紫龙金片联合表皮生长因子受体酪氨酸激酶抑制剂治疗晚期非小细胞肺癌的真实世界疗效分析  

Real-world Efficacy Analysis of Zilongjin Tablets Combined with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor for the Treatment of Advanced Non-small Cell Lung Cancer

作　　者：李朕 蔡钢 李皖豫 雷丽霞 何文婷[3] 张洪亮[3] LI Zhen;CAI Gang;LI Wan-yu;LEI Li-xia;HE Wen-ting;ZHANG Hong-liang(The Fourth Clinical Medical College of Xinjiang Medical University,Urumqi 830000 Xinjiang,China;Department of Traditional Chinese Medicine and Respiratory,the First Affiliated Hospital of Shihezi University,Shihezi 832000 Xinjiang,China;The Second Department of Oncology,the Affiliated Hospital of Traditional Chinese Medicine,Xinjiang Medical University,Urumqi 830000 Xinjiang,China)

机构地区：[1]新疆医科大学第四临床医学院,新疆乌鲁木齐830000 [2]石河子大学第一附属医院中医科呼吸科,新疆石河子832000 [3]新疆医科大学附属中医医院肿瘤二科,新疆乌鲁木齐830000

出　　处：《中医肿瘤学杂志》2024年第2期42-48,共7页Journal of Oncology in Chinese Medicine

基　　金：蔡钢全国名中医传承工作室建设项目;北京市中医药科技发展资金重点项目(编号:BJZYZD-2023-10)。

摘　　要：目的观察紫龙金片联合表皮生长因子受体酪氨酸激酶抑制剂(epidermal growth factor receptor tyrosine kinase inhibitors,EGFR-TKIs)治疗晚期非小细胞肺癌的疗效。方法采用真实世界前瞻性队列研究方法,选取2021年1月—2022年6月在新疆维吾尔自治区中医医院、石河子大学第一附属医院就诊的表皮生长因子受体(epidermal growth factor receptor,EGFR)基因敏感突变的晚期非小细胞肺癌患者76例,以是否服用紫龙金片划分为暴露组35例、非暴露组41例。非暴露组给予EGFR-TKIs,服药至疾病进展或无法耐受;暴露组在非暴露组基础上加用紫龙金片,至少服用8周。8周后比较两组的生活质量、体力状况、临床症状等指标情况,并观察不良反应,随访两组无进展生存期(progression free survival,PFS)。结果暴露组的平均无进展生存时间高于非暴露组(14.9个月vs 12.9个月,P<0.05),Cox回归分析显示服用紫龙金片和无肿瘤家族史是独立的保护因素。在生活质量EQ-5D评分方面,暴露组在“活动能力”、“日常活动”和“疼痛/不适”方面得分较低(P<0.05);在临床症状改善方面,暴露组胸闷、疲乏无力的改善率高于非暴露组(P<0.05);治疗后,暴露组的体力状况ECOG评分明显降低(P<0.05),而非暴露组降低不显著。两组患者的不良反应均在可接受范围内,差异没有统计学意义(P>0.05)。结论紫龙金联合EGFR-TKIs治疗晚期非小细胞肺癌患者,有延长无进展生存期的趋势,可改善患者临床症状、提高生活质量。Objective To observe the efficacy of Zilongjin Tablets combined with epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKIs)in the treatment of advanced non-small cell lung cancer.Methods A real-world prospective cohort study method was used.76 advanced non-small cell lung cancer patients with sensitive mutation of epidermal growth factor receptor(EGFR)gene who were treated in the Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region and the First Affiliated Hospital of Shihezi University from January 2021 to June 2022 were selected.The patients were divided into an exposure group of 35 cases and a non exposure group of 41 cases according to whether they took Zilongjin Tablets or not.In the non-exposure group,EGFR-TKIs were given until disease progression or intolerance.Zilongjin Tablets were applied to the non-exposure group for at least 8 weeks.After 8 weeks of treatment,the quality of life,physical condition,clinical symptoms,and other indicators of the two groups were compared,adverse reactions were observed,and progression free survival(PFS)was followed up.Results The mean PFS of the exposure group was significantly higher than that of the non exposure group(14.9 months vs 12.9 months,P<0.05).Cox regression analysis showed that the use of Zilongjin Tablets and the absence of family history of tumour were independent protective factors.In terms of EQ-5D scores representing quality of life,the exposure group had lower scores in“activity ability”,“daily activity”,and“pain/discomfort”(P<0.05).In terms of improvement of clinical symptoms,the improvement rates of chest tightness,fatigue and weakness in the exposure group were higher than those in the non-exposure group(P<0.05).The ECOG score of physical condition in the exposure group significantly decreased after treatment(P<0.05),while the decrease in the non-exposure group was not significant.The adverse reactions of the two groups were within an acceptable range,and the difference was not statistically significant

关 键 词：非小细胞肺癌 真实世界研究 紫龙金片 EGFR-TKIS 生存分析 

分 类 号：R273[医药卫生—中西医结合] R734[医药卫生—中医肿瘤科]