基于真实世界仝小林教授临床应用制何首乌经验总结及不良事件分析

发布时间：2018-06-20 18:44

本文选题：制何首乌 + 数据挖掘　；参考：《北京中医药大学》2017年硕士论文

【摘要】：研究目的:本文通过对仝小林教授门诊应用制何首乌病例数据进行回顾性分析,观察门诊应用制何首乌病例患者基本情况(年龄、性别)、疾病情况(糖尿病及并发症、高血压等)、用药情况(日用剂量、疗程、累计剂量等)、四诊情况(乏力、脱发等)、配伍情况以及合并用药、过敏史对处方中含制何首乌病例出现不良事件类型统计并进行分析。通过基于真实世界的数据挖掘,总结仝小林教授临床应用制何首乌经验。研究方法:收集违反仝小林教授门诊病历系统录入应用制何首乌的病例,采用回顾性分析,对病历基本信息采用描述性分析,采用关联分析法挖掘症-药配伍经验,不良事件采用Karch与Lasagna评定方法评价与制何首乌的相关性。研究结果:(1)基本情况：本研究根据纳入排除标准,从仝小林教授门诊2008年7月至2015年3月期间门诊病例筛选出143例应用制何首乌病例,共271诊次。其中男性患者26例,占比18.18%,女性患者117例,占比81.82%。40岁以上中老年患者居多,共计112例,占比78.61%,其中40～60岁年龄段患者较多,共计90例,占比62.93%。病例诊断主要以糖尿病、代谢性疾病为主。(2)制何首乌用量和疗程:何首乌单日剂量主要以30g和15g居多,其15g占比75.81%,30g占比20.95%。少部分病情较轻者小剂量服用水丸,单日剂量0.3～9.6g之间,占比3.24%。总体单日平均剂量(16.55±6.86)g。疗程最长为502天,最短14天,平均疗程(81.11±82.83)天;累计剂量最大6720g,最小180g,平均累计剂量(1105.26±1015.17)g(3)制何首乌治疗主症及舌脉:刻下症以失眠、乏力、便秘、四肢麻木疼痛,腰部酸痛,多汗,脱发较常见;舌象以舌红、舌底瘀滞、舌胖大、齿痕、舌细颤、苔黄、苔腻较常见;脉象以脉弦、脉沉、脉数、脉细、脉滑较常见。(4)基于关联分析法进行数据挖掘:分析对象选取频次出现较高的刻下症:失眠、乏力、便秘、烘热汗出、腰部酸痛、四肢麻木、脱发,临床应用制何首乌配伍情况分析,结果发现大部分与临床实际符合,但也存在偏差。具体结果以网络图和关联性指数排列表呈现。(5)不良事件:143例患者中,出现不良事件共17例,以胃肠道反应、皮肤异常较多,胃肠道反应8例,皮肤异常4例,肝功异常2例,腰酸小便频1例,上火反应2例。根据Karch与Lasagna评定方法对不良事件进行评价,判断仅1例不良事件与服用制何首乌相关性强。结论:本研究发现仝小林教授主要应用制何首乌治疗肝肾亏虚、气血虚弱证型的患者。制何首乌治疗常见症状主要有失眠、乏力、便秘、脱发、腰部酸痛等症状。不良反应发生率较低可能与何首乌的炮制以及导师在应用时多随时关注患者的病史及实验室指标变化,并相应及时配伍保肝药物有关;但不良反应事件的发生影响因素多,个体差异大,医生需辨证准确,谨慎用药,合理配伍减毒预防不良反应的发生。
[Abstract]:Objective: through retrospective analysis of the data of outpatient application of Polygonum multiflorum by Professor Tong Xiaolin, we observed the basic condition (age, sex, disease (diabetes and complication) of the case of polygonum multiflorum). Hypertension and so on, medication (daily dosage, course of treatment, cumulative dose, etc.), four diagnosis (fatigue, alopecia, compatibility and combination of medication, allergy history of the prescription of polygonum multiflorum) adverse events type statistics and analysis. Based on real-world data mining, Professor Tong Xiaolin's experience in clinical application of Polygonum multiflorum is summarized. Methods: to collect the cases that violated Professor Tong Xiaolin's out-patient medical record system input into the application system of Polygonum multiflorum, to use retrospective analysis, to use descriptive analysis to the basic information of medical records, and to use the correlation analysis method to excavate the experience of symptom-drug compatibility. The adverse events were evaluated by Karch and Lasagna methods. Results: according to the exclusion criteria, 143 cases of Polygonum multiflorum were selected from Professor Tong Xiaolin outpatient between July 2008 and March 2015, with 271 diagnoses. Among them, there were 26 male patients (18.18%), 117 female patients (81.82%), 112 cases (78.61%), and 90 cases (62.93%) in 40 ~ 60 years old patients. The dosage and course of treatment of Radix Polygoni multiflorum were mainly composed of diabetes mellitus and metabolic disease. The daily dose of Radix Polygoni multiflorum was mainly 30g and 15g, and the ratio of 15g / day was 75.81g / 30g and 20.95g / day respectively. A small number of patients with mild illness took water pills at a daily dose of 0.3c9.6g, accounting for 3.24g. The total daily average dose was 16.55 卤6.86g. The longest course of treatment was 502 days, the shortest 14 days, the average course of treatment was 81.11 卤82.83 days, the maximum cumulative dose was 6720g, the minimum was 180g, the average cumulative dose was 1105.26 卤1015.17g / g) the main symptoms and tongue veins of Polygonum multiflorum were treated with insomnia, fatigue, constipation, numb pain in limbs, aching waist, sweating, etc. Alopecia is more common; tongue appearance is red, the base of tongue is stagnant, fat tongue is large, teeth mark, thin tremor of tongue, yellow fur, greasy fur; pulse is more common in string, sink, number and fine vein, Data mining based on correlation analysis: the subjects were selected frequently: insomnia, fatigue, constipation, heat sweating, waist ache, limb numbness, alopecia, etc. According to the analysis of the compatibility of the clinical application of Polygonum multiflorum, it was found that most of them were in accordance with the clinical practice, but there were some deviations. Results among 143 patients with adverse events, 17 had adverse events, including gastrointestinal reactions, gastrointestinal reactions in 8 cases, skin abnormalities in 4 cases and liver dysfunction in 2 cases. Lumbar acid urination frequency in 1 case, fire reaction in 2 cases. According to the Karch and Lasagna evaluation methods, only one case of adverse events was found to be strongly correlated with the use of Radix Polygoni multiflorum. Conclusion: this study found that Professor Tong Xiaolin mainly used Polygonum multiflorum for the treatment of deficiency of liver and kidney, deficiency of qi and blood. The common symptoms of Polygonum multiflorum are insomnia, fatigue, constipation, alopecia, pain in the waist and so on. The low incidence of adverse reactions may be related to the preparation of Radix Polygoni multiflorum and the frequent attention paid by mentors to the changes of patients' history and laboratory indexes, and the corresponding timely compatibility of liver protection drugs, but there are many factors affecting the occurrence of adverse events. The individual difference is big, the doctor needs to differentiate the syndrome accurately, uses the medicine carefully, the reasonable compatibility reduces the poison to prevent the adverse reaction the occurrence.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R249

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