乳腺癌后绝经期患者使用穴位线嵌入结合温肾补骨汤治疗芳香化酶抑制剂相关肌肉骨骼症状的研究方案:随机对照试验的研究计划。
Acupoint Thread Embedding Combined With Wenshen Bugu Decoction for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptom Among Postmenopausal Breast Cancer Patients: Study Protocol of a Randomized Controlled Trial.
发表日期:2023
作者:
Xuan Zou, Zi-Yi Chen, Yu-Han Yang, Yu Qiao, Shu-Jin He, Qiong Li, Wei-Li Chen, Xin-Yue Zhang, Si-Yu Li, Shan-Yan Sha, Min-Hao Hu, Xi-Yin Zhang, Ming-Ju Yang, Rui-Ping Wang, Huan-Gan Wu, Yin Shi, Xiao-Hong Xue, Ya-Jie Ji
来源:
Bone & Joint Journal
摘要:
芳香化酶抑制剂(AIs)被推荐作为激素受体阳性(HR+)乳腺癌绝经后妇女的首选治疗方案。因此,芳香化酶抑制剂相关肌肉骨骼症状(AIMSS)已成为患者在接受辅助性AIs治疗过程中停药和生活质量下降的重要问题。已尝试多种治疗方法,但临床疗效有限。本研究旨在确定针灸穴位埋线疗法(ATE)与补骨衰割决煎汤(Wenshen Bugu Decoction)联合治疗是否能有效治疗AIMSS,以提高绝经后乳腺癌患者接受AIs药物依从性。本研究将采用随机、两组对照试验设计。共纳入128例符合条件的AIMSS绝经后乳腺癌患者,以1:1的比例随机分为两组:补骨衰割决煎汤单独治疗组(对照组)和联合ATE治疗组(治疗组),每组治疗12周。主要观察指标为12周时的Brief Pain Inventory Worst Pain (BPI-WP)评分。次要观察指标包括治疗反应率,Brief Pain Inventory-Short Form (BFI-SF),Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC),Functional Assessment of Cancer Therapy-Endocrine Symptom (FACT-ES),Functional Assessment of Cancer Therapy-Breast (FACT-B),骨密度(BMD),骨代谢物血标记物,Morisky药物依从性量表-8 (MMAS-8),可信度和期望度,以及生存结局。本试验可能为绝经后乳腺癌幸存者治疗AIMSS提供临床证据,表明ATE联合补骨衰割决煎汤可能有益。我们的研究结果有助于提高生活质量、减少停药情况的发生。
Aromatase inhibitors (AIs) are recommended as the preferred therapy for postmenopausal women with hormone receptor-positive (HR+) breast cancer. As a result, aromatase inhibitor-associated musculoskeletal symptom (AIMSS) have become a major problem leading to therapy discontinuation and decreased quality of life in patients receiving adjuvant AIs treatment. Multiple therapies have been attempted, but have yielded limited clinical results. This study will be performed to determine whether acupoint thread embedding (ATE) combined with Wenshen Bugu Decoction can effectively treat AIMSS, so as to improve the AIs medication compliance of postmenopausal breast cancer patients.This study will utilize a randomized, 2 parallel groups controlled trial design. A total of 128 eligible postmenopausal breast cancer women with AIMSS will be randomized to receive a 12-week treatment with Wenshen Bugu Decoction alone (control group) or in combination with ATE (treatment group) in a 1:1 ratio. The primary outcome will be the 12 week Brief Pain Inventory Worst Pain (BPI-WP) score. The secondary outcome measures will include response rate, Brief Pain Inventory-Short Form (BFI-SF), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Functional Assessment of Cancer Therapy-Endocrine Symptom (FACT-ES), Functional Assessment of Cancer Therapy-Breast (FACT-B), bone marrow density (BMD), blood markers of bone metabolite, Morisky medication adherence scale-8 (MMAS-8), credibility and expectancy, and survival outcomes.This trial may provide clinical evidence that ATE combined with Wenshen Bugu Decoction can be beneficial for treating AIMSS among postmenopausal breast cancer survivors. Our findings will be helpful to enhance the quality of life and reduce the occurrence of AIs withdrawal.