芪桂通络方防治奥沙利铂神经毒性的临床研究

发布时间：2018-05-15 22:21

本文选题：奥沙利铂 + 神经毒性　；参考：《山东中医药大学》2017年硕士论文

【摘要】：目的:通过临床应用芪桂通络方内服外洗,观察其在治疗奥沙利铂所致神经毒性方面的疗效,如患者神经毒性分级和中医临床症状的改善,对生活质量的改善以及不良反应的发生,从而为中医药治疗奥沙利铂化疗所致神经毒性的疗效提供一定的理论及临床支持,并为进一步研究提供参考。方法:将符合纳入标准的70例胃癌、结直肠癌患者随机分为观察组和对照组,每组病例35例。所有患者均采用含有奥沙利铂的方案化疗。观察组在第3周期化疗始予芪桂通络方内服加外洗,在第3、4周期化疗期间连续服用2个周期。对照组口服甲钴胺片0.5mg,每日3次,疗程同观察组。结束后记录患者发生神经毒性的发生情况(发生率和严重程度),记录化疗结束后患者的中医证候评分及生活质量评分,并观察评估芪桂通络方的安全性。结果:共纳入70例病例,对照组2例因更换、终止化疗方案而脱落,观察组1例因呕吐停止服用中药停止观察。对照组33例,观察组34例。(1)观察3周期、4周期后奥沙利铂神经毒性增加,观察组神经毒性发生率与对照组比较,有统计差异(P0.05)。(2)第4周期化疗后,两组患者神经毒性分级情况:对照组0级为9例,1级10例,2级7例,3级为4例,4级2例;观察组34例患者,0级是22例,1级神8例,2级3例,3级1例,4级0例。经统计学分析,观察组神经毒性严重程度较对照组低,其差异具有统计学意义(P0.05)。(3)在中医临床症状变化方面,观察组显效的13例,有效11例,无效10例;对照组显效3例,有效7例,无效23例,经统计学分析,二者差异有统计学意义(P0.05),且观察组有效率高于对照组。(4)观察组与对照组的骨髓抑制发生情况无统计学意义(P0.05),骨髓抑制的发生或与化疗有关。入组患者未发生治疗相关不良事件。结论:芪桂通络方内外合用可明显降低奥沙利铂神经毒性的发生率,减轻神经毒性的发生程度,缓解患者的中医临床症状。并且芪桂通络方外洗内服疗效确切,安全可靠,有良好应用前景。
[Abstract]:Objective: to observe the efficacy of Qigui Tongluo recipe in the treatment of neurotoxicity induced by oxaliplatin, such as the classification of neurotoxicity and the improvement of clinical symptoms of traditional Chinese medicine. It provides some theoretical and clinical support for the treatment of neurotoxicity induced by oxaliplatin chemotherapy with traditional Chinese medicine, and provides a reference for further study on the improvement of quality of life and the occurrence of adverse reactions. Methods: 70 patients with gastric cancer and colorectal cancer were randomly divided into observation group and control group, 35 cases in each group. All patients received chemotherapy regimen containing oxaliplatin. In the observation group, Qigui Tongluo recipe was given orally and washed in the third cycle of chemotherapy, and was taken continuously for 2 cycles during the 3rd cycle of chemotherapy. The control group was given megalobalamin tablets 0.5 mg, 3 times a day, the course of treatment was the same as that in the observation group. The incidence and severity of neurotoxicity were recorded after the end of chemotherapy. The TCM syndromes score and quality of life score were recorded and the safety of Qigui Tongluo recipe was evaluated. Results: 70 cases were included in the study group, 2 cases in the control group were dropped off because of replacement and termination of chemotherapy regimen, and 1 case in the observation group stopped taking Chinese medicine because of vomiting. There were 33 cases in control group and 34 cases in observation group. The neurotoxicity of oxaliplatin was increased after 3 cycles and 4 cycles. Compared with the control group, the incidence of neurotoxicity in the observation group was statistically different from that in the control group. The neurotoxicity grading of the two groups was as follows: in the control group, 9 cases were grade 1, 10 cases were grade 1, 7 cases were grade 2, 7 cases were grade 3, 4 cases were grade 4, 2 cases were grade 0, 34 cases were grade 0 were 22 cases, grade 1, grade 2, grade 3, grade 4, 0 cases. According to statistical analysis, the severity of neurotoxicity in the observation group was lower than that in the control group, and the difference was statistically significant in the changes of clinical symptoms of traditional Chinese medicine. In the observation group, there were 13 cases with remarkable effect, 11 cases with effective effect, 10 cases with no effect, and 3 cases with remarkable effect in control group. 7 cases were effective and 23 cases were ineffective. The effective rate of the observation group was higher than that of the control group. There was no significant difference in the incidence of bone marrow suppression between the observation group and the control group. The occurrence of bone marrow suppression was related to chemotherapy. There were no adverse events associated with treatment. Conclusion: the combination of QGuitongluo recipe can obviously reduce the incidence of neurotoxicity of oxaliplatin, alleviate the degree of neurotoxicity and alleviate the clinical symptoms of TCM. And Qigui Tongluo prescription external washing is effective, safe and reliable, and has a good application prospects.
【学位授予单位】：山东中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R730.53

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