Hong Jin, Chen Xiaosong, Huang Jiahui, Li Chunqing, Zhong Li, Chen Leying, Wu Jiayi, Huang Ou, He Jianrong, Zhu Li, Chen Weiguo, Li Yafen, Wan Hua, Shen Kunwei
1 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Peoples' Republic of China.
2 Shuguang Hospital, affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, Peoples' Republic of China.
Integr Cancer Ther. 2017 Sep;16(3):406-413. doi: 10.1177/1534735416675952. Epub 2016 Nov 10.
Danggui Buxue Decoction (DBD), a classical formula of traditional Chinese medicine (TCM), has an impact on promoting hematopoiesis. The aim of our study was to determine whether DBD can prevent myelosuppression in breast cancer patients treated with adjuvant chemotherapy. We conducted a phase II randomized prospective controlled clinical study. From December 2013 to February 2015, 106 patients were enrolled and randomly assigned (1:1) to the TCM group and control group. The primary end point was incidence of grade 3-4 neutropenia. The secondary end points included incidence of grade 3-4 neutropenia in each cycle, incidence of anemia, and incidence of thrombopenia during 4 cycles. Seventeen patients withdrew from this study, and 89 patients were included in the final analysis. Incidences of grade 3-4 neutropenia during 4 cycles were 57.1% in the TCM group and 59.6% in the control group, and there was no significant difference ( P = .816). Similarly, no significant differences were observed between the 2 groups for incidence of grade 3-4 neutropenia in each cycle. While incidences of anemia were 54.8% and 66.6% for the TCM group and control group, respectively ( P = .280), incidences of thrombopenia were 11.9% for the TCM group and 4.3% for the control group ( P = .248). No significant differences were observed for the incidence of other nonhematological toxicities between the 2 groups. DBD failed to prevent myelosuppression in breast cancer patients treated with adjuvant chemotherapy. Further studies are warranted to validate the efficacy of DBD in selected patients.
当归补血汤（DBD）是一种经典的中药方剂，对促进造血有影响。我们研究的目的是确定DBD是否能预防接受辅助化疗的乳腺癌患者发生骨髓抑制。我们进行了一项II期随机前瞻性对照临床研究。2013年12月至2015年2月，招募了106例患者并将其随机（1:1）分配到中药组和对照组。主要终点是3-4级中性粒细胞减少的发生率。次要终点包括每个周期3-4级中性粒细胞减少的发生率、贫血的发生率以及4个周期内血小板减少的发生率。17例患者退出本研究，89例患者纳入最终分析。中药组4个周期内3-4级中性粒细胞减少的发生率为57.1%，对照组为59.6%，差异无统计学意义（P = 0.816）。同样，两组间每个周期3-4级中性粒细胞减少的发生率也无显著差异。中药组和对照组贫血的发生率分别为54.8%和66.6%（P = 0.280），中药组血小板减少的发生率为11.9%，对照组为4.3%（P = 0.248）。两组间其他非血液学毒性的发生率无显著差异。当归补血汤未能预防接受辅助化疗的乳腺癌患者发生骨髓抑制。有必要进一步研究以验证当归补血汤对特定患者的疗效。
