摘要
目的 首次将雾化吸入灭活草分枝杆菌用于防治中度支气管哮喘,并观察临床效果.方法 本研究为前瞻性、对照性研究.收集2009年3月至2010年12月于广西医科大学第一附属医院门诊确诊的哮喘患者,满足以下条件纳入研究：年龄≥14岁,符合2008年全球哮喘防治创议（GINA）支气管哮喘慢性持续中度标准,在1个月内无全身使用糖皮质激素、酮替芬或孟鲁斯特等抗炎抗过敏药物并无明显呼吸道感染及已知有其他任何严重的疾病或异常.选取100名哮喘患者,其中男/女比例为37/63,年龄（32.11±12.95）岁.将其随机（随机数字法）分为两组,A组为治疗组,男/女比例为16/34,年龄（33.56±14.23）岁;B组为对照组,男/女比例为21/29,年龄（30.66±11.50）岁;各50名.两组患者的年龄、性别构成差异均无统计学意义,具有可比性.A组雾化吸入灭活草分枝杆菌F.U.36注射液1.72μg/mL×2支加入3 mL生理盐水,1次/d,连续5 d.B组吸入沙美特罗替卡松粉吸入剂（50/100μg）,每天两次,持续使用.观察1个月,期间两组患者均可按需吸入硫酸沙丁胺醇气雾剂缓解症状并记录使用喷数.于第0天、第6天、第31天查患者肺功能及哮喘激发试验,治疗前后测ACT评分.结果 于治疗后第6天、第31天,A组哮喘激发试验转阴率分别为82%,78%,B组分别为84%,90%,两组治疗后患者激发试验均明显转阴,经x2检验两组间相比差异无统计学意义（P＞0.05）.经完全随机设计资料的方差分析：治疗后A,B组乙酰甲胆碱累积用量明显增加（P＜0.05）,而两组之间无差别;A组治疗后第一秒用力呼气容积（FEV1）有改善趋势,但差异无统计学意义,B组显著增高（P＜0.05）,在第31天较A组明显增高（P＜0.05）;两组最大呼气流量（PEF）在治疗后第6天、第31天均显著增高（P＜0.05）,在第31天B组较A组增高明显（P＜0.05）;治疗后两组患者哮喘控制测试（ACT）评分均显著提高、硫酸沙丁胺醇气雾剂的使用量均明显减少（P＜0.01）,B组较A组明显（P＜0.05）.治疗期间仅有2例患者在治疗期间出现一过性低热的不良反应,以第3天明显.结论 雾化吸入灭活草分枝杆菌能在短期内抑制中度哮喘患者的气道高反应性并改善症状、减少发作,减少缓解药物的使用量,在一定时间内对中度哮喘发作有防治作用.
Objective To introduce inhaled inactivated-mycobacterium phlei on prevention and treatment of moderate bronchial asthma to observe the clinical effect. Method This study was a prospective and controlled study. The patients diagnosed with asthma in our out-patient from March 2009 to December 2010 were collected, who met the following conditions were included in the study： age≥ 14 years; met the criteria of moderate chronic persistent bronchial asthma in Global Initiative for Asthma （GINA） in 2008; suspended receiving systemic corticosteroids, Montelukast, ketotifen and other anti-inflammatory and anti-allergic drugs in one month; no significant respiratory tract infections; and other serious illnesses or abnormalities known.A total of 100 patients with asthma were selected, including 37 males and 63 females, age （32.11 ± 12.95 ）years. The patients were randomly（random number） divided into two groups： A group（treatment group; 16males and 34 females, age 33.56 ± 14.23 years） and B group （control group; 21 males and 29 females,age 30.66 ± 11.50 years）; 50 in each group. No significant difference was noted between the two groups on age and gender composition. The patients in A group were treated with inhaled inactivated-mycobacterium phlei F. U. 36 Injection 1.72 μg/mL × 2 that adding 3 mL normal saline, once a day for 5 days. The patients in B group were treated with salmeterol xinafoate and fluticasone propionate powder for inhalation （50/100 μg）, twice daily for sustainable use. The patients in the two groups were observed for one month. During this course, the patients in the two groups could inhale the salbutamol sulphate aerosol as need to relieve symptoms. And the number of using was recorded. Pulmonary function test and asthma provocative test were carried out on the Day O, 6 and 31. ACT scores were measured before and after the treatment. Results On Day 6 and 31 after treatment, the negative conversion rates of asthma provocative test of the patients in A group were 82% and 78% respectively, B group were 84% and 90% respectively. Provocative test of the patients in the two groups were negative conversion significantly before and after treatment. There was no significant difference between the two groups by chi-square test （P 〉 0. 05 ）. Completely random designed data was analyzed by analysis of variance. The analysis showed that the accumulated doses of methacholine of the patients in the two group increased significantly （ P 〈 0. 05 ）, but no difference between the two groups.There was a improvement trend on forced expiratory volume in one second（ FEV1 ）of the patients in A group after treatment, but no difference. FEV1 of the patients in B group increased significantly higher （ P 〈0.05）, which was significantly higher than A group on the 31th day （P 〈0. 05）; Peak expiratory flow （PEF） of the patients in the two group increased significantly on Day 6 and 31 after treatment （P 〈0.05 ）.On Day 31, B group was significantly higher than A group （ P 〈 0. 05 ）; Scores of asthma control test （ACT）of the patients in the two group were significantly increased, and the number of using of salbutamol sulfate aerosol was significantly reduced （P 〈0.01 ）. B group was obvious than group A （P 〈0.05 ）. During treatment, there were only two adverse reaction cases of transient low fever; most obvious was on the third day.Conclusions Inhaled inactivated-mycobacterium phlei would inhibit the airway hyperresponsiveness of the patients with moderate bronchial asthma in short time, improve the symptoms, reduce the acute exacerbation, and reduce the use of rescue medication, which has the roles of prevention and treatment of moderate asthma in a certain period of time.
出处
《中华急诊医学杂志》
CAS
CSCD
北大核心
2011年第4期413-417,共5页
Chinese Journal of Emergency Medicine
基金
广西科学基金（桂科基0575074）
关键词
哮喘
草分枝杆菌
雾化吸入
气道高反应性
哮喘控制测试
第一秒用力呼气容积
最大呼气流量
Asthma
Mycobaterium phlei
Airway hyperresponsiveness
Aerosol inhalation
Asthma control test
Forced expiratory volume in one second
Peak expiratory flow
