title: [A clinical comparative study on treatment of severe newly diagnosed immune thrombocytopenia by recombinant human thrombopoietin combined with glucocorticoid].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) combined with glucocorticoid in treatment of severe newly diagnosed primary immune thrombocytopenia (ITP).
  
  
  METHODS
  From June 2009 to December 2012, 24 male patients and 38 female patients with the diagnosis of severe primary ITP in our hospital were randomized into trial group (31 cases) or control group (31 cases), the median age was 50 years (range: 21-84 years). Trial group was treated with rhTPO combined with glucocorticoid, and control group was treated with glucocorticoid only.
  
  
  RESULTS
  At the day 3, 7 and 14 from the beginning of treatment, the average platelet count (APC) in trial group[(35.5±24.9)×10⁹/L, (135.2±94.9)×10⁹/L and (192.0±109.1)×10⁹/L]were significantly higher than that in control group[(24.5±15.6)×10⁹/L, (78.2±121.9)×10⁹/L and (95.8±60.5)×10⁹/L, P=0.022, 0.009 and 0.001, respectively]. There was no significant difference in APC between the two groups at day 28 and 90 after treatment[(147.8±59.1)×10⁹/L vs (105.1±56.9)×10⁹/L, P=0.243; (137.4±52.3)×10⁹/L vs (104.3±59.8)×10⁹/L, P=0.568, respectively]. At the day 7, 14 and 28, the complete response rates in trial group were 61.3%, 87.1% and 80.6%, which were also significantly higher than that in control group (16.1%, 29.0% and 48.3%, P=0.000, 0.000 and 0.004, respectively). The median time to response in trial group was 3 days while in the control group was 5 days; the median duration of complete response in trial group was 76 days while in the control group was 54 days. In trial group, there were 4 cases treated with platelet transfusion, while in control group there were 11 cases, respectively.
  
  
  CONCLUSIONS
  For patients with severe primary ITP, rhTPO combined with glucocorticoid could rapidly increase the platelet count, significantly improve the complete response rate and prolonged the effect with a low incidence of tolerable adverse events compared to single use of glucocorticoid. rhTPO combined with glucocorticoid could be a new therapeutic choice to those patients.
authors.affiliation: Department of Hematology, Zhong Shan Hospital of Shanghai Medical College, Fudan University, Shanghai 200032, China.
authors.forename: Shi-yang
authors.initials: SY
authors.lastname: Gu
authors.forename: Jing-li
authors.initials: JL
authors.lastname: Zhuang
authors.forename: Shan-hua
authors.initials: SH
authors.lastname: Zou
authors.forename: Feng
authors.initials: F
authors.lastname: Li
authors.forename: Zhi-mei
authors.initials: ZM
authors.lastname: Wang
authors.forename: Yun-feng
authors.initials: YF
authors.lastname: Cheng
authors.forename: Wei-guang
authors.initials: WG
authors.lastname: Wang
authors.forename: Zhi-xiang
authors.initials: ZX
authors.lastname: Cheng
authors.forename: Ling
authors.initials: L
authors.lastname: Yuan
authors.forename: Lu-ya
authors.initials: LY
authors.lastname: Cheng
authors.forename: Zheng
authors.initials: Z
authors.lastname: Wei
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D017713:Platelet Transfusion; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use; D013926:Thrombopoietin / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D011994:Recombinant Proteins; D013926:Thrombopoietin