一项使用扶正消瘤贴治疗原发性肝癌疼痛的随机、双盲、安慰剂对照试验方案
A Randomized, Double-Blind, Placebo-Controlled Trial Protocol Using the Fuzhengxiaoliu Patch for the Management of Primary Liver Cancer Pain.
作者信息
Li Siman, Wang Binding, Deng Jiayao, Li Haiyan, Wu Yong, Fang Yu, Chen Yu, Yan Bohua
机构信息
School of Clinical Medicine, Chengdu University of TCM, Chengdu, Sichuan, People's Republic of China.
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China.
出版信息
J Pain Res. 2025 Jan 6;18:33-42. doi: 10.2147/JPR.S500305. eCollection 2025.
OBJECTIVE
Chronic pain strongly affects the quality of life of patients with liver cancer pain. Safe and effective management of cancer-related pain is a worldwide challenge. Traditional Chinese medicine (TCM) has rich clinical experience in the treatment of cancer pain. The Fuzhengxiaoliu patch (FZXLP) is a compound TCM with the effects of detoxification and pain relief and has shown great efficacy in the treatment of patients with liver cancer, but high-quality clinical research that provides research-based evidence is lacking. We designed a randomized, double-blind, placebo-controlled trial to explore and evaluate the efficacy of FZXLP for the treatment of liver cancer pain.
METHODS
This is a prospective, randomized, double-blind, placebo-controlled trial. The trial will enrol 72 participants with primary liver cancer with cancer pain (damp-heat stagnation and toxin and blood stasis syndrome). The primary objective is to measure the reduction in pain using FZXLP in combination with tegafur, gimeracil and oteracil potassium capsule (S-1) compared to the placebo group with S-1. Pain will be measured by the number of opioids used, Chinese versions of the numerical rating scale (NRS), pain relief rate and number of breakthrough cases of cancer pain (BTcP). The secondary objectives include response evaluation criteria in solid tumors (RECIST), tumor markers, TCM syndrome scores, weight, functional assessment of cancer therapy-hepatobiliary (FACT-Hep) questionnaire scores, and self-rating anxiety scale scores. Adverse events (AEs) will be recorded throughout the study.
DISCUSSION
This study integrated TCM with clinical research to assess the efficacy and safety of the addition of FZXLP in the treatment of primary liver cancer pain.
TRIAL REGISTRATION
Chinese clinical trial registry, ChiCTR2300076951, Registered on October 25, 2023. https://www.chictr.org.cn/showproj.html?proj=209608.
目的
慢性疼痛严重影响肝癌疼痛患者的生活质量。安全有效地管理癌症相关疼痛是一项全球性挑战。中医在癌症疼痛治疗方面有着丰富的临床经验。扶正消瘤贴（FZXLP）是一种具有解毒止痛作用的复方中药，在肝癌患者治疗中已显示出显著疗效，但缺乏提供循证依据的高质量临床研究。我们设计了一项随机、双盲、安慰剂对照试验，以探索和评估FZXLP治疗肝癌疼痛的疗效。
方法
这是一项前瞻性、随机、双盲、安慰剂对照试验。该试验将招募72名患有原发性肝癌且伴有癌痛（湿热瘀毒证）的参与者。主要目的是比较FZXLP联合替吉奥胶囊（S-1）与S-1安慰剂组相比，使用FZXLP后疼痛的减轻情况。疼痛将通过使用阿片类药物的数量、中文版数字评分量表（NRS）、疼痛缓解率和癌痛爆发性发作次数（BTcP）来衡量。次要目标包括实体瘤疗效评价标准（RECIST）、肿瘤标志物、中医证候评分、体重、癌症治疗功能评估-肝胆（FACT-Hep）问卷评分和自评焦虑量表评分。在整个研究过程中记录不良事件（AE）。
讨论
本研究将中医与临床研究相结合，以评估加用FZXLP治疗原发性肝癌疼痛的疗效和安全性。
试验注册
中国临床试验注册中心，ChiCTR2300076951，于2023年10月25日注册。https://www.chictr.org.cn/showproj.html?proj=209608 。
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