摘要
中医药以其"整体观念""治病求本"的原则治疗特发性肺间质纤维化(idiopathic pulmonary fibrosis,IPF)显示出了其他现代医学不可替代的作用,但目前研究还存在一些问题:(1)IPF的对应中医病名行业内仍未能达成共识,缺少权威的指南规范。(2)目前,研究中的地域和研究中心较为单一,缺乏多中心联合的观察性研究,从而忽视由地域差异而造成IPF在病因病机、证候分布上的区别,且目前文献纳入的病例数偏少,结果易受干扰,可重复性差。(3)研究所釆用的评价工具多为欧美国家直接翻译的问卷或经过国内专家翻译改进的普通性量表,由于存在地域差异性,其研究结果难以令人信服。中医在IPF的科研方面,缺乏具有中医自身特色的疗效评估量表,导致大多临床研究在疗效评价时缺乏对"证"改善的判定,而以"候"作为唯一评价,将中医的"证候"一分为二,缺乏了对患者整个人体状态的把握。(4)多数的随机对照研究应用的复方均为自拟方,缺乏针对同证型的古代经方作为对照,因此,在国际上的认可度较低。另外,传统中药复方剂型除了汤剂外,还包含了丸、散、膏、丹等,而这些剂型有的能在IPF稳定期治疗时发挥无法替代的优势,目前相关临床研究中的中药复方剂型均为汤剂,未见其他剂型的研究报道。(5)研究方法比较单一,临床疗效评估停留在对短期症状改善的观察水平上,缺乏终点指标(如再住院率、生存率等)的统计。针对以上问题,我们今后研究方向:(1)明确IPF疾病诊断及分期分型标准,加强疾病分期分型与中医主证的研究,对古代文献关于IPF类似疾病的资料进行全面整理,并经过临床验证,规范IPF的中医病名。(2)对于证候研究有必要加强不同地区医家经验交流,开展不同地区大规模、多中心的联合观察研究,按患者生活的地域进行划分统计,深入研究地理、环境因素对IPF的影响。(3)参照国际生活质量量表研究规范中的步骤,研制符合我国国情、具有中医内涵、符合患者报告结局特点的IPF患者生活质量量表,完善疗效评价体系,用以满足中医对IPF的临床和科研需求,并在临床研究中推广应用。(4)加强古代经方对IPF的疗效研究,可以经方作对照,拓宽中医药治疗IPF的应用。(5)在今后的研究中应采用多中心、大样本研究,尤其是加强远期疗效观察、卫生经济学评价及再住院率、生存率等终点事件的随访。
Traditional Chinese medicine with its ＂ overall concept＂ and ＂ treating disease from the root＂ principle in the treatment of idiopathic pulmonary fibrosis（IPF） has irreplaceable role from the other modern medicine,but the research also has some problems：（1） the corresponding TCM name of IPF in the medicine industry is still unable to reach a consensus,the lack of authoritative guide specification.（2）The present research areas and research center is a single,lack of observational studies combined with multi center,thus ignoring regional differences caused by differences in IPF pathogenesis,syndrome distribution,and the number of casesincluded in the literature is less,the results are easy to be interfered,and poor reproducibility.（3）At present,most of the evaluation tools used in the study are the direct translation of the European and American countries,or the general scale which has been improved by the translation of the domestic experts.Due to the regional differences,the results of the study are not convincing.Chinese medicine in the research of IPF,the lack of its own characteristics with traditional Chinese medicine curative effect assessment scale,lead to most of clinical research in evaluating the effect lacking of the determination of improvement of ＂ syndrome＂,and to ＂ symptom＂ as the only evaluation,and the TCM ＂ syndrome＂ is divided into two parts,the lack of grasp of the whole state of the patient.（4）At present,the application of compound in most of the randomized controlled study are self-made prescription,lack of ancient classics prescription with the same type as a control,so low on international recognition.In addition,traditional Chinese medicine compound preparation but also contains the decoction,pill,powder,ointment,Dan,and some of these dosage forms can play irreplaceable advantages in the treatment of stable stage of IPF,the compound Chinese medicine formulations of related clinical research in all other forms of the decoction,no research reports.（5）The research method is single,and the clinical efficacy evaluation stays at the observation level of short-term symptom improvement,and lack of the end points statistics,such as re-hospitalization rate,survival rate,etc.Future research directions：（1） To define the criteria for IPF diagnosis and staging,Study on classification of diseases and TCM syndrome,The data of the ancient literature about IPF similar diseases were all sorted out,And after clinical verification,standardize the name of Chinese medicine IPF.（2）It is necessary to strengthen the exchange of experience in different areas of medicine syndrome study,carry out large-scale,multi center observation study in different areas,classify statistics according to the patient＇s life areas,in-depth study of geography,environmental factors on IPF.（3）Reference to the international study of quality of life scale step,developed IPF patients quality of life scale in accordance with China＇ s national conditions,the connotation of traditional Chinese medicine,accord with the characteristics of patients report conclusion,improved the curative effect evaluation system,to meet the needs of TCM clinical and research IPF,and widely used in clinical research.（4）Strengthen the curative effect of IPF research on the ancient classical prescription,and broaden the application of traditional Chinese medicine in the treatment of IPF.（5）In the future study,we should use multi center,large sample study,especially strengthening the longterm efficacy observation,health economics evaluation and re hospitalization rate,survival rate and other end points follow-up visit.
出处
《中医学报》
CAS
2017年第4期520-524,共5页
Acta Chinese Medicine
基金
北京市中医药科技项目(JJ2014-08)
关键词
特发性肺间质纤维化
肺痹
肺痿
辨证分型
中药复方
中医药治疗
idiopathic pulmonary fibrosis
Bi syndrome of lung
consumptive lung disease
syndrome differentiation
Chinese herbal compound
TCM therapy
作者简介
符竣杰（1987-），男，广西北海人，医学硕士，主要从事中医肺系疾病及老年病临床工作。
通信作者：辛大永，男，主任医师，研究方向：肺间质纤维化。Email：jiangweixiaoe@126．com
