奈达铂或顺铂联合吉西他滨治疗中晚期NSCLC的临床效果及其安全性评价

中国药物警戒 ›› 2018, Vol. 15 ›› Issue (3): 136-139.

奈达铂或顺铂联合吉西他滨治疗中晚期NSCLC的临床效果及其安全性评价

薛雁鸿¹, 王来成², 胡丽丽²，³*, 杨波⁴

1 徐州医科大学附属医院西院/中煤第五建设公司职工医院药剂科, 江苏徐州 221006；
2 徐州医科大学附属医院药学部，江苏徐州 221006；3徐州医科大学临床学院, 江苏徐州 221006；4徐州市食品药品监督管理局，江苏徐州221018

收稿日期:2017-12-20 修回日期:2018-05-04 出版日期:2018-03-20 发布日期:2018-05-04
通讯作者: 胡丽丽，女，硕士，主管药师，临床药学与临床药理学。E-mail：elieven1982@163.com
作者简介:薛雁鸿，女，本科，副主任药师，医院药学。
基金资助:
2016年徐州市科技（社会发展）项目（KC16SH046）；江苏省药学会-奥赛康临床药学基金科研项目（A201622）：CDAC435T基因多态性与吉西他滨疗效及血液毒性的相关性研究。

Clinical Efficacy and Safety Evaluation of Advanced NSCLC Treated by Gemcitabine Combined Platin or Cisplatin

XUE Yan-hong¹, WANG Lai-cheng², HU Li-li²,³*, YANG Bo⁴

1 Department of Pharmacy, Xuzhou Medical University Affiliated Hospital West Court Middle Coal Fifth Construction Company Staff Hospital, Jiangsu Xuzhou 221006, China;
2 Department of Pharmacy, Xuzhou Medical University Affiliated Hospital, JiangSu Xuzhou 221006, China; 3Department of Pharmacy, Xuzhou Medical University, Jiangsu Xuzhou 221006, China; 4Xuzhou Food and Drug Administration, Jiangsu Xuzhou 221018, China

Received:2017-12-20 Revised:2018-05-04 Online:2018-03-20 Published:2018-05-04

摘要/Abstract

摘要： 目的比较两种含吉西他滨非小细胞肺癌（NSCLC）化疗方案，吉西他滨(GEM)联合顺铂（DDP）与吉西他滨（GEM）联合奈达铂（NDP），分析其疗效及不良反应（ADR）上的差异，为临床制定个体化给药方案提供参考。方法选择徐州医科大学附属医院2015年1月至2017年4月诊断为中晚期非小细胞肺癌的患者58例，GEM联合NDP方案组（GN方案）30例，GEM联合DDP方案组（GP方案）28例，治疗周期为21天，每次化疗周期记录不良反应，第3次化疗开始前检测肿瘤CT进行疗效评估，开展两方案不良反应及疗效比较。结果 GN方案有效率为43.33%，GP方案有效率为42.86%，二者在疗效上无显著性差异（P＞0.05）；GN方案消化道症状的发生率低于GP方案（P＜0.05），两方案在NEUT、WBC、HGB及PLT计数下降及肝肾毒性上的差异均无统计学意义（P＞0.05）。结论 GN方案与GP方案疗效接近，而GN方案的胃肠道反应更轻，且无需水化治疗，耐受性好。从有效性、安全性等考虑，GN方案可作为GP方案替代治疗方案。

关键词: 吉西他滨, 顺铂, 奈达铂, 非小细胞肺癌, 不良反应

Abstract: Objective To compare the two gemcitabine related chemotherapy regimens(gemcitabine (GEM) in combination with cisplatin (DDP) or nedaplatin(NDP)) on non-small cell lung cancer(NSCLC), analyze the differences of curative effect and adverse drug reactions (ADR), and provide reference to clinical individualized regimen. Methods The 58 cases diagnosed with NSCLC patients in Xuzhou Medical University Affiliated Hospital between January 2015 and April 2017 were divided into 2 groups, 30 cases of NDP combined with GEM (GN), 28 cases of DDP combined with GEM (GP), treatment cycles within 21 days. Recorded ADR of each cycle of chemotherapy regimens; evaluated curative effect using CT when the third cycle chemotherapy had been finished, then analyzed the adverse reactions and curative effect between the two regimens. Results GN regimen effective rate is 43.33%, GP is 42.86%, there is no significant difference (P>0.05). Gastrointestinal symptoms incidences of NP are lower than GP regimens (P<0.05), and there are no statistical significant differences in decreasing of NEUT, WBC, HGB and PLT, liver toxicity, kidney toxicity(P>0.05). Conclusion Curative effect of GN is similar to GP, and the gastrointestinal reaction of GN is slighter, good tolerance, without hydration treatment. From the effectiveness and safety considerations, GN scheme is comparable with GP for treatment options.

