加味下瘀血颗粒联合醋酸泼尼松片治疗特发性肺间质纤维化气阴两虚、肺络痹阻证的临床研究

Clinical study on Modified Xiayuxue Granule combined with prednisone acetate tablets in the treatment of idiopathic pulmonary fibrosis with syndromes of deficiency of qi and yin and obstruction of lung collaterals

目的:评价加味下瘀血颗粒联合醋酸泼尼松片治疗特发性肺间质纤维化(IPF)气阴两虚、肺络痹阻证患者的临床疗效,为治疗IPF提供临床依据。方法:纳入60例IPF气阴两虚、肺络痹阻证患者,随机分为治疗组和对照组,每组各30例。治疗组患者给予醋酸泼尼松片联合加味下瘀血颗粒口服,对照组患者给予醋酸泼尼松片联合加味下瘀血颗粒模拟剂口服,治疗周期均为12个月。治疗前后评价并比较两组患者的高分辨率CT(HRCT)计分、中医证候积分、6 min步行距离(6MWD)及醋酸泼尼松片的服用情况。结果:治疗过程中,治疗组2例患者、对照组4例患者被剔除或脱落,最终治疗组28例、对照组26例患者纳入统计分析。(1)治疗前后,两组患者的HRCT计分比较,差异均无统计学意义(P>0.05)。(2)治疗后,治疗组患者的中医证候积分较治疗前降低(P<0.05),对照组患者的积分与治疗前比较差异无统计学意义(P>0.05),且治疗组患者的积分低于对照组(P<0.05)。(3)治疗后,治疗组患者的6MWD较治疗前明显延长(P<0.05),对照组患者的6MWD与治疗前比较差异无统计学意义(P>0.05),且治疗组患者的6MWD较对照组亦明显延长(P<0.05)。(4)两组醋酸泼尼松片使用情况比较,差异具有统计学意义(P<0.05),治疗组患者的醋酸泼尼松片服用剂量较对照组减少。结论:加味下瘀血颗粒联合醋酸泼尼松片治疗IPF气阴两虚、肺络痹阻证患者,可有效改善患者的临床症状,减少醋酸泼尼松片的服用剂量,在一定程度上延缓肺纤维化进展。

Objective:To evaluate the clinical efficacy of Modified Xiayuxue Granule combined with prednisone acetate tablets in the treatment of idiopathic pulmonary fibrosis(IPF)with syndromes of deficiency of qi and yin and obstruction of lung collaterals,and provide the clinical evidence for the treatment of IPF.Methods:Sixty IPF patients with syndromes of deficiency of qi and yin and obstruction of lung collaterals were included and randomly divided into the treatment group and the control group,30 cases in each group.The patients in the treatment group were orally treated with prednisone acetate tablets combined with Modified Xiayuxue Granule,and the patients in the control group were orally treated with prednisone acetate tablets combined with Modified Xiayuxue Granule placebo,with a course of 12 months.Before and after treatment,the scores of high resolution CT(HRCT)and Chinese medical syndrome,the 6-minute walking distance(6 MWD)and the dosage of prednisone acetate tablets in both groups were evaluated and compared.Results:In the course of treatment,2 patients in the treatment group and 4 patients in the control group were removed or fell off,and finally 28 patients in the treatment group and 26 patients in the control group were included for statistical analysis.(1)Before and after treatment,there was no statistically significant difference on the HRCT score between the two groups(P>0.05).(2)After treatment,the score of Chinese medical syndrome in the treatment group was decreased compared with that before treatment(P<0.05),but there was no statistically significant difference on the score of Chinese medical syndrome in the control group between treatment before and after(P>0.05),and the score of the treatment group was lower than that of the control group(P<0.05).(3)After treatment,the 6 MWD of the treatment group was obviously prolonged compared with that before treatment(P<0.05),but there was no statistically significant difference on the 6 MWD in the control group between treatment before and after(P>0.05),and the 6 MWD of the treatment group was longer than that of the control group(P<0.05).(4)There was statistically significant difference on the dosage of prednisone acetate tablets between the two groups(P<0.05),and the dosage of prednisone acetate tablets in the treatment group was less than that in the control group.Conclusion:Modified Xiayuxue Granule combined with prednisone acetate tablets can effectively improve the clinical symptoms of IPF patients with syndromes of deficiency of qi and yin and obstruction of lung collaterals,reduce the dosage of prednisone acetate tablets,and delay the progression of pulmonary fibrosis to some extent.