Exclusive:Real world clinical research of Traditional Chinese Medicine
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
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.