| 叶知锋,黄挺,杨雪飞,张志娣,黄伶,郭俊华.低分子肝素预防性抗凝治疗对晚期非小细胞肺癌预后的影响[J].中国临床保健杂志,2019,22(2):215-219. |
| 低分子肝素预防性抗凝治疗对晚期非小细胞肺癌预后的影响 |
| Effect of prophylactic anticoagulation by low molecular weight heparin on the prognosis of advanced non-small cell lung cancer and the dominant population |
| 投稿时间：2018-09-10 |
| DOI：10.3969/J.issn.1672-6790.2019.02.019 |
| 中文关键词: 癌,非小细胞肺 肝素,低分子量 化学预防 预后 |
| 英文关键词: Carcinoma,non-small-cell lung Heparin,low-molecular-weight Chemoprevention Prognosis 〖FL |
| 基金项目:浙江杭州市科技局重点专科专病项目(20150733Q53) |
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| 中文摘要: |
| 目的 观察低分子肝素预防性抗凝治疗对晚期非小细胞肺癌生存预后的影响,分析低分子肝素预防性抗凝治疗的优势人群。 方法 研究入组血栓形成高风险的晚期非小细胞肺癌226例,采用抽签法分为治疗组(113例)与对照组(113例),治疗组予那屈肝素钙注射液4100 u皮下注射1次/日,疗程6个月,并给予标准抗肿瘤治疗,对照组仅予标准抗肿瘤治疗,随访观察治疗组与对照组患者无进展生存期(PFS)与总生存期(OS)。 结果 治疗组与对照组中位无进展生存时间(mPFS)分别为6.4月(95%CI:5.97~6.83月) 与6.3月(95%CI:5.98~6.62月),P=0.18；治疗组与对照组中位总生存时间(mOS)分别为20.9月(95%CI:18.90~22.90月)与20.7月(95%CI:17.70~23.70月),P=0.15。表皮生长因子受体(EGFR)突变亚组治疗组与对照组mPFS分别为10.2月(95%CI:7.98~12.42月)与9.9月(95%CI:9.17~10.63月),P=0.03；EGFR突变亚组治疗组与对照组mOS分别为28.9月(95%CI:26.62~31.18月)与28.6月 (95%CI:28.08~29.13月),P=0.01。 表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)治疗亚组治疗组与对照组mPFS为分别11.9月(95%CI:10.55~13.25月)与10.8月(95%CI:10.03~11.57月),P=0.03；EGFR-TKI治疗亚组治疗组与对照组的中位生存期(mOS)分别为28.1月 (95%CI:27.29~28.91月) 与27.8月 (95%CI:25.86~29.74月),P=0.02。EGFR突变亚组,治疗组相对于对照组PFS的HR=0.65,95%CI:0.43~0.97,P=0.03,治疗组相对于对照组OS的HR=0.53,95%CI:0.33~0.84,P=0.01；EGFR-TKI治疗亚组,治疗组相对于对照组的PFS的HR=0.59,95%CI:0.37~0.95,P=0.03,治疗组相对于对照组OS的HR=0.55,95%CI:0.33~0.91,P=0.02。 结论 低分子肝素那屈肝素钙注射液预防性抗凝治疗对晚期(ⅢB/Ⅳ期)非小细胞肺癌PFS及OS无改善,但能延长EGFR突变及使用EGFR-TKI治疗患者的PFS与OS,降低死亡风险。 |
| 英文摘要: |
| Objective To observe the effect of prophylactic anticoagulation by low molecular weight heparin (LMWH) on the prognosis of advanced non-small cell lung cancer (NSCLC) and analyze the dominant population. Methods Two hundred and twenty-six patients with NSCLC at high risk for thromboembolism were randomly divided into the treatment group (113 cases) and the control group (113 cases).The progression-free survival (PFS) and overall survival (OS) were observed in both groups. Results The median progression-free survival time(mPFS)of the treatment group and the control group were 6.4 months (95%CI:5.97-6.83 months) and 6.3 months (95%CI:5.98-6.62 months),respectively,P=0.18.The median overall survival(mOS) of the treatment group and the control group were 20.9 months (95%CI:18.90-22.90 months) and 20.7m(95%CI:17.70-23.70 months),P=0.15.The mPFS of EGFR mutation subgroup and control group were 10.2 months (95%CI:7.98-12.42 months) and 9.9 months (95%CI:9.17-10.63 months),P=0.03.The mOS of EGFR mutation subgroup and control groupwere 28.9 months (95%CI:26.62-31.18 months) and 28.6 months (95%CI:28.08-29.13 months),P=0.01.The mPFS of EGFR-TKI treatment group and control group were 11.9 months (95%CI:10.55-13.25 months) and 10.8 months (95%CI:10.03-11.57 months),P=0.03.The mOS of EGFR-TKI treatment subgroup and control group were 28.1 months (95%CI:27.29-28.95 months) and 27.8 months (95%CI:25.8-29.74 months),P=0.02.In EGFR mutation subgroup,HR of PFS was 0.65(95%CI:0.43-0.97) in treatment subgroup,P=0.03,HR of OS was 0.53(95%CI:0.33-0.84) in treatment subgroup,P=0.01.In EGFR-TKI treatment subgroup,HR of PFS was 0.59(95%CI:0.37-0.95) in treatment subgroup,P=0.03,HR of OS was 0.55(95%CI:0.33-0.91) in treatment subgroup,P=0.02. Conclusion The prophylactic anticoagulation by low molecular weight heparin(nadroparin) has no significant effect on prolong PFS and OS in advanced NSCLC,but it can prolong PFS and OS and reduce risk of death in patients with EGFR mutation and EGFR-TKI. |
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