1 China Medical University, Taichung, Taiwan.
2 China Medical University Hospital, Taichung, Taiwan.
Integr Cancer Ther. 2018 Sep;17(3):665-673. doi: 10.1177/1534735418756736. Epub 2018 Feb 11.
Hematopoietic stem cell transplantation has become a well-established treatment for hematologic disorders including acute leukemia. However, long-term survival rates following this procedure are still extremely low, due to posttransplantation relapse, infections, and graft-versus-host disease. We propose that adjunctive Chinese herbal medicine may benefit posttransplantation patients. In preparation for a randomized clinical trial, we conducted a pilot trial. Methods and Analysis: Between September 2015 and June 2017, 18 patients were consecutively enrolled at China Medical University Hospital and followed for up to 1 year. Fresh blood samples were obtained on a monthly basis, and immune reconstitution was analyzed. In addition to the standard-care treatment administered by their oncologist, a number of patients also received a Chinese herbal formula (Sheng-Yu-Tang) for up to 6 months. Results were used to improve on study protocol and estimate required sample size for a future randomized trial. Ethics and Dissemination: Study protocol was approved by the institutional review board of China Medical University Hospital (DMR-105-005), and all participants provided informed consent.
造血干细胞移植已成为治疗血液系统疾病（包括急性白血病）的一种成熟疗法。然而，由于移植后复发、感染和移植物抗宿主病，该治疗方法的长期存活率仍然极低。我们认为辅助中药可能对移植后患者有益。为准备一项随机临床试验，我们进行了一项试点试验。
2015 年 9 月至 2017 年 6 月，连续在台湾中国医药大学附设医院招募了 18 名患者，并随访了长达 1 年。每月采集新鲜血样，并进行免疫重建分析。除了他们的肿瘤学家提供的标准治疗外，一些患者还服用了一种中药配方（生元汤）长达 6 个月。结果用于改进研究方案并估计未来随机试验所需的样本量。
研究方案已获得中国医药大学附设医院机构审查委员会的批准（DMR-105-005），所有参与者均提供了知情同意书。
