曲尼司特滴眼液治疗过敏性结膜炎的多中心临床研究

A Multi-Center Clinical Trial of Tranilast Drops for Allergia Conjunctivitis

目的观察与评价曲尼司特滴眼液治疗过敏性结膜炎的有效性与安全性。方法多中心随机单盲阳性药平行对照非劣效性检验临床试验。试验组曲尼司特滴眼液113例,113眼,对照组色甘酸钠滴眼液114例,114眼。结果①治疗28 d后临床综合疗效等级比较:痊愈率曲尼司特滴眼液30.97%,色甘酸钠滴眼液26.32%,P=0.393 6。有效率曲尼司特滴眼液91.15%,色甘酸钠滴眼液83.33%,P=0.063 6;两率之差的95%可信下限=0.59%,统计量u=4.021,P=0.000 0,曲尼司特滴眼液非劣效于色甘酸钠滴眼液。②安全性评价:随访期不良事件发生率:曲尼司特滴眼液组7.50%,色甘酸钠滴眼液组4.17%;不良反应发生率:曲尼司特滴眼液组3.33%,色甘酸钠滴眼液组0.83%,P均>0.05。不良反应症状为头昏、双眼痛、鼻塞咳嗽、胃部不适、胃口差、WBC异常。结论曲尼司特滴眼液治疗过敏性结膜炎安全、有效。

OBJECTIVE To observe and evaluate the clinical efficacy and safety of tranilast drops in treatment of allergia conjunctivitis. METHODS A multi-center, randomized, single-blind, positive-control, and non-inferior clinical trial was carried out in 227 patients. 113 patients with 113 eyes were assigned to tranilast drops group （experimental group） , and l l4 patients with 114 eyes were assigned to sodium cromoglieate drops （ control group）. RESULTS The cure rates in tranilast group and sodium cromoglieate af- ter 28 d treatment were 30. 97% and 26. 32% , respectively （P =0. 393 6） , and the efficacy rate of the two groups were 91.15% and 83.33% , respectively （P =0. 063 6） ; the lower limit of the confidence interval of the difference between the two groups was 0. 59% and statistic u was 4. 021 （P =0. 000 0）. Tranilast drops was not inferior to sodium cromoglicate drops. The incidences of adverse e- vents in the two groups were 7.50% and 4. 17% , respectively （P 〉0. 05） , and the incidences of adverse reactions in the two groups were 3.33% and 0. 83%, respectively （P 〉 0. 05）. The symptoms of adverse reactions included dizziness, eye irritation, nasal ob- struction, cough, gastrointestinal discomfort and abnomal white blood cell count. CONCLUSION Tranilast drops is safe amt effective in treatment of allergia conjunctivitis.