山腊梅叶颗粒联合利巴韦林治疗儿童急性上呼吸道感染的临床研究

Clinical study on Shanlameiye Granules with ribavirin in treatment of pediatric acute upper respiratory infection

目的探讨山蜡梅叶颗粒联合利巴韦林注射液治疗儿童急性上呼吸道感染的疗效及安全性。方法选取2014年1月—2015年1月上海交通大学附属上海市第六人民医院收治的急性上呼吸道感染患儿128例,随机分为对照组和治疗组,每组各64例。对照组静脉滴注利巴韦林注射液,10 mg/kg,1次/d,7 d为1疗程。治疗组在对照组基础上,口服山蜡梅叶颗粒,1袋/次,3次/d,7 d为1疗程。观察两组的临床疗效,同时比较两组治疗前后患者临床症状改善时间、住院时间、血常规、免疫功能指标、不良反应的情况。结果治疗后,对照组和治疗组的总有效率分别为89.06%、98.44%,两组比较差异有统计学意义(P<0.05)。治疗后,治疗组患者体温正常、咳嗽消失、咽痛充血、扁桃体发炎、流涕鼻塞的改善时间及住院时间显著低于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组白细胞(WBC)计数显著升高,淋巴细胞比例显著下降,同组治疗前后比较差异有统计学意义(P<0.05);治疗3 d后,治疗组这些观察指标改善程度优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者免疫球蛋白A(IgA)、免疫球蛋白E(IgE)、免疫球蛋白M(IgM)、血清腺普脱氨酶(ADA)均显著降低,免疫球蛋白G(IgG)显著升高,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组这些观察指标改善程度明显优于对照组,两组比较差异具有统计学意义(P<0.05)。对照组和治疗组的不良反应发生率分别为18.75%、6.25%,两组比较差异有统计学意义(P<0.05)。结论山蜡梅叶颗粒联合利巴韦林注射液治疗儿童急性上呼吸道感染疗效较好,能快速改善临床症状,缩短住院时间,不良反应少,具有一定的临床推广应用价值。

Objective To investigate the clinical effect and safety of Shanlameiye Granules with Ribavirin Injection in treatment of pediatric acute upper respiratory infection. Methods Children （128 cases） with acute upper respiratory infection in Shanghai the Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University from January 2014 to January 2015 were randomly divided into control and treatment groups, and each group had 64 cases. Patients in the control group were iv administered with Ribavirin Injection, 10 mg/kg, once daily, 7 d as one course. Patients in the treatment group were po administered with Shanlameiye Granules on the basis of control group, 1 bag/time, three time daily, 7 d as one course. After treatment, the clinical efficacies were evaluated, and the improvement time of clinical symptoms, hospital stay time, blood routine, immune function indexes, and adverse reaction in two groups before and after treatment were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 89.06% and 98.44%, respectively, and there was difference between two groups （P 〈 0.05）. After treatment, the time of hospitalization and the clinical symptom improvement including normal temperature, cough disappeared, pharyngalgia and hyperemia, infection of tonsil, and runny nose and nasal congestion in the treatment group were significantly lower than those in the control group, and there were differences between two groups （P 〈 0.05）. After treatment, WBC in two groups were significantly increased, but lymphocyte ratio in two groups were significantly decreased, and the difference was statistically significant in the same group （P 〈0.05）. After treatment for 3 d, the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups （P 〈 0.05）. After treatment, IgA, IgE, IgM, and ADA in two groups were significantly.