莲龙消积方联合TACE治疗原发性肝癌近期疗效评价
发布时间：2018-09-08 18:07
【摘要】：目的:通过对中药莲龙消积方联合TACE治疗中晚期原发性肝癌患者近期疗效的临床研究,观察莲龙消积方对TACE术后患者近期瘤体疗效、临床症状及生存质量、免疫功能、安全性疗效等方面的影响,以探讨中药联合TACE治疗中晚期原发性肝癌的临床疗效,为中药治疗原发性肝癌提供临床依据。方法:本研究采用前瞻性、随机对照临床试验方法,将符合纳入标准的临床病例50例按随机分配的原则分为治疗组与对照组,治疗组采用莲龙消积方联合TACE方案,对照组则单纯采用TACE术治疗,以近期瘤体疗效、中医证候积分、生活质量(KPS评分)、外周血T淋巴细胞亚群、AFP、血常规、肝肾功能为观察指标,两组均在介入4周后观察比较上述指标,以评价中药莲龙消积方联合TACE方案治疗中晚期肝癌患者的近期疗效。结果:(1)近期瘤体疗效比较:治疗组有效率(RR)为12.00%,临床获益率(CBR)为96.00%,对照组有效率(RR)为8.00%,临床获益率(CBR)为84.00%,两组瘤体疗效比较,经统计学分析,差异无统计学意义(P0.05);(2)中医证候积分比较:①组内比较:两组治疗后中医症状评分均有所下降,两组治疗前后比较均具有统计学意义(P0.05);②组间比较:两组治疗前后积分差值经统计学分析,差异具有统计学意义(P0.01)。(3)中医证候疗效比较:治疗组病例显著改善4例(16.00%),部分改善16例(64.00%),无改善5例(20.00%),改善率达80.00%;对照组无显著改善病例,部分改善病例9例(36.00%),无改善16例(64.00%),改善率达36.00%,两组经统计学分析,治疗组的中医证候改善率要明显优于对照组,差异具有统计学意义(P0.01)。(4)生活质量评分(卡式评分)比较:①组内比较:治疗组治疗前后比较,治疗后KPS评分显著升高,差异具有统计学意义(P0.01),而对照组治疗前后比较,差异则无统计学意义(P0.05)。②组间比较:两组治疗前后KPS评分差值经统计学分析,差异具有统计学意义(P0.01)。(5)KPS疗效比较:治疗组病例改善14例(56.00%),稳定10例(40.00%),降低1例(4.00%);对照组病例改善3例(12.00%),稳定16例(64.00%),降低6例(24.00%),经统计学分析,治疗组在生活质量的改善率上明显优于对照组,差异具有统计学意义(P0.01)。(6)免疫功能指标比较:①组内比较:治疗组治疗前后CD3+、CD4+、CD8+、CD4+/CD8+均无显著变化(P0.05);对照组治疗前后CD4+、CD4+/CD8+无显著变化(P0.05),而CD3+、CD8+较治疗前升高,差异有统计学意义(P0.05);②组间比较:CD3+、CD4+、CD4+/CD8+两组治疗前后差值经统计学检验,比较差异无统计学意义(P0.05),而CD8+两组治疗前后差值比较,差异具有统计学意义(P0.05)。(7)AFP值变化情况比较:①组内比较:两组治疗前后AFP值均有所下降,经统计学分析,差异均具有统计学意义(P0.05)。②组间比较:两组AFP前后差值比较,经统计学分析,差异无统计学意义(P0.05)。(8)安全性评价:①血常规:治疗组治疗前后WBC、HGB、PLT均无明显变化,差异无统计学意义(P0.05);对照组治疗前后WBC、PLT有所下降,差异具有统计学意义(P0.05),而HGB治疗前后无明显变化,差异无统计学意义(P0.05)。②肝功能:治疗组治疗前后ALT有所降低,差异有统计学意义(P0.05),ALB、AST差异则无统计学意义(P0.05);对照组治疗前后ALB、ALT、AST均无统计学意义(P0.05)。③肾功能:两组治疗前后BUN、Cr均无明显变化,差异无统计学意义(P0.05)。结论:莲龙消积方联合TACE方案,可显著缓解临床症状、改善中医证候疗效,并明显提高患者的生活质量,且能够一定程度地减轻术后肝功损害,对介入术后细胞免疫具有一定的保护作用,并具有较好的安全性,突出了莲龙消积方辅助西医治疗原发性肝癌的优势,值得临床进一步推广。
[Abstract]:Objective:To observe the effect of Lianlong Xiaoji Prescription combined with TACE on tumor, clinical symptoms, quality of life, immune function and safety of patients with advanced primary liver cancer after TACE. Methods: A prospective, randomized controlled clinical trial was conducted to divide 50 clinical cases into treatment group and control group according to the principle of randomization. The treatment group was treated with Lianlong Xiaoji Fang combined with TACE, while the control group was treated with TACE alone. The short-term curative effect of tumor, integral of TCM syndrome, quality of life (KPS score), peripheral blood T lymphocyte subsets, AFP, blood routine, liver and kidney function were observed and compared between the two groups after 4 weeks of intervention to evaluate the short-term curative effect of Lianlong Xiaoji Prescription combined with TACE regimen in the treatment of advanced liver cancer. Comparing the curative effect of stage tumor: the effective rate (RR) of treatment group was 12.00%, the clinical benefit rate (CBR) was 96.00%, the effective rate (RR) of control group was 8.00%, the clinical benefit rate (CBR) was 84.00%. There was no significant difference between the two groups (P 0.05). (2) Comparing the scores of TCM syndromes between the two groups: (1) Comparing the scores of TCM symptoms after treatment; There were significant differences between the two groups before and after treatment (P 0.05). 2. Comparison between the two groups before and after treatment, the difference between the two groups was statistically significant (P 0.01). (3) Comparison of the curative effect of TCM syndromes: treatment group cases significantly improved in 4 cases (16.00%), partial improvement in 16 cases (64.00%), no improvement in 5 cases (20.00%), improvement rate The improvement rate was 36.00%. After statistical analysis, the improvement rate of TCM syndromes in the treatment group was significantly better than that in the control group (P 0.01). (4) Quality of life score (card score) comparison: 1) comparison within the treatment group: treatment group: treatment group Before and after treatment, KPS score significantly increased after treatment, the difference was statistically significant (P 0.01), and the control group before and after treatment, the difference was not statistically significant (P 0.05). 