下肢动脉硬化闭塞症证候要素诊断量表的研制

【作者】 张凡帆；

【导师】 庞鹤； 刘继前；

【作者基本信息】 北京中医药大学 ， 中医外科， 2012， 博士

【摘要】 [目的]本课题隶属于国家科技部重大专项——重大新药创制,“显示中医药疗效优势的中药临床药效评价关键技术研究”(课题编号：2009ZX09502-028)。证候规范化研究是近年来研究的热点,研究的一项重要基础性工作,便是建立用于中医诊断和疗效评价的工具。在内科相关疾病研究的启发和引导下,本研究拟建立下肢动脉硬化闭塞症证候要素诊断量表,形成宏观量化诊断模型,探索中医外科疾病证候诊断规范化研究的思路与方法。[方法]在文献调研、临床病例回顾分析、三轮德尔菲法专家咨询的基础上,形成了下肢动脉硬化闭塞证证候要素诊断量表维度,即寒凝、血瘀、湿热、热毒、痰湿、气虚、阳虚、阴虚九个证候要素维度,并确立了每个证候要素下所对应的四诊信息条目池。并通过专家意见咨询说明了局部症状在本病辨证中的重要性,确定了基于局部症状作为辨证依据的辨证模式。通过临床病例收集,结合临床实际情况,在流行病学调查基础上,筛选证候要素条目及其下所涉及的局部症状条目,经过指标赋权,建立基于局部症状的下肢动脉硬化闭塞症的宏观量化诊断模型,即分别建立适用于下肢动脉硬化闭塞症无溃破患者(fortaine分期1-3期)与已破溃患者(fortaine分期4期)证候要素诊断量表。最后对该标准进行临床诊断性试验。统计学方法采用SPSS17.0软件包处理数据。[结果]分别编制了适用于下肢动脉硬化闭塞症无溃破患者(fortaine分期1-3期)与已破溃患者(fortaine分期4期)证候要素诊断量表。在此基础上建立了下肢动脉硬化闭塞症证候要素量化诊断模型,对于未溃患者,寒凝要素诊断阈值为47,血瘀要素诊断阈值为31,痰湿要素诊断阈值为35,气虚要素诊断阂值为20,对于已溃患者,血瘀要素诊断阈值为13,热毒要素诊断阈值为31,气虚要素诊断阈值为5,各证候要素下对应症状条目分别赋予权重。临床回顾性试验结果显示,该证候要素诊断量表具有较高的灵敏庆(均高于85%)、特异度除未溃组寒凝要素外(均高于85%),阳性似然比(优登指数)除未溃组寒凝要素外(均高于0.85)。[结论]通过文献研究、临床流行病学调查、量表研制、统计分析及临床验证建立的规范的下肢动脉硬化闭塞症证候要素诊断量表具有较好的可行性、准确性和实用价值。本研究成果将为下肢动脉硬化闭塞症的进一步深入研究和临床证候诊断与疗效的客观评价提供标准化尺度,为其它外科疾病病证的证候规范化研究提供规范的可供借鉴的研究思路与方法。更多还原

【Abstract】 [Objective] This study is under the’Significant New Drug Creation’,Project of National Science and Technology Major Project——Research of key techniques in clinical efficacy evaluation of Chinese medicine that displays the therapeutic advantages of Chinese medicine (Research Index:2009ZX09502-028). Studies on standardization of syndromes have been a hot topic in recent years, and one of the key basic work of the research, is constructing tools for Chinese medicine diagnostic and therapeutic evaluation. Under the inspiration and guidance of internal medicine related researches, this study aims to construct the syndrome key elements diagnostic scale for arteriosclerosis obliterans, form a macro-level quantitative diagnostic standard, and explore the ideas and methods of syndrome diagnosis standardization research in Chinese medicine external disease.[Methodology] Using literature research, clinical epidemiological survey, and by three times Delphi method, the syndrome key elements diagnostic scale dimensions of lower limb arteriosclerosis obliterans were formed, and categorized into nine syndrome key element dimensions:cold condensation, blood stasis, damp heat, toxic heat, phlegm dampness, qi deficiency, yang deficiency, yin deficiency, and established the corresponding four-diagnostic information entry pools for every syndrome key element. Through collection of clinical cases, combined with clinical practice, and on the basis of epidemiological surveys, syndrome key element entries and local symptom entries were selected, after index weighting, macro-level quantitative diagnostic model and standards based on local symptoms of the lower limb arteriosclerosis obliterans syndrome were constructed. The syndrome key elements diagnostic scales suitable for lower limb arteriosclerosis obliterans patients without gangrene (Fontaine stages 1-3) and patients with gangrene (Fontaine stage 4) were respectively established, and finally the standards were subjected to clinical diagnostic testing.[Results] Syndrome key elements diagnostic scales suitable for lower limb arteriosclerosis obliterans patients without ulcerous (Fontaine stages 1-3) and ulcerous patients (Fontaine stage 4) were established respectively. Using this as the basis, the syndrome key element quantitative diagnostic standards of lower limb arteriosclerosis obliterans were constructed, for non-ulcerous patients, cold condensation key element diagnosis threshold value was 47, blood stasis key element diagnosis threshold value was 13, phlegm dampness key element diagnosis threshold value was 35, qi deficiency key element diagnosis threshold value was 20, for ulcerous patients, blood stasis key element diagnosis threshold value was 13, toxic heat key element diagnosis threshold value was 31, qi deficient key element diagnosis threshold value was 5. Clinical diagnostic testing results indicated, the syndrome key element diagnostic scale possessed relatively high sensitivity (higher than 85%), all syndrome element diagnostic scale except cold condensation possessed relatively high specificity (higher than 85%), and positive likelihood ratio (Youden index) (higher than 0.85).[Conclusion] The standardized syndrome key elements diagnostic scale for lower limb arteriosclerosis obliterans constructs via literature research, clinical epidemiological survey, diagnostic scale development, statistical analysis, and clinical validation possesses good feasibility, accuracy and practical value. The results from this research will provide a standardized scale for further study and objective evaluation of clinical syndrome diagnosis and therapeutic effects on lower limb arteriosclerosis obliterans, providing reference for ideas and methods to syndrome standardization research in other external diseases.更多还原