TACE聯(lián)合阿帕替尼與單純TACE治療中晚期肝癌的療效對比：單中心隨機(jī)對照臨床研究
發(fā)布時(shí)間：2018-08-22 14:59
【摘要】：[目的]比較經(jīng)皮肝動(dòng)脈灌注化療栓塞術(shù)(transcatheter arterial chemoembolization,TACE)聯(lián)合阿帕替尼(apatinib)與單純TACE治療中晚期肝細(xì)胞肝癌(hepatocellular carcinoma,HCC)患者的臨床療效和安全性差異。[方法]1、選取海軍總醫(yī)院2015年3月至2015年8月收治的44例中晚期肝細(xì)胞肝癌患者(男性33例,女性11例;年齡34-79歲,中位年齡58.5歲),隨機(jī)分為A、B兩組。A組行單純TACE治療,B組行TACE聯(lián)合阿帕替尼治療。2、共隨訪12-18個(gè)月。比較治療后3個(gè)月時(shí)兩組甲胎蛋白(alpha fetoprotein,AFP)指標(biāo)變化情況,及3、6、9、12個(gè)月時(shí)客觀緩解率(objective response rate,ORR)。同時(shí)比較兩組患者疾病無進(jìn)展生存期(progression-free survival,PFS)和不良反應(yīng)的發(fā)生情況。3、統(tǒng)計(jì)學(xué)處理:計(jì)量資料以x±s表示,兩組內(nèi)比較使用配對t檢驗(yàn),組間比較采用獨(dú)立樣本t檢驗(yàn);記數(shù)資料以頻數(shù)/百分率表示,采用χ2檢驗(yàn);非正態(tài)分布數(shù)據(jù)用中位數(shù)(范圍)表示,采用Wilcoxon秩和檢驗(yàn)。中位PFS采用Kaplan-Meier法進(jìn)行統(tǒng)計(jì)分析,同時(shí)繪制生存率曲線,兩組組間生存差異分析采用Log-rank檢驗(yàn)。p0.05為差異有統(tǒng)計(jì)學(xué)意義。[結(jié)果]1、兩組患者一般資料包括年齡、性別、Child-pugh分級(jí)、KPS評分、病因?qū)W、主瘤直徑等差異均無統(tǒng)計(jì)學(xué)意義(p0.05),具有良好的可比性。其中,AFP升高A組19例、B組16例。2、兩組患者臨床療效的比較:治療后三個(gè)月,A、B兩組AFP水平均顯著下降,分別較治療前差異有統(tǒng)計(jì)學(xué)意義(Z=-2.289、-2.953,p均0.05),治療后兩組間比較差異無統(tǒng)計(jì)學(xué)意義(Z-0.126,p=0.90)。A組5例患者AFP降至正常,B組6例降至正常。3、治療后3、6、9、12個(gè)月 A組ORR分別為36.36%、27.27%、13.64%、9.09%;而B組分別為60%、50%、45%、35%。其中治療3、6個(gè)月時(shí)兩組差異均無統(tǒng)計(jì)學(xué)意義(χ2=2.346;χ2=2.295,均0.05),治療后9、12個(gè)月時(shí)兩組差異均有統(tǒng)計(jì)學(xué)意義(χ2=5.050;χ2=4.177,均0.05)。4、A組中位無進(jìn)展生存期為6.0個(gè)月;B組中位無進(jìn)展生存期為12.5個(gè)月,差異有統(tǒng)計(jì)學(xué)意義(χ2=6.576,p=0.01)。5、兩組栓塞后綜合癥包括發(fā)熱、腹痛、惡心嘔吐等不良反應(yīng)發(fā)生率差異均無統(tǒng)計(jì)學(xué)意義(p均0.05)。B組阿帕替尼相關(guān)不良反應(yīng)高血壓、手足綜合癥、蛋白尿發(fā)生率高于A組,差異有統(tǒng)計(jì)學(xué)意義(p均0.05)。兩組均未發(fā)生嚴(yán)重不良反應(yīng),且經(jīng)對癥處理后均可緩解。[結(jié)論]1、對于中晚期肝癌患者,TACE聯(lián)合阿帕替尼與單純TACE治療均可有效降低患者AFP水平。聯(lián)合組治療的中遠(yuǎn)期療效較單純組更具優(yōu)勢,且更顯著延長患者疾病無進(jìn)展生存期。2、兩組的大多數(shù)不良反應(yīng)較輕微,經(jīng)對癥處理后不會(huì)導(dǎo)致治療中斷,阿帕替尼聯(lián)合使用的安全性得以證實(shí)。
[Abstract]:[objective] to compare the clinical efficacy and safety of percutaneous transcatheter arterial chemoembolization (transcatheter arterial chemoembolization TACE) combined with apatinib (apatinib) and TACE alone in the treatment of middle and advanced hepatocellular carcinoma (hepatocellular carcinoma). [methods] A total of 44 patients with advanced hepatocellular carcinoma (33 males, 11 females, aged 34 to 79 years) were selected from the Naval General Hospital from March 2015 to August 2015. The median age was 58.5 years old. Group A was randomly divided into two groups: group A and group A were treated with TACE alone and group B were treated with TACE combined with apatinib for 12 to 18 months. The changes of alpha fetoprotein (alpha) in the two groups were compared 3 months after treatment, and the objective remission rate (objective response rrr) at 12 months after treatment was compared. At the same time, the incidence of progression-free survival and adverse reactions were compared between the two groups. Statistical processing: the metrological data were expressed as x 鹵s, the matched t test was used in the two groups, and the independent sample t test was used in the comparison between the two groups. The data were expressed as frequency / percentage, 蠂 ~ 2 test was used, and non-normal distribution data was expressed as median (range), and Wilcoxon rank sum test was used. The median PFS was statistically analyzed by Kaplan-Meier method and the survival rate curve was drawn. The survival difference between the two groups was analyzed by Log-rank test. P0.05 was statistically significant. [results] 1. There were no significant differences between the two groups in general data including age, sex, Child-pugh grade, KPS score, etiology and diameter of the main tumor (p0.05). There were 19 patients with elevated AFP in group A and 16 patients in group B. The comparison of clinical efficacy between the two groups: the level of AFP in group A and group B were significantly decreased three months after treatment. There was no significant difference between the two groups after the treatment (Z-0.126 p0.90). The AFP in group A decreased to normal group (6 cases, normal group, 6 cases), and the ORR of group A was 36.3627.2727.277.277.27 (13.64), 9.09, respectively, and that of group A was 60,504545, 359.09, respectively, compared with that before treatment (P < 0.05), and the ORR of group A was 36.3627.277.2713.64 / 9.09, respectively, and the ORR of group A was 36.3627.277.277.2713.64 / 9.09, and the ORR of group A was 36.3627.277.27 and 13.649.09 respectively after treatment. There was no significant difference between the two groups at 3 and 6 months after treatment (蠂 2 + 2.346; 蠂 2 + 2.295, all 0.05). There were significant differences between the two groups at 9 and 12 months after treatment (蠂 25.050; 蠂 2 4.177, both 0.05). The median progression-free survival time of group A was 6.0 months and that of group B was 12.5 months. There was