金龍膠囊配合肝動(dòng)脈灌注化療栓塞治療肝癌的臨床研究

1、1416 臨床應(yīng)用研究金龍膠囊配合肝動(dòng)脈灌注化療栓塞治療肝癌的臨床研究賈長(zhǎng)河,王文玉,康誼河南省人民醫(yī)院(老年醫(yī)學(xué)部:賈長(zhǎng)河;腫瘤科:王文玉;消化科:康誼),河南鄭州450003ClinicalstudiesoncombinationtherapyofjinlongcapsuleandtransarterialchemoembolizationintreatmentofprimaryhepaticJIAChang2he,WANGWen2yu,KANGYiHenanProvincialPeoplesHospital,P.R.【摘要】方法:選取60,隨機(jī)分為試驗(yàn)組和對(duì)照組,對(duì)照組單純應(yīng)用肝動(dòng)脈灌注

2、化療栓(TACE)治療,試驗(yàn)組在TACE治療基礎(chǔ)上配合應(yīng)用金龍膠囊。3個(gè)月后比較2組生存質(zhì)量、免疫功能及病灶大小變化。結(jié)果:試驗(yàn)組有效率(5617%,17/30)和對(duì)照組(3313%,10/30)比較差異無統(tǒng)計(jì)學(xué)意義,P0105,但進(jìn)展率(617%,2/30)明顯低于對(duì)照組(3313%,10/30),差異有統(tǒng)計(jì)學(xué)意義,P0105。生存質(zhì)量評(píng)分及免疫功能指標(biāo)試驗(yàn)組均優(yōu)于對(duì)照組,P0105。結(jié)論:金龍膠囊與肝動(dòng)脈灌注化療栓塞配合有明顯協(xié)同、增效作用,能夠提高患者生存質(zhì)量、延緩病灶進(jìn)展及改善免疫功能。中華腫瘤防治雜志,2008,15(18):1416-1418OBJECTIVE:Tostudythe

3、clinicaleffectofthecombinationtherapyofjinlongcapsuleandtransarterialchemoembo2lization(TACE)inthetreatmentofprimaryhepaticcarcinoma(PHC).METHODS:SixtycasesofPHCwereclassifiedrandomlyintotwogroups:acombinationtherapygroup(trialgroup,30cases)andaTACEgroup(controlgroup,30cases).Afterthetreatmentforthr

4、eemonths,thedifferencesbetweenthetwogroupsinthequalityoflife,immunityindexandtumorvolumevariationwereanalyzed.RESULTS:Theresponserate(5617%,17/30)ofthetrialgroupwasnotsignificantdifferentfromthat(3313%,10/30)ofthecontrolgroup,buttheaggra2vationrate(617%,2/30)waslessthanthat(3313%,10/30)ofthecontrolg

5、roupsignificantly,P0105.Thelifequalityandthecelluarimmunityfuntionofthetrialgroupwerebetterthanthoseofthecontrolgroupsignificantly,P60,預(yù)計(jì)生存期3個(gè)月,愿意接受此項(xiàng)治療;4)治療期間不接受其他治療。排除標(biāo)準(zhǔn):1)危重患者或預(yù)計(jì)生存期0105,但對(duì)照組進(jìn)展率高于試驗(yàn)組,差異有統(tǒng)計(jì)學(xué)意義,P0105。2.2免疫功能對(duì)照組治療后CD3+、CD4+/CD8+細(xì)胞較治療前進(jìn)一步下降,P0105;試驗(yàn)組CD3+、CD4+、CD4+/CD8+和NK細(xì)胞較治療前均明顯升高,并

6、顯著高于對(duì)體瘤評(píng)價(jià)標(biāo)準(zhǔn)3分為完全緩解(CR)、部分緩解(PR)、無變化(NC)和進(jìn)展(PD)。毒副反應(yīng)按2000年新修訂WHO評(píng)價(jià)標(biāo)準(zhǔn)評(píng)定。有效率(%)=100%CR+PR+NC+PD進(jìn)展率(%)=100%CR+PR+NC+PD照組治療后水平,P均0105,提示介入治療有進(jìn)一步抑制患者細(xì)胞免疫功能傾向,而金龍膠囊有提高細(xì)胞免疫功能作用(表1)。2.3生存質(zhì)量治療前兩組各項(xiàng)評(píng)分差異無統(tǒng)計(jì)學(xué)意義,治療后試驗(yàn)組整體生命質(zhì)量及部分功能項(xiàng)目得分增高,部分癥狀項(xiàng)目得分下降,與對(duì)照組比較差異有統(tǒng)計(jì)學(xué)意義,P0105,說明生存質(zhì)量提高(表2)。發(fā)的生命質(zhì)量核心量表(EORTCQLQ2C30),它包括1個(gè)整體生

