板蓝根滴眼液治疗热重于风证急性细菌性结膜炎的多中心临床试验  

A multicenter clinical trial of Banlangen eye drops in the treatment of acute bacterial conjunctivitis of heat predominating over wind

作　　者：余杨桂[1] 袁平 孟亮 邢晔 文欢 亢泽峰[4] YU Yanggui;YUAN Ping;MENG Liang(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China)

机构地区：[1]广州中医药大学附属第一医院,广州510405 [2]成都明慈医药科技有限公司,成都610041 [3]四川禾亿制药有限公司,成都611630 [4]中国中医科学院眼科医院,北京100040

出　　处：《中国中医眼科杂志》2021年第3期164-167,173,共5页China Journal of Chinese Ophthalmology

摘　　要：目的评价板蓝根滴眼液治疗热重于风证急性细菌性结膜炎的有效性及安全性。方法以4个中心收集的200例(200只眼)急性细菌性结膜炎患者为研究对象,随机分为试验组和对照组各100例(100只眼)。试验组采用板蓝根滴眼液进行治疗,对照组采用鱼腥草滴眼液进行治疗。观察2组用药后的临床疗效、眼部症状及安全性指标。结果(1)中性粒细胞消失率:治疗后,试验组、对照组的消失率分别为88.00%、90.00%,与治疗前相比均有统计学意义(P<0.05),而组间比较差异无统计学意义(P>0.05)。(2)症状积分:治疗前后比较,试验组和对照组的各项主症积分、次症积分、症状总积分均有统计学意义(P<0.05);治疗后组间比较,2组各项积分、症状总积分差值均无统计学意义(P>0.05)。(3)临床疗效:试验组和对照组总有效率分别为97.00%、96.00%,2组比较差异无统计学意义(P>0.05)。(4)不良事件发生率:试验组不良事件发生率为3.00%,对照组为4.00%,2组差异无统计学意义(P>0.05)。结论板蓝根滴眼液治疗热重于风证急性细菌性结膜炎,临床疗效确切,对眼部刺激小,具有较好的应用前景。OBJECTIVE To evaluate the effectiveness and safety of Banlangen eye drops in the treatment of acute bacterial conjunctivitis of heat predominating over wind syndrome.METHODS A total of 200 cases(200 eyes) of patients with acute bacterial conjunctivitis collected from four centers were randomly divided into experimental group and control group with100 cases(100 eyes) in each group. The experimental group was treated with Banlangen eye drops,and the control group was treated with Yuxingcao eye drops. The clinical effectiveness, eye symptoms and reaction to drug after administration were assessed as the observation indexes.RESULTS(1) Neutrophil disappearance rate: After treatment, the loss rates of neutral granu-locytes in the conjunctival sac in the experimental group and the control group were 88.00%and 90.00%, respectively. Both showed statistical significance with results before treatment(P<0.05),but there was no statistical difference between them(P>0.05).(2) Symptom scores: After treatment,all the main, secondary and total symptom scores of the experimental group and the control group experienced statistically significant variations(P <0.05). After treatment, there was no statistical difference of the every particular symptom scores and total symptom scores between the two groups(P>0.05).(3) Clinical efficacy: The total efficiency of the experimental group and the control group were 97.00% and 96.00%, respectively, and the difference between the two groups was not statistically significant(P>0.05).(4) Adverse event rate: The incidence rate of adverse events in the experimental group was 3.00% and that in the control group was 4.00%. There was no statistically significant difference between the two groups(P >0.05). CONCLUSIONS The Banlangen eye drops is effective in the treatment of acute bacterial conjunctivitis of heat predominating over wind, it poses little irritation to the eyes and therefore has bright application prospects.

关 键 词：板蓝根滴眼液 急性细菌性结膜炎 热重于风证 

分 类 号：R777.31[医药卫生—眼科]