疏肝健脾颗粒治疗乳腺癌癌因性疲乏的临床研究

发布时间：2018-05-07 06:00

本文选题：乳腺癌 + 癌因性疲乏　；参考：《北京中医药大学》2017年硕士论文

【摘要】：本论文主要包括文献综述和临床研究两部分.文献综述:本文回顾了癌因性疲乏的研究现况,对癌因性疲乏的定义、机制、影响因素、诊断方法及治疗手段等进行综述。癌因性疲乏是一种主观感受,主要表现为身心疲劳和认知能力降低等,癌因性疲乏在乳腺癌患者中尤为常见,不仅仅影响患者的生活质量,而且可以影响诊治和预后。目前,关于癌因性疲乏的发病机制尚不清楚,研究包括体内异常的细胞因子水平、五羟色胺神经递质传导异常、垂体轴功能异常、体内ATP代谢障碍等。影响癌因性疲乏的因素繁多,包括肿瘤治疗手段、焦虑抑郁状态、睡眠质量等,亦有研究报道患者体内某些细胞因子水平及C反应蛋白可以影响疲乏程度,可以作为预测和评估的客观手段之一,但论证强度不高,需要进一步验证。针对癌因性疲乏的诊断和评估主要借助量表,包括Piper疲乏量表、BFI量表等。癌因性疲乏的治疗包括精神兴奋剂、抗贫血、抗抑郁、激素等药物疗法及社会心理行为干预、运动疗法等非药物疗法,但这些治疗手段疗效一般,甚有副作用大于获益,尚缺乏高等级的循证医学证据。目前,关于中医药治疗乳腺癌癌因性疲乏的临床经验报道较多,且以疏肝健脾为主的治法取得较好的疗效,但其疗效和安全性还有待进一步的临床试验来验证。临床研究:目的:观察疏肝健脾颗粒剂治疗乳腺癌癌因性疲乏的疗效和安全性,探索细胞因子水平和C反应蛋白与癌因性疲乏的相关性,以及该颗粒剂对治疗后细胞因子水平和C反应蛋白的影响。方法:本研究采用多中心、单臂临床试验,选择患有癌因性疲乏且满足中医肝郁脾虚辨证标准的乳腺癌患者,服用疏肝健脾颗粒剂8周,随访12周。观察在治疗前、治疗第4周、第8周及第12周患者Piper疲乏量表、ECOG体能状况、肝郁脾虚中医症候量表、HAD综合医院焦虑抑郁量表、PSQI匹兹堡睡眠指数量表评分,在治疗前及治疗第8周评估患者血液中细胞因子、C反应蛋白、血尿便常规、肝肾功、心电图等相关指标的变化。结果:研究共纳入40例患者,38例患者完成全部随访,2例患者发生脱落,在治疗第4周、第8周、第12周患者的Piper评分、肝郁脾虚中医症候评分、焦虑量表评分均显著下降,差异具有统计学意义;ECOG体能评分及抑郁量表均在治疗第8周、第12周下降,差异具有统计学意义;PSQI评分在治疗第4、8周下降,差异不具有统计学意义。患者体内细胞因子及C反应蛋白与疲乏的相关性无统计学意义,且治疗后细胞因子及C反应蛋白无显著性改变。随访期间,无一例患者因为服药出现血尿便常规、肝肾功、心电图的特异性改变。结论:疏肝健脾颗粒剂可以改善乳腺癌患者的疲乏、焦虑抑郁状态、体能状况,具有较好的临床疗效和安全性,但本研究结果尚无法支持疏肝健脾颗粒剂能改善睡眠质量、降低治疗后体内细胞因子和C反应蛋白水平,也无法证实疲乏程度与细胞因子、C反应蛋白之间具有相关性。今后,还应该开展设计上更为严格的临床试验以进一步验证疏肝健脾颗粒剂的疗效和安全性。
[Abstract]:This paper mainly includes two parts of literature review and clinical study. Literature review: This article reviews the current status of cancer induced fatigue, reviews the definition, mechanism, influencing factors, diagnostic methods and treatment methods of cancer-related fatigue. Cancer induced fatigue is a subjective feeling, mainly manifested in physical and mental fatigue and cognitive impairment, etc. Cancer - induced fatigue is particularly common in patients with breast cancer, which not only affects the quality of life of the patients, but also affects the diagnosis and treatment and prognosis. At present, the pathogenesis of cancer induced fatigue is not clear. The study includes abnormal cytokine levels in the body, abnormal five serotonin nerve conduction, abnormal pituitary axis function, and ATP metabolic barrier in the body. There are various factors affecting cancer induced fatigue, including tumor treatment, anxiety and depression, sleep quality, and some research reports that the level of cytokines and C reactive protein can affect the degree of fatigue, which can be used as an objective means of prediction and evaluation, but the strength of the demonstration is not high and needs further verification. The diagnosis and evaluation of cancer induced fatigue mainly rely on the scale, including the Piper fatigue scale, the BFI scale, etc.. The treatment of cancer induced fatigue includes psychostimulants, antianaemia, antidepressant, hormone, and other non drug therapy, such as social psychological behavior intervention, exercise therapy, and exercise therapy, but these treatments have a general effect and have more side effects than the benefit, There is still a lack of evidence-based evidence-based medical evidence. At present, there are more clinical experiences on the treatment of cancer of breast cancer caused by traditional Chinese medicine, and the treatment with liver and spleen is a good therapeutic effect, but its efficacy and safety are still to be verified by further clinical trials. The effect and safety of cancer induced fatigue in adenocarcinoma, the correlation between the level of cytokine and C reactive protein and cancer induced fatigue, and the effect of the granule on the level of cytokines and the C reactive protein after treatment. Methods: This study adopts multi center and single arm clinical trial, and chooses to suffer from cancer induced fatigue and meets the syndrome differentiation of liver depression and spleen deficiency in traditional Chinese medicine. Standard breast cancer patients were followed up for 8 weeks and followed up for 12 weeks. The Piper fatigue scale, ECOG physical status, liver depression and spleen deficiency TCM syndrome, HAD General Hospital Anxiety and depression scale, PSQI Pittsburgh sleep index scale score, before treatment and eighth weeks of treatment were evaluated before treatment, fourth weeks, eighth and 12 weeks. Changes in cytokines, C reactive protein, hematuria, hematuria routine, liver and kidney work, electrocardiogram and other related indexes. Results: a total of 40 patients were included in the study. 38 patients completed all follow-up, 2 cases were dropped, the Piper score of the patients for fourth weeks, eighth weeks, Twelfth weeks, TCM syndrome score of liver depression and spleen deficiency, and the Anxiety Scale score were all obvious The difference was statistically significant, the ECOG physical score and the depression scale decreased in eighth weeks and twelfth weeks, and the difference was statistically significant. The difference was not statistically significant in the PSQI score in the treatment of week 4,8. There was no statistically significant correlation between the cytokines and C reactive protein in patients with fatigue, and the cell causes after treatment were not statistically significant. There was no significant change in the protein and C reaction protein. During the follow-up period, none of the patients had the hematuria routine, liver and kidney function and the specific change of electrocardiogram in the follow-up period. Conclusion: Shugan Jianpi Granule can improve the fatigue, anxiety and depressive state and physical condition of the breast cancer patients with better clinical efficacy and safety, but the results of this study have not yet been studied. The method supports Shugan Jianpi Granules to improve the quality of sleep, reduce the level of cytokines and C reactive protein in the after treatment, and can not confirm the correlation between the degree of fatigue and the cytokine, C reactive protein. Full nature.

【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】：R737.9

【参考文献】