Chen Ping, Zhao Hai-tao, Sun Li, Lin Jiang-tao, Zhang Hong-yu, Huang Shao-guang, Zhu Bao-yu, Yin Kai-sheng, Zheng Jing-ping, Xu Wen-bing, Shen Hua-hao, Li Qiang, Zhong Nan-shan
Department of Respiratory Medicine, General Hospital of Shenyang Military Region, Shenyang 110016, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2005 Jul;28(7):458-63.
To explore the optimal doses of inhaled corticosteroids (ICS) for the management of Chinese asthmatics in order to enhance cost-effectiveness.
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 propionate (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).
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 (salbutamol, 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).
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.
探索吸入性糖皮质激素（ICS）治疗中国哮喘患者的最佳剂量，以提高成本效益。
在11家省级医院开展了一项随机、平行对照的多中心研究。在仅按需给予吸入沙丁胺醇的1周导入期后，将哮喘患者（n = 86）分为两组：G组（n = 42）患者接受全球哮喘防治创议（GINA）推荐剂量的吸入ICS，即中度哮喘患者使用丙酸氟替卡松（FP）250 μg，每日2次，重度哮喘患者使用375 μg，每日2次。H组（n = 44）患者接受上述FP剂量的一半（中度哮喘患者为125 μg，每日2次，重度哮喘患者为早晨125 μg，晚上250 μg）。
治疗后32项指标在G组和H组之间无显著差异，包括日间症状评分（G组重度哮喘为0.7±0.8，H组为0.4±0.6；G组中度哮喘为0.4±0.5，H组为0.3±0.5）、第1秒用力呼气容积（FEV₁）[G组重度哮喘为（1.5±0.5）L，H组为（1.8±0.6）L/min；G组中度哮喘为（2.3±0.6）L，H组为（2.3±0.8）L/min]、预测值的FEV₁%[G组重度哮喘为（54±17）%，H组为（59±19）%；G组中度哮喘为（79±14）%，H组为（79±15）%]、早晨呼气峰流速（PEF）增加值（G组中度和重度哮喘分别为45、67 L/min，H组中度和重度哮喘分别为56、65 L/min）、夜间觉醒次数（G组和H组重度哮喘分别为81、69次）、病情完全控制的病例数（G组和H组重度哮喘分别为88和98天）以及额外支气管扩张剂的使用情况（G组和H组重度哮喘分别为沙丁胺醇，喷/天，5.0和3.4天，P>0.05）。另一方面，在中度哮喘亚组中，夜间症状评分（G组为0.30±0.22，H组为0.13±0.33，t = -2.06，P<0.05）、急性加重次数（G组为3/22，H组为|11/24，χ² = 4.74，P<0.05）、病情完全控制的病例总数（G组为18/22例，H组为12/24例，χ² = 4.97，P<0.05）在G组和H组之间有显著差异。在重度哮喘亚组中，G组和H组的急性加重总天数不同（G组为11天，H组为6天，U = 31，P<0.05）。
总体而言，与接受GINA推荐的ICS全剂量的患者相比，大多数中国哮喘患者按需吸入/不吸入沙丁胺醇时，使用GINA推荐剂量一半的ICS可获得相似的治疗效果。
