title: Clinical observation of Shuanghuang Shengbai Granule () on prevention and treatment of myelosuppression caused by chemotherapy in cancer patients.
abstract: OBJECTIVE
  To study the efficacy and safety of Shuanghuang Shengbai Granule (, SSG), a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy.
  
  
  METHODS
  A total of 330 patients were randomly assigned to the treatment group (220 cases, analysed 209 cases) and the control group (110 cases, analysed 102 cases) with a 2:1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation.
  
  
  RESULTS
  At the 7th day of chemotherapy, the white blood cells (WBCs) level in the treatment group was significantly higher than that in the control group (P<0.05). After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade I, while 8.1% and 5.7% of patients emerged grade III and grade IV myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group (P<0.05). The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group (84.2% vs. 72.5%, P<0.05). The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3+and CD4+cells were significantly increased in the treatment group after treatment (P<0.05). The discrepancy of CD3+and CD4+cell activity before and after treatment in both groups were significantly different (P<0.05). No obvious adverse event occurred in both groups.
  
  
  CONCLUSIONS
  SSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.
authors.affiliation: Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
authors.forename: Li-Fang
authors.initials: LF
authors.lastname: Wang
authors.affiliation: Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. xuzhenye1947@126.com.
authors.forename: Zhen-Ye
authors.initials: ZY
authors.lastname: Xu
authors.affiliation: Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
authors.forename: Zhong-Qi
authors.initials: ZQ
authors.lastname: Wang
authors.affiliation: Department of Integrated Medicine, Shanghai Chest Hospital, Shanghai, 200030, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Zhang
authors.affiliation: Department of Oncology, Shanghai Punan Hospital of Pudong New District, Shanghai, 200125, China.
authors.forename: Gui-Ying
authors.initials: GY
authors.lastname: Yan
authors.affiliation: Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
authors.forename: An-Ji
authors.initials: AJ
authors.lastname: Hou
authors.affiliation: Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
authors.forename: Hai-Bin
authors.initials: HB
authors.lastname: Deng
authors.affiliation: Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
authors.forename: Ji
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
authors.forename: Xiao-Zhen
authors.initials: XZ
authors.lastname: Zhao
authors.affiliation: Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Xiang
authors.affiliation: Department of Oncology, Shanghai Seventh People's Hospital, Shanghai, 310000, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Yu
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D042381:Granulocyte Precursor Cells / Q000187:drug effects*; D006801:Humans; D007108:Immune Tolerance / Q000187:drug effects*; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010198:Pancytopenia / Q000139:chemically induced / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D004365:Drugs, Chinese Herbal; C000617180:shuanghuang shengbai
keywords: Chinese medicine; Shuanghuang Shengbai Granule; chemotherapy; malignant tumor; myelosuppression