| ObjectiveThrough statistical analysis of the clinical data of patients after unrelated cord bl ood transplantation(UCBT)with or without pre-engraftment syndrome,finding o ut the differences between the two groups and the high-risks of 180 days non-rel apse mortality rate,then making the risk score of PES.Through risk assessment for patients with PES according to risk score,we adopted stratification treatmen t with different dosage of methylprednisolone and searched the correlation betwee n the clinical efficacy and risk score of PES.MethodsThis study is divided into two parts.Part 1:The part that of searching for risk factors of PES and the establishment o f risk score was divided into two aspects.First,through retrospective analysis for136 cases of patients with hematologic malignancies after UCBT during April 2000 to February 2012 who were divided into PES group with 92 cases and No-P ES group with 44 cases,we explored the clinical characteristics of PES patients.In the second:we conducted a retrospective analysis of 92 cases of patients with PES on possible risk factors(PES occurrence time,body temperature when PES happened,age,clinical symptoms when PES happened,cyclosporin A concentratio n when PES happened,the number of TNC,the number of CD34~+cells,diseas e type,the disease remission and invalid MP treatment)of 180 days non-relapse mortality rate after UCBT.Then univariate analyses and multivariate analyses were performed to determine independent risk factors for NRM at 180 days in PES patients.According to the independent risk factors,PES can be divided into PES-0(no risk factors),PES-1(one risk factor),PES-2(two risk factors),PES-3(thre e risk factors).According to the PES risk score to make a diagnosis for PES pati ents,we contrasted the occurred of NRM by 180d and overall survival of 3 yea rs in PES patients with different risk scores.Part 2:The verification of PES risk score system and the study of and stratificati on treatment were divided into two aspects.First,221 cases of PES patients who were taken UCBT in January 2013 to August 2016 with hematologic malignancie s were diagnosed by risk score system and analyzed in incidence and baseline d ata.Second,PES patients were given MP accordingly(PES-0 with MP 0.5 mg/kg/d,PES-1 with MP 1 mg/kg/d,PES-2 with MP 2 mg/kg/d),then contrasted the o ccurred of NRM by 180d and overall survival of 3 years in patients with differe nt risk scores of PES.We were to compare the clinical efficacy patients before a nd after taking PES risk score system and stratification treatment.Results1.Part one1.1 The comparison of clinical data about PES patients and No-PES patients sho wed that PES patients'neutrophilic engraftment rate in 60d was significantly incr eased[(97.8%(95%CI 89.9-99.5%)vs 70.5%(95%CI 54.2-81.9%),P<0.001],a nd PES patients'platelet engraftment rate in 120d was higher than No-PES patie nts,75.0%(95%CI 64.6-82.7%)vs.54.5%(95%CI 385-68.0%)respectively.The rat e of CSA/MMF/ATG for aGVHD prophylaxis in PES group was significantly lo wer than that in No-PES group(7.6%vs.38.6%,P<0.001).The proportion of d ouble cord blood and ALL in PES group was lower than that in No-PES group,20.7%vs.31.8%,P=0.155;36.9%vs 43.2%,P=0.843 respectively.The incidence of aGVHD was also increased(22.2%vs9.4%,P=0.099)in PES group,without statistically significant difference in outcomes.PES group and No-PES group sho wed no significant difference in patients'age,pre-transplant disease status,HLA match,ABO blood group,pre-transplant regimen,and cell number(TNC,CD34~+)in cord blood.The NRM rate,3-year OS rate,DFS rate,recurrence rate and G RFS rate in the PES group and the No-PES group after UCBT 180 days also sh owed no statistical difference.1.2 The searched for PES high-risk factors:univariate analysis and multivariate an alysis of all possible risk factors showed that MP treatment invalid(P<0.001),t hree or more clinical symptoms(P=0.035),the earlier occurrence(P=0.038)were in dependent risk factors for 180 days non-relapse mortality rate after transplantatio n.1.3 Risk score was performed for PES patients according to the PES risk score system.Among the 92 patients with PES,there were 41(44.6%)patients with PE S-0,32(34.8%)patients with PES-1,16(17.4%)patients with PES-2 and 3(3.2%)patients with PES-3.aGVHD occurrence:with PES risk score decreasing,the cum ulative incidence of NRM by 180d decreased(100%vs 62.5%vs 21.9%vs 17.7%,P<0.001),with statistical difference(P<0.001).3-year cumulative overall survial:with PES risk score increasing,the cumulative incidence of overall survial in 3-y ear decreased significantly(68.3%vs 56.2%vs 25.0%vs 0%,P<0.001).2.Part two2.1 221 patients with malignant hematological diseases after UCBT from January2013 to August 2016 were selected,and PES risk score was performed accordi ng to PES risk score system.Among 221 patients with PES,105(47.5%)patients with PES-0,82(37.1%)patients with PES-1,and 34(15.4%)patients with PES-2.Stratification treatment was used according to different scores of risk.2.2 The overall survival in 3 years and NRM by 180d in different risk scores in PES patients after UCBT:with PES risk score decreasing,the cumulative incide nce of 180d NRM decrease(38.2%vs 15.2%vs 11.0%,P<0.001).3-year cumulativ e overall survial:with PES risk score increasing,the 3-year cumulative overall sur vial in PES-0 and PES-1 patients was significantly higher than that of PES-2 pat ients(65.7%vs.68.3%vs.43.1%,P=0.013).2.3 Comparison of patients with different PES scores before and after stratificatio n treatment.On the one hand,to patients with PES-0,there was no significant diffe rence in outcomes(P>0.05).On the second aspect:For patients with PES-1,after st ratification treatment,180d NRM of patients was lower than that before stratifica tion treatment,meantime,OS,DFS,GRFS were higher than that before stratification treatment,but there was no statistical difference.For patients with PES-2,after s tratification treatment,180d NRM[38.2%(95%CI 22.0-54.3%)vs 68.4%(95%CI 41.1-85.0%),P=0.034]of patients was less than that before stratification treatment,me antime,OS[43.1%(95%CI 26.0-59.0%)vs 21.1%(95%CI 6.6-41.0%),P=0.036],DFS[40.1%(95%CI 23.5-56.1%)vs 21.1%(95%CI 6.6-41.0%),P=0.072],GRFS[26.5%(95%CI 13.2-41.8%)vs 5.26%(95%CI 0.3-21.4%),P=0.001]were higher than that b efore stratification treatment.The results of NRM and OS were in accordance wit h univariate analysis,multivariate analysis.Conclusion1.PES is a immune response after UCBT transplantation before neutrophil engra ftment.In our transplantation center,modified myeloablative conditioning without a ntithymocyte globulin was adopted,and PES had a high incidence,reaching 76.9%.In addition,the engraftment rate of neutrophil in PES patients was significant ly higher which was 97.8%,indicating that the occurrence of PES after UCBT was beneficial to the engraftment.2.Possible high-risk factors affecting the NRM rate of patients with PES for 180 days were analyzed.Cox regression analysis was performed and found three in dependent risk factors.PES risk score system was established by score accumulati on and invalided prospectively.3.Stratified treatment with MP for PES patients with different risk scores could significantly improve OS,DFS and GRFS in PES-1 and PES-2 patients,and red uce NRM rate for 180 days after transplantation. |
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