7、命質(zhì)量表、3個(gè)癥狀量表(疲勞、惡心嘔吐和-表1治療前后免疫指標(biāo)的變化(xs)組別試驗(yàn)組治療前治療后對(duì)照組治療前治療后CD3+CD4+CD8+CD4+/CD8+NKvs治療前,試驗(yàn)組的CD3+(t=2128)、CD4+(t=2114)和CD4+/CD8+(t=2109)和NK(t=2126),P0105;對(duì)照組的CD3+(t=2131)、CD8+(t=2124)、CD4+/CD8+(t=2131)和NK(t=2119),P0105;vs對(duì)照組治療后,CD3+(t=2117)、CD4+(t=2120)、CD4+/CD8+(t=2113),P01051418-表2治療前后兩組生活質(zhì)量評(píng)分比較(xs,

8、分)項(xiàng)目治療前治療后56.820.2治療前后分差10.65.023.57.511.96.022.68.620.69.517.47.511.0812.65.5-8.34.0-23.711.3-8.56.6-20.39.4-25.610.7-26.310.3-1.0-5.51.4-17.25.9-8.63.6-18.78.3-11.04.2-21.48.7-6.62.5-15.06.4-7.53.1-5.62.3t值整體生命質(zhì)量對(duì)照組45.119.4試驗(yàn)組43.616.3軀體對(duì)照組53.017.4試驗(yàn)組55.821.4角色對(duì)照組40.51

9、7.4試驗(yàn)組42.618.6情緒對(duì)照組42.819.5試驗(yàn)組45.221.1認(rèn)知對(duì)照組53.418.6試驗(yàn)組53.218.5社會(huì)對(duì)照組試驗(yàn)組55.2疲勞對(duì)照組68.14試驗(yàn)組65.723.5惡心/嘔吐對(duì)照組56.221.6試驗(yàn)組56.722.5疼痛對(duì)照組57.525.8試驗(yàn)組60.728.3呼吸困難對(duì)照組32.58.8試驗(yàn)組30.412.4失眠對(duì)照組62.325.7試驗(yàn)組58.025.4食欲對(duì)照組68.430.4試驗(yàn)組63.725.7便秘對(duì)照組53.620.4試驗(yàn)組55.223.9腹瀉對(duì)照組46.719.3試驗(yàn)組45.819.8經(jīng)濟(jì)困難對(duì)照組68.425.6試驗(yàn)組9基礎(chǔ)上

10、加強(qiáng)中醫(yī)中藥等綜合治療手段,以增強(qiáng)療效,提高生存質(zhì)量,延長(zhǎng)生存期尤為重要。金龍膠囊是由守宮、金錢白花蛇等鮮活動(dòng)物經(jīng)特殊方法提取制成。研究證實(shí),鮮活金錢白花蛇提取物具有細(xì)胞毒作用,直接作用于細(xì)胞的核酸,影響細(xì)胞的代謝,損傷DNA,促進(jìn)細(xì)胞凋亡發(fā)生,具有扶正解毒、益氣補(bǔ)血、填精培元和化瘀散結(jié)之功1;同時(shí)對(duì)人體有免疫調(diào)節(jié)作用,通過刺7,同時(shí)能補(bǔ)充人、。,差異有統(tǒng)。對(duì)照組治療后CD3+、CD4+/CD8+細(xì)胞較治療前進(jìn)一步下降,而試驗(yàn)組CD3+、CD4+、CD4+/CD8+和NK細(xì)胞較治療前均明顯升高,并顯著高于對(duì)照組治療后水平。生存質(zhì)量方面治療前兩組各項(xiàng)評(píng)分差異無統(tǒng)計(jì)學(xué)意義,治療后試驗(yàn)組整體生命質(zhì)量

11、及部分功能部分癥狀得到改善,與對(duì)照組比較差異有統(tǒng)計(jì)學(xué)意義,P0105。以上結(jié)果提示,金龍膠囊與TACE配合應(yīng)用對(duì)控制瘤體進(jìn)展、提高晚期肝癌患者生活質(zhì)量及增強(qiáng)細(xì)胞免疫功能有顯著作用,且無明顯不良反應(yīng),可作為腫瘤患者較理想的輔助治療,其遠(yuǎn)期療效有待進(jìn)一步研究。2.15-2.23-2.212.18-2.32【參考文獻(xiàn)】2.171高益民.對(duì)治療癌癥新藥金龍膠囊上市后的再評(píng)價(jià)J.首都醫(yī)2.24藥,2005,12(1):44246.2賈立群,李學(xué),萬冬佳,等.金龍膠囊的免疫雙向調(diào)節(jié)作用J.北京醫(yī)學(xué),2005,27(5):552.2.153TherasseP,ArbuckSG,EisenhauerEA,et

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