补益肺肾法对支气管哮喘患者生存质量影响的研究

【作者】 王宁群；

【导师】 姜良铎；

【作者基本信息】 北京中医药大学 ， 中医内科学， 2005， 博士

【摘要】 支气管哮喘是临床常见病、多发病,其发病率和死亡率一直呈逐年增高的趋势,近年来一直是国内外医学界研究的热点。哮喘不仅能够引起患者的日常活动受限,而且会导致患者的情绪、心理和社会功能等多方面的损害,是严重影响患者生存质量的一种疾病,对患者的健康形成严重的威胁,给家庭和社会带来严重的负担。探索能有效提高哮喘患者生存质量的治疗方法,具有重要的临床意义和社会价值。目的: 1.本研究主要观察中医补益肺肾法对支气管哮喘慢性持续期患者的临床疗效及其对哮喘患者生活质量的影响,并初步探讨补益肺肾法对哮喘的作用机制,客观地评价中医对哮喘的治疗作用,为探索中医对支气管哮喘的有效干预方法提供一定的依据;2.研究生存质量与中医证候及其它观察指标之间的相关性,为探索中医药治疗哮喘的有效评价体系提供一定的依据;3.对影响哮喘患者生存质量的因素进行初步分析。方法: 本研究是一项随机、对照、非盲法的临床研究,研究对象为支气管哮喘慢性持续期中度持续型患者。分为治疗组、对照组,各 30 例。两组的西医治疗相同,均根据英国胸科协会治疗支气管哮喘指南和中华医学会呼吸学分会制定的支气管哮喘防治指南进行,用药为吸入激素和短效支气管扩张剂;治疗组在西医治疗的同时加用补益肺肾的药物——冬虫夏草软胶囊,服用二个月。疗程结束后继续随访,共随访至六个月。运用“成人哮喘生存质量评分表”和“健康状况调查问卷SF-36”对生存质量进行评分,于入组时、入组后 1 月、2 月、3 月、4 月、5 月、6 月各进行一次评分,共 7 次;哮喘症状、体征、中医证候、哮喘发作频率、夜间因哮喘而觉醒次数、短效β2受体激动剂的使用频率、激素使用量、治疗等级、无症状天数等指标于入组时、入组后 2 月、4 月、6 月时各进行一次评估,共 4 次;肺功能和血清学指标于入组时和入组后 2 月时各测一次,共 2 次。结果: 治疗组对 AQLQ 生存质量的各维度(活动受限、哮喘症状、心理功能状况、对刺激源的反应、对自我健康的关心)及总均分的改善幅度均大于对照组,其中以活动受限、哮喘症状、心理功能状况、及 AQLQ 总分两组间差别更明显,但未达到统计学有意义水平。治疗组对 SF-36 中躯体健康、躯体角色、心理健康、情绪角色的改善显著优于对照组,P<0.05。对身体疼痛、精力、总体健康的改善幅度治疗组大于对照组,但未达到统计学有意义水平。 两组患者经治疗后喘息、咳嗽、咯痰、胸膈满闷、哮鸣音、症状总分较治疗前均有不同程度的改善,两组间比较,治疗组与对照组在症状总分的改善上差异显著,P 为 0.05;对胸膈满闷的改善非常显著,P<0.01;对喘息的改善两组差别极为显著,P<0.001;治疗组对喘息、胸膈满闷以及总体症状的改善优于对照组。治疗组哮喘总体症状的控显率为13.3%,总有效率为 63.3%,显著高于对照组的 8.7%、25.1%。 两组患者喘促气短、乏力、少气懒言、精神倦怠、易外感以及证候总分的改善均非常显著。两组间比较,治疗组对喘促气短、乏力、自汗、精神倦怠、证候总分的改善显IV 补益肺肾法对支气管哮喘患者生存质量影响的研究著优于对照组,P<0.05。眩晕、耳鸣、腰膝酸软、易外感、畏风寒、面色恍白、小便频数、性欲减退等证候的控显率和总有效率治疗组均明显高于对照组,但未产生统计学差异。治疗组对总体证候改善的控显率为 3.3%,总有效率为 60.0%,显著高于对照组的 0%、26.1%。对症状与证候总体的改善治疗组控显率、总有效率分别为 10.0%、70.0%,显著高于对照组的 0%和 13.0%,组间比较的 P 值为 0.000,说明治疗组对哮喘症状、中医证候的总体改善显著优于对照组。治疗组经治疗后其哮喘发作次数、夜间因哮喘而觉醒的次数逐渐减少,无症状天数逐渐增多,支气管舒张剂的使用次数和激素的用量明显减少。其中,无症状天数的增加P<0.01,支气管舒张剂的使用次数的减少 P<0.05,两组间差异显著。治疗组接受较高级别治疗的患者逐渐减少,而接受较低级别治疗的患者逐渐增多。治疗组对血清指标 IgE、sICAM-1、IL-4、MMP-9 的改善优于对照组,其中 IgE、MMP-9两组间比较 P<0.05,sICAM-1、IL-4 两组间比较 P<0.01。对生存质量影响因素的分析结果:证候学受损重的患者生存质量明显较低。既往使用激素治疗超过 3 个月的患者其生存质量高于未使用激素治疗或使用不足 3 个月者。中长程患者(病程>5 年)AQLQ 和 SF-36 生存质量均较差,对治疗的反应性也较差。低中龄组(<60 岁)AQLQ 生存质量的损害较重,中高龄组(>40 岁)SF-36 生存质量的损害较重;低龄组经治疗干预后生存质量的改善幅度明显优于中、高龄组,中龄组生存质量对治疗的反应性较差。女性 AQLQ 生存质量较男性受损更为明显,但女性对治疗的反应较男性稍好。生存质量与其它观察指标的相关性结果:生存质量与其它观察结果之间存在轻到中度相关。结论:1.支气管哮喘慢性持续期运用中医补益肺肾法能提高患者生存质量,尤其是哮喘非特异的生存质量。补益肺肾法不仅能显著改善哮喘患者的躯体健康,继而改善与躯体健康密切相关的躯体角色功能,并且对患者的心理和情绪亦有显著的改善作用;2.补益肺肾法能较平稳地减少哮喘患者激素和快速支更多还原

