炎可宁片联合氧氟沙星滴耳液治疗急性化脓性中耳炎的临床研究

Clinical study on Yankening Tablets combined with Ofloxacin Ear Drops in treatment of acute suppurative otitis media

目的探讨炎可宁片联合氧氟沙星滴耳液治疗急性化脓性中耳炎的安全性和有效性。方法选取内蒙古医科大学附属医院2015年6月—2016年6月收治的急性化脓性中耳炎患者167例,随机分成对照组(84例)和治疗组(83例)。对照组患者给予氧氟沙星滴耳液,6~8滴/次,1次/d;治疗组在对照组的基础上口服炎可宁片,4~6片/次,3次/d。两组患者均连续治疗14 d。比较分析两组患者治疗前后临床疗效、起效时间、病原菌清除率、听力改善程度、炎症因子以及不良反应发生情况。结果治疗后,对照组的总有效率为83.33%,显著低于治疗组的96.38%,两组总有效率比较差异有统计学意义(P<0.05)。治疗后,治疗组的起效时间、病原菌清除率以及听力改善程度均优于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组患者的肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)与治疗前相比均明显降低(P<0.05);且治疗后治疗组患者TNF-α、IL-6均明显低于对照组患者(P<0.05)。治疗后,对照组的不良反应发生率为16.67%,显著高于治疗组的4.82%,两组不良反应比较差异有统计学意义(P<0.05)。结论炎可宁片联合氧氟沙星滴耳液治疗急性化脓性中耳炎临床疗效好,安全性高,具有一定的临床推广应用价值。

Objective To explore the clinical safety and efficacy of Yankening Tablets combined with Ofloxacin Ear Drops in treatment of acute suppurative otitis media.Methods Patients （167 cases） with acute suppurative otitis media in the Affiliated Hospital of Inner Mongolia Medical University from June 2015 to June 2016 were randomly divided into control （84 cases） and treatment （83 cases） groups. Patients in the control group weregivenOfloxacin Ear Drops, 6 — 8 drops/time, once daily. Patients in the treatment group were poadministered with Yankening Tablets on the basis of the control group, 4 — 6 tablets/time, three times daily. Patients in two groups were treated for 14 d. After treatment, the clinical efficacy, onset time, pathogen clearance, hearing improvement, inflammatory factors, and adverse reactions in two groups were analyzed and compared.ResultsAfter treatment, the clinical efficacy in the control group was 83.33%, which was significantly lower than 96.38% in the treatment group, with significant difference between two groups （P 〈 0.05）. After treatment, the onset time, pathogen clearance, and hearing improvement in the treatment group were significantly better than those in the control group, with significant difference between two groups （P 〈 0.05）. After treatment, TNF-α and IL-6 levels in two groups were significantly decreased （P 〈 0.05）. And these inflammatory factors levels in the treatment group were significantly lower than those in the control group （P 〈 0.05）. After treatment, the adverse reaction rate in the control group was 16.67%, which was significantly higher than 4.82% in the treatment group, with significant difference between two groups （P 〈 0.05）.Conclusion Yankening Tablets combined with Ofloxacin Ear Drops has good clinical efficacy and high safety in treatment of acute suppurative otitis media, which has a certain clinical application value.