CAJ | 학술논문

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50 μg),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.
목적 평개병산배록미송수용비분무제치료과민성비염적료효화안전성.방법 시험설계위다중심、수궤、쌍맹、양성약물평행대조시험.장부합납입표준적과민성비염환자채용안연구중심분층적분단구조수궤방법분위시험조화대조조.시험조채용병산배록미송수용비분무제,대조조채용병산배록미송비분무제,균위2차/d,매차매개비공2분(매분함병산배록미송50 μg),련속용약14 d.료정결속시이비염증상총적분、비염체정평분、비염대생활염곤우정도평분이급상술3항평분중환자구성비적개변평고약물료효;이불량사건/반응발생정황,실험실검사급심전도검사결과평고약물안전성.결과 공유239례수시자납입료효분석,시험조120례,대조조119례.2조수시자용약전성별、년령분포화비염증상、체정차이무통계학의의(균P＞0.05);용약제7、14천,비염증상총적분、비염체정평분급비염대일상생활곤우정도평분균교용약전명현하강(균P＜0.05),이2조간비교하강정도차이무통계학의의(P＞0.05);료정결속시2조수시자비염증상총적분、비염체정평분、비염대생활염곤우정도평분구성비여용약전비교차이균유통계학의의(균P＜0.05),2조간비교차이무통계학의의(균P＞0.05).공유241례수시자납입안전성분석,시험조121례,대조조120례.시험조유10례수시자발생불량사건12례차,기중여약물상관불량반응2례공2례차,포괄인부불괄화비강출혈각1례;대조조유13례수시자발생불량사건20례차,여약물상관불량반응7례11례차,주요표현위비강출혈화간조등.2조간불량반응발생솔차이무통계학의의(P＞0.05).무엄중불량사건발생.결론 병산배록미송수용비분무제가유효공제과민성비염증상,료효화안전성균여병산배록미송비분무제상당.
Objective To evaluate the efficacy and safety of beclometasone dipropionate aqueous nasal spray in the treatment of allergic rhinitis.Methods This is a multicenter,randomized,double-blind,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 (P ＞ 0.05).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 (P ＜ 0.05),but there was no significant difference in the extent of decrease between the 2 groups (P ＞ 0.05).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 (P ＞ 0.05).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 (P ＞ 0.05).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.