全球哮喘防治创议推荐糖皮质激素的半量吸入分级治疗支气管哮喘患者的疗效分析

目的为减轻支气管哮喘(简称哮喘)患者的经济负担,探讨中国控制哮喘最小吸入糖皮质激素(ICS)剂量。方法86例患者随机分为:(1)G组42例:应用全球哮喘防治创议(GINA)推荐高限剂量,中度患者每次250μg,每天2次;重度患者每次375μg,每天2次;(2)H组44例:应用G组剂量半量,中度患者每次125μg,每天2次;重度患者早晨125μg、晚上250μg,每天各1次。采用随机、对照、平行分组、多中心临床研究,筛选期1周仅按需吸入沙丁胺醇。治疗期共24周。结果治疗后G和H组日间症状评分:重度哮喘G组为(0.7±0.8)分,H组为(0.4±0.6)分,中度G组为(0.4±0.5)分,H组为(0.3±0.5)分;第一秒用力呼气容积(FEV1):重度G组为(1.5±0.5)L,H组为(1.8±0.6)L,中度G组为(2.3±0.6)L,H组为(2.3±0.8)L;第一秒用力呼气容积占预计值百分比(FEV1占预计值%):重度G组为(54±17)%,H组为(59±19)%,中度G组为(79±14)%,H组为(79±15)%;晨间最大呼气流量(PEF)增加值:中、重度G组分别为45、67L/min,中、重度H组分别为56、65L/min;夜间憋醒天数:重度G、H组分别为81、69d;无症状天数:重度G、H组分别为88、98d;合并用沙丁胺醇剂量(重度G、H组分别为5.0、3.4喷/d)等32项(次)比较差异均无统计学意义(P均>0.05)。G组中度哮喘患者首次加重3例,H组为11例,两组比较差异有统计学意义(χ2=4.74,P<0.05);G组中度哮喘控制例数为18例,H组为12例,两组比较差异有统计学意义(χ2=4.97,P<0.05);而G组中度哮喘患者夜间症状评分为(0.30±0.22)分,H组为(0.13±0.33)分,两组比较差异有统计学意义(t=-2.06,P<0.05)、重度哮喘加重天数G组为11d,H组为6d,两组比较差异有统计学意义(U=31.00,P<0.05)。结论大多数中国哮喘患者应用GINA推荐的ICS高限剂量与其半量分级治疗,可取得相似的疗效。

The efficacy of half of the Global Initiative for Asthma recommended dose of inhaled corticosteroids in the management of Chinese asthmatics

OBJECTIVE: To explore the optimal doses of inhaled corticosteroids (ICS) for the management of Chinese asthmatics in order to enhance cost-effectiveness. METHODS: A randomized, paralleled and controlled multi-center study was carried out in 11 provincial hospitals. After one week run-in period when only inhaled salbutamol as needed was given, the asthmatic patients (n = 86) were divided into two groups: patients in group G (n = 42) received inhaled ICS with the doses recommended by Global Initiative for Asthma (GINA), ie, fluticasone proprionate (FP) 250 microg bid for moderate asthma and 375 microg bid for severe asthma. Patients in group H (n = 44) received half of the above doses of FP (125 microg bid for moderate asthma and 125 microg in the morning, 250 microg in the evening for severe asthma). RESULTS: There were no significant differences between group G and group H in the 32 measurements after management, including day symptom score (severe asthma in group G 0.7 +/- 0.8, group H 0.4 +/- 0.6 and moderate asthma in group G 0.4 +/- 0.5, group H 0.3 +/- 0.5), FEV(1) [severe asthma in group G (1.5 +/- 0.5) L, group H (1.8 +/- 0.6) L/min and moderate asthma in group G (2.3 +/- 0.6) L, group H (2.3 +/- 0.8) L/min, FEV(1)% of predicted [severe asthma in group G (54 +/- 17)%, group H (59 +/- 19)%, and moderate asthma in group G (79 +/- 14)%, group H (79 +/- 15)%], the increased morning PEF value (45, 67 L/min in moderate and severe asthma in group G and 56, 65 L/min in moderate and severe asthma in group H respectively), frequency of nights awakened (81, 69 in severe asthma in groups G and H respectively), numbers of well controlled cases (88 and 98 d in severe asthma in groups G and H respectively) and the use of extra bronchodilators (salbutomol, puff/day, 5.0 and 3.4 d in severe asthma in groups G and H respectively, P > 0.05). On the other hand, in the subgroups of moderate asthma, night symptom score (0.30 +/- 0.22 in group G, 0.13 +/- 0.33, t = -2.06, P < 0.05), number of exacerbations (3/22 in group G, 11/24 in group H, chi(2) = 4.74, P < 0.05), number of total controlled cases (18/22 cases in group G, 12/24 cases in group H, chi(2) = 4.97, P < 0.05) were significantly different between group G and group H. In the subgroups of severe asthma, the total days of exacerbations were different between group G and group H (11 days in group G, 6 days in group H, U = 31, P < 0.05). CONCLUSION: As a whole, similar therapeutic effect was achieved using half of the GINA recommended dose of ICS with/without salbutamol inhalation as needed compared with those receiving the GINA recommended full dose of ICS in most Chinese asthmatics.