健脾通络方治疗特发性肺纤维化脾虚络瘀型患者58例随机对照试验

Jianpi Tongluo Formula(健脾通络方)in the Treatment of 58 Cases of Idiopathic Pulmonary Fibrosis with Spleen Deficiency and Collateral Stasis Pattern:A Randomized Controlled Trial

目的评价健脾通络方治疗特发性肺纤维化(IPF)脾虚络瘀型的临床疗效及安全性。方法58例IPF脾虚络瘀型患者按照1∶1随机分为治疗组各29例。两组均予氧疗、肺康复常规非药物治疗,在此基础上治疗组予健脾通络方颗粒剂(每袋10.7 g)口服,每日2次,每次2袋;对照组予N-乙酰半胱氨酸(NAC)颗粒剂口服,每次0.6 g,每日3次。两组均治疗3个月。比较治疗前后各项指标,主要疗效指标为中医证候积分[包括单项主症积分(喘息、憋气、胸闷、气短、Velcro啰音、咳嗽)和中医证候总积分];次要疗效指标包括高分辨率计算机断层扫描(HRCT)评分[包括L1、L2、L3、L4、L5、L6分级评分及HRCT总评分]、六分钟步行测试(6 min步行距离)、圣乔治呼吸问卷(SGRQ)评分(包括症状积分、活动积分、影响积分及SGRQ总分),检测血清炎症因子[包括白细胞介素6(IL-6)、肿瘤坏死因子α(TNF-α)、干扰素γ(IFN-γ)]水平,并观察不良反应。结果最终共有51例患者完成试验,其中治疗组26例、对照组25例。与本组治疗前比较,治疗组治疗后喘息、咳嗽评分及中医证候总积分减少,HRCT总评分、SGRQ症状评分、TNF-α水平降低,6 min步行距离增加(P<0.05或P<0.01),对照组仅中医证候总积分较治疗前降低(P<0.01)。治疗后组间比较,治疗组中医证候总积分低于对照组(P<0.01)。治疗过程中,两组均未发生不良反应及严重不良事件。结论健脾通络方能显著改善IPF脾虚络瘀型患者咳嗽、喘息症状,提高运动耐力和生活质量,其机制可能与下调血清TNF-α有关。

Objective To evaluate the clinical efficacy and safety of Jianpi Tongluo Formula(健脾通络方,JPTLF)in the treatment of idiopathic pulmonary fibrosis(IPF)with spleen deficiency and collateral stasis pattern.Methods Fifty-eight IPF patients of spleen deficiency and collateral stasis pattern were randomly divided into 29 cases in TCM group and 29 cases in control group at the ratio of 1∶1.TCM group was given JPTLF(10.7 g per bag)orally,two bags each time,twice daily,while control group was given N-acetylcysteine(NAC)granules,0.6 g each time,three times daily,and both were given routine non-drug treatment including oxygen therapy and pulmonary re⁃habilitation.Before and after 3 months of treatment,indicators were observed,such as the primary efficacy indica⁃tors including single TCM symptom scores(wheezing,breathlessness,chest tightness,shortness of breath,Velcro rales,cough)and total TCM syndrome score,as well as the secondary efficacy indicators including high resolution computed tomography(HRCT)scores(L1,L2,L3,L4,L5,L6 grading scores and total score),6-minute walk test(6MWT),St.George's Respiratory Questionnaire(SGRQ)scores(symptom score,activity score,impact score and total score),and serum levels of inflammatory factors[interleukin 6(IL-6),tumor necrosis factor alpha(TNF-α),interferon gamma(IFN-γ)].And the adverse reactions were observed.Results Totally,51 patients including 26 patients in TCM group and 25 patients in control group completed the trial.After treatment,TCM group had reduced wheezing,cough scores,total TCM syndrome score,total HRCT score,total SGRQ score,TNF-αlevel,and in⁃creased 6MWT(P<0.05 or P<0.01),while the control gorup had decreased total TCM syndrome score(P<0.01).There was significantly lower total TCM syndrome score in the TCM group than the control group(P<0.01).There was no adverse reaction in both groups.Conclusion JPTLF could improve the cough and wheezing symp⁃toms,and increase exercise endurance and quality of life in the treatment of IPF of spleen deficiency and collateral sta⁃sis pattern.Its mechanism may be related to the down-regulation of TNF-α.