盐酸奥洛他定片治疗慢性特发性荨麻疹疗效和安全性的多中心临床研究

A multi center clinical trial to evaluate efficacy and safety of olopatadine hydrochloride tablets against chronic idiopathic urticaria

目的:观察盐酸奥洛他定片治疗慢性特发性荨麻疹的临床疗效及安全性。方法:采用随机、双盲双模拟、阳性药物平行对照、多中心的试验方法,试验组和对照组共纳入150例。分别采用盐酸奥洛他定片,每次1片,每日2次;氯雷他定片,每次1片,每日1次,2组分别给予盐酸奥洛他定和氯雷他定模拟片,连续给药4周。疗程结束时以症状体征总积分下降指数、总有效率及疾病总体改善情况等来评估其临床疗效,以不良事件及不良反应、实验室检查来评估其安全性。结果:纳入符合方案分析集(PPS)的病例数为143例,试验组72例,对照组71例。总有效率分别为83.33%和80.28%(P>0.05)。25例患者发生43例次不良事件(试验组14人20例次,对照组11人23例次),其中37例次不良事件与药物相关,主要表现为口干、头晕、嗜睡、乏力、上腹痛、谷丙转氨酶ALT升高、谷草转氨酶AST升高等。2组间不良事件及不良反应发生率差异无统计学意义(P>0.05),无严重不良事件发生。结论:盐酸奥洛他定片治疗慢性特发性荨麻疹,疗效显著,安全性好。

OBJECTIVE To evaluate the clinical efficacy and safety of olopatadine hydrochloride tablets in the treatment of chronic idiopathic urticaria.METHODS Totally 150 cases were divided into test group and control group equally by a randomized,double blind,double simulation,positive drug parallel control,multi center test method.Olopatadine hydrochloride tablets were administered by 1 tablet each time,2 times a day,loratadine tablets by 1 tablet each time and 1 time a day.Patients in two groups were given olopatadine hydrochloride and loratadine simulation tablets,consecutively for 4 weeks.At the end of the treatment,the total score of symptoms and signs,the total effective rate and the overall improvement of the disease were observed to assess the clinical efficacy,adverse events and adverse reactions,laboratory tests were used to assess their safety.RESULTS Totally143 patients were included in the PP analysis set,72 patients in the test group and71 patients in the control group.The total effective rates were 83.33% and 80.28%,respectively（P〉0.05）.Forty three cases of adverse events occurred in 25 patients（20 cases in14 patients in the test group,23 cases in11 patients in the control group）,37 cases were related with the drugs,mainly including dry mouth,dizziness,drowsiness,fatigue,abdominal pain,elevated ALT and AST.No significant difference was observed in the incidence of adverse events and adverse reactions between the two groups（P〉0.05）.No serious adverse event occurred.CONCLUSION Olopatadine hydrochloride tablets have obvious curative effect and good safety in the treatment of chronic idiopathic urticaria.