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环索奈德气雾剂治疗成人哮喘的有效性和安全性研究
Ciclesonide Aerosols in the Treatment of Adult Asthma: Effectiveness and Reliability
【作者】 张颖；
【导师】 刘升明；
【作者基本信息】 暨南大学 ， 呼吸内科， 2009， 硕士
【摘要】 目的：通过随机、单盲、平行阳性对照临床试验,评价环索奈德气雾剂治疗成人支气管哮喘的临床疗效和安全性。方法：72例符合入选标准的轻中度支气管哮喘非急性发作的门诊患者被分成两组,采用随机分层、单盲、平行阳性药(布地奈德气雾剂)对照的方法治疗12周,试验组给予环索奈德气雾剂(安徽威尔曼振星药业有限公司,100 u g／喷,200喷／瓶),1次／日,2喷／次；对照组给予布地奈德气雾剂(山东鲁南贝特制药有限公司,100μg／喷,200喷／瓶),2次／日,2喷／次,治疗期共为84±2天。以晨间PEF值作为主要评价指标,以夜间PEF值、临床随访时测定的使用支气管扩张剂前的FEV1、FVC、哮喘症状评分、缓解症状的短效β-2受体激动剂用量、哮喘控制问卷(ACQ)来评价环索耐德的有效性,同时通过对不良事件、心电图、口咽部检查及实验室检查的分析评价其安全性。结果：65例患者完成了实验。主要疗效指标结果显示：12周治疗结束时,试验组和对照组晨间PEF变化值和试验前有显著性差异(P<0.05)。12周治疗结束时,试验组和对照组晨间PEF变化值两组无统计学差异(P>0.05)。次要疗效指标结果显示：治疗结束时试验组和对照组哮喘症状评分均得到显著性降低,同时病人每周使用万托林的次数也显著性降低,晚间PEF、肺功能和哮喘控制问卷较治疗前有明显改善,但两组间的症状改善情况无统计学差异(P>0.05)。主要不良事件有口干、声音嘶哑、咽部痒痛、皮肤瘙痒,环索耐德组发生率为8.85%,对照组7.55%,组间比较无统计学差异(P>0.05)。试验过程中无患者因不良事件退出研究,亦无严重不良事件发生。结论：本研究证实环索奈德气雾剂1次／日,2喷／次(200μg)治疗哮喘是有效而安全的。
【Abstract】 Objective:A random, single-blinded, positive drug parallel controlled experiment was conducted in order to evaluate the effectiveness and reliability of ciclesonide aerosols in the treatment of adult asthma.Method:We randomly assigned 72 out-patients with mild or moderate asthma to receive a random, single-blinded, positive drug (budesonide aerosols) parallel controlled therapy for 12 weeks. The primary analysis was morning PEF value, and other outcome measures include night PEF values changes, FEV1 before any therapeutic intervention, FVC、asthma symptom scores, miinimum effective dosage of SABA, asthma control question (ACQ), and also self-evaluation of the patients. The reliability of ciclesonide aerosols was analyzed by the incidence of adverse events, ECG, examinations of the larynx and pharynx, as well as laboratory findings.Result:65 patients completed the experiment. The primary analysis indicated that there was significant difference including the experimental group and the control group in the value of PEF after 12 weeks’treatment (P<0.05). Of other outcome measures, the experimental group showed a significant elevation of asthma symptom scores and a decrease of using Ventolin both day and night as compared to the control group. The value of PEF at night, pulmonary function and ACQ seemed to be improved, but without statistical significance (P>0.05). The incidence of adverse reactions in the experimental group and the control group were 8.85%and 7.55% respectively, which includes dry mouth, hoarseness, pharyngeal indisposition, and itch of skin. These reactions were mild and no patient exits the experiment because of them.Conclusion:Our findings suggest that ciclesonide aerosols once daily, two sprays each time (200ug) was effective and reliable in patients with asthma.