【作者】 宋树立；

【导师】 高学敏；

【作者基本信息】 北京中医药大学 ， 中药学， 2003， 博士

【摘要】 目的：阿片类物质依赖稽延性戒断症状是又称迁延性戒断症状，属中医断瘾后诸症范畴，是指急性戒断综合征之后(如果不予治疗，自然过程一般为7至10天)持续存在的一组综合征，包括精神症状(情绪焦虑、药物渴求)和躯体症状(躯体不适、睡眠障碍)是导致复吸的因素之一，对稽延性戒断症状的处理也就成为从医学角度干预复吸的一个作用点。目前西药治疗方法有阿片类药物替代治疗、非阿片类药物对症治疗、阿片类药物拮抗剂治疗和对症治疗，在减轻症状、预防复吸方面发挥了积极的作用，但也伴随一些不良反应。中医药治疗此类病证，有较完整的理论认识和确切的临床经验，多样的治疗手段和丰富的药物资源，正在引起越来越广泛的关注，临床应用和新药开发十分活跃。但目前缺乏对稽延性戒断症状临床治疗和辨证用药的宏观规律性研究，尚未形成规范化的诊断标准，对观测指标、疗效判定标准、临床试验等，都缺乏统一的、科学的要求。西医正在探讨制定稽延性症状评定量表，但不能反映中医学特点，难以起到指导中医临床的作用。本课题开展阿片类药物依赖稽延性戒断症状中医证候学及其计量诊断的研究，主要目的是通过文献、理论研究，对以往证候研究经验进行总结，通过开展多中心、大样本的临床流行病学调查，运用临床流行病调查学和计量诊断学等方法，统计分析调研资料，确立稽延性戒断症状的中医证候分类和诊断标准。研究不仅符合中医药标准化、规范化的总体发展趋势，而且将对中医药治疗稽延性戒断症状的临床实践和中药新药开发起到一定的指导作用。 方法：(1)文献研究和临床研究：系统整理清代以来中医药有关戒毒的文献，深入戒毒机构进行走访了解，筛选出阿片类物质依赖稽延期常见中医症状，初步建立中医证候学概念和诊断标准。(2)设计中医稽延性戒断症状量表：包括一般资料、症状资料、症状分级标准及证候判别标准等4项内容，并请相关专家进行初步鉴定。(3)预试验：进行小样本临床流行病学预试验，检验量表的准确性、完整性和可行性。(4)修订量表：在预试验的基础上，再次进行专家咨询，修订完善量表，使证候分类和诊断标准既符合中医学证治规律，反映稽延性戒断症状的中医学特点，又有较强的临床 ＿＿＿一可操作性。（5）多中心、大样本临床流行病学调查，填写量表。（6）运用临床流行病调查学（DME）和计量诊断学等方法，统计分析量表资料，确立稽延性戒断症状的中医证候分类和计量诊断标准。 结果：门）稽延性戒断症状基本证候要素及其演变规律。7类基本证候要素是热毒证，血瘀证，气郁证，气虚证，血虚证，阳虚证和阴虚证，从跨度为120天的5次调查结果看，热毒证至调查终止时，始终处于较高水平，阳虚证始终处于最低水平，阴虚证呈明显下降趋势，血瘀证、气虚证、血虚证均略呈下降趋势，而气郁证无明显变化c说明不经任何药物治疗；潮热盗汗、阳萎遗精、消瘦疲乏等躯体症状会较快地得到改善，而焦虑抑郁、渴求毒品等精神症状会在相对较长的一段时间内出现；是医学于预的重点环节。（2）证候组合规律。调查结果显示，绝大多数病例表现为二证至四证组合，其中最常见的中医证候组合是毒瘀蕴结，气血亏虚型（热毒证＋气虚证＋血虚证，或瘀血证＋气虚证＋血虚证），毒瘀蕴结，气阴不足型（热毒证＋气虚证＋阴虚证，或瘀血证＋气虚证＋阴虚证统），毒瘀蕴结，阴虚火旺型（热毒证＋阴虚证，或瘀血证＋阴虚证），毒瘀蕴结，阴阳两虚型（热毒证＋阴虚证＋阳虚证和瘀血证＋阴虚证＋阳虚证）。随着时问的推移，在组合形式上，四证、五证组合逐渐减少，单证、二证组合所占比例逐渐升高；在组合形态上，由阴虚证、阳虚证构成的组合逐渐减少，热毒证、瘀血证、气虚证、血虚证、气郁证等单证所占比例相对增加，提示后者是诊断和治疗稽延性戒断症状的关键因素。（3）稽延性戒断症状的中医证候计量诊断探讨。以稽延期常见的21项症状为观察指标，参照多指标多类线性判别法对7种基本证候要素建立了多指标多类线性判别函数式，参照最大似然对4种常见证型建立了诊断指数表，并将其诊断结果与原拟参照标准诊断结果进行比较研究，评价其诊断效能。线性判别函数式的回代结果、证型诊断指数表的回顾性检验和前瞻性检验结果令人满意。其中诊断指数表的回顾性检验显示：门）对毒瘀蕴结，气血亏虚型诊断的灵敏度91．79儿 特异度95．80儿 误诊率4．20儿 漏诊率8．21丸 灵敏度和特异度匀较高，误诊率和漏诊率较低，检出非患者的能力略高于诊断患者的能力；（2）对毒瘀蕴结，气阴不足诊断的灵敏度93．52儿 特异度88．77丸 误诊率11．23儿漏诊率6．48儿 诊断患者的能力略高于检出非患者的能力；（3）对毒瘀蕴结。阴虚火旺诊断的灵敏度——89．76％，特异度94 78％；误诊率5．52％，漏诊率10．24％，检出非患者的能力略高于诊断患者的能力；（4）对毒瘀蕴结，阴阳两虚诊断的灵敏度89．34％，特异度94．85％，误诊率5．15儿 漏诊率10．66兄 检出非患者的能力略高于诊断患者的能力。诊断指数更多还原

