CAJ | 학술논문

目的：比较中西医结合综合方案和单纯西医方案治疗脾肾阳虚证和痰湿内蕴证慢性阻塞性肺疾病急性加重（AECOPD）合并呼吸衰竭（呼衰）的疗效差异。方法采用随机、双盲、多中心、前瞻性、对照的研究方法。选择成都中医药大学附属医院等5家医院重症医学科收治的、符合纳入标准的脾肾阳虚证和痰湿内蕴证AECOPD合并呼衰患者160例，按随机数字表法分为两组。对照组（78例）给予单纯西医常规治疗并加用安慰剂；治疗组（82例）在常规西医治疗基础上加用肺衰合剂25 mL，每日4次，治疗周期均为2周。观察患者治疗结束后28 d的全因病死率、呼衰病死率和呼吸困难程度积分、6 min步行距离积分、第1秒用力呼气容积/用力肺活量（FEV1/FVC）分级患者数的变化。结果与对照组比较，治疗组治疗后28 d患者的全因病死率〔54.87%（45/82）比64.10%（50/78）〕、FEV1/FVC分级患者数比较差异无统计学意义（均P＞0.05），而28 d呼衰病死率则明显降低〔19.51%（16/82）比33.33%（26/78），P＜0.05〕，呼吸困难程度积分较低（1~2分）的患者例数明显增多（22例比7例，P＜0.05），6 min步行距离积分较高（4～6分）的患者数明显增多（21例比8例，P＜0.05）。结论中西医结合综合方案治疗脾肾阳虚证和痰湿内蕴证的AECOPD合并呼衰患者，在改善患者呼吸困难程度、6 min步行距离、呼衰病死率方面优于单纯西医治疗；短期内中西结合综合治疗AECOPD合并呼衰对患者的肺功能、全因病死率无明显影响。
목적：비교중서의결합종합방안화단순서의방안치료비신양허증화담습내온증만성조새성폐질병급성가중（AECOPD）합병호흡쇠갈（호쇠）적료효차이。방법채용수궤、쌍맹、다중심、전첨성、대조적연구방법。선택성도중의약대학부속의원등5가의원중증의학과수치적、부합납입표준적비신양허증화담습내온증AECOPD합병호쇠환자160례，안수궤수자표법분위량조。대조조（78례）급여단순서의상규치료병가용안위제；치료조（82례）재상규서의치료기출상가용폐쇠합제25 mL，매일4차，치료주기균위2주。관찰환자치료결속후28 d적전인병사솔、호쇠병사솔화호흡곤난정도적분、6 min보행거리적분、제1초용력호기용적/용력폐활량（FEV1/FVC）분급환자수적변화。결과여대조조비교，치료조치료후28 d환자적전인병사솔〔54.87%（45/82）비64.10%（50/78）〕、FEV1/FVC분급환자수비교차이무통계학의의（균P＞0.05），이28 d호쇠병사솔칙명현강저〔19.51%（16/82）비33.33%（26/78），P＜0.05〕，호흡곤난정도적분교저（1~2분）적환자례수명현증다（22례비7례，P＜0.05），6 min보행거리적분교고（4～6분）적환자수명현증다（21례비8례，P＜0.05）。결론중서의결합종합방안치료비신양허증화담습내온증적AECOPD합병호쇠환자，재개선환자호흡곤난정도、6 min보행거리、호쇠병사솔방면우우단순서의치료；단기내중서결합종합치료AECOPD합병호쇠대환자적폐공능、전인병사솔무명현영향。
Objective To evaluate the efficacy of integrated traditional Chinese medicine(TCM)and western medicine in treatment of acute exacerbations of chronic obstructive pulmonary disease(AECOPD)combined with respiratory failure,TCM syndromes of spleen-kidney-yang deficiency and phlegm-dampness by comparison between the integrated therapy and simple western therapy in treatment of the disease. Methods 160 patients with AECOPD combined with respiratory failure,spleen-kidney-yang deficiency and phlegm-dampness syndrome in the intensive care units(ICU)of Affiliated Hospital of Chengdu University of TCM and other four hospitals were randomly allocated into two groups in this double-blinded,multicenter,prospective,randomized,controlled trial. In the control group (78 cases),western medicine and placebo were given to the patients,and in the treatment group(82 cases), conventional western medicine plus fei-shuai mistura 25 mL were administered,four times per day,the therapeutic course lasting for 2 weeks in both groups. The all-cause mortality,respiratory failure-cause mortality,improvement of modified Medical Research Council(mMRC)Dyspnea Scale grades,6 minutes walk distance(6MWD),the forced expiratory volume in 1 second/forced vital capacity(FEV1/FVC)were observed in the 28 days after the end of treatment. Results In the comparisons between the control and treatment groups,there were no statistical significant differences in the all-cause mortality〔54.87%(45/82)vs. 64.10%(50/78)〕and the cases of FEV1/FVC(both P>0.05)in the 28 days after the end of treatment;the 28 day respiratory failure-cause mortality was significantly decreased〔19.51%(16/82)vs. 33.33%(26/78),P<0.05〕,the number of patients with mMRC Dyspnea Scale grades (1-2)was obviously increased(22 cases vs. 7 cases,P<0.05),and the number of patients with 6 MWD grades (4-6)was markedly enhanced in the treatment group(21 cases vs. 8 cases,P<0.05). Conclusions The integrated TCM and western medicine has better therapeutic results in improvement of the patients' degree of dyspnea, 6 MWD and respiratory failure mortality than simple treatment with western therapy for treatment of patients with AECOPD combined with respiratory failure, spleen-kidney-yang deficiency and phlegm-dampness syndrome. However,in regard to the effect on pulmonary function and all cause mortality,the integrated therapy for treatment of such patients in short term has no significant effect.