中药熏洗治疗含奥沙利铂方案致周围神经病变疗效观察

发布时间：2018-01-18 06:15

本文关键词：中药熏洗治疗含奥沙利铂方案致周围神经病变疗效观察　出处：《新疆医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:本试验旨在观察以新疆道地药材雪莲为君药中药熏洗治疗奥沙利铂所致神经病变的疗效。包括对患者周围神经病变Levi分级变化、NTX-12分值变化、肌电图速度变化、生活质量影响及安全性观察。方法:根据诊断标准及样本量计算公式,拟定理论样本含量72例,实际纳入合格病例60例。根据临床药物试验设计方案,将其随机分配为治疗组(弥可保+雪莲通络汤)30例、对照组(弥可保)30例,均于化疗(含奥沙利铂方案)两周期后开始给药,持续观察1疗程治疗。观察使用中药熏洗后患者Levi评分的改变、NTX-12分值变化、中药熏洗前后行肌电图检查观察肌电图检测双侧正中神经(中指到腕)、腓神经(足到至踝)的感觉神经传导速度(SCV)及运动神经传导速度(MCV),KPS评分之变化,并记录治疗过程中出现的不良反应。结果:(1)一般资料分析:治疗前对两组年龄、性别行卡方检验和t检验,KPS评分行秩和检验,得出P值均大于0.05,差异无显著性,两组组间具有可比性;(2)对临床疗效评价行卡方检验或Fisher精确检验:两组患者治疗后,(1)奥沙利铂Levi分级评价方面,治疗组有效人数为26例,无效为4例,总有效率为86.67%;对照组有效人数为15例,无效为15例,总有效率50.00%,经Fisher精确检验后,两组比较具有统计学意义(P=0.0048)。(2)NTX-12评分:经t检验,P0.05,两组具有统计学意义。(3)肌电图评价方面:两组MCV正中神经、MCV腓神经、SCV正中神经、SCV腓神经疗效评价,P均大于0.05,提示差别无统计学意义。(4)KPS:行秩和检验后,P0.05,得知疗效不显著;(5)通过对与药物相关的不良事件、患者依从及药物安全性之评价,得知试验药物在本试验中安全可靠,毒副作用不显著。结论:在此临床试验中,雪莲通络汤熏洗对奥沙利铂化疗所引起的周围神经病变的神经传导速度、体力状况的提高与对照组相比其疗效不显著,不具统计学意义,通过两组治疗前后奥沙利铂Levi分级评定、NTX-12自评量表评分有统计学意义,表明本实验在OXPIN临床症状的改善上有一定的作用。雪莲通络汤在试验研究期间,无明显不良反应,安全性良好,值得推广。
[Abstract]:Objective: to observe the efficacy of fumigation and washing of Xuelian, a traditional Chinese medicine from Xinjiang, in the treatment of neuropathy induced by oxaliplatin, including the changes of Levi grading of peripheral neuropathy. NTX-12 score, EMG speed, quality of life and safety were observed. Methods: according to the diagnostic criteria and the formula of sample size, 72 cases of theoretical samples were determined. According to the design of clinical drug trial, the patients were randomly divided into treatment group (30 cases) and control group (30 cases). After two cycles of chemotherapy (including oxaliplatin regimen), the patients were treated continuously for one course of treatment. The changes of Levi scores and NTX-12 scores were observed after fumigation and washing of traditional Chinese medicine. Observation of electromyography before and after fumigation of traditional Chinese medicine. Electromyography was used to detect the sensory nerve conduction velocity (SCV) and motor nerve conduction velocity (MCV) of bilateral median nerve (middle finger to carpal nerve, peroneal nerve (foot to ankle)). The changes of KPS score and adverse reactions during treatment were recorded. Results: general data analysis: before treatment, chi-square test and t test were performed for age, sex and rank sum test. P values were all greater than 0.05, there was no significant difference between the two groups, and there was comparability between the two groups. 2) to evaluate the clinical curative effect by chi-square test or Fisher accurate test: after treatment, the patients in the two groups were evaluated with oxaliplatin Levi grade. The effective number of patients in the treatment group was 26 cases. The total effective rate was 86.67; In the control group, 15 cases were effective and 15 cases were ineffective. The total effective rate was 50.005. 00. after accurate test by Fisher. The difference between the two groups was statistically significant (P < 0.05). The evaluation of electromyography in the two groups was statistically significant (P > 0. 05): the median nerve of MCV and the median nerve of the peroneal nerve of the two groups were all more than 0. 05 in the evaluation of the curative effect of the median nerve of the peroneal nerve and the peroneal nerve. The results showed that the difference was not statistically significant. KPS: after rank sum test, it was found that the curative effect was not significant. 5) through the evaluation of adverse events related to drugs, patients' compliance and drug safety, we know that the test drugs are safe and reliable in this trial, and the side effects are not significant. Conclusion: in this clinical trial. Xuelian Tongluo decoction fumigation washing on oxaliplatin chemotherapy induced peripheral neuropathy nerve conduction velocity, physical status improvement compared with the control group is not significant, there is no statistical significance. The scores of NTX-12 self-rating scale before and after treatment with oxaliplatin Levi were statistically significant. The results indicated that this experiment had certain effect on the improvement of clinical symptoms of OXPIN. Xuelian Tongluo decoction had no obvious adverse reactions during the experimental study and was safe and worth popularizing.
【学位授予单位】：新疆医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R730.5

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