1.上海中医药大学附属曙光医院肺病科(上海 201203)
徐贵华,男,博士,副主任医师,主要从事中西医结合治疗呼吸系统疾病的临床研究工作
张炜,主任医师,博士研究生导师; E-mail:zhangw1190a@sina.com
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徐贵华,张炜,史苗颜等.补肺益肾方联合西医常规疗法治疗慢性阻塞性肺疾病稳定期的临床研究[J].上海中医药杂志,2022,56(06):50-54.
XU Guihua,ZHANG Wei,SHI Miaoyan,et al.Clinical study on the treatment of patients with stable chronic obstructive pulmonary disease with Bufei Yishen Decoction combined with conventional western medicine[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(06):50-54.
徐贵华,张炜,史苗颜等.补肺益肾方联合西医常规疗法治疗慢性阻塞性肺疾病稳定期的临床研究[J].上海中医药杂志,2022,56(06):50-54. DOI: 10.16305/j.1007-1334.2022.2111023.
XU Guihua,ZHANG Wei,SHI Miaoyan,et al.Clinical study on the treatment of patients with stable chronic obstructive pulmonary disease with Bufei Yishen Decoction combined with conventional western medicine[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(06):50-54. DOI: 10.16305/j.1007-1334.2022.2111023.
目的,2,观察补肺益肾方联合西医常规疗法治疗肺肾两虚型中重度慢性阻塞性肺疾病(COPD)稳定期患者的临床疗效,以及对患者血清炎症因子水平的影响。,方法,2,将120例肺肾两虚型中重度COPD稳定期患者随机分为治疗组和对照组,每组60例。对照组采用西医常规治疗,治疗组在西医常规治疗的基础上加用补肺益肾方,两组疗程均为3个月,治疗结束后随访1年。观察临床疗效,比较中医证候积分、肺功能指标、6 min步行试验(6MWT)、慢性阻塞性肺疾病评估测试(CAT)问卷评分、年急性加重次数、血清炎症因子水平的变化情况,同时进行安全性评价。,结果,2,①治疗组、对照组总有效率分别为83.33%、31.67%,治疗组临床疗效优于对照组(,P,<,0.01)。②治疗后、随访结束时与治疗前组内比较,治疗组中医证候积分减少(,P,<,0.05,,P,<,0.01),对照组中医证候积分增加(,P,<,0.05);治疗后、随访结束时组间比较,治疗组中医证候积分少于对照组(,P,<,0.05)。③治疗后,治疗组年急性加重次数减少(,P,<,0.01),且明显少于对照组(,P,<,0.05)。④治疗前后组内比较,治疗组第1秒用力呼气容积(FEV,1,)、6MWT值增加(,P,<,0.05,,P,<,0.01),对照组肺功能指标、6MWT无明显变化(,P,>,0.05);随访结束时与治疗前组内比较,治疗组6MWT值增加(,P,<,0.05),对照组肺功能指标、6MWT无明显变化(,P,>,0.05)。治疗后、随访结束时组间比较,治疗组FEV,1,、FEV,1,/用力肺活量(FVC)、6MWT值大于对照组(,P,<,0.05)。⑤治疗后、随访结束时与治疗前组内比较,两组CAT问卷评分降低(,P,<,0.01);治疗后、随访结束时组间比较,治疗组CAT问卷评分低于对照组(,P,<,0.05)。⑥治疗前后组内比较,治疗组血清白介素-10(IL-10)水平升高(,P,<,0.05),血清白介素-17(IL-17)、 肿瘤坏死因子-α(TNF-α)水平下降(,P,<,0.01);组间治疗后比较,血清IL-10、IL-17、TNF-α水平差异有统计学意义(,P,<,0.05,,P,<,0.01)。⑦试验期间,两组均未发生明显不良反应。,结论,2,补肺益肾方联合西医常规疗法治疗肺肾两虚型中重度COPD稳定期患者疗效满意,能有效减少急性加重次数,改善肺功能,提高患者的运动耐力和生活质量,其机制可能与调节血清炎症因子水平有关。
Objective,2,To observe the clinical effect of Bufei Yishen Decoction combined with conventional western medicine on patients with moderate or severe chronic obstructive pulmonary disease (COPD) in stable stage and with lung-kidney deficiency syndrome, and investigate its influence on the level of serum inflammatory factors of patients.,Methods,2,Totally 120 patients with moderate or severe COPD in stable stage and with lung-kidney deficiency syndrome were randomly divided into a treatment group (,n,=60) and a control group (,n,=60). The control group was treated with conventional western medicine, while the treatment group was treated with Bufei Yishen Decoction besides the treatment measures of the control group. The course of treatment of both groups was 3 months, and the patients were followed up for 1 year after treatment. The clinical effect was observed, the changes of TCM syndrome scores, pulmonary function indexes, the 6-min walking test (6MWT), chronic obstructive pulmonary disease assessment test (CAT) score, annual acute exacerbation frequency and serum levels of inflammatory factors were compared, and the safety evaluation was also conducted.,Results,2,①The total effective rate of treatment group was 83.33% and that of control group was 31.67%, and the treatment group showed more significant clinical efficacy than the control group (,P,<,0.01). ②After treatment and at the end of follow-ups, the TCM syndrome scores in the treatment group decreased (,P,<,0.05, ,P,<,0.01), while the TCM syndrome scores in the control group increased (,P,<,0.05). After treatment and at the end of follow-ups, TCM syndrome scores in the treatment group were comparatively lower than those in the control group (,P,<,0.05). ③After treatment, the frequency of acute exacerbations in the treatment group decreased (,P,<,0.01) and was lower than that in the control group (,P,<,0.05). ④According to the intra-group comparison before and after treatment, there was an increase in the forced expiratory volume in the first second (FEV,1,) and 6MWT in the treatment group after treatment (,P,<,0.05, ,P,<,0.01), while the pulmonary function indexes and 6MWT in the control group did not change significantly after treatment (,P,>,0.05). Compared with the condition before treatment, there was an increase in the 6MWT in the treatment group at the end of follow-ups (,P,<,0.05), while the lung function indexes and 6MWT in the control group had no significant change (,P,>,0.05). After treatment and at the end of follow-ups, FEV,1,, FEV,1,/FVC and 6MWT in the treatment group were higher than those in the control group (,P,<,0.05). ⑤Compared with the CAT scores before treatment, the CAT scores in the two groups were lowered after treatment and at the end of follow-ups (,P,<,0.01); The CAT scores in the treatment group were lower than those in the control group after treatment and at the end of follow-ups (,P,<,0.05). ⑥After treatment, the level of IL-10 in serum increased (,P,<,0.05), but the IL-17 and TNF-α levels in serum decreased in the treatment group (,P,<,0.01). There were significant differences in serum IL-10, IL-17 and TNF-α levels between the two groups after treatment (,P,<,0.05, ,P,<,0.01). ⑦During the trial, there was no significant adverse reaction in the two groups.,Conclusion,2,Bufei Yishen Decoction combined with conventional western medicine is effective in treating patients with moderate or severe COPD in stable stage and with lung-kidney deficiency syndrome, because it can effectively reduce the frequency of acute exacerbations, improve the lung function, exercise endurance and quality of life of patients, and its mechanism may be related to the regulation of serum inflammatory factors.
慢性阻塞性肺疾病稳定期补肺益肾方中西医结合疗法炎症因子临床试验
chronic obstructive pulmonary diseasestable stageBufei Yishen Decoctionintegrated traditional Chinese and western medicine therapyinflammatory factorclinical trial
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