【Abstract】 Objective Protracted abstinence symptom (PSA ) of opium-addicts is included in the syndrome after cutting the addiction in CM theory. PAS means a series of sustained symptoms following the acute abstinence syndrome, which disappears in 7 to 10 days if without any treatments, consisting psychological symptoms (etc. anxiety, craving for drugs) and physical symptoms (etc. uncomfortableness, sleeping obstacles). In this way, PAS becomes a factor of relapse. Therefore it’s a point of intervening relapse from the medical perspective to deal with PAS. At present, there are several Western Medicine treating methods, substitutive treatment of opium drugs, focalized treatment by non-opium drugs and antagonist treatment and focalized treatment by opium drugs. Those have positive effects in releasing symptoms and preventing from reusing dugs, but they also bring out some unhealthy reactions. In the field of treating that kind of illnesses, CM has a comparatively intact theoretical understanding, reliable clinical experience, various treating methods and abundant medicine resource. CM treatments are more and more concerned and its clinical practice and the new medicine development are greatly active. However, because of the shortness of macro-research of regularity on clinical treatments and using medicine based on overall analysis against PAS, standardized diagnostic criterion has not been established, and unified and scientific requirements of observation indexes, curative effect evaluation standards and clinical experiments are insufficient. Nowadays Western Medicine is researching how to scaleulate the quantifying scale on protracted syndromes. But it can’t reflect the features of CM and is difficult to direct clinical practice of CM. This topic aims to establish CM syndrome classification and diagnostic criterion, through summarizing the past experience by literature and theory research, launching polycentric and vast-sampled investigations by clinical epidemiological investigation methods, analyzing the investigation and research data by diagnostic evaluation methods. This research not only conscales to the general tendency of standardization development of CM,but also, more or less, can guide the clinical practice and new medicine development of CM against PAS.Methods (1) Documentary research and clinical research: Sort out the data about opium-abstinence systematically from the documents of CM since Qing Dynasty, and make thorough investigations into drug rehabilitation centers, to select out the common syndromes of CM during the protracting period after the abstinence of opium-addiction, and establish the syndrome concepts and diagnostic criterion of CM tentatively. (2) Designing quantifying scale of CM on PAS: The scale should involve 4 items: general data, the inscaleation of symptoms, syndrome classification standard and syndrome evaluation criterion. Then consult to experts for initial evaluating. (3) Pre-experiment: Engage in the narrow-sampled clinical epidemiological experiment, and examine the accuracy, integrity and feasibility of the scale. (4) Revising the scale: Based on the pre-experiment. Consult to experts again and revise the quantifying scale, in order to make the syndrome classification and diagnostic criterion not only accord with the principles of diagnosis and treatment of CM, reflecting the features of CM against PAS, but also be easy to use. (5) Launch polycentric and vast-sampled clinical epidemiological investigation and fill the scale. (6) Make the statistics and analysis on the scale data, to establish the CM syndrome classification and measurable diagnostic criterion, with DME and diagnostic metrological methods.Results (1) Laws of development and basic elements of PAS. Seven basic syndrome elements are heat-toxin syndrome, blood-stagnation syndrome, qi-stagnation syndrome, qi-deficiency syndrome, blood-deficiency syndrome, yang-deficiency syndrome and yin-deficiency syndrome. Referring to the 5 results of an investigation lasting 120 days, heat-toxin syndrome was always at a hig更多还原