【Abstract】 Bronchial asthma is commonly seen in clinical practice. With its incidence and mortalityrate increasingly rising year after year, this disease has been the hotspot of medical researchin recent years in our country and abroad. This disease, significantly impacting patients’quality of life(QOL), not only affects patients’ daily-activity, but also impairs theiremotion, mental health and social function. The health of asthmatics are severely threatenedand the burden of the families and the society are heavy. It is of clinical importance andsocial value to explore effective ways to improve asthmatics’ quality of life.Objectives: 1.The main aim of this study is to evaluate the treatment effects of the method buyifeishen(replenishing Qi of lung and kidney)on moderate persistent asthmatics and its impact onpatients’ QOL. To explore the therapeutic mechanisms of this therapy and objectively evaluatethe theraputic effects of traditional Chinese medcine(TCM) on asthma in order to provideevidence for determining effective interferance of asthma by TCM. 2.To study the relationshipbetween QOL and other clinical outcomes such as TCM syndromes in order to provide evidencefor determining effective evaluation system of asthma treatment by TCM. 3.Analyzing theinfluencing factors of asthmatics’ QOL.Methods: In this randomized, open-labeled, parallel-group study, sixty patients with moderarepersistent asthma have been randomized into experimental group and control group. Accordingto the guidelines on asthma management by British Thoracic Society and Chinese MedicalAssociation, Inhaled corticosteroid and as-needed β-agonist were used in the treatment ofthe experiment group while this therapy plus dongchongxiacao capsule were used in the controlgroup for two months. After 2 months the observation continued untill 6 months afterrandomization. Patients’ QOL were assessed by AQLQ and SF-36 at randomization, 1, 2, 3, 4,5, 6 months after randomization. Patients’ symptoms, TCM syndromes, asthma attack incidence,noctural awakenings, dosage of β-agonist and corticosteroid, therapy steps, symptom-freedays were assessed at randomization and 2, 4, 6 months after randomization. Pulmonary functiontesting and blood testing were performed at randomization and 2 months after that.Results: Significant treatment effects(P<0.05) were found in the physical function, role-physical,mental health and role-emotional of the generic SF-36 for the experiment group compared withthe control group. Greater improvements in all the AQLQ domains (activity limitations, asthmasymptoms, mental state, response to environmental exposure and care for one’s own health)andmean AQLQ overall, as well as bodily pain, vitality, general health of SF-36 had been observedin the experiment group but didn’t reach the statistically significant level. Pant, cough, phlegm spitting, chest tightness, wheeze, symptoms overall changed greatlyin both groups.However, the experiment group had experienced greater improvement in overallsymptoms(P=0.05), chest tightness(P<0.01), pant(P<0.001) than the control group.The curativerate and total effective rate in the experiment group were 13.3% and 63.3%, significantlyhigher than that of the control group, which were 8.7% and 25.1%. Shortness of breath, lassitude, lack of strengh to speak, accidie, easiness to get coldand syndromes overall were ameliorated in both groups. Greater improvements were seen inshortness of breath, lassitude, daytime perspiration, accidie, syndromes overall for theexperiment group compared with the control group (P<0.05).The curative rate and totaleffective rate of dizziness, tinnitus, tartness of waist and knee, easiness to get cold, fearof wind and cold, pale complexion, frequent urination, libido impairment were higher in theexperiment group than the control group, but statistical analysis didn’t produce significantresults. The curative rate and total effective rate of syndromes overall in the experimentgroup were 3.3% and 60.0%, significantly higher than that of the control group,which were0% and 26更多还原