背景:提高慢性阻塞性肺疾病患者免疫功能,可具有控制慢性阻塞性肺疾病病变进程的作用。目的:观察慢性阻塞性肺疾病缓解期患者应用以补肺益肾法则制剂的补肺益肾颗粒后免疫功能和肺通气功能的变化情况,并与安慰剂作对比。设计:随机对比观察,安慰剂对照。单位:河南中医学院第一附属医院呼吸内科。对象:选择1999—01/2004—10在河南中医学院第一附属医院呼吸内科住院的慢性阻塞性肺疾病缓解期患者62例,均自愿参加观察。随机分为2组,观察组、对照组各31例。方法:观察组患者服用补肺益肾颗粒(由人参、黄芪、白术、防风、麦冬、五味子、补骨脂、蛤蚧、山萸肉、冬虫夏草、沉香、苇茎、全虫、杏仁、浙贝母、川芎等组成,河南中医学院第一附属医院药剂科提供,每克颗粒剂相当于原生药5.78g),3次/d,10g/次。对照组服用安慰剂(由山楂和麦芽组成),剂量及服法同观察组。2个月为1个疗程,1个疗程后观察两组疗效。以下指标于两组患者入选后和疗程结束后各测定1次。①免疫功能测定:血清中IgG,IgA,IgM含量采用单向琼脂扩散法测定。②淋巴细胞核仁形成区嗜银蛋白测定:应用普通细胞银染技术,计算硝酸银染色酸性非组蛋白面积与核面积比值。③肺功能测定:选择第1秒用力呼气容积、最大呼吸中期流量、最大呼气流速作为观察指标,每次检查均应重复3次,取其高值,3次之间差异在±5%以内。主要观察指标:两组患者治疗前及治疗1个疗程后肺通气功能、T淋巴细胞亚群数量比较。结果:慢性阻塞性肺疾病缓解期患者62例全部进入结果分析,无脱落。①两组患者治疗前及治疗1个疗程后肺通气功能比较:观察组治疗1个疗程后1秒钟用力呼气容积、最大呼气中期流量、最大呼气流速及第1秒用力呼气容积占
BACKGROUND: Promoting immunological function of patients with chronic obstructive pulmonary disease (COPD) ean control development of COPD. OBJECTIVE: To investigate the effect of bufei yishen granule on pulmonary ventilation function and immunological function of COPD patients and eompare with placebo. DESIGN: A randomized grouping comparison and placebo controlled study. SETTING: Respiration Department of the First Affiliated Hospital of Henan Traditional Chinese Medical. PARTICIPANTS: A total of 62 COPD patients selected from Department of Respiration of the First Affiliated Hospital of Henan College of Traditional Chinese Medieine from January 1999 to Qetober 2004,were randomly divided into two groups:Observation group and control group with 31 in each group. METHODS: Patients in observation group were treated with bufei yishen granule consisting of ginseng, mongolian milkvetch root, largehead atraetylodes rhizome, divarieate saposhnikovia root, dwarf lilyturf tuber, Chinese magnoliavine fruit, malytea scurfpea fruit, medicinal evodia fruit, Chinese ester pillar fungus, Chinese eaglewood wood, scorpion, almond, thuhberg fritillary bulb, szeehwan lovge rhizome, etc., produeed by Pharmaceutic Department of the First Affiliated Hospital of Henan College of Traditional Chinese Medicine. Each granule of 1 g eontained an equivalent of 5.78 g raw drugs. Three times a day with 10 g for each; and patients in control greup were treated with placebo consisting of hawthorn fruit and malt. The dosage and medication were the same as those in observation group, Both therapies were respeetively administered in a treatment course of two months. Before and after the therapy course, the followed indexes were measured. ①Assay of immunological funetion: The levels of IgG, IgA and IgM from blood serum were detected with simple agar diffusion. ② Assay of Ag level in nueleolus organizer region (Ag-NORs): The ratios non-histone staining acidity non-histone vs core area (IS%) was calculated by stainin