加味小补肝汤治疗阳气不足型癌因性疲乏的临床研究

发布时间：2018-08-21 20:08

【摘要】：目的：随着医学技术的不断进展,对恶性肿瘤的治疗方式不断更新进步,恶性肿瘤患者的生存期得到了明显延长,而恶性肿瘤相关症状,例如癌性疼痛、恶心呕吐、食欲减弱、营养不良、贫血及抑郁焦虑等也多有对症治疗之法。但是癌性疲乏却未得到足够的重视,因此至今尚无十分有效的治疗手段。然而癌因性疲乏症状时刻影响病人的日常生活,它会影响到患者的情绪、饮食等方面,导致病情加重,致使肿瘤的相关治疗无法继续进行。本课题基于“肝者,罢极之本”的中医理论,通过以小补肝汤为基本方加减治疗恶性肿瘤患者的癌因性疲乏,从而缓解患者的临床症状,提高患者的生活质量。方法：我们将在苏州市中医院(三级甲等医院)收集相关病例,要求具有明确细胞学和／或病理学依据,同时符合癌因性疲乏诊断标准的患者。我们将符合纳入标准的病例按照随机方法分为治疗组和对照组。分别对两组患者进行不同的治疗,治疗组患者治以加味小补肝汤,对照组患者以单纯中医辨证治疗用药,两组均治疗2个疗程,预计共收60个病例。两组都以治疗4周为一个疗程,治疗两个疗程,分别评价观察两组治疗0周、4周及8周时,患者的临床症状体征的评价分值以及实验室指标的变化趋势。记录评估患者的基本信息、治疗情况、临床评估量表和实验室检查指标。客观地评价加味小补肝汤对癌因性疲乏的临床治疗效果。结果：研究结束时,有53人完成三次piper量表评分、临床中医症候评分及KPS评分,其中治疗组27人,对照组26人。在这53名患者中有41名患者完成三次后免疫指标,白介素6及C反应蛋白指标的检测,其中治疗组21人,对照组20人。结果发现：①统计分析两组患者的Piper量表评分情况,两组患者治疗前癌性疲乏得分无明显差异。治疗4周时,两组患者疲乏得分依旧没有显示出变化趋势。治疗8周时,治疗组患者癌性疲乏总分、情感疲乏、躯体疲乏、行为疲乏得分显著下降,仅认知疲乏得分无明显下降趋势。对照组治疗8周后,患者仅行为疲乏得分下降,其他得分并无明显变化趋势。②卡氏评分情况：经4周的治疗后,对照组患者KPS得分未显示明显变化趋势,治疗组患者KPS得分虽然呈现上升趋势,但经分析结果不具有统计学意义。治疗8周后,对照组患者KPS得分有所下降,而对照组患者KPS得分明显升高。③中医症候积分情况：两组患者治疗两个疗程后中医症候均有所改善,但是加味小补肝汤治疗组疗效更为显著。④白介素6浓度情况：加味小补肝汤治疗4周时,患者血清IL-6水平已经呈现下降趋势,待到第8周时,IL-6水平明显下降。单纯中医辨证治疗4周时,患者血清IL-6水平无明显变化趋势,治疗到第8周时,患者血清IL-6水平呈现下降趋势。且第8周时,治疗组患者血清IL-6水平普遍低于对照组。⑤C反应蛋白浓度情况：两组患者治疗4周时,CRP未显现出明显变化趋势。第8周时,治疗组患者CRP明显降低,而对照组患者CRP明显升高。⑥免疫指标情况：治疗第4周时,治疗组患者的CD8+细胞开始呈现下降趋势,对照组患者5项免疫指标均无明显变化趋势；治疗第8周时,治疗组患者的CD8+细继续下降,而CD4+、NK细胞呈现上升趋势的。对照组患者的CD4+、CD8+细胞均下降。结论：①阳气不足是癌因性疲乏的重要病机特征；②加味小补肝汤能有效缓解肿瘤患者的癌因性疲乏症状,改善中医临床症候和提高生活质量,已达到统计学意义；单纯中医辨证治疗也能改善癌因性疲发症状,但效果不及加味小补肝汤。③加味小补肝汤治疗癌因性疲乏,治疗时间需达到8周以上,才能取得临床疗效。④中医治疗癌因性疲乏,可联合运用小补肝汤,已达到更好的疗效。
[Abstract]:OBJECTIVE: With the development of medical technology, the treatment of malignant tumors has been constantly updated and progressed. The survival time of patients with malignant tumors has been significantly prolonged. The symptoms related to malignant tumors, such as cancer pain, nausea and vomiting, loss of appetite, malnutrition, anemia, depression and anxiety, are also often treated symptomatically. However, the symptoms of cancer-related fatigue always affect the daily life of patients, it will affect the mood of patients, diet and other aspects, leading to aggravation of the disease, resulting in the relevant treatment of cancer can not continue. Methods: We will collect the related cases in Suzhou Hospital of Traditional Chinese Medicine (Grade Three A Hospital), which require clear cytological and / or pathological basis, and accord with the cause of cancer at the same time. We divided the patients who met the inclusion criteria into treatment group and control group according to the randomized method. The patients in the treatment group were treated with modified Xiao Bu Gan Tang and the patients in the control group were treated with TCM syndrome differentiation alone. Both groups were treated for 2 courses, with a total of 60 cases expected to be admitted. The clinical symptoms and signs of the two groups were evaluated and observed at 0, 4 and 8 weeks of treatment. The basic information, treatment, clinical evaluation scale and laboratory examination indexes were recorded and evaluated. Results: At the end of the study, 53 patients completed three Piper scales, clinical symptoms and KPS scores, including 27 in the treatment group and 26 in the control group. There were 21 patients in the treatment group and 20 in the control group. Behavioral fatigue score decreased significantly, but cognitive fatigue score did not decrease significantly. In the control group, only behavioral fatigue score decreased after 8 weeks of treatment, and other scores did not change significantly. 2. Karl's score: After 4 weeks of treatment, KPS score in the control group did not show a significant trend of change, although KPS score in the treatment group showed a trend of change. After 8 weeks of treatment, the KPS score of the control group decreased, while the KPS score of the control group increased significantly. Concentration of IL-6: After 4 weeks of treatment with Jiawei Xiaobugan Decoction, the serum IL-6 level of the patients showed a downward trend. After 8 weeks of treatment, the serum IL-6 level of the patients showed a downward trend. The level of serum IL-6 in the treatment group was generally lower than that in the control group. _C-reactive protein concentration: CRP did not show a significant change trend in the two groups after 4 weeks of treatment. At the 8th week, CRP in the treatment group decreased significantly, while CRP in the control group increased significantly. _Immune indicators: At the 4th week of treatment, CD8 + cells in the treatment group began to show a downward trend. In the control group, the CD4 + and CD8 + cells were decreased. Conclusion: The deficiency of Yang Qi is an important pathogenesis of cancer-related fatigue; 2) Jiawei Xiaobugan Decoction can be used to treat cancer-related fatigue. Effectively alleviate cancer-related fatigue symptoms of cancer patients, improve the clinical symptoms of traditional Chinese medicine and improve the quality of life, has reached statistical significance; simple treatment of TCM syndrome differentiation can also improve cancer-related fatigue symptoms, but the effect is not as good as Jiawei Xiaobugan Tang. 3 Jiawei Xiaobugan Tang treatment of cancer-related fatigue, treatment time needs to reach more than 8 weeks to achieve Clinical curative effect. 4. Chinese medicine treatment of cancer-related fatigue can be combined with Xiao Bu Gan Tang, has achieved better results.
【学位授予单位】：南京中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R273

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