为了对正在实施的紫龙金片治疗非小细胞肺癌的前瞻性真实世界研究数据进行中期分析，初步评估紫龙金片改善患者临床结局的可能优势，采用前瞻性注册登记研究设计，招募确诊为非小细胞肺癌的患者，依据是否使用过紫龙金片区分为暴露组和非暴露组。选择其中随访时长超过18个月的患者数据，采用倾向性评分匹配对重要临床因素进行控制，对患者生存时间数据进行生存分析，采用Kaplan-Meier法计算估计生存率，采用Cox比例风险回归模型估算2组间的风险比（HR），比较2组人群的终点事件发生率、估计生存率、体力状态和生活质量评分。结果表明：暴露组死亡和失访发生率在匹配前后均低于非暴露组（P<0.05）。生存分析显示匹配前后暴露组估计生存率高于非暴露组，其中第18个月2组估计生存率匹配前分别为0.872和0.823，匹配后分别为0.865和0.816。2组生存曲线具有显著差异（P<0.05），匹配前后HR分别为0.661和0.474。匹配前后在第6个月和第18个月访视点时，暴露组美国东部肿瘤协作组体力状态评分（ECOG-PS）评分0分的比例较高（P<0.05）。匹配后在第6个月访视点时暴露组欧洲五维健康量表健康状况视觉模拟评分（EQ-VAS）显著高于非暴露组（P<0.05）。研究结果证明紫龙金片的临床应用能降低非小细胞肺癌患者的死亡终点发生率，提高患者生存率，并在维持患者体力状态和生活质量评分方面表现出优于非暴露组的趋势。
刘强
,
于明薇
,
吴万垠
,
郭勇
,
陈军
,
贺宇彤
,
薛文翰
,
张洪珍
,
郭秋香
,
杨国旺
,
张怡
,
游佳凤
,
杨永
,
高宠
,
念家云
,
何丽云
,
王笑民
. 紫龙金片对非小细胞肺癌患者临床结局影响的真实世界研究[J]. 科技导报, 2023
, 41(14)
: 82
-91
.
DOI: 10.3981/j.issn.1000-7857.2023.14.010
To conduct an interim analysis on the data of an ongoing prospective real world study of Zilongjin tablet in the treatment of non-small cell lung cancer (NSCLC), and preliminarily evaluate the potential advantages of Zilongjin tablets in improving clinical outcomes of patients, a prospective registry study was designed to enroll patients with NSCLC. The patients were divided into exposure group and non-exposure group according to using Zilongjin tablets for treatment. Analysis was focused on the subjects been followed up for more than 18 months, and propensity score matching was adopted to control confounding factors. Kaplan-Meier method was used to calculate the estimated survival rate, Cox proportional risk regression model was used to estimate the risk ratio between the two groups, and the incidence of end events, estimated survival rate, physical strength and quality of life scores were compared between groups. The mortality and loss of follow-up in exposure group was lower than that in non-exposure group before and after matching (P<0.05). The survival analysis showed that the estimated survival rate of the exposure group before and after matching was higher than that of the non-exposure group. The estimated survival rates of the two groups at the 18th month were 0.872 and 0.823 before the match, and 0.865 and 0.816 after matching, respectively. There was a significant difference in the survival curve between the two groups (P<0.05). The risk ratio (HR) before and after matching was 0.661 and 0.474, respectively. For ECOG-PS score before and after matching, the proportion of zero point in exposure group at the 6th and 18th month was higher (P<0.05). After matching, the EQ-VAS of exposure group was significantly higher than that of non-exposure group at the 6th month (P<0.05). The clinical application of Zilongjin tablets can reduce the incidence of death end points and improve the survival rate of patients with non-small cell lung cancer. Compared with the non-exposure group, it also showed potential advantages in maintaining patients' physical strength and quality of life scores.
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