Analysis Of Clinical Efficacy Of Yiqi Yangyin Jiedu Decoction Combined With Hypomethylating Agents In The Treatment Of Intermediate And High Risk Myelodysplastic Syndrome

Objective: To evaluate the clinical efficacy and safety of Yiqi Yangyin Jiedu Decoction combined with hypomethylating agents in intermediate and high risk myelodysplastic syndrome(MDS)patients,and to initially explore the factors that may affect patient survival.Methods: Retrospectively analyzed the clinical data of 58 newly treated intermediate and high risk MDS patients treated with Yiqi Yangyin Jiedu Decoction combined with hypomethylating agents from January 2018 to December2021 at the Affiliated Hospital of Shandong University of Traditional Chinese medicine,including 24 patients treated with Yiqi Yangyin Jiedu Decoction combined combined with decitabine and 34 patients treated with Yiqi Yangyin Jiedu Decoction combined combined with azacitidine.Clinical data of all patients before and after treatment,including patients’ gender,age,number of bone marrow blasts,karyotype of bone marrow,MDS gene mutations,kind of demethylating drugs,risk stratification and peripheral blood cell count,were collected and analyzed to summarize the clinical efficacy and safety of patients;Meanwhile,the survival time of patients was further observed and factors affecting survival were analyzed.Results: 1.Clinical efficacy of Western medicine: a total of 343 cycles were administered to 58 patients with intermediate and high risk MDS,with a median treatment period of 5(4-17)cycles.The clinical efficacy of patients was evaluated after 4 cycles of treatment,including 14 cases of CR,6 cases of only m CR,9 cases of m CR with HI,15 cases of only HI,and 14 cases of PD,the ORR was 75.9%;after 4 cycles of treatment,a total of 24 cases(41.4 %)patients obtained HI.The efficacy analysis of patients with different risk stratifications showed that among the 26 patients in the intermediate risk group,4 cases of CR,5 cases of m CR with HI,11 cases of only HI,and 6 cases of PD,and the ORR was 76.9%;among the 32 patients in the high risk group,10 cases of CR,6 cases of only m CR,4 cases of m CR with HI,4 cases of only HI,and 8 cases of PD,the ORR was 75%,the ORR of patients in the middle and high risk groups was similar,and the difference was not statistically significant(P>0.05).2.Survival analysis: Follow-up was up to February 1,2022,and the median follow-up time was 16.0(4.0-48.0)months.The median OS of 58 patients with intermediate and high risk MDS was 24.0 months.According to the clinical efficacy of the patients,58 MDS patients were divided into effective group and ineffective group.There were 44 cases in the effective group,including patients with CR,m CR and HI,and 14 cases in the ineffective group,including PD patients.The median OS of the effective group was longer than that of the ineffective group(33.0 months vs.16.0months),the difference was statistically significant(P < 0.05).Cox proportional hazards regression model was used to analyze the factors that may affect the survival of patients.Multivariate analysis found that the gender,bone marrow blast cell number,IPSS-R risk stratification,peripheral blood cell count,and type of demethylating drugs did not affect the patients,however,age ≥ 65 years(HR=3.778,95% CI: 1.336-10.682,P=0.012)and ineffective treatment(HR=5.328,95% CI: 1.718-16.524,P=0.004)were adverse factors affecting OS.3.TCM syndromes and quality of life efficacy: compared to before treatment,the TCM syndrome score of patients was reduced(P<0.05),and the total effective rate of treatment was 75.9%;In terms of quality of life,53.4%(n=31)of patients had improved quality of life,32.8%(n=19)had stable quality of life,and 13.8%(n=8)had reduced quality of life.4.Safety assessments:The 58 patients with intermediate and high risk MDS included in the study had good tolerance to the treatment regimen in this study,≥grade3 hematological adverse reactions: neutropenia 24.1%,anemia 20.7%,thrombocytopenia 20.7%,all patients after symptomatic and supportive treatment,peripheral blood cell counts were significantly increased.Infection was the most common non-hematological adverse reaction,23 patients(39.7%)had different degrees of infection.The highest incidence was lung infection(27.6%),and other infections,including urinary tract infections and skin soft tissue infections,and all of Infection was effectively controlled after active anti infective treatment;17.2% of patients had obvious bleeding tendency,including nasal mucosa bleeding,skin ecchymosis and gastrointestinal bleeding,etc.,which could be significantly relieved after symptomatic treatment;6.9% patients had mild nausea and vomiting during treatment;8.6% patients had elevated transaminases during treatment,which decreased after treatment with liver protection;3.4%patients had constipation,which was improved after treatment with Runchang laxative;all adverse reactions did not affect the subsequent treatment of patients,and the patients had no diarrhea and abnormal renal function during the treatment.Conclusion: Yiqi Yangyin Jiedu Decoction combined with hypomethylating agents can effectively treat intermediate and high risk MDS,prolong the survival time of patients,improve clinical symptoms,improve the quality of life of patients andand reduce the occurrence of adverse.Age ≥ 65 years old and poor treatment effect are adverse factors affecting the survival of patients.