固本咳喘颗粒联合布地格福吸入气雾剂治疗脾肾两虚型老年慢性阻塞性肺疾病稳定期的临床观察

doi:10.19983/j.issn.2096-8493.20260075

摘要/Abstract

摘要：

目的: 观察固本咳喘颗粒联合布地格福吸入气雾剂治疗脾肾两虚型老年慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)稳定期患者的临床疗效及对急性加重风险的影响。方法: 本研究为前瞻性随机对照研究。选取2024年7月至2025年1月杭州市临平区中医院医共体就诊的老年COPD稳定期患者80例作为研究对象,按随机数字表法分为观察组和对照组,各40例。对照组给予布地格福吸入气雾剂治疗,观察组在对照组基础上加用固本咳喘颗粒,疗程均为12周。比较两组治疗前后中医证候积分、慢性阻塞性肺疾病评测量表(COPD assessment test, CAT)评分、肺功能指标[第1秒用力呼气容积(forced expiratory volume in one second,FEV₁)、用力肺活量(forced vital capacity,FVC)、第1秒用力呼气容积占预计值百分比(FEV₁% predicted,FEV₁%pred)],以及血清白细胞介素-17(interleukin-17,IL-17)、IL-23水平;治疗期间记录不良反应;治疗结束后随访12个月,记录急性加重发生情况。结果: 治疗前,两组一般资料及各项观察指标比较,差异均无统计学意义。治疗后,对照组和观察组中医证候积分分别为(16.00±2.64)分和(14.05±3.19)分,CAT评分分别为(12.03±2.68)分和(10.40±2.52)分,均较治疗前下降,且观察组明显低于对照组,差异均有统计学意义(t值分别为2.965和2.795,P值分别为0.004和0.007)。治疗后,对照组和观察组FEV₁分别为(1.37±0.29)L和(1.58±0.31)L,FVC分别为(2.08±0.51)L和(2.39±0.55)L,FEV₁%pred分别为(58.41±4.83)%和(62.39±5.09)%,均较治疗前升高,且观察组明显高于对照组,差异均有统计学意义(t值分别为-3.277、-2.605、-5.390,P值分别为0.009、0.011、<0.001)。治疗后,对照组和观察组血清IL-17分别为(45.42±4.21)pg/ml和(42.20±4.38)pg/ml,IL-23分别为(239.05±28.11)pg/ml和(221.48±27.54)pg/ml,均较治疗前下降,且观察组明显低于对照组,差异均有统计学意义(t值分别为3.351和2.902,P值分别为0.001和0.005)。治疗期间,对照组不良反应发生率为2.5%(1/40),观察组为5.0%(2/40),组间比较差异无统计学意义(Fisher精确概率检验,P=1.000)。随访12个月内,观察组急性加重发生率为12.5%(5/40),低于对照组的35.0%(14/40),差异有统计学意义(χ²=5.590,P=0.018)。结论: 在布地格福吸入治疗基础上加用固本咳喘颗粒,可进一步改善脾肾两虚型老年COPD稳定期患者的临床症状、肺功能及部分炎症指标,并可能降低12个月内急性加重发生风险,整体安全性较好。

关键词: 老年人, 肺疾病,慢性阻塞性, 医学,中国传统, 治疗应用, 随机对照试验

Abstract:

