Danggui Buxue Decoction, a Classical Formula of Traditional Chinese Medicine, Fails to Prevent Myelosuppression in Breast Cancer Patients Treated With Adjuvant Chemotherapy: A Prospective Study.
Danggui Buxue Decoction, a Classical Formula of Traditional Chinese Medicine, Fails to Prevent Myelosuppression in Breast Cancer Patients Treated With Adjuvant Chemotherapy: A Prospective Study.
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当归补血汤是传统中药方剂，未能预防接受辅助化疗的乳腺癌患者的骨髓抑制：一项前瞻性研究
DOI：
10.1177/1534735416675952
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发表时间：
2017-09
影响因子：
2.9
通讯作者：
Shen K
中科院分区：
文献类型：
--
作者：
Hong J;Chen X;Huang J;Li C;Zhong L;Chen L;Wu J;Huang O;He J;Zhu L;Chen W;Li Y;Wan H;Shen K
当归补血汤是中医经典方剂，具有促进造血作用。我们研究的目的是确定DBD是否可以预防接受辅助化疗的乳腺癌患者的骨髓抑制。我们进行了一项II期随机前瞻性对照临床研究。从2013年12月至2015年2月，106例患者被纳入，并按1：1随机分配到中药组和对照组。主要终点是3-4级中性粒细胞减少症的发生率。次要终点包括每个周期内3-4级中性粒细胞减少症的发生率、4个周期内贫血的发生率和血小板减少症的发生率。17例患者退出本研究，89例患者纳入最终分析。4个周期内3-4级中性粒细胞减少的发生率，中药组为57.1%，对照组为59.6%，两组无显著差异（P = 0.816）。同样，在每个周期中，2组之间3-4级中性粒细胞减少症的发生率也没有观察到显著差异。中药组和对照组的贫血发生率分别为54.8%和66.6%（P = 0.280），中药组和对照组的血小板减少发生率分别为11.9%和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。DBD未能预防接受辅助化疗的乳腺癌患者的骨髓抑制。需要进一步的研究来验证DBD在选定患者中的疗效。
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.
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影响因子：
158.5
作者：
Martin, M;Pienkowski, T;Vogel, C
通讯作者：
Vogel, C
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