主 办:北 京 中 医 药 大 学
ISSN 1006-2157 CN 11-3574/R

JOURNAL OF BEIJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE ›› 2020, Vol. 43 ›› Issue (3): 252-258.doi: 10.3969/j.issn.1006-2157.2020.03.012

• Clinical Studies • Previous Articles     Next Articles

Preliminary evaluation of clinical efficacy of Zaizao Shengxue Capsule in treating myelodysplastic syndrome*

Ding Hao1, Zeng Qing2, Di Haixia3, Luo Meihong4, Shen Xiaohui5, He Chunling6, Tian Shaodan1#   

  1. 1 Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China;
    2 The First Affiliated Hospital of Guangxi University of Chinese Medicine, Guangxi 530013, China;
    3 Department of Hematology, Langfang Chinese Medicine Hospital, Hebei 065000, China;
    4 Baoshan Branch of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201999, China;
    5 Department of Hematology, Gansu Provincial Hospital of TCM, Gansu 730050, China;
    6 The Third Affiliated Hospital, Shaanxi University of Chinese Medicine, Shaanxi 712000, China
  • Received:2019-03-22 Published:2020-04-13
  • Contact: Associate Prof. Tian Shaodan, M.D., Chief Physician, Master’s Supervisor. Dongzhimen Hospital, Beijing University of Chinese Medicine. No.5 Haiyuncang Street, Dongcheng District, Beijing 100700. E-mail: oliviatsd@126.com

Abstract: Objective To investigate the clinical efficacy of Zaizao Shengxue (Blood-engendering Renewal) Capsule (ZZSXC) in the treatment of myelodysplastic syndrome. Methods A total of 139 patients who met the diagnostic criteria of Chinese and Western medicine for myelodysplastic syndrome were enrolled according to the principles of randomized multicenter controlled trials. The 103 patients in the treatment group were given 5 ZZSXCs each time, thrice daily. The 36 patients in the control group were given 8 Fufang Zaofan (Compound Zaofan) Pills (FFZFP) each time, thrice daily. The two groups were treated for 3 months. Then their hematological improvements in HI-E, HI-P and HI-N and peripheral blood parameters (HGB, RBC, MCV, PLT, WBC and NEUT) as well as subgroup analysis, TCM pattern and physical sign scores, bleeding, infection, clinical efficacy and safety were evaluated. Results In both the treatment group and the control group, the overall percentages of improvement in such hematological parameters as HI-E, HI-P and HI-N were 51.6% and 38.5%, 44.8% and 40.0%, and 51.0% and 68.2% respectively without statistically significant difference between the two groups (P>0.05). The differences in RBC and HGB of all the patients and the subgroup of low-risk patients in the treatment group before and after treatment were statistically significant (P<0.05). The differences in WBC of the subgroup of high-risk patients in the treatment group before and after treatment were statistically significant (P<0.05). The differences in NEUT of all the patients and the subgroup of low-risk patients in the control group before and after treatment were statistically significant (P<0.05). MCV was decreased of the subgroup of low-risk patients in the treatment group after treatment compared with that before treatment with statistical significance (P<0.05). The percentages of patients that enjoyed marked curative effects and curative effects in terms of TCM patterns in the treatment group and the control group were 29.9% and 30.3%, and 62.1% and 57.6%, respectively, with no statistically significant difference between the two groups (P>0.05). There was no statistically significant difference in curative effects for individual symptoms and signs between the two groups (P>0.05). There was no statistically significant difference in hemostasis, incidence of infection and safety parameters between the two groups (P>0.05). Conclusion Both ZZSXC and FFZFP can improve morbid hematopoiesis and hematological parameters in patients with MDS, and remarkably improve their TCM patterns and individual symptoms and signs with good clinical drug safety.

Key words: Zaizao Shengxue Capsule, Fufang Zaofan Pill, myelodysplastic syndrome, peripheral blood parameter, TCM pattern

CLC Number: 

  • R259