 89.8%,higher than that in the control group,75.4%( P < 0.05 ). AHI,OSA-18 and TCM syndromes in the observation group improved much more significantly than those in the control group ( P < 0.05 ). The serum levels of GSH-Px,hEGF,CGRP and ET-1 of the observation group improved much more significantly than those in the control group ( P < 0.05 ). The incidence of adverse reactions was 1.7% in the observation group,lower than 15.8% in the control group ( P < 0.05 ). CONCLUSION Modified Fucong decoction can significantly improve the clinical symptoms of SOM with OSAHS and the incidence of adverse reactions is low,which is worthy of clinical application.