摘要
目的 比较硫酸沙丁胺醇缓释胶囊与盐酸班布特罗片剂治疗成人支气管哮喘的疗效和安全性。方法 用多中心随机对照试验设计,将94例轻中度支气管哮喘患者分为2组,试验组给予硫酸沙丁胺醇缓释胶囊4mg,每日2次,用药1周;继以8mg,每日2次,用药1周。对照组给予盐酸班布特罗片剂10 mg,每日1次,用药1周;继以20 mg,每日1次,用药1周。结果 与治疗前比较,试验组和对照组肺功能与临床表现均明显改善,加大剂量进一步好转。治疗1,2周的临床有效率分别为试验组32.0%与64.0%,对照组31.8%与61.4%;治疗2周后,治疗组的临床控制率(56%)明显优于对照组(32%);治疗1周后,治疗组β2受体激动剂吸入次数明显减少,而对照组的改变无统计学意义。药物不良反应发生率试验组和对照组分别为15.7%和19.1%。结论 硫酸沙丁胺醇缓释胶囊是治疗支气管哮喘的安全有效药物。
Objective To compare the clinical efficacy and safety of salbutamol sulfatesustained-release capsules and bambuterol hydrochloride tablets in the treatmentof bronchial asthma in adults. Methods A multicenter randomized controlled clinicaltrial was conducted.Ninety four patients with mild-to-moderate bronchial asthmawere enrolled in the study, of which 50 patients in the test group (salbutamolsulfate sustained-release capsules group), 44 patients in the control group(bambuterol hydrochloride tablets group). The test group was treated withsalbutamol sulfate sustained-release capsules 4mg twice daily for 1 week, followedby salbutamol sulfate sustained-release capsules 8mg twice daily for another 1 week.The control group was treated with bambuterol hydrochloride tablets 10mg oncedaily for 1 week, followed by bambuterol hydrochloride tablets 8mg once daily foranother 1 week. Results The lung function and clinical manifestation weresignificantly improved in both groups after treatment, the clinical manifestationgained further improvement with larger dosage in two groups. The clinical efficacyrates after 1-week treatment and 2-week treatment were 32.0% and 64.0% in testgroup, respectively. In the control group, there were 31.8% and 61.4%, respectively.After 2-week treatment, the clinical control rate of the test group(56%) was betterthan that of the control group(32%). After 1-week treatment, average inhalation timesof β2 -agonist in the test group were decreased compared with pretreatment, whilethere was no statistical deference in the control group. The incidences of adversereaction were 15.7% and 19.1%, respectively in the test group and control group.Conclusion Salbutamol sulfate sustained-release capsules is a safe and effectivedrug in the treatment of bronchial asthma in adults.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2004年第5期323-327,共5页
The Chinese Journal of Clinical Pharmacology
