支气管活瓣系统治疗重度异质性肺气肿的临床分析

Clinical analysis of the spiration valve system for treatment of severe heterogeneity emphysema

目的探讨支气管活瓣系统(SVS)对重度肺气肿患者的肺减容疗效及安全性。方法根据入排标准筛选符合纳入条件的患者,随机分为活瓣治疗组及对照组。活瓣治疗组进行SVS活瓣肺减容治疗,对照组采取常规治疗。分析两组治疗前、治疗后第1、3、6、12月FEV1、RV、TLC、目标肺叶体积、6 min步行试验、改良m MRC问卷、COPD评估检验(CAT)变化,同时进行安全性评估。结果自2014年2月至2015年10月共筛查患者38例,最终纳入患者9例,其中活瓣治疗组5例,对照组4例,治疗组1人术后失访,未取得观察数据,对照组1例在入组后9个月死亡,最终纳入分析7例。活瓣治疗组2例术后出现靶肺不张,3例靶肺叶体积缩小明显。治疗组第1、3月FEV1%明显增高,与基线对照,差异有统计学意义,但与对照组相比较,差异无统计学意义。治疗组RV、TLC、6MWT、m MRC、CAT在术后与对照组相比差异无统计学意义。不良事件两组均主要为慢性阻塞性肺疾病急性加重期(AECOPD),两组间差异无统计学意义,其次为上呼吸道感染。结论本组资料结果显示,SVS置入后减容效果明确,患者症状均有改善。但观察指标统计结果与自主症状变化不相符,考虑可能与样本量过小以及病情的复杂性有关,需要临床进一步研究。

Objective To observe the effect and safety of lung volume reduction of the spiration valve system(SVS)treatment of severe heterogeneity emphysema.Methods Patients who meet eligibility requirements were randomized into the spiration valve treatment group and the control group.The spiration valve system was used in treatment group while conventional treatment was used in control group.FEV 1,RV,TLC,volume of target lung,6MWT,mMRC and CAT were compared within the two groups,and safety assessment were analyzed.Results All of 38 cases were screened in 20 months,finaly 9 cases were included,among them 5 cases in treatment group and 4 cases in control group.In the treatment group 1 people has not obtained observation data because of lost to follow-up after operation.In the control group 1 people died after admission 9 months.Two cases with atelectasis,and three cases with volume decrease in target lung.In the treatment group,compared with the baseline,FEV1%was higher of the first and third month after treatment,there was statistical significance.But there was no significant difference between the two groups.There same results occur in RV,TLC,6MWT,mMRC and CAT after treatment.acute exacerbation of chronic obstructive pulmonary disease(AECOPD)was the main adverse events in the treatment group and the control group,upper respiratory infection.Conclusions The data show that SVS is effective in volume reduction,the patient′s symptoms have improved.However,the statistical results do not match the symptoms,the complexity of the disease and too small samples may be the reason,further clinical study is needed.