血液肿瘤疾病中医临床疗效评价方法探析

Analysis of Traditional Chinese Medicine Clinical Efficacy Evaluation Methods for Hematological Neoplasms Diseases

针对血液肿瘤疾病特点,简要介绍中医古代临床疗效评价方法,并结合现代血液肿瘤中医临床疗效评价指标,从临床研究设计、盲法设计以及中医观察指标权重等方面,对血液肿瘤疾病临床疗效评价方法进行探讨。强调血液肿瘤属于难治疾病,要体现整体疗效,需要从单一评价指标向多元化指标集成转变。在盲法设计方面,如以国际规范的血液肿瘤疗效指标为主者,在严格随机、对照情况下,可以不采用盲法;而以临床证候、症状、生存质量为主要观察指标的临床研究,必须使用盲法设计并建立科学的评价方法和评价体系。对于治疗无反应或复发难治性血液肿瘤,坚持"以人为本,治病留人""带瘤生存"等理念,加大临床证候(症状)改善、生存质量提高、生存期延长等疗效评价指标权重更能让患者临床受益。

Aiming at the characteristics of hematological tumor diseases,the ancient clinical efficacy evaluation methods of traditional Chinese medicine was briefly introduced.Combined with modern Chinese medicine hematological tumor clinical efficacy evaluation indicators,from the aspects of clinical research design,blind design and the weight of TCM observation indicators,the clinical efficacy evaluation method for hematological tumor diseases was explored.It was emphasized that blood tumors were refractory diseases.In order to reflect the overall therapeutic effect,it is necessary to change from a single evaluation index to diversified index integration.In terms of blind design,such as the international standard of blood tumor efficacy indicators,in a strictly random,controlled case,blind method cannot be used;For clinical researches with clinical syndrome,symptoms,quality of life as the main observational indicators,the blind method must be used to design and establish a scientific evaluation method and evaluation system.For the treatment of non-responsive or relapsed and refractory hematological tumors,it should adhere to the concept of＂people-oriented,treatment-for-living,＂and＂＂survival with tumors＂to increase the weight of clinical syndrome（symptoms）improvement,quality of life,and prolonged survival,which can make the patient benefit clinically.