金水复元方治疗肺肾阴虚型癌因性疲乏的临床研究

发布时间：2018-11-24 19:32

【摘要】：目的：通过对癌因性疲乏患者进行研究,观察金水复元方治疗肺肾阴虚型癌因性疲乏的临床疗效及安全性。方法：从本院肿瘤科选取66例符合纳入标准的试验对象,并将其按照1：1的比例随机分为两组(对照组和治疗组)。采用前瞻性随机对照法进行研究,对照组仅予基础治疗,治疗组在基础治疗的基础上加予金水复元方(熟地黄30g、当归15g、茯苓10昏姜半夏9g、陈皮10g、甘草10g、焦神曲10g、焦麦芽10g、焦山楂10g)口服,观察周期14天,以两组治疗前后的中医证候积分、Piper疲乏量表评分、功能状态评分(KPS评分)等为疗效观察指标,来判定患者治疗后疲乏的缓解率及体力状况的改善情况,以血常规、肝肾功能、心电图为安全性观测指标,评价金水复元方治疗肺肾阴虚型癌因性疲乏的近期疗效及其安全性。结果：研究共纳入试验对象66例,其中两组各有30例完成临床试验。在治疗开始前,分别对两组患者的性别组成、年龄分布、癌种、体重、功能状态评分(KPS评分)、中医证候积分、Piper疲乏量表总得分及行为疲乏、情感疲乏、感知疲乏和认知疲乏等方面进行统计分析,P值均0.05,分组成立,可进行研究。以两组治疗前后中医证候积分作为疗效评价标准,治疗组30例有效率为96.66%,对照组30例有效率23.33%,P0.01,差异有显著统计学意义。比较两组治疗前后疲乏量表总分、行为疲乏评分、情感疲乏评分、感知疲乏评分及认知疲乏评分,差异均有统计学意义(P0.05),比较两组疲乏量表总分、行为疲乏评分、情感疲乏评分、感知疲乏评分及认知疲乏评分治疗前后差值(治疗前-治疗后),差异有统计学意义(P0.05)。治疗组KPS评分治疗前后组内比较,差异无统计学意义(P0.05),对照组KPS评分治疗前后组内比较差异无统计学意义(P0.05),治疗后两组KPS评分组间比较差异无统计学意义(P0.05),说明金水复元方对本研究中患者治疗前后KPS评分无明显影响。治疗组体重治疗前后组内比较差异有显著统计学意义(P0.01),对照组体重治疗前后组内比较差异有统计学意义(P0.05),治疗后两组患者体重组间比较差异无统计学意义(P0.05),两组患者体重治疗前后差值(治疗后-治疗前)比较,差异具有统计学意义(P0.05)。两组试验对象安全性指标通过治疗前后组间比较、组内比较差异均无统计学意义(P0.05)。结论：金水复元方可有效改善肺肾阴虚型癌因性疲乏患者的疲乏症状,降低患者Piper疲乏量表评分,使患者生活质量得到提高,该方安全有效,无明显不良反应,值得临床推广。
[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.
【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】：2016
【分类号】：R273

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