Objective: To observe the clinical efficacy of Guben Kechuan Granules combined with budesonide-glycopyrronium-formoterol inhalation aerosol in elderly stable-stage chronic obstructive pulmonary disease (COPD) patients with spleen-kidney deficiency pattern, and its influence on the risk of acute exacerbation. Methods: This was a prospective randomized controlled study. A total of 80 elderly patients with stable COPD treated in the medical consortium of Linping District Hospital of Traditional Chinese Medicine in Hangzhou from July 2024 to January 2025 were enrolled. Patients were divided into observation group and control group by random number table method, with 40 cases in each group. The control group received budesonide-glycopyrronium-formoterol inhalation aerosol, while the observation group was additionally given Guben Kechuan Granules on the basis of the control group. Both groups were treated for 12 weeks. Traditional Chinese Medicine (TCM) syndrome score, COPD assessment test (CAT) score, pulmonary function indicators (forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), FEV₁ percentage of predicted value (FEV₁%pred)), serum interleukin-17 (IL-17) and IL-23 levels were compared between the two groups before and after treatment. Adverse reactions were recorded during treatment. Patients were followed-up for 12 months after treatment completion to record the occurrence of acute exacerbations. Results: There were no statistically significant differences in baseline general data and observation indicators between the two groups before treatment. After treatment, the TCM syndrome scores of the control group and observation group were 16.00±2.64 and 14.05±3.19, and the CAT scores were 12.03±2.68 and 10.40±2.52, respectively. Both scores decreased compared with baseline, and were significantly lower in the observation group (t=2.965, P=0.004; t=2.795, P=0.007). After treatment, FEV₁ were (1.37±0.29) L and (1.58±0.31) L; FVC were (2.08±0.51) L and (2.39±0.55) L; FEV₁%pred were (58.41±4.83) % and (62.39±5.09) % for the control and observation group. All pulmonary-function parameters increased after treatment and were significantly higher in the observation group (t=-3.277, P=0.009; t=-2.605, P=0.011; t=-5.390, P<0.001). Post-treatment serum IL-17 were (45.42±4.21) pg/ml and (42.20±4.38) pg/ml; IL-23 were (239.05±28.11) pg/ml and (221.48±27.54) pg/ml for the control and observation group. Both inflammatory biomarkers decreased after treatment and were significantly lower in the observation group (t=3.351, P=0.001; t=2.902, P=0.005). During treatment, the incidence of adverse reactions was 2.5% (1/40) in the control group and 5.0% (2/40) in the observation group, without statistical difference (Fisher’s exact test, P=1.000). Within the 12-month follow-up period, the incidence of acute exacerbations in the observation group was 12.5% (5/40), which was lower than 35.0% (14/40) in the control group (χ²=5.590, P=0.018). Conclusion: Adding Guben Kechuan Granules to budesonide-glycopyrronium-formoterol inhalation therapy can further improve clinical symptoms, pulmonary function and partial inflammatory markers in elderly stable-COPD patients with Spleen-Kidney Deficiency Pattern, and may reduce the risk of acute exacerbations within 12-month follow-up with satisfactory safety profile.

Key words: Aged, Pulmonary disease, chronic obstructive, Medicine, Chinese traditional, Therapeutic uses, Randomized controlled trial

中图分类号:

R563

方建庆, 沈瑜, 唐静雅, 武学农, 王哲, 余婷. 固本咳喘颗粒联合布地格福吸入气雾剂治疗脾肾两虚型老年慢性阻塞性肺疾病稳定期的临床观察[J]. 结核与肺部疾病杂志,2026, 7(5): 608-614. doi: 10.19983/j.issn.2096-8493.20260075

Fang Jianqing, Shen Yu, Tang Jingya, Wu Xuenong, Wang Zhe, Yu Ting. Clinical observation of Guben Kechuan Granules combined with budesonide/glycopyrrolate/formoterol fumarate inhalation aerosol in elderly patients with stable chronic obstructive pulmonary disease of the spleen-kidney deficiency syndrome type[J]. Journal of Tuberculosis and Lung Disease, 2026, 7(5): 608-614. doi: 10.19983/j.issn.2096-8493.20260075

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项目	观察组(40例)	对照组(40例)	统计检验值	P值
性别[例(构成比,%)]			χ²=0.457	0.499
男性	24(60.0)	21(52.5)
女性	16(40.0)	19(47.5)
年龄(岁,$\bar{x}±s$)	67.50±3.82	68.50±3.99	t=1.144	0.256
体质量指数(kg/m²,$\bar{x}±s$)	22.10±2.00	22.00±1.89	t=-0.230	0.819
病程(年,$\bar{x}±s$)	5.28±1.89	5.43±1.92	t=0.352	0.726
吸烟史[例(构成比,%)]			χ²=0.220	0.639
有	15(37.5)	13(32.5)
无	25(62.5)	27(67.5)