血液肿瘤疾病中医临床疗效评价方法探析
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摘要
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.
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.
引文
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[22]郭玥,王怡.中医药临床研究方法的应用[J].中国中医药现代远程教育,2017,15(10):146-149.
[23]张菀桐,翁维良,陆芳,等.中医临床课题研究进度与课题质量评估的相关性探讨[J].世界科学技术-中医药现代化,2017,19(3):419-423.
[24]杜仲平,杜渐,王巧娥,等.带瘤生存是中医治癌的优势所在[J].长春中医药大学学报,2011,27(3):407-409.
[25]郑刚.中西医结合改善中晚期肿瘤患者生存质量[J].重庆医学,2012,41(25):2665-2666.
[2]崔伟锋,王素花,王会丽,等.真实世界中医临床研究方法与实践[J].中国全科医学,2016,19(13):1586-1590.
[3]王吉耀,唐金陵,陈世耀,等.再谈循证医学[J].中国循证儿科杂志,2017,12(3):161-163.
[4]王洋,王昌恩,林雪娟,等.论中医临床疗效评价的发展[J].中医药通报,2016,15(6):1-4.
[5]李君,刘保延.古代中医临床疗效评价方法研究[J].中国中医基础医学杂志,2011,17(4):383-385.
[6]陈访杰.中医识病之“目”:“有诸内必形诸外”[J].中国中医药现代远程教育,2009,7(8):208-209.
[7]曹建新.整体医学模式下心身医学评估的临床实践[J].中华诊断学电子杂志,2015,3(2):128-132.
[8]董超,赵进喜.中医药临床疗效评价的研究进展[J].环球中医药,2016,9(1):110-115.
[9]薛爱玲,王凤玉,张晓岳,等.伊马替尼治疗慢性髓性白血病临床疗效及毒性反应观察[J].中国临床医生杂志,2016,44(9):59-61.
[10]宋娜莎.复方浙贝颗粒联合化疗对难治性急性白血病临床疗效的影响[J].中国现代药物应用,2016,10(4):139-140.
[11]周仲昊,赵晓红,陆时运,等.两种化疗方案治疗高龄MDS患者继发AML的临床对比研究[J].中国实验血液学杂志,2016,24(5):1484-1488.
[12]赵晖,王大伟,姜幼明,等.亚健康中医证候量化诊断标准研究思路探析[J].北京中医药大学学报,2016,39(4):269-272.
[13]殷悦,占文琪,黄慧芳,等.103例急性红白血病患者生物学特征与疗效观察[J].中国实验血液学杂志,2017,25(3):678-682.
[14]陈明明,熊乙霓,郭旭,等.中西医结合治疗对肿瘤患者生存质量的影响[J].光明中医,2017,32(18):2697-2699.
[15]李冬云.益髓灵降低骨髓增生异常综合征患者感染率临床与机制研究[D].北京:北京中医药大学,1997.
[16]李洁,陈信义.陈信义教授治疗骨髓增生异常综合征的思路[J].成都中医药大学学报,2012,35(4):68-69.
[17]高宠,陈信义,张雅月,等.骨髓增生异常综合征中医治法研究进展[J].世界中西医结合杂志,2017,12(6):874-876,880.
[18]徐婷婷,方海.卫生经济学评价指南介绍[J].中国卫生经济,2016,35(5):5-8.
[19]周平.中医整体观与后现代有机整体哲学之比较[J].佳木斯职业学院学报,2017,29(9):64-65.
[20]蒋兴国.临床治疗性试验研究[J].宁夏医学杂志,2009,31(1):91-93.
[21]李洪,魏来,贾继东,等.观察性临床研究是随机对照临床研究的重要补充[J].中华肝脏病杂志,2015,23(5):389-392.
[22]郭玥,王怡.中医药临床研究方法的应用[J].中国中医药现代远程教育,2017,15(10):146-149.
[23]张菀桐,翁维良,陆芳,等.中医临床课题研究进度与课题质量评估的相关性探讨[J].世界科学技术-中医药现代化,2017,19(3):419-423.
[24]杜仲平,杜渐,王巧娥,等.带瘤生存是中医治癌的优势所在[J].长春中医药大学学报,2011,27(3):407-409.
[25]郑刚.中西医结合改善中晚期肿瘤患者生存质量[J].重庆医学,2012,41(25):2665-2666.