蒲地蓝消炎口服液联合盐酸左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 Pudilan Xiaoyan Oral Liquid combined with Levofloxacin Hydrochloride Ear Drops in treatment of acute suppurative otitis media

目的探讨采取蒲地蓝消炎口服液联合盐酸左氧氟沙星滴耳液治疗中耳炎患者的临床疗效。方法选取监利县人民医院2016年4月—2017年4月收治的急性化脓性中耳炎患者153例,随机分成对照组(76例)和治疗组(77例)。对照组患者给予盐酸左氧氟沙星滴耳液,6滴/次,保持患耳朝上5 min,3次/d。治疗组患者在对照组基础上口服蒲地蓝消炎口服液,10 m L/次,3次/d。两组均连续治疗14 d。观察两组临床疗效和复发率,比较治疗前后两组细菌清除率、炎性指标水平和不良反应情况。结果治疗后,对照组临床总有效率为86.84%,明显低于治疗组的97.40%,两组比较差异具有统计学意义(P<0.05)。治疗后对照组复发率为11.84%,明显高于治疗组的2.60%,两组比较差异具有统计学意义(P<0.05)。治疗后,对照组和治疗组细菌清除率分别为72.37%、92.21%,两组比较差异具有在统计学意义(P<0.05)。治疗后,两组患者肿瘤坏死因子-α(TNF-α)、IL-8和IL-1β水平均显著降低(P<0.05);且治疗组炎性指标水平降低的更明显(P<0.05)。治疗期间,对照组和治疗组不良反应发生率分别为14.47%、3.90%,两组比较差异具有在统计学意义(P<0.05)。结论蒲地蓝消炎口服液联合盐酸左氧氟沙星滴耳液治疗急性化脓性中耳炎患者临床疗效显著,不良反应低,具有一定的临床推广应用价值。

Objective To explore the clinical efficacy of Pudilan Xiaoyan Oral Liquid combined with Levofloxacin Hydrochloride Ear Drops in treatment of acute suppurative otitis media. Methods Patients（153 cases） with acute suppurative otitis media in Jianli County People＇s Hospital from April 2016 to April 2017 were randomly divided into control（76 cases） and treatment（77 cases） groups. Patients in the control group were given administered with Levofloxacin Hydrochloride Ear Drops, 6 drops/time, then kept the ear up for 5 min, three times daily. Patients in the treatment group were po administered with Pudilan Xiaoyan Oral Liquid on the basis of the control group, 10 m L/time, three times daily. Patients in two groups were treated for 14 d. After treatment, the clinical efficacy and recurrence rate was evaluated, and the bacterial clearance rate, the levels of inflammatory markers and adverse events in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 86.84%, which was significantly lower than 97.40% in the treatment group, and there were differences between two groups（P〈0.05）. After treatment, the recurrence rate in the control group was 11.84%, which was significantly higher than 2.60% in the treatment group, with significant difference between two groups（P〈0.05）. After treatment, the bacterial clearance rate in the control and treatment groups were 72.37% and 92.21%, respectively, and there were differences between two groups（P〈0.05）. After treatment, the TNF-α, IL-8 and IL-1β levels in two groups were significantly decreased（P〈0.05）. And these inflammatory markers levels in the treatment group decreased more significantly than those in the control group（P〈0.05）. During the treatment, the incidence of adverse reactions in the control and treatment groups was 14.47% and 3.90%, respectively, with significant difference between two groups（P〈0.05）. Conclusion Pudilan Xiaoyan Oral Liquid combined with Levofloxacin Hydrochloride Ear Drops has significant clinical efficacy in treatment of acute suppurative otitis media with low adverse reaction, which has a certain clinical application value.