CAJ | 학술논문

目的：观察并探讨艾迪注射液联合奥沙利铂（ L-OHP）＋多西紫杉醇（ DXL）治疗晚期非小细胞肺癌（NSCLC）的近远期疗效并安全性。方法入选2009年9月-2010年8月NSCLC患者91例并随机单盲分为观察组（47例）与对照组（44例），对照组采用L-OHP＋DXL 4周期化疗方案，观察组在此基础上静脉滴注艾迪注射液，50 ml/d，连用14 d，周期同对照组，化疗结束后3个月对比2组近期疗效与生活质量，36个月后对比2组远期生存率。结果（1）化疗结束3个月后，观察组与对照组患者总体有效率分别为72(．3％和52．3％，KPS生活质量评分分别为（81．4±5．4）分、（78．7±5．7）分，差异均具有统计学意义（ P ＜0．05）。（2）观察组与对照组化疗期间毒性反应发生率顺位依次为胃肠道反应、粒细胞减少、血小板减少、末梢神经毒性、肝功能损害、肾功能损害、皮疹，2组毒性反应级别构成、发生率差异均无统计学意义（ P ＞0．05）。（3）化疗结束后36个月，观察组与对照组平均生存时间分别为31．030（95％CI 30．752～31．308）个月、28．884（95％CI 28．609～29．459）个月，累积生存概率分别为（0．232±0．011）、（0．088±0．008），差异具有统计学意义（ P ＜0．01）。结论 L-OHP＋DXL方案基础上加用艾迪注射液能显著提高晚期NSCLC近期化疗有效率，延长化疗后生存时间，且具备较好的临床安全性。
목적：관찰병탐토애적주사액연합오사리박（ L-OHP）＋다서자삼순（ DXL）치료만기비소세포폐암（NSCLC）적근원기료효병안전성。방법입선2009년9월-2010년8월NSCLC환자91례병수궤단맹분위관찰조（47례）여대조조（44례），대조조채용L-OHP＋DXL 4주기화료방안，관찰조재차기출상정맥적주애적주사액，50 ml/d，련용14 d，주기동대조조，화료결속후3개월대비2조근기료효여생활질량，36개월후대비2조원기생존솔。결과（1）화료결속3개월후，관찰조여대조조환자총체유효솔분별위72(．3％화52．3％，KPS생활질량평분분별위（81．4±5．4）분、（78．7±5．7）분，차이균구유통계학의의（ P ＜0．05）。（2）관찰조여대조조화료기간독성반응발생솔순위의차위위장도반응、립세포감소、혈소판감소、말소신경독성、간공능손해、신공능손해、피진，2조독성반응급별구성、발생솔차이균무통계학의의（ P ＞0．05）。（3）화료결속후36개월，관찰조여대조조평균생존시간분별위31．030（95％CI 30．752～31．308）개월、28．884（95％CI 28．609～29．459）개월，루적생존개솔분별위（0．232±0．011）、（0．088±0．008），차이구유통계학의의（ P ＜0．01）。결론 L-OHP＋DXL방안기출상가용애적주사액능현저제고만기NSCLC근기화료유효솔，연장화료후생존시간，차구비교호적림상안전성。
Objective To explore the short and long term efficacy and clinical safety of Aidi injection combined with oxaliplatin (L-OHP) and docetaxel (DXL) in treatment of advanced non-small cell lung cancer (NSCLC).Methods Selected 91 patients from September 2009 to August 2010 with NSCLC, they were randomly divided into single-blind observation group (47 cases) and control group (44 cases).The control group using L-OHP +DXL 4 cycles of chemotherapy, observation group added Aidi intravenous injection , 50 ml/d, in 14 d, same cycles as control group , three months after the end of chemo-therapy , two groups were compared the efficacy and quality of life , 36 months after the therapy , long-term survival comparison were performed between the two groups .Results (1) 3 months after the end of chemotherapy , the observation group and the control group patients'overall response rate was 72.3%and 52.3%, respectively, KPS quality of life score was (81.4 ±5.4) points, and (78.7 ±5.7) points, respectively, the differences were statistically significant ( P <0.05).(2) The observa-tion group and the control group during chemotherapy overall incidence of toxicities are as follows , gastrointestinal reactions , neutropenia, thrombocytopenia, peripheral neurotoxicity, liver damage, kidney damage, skin rash, two groups'toxicity level constitute revealed no significant difference ( P >0.05).(3) 36 months after the end of chemotherapy , in the observation group and the control group , the average survival time was 31.030 (95%CI 30.752-31.308) months, 28.884 (95% CI 28.609-29.459) months, the cumulative probability of survival was (0.232 ±0.011), (0.088 ±0.008), showed a statis-tically significant difference ( P <0.01).Conclusion Aidi injection combined with L-OHP+DXL regimen in treatment of advanced NSCLC could significantly improve the recent efficiency , prolong survival duration after chemotherapy , and show good clinical safety .