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不同疗程中成药治疗Ⅱ-Ⅲ期非小细胞肺癌患者2年生存率改善情况的比较:一项回顾性队列研究

Comparison of Improvement in 2-Year Survival Rate of Patients with Stage II-III Non-Small Cell Lung Cancer Treated with Different Durations of Chinese Patent Medicine: A Retrospective Cohort Study.

作者信息

Wang Li, Jia Kegang, Li Fang, Zhang Chenxu, Feng Gang, Du Jun

机构信息

Oncology Department of Jiangsu Institute of Cancer Research (Jiangsu Cancer Hospital), Nanjing, China.

Department of Thoracic Surgery, Sichuan Provincial People's Hospital, Chengdu, China.

出版信息

Front Pharmacol. 2021 Sep 2;12:719802. doi: 10.3389/fphar.2021.719802. eCollection 2021.

Abstract

Chinese patent medicine is widely used among patients with malignant tumors, and current studies have shown that long-term treatment with Chinese patent medicine is related to improved outcomes of patients. Huisheng Oral Liquid is a kind of Chinese patent medicine with the effects of curing dispersion-thirst and dissipating blood stasis. However, little is known about how it affects the survival rate of patients. Thus, patients with stage II-III NSCLC (non-small-cell lung cancer) were chosen to participate in a retrospective cohort study, which was conducted to preliminarily investigate the effects of using Chinese patent medicine and Huisheng Oral Liquid for different treatment durations on patients' 2-year survival rate and explore the prognostic factors affecting the 2-year survival rate of those patients. This work compares the effect of different durations of treatment with Chinese patent medicine and Huisheng Oral Liquid on the 2-year survival rate of patients with stage II-III NSCLC and explores the prognostic factors of the patients' 2-year survival rate. This retrospective cohort study included patients with non-small cell lung cancer stage II-III according to the 2015 NCCN Guidelines: Non-Small Cell Lung Cancer. The Kaplan-Meier method was used to compare the 2-year survival rate of patients treated with different durations of Chinese medicine and Huisheng Oral Liquid. The relationship between different treatment durations and degree of improvement of 2-year survival rate was explored using the Cochran-Armitage trend test. The Cox proportional-hazards regression models were used to explore factors affecting the 2-year survival rate of patients. A total of 614 patients with stage II-III NSCLC diagnosed from January 2015 to December 2018 were included in this study. Patients treated with Chinese patent medicine were divided into three groups by treatment durations: < 3 months, ≥ 3 months, and ≥6 months, and those treated with Huisheng Oral Liquid were divided into < 3 months and ≥3 and ≥6 months. The results showed that ① the 2-year survival rate of patients treated with Chinese patent medicine for ≥3 months and ≥6 months was higher than that of patients treated for <3 months and the difference was statistically significant ( < 0.05). Further analysis of Huisheng Oral Liquid treatment revealed that ② the 2-year survival rate of patients treated with Huisheng Oral Liquid for ≥3 months was higher than that of patients treated for <3 months ( < 0.05). Because the total number of patients treated with Huisheng Oral Liquid for ≥6 months and the number of patients with improved outcomes were too small, there was no statistically significant difference in the 2-year survival rate between the two groups ( > 0.05). The results of the Cochran-Armitage trend test showed that the 2-year survival rate tended to increase with the duration of Huisheng Oral Liquid treatment ( < 0.05). ③ The Cox proportional -hazards regression model revealed that among all 614 patients, surgery [HR = 0.48, 95% CI = (0.34, 0.68)], chemotherapy [HR = 0.46, 95% CI = (0.31,0.67)], and treatment with Huisheng Oral Liquid for ≥3 months were protective factors [HR = 0.48, 95%CI = (0.27,0.88)], whereas male gender [HR = 1.59, 95% CI = (1.01, 2.50)] and FIB ≥4 g/L [HR = 1.95, 95% CI = (1.37, 2.77)] were risk factors. Chinese patent medicine treatment for ≥3 months showed an improvement in the 2-year survival rate of patients with stage II-III NSCLC. Patients treated with Huisheng Oral liquid for ≥3 months also showed an improvement in the 2-year survival rate, and the 2-year survival rate tended to increase as the treatment duration increased. Finally, male and FIB ≥ 4 g/L were risk factors for prognosis.

摘要

中成药在恶性肿瘤患者中广泛应用,目前研究表明,长期服用中成药与患者预后改善有关。回生口服液是一种具有养阴生津、散瘀止痛作用的中成药。然而,其对患者生存率的影响尚不清楚。因此,选取II-III期非小细胞肺癌(NSCLC)患者参与一项回顾性队列研究,初步探讨使用中成药及不同疗程回生口服液对患者2年生存率的影响,并探索影响这些患者2年生存率的预后因素。 本研究比较了中成药及回生口服液不同疗程治疗对II-III期NSCLC患者2年生存率的影响,并探索患者2年生存率的预后因素。 这项回顾性队列研究纳入了根据2015年美国国立综合癌症网络(NCCN)非小细胞肺癌指南诊断为II-III期非小细胞肺癌的患者。采用Kaplan-Meier法比较不同疗程中药及回生口服液治疗患者的2年生存率。使用Cochran-Armitage趋势检验探索不同疗程与2年生存率改善程度之间的关系。采用Cox比例风险回归模型探索影响患者2年生存率的因素。 本研究共纳入2015年1月至2018年12月诊断为II-III期NSCLC的614例患者。服用中成药的患者按疗程分为三组:<3个月、≥3个月和≥6个月,服用回生口服液的患者分为<3个月组和≥3个月且≥6个月组。结果显示,①服用中成药≥3个月和≥6个月的患者2年生存率高于服用<3个月的患者,差异有统计学意义(<0.05)。对回生口服液治疗的进一步分析显示,②服用回生口服液≥3个月的患者2年生存率高于服用<3个月的患者(<0.05)。由于服用回生口服液≥6个月的患者总数及预后改善的患者数量过少,两组2年生存率差异无统计学意义(>0.05)。Cochran-Armitage趋势检验结果显示,回生口服液治疗时间越长,2年生存率越高(<0.05)。③Cox比例风险回归模型显示,在全部614例患者中,手术[风险比(HR)=0.48,95%置信区间(CI)=(0.34,0.68)]、化疗[HR=0.46,95%CI=(0.31,0.67)]以及服用回生口服液≥3个月是保护因素[HR=0.48,95%CI=(0.27,0.88)],而男性[HR=1.59,95%CI=(1.01,2.50)]和纤维蛋白原(FIB)≥4g/L[HR=1.95,95%CI=(1.37,2.77)]是危险因素。 服用中成药≥3个月可提高II-III期NSCLC患者的2年生存率。服用回生口服液≥3个月的患者2年生存率也有所提高,且2年生存率随治疗时间延长而升高。最后,男性和FIB≥4g/L是预后的危险因素。

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