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A Meta-Analysis Of Clinical Efficacy And Safety Of Ruxolitinib In Treatment Of Myeloprolifera-Tive Disorder And Clinical Data Of 52 Cases Of Myelofibrosis In Fujian Province

Posted on:2020-04-24Degree:MasterType:Thesis
Country:ChinaCandidate:L L ChenFull Text:PDF
GTID:2404330623454893Subject:Internal Medicine
Abstract/Summary:PDF Full Text Request
Objective Myeloproliferative disorder,also known as myeloproliferative neoplasm,are a group of clonal hematopoietic stem cell diseases characterized by continuous clonal proliferation of one or more myeloid cell lines,such as granulocytes,red blood cells,megakaryocytes or mast cells,splenomegaly,liver enlargement,or(and)lymph node enlargement,peripheral hemogram,fatigue and abdominal discomfort.Early satiety,night sweat,itching,fever,bone pain and other discomforts greatly affect the quality of life of patients.Although the disease progresses slowly,it can eventually transform into acute leukemia.Common Philadelphia chromosome-negative bone marrow proliferative tumors include polycythemia vera(PV),essential thrombocythemia(ET),primary myelofibrosis(PMF).There are many traditional treatments for these diseases,including androgen,EPO,HU,interferon,thalidomide,Aspirin,Marran,other treatments include spleen resection,radiotherapy,hematopoietic stem cell transplantation,etc.In recent years,many studies and practices have failed that JAK2 inhibitor,Jakafi Incyte,has certain efficacy in the treatment of MPN-related splenomegaly and related symptoms.In this paper,the clinical efficacy and safety of Ruxolitinib in the treatment of myeloproliferative diseases were discussed and evaluated by meta-analysis.Methods The experimental group received Ruxolitinib treatment,and the control group received placebo and/or the best effective treatment.Major databases such as PubMed database,Cochrane library,CNKI,Wanfang database,Weipu database and Embase database were retrieved by computer,and the references included in the literature were further expanded.According to Cochrane's systematic evaluation method,the randomized controlled trials(RCT)literature that met the inclusion criteria were independently extracted,evaluated and cross-checked,and then meta-analyzed by Stata 14.0 software.Results A total of 5 studies were included,with a total of 1009 patients.Recotinib group had better splenic contraction effect(RR = 54.03,95% CI = 15.49-188.42,P < 0.001)and alleviating effect of systemic symptoms(RR = 10.43,95% CI = 5.30-20.55,P < 0.001),with a lighter incidence of grade 3-4 pruritus(RR = 0.30,95% CI = 0.13-0.70,P = 0.005).However,the incidence of grade 3-4 anemia(RR = 2.83,95% CI = 1.97-4.06,P < 0.001),grade 3-4 diarrhea(RR = 2.09,95% CI = 1.09-4.03,P = 0.027)and grade 3-4 infection(RR = 3.65,95% CI = 1.39-9.58,P = 0.009)were more severe in Ruxolitinib group than in placebo/BAT group.There were no significant differences in mortality,grade 3-4 thrombocytopenia,thrombosis,grade 3-4 dyspnea,arthralgia and abdominal pain between the two groups.Conclusions Ruxolitinib has better splenomegaly and Improve symptoms of myelofibrosis in the treatment of myeloproliferative diseases,but it also has more serious hematological,non-hematologic and infection rates.Objective To evaluate the clinical efficacy and safety of Ruxolitinib in patients with myelofibrosis in Fujian.Methods A retrospective analysis was made on the clinical efficacy and safety of 52 patients with myelofibrosis treated with Ruxolitinib from 2017 to 2018 in major hospitals of Fujian Province.There were 26 males and 26 females with a median age of 64 years(34-89 years).The initial dosage of Ruxolitinib was 10-40 mg/d.Splenic volume and symptoms were assessed by B-mode ultrasonography,subcostal palpation and bone marrow proliferative tumors total symptom assessment scale(MPN-SAF-TSS).SPSS 22.0 was used for data analysis in this study.Results Up to the present follow-up,37 patients(71.2%)were still continuing treatment,4 patients(7.7%)stopped taking medicine,2 of them were due to intolerance,leading to severe anemia,1 patient was due to cerebral hemorrhage,and 1 patient was due to poor curative effect.There was no significant improvement in conscious symptoms and spleen size.11 cases(21.2%)died,of which 3 died of acute leukemia,1 died of heart failure,1 died of renal failure,and the rest died of severe infection,mainly pulmonary infection.Before treatment,39 cases(75%)had splenomegaly,29 cases(74.5%)had splenomegaly,3 cases(7.7%)had no obvious changes,and 5 cases(12.8%)had splenomegaly.Four patients(7.7%)had no splenomegaly before treatment,and one patient had splenic hypertrophy during treatment.During the treatment period,patients with fatigue,early satiety,abdominal discomfort,inactivity,lack of attention,night sweating,itching,bone pain,weight loss in the past six months can be improved,and the quality of life can be improved.The most common hematological adverse events included anemia and decreased platelet count.Infection,weight gain and fatigue were the main non-hematological adverse events.Pulmonary infection was common in infections.Among the adverse hematological events,anemia occurred in 25 cases(34.2%).Among them,19 cases(26.4%)had grade 3/4 anemia,which could be improved by blood transfusion or promoting hematopoietic drugs.During the follow-up,4 patients had severe anemia after taking Ruxolitinib,and needed blood transfusion and/or oral promoting hematopoietic drugs to improve anemia.Among them,2 patients stopped taking drugs for severe anemia.Thrombocytopenia occurred in 17 cases(23.3%)with grade 1-2 predominantly and grade 3/4 thrombocytopenia in 7 cases(9.6%).Among them,1 case was discontinued because of cerebral hemorrhage after severe thrombocytopenia.Among non-hematological adverse events,there were 14 cases of infection(19.2%)and 2 cases of hemorrhage(2.7%),including alveolar diffuse hemorrhage and cerebral hemorrhage.Weight gain was 6 cases(8.2%),fatigue was 5 cases(6.8%),dizziness was 2 cases(2.7%),residual dark haze,systemic edema and insomnia were 1 case(1.4%)respectively,mainly in grade 1/2,only 1 case stopped taking medicine due to cerebral hemorrhage.Conclusions Ruxolitinib can reduce spleen size,improve symptoms and improve quality of life in patients with myelofibrosis.The main adverse reactions were anemia,thrombocytopenia and infection,which were alleviated and improved over time,and the adverse reactions were tolerable.During the follow-up,it was also found that the low initial dose of Ruxolitinib was a common phenomenon in Fujian,which would have an impact on the curative effect of the disease,resulting in poor splenic contraction effect and poor symptoms improvement.The current treatment situation in Fujian is not only related to insufficient knowledge of disease and drug dosage,but also related to poor medical compliance of patients.The main reason for poor medical compliance is due to economic reasons.In addition,it is also related to the limitation of drug dosage in charitable assistance projects.
Keywords/Search Tags:Ruxolitinib, Myeloproliferative disorder, Randomized controlled, Meta-analysis, Myelofibrosis, Safety, Efficacy, Initial Dose
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