蓮龍消積方聯(lián)合TACE治療原發(fā)性肝癌近期療效評價
發(fā)布時間：2018-09-08 18:07
【摘要】：目的:通過對中藥蓮龍消積方聯(lián)合TACE治療中晚期原發(fā)性肝癌患者近期療效的臨床研究,觀察蓮龍消積方對TACE術(shù)后患者近期瘤體療效、臨床癥狀及生存質(zhì)量、免疫功能、安全性療效等方面的影響,以探討中藥聯(lián)合TACE治療中晚期原發(fā)性肝癌的臨床療效,為中藥治療原發(fā)性肝癌提供臨床依據(jù)。方法:本研究采用前瞻性、隨機對照臨床試驗方法,將符合納入標(biāo)準(zhǔn)的臨床病例50例按隨機分配的原則分為治療組與對照組,治療組采用蓮龍消積方聯(lián)合TACE方案,對照組則單純采用TACE術(shù)治療,以近期瘤體療效、中醫(yī)證候積分、生活質(zhì)量(KPS評分)、外周血T淋巴細(xì)胞亞群、AFP、血常規(guī)、肝腎功能為觀察指標(biāo),兩組均在介入4周后觀察比較上述指標(biāo),以評價中藥蓮龍消積方聯(lián)合TACE方案治療中晚期肝癌患者的近期療效。結(jié)果:(1)近期瘤體療效比較:治療組有效率(RR)為12.00%,臨床獲益率(CBR)為96.00%,對照組有效率(RR)為8.00%,臨床獲益率(CBR)為84.00%,兩組瘤體療效比較,經(jīng)統(tǒng)計學(xué)分析,差異無統(tǒng)計學(xué)意義(P0.05);(2)中醫(yī)證候積分比較:①組內(nèi)比較:兩組治療后中醫(yī)癥狀評分均有所下降,兩組治療前后比較均具有統(tǒng)計學(xué)意義(P0.05);②組間比較:兩組治療前后積分差值經(jīng)統(tǒng)計學(xué)分析,差異具有統(tǒng)計學(xué)意義(P0.01)。(3)中醫(yī)證候療效比較:治療組病例顯著改善4例(16.00%),部分改善16例(64.00%),無改善5例(20.00%),改善率達80.00%;對照組無顯著改善病例,部分改善病例9例(36.00%),無改善16例(64.00%),改善率達36.00%,兩組經(jīng)統(tǒng)計學(xué)分析,治療組的中醫(yī)證候改善率要明顯優(yōu)于對照組,差異具有統(tǒng)計學(xué)意義(P0.01)。(4)生活質(zhì)量評分(卡式評分)比較:①組內(nèi)比較:治療組治療前后比較,治療后KPS評分顯著升高,差異具有統(tǒng)計學(xué)意義(P0.01),而對照組治療前后比較,差異則無統(tǒng)計學(xué)意義(P0.05)。②組間比較:兩組治療前后KPS評分差值經(jīng)統(tǒng)計學(xué)分析,差異具有統(tǒng)計學(xué)意義(P0.01)。(5)KPS療效比較:治療組病例改善14例(56.00%),穩(wěn)定10例(40.00%),降低1例(4.00%);對照組病例改善3例(12.00%),穩(wěn)定16例(64.00%),降低6例(24.00%),經(jīng)統(tǒng)計學(xué)分析,治療組在生活質(zhì)量的改善率上明顯優(yōu)于對照組,差異具有統(tǒng)計學(xué)意義(P0.01)。(6)免疫功能指標(biāo)比較:①組內(nèi)比較:治療組治療前后CD3+、CD4+、CD8+、CD4+/CD8+均無顯著變化(P0.05);對照組治療前后CD4+、CD4+/CD8+無顯著變化(P0.05),而CD3+、CD8+較治療前升高,差異有統(tǒng)計學(xué)意義(P0.05);②組間比較:CD3+、CD4+、CD4+/CD8+兩組治療前后差值經(jīng)統(tǒng)計學(xué)檢驗,比較差異無統(tǒng)計學(xué)意義(P0.05),而CD8+兩組治療前后差值比較,差異具有統(tǒng)計學(xué)意義(P0.05)。(7)AFP值變化情況比較:①組內(nèi)比較:兩組治療前后AFP值均有所下降,經(jīng)統(tǒng)計學(xué)分析,差異均具有統(tǒng)計學(xué)意義(P0.05)。②組間比較:兩組AFP前后差值比較,經(jīng)統(tǒng)計學(xué)分析,差異無統(tǒng)計學(xué)意義(P0.05)。(8)安全性評價:①血常規(guī):治療組治療前后WBC、HGB、PLT均無明顯變化,差異無統(tǒng)計學(xué)意義(P0.05);對照組治療前后WBC、PLT有所下降,差異具有統(tǒng)計學(xué)意義(P0.05),而HGB治療前后無明顯變化,差異無統(tǒng)計學(xué)意義(P0.05)。②肝功能:治療組治療前后ALT有所降低,差異有統(tǒng)計學(xué)意義(P0.05),ALB、AST差異則無統(tǒng)計學(xué)意義(P0.05);對照組治療前后ALB、ALT、AST均無統(tǒng)計學(xué)意義(P0.05)。③腎功能:兩組治療前后BUN、Cr均無明顯變化,差異無統(tǒng)計學(xué)意義(P0.05)。結(jié)論:蓮龍消積方聯(lián)合TACE方案,可顯著緩解臨床癥狀、改善中醫(yī)證候療效,并明顯提高患者的生活質(zhì)量,且能夠一定程度地減輕術(shù)后肝功損害,對介入術(shù)后細(xì)胞免疫具有一定的保護作用,并具有較好的安全性,突出了蓮龍消積方輔助西醫(yī)治療原發(fā)性肝癌的優(yōu)勢,值得臨床進一步推廣。
[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.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R735.7
本文編號：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.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R735.7
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