2 Comparison between the two groups: before and after treatment, KPS score difference between the two groups was statistically significant (P 0.01). (5) KPS curative effect comparison: treatment group improved 14 cases. (56.00%), stable in 10 cases (40.00%) and decreased in 1 case (4.00%); control group improved in 3 cases (12.00%), stable in 16 cases (64.00%) and decreased in 6 cases (24.00%). Statistical analysis showed that the improvement rate of quality of life in the treatment group was significantly better than that in the control group, the difference was statistically significant (P 0.01). (6) Comparison of immune function indicators between the treatment group and the control group before treatment: 1. There were no significant changes in CD3 +, CD4 +, CD8 +, CD4 + / CD8 + after treatment (P 0.05); no significant changes in CD4 +, CD4 + / CD8 + before and after treatment in the control group (P 0.05), while CD3 +, CD8 + were higher than before treatment, the difference was statistically significant (P 0.05); 2 Comparison between the two groups: CD3 +, CD4 +, CD4 + / CD8 + before and after treatment, the difference was not statistically significant (P 0.05). The difference between the two groups before and after treatment was statistically significant (P 0.05). (7) AFP value changes were compared: (1) intra-group comparison: AFP value of the two groups before and after treatment were decreased, statistically significant (P 0.05). 2) Comparison between groups: AFP difference between the two groups before and after comparison, statistically significant difference (P 0.0). (8) Safety evaluation: (1) Blood routine: There was no significant change in WBC, HGB, PLT before and after treatment in the treatment group, no significant difference (P 0.05); WBC, PLT in the control group before and after treatment decreased, the difference was statistically significant (P 0.05), but there was no significant change in HGB before and after treatment, no significant difference (P 0.05). 2 Liver function: ALT in the treatment group before and after treatment. There was no significant difference in ALB, ALT and AST between the two groups (P 0.05). There was no significant difference in ALB, ALT and AST before and after treatment in the control group (P 0.05). 3 Renal function: There was no significant difference in BUN and Cr between the two groups before and after treatment (P 0.05). It can improve the curative effect of TCM syndromes, improve the quality of life of patients, reduce the damage of liver function to a certain extent, protect the cellular immunity after interventional surgery, and has better safety. It highlights the advantages of Lianlong Xiaoji Formula in assisting western medicine in the treatment of primary liver cancer, and is worthy of further clinical promotion.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.7
本文编号：2231288
[Abstract]:Objective:To observe the effect of Lianlong Xiaoji Prescription combined with TACE on tumor, clinical symptoms, quality of life, immune function and safety of patients with advanced primary liver cancer after TACE. Methods: A prospective, randomized controlled clinical trial was conducted to divide 50 clinical cases into treatment group and control group according to the principle of randomization. The treatment group was treated with Lianlong Xiaoji Fang combined with TACE, while the control group was treated with TACE alone. The short-term curative effect of tumor, integral of TCM syndrome, quality of life (KPS score), peripheral blood T lymphocyte subsets, AFP, blood routine, liver and kidney function were observed and compared between the two groups after 4 weeks of intervention to evaluate the short-term curative effect of Lianlong Xiaoji Prescription combined with TACE regimen in the treatment of advanced liver cancer. Comparing the curative effect of stage tumor: the effective rate (RR) of treatment group was 12.00%, the clinical benefit rate (CBR) was 96.00%, the effective rate (RR) of control group was 8.00%, the clinical benefit rate (CBR) was 84.00%. There was no significant difference between the two groups (P 0.05). (2) Comparing the scores of TCM syndromes between the two groups: (1) Comparing the scores of TCM symptoms after treatment; There were significant differences between the two groups before and after treatment (P 0.05). 