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.
LIU Qiang
,
YU Mingwei
,
WU Wanyin
,
GUO Yong
,
CHEN Jun
,
HE Yutong
,
XUE Wenhan
,
ZHANG Hongzhen
,
GUO Qiuxiang
,
YANG Guowang
,
ZHANG Yi
,
YOU Jiafeng
,
YANG Yong
,
GAO Chong
,
NIAN Jiayun
,
HE Liyun
,
WANG Xiaomi
. Real-world study on the effect of Zilongjin tablets in improving clinical outcome of patients with non-small cell lung cancer[J]. Science & Technology Review, 2023
, 41(14)
: 82
-91
.
DOI: 10.3981/j.issn.1000-7857.2023.14.010
[1] 国家卫生健康委办公厅 . 原发性肺癌诊疗指南(2022 年版)[J]. 协和医学杂志, 2022, 13(4): 549-570.
[2] 游佳凤, 于明薇, 杨国旺 . 紫龙金片临床应用及相关机理研究进展[J/OL]. 世界科学技术-中医药现代化 .[2022-12-18]. http://kns.cnki.net/kcms/detail/11.5699.R.20221027.1844.004.html.
[3] 林洪生, 李萍萍, 薛冬, 等. 肿瘤姑息治疗中成药使用专家共识(2013 版)[J]. 中国中西医结合杂志, 2016, 36(3): 269-279.
[4] 叶思思, 肖祖林, 任真, 等. 紫龙金片联合化疗治疗非小细胞肺癌的疗效及安全性 Meta 分析[J]. 中医药导报, 2020, 26(5): 97-102.
[5] 刘春香, 王辉, 翟静波, 等. 紫龙金治疗非小细胞肺癌的系统评价[J]. 辽宁中医杂志, 2013, 40(12): 2448-2453, 2637.
[6] 于明薇, 刘强, 张怡, 等. 紫龙金片治疗肺癌的真实世界数据回顾性研究[C]//第十七届全国中西医结合肿瘤学术大会摘要集. 上海: 中国中西医结合学会肿瘤专业委员会, 2019: 126.
[7] 于明薇, 刘强, 吴万垠, 等. 基于多中心真实世界数据的紫龙金片辅助治疗肺癌患者生存分析[J]. 中草药, 2022, 53(12): 3730-3739.
[8] Neeman E, Gresham G, Ovasapians N, et al. Comparing physician and nurse eastern cooperative oncology group performance status (ecog-ps) ratings as predictors of clinical outcomes in patients with cancer[J]. Oncologist, 2019, 24(12): e1460-e1466.
[9] Krishnan M, Temel J S, Wright A A, et al. Predicting life expectancy in patients with advanced incurable cancer: A review[J]. The Journal of Supportive Oncology, 2013, 11(2): 68-74.
[10] 李明晖, 罗南 . 欧洲五维健康量表(EQ-5D)中文版应用介绍[J]. 中国药物经济学, 2009(1): 49-57.
[11] Liu G G, Wu H, Li M, et al. Chinese time trade-off values for EQ-5D health states[J]. Value in Health, 2014, 17(5): 597-604.
[12] 史钊, 李顺平, 扎西达娃, 等. EQ-5D-3L量表两种中国效用积分体系的比较: 基于西藏城乡居民的应用[J]. 中国卫生经济, 2019, 38(12): 9-12.
[13] 柏柳安宁, 夏结来, 王陵, 等 . 真实世界研究中的常见偏倚及其控制[J]. 中国临床药理学与治疗学, 2020, 25(12): 1422-1428.
[14] 中医真实世界研究技术规范通则: T/CACM 022—2017[S]. 北京: 中华中医药学, 2017.
[15] Zhang P, Wang X, Xiong S, et al. Genome wide expression analysis of the effect of the Chinese patent medicine Zilongjin tablet on four human lung carcinoma cell lines[J]. Phytotherapy Research, 2011, 25(10): 1472-1479.
[16] 王代树, 施学东, 梁云燕, 等 . 中药白龙与 HMBA 对人癌周期细胞CKI-P16的调控[J]. 中国中西医结合杂志, 2001(10): 763-766.
[17] 史东升, 周静敏, 马淑萍 . 紫龙金对人非小细胞肺癌A549 细胞生长及 VEGF 表达的影响[J]. 中国肿瘤临床, 2011, 38(20): 1267-1270.
[18] 谢远平, 田宁, 宁华, 等 . 基于网络药理学和分子对接的紫龙金片治疗肺癌的作用机制研究[J/OL]. [2022-12-18]. http://kns.cnki.net/kcms/detail/21.1128.R.20220815.1820.126.html.
[19] 陈吉, 孙月, 布优祥, 等 . 中医领域真实世界研究现状分析[J]. 中国循证医学杂志, 2018, 18(11): 1216-1223.
[20] 张妮楠, 史华新, 周洪伟, 等 . 中医真实世界研究的特征探析[J]. 世界科学技术-中医药现代化, 2018, 20(9): 1496-1500.
[21] 叶晓勤, 谢雁鸣, 王利娜, 等 . 倾向性评分法在中医复杂干预非随机化数据疗效评价中的应用[J]. 中华中医药杂志, 2015, 30(10): 3414-3417.
[22] 焦明旭, 张晓, 刘迪, 等 . 倾向性评分匹配在非随机对照研究中的应用[J]. 中国卫生统计, 2016, 33(2): 350-352.
[23] 黎国威, 张玲, 陈裕明, 等 . 倾向性评分方法在观察性研究中的应用[J]. 中国循证医学杂志, 2021, 21(4): 469-474.
