【摘要】：目的：通過對癌因性疲乏患者進行研究,觀察金水復元方治療肺腎陰虛型癌因性疲乏的臨床療效及安全性。方法：從本院腫瘤科選取66例符合納入標準的試驗對象,并將其按照1：1的比例隨機分為兩組(對照組和治療組)。采用前瞻性隨機對照法進行研究,對照組僅予基礎(chǔ)治療,治療組在基礎(chǔ)治療的基礎(chǔ)上加予金水復元方(熟地黃30g、當歸15g、茯苓10昏姜半夏9g、陳皮10g、甘草10g、焦神曲10g、焦麥芽10g、焦山楂10g)口服,觀察周期14天,以兩組治療前后的中醫(yī)證候積分、Piper疲乏量表評分、功能狀態(tài)評分(KPS評分)等為療效觀察指標,來判定患者治療后疲乏的緩解率及體力狀況的改善情況,以血常規(guī)、肝腎功能、心電圖為安全性觀測指標,評價金水復元方治療肺腎陰虛型癌因性疲乏的近期療效及其安全性。結(jié)果：研究共納入試驗對象66例,其中兩組各有30例完成臨床試驗。在治療開始前,分別對兩組患者的性別組成、年齡分布、癌種、體重、功能狀態(tài)評分(KPS評分)、中醫(yī)證候積分、Piper疲乏量表總得分及行為疲乏、情感疲乏、感知疲乏和認知疲乏等方面進行統(tǒng)計分析,P值均0.05,分組成立,可進行研究。以兩組治療前后中醫(yī)證候積分作為療效評價標準,治療組30例有效率為96.66%,對照組30例有效率23.33%,P0.01,差異有顯著統(tǒng)計學意義。比較兩組治療前后疲乏量表總分、行為疲乏評分、情感疲乏評分、感知疲乏評分及認知疲乏評分,差異均有統(tǒng)計學意義(P0.05),比較兩組疲乏量表總分、行為疲乏評分、情感疲乏評分、感知疲乏評分及認知疲乏評分治療前后差值(治療前-治療后),差異有統(tǒng)計學意義(P0.05)。治療組KPS評分治療前后組內(nèi)比較,差異無統(tǒng)計學意義(P0.05),對照組KPS評分治療前后組內(nèi)比較差異無統(tǒng)計學意義(P0.05),治療后兩組KPS評分組間比較差異無統(tǒng)計學意義(P0.05),說明金水復元方對本研究中患者治療前后KPS評分無明顯影響。治療組體重治療前后組內(nèi)比較差異有顯著統(tǒng)計學意義(P0.01),對照組體重治療前后組內(nèi)比較差異有統(tǒng)計學意義(P0.05),治療后兩組患者體重組間比較差異無統(tǒng)計學意義(P0.05),兩組患者體重治療前后差值(治療后-治療前)比較,差異具有統(tǒng)計學意義(P0.05)。兩組試驗對象安全性指標通過治療前后組間比較、組內(nèi)比較差異均無統(tǒng)計學意義(P0.05)。結(jié)論：金水復元方可有效改善肺腎陰虛型癌因性疲乏患者的疲乏癥狀,降低患者Piper疲乏量表評分,使患者生活質(zhì)量得到提高,該方安全有效,無明顯不良反應,值得臨床推廣。
[Abstract]:Objective: to observe the clinical efficacy and safety of Jinshui Fuyuan recipe in treating lung and kidney yin deficiency cancer related fatigue. Methods: 66 subjects were selected from oncology department of our hospital and randomly divided into two groups (control group and treatment group) according to the proportion of 1:1. A prospective randomized controlled study was conducted. The control group was treated only with basic treatment. The treatment group was treated with Jinshui Fuyuan recipe (30 g of Rehmannia glutinosa, 15 g of Angelica sinensis, 9 g of Poria cocos 10 faint ginger, 10 g of orange peel, 10 g of Glycyrrhiza uralensis, 10 g of Jiaoshenqu), and 10 g of Jiaoshenqu, respectively. 10g of pyromalt and 10g of Hawthorn were taken orally. The observation period was 14 days. The scores of TCM syndromes, Piper fatigue scale and functional state score (KPS) before and after treatment were taken as therapeutic indexes. To determine the relief rate of fatigue and the improvement of physical condition after treatment, taking blood routine, liver and kidney function and electrocardiogram as the safety observation index, to evaluate the short-term curative effect and safety of Jinshui Fuyuan prescription in the treatment of lung and kidney yin deficiency cancer due to fatigue. Results: 66 subjects were included in the study, including 30 cases in each group. Before treatment, the sex composition, age distribution, cancer type, weight, functional status score (KPS score), TCM syndrome score, total score of Piper fatigue scale, behavioral fatigue, emotional fatigue were measured. Perceptual fatigue and cognitive fatigue were statistically analyzed, P values were 0.05, which could be studied in groups. The effective rate of 30 cases in the treatment group was 96.66 and that in the control group was 23.33g / 0.01, the difference was statistically significant. The total score, behavioral fatigue score, emotional fatigue score, perceptual fatigue score and cognitive fatigue score of the two groups before and after treatment were significantly different (P0.05), the total score of fatigue scale and the score of behavioral fatigue were compared between the two groups. Emotional fatigue score, perceived fatigue score and cognitive fatigue score before and after treatment difference (pre-treatment-after treatment), the difference was statistically significant (P0.05). There was no significant difference in KPS score before and after treatment in the treatment group (P0.05), but there was no significant difference in the KPS score in the control group before and after treatment (P0.05). There was no significant difference in KPS score between the two groups after treatment (P0.05), indicating that Jinshui Fuyuan recipe had no significant effect on KPS score before and after treatment. There was significant difference between the treatment group and the control group before and after treatment (P0.01), while the comparison between the control group and the control group was statistically significant (P0.05). There was no significant difference between the two groups after treatment (P0.05), the difference between the two groups before and after treatment (after treatment-before treatment), the difference was statistically significant (P0.05). The safety indexes of the two groups were compared before and after treatment, there was no significant difference between the two groups (P0.05). Conclusion: Jinshui Fuyuan prescription can effectively improve the fatigue symptoms of patients with lung and kidney yin deficiency type cancer fatigue, reduce the score of Piper fatigue scale, and improve the quality of life of the patients. The prescription is safe and effective, without obvious adverse reactions, and is worth popularizing in clinical practice.
【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】：2016
【分類號】：R273

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