CAJ | 학술논문

目的：探讨奥沙利铂分别与吉西他滨固定剂量率输注、常规输注联合应用对进展胰腺癌的治疗效果。方法67例初治、无法手术切除的进展期胰腺癌患者，随机分成研究组和对照组。研究组采用吉西他滨固定剂量率（10 mg· m－2· min－1）输注联合奥沙利铂方案，对照组采用吉西他滨标准输注（30 min）联合奥沙利铂方案化疗，每21天为一个周期，每例患者完成4周期（至少2周期）化疗。治疗期间随访评价2组疗效、不良反应。结果研究组、对照组的客观缓解率分别为32．35％（11／34）、12．12％（4／33），差异有统计学意义（P＜0．05）；临床获益率及临床受益反应研究组亦优于对照组，分别为67．65％ vs．36．36％、61．76％ vs．42．42％，二者比较差异有统计学意义（P＜0．05）；研究组、对照组的总生存时间分别为（335．36±19．45）天、（243．59±21．87）天，至肿瘤进展时间分别为（163．52±17．08）天、（147．39±16．44）天，组间比较差异有统计学意义（P＜0．05）。不良反应方面，主要为血液学毒性，尤其Ⅲ－Ⅳ度白细胞、血小板减少发生率研究组明显高于对照组（ P＜0．05）；而非血液学不良反应发生率2组相似（ P＞0．05）。结论吉西他滨固定剂量率输注联合奥沙利铂方案治疗进展期胰腺癌具有较高的客观缓解率及临床受益反应，延长了总生存时间及至肿瘤进展时间；非血液学不良反应发生率较低，患者耐受性较好；但其血液学毒性较为显著，需引起足够重视。
목적：탐토오사리박분별여길서타빈고정제량솔수주、상규수주연합응용대진전이선암적치료효과。방법67례초치、무법수술절제적진전기이선암환자，수궤분성연구조화대조조。연구조채용길서타빈고정제량솔（10 mg· m－2· min－1）수주연합오사리박방안，대조조채용길서타빈표준수주（30 min）연합오사리박방안화료，매21천위일개주기，매례환자완성4주기（지소2주기）화료。치료기간수방평개2조료효、불량반응。결과연구조、대조조적객관완해솔분별위32．35％（11／34）、12．12％（4／33），차이유통계학의의（P＜0．05）；림상획익솔급림상수익반응연구조역우우대조조，분별위67．65％ vs．36．36％、61．76％ vs．42．42％，이자비교차이유통계학의의（P＜0．05）；연구조、대조조적총생존시간분별위（335．36±19．45）천、（243．59±21．87）천，지종류진전시간분별위（163．52±17．08）천、（147．39±16．44）천，조간비교차이유통계학의의（P＜0．05）。불량반응방면，주요위혈액학독성，우기Ⅲ－Ⅳ도백세포、혈소판감소발생솔연구조명현고우대조조（ P＜0．05）；이비혈액학불량반응발생솔2조상사（ P＞0．05）。결론길서타빈고정제량솔수주연합오사리박방안치료진전기이선암구유교고적객관완해솔급림상수익반응，연장료총생존시간급지종류진전시간；비혈액학불량반응발생솔교저，환자내수성교호；단기혈액학독성교위현저，수인기족구중시。
Objective To compare the efficacy of oxaliplatin combined with gemcitabine through fixed-dose or rou-tine infusion to treat advanced pancreatic cancer.Methods A total of 67 advanced pancreatic cancer patients who were recently diagnosed and unable to perform surgery were enrolled into the current study.They were randomly divided into the following groups:a research group in which patients received oxaliplatin in combination with gemcitabine through infu-sion at a fixed dose rate of 10 mg/m2 per minute, and a control group in which patients were administrated with oxalipla-tin combined with gemcitabine through routine infusion within 30 min.Each patient underwent at least two courses of treatment, 21 days in each course.Then, both groups were compared for efficacy and adverse reactions during follow-up visits.Results The objective response rate (ORR) was 32.35 % (11/34) for the research group and 12.12% (4/33) for the control.The clinical benefit rate and clinical benefit response( CBR) were 67.65%and 36.36%for the re-search group, and 61.76%and 42.42% for the control.These data were significantly different from each other ( P<0.05).The overall survival (OS) was (335.36 ±19.45) days for the research group and (243.59 ±21.87) days for the control.The time to progression (TTP) was (163.52 ±17.08) days for the research group and (147.39 ±16.44) days for the control.These data were significantly different from each other (P<0.05).The major adverse events in-cluded hematological toxicity, especially significantly increased incidence of Grade III/IV leucocytopenia and thrombocy-topenia (P<0.05).The incidence of non-hematological toxicity was similar between both groups (P>0.05).Con-clusion Oxaliplatin in combination with gemcitabine through fixed dose infusion is effective for treatment of advanced pancreatic cancer, with a higher ORR and CBR as well as longer OS and TTP.Its non-hematological toxicity is less fre-quent and well-tolerated, despite of its remarkable hematological toxicity which needs special attention.