title: The efficacy and safety of sirolimus-based graft-versus-host disease prophylaxis in patients undergoing allogeneic hematopoietic stem cell transplantation: a meta-analysis of randomized controlled trials.
abstract: BACKGROUND
  The efficacy and safety of sirolimus (SIR)-based graft-versus-host disease (GVHD) prophylaxis in patients who were subjected to allogeneic hematopoietic stem cell transplantation (allo-HSCT) remain to be clarified; this meta-analysis was conducted to evaluate these factors.
  
  
  METHODS
  Data from original research were obtained from PubMed, Embase, and Cochrane central register of controlled trials databases. Randomized controlled trials (RCTs) evaluating the efficacy of SIR-based prophylaxis in allo-HSCT were included. The risk ratio (RR), with a 95% confidence interval (CI), was used to pool data. The random effects model was used, irrespective of the presence or absence of heterogeneity.
  
  
  RESULTS
  Five RCTs were included in the meta-analysis. SIR was observed to significantly decrease the incidence of Grade II to IV acute GVHD (aGVHD; RR, 0.65; 95% CI, 0.47-0.89). However, the incidence of Grade III to IV aGVHD and chronic GVHD was not decreased (RR, 0.91; 95% CI, 0.59-1.40; RR, 1.04; 95% CI, 0.88-1.23, respectively). An analysis of the toxic effects of SIR revealed that SIR effected a significant increase in the incidence of sinusoidal obstructive syndrome (RR, 2.24; 95% CI, 1.26-4.01), while that of thrombotic microangiopathy was not significantly increased (RR, 2.48; 95% CI, 0.87-7.06). Moreover, SIR did not improve event-free survival and overall survival (RR, 0.97; 95% CI, 0.85-1.10; and RR, 0.92; 95% CI, 0.82-1.02, respectively).
  
  
  CONCLUSIONS
  This meta-analysis indicated that the SIR-based regimen is an effective and safe alternative prophylaxis strategy for GVHD.
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Li
authors: L
authors: Wang
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Zhenyang
authors: Z
authors: Gu
authors: Department of Hematology and Oncology, Laoshan Branch of No. 401 Hospital of Chinese PLA, Qingdao, China.
authors: Ruiren
authors: R
authors: Zhai
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Dandan
authors: D
authors: Li
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Shasha
authors: S
authors: Zhao
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Lan
authors: L
authors: Luo
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Xiaoli
authors: X
authors: Zhao
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Huaping
authors: H
authors: Wei
authors: Department of Hematology and Oncology, Laoshan Branch of No. 401 Hospital of Chinese PLA, Qingdao, China.
authors: Zhaoxia
authors: Z
authors: Pang
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Lili
authors: L
authors: Wang
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Daihong
authors: D
authors: Liu
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Quanshun
authors: Q
authors: Wang
authors: Department of Hematology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
authors: Chunji
authors: C
authors: Gao
mesh_terms: D000208:Acute Disease; D064591:Allografts; D018572:Disease-Free Survival; D005260:Female; D006086:Graft vs Host Disease / Q000401:mortality* / Q000517:prevention & control*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D020123:Sirolimus / Q000009:adverse effects / Q000627:therapeutic use; D015996:Survival Rate
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus