微调二号方(WD-2)联合肝动脉灌注化疗栓塞术(TACE)治疗原发性肝癌的临床研究
本文选题:微调二号方 + 中医药治疗 ; 参考:《南京中医药大学》2017年硕士论文
【摘要】:目的:应用微调二号方联合肝动脉灌注化疗栓塞术治疗原发性肝癌,并与单纯肝动脉灌注化疗栓塞术治疗原发性肝癌随机对照,观察前法在实体瘤大小缩小、临床症状缓解、生活质量改善以及毒副反应减轻等方面是否具有优势。评价微调二号方治疗原发性肝癌的疗效及安全性,进一步推广其在原发性肝癌的应用。方法:选用随机对照的临床试验研究设计方法,将经纳排标准筛选的60例原发性肝癌患者随机分成对照组和治疗组,两组各30例,其中对照组在治疗上行单纯TACE,4周为1周期,2周期为1个疗程,治疗组则在TACE后连续口服微调二号方直至疗程结束,两组行TACE后均予常规补液及对症治疗。疗程结束后观察两组原发性肝癌患者瘤体大小、临床常见症状、KPS评分、生存质量评分、毒副反应、肿瘤指标、淋巴细胞亚群等变化情况。结果:在实体瘤大小缩小方面,疾病控制率上,治疗组和对照组分别为83.3%和73.3%,无统计学差异(P0.05);在临床常见症状改善方面,治疗组治疗后症状总积分明显比对照组更低,具有显著统计学差异(P0.01),较之于对照组,有效率亦更高,两组之间有统计学差异(P0.05);在肿瘤指标改善方面,治疗后两组均能明显降低AFP、和CEA,具有显著统计学差异(P0.01),但两组之间的差异无优劣性(P0.05);在免疫功能提高方面,较之对照组,治疗组治后CD3+、CD4+均更高,且两组之间有统计学差异(P0.05);在KPS评分改善方面,较之于对照组,治疗组治疗后明显更高,具有显著统计学差异(P0.01),同时治疗组在有效率方面亦更高,两组之间有统计学差异(P0.05);在生存质量改善方面,治疗组治疗后在情绪功能、总体健康等领域积分均高于对照组,两组之间有统计学差异(P0.05),而在疲倦、恶心呕吐、疼痛、失眠、腹泻、食欲等领域积分均低于对照组,其中食欲领域两组之间比较具有显著统计学差异(P0.01),其余领域均具有统计学差异(P0.05);在毒副反应减轻方面,治疗组治疗后在恶心呕吐、腹泻、发热等方面发生程度均轻于对照组,其中发热方面两者之间具有显著统计学差异(P0.01),恶心呕吐、腹泻方面亦有统计学差异(P0.05),同时治疗组发热发生率更低,两组之间有统计学差异(P0.05)。结论:WD-2联合TACE方案治疗原发性肝癌,虽然在实体瘤大小缩小方面较单纯TACE方案未能体现出优势,但其在临床症状改善、生活质量提高及TACE毒副反应减轻等方面拥有优势。
[Abstract]:Objective: to treat primary liver cancer with Wei Tiao No. 2 prescription combined with hepatic artery infusion chemoembolization, and compared with simple hepatic artery infusion chemoembolization to treat primary liver cancer at random, and to observe the reduction of solid tumor size and the relief of clinical symptoms. The improvement of quality of life and the reduction of side effects have the advantage or not. To evaluate the efficacy and safety of Weitiao No. 2 prescription in the treatment of primary liver cancer and to promote its application in primary liver cancer. Methods: 60 patients with primary liver cancer were randomly divided into control group (n = 30) and treatment group (n = 30). The patients in the control group were treated with TACEE for 4 weeks and 1 cycle and 2 cycles as a course of treatment, while the treatment group received routine rehydration and symptomatic treatment after the treatment of TACE. The treatment group took the second prescription of fine tuning until the end of the course of treatment. Both groups were given routine rehydration and symptomatic therapy after TACE. The changes of tumor size, KPS score, quality of life score, toxic side effect, tumor index and lymphocyte subgroup of patients with primary liver cancer were observed at the end of the course of treatment. Results: the disease control rate was 83.3% in the treatment group and 73.3% in the control group, with no statistical difference (P 0.05), and the total symptom score in the treatment group was significantly lower than that in the control group in the improvement of common clinical symptoms. There was significant statistical difference between the two groups (P 0.01), the effective rate was higher than that in the control group, and there was a statistical difference between the two groups (P 0.05). After treatment, AFP and CEA were significantly decreased in both groups (P 0.01), but there was no significant difference between the two groups (P 0.05), and the improvement of immune function in the treatment group was higher than that in the control group. The improvement of KPS score in the treatment group was significantly higher than that in the control group (P 0.01), and the effective rate in the treatment group was higher than that in the control group. In terms of quality of life improvement, the scores of emotional function and general health in the treatment group were higher than those in the control group, and there was a significant difference between the two groups (P 0.05), while the scores of fatigue, nausea, vomiting, pain, insomnia, and so on were significantly higher in the treatment group than in the control group. The scores of diarrhea, appetite and other fields were lower than those of the control group, among which there was significant difference between the two groups in the area of appetite (P 0.01), and in the other fields there was a statistical difference (P 0.05), and in the side effect relief, the treatment group had nausea, vomiting and diarrhea after treatment. The incidence of fever was lower in the treatment group than in the control group. There was a significant difference in fever between the two groups (P 0.01), nausea and vomiting, diarrhea, and the incidence of fever in the treatment group was lower than that in the control group, and there was a significant difference between the two groups (P 0.05). Conclusion although the treatment of primary liver cancer with TACE combined with WD-2 has no advantage over that of TACE alone, it has advantages in improving clinical symptoms, improving quality of life and alleviating side effects of TACE.
【学位授予单位】:南京中医药大学
【学位级别】:硕士
【学位授予年份】:2017
【分类号】:R735.7
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