参灵草口服液用于非小细胞肺癌根治术后辅助化疗患者的多中心随机对照试验。

Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial.

机构信息

Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, China.

Department of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou 310003, China.

出版信息

Phytomedicine. 2023 May;113:154723. doi: 10.1016/j.phymed.2023.154723. Epub 2023 Feb 21.

DOI:10.1016/j.phymed.2023.154723

PMID:36871476

Abstract

BACKGROUND

Low quality of life (QoL) in patients with non-small cell lung cancer (NSCLC) receiving adjuvant chemotherapy after radical resection is a major global health issue. High-quality evidence for the effectiveness of Shenlingcao oral liquid (SOL) as a complementary treatment in this patients is lacking at present.

PURPOSE

To determine whether complementary SOL treatment in NSCLC patients receiving adjuvant chemotherapy would yield greater improvements in QoL than chemotherapy alone.

STUDY DESIGN

We conducted a multicenter, randomized controlled trial of stages IIA-IIIA NSCLC patients undergoing adjuvant chemotherapy in seven hospitals.

METHODS

Using stratified blocks, participants were randomized in a 1:1 ratio to receive SOL combined with conventional chemotherapy or conventional chemotherapy alone. The primary outcome was the change in global QoL from baseline to the fourth chemotherapy cycle, and intention-to-treat analysis was applied with a mixed-effect model. Secondary outcomes were functional QoL, symptoms, and performance status scores at the 6-month follow-up. Missing data were handled with multiple imputation and a pattern-mixture model.

RESULTS

Among 516 randomized patients, 446 (86.43%) completed the study. After the fourth chemotherapy cycle, in comparison with the control group, patients receiving SOL showed a lower reduction in mean global QoL (-2.76 vs. -14.11; mean difference [MD], 11.34; 95% confidence interval [CI], 8.28 to 14.41), greater improvement in physical function (MD, 11.61; 95% CI, 8.57 to 14.65), role function (MD, 10.15; 95% CI, 5.75 to 14.54), and emotional function (MD, 4.71; 95% CI, 1.85 to 7.57), and greater improvements in lung cancer-related symptoms (e.g., fatigue, nausea/vomiting, and appetite loss) and performance status during the 6-month follow-up period (treatment main effect, p < 0.05).

CONCLUSION

SOL treatment for NSCLC patients receiving adjuvant chemotherapy can significantly improve QoL and performance status within 6 months after radical resection.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT03712969.

摘要

背景

接受根治性手术后的非小细胞肺癌（NSCLC）患者在接受辅助化疗后生活质量（QoL）较差，这是一个全球性的主要健康问题。目前缺乏对参灵草口服液（SOL）作为该患者辅助治疗有效性的高质量证据。

目的

确定 NSCLC 患者在接受辅助化疗时，补充 SOL 治疗是否比单纯化疗能带来更大的 QoL 改善。

研究设计

我们在 7 家医院进行了一项 IIA-IIIA 期 NSCLC 患者接受辅助化疗的多中心、随机对照试验。

方法

采用分层分组，参与者以 1:1 的比例随机接受 SOL 联合常规化疗或单纯常规化疗。主要结局是从基线到第 4 个化疗周期的全球 QoL 变化，采用混合效应模型进行意向治疗分析。次要结局是 6 个月随访时的功能 QoL、症状和表现状态评分。缺失数据采用多重插补和模式混合模型处理。

结果

在 516 名随机患者中，有 446 名（86.43%）完成了研究。与对照组相比，在第 4 个化疗周期后，接受 SOL 治疗的患者的全球 QoL 平均下降幅度较小（-2.76 对-14.11；平均差值[MD]，11.34；95%置信区间[CI]，8.28 至 14.41），身体功能（MD，11.61；95%CI，8.57 至 14.65）、角色功能（MD，10.15；95%CI，5.75 至 14.54）和情绪功能（MD，4.71；95%CI，1.85 至 7.57）改善更大，在 6 个月随访期间肺癌相关症状（如疲劳、恶心/呕吐和食欲减退）和表现状态也有更大改善（治疗主效应，p<0.05）。