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中国中医药治疗HIV/AIDS疗效评价指标体系初步建立
http://www.sina.com.cn 2009年11月26日17:51 中国广播网
中广网北京11月26日消息（记者刘天思）国家中医药管理局于2004年开始组织实施了中医药治疗艾滋病试点项目，为保证治疗工作的顺利实施，在项目实施之初由国家中医药管理局组织中西医专家制定了“中医药治疗艾滋病临床技术方案－疗效评价标准”，对项目实施效果的评价起到了重要作用。但该疗效评价标准的评价方法比较单一，难以全面、客观地反映中医药治疗HIV/AIDS的临床疗效。例如实践证明，中医药对HIV/AIDS患者的乏力、长期低热、腹泻、易感冒、反复咳嗽、皮肤瘙痒、纳差、身体消瘦等症状有明显的改善作用，大量患者原来不能从事日常生活劳动，但接受中医药治疗后，许多患者一边服药一边外出打工，甚至有一些患者的CD4细胞数量已不多，服用中药后自己却感觉精力旺盛，能够胜任一般体力劳动，生活比较正常；一些患者坚持多年服用中医药治疗，病情稳定没有不舒服的感觉，像健康人一样。这类患者一般CD4数量、病毒载量等变化不大，但生活质量明显改善。对此，应用目前国际公认的免疫功能和病毒载量这两个艾滋病治疗疗效的金指标，并不能完全准确反映出中医药的疗效。同时，随着中医药治疗HIV/AIDS的临床研究逐步深入，临床疗效评价的方法不断丰富，为标准的修订提供了基础。
因此，为了客观反映中医药治疗HIV/AIDS的效果，体现出中医药特色与优势，使用能恰当衡量中医药效果又能为现代医学认同的指标，2007年由国家中医药管理局组织成立了“中医药治疗HIV/AIDS疗效评价标准”修订工作组，对原有的评价标准进行了修订。
国家中医药管理局采用循证医学方法，详细总结分析了2004年5月份以来开展的中医药治疗艾滋病试点项目中获得的大量临床数据以及文献资料，又深入河南、云南等地区临床一线，对患者、基层医生、省级临床专家进行专题访谈，同时，多次召开中西医艾滋病临床专家和临床评价方法学专家的论证会，并在北京、河南、云南、安徽和广东5省（市）进行了2000例次的临床观察，最终形成了《中医药治疗HIV/AIDS疗效评价指标体系》。该评价体系从HIV/AIDS疗效评价分期标准、基于HIV/AIDS病人报告的临床结局评价、HIV/AIDS生存质量评价、终点指标的评价、相关病症及体征指标评价、生物学指标评价等六个方面对中医药治疗HIV/AIDS临床疗效进行评价，这一评价体系与既往艾滋病等疾病评价标准的最大区别就是不仅将评价指标局限于实验室指标，而是更加关注生活质量、生存时间和治疗后的反映，引入了生存质量评价量表和基于HIV/AIDS病人报告的临床结局评价（PRO，patient report outcome），从患者对自己健康状况的测量等方面进行评价。这一指标体系以现有标准和最新证据为基础，参考我国和国际上较为通用的评价方法和指标，充分考虑我国的国情，体现中医药特色与优势，得到了初步的认可，目前拟在中医药治疗艾滋病试点省内试用，同时继续扩大规模进行临床验证，不断完善，待成熟后正式公布。
PRO是一种直接来自于患者对自己健康状况的测量，由PRO测量所得的数据从患者角度提供了有关治疗效果的证据。美国、法国已经将这种方法在肿瘤、糖尿病等很多疾病疗效评价中应用，这种方法对以往疗效价体系是重要的补充，体现了以患者为中心，重视患者感受的治疗观念。目前许多疾病如癌症治愈基本不可能，如何使患者生活得好些，痛苦少些，生存时间延长？这不仅是绝大多数患者的迫切需求，也是广大医务工作者的追求。因此，患者的PRO 在临床疗效评价中的作用日益受到重视。
国家中医药管理局研制的PRO量表，关注了我国广大农村艾滋病患者特点，以“不适”和“能力减退”为主要测量内容，分为一般情况、身体状况、情志状况、能力状况等方面，用于HIV/AIDS治疗前后的疗效评价。经过对全国5个艾滋病高发地区即河南、云南、广东、安徽、北京的512例病例连续4个月的临床观察，初步研究结果显示，PRO量表的信度系数较高，结构效度较为合理。而且发现PRO量表与生存质量量表的变化有一致性，即随着生存质量的改善，患者自我不适的主述也明显减少，反映出生活质量有了明显改善。目前PRO量表在十一五重大传染病专项中继续深入研究，观察样本已经扩大到全国。
此外，国家中医药管理局在评价体系修订过程中还发现，患者每月感冒次数和天数、每月发热次数和天数、每月腹泻次数和天数、每月皮疹和疱疹的次数和天数都能反映患者病情和治疗效果。
Chinese medicine treatment of HIV / AIDS Clinical evaluation index system for the initial establishment of http://www.sina.com.cn 2009 Nian 11 Yue 26 Ri 17:51 China Radio Network
Zhong Guangwang Beijing November 26 (Xinhuanet Liu days thinking) The State of Traditional Chinese Medicine in 2004, organized and implemented a pilot project of Chinese medicine to treat AIDS in order to ensure the smooth implementation of treatment, at the beginning of project implementation by the state of the Chinese Medicine Bureau of Chinese and Western medicine experts to create a "Chinese Medicine Treatment of AIDS clinical technology solutions - Evaluation of standard" evaluation of the effectiveness of the project has played an important role. However, the efficacy of the evaluation criteria of the evaluation method relatively simple, it is difficult to comprehensively and objectively reflect the traditional Chinese medicine HIV / AIDS clinical effect. For example, proven, traditional Chinese medicine for HIV / AIDS patients with weak, long-term low-grade fever, diarrhea, easy cold, repeated coughing, skin itching, anorexia, body weight loss and other symptoms have improved significantly the role of a large number of patients had not engaged in daily labor, However, accept medical treatment, many patients with medication side while work outside the home, and even some patients with low CD4 cell count has been taking medicine after they got the feeling energetic, competent in general manual labor, relatively normal; Some patients insist on multi-year taking Chinese medicine treatment in a stable condition there is no uncomfortable feeling, like a healthy person. In general the number of these patients CD4, viral load and so little change, but the quality of life improved significantly. In this regard, application of the current internationally recognized immune function and viral load in HIV treatment efficacy of these two gold standard, and can not accurately reflect the efficacy of Chinese medicine. Meanwhile, with the Chinese medicine treatment of HIV / AIDS clinical study of the gradual deepening of clinical evaluation method continuously enriched, in order to provide the basis for the revised standard.
