| 郑勤红,余洁,缪倩,王思为.埃克替尼联合榄香烯注射液治疗晚期肺腺癌的前瞻性、随机对照研究[J].浙江中西医结合杂志,2021,31(5): |
| 埃克替尼联合榄香烯注射液治疗晚期肺腺癌的前瞻性、随机对照研究 |
| Efficacy assessment of icotinib combined with β-elemene injection in patients with EGFR sensitive mutant unresectable lung adenocarcinoma cancer, a prospective, randomized comtrolled study |
| 投稿时间：2020-10-12 修订日期：2021-03-15 |
| DOI： |
| 中文关键词: 埃克替尼，β-榄香烯，晚期肺腺癌 |
| 英文关键词:Icotinib, β-elemene injection, lung adenocarcinoma cancer |
| 基金项目:浙江省医学临床科研资金项目（2016ZYC-B19） |
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| 中文摘要: |
| 目的：本研究旨在比较盐酸埃克替尼联合β-榄香烯对比单用埃克替尼在EGFR敏感突变型晚期肺腺癌患者的疗效及安全性。方法：筛选EGFR敏感突变型晚期肺腺癌初治患者，按1:2的比例随机分组。联合治疗组接受盐酸埃克替尼联合β-榄香烯方案，对照组接受单用盐酸埃克替尼治疗。观察两组患者无进展生存期（PFS），疾病缓解率（ORR），疾病控制率（DCR）及药物不良反应。结果：共纳入38例患者，其中联合治疗组12例，对照组26例。结果显示PFS在联合治疗组及对照组分别为11.5个月对比7.0个月（P=0.037）。ORR在联合治疗组及对照组分别为83.33%对比76.92%（P=0.652）。DCR在联合治疗组及对照组分别为100%对比96.15%（P=0.491）。两组患者皮疹（χ2=2.063，P=0.287）和肝功能异常（χ2=0.01，P=0.920）的不良反应发生率无统计学差异。结论：本研究结果提示与单用埃克替尼相比，β-榄香烯联合盐酸埃克替尼治疗EGFR敏感突变型晚期肺腺癌可能延长患者的PFS，且不良反应可耐受。 |
| 英文摘要: |
| Objective: The present study was conducted to compare the efficacy and safety profile between regimen of icotinib combined with β-elemene injection and icotinib alone in patients with EGFR sensitive mutant unresectable lung adenocarcinoma cancer. Patients and Methods: Patients initially diagnosed with unresectable lung adenocarcinoma cancer harboring EGFR sensitive mutations were 1:2 randomly assigned to combined group and control group. Patients in combined group, and control group received icotinib combined with β-elemene injection treatment, or icotinib alone treatment, respectively. The primary outcome was set as progressive free survival (PFS), while objective response rate (ORR), disease control rate (DCR) and safety being secondary ones. Results: A total of 38 patients were included in the present study, with 12 patients in the combined group and 26 ones in the control group. It was revealed that there was a superior PFS in combined group compared to control group (11.5 versus 7.0 months, P=0.037). However, there was no statistical difference observed on ORR (83.33% versus 76.92, P=0.652) or DCR (100% versus 96.15%, P=0.491) between combined group and control group. In addition, there was no significant difference on the incidence of rash (χ2=2.063，P=0.287) or abnormal liver function (χ2=0.01，P=0.920) between the groups. Conclusion: The results of the present study revealed that icotinib combined with β-elemene injection may significantly prolong PFS, with tolerable toxicities compared to icotinib alone in patients with EGFR sensitive mutant unresectable lung adenocarcinoma cancer. |
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