| Objective:Analysis the therapeutic effect and safety of the use of methylation drug, azacitidine (AZA), in treatment of intermediate-2 and high-risk group of myelodysplastic syndrome (MDS). Search and study the abroad and domestic literature and discuss the efficacy, administration route, administration dosage, safety and other related aspects of AZA in treating MDS.Methods:Research 7 patients with MDS, who received treatment in Qilu Hospital, Shandon University between April 2014 and April 2015. All 7 patients were diagnosed as MDS according to International diagnostic criteria and classified into intermediate-2 and high-risk groups according to International prognostic scoring system classifications (IPSS). None had ever received AZA or other demethylation treatment. According to the regimen, each patient is given azacitidine 75 mg/m2 per day for 7 days every 28 days. Before the start of each treatment cycle, evaluation of patients’ general situation is performed. If the complete blood counting shows that the leukocyte counting is greater than 3.0×109/L, neutrophils greater than 1.5×109/L and platelet greater than 75.0×109/L, than the dosage remains the same as that of the last cycle, otherwise be readjusted. On the 1st,7th,14th day of each cycle, complete blood counting, liver function and renal function are required. On the 14th day of the 3rd and 6th cycle, bone marrow aspiration is done to evaluate the therapeutic effect. After the 3rd and 6th cycle, bone marrow and hematologic conditions are evaluated separately. If no improvement is observed even after 6 cycles of treatment, then the regimen comes to a termination, while regimen can be continued with any effect. Throughout the courses of AZA treatment, G-CSF, blood transfusion and anti-infection are combined when necessary. Assess and handle in time when adverse events occur and decide whether to continue AZA treatment or not according to the severity.Results:In 7 cases,2 cases received 8 cycles of treatment,1 case 7,1 case 5,2 case 4 and lease 2. After AZA treatment,5 cases reached hematologic improvement (HI),2 cases reached marrow complete remission (mCR) with HI and 2 patients who reached HI died. Of the 2 died patients,1 case died of septic shock and the other died of multiple organic failure. In total,7 patients had received 38 cycles of treatment and the main adverse events were bone marrow depression and neutropenia with fever. In one case, the patient underwent gastrointestinal hemorrhage, which might be related to his duodenal ulcer history and long-term oral administration of aspirin after percutaneous coronary intervention. One patient was found to have abnormal hepatic function, which was considered to be caused by preventive administration of voriconazole. This patient’s hepatic function returned to normal after stopping taking voriconazole.Conclusion:Intermediate-2 and high-risk MDS belong to the higher-risk group with poor prognosis, high risk transforming to acute leukemia, short survival time and poor response to many medications. Azacitidine, a demethylation drug, has confirmed positive effect to intermediate-2 and high-risk MDS patients with good tolerance and little adverse effect. In this study, none severe adverse event about hepatic or renal damage were reported related to AZA. However, the number of cases in this study is less. Large sample clinical trials are needed to further evaluate the efficacy and safety of AZA treatment. |
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