no significant difference in the incidence of adverse reactions such as fever, abdominal pain, nausea and vomiting between the two groups (p 0.05). The incidence of proteinuria was significantly higher than that in group A (p 0.05). There was no serious adverse reaction in both groups, and it was alleviated after symptomatic treatment. [conclusion] 1. TACE combined with apatinib and TACE can effectively reduce the level of AFP in patients with advanced liver cancer. The medium and long term curative effect of the combined treatment group was superior to that of the simple group, and the survival time of the patients without progression was significantly prolonged. Most of the adverse reactions in the two groups were mild, and the treatment would not be interrupted after symptomatic treatment. The safety of combined use of apatinib was confirmed.
【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R735.7
本文編號(hào)：2197454
[Abstract]:[objective] to compare the clinical efficacy and safety of percutaneous transcatheter arterial chemoembolization (transcatheter arterial chemoembolization TACE) combined with apatinib (apatinib) and TACE alone in the treatment of middle and advanced hepatocellular carcinoma (hepatocellular carcinoma). [methods] A total of 44 patients with advanced hepatocellular carcinoma (33 males, 11 females, aged 34 to 79 years) were selected from the Naval General Hospital from March 2015 to August 2015. The median age was 58.5 years old. Group A was randomly divided into two groups: group A and group A were treated with TACE alone and group B were treated with TACE combined with apatinib for 12 to 18 months. The changes of alpha fetoprotein (alpha) in the two groups were compared 3 months after treatment, and the objective remission rate (objective response rrr) at 12 months after treatment was compared. At the same time, the incidence of progression-free survival and adverse reactions were compared between the two groups. Statistical processing: the metrological data were expressed as x 鹵s, the matched t test was used in the two groups, and the independent sample t test was used in the comparison between the two groups. The data were expressed as frequency / percentage, 蠂 ~ 2 test was used, and non-normal distribution data was expressed as median (range), and Wilcoxon rank sum test was used. The median PFS was statistically analyzed by Kaplan-Meier method and the survival rate curve was drawn. The survival difference between the two groups was analyzed by Log-rank test. P0.05 was statistically significant. [results] 1. There were no significant differences between the two groups in general data including age, sex, Child-pugh grade, KPS score, etiology and diameter of the main tumor (p0.05). There were 19 patients with elevated AFP in group A and 16 patients in group B. The comparison of clinical efficacy between the two groups: the level of AFP in group A and group B were significantly decreased three months after treatment. There was no significant difference between the two groups after the treatment (Z-0.126 p0.90). The AFP in group A decreased to normal group (6 cases, normal group, 6 cases), and the ORR of group A was 36.3627.2727.277.277.27 (13.64), 9.09, respectively, and that of group A was 60,504545, 359.09, respectively, compared with that before treatment (P < 0.05), and the ORR of group A was 36.3627.277.2713.64 / 9.09, respectively, and the ORR of group A was 36.3627.277.277.2713.64 / 9.09, and the ORR of group A was 36.3627.277.27 and 13.649.09 respectively after treatment. There was no significant difference between the two groups at 3 and 6 months after treatment (蠂 2 + 2.346; 蠂 2 + 2.295, all 0.05). There were significant differences between the two groups at 9 and 12 months after treatment (蠂 25.050; 蠂 2 4.177, both 0.05). The median progression-free survival time of group A was 6.0 months and that of group B was 12.5 months. There was no significant difference in the incidence of adverse reactions such as fever, abdominal pain, nausea and vomiting between the two groups (p 0.05). The incidence of proteinuria was significantly higher than that in group A (p 0.05). There was no serious adverse reaction in both groups, and it was alleviated after symptomatic treatment. [conclusion] 1. TACE combined with apatinib and TACE can effectively reduce the level of AFP in patients with advanced liver cancer. The medium and long term curative effect of the combined treatment group was superior to that of the simple group, and the survival time of the patients without progression was significantly prolonged. Most of the adverse reactions in the two groups were mild, and the treatment would not be interrupted after symptomatic treatment. The safety of combined use of apatinib was confirmed.
【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R735.7
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