Observation On Therapeutic Effect Of Azacitidine Combined With Jieduquyu Decoction On Myelodysplastic Syndrome

Objective:Although azacitidine has been widely used in the treatment of myelodysplastic syndrome abroad,it has just been applied in clinical practice in China in 2018.Through azacitidine combined with traditional Chinese medicine syndrome differentiation treatment of 30 patients with IPSS-R and MDS,to explore the efficacy and safety of azacitidine combined with Jieduquyu Decoction in the treatment of MDS.Methods:A total of 30 patients with myelodysplastic syndrome diagnosed as IPSS-R in the Department of Hematology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine from August 2018 to August 2020were analyzed and treated with azacitidine combined with Jiedu Quyu Decoction.Azacitidine was administered at a standard dose,subcutaneously,75·m^-2·d^-1for 7 consecutive days.Jiedu Quyu Decoction Hospital was decocted,1 dose and 2 bags,250 ml per bag,divided into two warm doses after meals in the morning and evening,every 28 days as a cycle.The effective rate of the patients after treatment was observed,and blood routine,bone marrow blasts and adverse reactions were recorded.Statistical analysis was performed using SPSS 26.0 software,and enumeration data were compared using Fisher’s exact test.P<0.05 indicated statistically significant results.Results:Four patients were not counted in the statistical results if they had less than 3 cycles of treatment,and a total of 18 of 26 patients responded,with an overall response rate（ORR）of 69%,3 in CR,11 in m CR,4 in H,and10 in m CR with HI.Cumulative ORR was 15%after 1 cycle,37%after 3 cycles,and 69%after 6 cycles.Among 26 patients who completed 3 cycles of treatment,there were 3 cases of intermediate-risk m CR and 2 cases of HI2;2 cases of CR,3 cases of m CR and 1 case of HI1.The difference in the effective rate between the two groups had statistical significance（P>0.05）;among 16patients who completed 6 cycles of treatment,there were 1 case of intermediate-risk CR,4 cases of m CR and 1 case of HI1;there were 2 cases of CR,2 cases of m CR and 1 case of HI1.The difference in the effective rate between the two groups had statistical significance（P>0.05）.After 1 cycle of treatment,4 patients achieved HI,a total of 7 patients achieved HI after3 cycles,and a total of 14 patients achieved HI after 6 cycles,including5 patients with one-lineage improvement,7 patients with two-lineage improvement,and 1 patient with three-lineage improvement.According to the curative effect criteria of TCM,2 cases were markedly effective and 4 cases were effective after 1 cycle,with an effective rate of 23%,2 cases were cured,6 cases were markedly effective and 6 cases were effective after 3 cycles,with an cumulative effective rate of 54%,3 cases were cured,10 cases were markedly effective and 7 cases were effective after 6 cycles,with an cumulative effective rate of 77%.During the treatment,8 patients had significant bleeding tendency,and the bleeding symptoms could be significantly improved after timely supportive treatment.Fourteen patients had experienced infection symptoms,and most of them occurred in the first three treatment cycles,and the patients could be effectively controlled after anti-infective treatment.The main adverse reactions were bone marrow suppression,gastrointestinal reactions and abnormal liver function.Patients without grade III-IV myelosuppression after treatment initiation;5 patients had nausea,vomiting,constipation,diarrhea and other gastrointestinal adverse reactions;2 patients had abnormal liver function,which returned to normal after liver protection treatment,and no patient had abnormal renal function.Conclusion:Azacitidine combined with Jieduquyu Recipe is effective in the treatment of myelodysplastic syndrome,with rapid onset,effective improvement of quality of life and alleviation of adverse reactions.