Key words: gemcitabine, cisplatin, nedaplatin, non-small-cell lung cancer, adverse drug reactions

中图分类号:

R979.11

薛雁鸿, 王来成, 胡丽丽，*, 杨波. 奈达铂或顺铂联合吉西他滨治疗中晚期NSCLC的临床效果及其安全性评价[J]. 中国药物警戒, 2018, 15(3): 136-139.

XUE Yan-hong, WANG Lai-cheng, HU Li-li,*, YANG Bo. Clinical Efficacy and Safety Evaluation of Advanced NSCLC Treated by Gemcitabine Combined Platin or Cisplatin[J]. Chinese Journal of Pharmacovigilance, 2018, 15(3): 136-139.

参考文献

[1] 刘晓, 贾燕花, 张可, 等. 非小细胞肺癌EML4-ALK靶向药物耐药机制及逆转耐药的研究进展[J].中国新药杂志, 2016, 25(9): 1018-1023.
[2] 旷琛, 陈敏, 毛棉, 等. 埃克替尼治疗晚期非小细胞肺癌的系统评价[J]. 中国药房, 2016, 27(9): 1219-1222.
[3] 刘淑, 郑玉龙, 王伟, 等. 吉西他滨联合奈达铂与吉西他滨联合顺铂治疗老年晚期非小细胞肺癌的临床研究[J]. 现代肿瘤医学, 2010, 18(4): 722-724.
[4] 刘淑俊, 邸立军, 王洁, 等. 国产盐酸吉西他滨治疗晚期非小细胞肺癌的Ⅱ期临床研究[J].中华肿瘤杂志, 2003, 25(6): 584-586.
[5] 罗扬, 张湘茹. 吉西他滨治疗晚期非小细胞肺癌的现状[J]. 中国癌症杂志, 2002, 11(1): 74-80.
[6] 韦灵玉, 邱晓春, 周彦来, 等. 我院907例抗肿瘤药物不良反应分析[J]. 中国药物警戒, 2017, 14 (4): 242-245.
[7] Parra H J S, Cavina R, Antonelli G, et al. Superiority of three-week vs. four-week schedule of cisplatin (CDDP) and gemcitabine (GEM): Results of a randomized phase II study[J]. Lung Cancer, 2000, 29(1): 48-48.
[8] 陈颖, 林昊. 84例奈达铂致不良反应分析[J]. 中国药物警戒, 2012, 9(11): 691-692.
[9] 王健, 曹东, 顾文静, 等. WHO标准与RECIST标准评价恶性肿瘤治疗效果的比较[J].中国基层医药, 2013, 20(5): 652-654.
[10] 李继东, 王舒, 肖永久, 等. 国产奈达铂联合吉西他滨治疗晚期非小细胞肺癌[J]. 实用医学杂志, 2008, 24(5): 811-812.
[11] 沈凡, 李会萍. 吉西他滨联合顺铂治疗晚期非小细胞肺癌临床观察[J]. 中华肿瘤防治杂志, 2015，22(b11): 100-101.
[12] Morabito A, Gebbia V, Maio M D, et al. Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: The CAPPA-2 study[J]. Lung Cancer, 2013, 81(1): 77-83.
[13] 王莉, 刘汉锋, 蔡正文, 等. 奈达铂与顺铂对人肝肾细胞损伤作用的对比[J]. 广东医学, 2012, 33(6): 736-738.
[14] 成卫, 王彩英. 吉西他滨联合奈达铂治疗晚期非小细胞肺癌疗效评价[J]. 实用临床医药杂志, 2012, 16(19): 89-90.
[15] 路太英, 樊青霞, 王留兴, 等. 改良水化法对以顺铂为主方案化疗所致肾毒性的影响[J].医药论坛杂志, 2006, 27(18): 79-80.
[16] 雷琳, 黄亚平, 张凌云, 等. 奈达铂联合吉西他滨治疗中晚期非小细胞肺癌的临床观察[J]. 实用癌症杂志, 2013, 28(2): 166-167.