Therefore, in order to objectively reflect the traditional Chinese medicine HIV / AIDS results reflect the features and advantages of Chinese medicine to use can be a proper measure of effectiveness of Chinese medicine to modern medicine can identify targets in 2007 by the National Organization of Traditional Chinese Medicine set up a " Traditional Chinese Medicine Treatment of HIV / AIDS Response Evaluation Criteria, "revision of the Working Group on the original evaluation criteria have been revised.
SATCM use of evidence-based medicine approach, a detailed summary analysis carried out since May 2004 in Chinese medicine to treat AIDS in the pilot project received a large number of clinical data and literature, but also in-depth Henan, Yunnan and other areas of clinical frontline of patient , primary physicians, clinical experts at the provincial level special interviews, while many Chinese and Western medicine held AIDS clinical experts and clinical evaluation of the feasibility studies experts, and in Beijing, Henan, Yunnan, Anhui and Guangdong five provinces (municipalities) were 2000 cases of clinical observation times and eventually the formation of a "Chinese Medicine Treatment of HIV / AIDS Clinical evaluation index system." The evaluation system from the HIV / AIDS Evaluation of staging criteria, based on HIV / AIDS patients in the clinical outcome evaluation of the report, HIV / AIDS quality of life assessment, end-point evaluation, the relevant indicators to assess symptoms and signs and biological evaluation of six indicators aspects of traditional Chinese medicine treatment of HIV / AIDS clinical evaluation, the evaluation system and chronic diseases such as AIDS is the greatest difference between the evaluation criteria will not only be confined to laboratory indicators of evaluation index, but pay more attention to quality of life, survival time and treatment reflection of the introduction of quality of life rating scale and based on HIV / AIDS patients in the report of evaluation of clinical outcomes (PRO, patient report outcome), from the patient's own state of health in areas such as evaluation of the measurement. This indicator system based on existing standards and the latest evidence-based reference to our country and internationally the more common evaluation methods and indicators, full account China's national conditions, reflects the characteristics and advantages of Chinese medicine, received the preliminary approval, is currently proposed in Medical treatment of AIDS in the province pilot trial, while continuing to expand the scale of clinical validation, continuous improvement, to be mature officially announced.
PRO is a direct from the patient's own health status measurement, measured by the PRO data collected from the patient point of view provides information about the treatment of evidence. The United States, France has used this approach in cancer, diabetes and many other diseases, Evaluation of the application, the method effect of past price system is an important complement, reflecting a patient-centered, attention to the treatment of patients with the concept of feelings. At present, many diseases such as cancer can not cure the basic how to make patients live better, less painful, prolonged survival? This is not only the vast majority of patients with urgent needs, but also the pursuit of broad masses of medical workers. Therefore, the patient's clinical evaluation of PRO in the growing role of attention.
SATCM developed PRO scale, attention to the characteristics of China's vast rural areas of AIDS patients to "discomfort" and "diminished capacity" as the main measurement of the content is divided into the general situation, physical condition, emotional status, ability status, etc. for HIV / AIDS before and after treatment efficacy evaluation. After a high incidence of AIDS in the country five areas namely Henan, Yunnan, Guangdong, Anhui, Beijing, 512 cases for 4 consecutive months of clinical observation, preliminary findings show that, PRO scale reliability coefficient higher, more reasonable construct validity . Moreover, he discovered PRO scale and quality of life scale of the changes are consistent, that is, with the improvement of quality of life, the patient is not the master of self-reference is also significantly reduced, reflecting the quality of life has improved significantly. PRO scales currently a major infectious disease in the Eleventh Five-Year Project to continue in-depth study to observe the sample has been expanded throughout the country.
In addition, the State Pharmaceutical Administration in the evaluation system of the revision process also found that the number of patients with colds and the number of days per month, the monthly heating times and the number of days, diarrhea frequency and the number of days per month, monthly rash and herpes can be reflected in the number and the number of days patient's condition and treatment.
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