麻杏石甘汤加减结合沙美特罗氟替卡松吸入治疗慢性阻塞性肺疾病急性加重的临床研究

A clinical study of Maxing-Shigan decoctio.n combined with salmeterol/fluticasone inhalation for acute exacerbation of chronic obstructive pulmonary disease

目的评价麻杏石甘汤加减结合沙美特罗氟替卡松吸入治疗慢性阻塞性肺疾病（chronic obstructive pulmonary disease，COPD）急性加重的疗效。方法将86例符合入选标准的COPD急性加重患者按随机数字表法分为沙美特罗氟替卡松组（41例）和联合治疗组（45例）。沙美特罗氟替卡松组给予沙美特罗氟替卡松吸入治疗，联合治疗组在此基础上加用麻杏石甘汤加减治疗。采用免疫散射比浊法测定血清CRP水平，流式细胞术检测血细胞Toll样受体9（Toll-like receptor 9，TLR9）表达。评价咳嗽、痰量、喘息和气短的中医证候积分、肺功能和临床疗效。结果治疗后，联合治疗组血清CRP[（4_3±1．2）mg／L比（8．4±2．5）mg／L；t=5．417，P〈0．01]显著低于沙美特罗氟替卡松组，血细胞TLR9表达[（1．9±0．7）比（1．6±0．4）；t=3．418，P〈0．05]显著高于沙美特罗氟替卡松组；联合治疗组咳嗽[（1．7±0．6）分比（3．8±1．1）分；t=2．859，P〈0．05]、痰量[（1．6±0．4）分比（3．9±1．2）分；t=3．027，P〈0．05]、喘息[（1．2±0．5）分比（3．4±1．3）分；t=3．416，P〈0．05]和气短[（1．5±0．7）分比（3．7±1．6）分；t=3．468，P〈0．05]评分均显著低于沙美特罗氟替卡松组。联合治疗组第一秒用力呼气量[（75．4±5．8）L比（62．8±6．9）L；t=3．526，P〈0．05]、第一秒用力呼气量占用力肺活量百分率[（85．7±10．3）％比（71．9±15．4）％；t=5．648，P〈0．01]显著高于沙美特罗氟替卡松组。联合治疗组症状缓解时间[（3．4±0．7）d比（5．6±1．2）d；t=3．256，P〈0．05]显著短于沙美特罗氟替卡松组，应用沙美特罗氟替卡松的剂量[（1．8±0．2）×10^3μg比（5．3±0．4）×10^3μg；t=5．627，P〈0．05]和次数[（7．4±1．3）次比（16．5±3．4）次；t=4．574，P〈0．05]均较沙美特罗氟替卡松组显著缩短和降低。联合治疗组总有效率显著高于沙美特罗氟替卡松组[84．4％（38／45）比73．2％（30／41）；x2=4．519，P〈0．05]。结论麻杏石甘汤加减结合沙美特罗氟替卡松吸入可改善COPD急性加重患者的肺功能，疗效优于单用沙美特罗氟替卡松吸入。

Objective To evaluate the therapeutic effect of Maxing-Shigan decoction combined with salmeterol/fluticasone inhalation for acute exacerbation of chronic obstructive pulmonary disease （COPD）. Methods A total of 86 patients with acute exacerbation of COPD were enrolled and randomly divided into a salmeterol/fluticasone group （41 patients） and a combined treatment group （45 patients）. The salmeterol/fluticasone group was treated by salmeterol/fluticasone inhalation, and the combined treatment group by Maxing-Shigan decoction combined with salmeterol/fluticasone inhalation. Serum C-reactive protein （CRP） was detected by a immunonephelomelric assay, and Toll-like receptor 9 （TLR9） in hemocytes was detected by flow cytometry. The score of the syndromes in traditional Chinese medicine （TCM）, such as cough, sputum, gasping and shortness of breath, as well as pulmonary function and therapeutic effect were evaluateds. Results After the treatrnent, the serum C-reactive protein in the combined treatment group was significantly lower than that in the salmeterol/fluticasone group （4.3 ± 1.2 mg/L vs. 8.4 ± 2.5 mg/L; t=5.417, P〈0.01）, and the TLR9 expression was significantly higher （1.9 ± 0.7 vs. 1.6 ± 0.4; t=3.418, P〈0.05）. The scores of the syndromes in TCM, such as cough （1.7 ± 0.6 vs. 3.8 ± 1.1; t=2.859, P〈0.05）, sputum （1.6 ± 0.4 vs. 3.9 ± 1.2; t=3.027, P〈0.05）, gasping （1.2 ± 0.5 vs. 3.4 ＋ 1.3; t=3.416, P〈0.05） and shortness of breath （1.5 ± 0.7 vs. 3.7 ± 1.6; t=3.468, P〈0.05） in the combined treatment group were significantly lower than those in the salmeterol/flutieasone group. The forced expiratory volume in first second （75.4 ± 5.8 L vs. 62.8 ± 6.9 L; I=3.526, P〈0.05） and the percentage of forced expiratory volume in first second to forced vital capacity （85.7% ± 10.3% vs. 71.9% ± 15.4%; t=5.648, P〈0.01） in the combined treatment group were significantly higher than those in the salmeteml/fluticasone group. The time to symptoms alleviated （3.4 ± 0.7 d vs. 5.6 ± 1.2 d; t=3.256, P〈0.05） and the use dose was （1.8 ± 0.2） × 10^3 μg vs. （5.3 ± 0.4）× 10^3 μg, and use limes of salmeterol/fluticasone （7.4 ± 1.3 vs. 16.5 ± 3.4; t=4.574, P〈0.05） in the combined treatment group were significantly decreased than those in the salmeterol/fluticasone group. The total effective rate in in the combined Ireatment group were significantly decreased than those in the group （84.4% vs. 73.2%; x2=4.519, P〈0.05）. Conclusion Maxing-Shigan decoction combined with salmeterol/ftuticasone inhalation can improve the pulmonary function in patients with acute exacerbation of COPD, its effiency is suppior to salmeterol/fluticasone inhalation alone. [Key words] Pulmonary disease, chronic obstructive; Symptom complex; Ma Xing Shi Gan Tang; Salmeterol xinafoate; Fluticasone; C-reactive protein; Toll-like receptor 9