芪桂通絡(luò)方防治奧沙利鉑神經(jīng)毒性的臨床研究
本文選題:奧沙利鉑 + 神經(jīng)毒性。 參考:《山東中醫(yī)藥大學(xué)》2017年碩士論文
【摘要】:目的:通過臨床應(yīng)用芪桂通絡(luò)方內(nèi)服外洗,觀察其在治療奧沙利鉑所致神經(jīng)毒性方面的療效,如患者神經(jīng)毒性分級(jí)和中醫(yī)臨床癥狀的改善,對(duì)生活質(zhì)量的改善以及不良反應(yīng)的發(fā)生,從而為中醫(yī)藥治療奧沙利鉑化療所致神經(jīng)毒性的療效提供一定的理論及臨床支持,并為進(jìn)一步研究提供參考。方法:將符合納入標(biāo)準(zhǔn)的70例胃癌、結(jié)直腸癌患者隨機(jī)分為觀察組和對(duì)照組,每組病例35例。所有患者均采用含有奧沙利鉑的方案化療。觀察組在第3周期化療始予芪桂通絡(luò)方內(nèi)服加外洗,在第3、4周期化療期間連續(xù)服用2個(gè)周期。對(duì)照組口服甲鈷胺片0.5mg,每日3次,療程同觀察組。結(jié)束后記錄患者發(fā)生神經(jīng)毒性的發(fā)生情況(發(fā)生率和嚴(yán)重程度),記錄化療結(jié)束后患者的中醫(yī)證候評(píng)分及生活質(zhì)量評(píng)分,并觀察評(píng)估芪桂通絡(luò)方的安全性。結(jié)果:共納入70例病例,對(duì)照組2例因更換、終止化療方案而脫落,觀察組1例因嘔吐停止服用中藥停止觀察。對(duì)照組33例,觀察組34例。(1)觀察3周期、4周期后奧沙利鉑神經(jīng)毒性增加,觀察組神經(jīng)毒性發(fā)生率與對(duì)照組比較,有統(tǒng)計(jì)差異(P0.05)。(2)第4周期化療后,兩組患者神經(jīng)毒性分級(jí)情況:對(duì)照組0級(jí)為9例,1級(jí)10例,2級(jí)7例,3級(jí)為4例,4級(jí)2例;觀察組34例患者,0級(jí)是22例,1級(jí)神8例,2級(jí)3例,3級(jí)1例,4級(jí)0例。經(jīng)統(tǒng)計(jì)學(xué)分析,觀察組神經(jīng)毒性嚴(yán)重程度較對(duì)照組低,其差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。(3)在中醫(yī)臨床癥狀變化方面,觀察組顯效的13例,有效11例,無(wú)效10例;對(duì)照組顯效3例,有效7例,無(wú)效23例,經(jīng)統(tǒng)計(jì)學(xué)分析,二者差異有統(tǒng)計(jì)學(xué)意義(P0.05),且觀察組有效率高于對(duì)照組。(4)觀察組與對(duì)照組的骨髓抑制發(fā)生情況無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),骨髓抑制的發(fā)生或與化療有關(guān)。入組患者未發(fā)生治療相關(guān)不良事件。結(jié)論:芪桂通絡(luò)方內(nèi)外合用可明顯降低奧沙利鉑神經(jīng)毒性的發(fā)生率,減輕神經(jīng)毒性的發(fā)生程度,緩解患者的中醫(yī)臨床癥狀。并且芪桂通絡(luò)方外洗內(nèi)服療效確切,安全可靠,有良好應(yīng)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.
【學(xué)位授予單位】:山東中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2017
【分類號(hào)】:R730.53
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