2. Comparison between the two groups before and after treatment, the difference between the two groups was statistically significant (P 0.01). (3) Comparison of the curative effect of TCM syndromes: treatment group cases significantly improved in 4 cases (16.00%), partial improvement in 16 cases (64.00%), no improvement in 5 cases (20.00%), improvement rate The improvement rate was 36.00%. After statistical analysis, the improvement rate of TCM syndromes in the treatment group was significantly better than that in the control group (P 0.01). (4) Quality of life score (card score) comparison: 1) comparison within the treatment group: treatment group: treatment group Before and after treatment, KPS score significantly increased after treatment, the difference was statistically significant (P 0.01), and the control group before and after treatment, the difference was not statistically significant (P 0.05). 2 Comparison between the two groups: before and after treatment, KPS score difference between the two groups was statistically significant (P 0.01). (5) KPS curative effect comparison: treatment group improved 14 cases. (56.00%), stable in 10 cases (40.00%) and decreased in 1 case (4.00%); control group improved in 3 cases (12.00%), stable in 16 cases (64.00%) and decreased in 6 cases (24.00%). Statistical analysis showed that the improvement rate of quality of life in the treatment group was significantly better than that in the control group, the difference was statistically significant (P 0.01). (6) Comparison of immune function indicators between the treatment group and the control group before treatment: 1. There were no significant changes in CD3 +, CD4 +, CD8 +, CD4 + / CD8 + after treatment (P 0.05); no significant changes in CD4 +, CD4 + / CD8 + before and after treatment in the control group (P 0.05), while CD3 +, CD8 + were higher than before treatment, the difference was statistically significant (P 0.05); 2 Comparison between the two groups: CD3 +, CD4 +, CD4 + / CD8 + before and after treatment, the difference was not statistically significant (P 0.05). The difference between the two groups before and after treatment was statistically significant (P 0.05). (7) AFP value changes were compared: (1) intra-group comparison: AFP value of the two groups before and after treatment were decreased, statistically significant (P 0.05). 2) Comparison between groups: AFP difference between the two groups before and after comparison, statistically significant difference (P 0.0). (8) Safety evaluation: (1) Blood routine: There was no significant change in WBC, HGB, PLT before and after treatment in the treatment group, no significant difference (P 0.05); WBC, PLT in the control group before and after treatment decreased, the difference was statistically significant (P 0.05), but there was no significant change in HGB before and after treatment, no significant difference (P 0.05). 2 Liver function: ALT in the treatment group before and after treatment. There was no significant difference in ALB, ALT and AST between the two groups (P 0.05). There was no significant difference in ALB, ALT and AST before and after treatment in the control group (P 0.05). 3 Renal function: There was no significant difference in BUN and Cr between the two groups before and after treatment (P 0.05). It can improve the curative effect of TCM syndromes, improve the quality of life of patients, reduce the damage of liver function to a certain extent, protect the cellular immunity after interventional surgery, and has better safety. It highlights the advantages of Lianlong Xiaoji Formula in assisting western medicine in the treatment of primary liver cancer, and is worthy of further clinical promotion.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.7
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