丙酸倍氯米松水溶鼻喷雾剂治疗过敏性鼻炎疗效和安全性的多中心随机双盲对照试验

Efficacy and safety of beclometasone dipropionate aqueous nasal spray in the treatment of allergic rhinitis:a multicenter,randomized,double-blind,and controlled trial

目的评价丙酸倍氯米松水溶鼻喷雾剂治疗过敏性鼻炎的疗效和安全性。方法试验设计为多中心、随机、双盲、阳性药物平行对照试验。将符合纳入标准的过敏性鼻炎患者采用按研究中心分层的分段区组随机方法分为试验组和对照组。试验组采用丙酸倍氯米松水溶鼻喷雾剂,对照组采用丙酸倍氯米松鼻喷雾剂,均为2次/d,每次每个鼻孔2喷(每喷含丙酸倍氯米松50μg),连续用药14 d。疗程结束时以鼻炎症状总积分、鼻炎体征评分、鼻炎对生活炎困扰程度评分以及上述3项评分中患者构成比的改变评估药物疗效;以不良事件/反应发生情况,实验室检查及心电图检查结果评估药物安全性。结果共有239例受试者纳入疗效分析,试验组120例,对照组119例。2组受试者用药前性别、年龄分布和鼻炎症状、体征差异无统计学意义(均P>0.05);用药第7、14天,鼻炎症状总积分、鼻炎体征评分及鼻炎对日常生活困扰程度评分均较用药前明显下降(均P<0.05),而2组间比较下降程度差异无统计学意义(P>0.05);疗程结束时2组受试者鼻炎症状总积分、鼻炎体征评分、鼻炎对生活炎困扰程度评分构成比与用药前比较差异均有统计学意义(均P<0.05),2组间比较差异无统计学意义(均P>0.05)。共有241例受试者纳入安全性分析,试验组121例,对照组120例。试验组有10例受试者发生不良事件12例次,其中与药物相关不良反应2例共2例次,包括咽部不适和鼻腔出血各1例;对照组有13例受试者发生不良事件20例次,与药物相关不良反应7例11例次,主要表现为鼻腔出血和干燥等。2组间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。结论丙酸倍氯米松水溶鼻喷雾剂可有效控制过敏性鼻炎症状,疗效和安全性均与丙酸倍氯米松鼻喷雾剂相当。

Objective To evaluate the efficacy and safety of beclometasone dipropionate aqueous nasal spray in the treatment of allergic rhinitis.Methods This is a multieenter,randomized,doubleblind,and positive drug parallel controlled clinical trial.The patients with allergic rhinitis and who met the eligibility criteria were enrolled and divided into the test group and the control group.The patients in the test group received beclometasone dipropionate aqueous nasal spray and the patients in the control group received beclometasone dipropionate nasal spray.All patients in the 2 groups were administered two inhalations of beclomethasone dipropionate into each nostril twice daily（each inhalation contains beclometasone dipropionate 50 μg） for 14 days.The efficacy of these two drugs was evaluated according to the total scores of symptoms of rhinitis,scores of signs and quality of life and percentage changes of patients in three scores mentioned above when the treatment was over.The safety of these two drugs was evaluated according to the incidence of adverse events/adverse reactions,the results of laboratory tests,and ECG when the treatment was over.Results A total of 239 patients were included into the efficacy analysis.Of them,120 patients were in the test group and 119 were in the control group.There was no significant differences in gender, age,rhinitis symptoms,and signs before the drug administration between the 2 groups（P0.05）.The total scores of symptoms of rhinitis,scores of signs and quality of life on days 7 and 14 of treatment decreased significantly as compared with those obtained before the treatment in the both groups（P0.05）, but there was no significant difference in the extent of decrease between the 2 groups（P0.05）.When the treatments were over,the differences in the percentage changes of patients of rhinitis symptoms,signs and quality of life scores before and after treatments in the both 2 groups were statistically significant（P 0.05）,but there was no significant difference between the 2 groups（P0.05）.A total of 241 patients were included into the safety analysis.Of them,121 patients were in the test group and 120 were in the control group.There were 12 adverse events in 10 patients in the test group.Of them,2 events in the 2 patients were adverse drug reactions,including 1 case with throat discomfort and another case with nose bleeding.There were 20 adverse events in the 13 patients in the control group.Of them,11 events in 7 patients were adverse drug reactions and nose bleeding and dry nose were their major manifestations.There was no significant difference in the incidence of adverse events between the 2 groups（P0.05）.No severe adverse events occurred during the clinical trial.Conclusion Beclometasone dipropionate aqueous nasal spray could effectively control the symptoms of allergic rhinitis and its efficacy and safety were similar to those of beclometasone dipropionate nasal spray.