中药治疗非小细胞肺癌的不朽时间偏倚校正有效性（C-EVID）：一项前瞻性队列研究。
Immortal Time Bias-Corrected Effectiveness of Traditional Chinese Medicine in Non-Small Cell Lung Cancer (C-EVID): A Prospective Cohort Study.
作者信息
Zhang Xing, Guo Qiujun, Li Conghuang, Liu Rui, Xu Tao, Jin Zhichao, Xi Yupeng, Qin Yinggang, Li Weidong, Chen Shuntai, Xu Ling, Lin Lizhu, Shao Kang, Wang Shenyu, Xie Ying, Sun Hong, Li Ping, Chu Xiangyang, Chai Kequn, Shu Qijin, Liu Yanqing, Zhang Yue, Hu Jiaqi, Shi Bolun, Zhang Xiwen, Zhang Zhenhua, Jiang Juling, He Shulin, He Jie, Sun Mingxi, Zhang Ying, Zhang Meiying, Zheng Honggang, Hou Wei, Hua Baojin
机构信息
Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Department of Oncology, Xiyuan Hospital of China Academy of Chinese Medicine, Beijing, China.
出版信息
Front Oncol. 2022 Apr 22;12:845613. doi: 10.3389/fonc.2022.845613. eCollection 2022.
BACKGROUND
Relatively little is known about the effect of traditional Chinese medicine (TCM) on prognosis of non-small cell lung cancer (NSCLC).
METHODS
In this nationwide, multicenter, prospective, cohort study, eligible patients aged 18-75 years with radical resection, and histologically confirmed stage II-IIIA NSCLC were enrolled. All patients received 4 cycles of standard adjuvant chemotherapy. Patients who received Chinese herbal decoction and (or) oral Chinese patent medicine for a cumulative period of not less than 6 months were defined as TCM group, otherwise they were considered as control group. The primary endpoint was DFS calculated using the Kaplan-Meier method. A time-dependent Cox proportional hazards model was used to correct immortal time bias. The secondary endpoints included DFS in patients of different characteristics, and safety analyses. This study was registered with the Chinese Clinical Trial Registry (ChiCTR1800015776).
RESULTS
A total of 507 patients were included (230 patients in the TCM group; 277 patients in the control group). The median follow-up was 32.1 months. 101 (44%) in the TCM group and 186 (67%) in the control group had disease relapse. The median DFS was not reached in the TCM group and was 19.4 months (95% CI, 14.2 to 24.6) in the control group. The adjusted time-dependent HR was 0.61 (95% CI, 0.47 to 0.78), equalling to a 39% reduction in the risk of disease recurrence with TCM. the number needed to treat to prevent one patient from relapsing was 4.29 (95% CI, 3.15 to 6.73) at 5 years. Similar results were observed in most of subgroups. Patients had a significant improvement in white blood cell decrease, nausea, decreased appetite, diarrhea, pain, and fatigue in the TCM group.
CONCLUSION
TCM may improves DFS and has a better tolerability profile in patients with stage II-IIIA NSCLC receiving standard chemotherapy after complete resection compared with those receiving standard chemotherapy alone. Further studies are warranted.
背景
关于中药对非小细胞肺癌（NSCLC）预后的影响，人们了解相对较少。
方法
在这项全国性、多中心、前瞻性队列研究中，纳入了年龄在18 - 75岁、接受根治性切除且经组织学证实为II - IIIA期NSCLC的合格患者。所有患者均接受4个周期的标准辅助化疗。接受中药汤剂和（或）口服中成药累计时间不少于6个月的患者被定义为中药组，否则被视为对照组。主要终点是使用Kaplan - Meier方法计算的无病生存期（DFS）。采用时间依赖性Cox比例风险模型校正不朽时间偏倚。次要终点包括不同特征患者的DFS以及安全性分析。本研究已在中国临床试验注册中心注册（ChiCTR1800015776）。
结果
共纳入507例患者（中药组230例；对照组277例）。中位随访时间为32.1个月。中药组101例（44%）疾病复发，对照组186例（67%）疾病复发。中药组未达到中位DFS，对照组为19.4个月（95%可信区间，14.2至24.6）。校正后的时间依赖性风险比为0.61（95%可信区间，0.47至0.78），相当于中药治疗使疾病复发风险降低39%。5年时预防1例患者复发所需治疗人数为4.29（95%可信区间，3.15至6.73）。在大多数亚组中观察到类似结果。中药组患者在白细胞减少、恶心、食欲减退、腹泻、疼痛和疲劳方面有显著改善。
结论
与单纯接受标准化疗的患者相比，中药可能改善II - IIIA期NSCLC患者在完全切除后接受标准化疗时的DFS，并具有更好的耐受性。有必要进行进一步研究。
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