CAJ | 학술논문

目的：探讨高强度聚焦超声（ HIFU）联合替吉奥（ S-1）治疗晚期胰腺癌的疗效。方法选取120例不能切除的晚期胰腺癌患者随机分为A组（n＝61）和B组（n＝59），两组均接受口服S-1治疗。根据体表面积（BSA）制定方案：BSA＜1?25m2，80mg/d；1?25～1?5m2，100mg/d；＞1?5m2，120mg/d；d1～d14，3周为1周期。仅A组在S-1基础上联合HIFU。根据实体瘤疗效评价标准（ RECIST）1?0版评价近期疗效并计算有效率（ RR）和疾病控制率（ DCR），采用NCI CTCAE 3?0标准评价毒副反应，记录疼痛缓解率并随访患者生存情况。结果全组均可评价近期疗效。 A组获CR 3例、PR 15例、SD 28例和PD 15例，RR和DCR分别为29?5％和75?4％；B组获CR 1例、PR 5例、SD 15例和PD 38例，RR和DCR分别为10?2％和35?6％；A组的RR和DCR均高于B组（ P＜0?05）。 A组的中位生存期（ OS）为11?2个月，6、12个月的生存率分别为80?0％和40?0％，均优于A组的7?9个月、70?0％和10?0％，差异有统计学意义（P＜0?05）。 A组的疼痛缓解率为57?4％（35/61），高于B组的20?3％（12/59），差异有统计学意义（ P＜0?05）。两组均无3～4级毒副反应，1～2级毒副反应为贫血、中性粒细胞减少、血小板减少、恶心、腹泻、手足综合征及神经毒性，组间差异均无统计学意义（ P＞0?05）。结论 HIFU联合S-1方案治疗晚期胰腺癌的疗效较好，毒副反应较轻且患者可耐受，是治疗晚期胰腺癌的一种有效手段。
목적：탐토고강도취초초성（ HIFU）연합체길오（ S-1）치료만기이선암적료효。방법선취120례불능절제적만기이선암환자수궤분위A조（n＝61）화B조（n＝59），량조균접수구복S-1치료。근거체표면적（BSA）제정방안：BSA＜1?25m2，80mg/d；1?25～1?5m2，100mg/d；＞1?5m2，120mg/d；d1～d14，3주위1주기。부A조재S-1기출상연합HIFU。근거실체류료효평개표준（ RECIST）1?0판평개근기료효병계산유효솔（ RR）화질병공제솔（ DCR），채용NCI CTCAE 3?0표준평개독부반응，기록동통완해솔병수방환자생존정황。결과전조균가평개근기료효。 A조획CR 3례、PR 15례、SD 28례화PD 15례，RR화DCR분별위29?5％화75?4％；B조획CR 1례、PR 5례、SD 15례화PD 38례，RR화DCR분별위10?2％화35?6％；A조적RR화DCR균고우B조（ P＜0?05）。 A조적중위생존기（ OS）위11?2개월，6、12개월적생존솔분별위80?0％화40?0％，균우우A조적7?9개월、70?0％화10?0％，차이유통계학의의（P＜0?05）。 A조적동통완해솔위57?4％（35/61），고우B조적20?3％（12/59），차이유통계학의의（ P＜0?05）。량조균무3～4급독부반응，1～2급독부반응위빈혈、중성립세포감소、혈소판감소、악심、복사、수족종합정급신경독성，조간차이균무통계학의의（ P＞0?05）。결론 HIFU연합S-1방안치료만기이선암적료효교호，독부반응교경차환자가내수，시치료만기이선암적일충유효수단。
Objective To evaluate the efficacy of high intensity focused ultrasound ( HIFU) in combination with S-1 in treat-ment of advanced pancreatic carcinoma. Methods A total of 120 patients with unresectable advanced pancreatic carcinoma were ran-domly assigned into group A( n=61) and group B( n=59) . All patients received oral S-1, Oral S-1 was administered at 80mg/day for body surface area( BSA) less than 1?25m2 , 100mg/day for BSA 1?25-1?5m2 , and 120mg/day for BSA more than 1?5m2 on days 1-14 every 3 weeks. Only group A received HIFU in combination with S-1. The response evaluation criteria for solid tumor( RECIST) 1?0 were adopted to evaluate recent curative effect and calculate the response rate( RR) and disease control rate( DCR) . The toxicity was assessed using NCI CTC 3?0. The pain relief rate was analyzed and patients were followed up. Results All patients were included in the objective response evaluation. The treatment achieved CR in 3 cases, PR in 15 cases, SD in 28 cases and PD in 15 cases of group A and CR in 1 case, PR in 5 cases, SD in 15 cases and PD in 38 cases of group B. The RR and DCR in group A were 29?5% and 75?4%, higher than 10?2% and 35?6% in group B with significant difference( P<0?05) . The median overall survival time was 11?2 months and 6-, 12-months survival rates were 80?0% and 40?0% in group A, were superior to 7?9 months, 70?0% and 10?0% in group B with significant difference(P<0?05). The pain relief rate in group A was 57?4%(35/61), higher than 20?3%(12/59) in group B with significant difference( P<0?05) . No significant difference was observed on grade 3-4 toxicities between both groups. No significant difference was observed on grade 1-2 toxicities, including anemia, neutropenia, thrombocytopenia, nausea, diarrhea, hand-foot syndrome and neurotoxicity( P>0?05) . Conclusion The HIFU in combination with S-1 shows a favorable benefit and can be well tolerated in patients with advanced pancreatic carcionoma.