| Purpose:Observe the efficacy and safety of amifostine(AMF)combined with dexamethasone(DXM)in the treatment of primary immune thrombocytopenia(ITP),and investigate the factors related to the efficacy,so as to provide an alternative treatment for patients.Patients and Methods:ITP patients admitted to the Department of Hematology of the 967 Hospital of the Joint Logistics support Force of the Chinese people’s Liberation Army from October 2006 to July 2019 were selected as the object of the study.The last follow-up period was October 31 st,2019.Inclusion criteria: patients who fulfilled the diagnostic criteria of ITP;patients who received AMF combined with DXM regimen or DXM monotherapy;no obvious abnormality in cardiopulmonary function,hepatorenal function;platelet count ≤ 30 × 109/L,or accompanied with bleeding symptoms requiring treatment;the general data of the patients were complete.Exclusion criteria: no precise diagnosis,or did not meet the diagnostic criteria of ITP;patients who did not receive AMF combined with DXM regimen or DXM monotherapy;patients with severe heart,lung,liver,kidney insufficiency,and active infection;patients with tumors and mental disorders;patients with severe osteoporosis;incomplete patient data.According to the treatment regimen,the patients were divided into AMF+DXM group(group A)and DXM group(group B).According to the baseline PLT level,the patients in group A were divided into twogroups: group A1 with baseline PLT ≥ 20 × 109/L(group A1)and group A2 with baseline PLT < 20 × 109/L(group A2).The differences of sex,age,history time,and bleeding score between group A,B and group A1,A2 were compared,and the levels of PLT and the increase of PLT on the 3rd,7th,14 th,28th and 90 th day after treatment were compared between group A,B and group A1,A2.The overall response(OR)rate,complete response(CR)rate and no response(NR)rate on the 7th,14 th,28th and 90 th day after treatment in group A,B and group A1,A2 were compared respectively.The onset time of patients in each group was recorded,and the release rate of patients in groups A,B and group A1,A2 were compared on the 28 th and 90 th day after treatment.The adverse events of all patients within 28 days after treatment were recorded.Results:1.A total of 80 ITP patients who were admitted to the 967 Hospital of the Joint Logistics support Force of the Chinese people’s Liberation Army from October 2006 to July 2019 were collected.17 patients did not meet the inclusion criteria,12 patients with varying degrees of hepatic and renal insufficiency,6 patients with an active infection,3 patients with incomplete hospitalization data,finally,42 patients were included in the study.2.There was no significant difference in age,gender,height,weight,medical history,bleeding score,and baseline PLT count between group A and group B(p > 0.05).There was no significant difference in age,gender,height,weight,medical history,and bleeding score between group A1 and group A2(p>0.05).3.On the 3rd,7th,14 th,and 28 th day after treatment,there was no significant difference in the level of PLT between group A and group B(p>0.05).On the 90 th day after treatment,the level of PLT was significantly higher in group A than in group B(p=0.006).On the 3rd,7th,and 14 th day after treatment,the PLT level was significantly higher in group A1 than that in group A2(p=0.001,0.007,0.025,respectively).On the 28 th and 90 th day after treatment,there was no significant difference in the PLT level between the two groups(p>0.05).4.On the 3rd,7th,14 th and 28 th day after treatment,there was no significant difference in the increase of PLT between group A and group B(p>0.05).On the 90 th day after treatment,the increase of PLT was significantly higher in group A than in group B(p=0.014).On the 3rd and 7th day after treatment,the increase of PLT was significantly higher in group A1 than t in group A2(p=0.022).There was no significant difference in the rise of PLT between the two groups on the 14 th,28th,and 90 th day after treatment.5.On the 7th,14 th,28th,and 90 th day after treatment,there was no significant difference in OR rate between group A and group B(p>0.05).On the 7th day after treatment,the OR rate in group A1 was significantly higher than in group A2(p=0.047).There was no significant difference in OR rate between the two groups on the 14 th,28th,and 90 th day after treatment(p>0.05).6.On the 90 th day after treatment,the CR rate in group A was significantly higher than in group B(p=0.036).On the 7th,14 th,and 28 th day,there was no significant difference in CR rate between the two groups(p>0.05).On the 7th day after treatment,the CR rate in group A1 was significantly higher than in group A2(p=0.027).On the 14 th,28th,and 90 th day,there was no significant difference in CR rate between the two groups(p>0.05).7.On the 7th,14 th,28th,and 90 th day after treatment,there was no significant difference in NR rate between group A and group B(p>0.05).On the 7th day after treatment,the NR rate in group A1 was significantly lower than in group A2(p=0.047).There was no significant difference in NR rate between the two groups on the 14 th,28th,and 90 th day after treatment.8.There was no significant difference in the onset time between group A and group B(p>0.05).There was no significant difference in the onset time between group A1 and group A2(p>0.05).9.On the 28 th and 90 th day after treatment,there was no significant difference in the recurrence rate between group A and group B(p>0.05).On the 28 th and 90 th day after treatment,there was no significant difference in recurrence rate between group A1 and group A2(p > 0.05).10.In group A,3 patients(15.8%)had mild nausea and vomiting,1 patient(5.3%)had elevated blood glucose,and 2 patients(10.5%)had elevated blood pressure.There were no adverse events such as hypotension,hypocalcemia,somnolence,allergy,and so on.In group B,2 patients(8.7%)had elevated blood glucose,3 patients(13.0%)had elevated blood pressure,and no toxic side effects such as peptic ulcer and osteoporosis were observed;all patients had no liver function,renal function damage and no obvious ECG changes.Conclusion:1.The efficacy of AMF+DXM regimen is similar to that of DXM alone,which can raise the PLT count of patients to a safe level in the early stage of treatment.2.The combination regimen is superior to the monotherapy regimen in maintaining the level of PLT and complete remission,which is of certain significance to the choice of treatment for patients with ITP.3.In the patients with baseline PLT ≥ 20 × 109/L,the early curative effect is more significant,and the increase of PLT is more obvious,but the results still need to be verified by further expanding the sample size. |
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