本文關鍵詞：中藥熏洗治療含奧沙利鉑方案致周圍神經病變療效觀察　出處：《新疆醫(yī)科大學》2017年碩士論文　論文類型：學位論文

  更多相關文章： 周圍神經病變 奧沙利鉑 中藥熏洗 雪蓮通絡湯

【摘要】：目的:本試驗旨在觀察以新疆道地藥材雪蓮為君藥中藥熏洗治療奧沙利鉑所致神經病變的療效。包括對患者周圍神經病變Levi分級變化、NTX-12分值變化、肌電圖速度變化、生活質量影響及安全性觀察。方法:根據診斷標準及樣本量計算公式,擬定理論樣本含量72例,實際納入合格病例60例。根據臨床藥物試驗設計方案,將其隨機分配為治療組(彌可保+雪蓮通絡湯)30例、對照組(彌可保)30例,均于化療(含奧沙利鉑方案)兩周期后開始給藥,持續(xù)觀察1療程治療。觀察使用中藥熏洗后患者Levi評分的改變、NTX-12分值變化、中藥熏洗前后行肌電圖檢查觀察肌電圖檢測雙側正中神經(中指到腕)、腓神經(足到至踝)的感覺神經傳導速度(SCV)及運動神經傳導速度(MCV),KPS評分之變化,并記錄治療過程中出現(xiàn)的不良反應。結果:(1)一般資料分析:治療前對兩組年齡、性別行卡方檢驗和t檢驗,KPS評分行秩和檢驗,得出P值均大于0.05,差異無顯著性,兩組組間具有可比性;(2)對臨床療效評價行卡方檢驗或Fisher精確檢驗:兩組患者治療后,(1)奧沙利鉑Levi分級評價方面,治療組有效人數為26例,無效為4例,總有效率為86.67%;對照組有效人數為15例,無效為15例,總有效率50.00%,經Fisher精確檢驗后,兩組比較具有統(tǒng)計學意義(P=0.0048)。(2)NTX-12評分:經t檢驗,P0.05,兩組具有統(tǒng)計學意義。(3)肌電圖評價方面:兩組MCV正中神經、MCV腓神經、SCV正中神經、SCV腓神經療效評價,P均大于0.05,提示差別無統(tǒng)計學意義。(4)KPS:行秩和檢驗后,P0.05,得知療效不顯著;(5)通過對與藥物相關的不良事件、患者依從及藥物安全性之評價,得知試驗藥物在本試驗中安全可靠,毒副作用不顯著。結論:在此臨床試驗中,雪蓮通絡湯熏洗對奧沙利鉑化療所引起的周圍神經病變的神經傳導速度、體力狀況的提高與對照組相比其療效不顯著,不具統(tǒng)計學意義,通過兩組治療前后奧沙利鉑Levi分級評定、NTX-12自評量表評分有統(tǒng)計學意義,表明本實驗在OXPIN臨床癥狀的改善上有一定的作用。雪蓮通絡湯在試驗研究期間,無明顯不良反應,安全性良好,值得推廣。
[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.
【學位授予單位】：新疆醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R730.5

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