CAJ | 학술논문

目的：观察重组人血管内皮抑制素（恩度）联合氟尿嘧啶腹腔灌注并配合深部热疗治疗恶性腹水的疗效和安全性。方法60例恶性腹水患者分为治疗组（腹腔内恩度联合氟尿嘧啶腹腔灌注后热疗）和对照组（腹腔内氟尿嘧啶单药灌注后热疗）。治疗前均先尽量排尽腹水，治疗组在腹腔内注入氟尿嘧啶1.0 g和恩度60 mg，每周3次（d1、d4、d7）。连续3次为1周期，间隔1周时间进行下一周期治疗。对照组除不加入恩度外，其余同治疗组。对照组和治疗组均在腔内治疗后30 min 行深部热疗，热疗温度为43℃以上，每次45～60 min。所有患者均接受2个周期治疗，第2周期治疗结束后，按照WHO腹水标准评价近期疗效，参照Karnofsky评分（KPS）变化评价生活质量（QOL），按照NCICTC 3.0版分级标准评价毒性反应。结果在可评价的60例患者中，治疗组客观有效率78.8%（26/33），对照组48.1%（13/27），两组疗效差异显著（P＝0.017）。治疗组获生活质量改善25例（75.8%），对照组获生活质量改善11例（40.7%），两组比较有统计学差异（P＝0.008）。治疗组与对照组比较，未明显增加毒副反应，全组患者耐受良好，无治疗相关性死亡。治疗组和对照组的中位疾病进展时间（TTP）分别为100 d和48 d，两组差异有统计学意义（P＝0.000）。结论恩度联合氟尿嘧啶腹腔灌注的给药模式并配合深部热疗治疗恶性腹水具有较好的近期疗效和生活质量改善，毒副反应均可耐受，可成为治疗恶性腹水的新手段之一，也可为恶性浆膜腔积液治疗提供新的思路，值得临床推广。
목적：관찰중조인혈관내피억제소（은도）연합불뇨밀정복강관주병배합심부열료치료악성복수적료효화안전성。방법60례악성복수환자분위치료조（복강내은도연합불뇨밀정복강관주후열료）화대조조（복강내불뇨밀정단약관주후열료）。치료전균선진량배진복수，치료조재복강내주입불뇨밀정1.0 g화은도60 mg，매주3차（d1、d4、d7）。련속3차위1주기，간격1주시간진행하일주기치료。대조조제불가입은도외，기여동치료조。대조조화치료조균재강내치료후30 min 행심부열료，열료온도위43℃이상，매차45～60 min。소유환자균접수2개주기치료，제2주기치료결속후，안조WHO복수표준평개근기료효，삼조Karnofsky평분（KPS）변화평개생활질량（QOL），안조NCICTC 3.0판분급표준평개독성반응。결과재가평개적60례환자중，치료조객관유효솔78.8%（26/33），대조조48.1%（13/27），량조료효차이현저（P＝0.017）。치료조획생활질량개선25례（75.8%），대조조획생활질량개선11례（40.7%），량조비교유통계학차이（P＝0.008）。치료조여대조조비교，미명현증가독부반응，전조환자내수량호，무치료상관성사망。치료조화대조조적중위질병진전시간（TTP）분별위100 d화48 d，량조차이유통계학의의（P＝0.000）。결론은도연합불뇨밀정복강관주적급약모식병배합심부열료치료악성복수구유교호적근기료효화생활질량개선，독부반응균가내수，가성위치료악성복수적신수단지일，야가위악성장막강적액치료제공신적사로，치득림상추엄。
Objective Tostudy the efficacy and safety of intracavitary injection of endostar combined with fluorouraci and with regional thermotherapy on malignant ascites. Methods 60 cancer patients with malignant ascites confirmed by cytopathology were divided intotwogroups, treatment group(intracavitary injection of endostar combined with fluorouraci and with regional thermotherapy), control group(intracavitary injection of fluorouraci with regional thermotherapy), 60 mg endostar combined with 1.0 g fluorouracil were injected intracavitary in treatment group, q3 d(d1,d4,d7), three consecutive cavity infusion was a cycle, next cycle of treatment were a week later. The control group were the same as treatment group except from endostar. Thirty minutes after cavity infusion, the control group and treatment group were all treated with regional thermotherapy with 43℃ for 45-60 min. All patients were treated with twocycles, The elfleacv was evaluated strictly according toWHO criteria and safety according toNCI-CTC AE 3.0 version criteria. Results Among the evaluable 76 cases, the objective response rate(ORR) was 78.8%in treatment group, the control group was 48.1%(P<0.05). The improvement rate of QOL was 75.8%(25/32) in treatment group comparing with 40.7%(11/28) in treatment group(P=0.008). Median TTP of treatment treatment(n=32) and control group(n=28) were l00 days vs. 48 days(P=0.000), all the patients were of good tolerance as a whole and nosevere side effects happened. Conclusions Intracavitary injection of endostar combined with fluorouraci and with regional thermotherapy results in a good response rate and improvement of QOL for the patients with malignant ascites.The combined regimen was low-toxic and tolerable.It is a new way totreat malignant ascites and worthy of further clinical promotion.