疏肝健脾顆粒治療乳腺癌癌因性疲乏的臨床研究
本文選題:乳腺癌 + 癌因性疲乏 ; 參考:《北京中醫(yī)藥大學》2017年碩士論文
【摘要】:本論文主要包括文獻綜述和臨床研究兩部分.文獻綜述:本文回顧了癌因性疲乏的研究現(xiàn)況,對癌因性疲乏的定義、機制、影響因素、診斷方法及治療手段等進行綜述。癌因性疲乏是一種主觀感受,主要表現(xiàn)為身心疲勞和認知能力降低等,癌因性疲乏在乳腺癌患者中尤為常見,不僅僅影響患者的生活質(zhì)量,而且可以影響診治和預后。目前,關于癌因性疲乏的發(fā)病機制尚不清楚,研究包括體內(nèi)異常的細胞因子水平、五羥色胺神經(jīng)遞質(zhì)傳導異常、垂體軸功能異常、體內(nèi)ATP代謝障礙等。影響癌因性疲乏的因素繁多,包括腫瘤治療手段、焦慮抑郁狀態(tài)、睡眠質(zhì)量等,亦有研究報道患者體內(nèi)某些細胞因子水平及C反應蛋白可以影響疲乏程度,可以作為預測和評估的客觀手段之一,但論證強度不高,需要進一步驗證。針對癌因性疲乏的診斷和評估主要借助量表,包括Piper疲乏量表、BFI量表等。癌因性疲乏的治療包括精神興奮劑、抗貧血、抗抑郁、激素等藥物療法及社會心理行為干預、運動療法等非藥物療法,但這些治療手段療效一般,甚有副作用大于獲益,尚缺乏高等級的循證醫(yī)學證據(jù)。目前,關于中醫(yī)藥治療乳腺癌癌因性疲乏的臨床經(jīng)驗報道較多,且以疏肝健脾為主的治法取得較好的療效,但其療效和安全性還有待進一步的臨床試驗來驗證。臨床研究:目的:觀察疏肝健脾顆粒劑治療乳腺癌癌因性疲乏的療效和安全性,探索細胞因子水平和C反應蛋白與癌因性疲乏的相關性,以及該顆粒劑對治療后細胞因子水平和C反應蛋白的影響。方法:本研究采用多中心、單臂臨床試驗,選擇患有癌因性疲乏且滿足中醫(yī)肝郁脾虛辨證標準的乳腺癌患者,服用疏肝健脾顆粒劑8周,隨訪12周。觀察在治療前、治療第4周、第8周及第12周患者Piper疲乏量表、ECOG體能狀況、肝郁脾虛中醫(yī)癥候量表、HAD綜合醫(yī)院焦慮抑郁量表、PSQI匹茲堡睡眠指數(shù)量表評分,在治療前及治療第8周評估患者血液中細胞因子、C反應蛋白、血尿便常規(guī)、肝腎功、心電圖等相關指標的變化。結果:研究共納入40例患者,38例患者完成全部隨訪,2例患者發(fā)生脫落,在治療第4周、第8周、第12周患者的Piper評分、肝郁脾虛中醫(yī)癥候評分、焦慮量表評分均顯著下降,差異具有統(tǒng)計學意義;ECOG體能評分及抑郁量表均在治療第8周、第12周下降,差異具有統(tǒng)計學意義;PSQI評分在治療第4、8周下降,差異不具有統(tǒng)計學意義。患者體內(nèi)細胞因子及C反應蛋白與疲乏的相關性無統(tǒng)計學意義,且治療后細胞因子及C反應蛋白無顯著性改變。隨訪期間,無一例患者因為服藥出現(xiàn)血尿便常規(guī)、肝腎功、心電圖的特異性改變。結論:疏肝健脾顆粒劑可以改善乳腺癌患者的疲乏、焦慮抑郁狀態(tài)、體能狀況,具有較好的臨床療效和安全性,但本研究結果尚無法支持疏肝健脾顆粒劑能改善睡眠質(zhì)量、降低治療后體內(nèi)細胞因子和C反應蛋白水平,也無法證實疲乏程度與細胞因子、C反應蛋白之間具有相關性。今后,還應該開展設計上更為嚴格的臨床試驗以進一步驗證疏肝健脾顆粒劑的療效和安全性。
[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.
【學位授予單位】:北京中醫(yī)藥大學
【學位級別】:碩士
【學位授予年份】:2017
【分類號】:R737.9
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