Objective Compare the efficacy of acute myeloid leukemia patients with different TCM syndromes with Homoharringtonine,and analyze the difference in the response of TCM syndromes to HHT treatment and the influence on the prognosis of AML patients.Methods The patients who met the inclusion criteria during September 2016 to September 2018,were enrolled in this study.And according to the traditional Chinese syndromes,typed on the basis of " Clinical pathway of Chinese Medicine for Acute Leukemia,.To observe the therapeutic effect indicators such as blood routine,remission extent,TCM syndrome score,etc;toxic and side-effect indicators such as the degree of myelosuppression,the incidence of adverse reactions,etc.And record the time of remission,recurrence,and death.The statistical methods for statistical analysis include chi-square test,paired t tests,nonparametric tests,kaplan-meier and so on.Results1.According to leukemia cytogenetics and molecular biology indicators to perform risk stratification,among the syndrome of pestilent toxicity,13 cases(54.2%)had a favourable prognosis,9 cases(37.5%)had a intermediate prognosis,and 2 cases(8.3%)had a unfavorable prognosis;and among the syndrome of deficiency,7 cases(25.9%)had a favourable prognosis,15 cases(55.6%)had a intermediate prognosis,and 5 cases(18.5%)had a unfavorable prognosis.There was a statistical difference in the distribution of prognosis grade between the two syndromes of patients(P=0.041),the prognosis of pestilent toxicity is better than deficiency.2.After 2 courses of treatment with HHT induction,there were 21 cases(87.5%)of complete remission,2 cases(8.3%)of partial remission,and 1 case(4.2%)of no remission among the syndrome of pestilent toxicity;there were 22 cases(81.5%)of complete remission,3 cases(11.1%)of partial remission,and 2 cases(7.4%)of no remission among the syndrome of deficiency.There was no significant difference in the CR rate between the two syndromes of patients(P=0.555).3.After 2 courses of treatment with HHT induction,the clinical symptom of TCM of both types were significantly improved compared with those before treatment.There were 1 case(4.2%)had no effects,8 cases(33.3%)had effective results,and 15 cases(62.5%)had apparent results with pestilent toxicity syndrome;there were 2 cases(7.4%)had no effects,16 cases(59.3%)had effective results and 9 cases(33.3%)had apparent results with positive and deficiency syndrome.There was a statistically significant difference in the overall TCM eff-icacy between the two syndromes of patients(P=0.045),the medical effect of pestilent toxicity is better than deficiency.4.During myelosuppression,the median neutrophil minimum of pestilent toxicity syndrome was 0.30(0.00~0.40)×109L-1 while the other was 0.20(0.00~0.40)×109L-1;the median platelet count minimum of pestilent toxicity syndrome was 13(3~16)×109L-1 while the other was 11(2~17)×109L-1;the median recovery time of neutrophil with pestilent toxicity syndrome was 14(2~35)d,the other was 16(3~17)d;the median recovery time of platelet count with pestilent toxicity syndrome was 14(7~32)d,the other was 15(8~38)d;the median influsion volume of red blood cells with pestilent toxicity syndrome was 12(0~28)U,the other was 16(2~30)U;the median infusion volume of apheresis platelets with pestilent toxicity syndrome was 72(22~228)U,the other was 90(25~232)U.There were statistical differences in each index(P<0.05),the degree of myelosuppression of pestilent toxicity is lower than that of deficiency.5.There was a statistically significant difference in the incidence petechiae of the skin and mucosa between the two syndromes of patients(P=0.035):Skin and mucosa petechiae was observed in 8 cases(33.3%)among pestilent toxicity syndrome,and there were 17 cases(63.0%)among deficiency syndrome.Also there was a statistically significant difference in the incidence of nausea and vomiting between the two syndromes(P=0.039);10 cases(41.7%)were observed nausea and vomiting among pestilent toxicity syndrome,and there were 19 cases(70.4%)among deficiency syndrome.However,there was no significant difference in the incidence of infection,gastrointestinal and intracranial hemorrhage,liver and kidney injury,and cardiac insufficiency(P>0.05).In general,patients of pestilent toxicity are more tolerant to HHT than others’.6.Up to the follow-up time,there were 5 patients(20.8%)died and the estimated 1-year OS rate was 84.8%with pestilent toxicity syndrome.And there were 8 patients(29.6%)died and the estimated 1-year OS rate was 70.6%with the other syndrome’s patients.About the rate of recurrence,there were 3 patients(14.3%)occurred recurrence and the estimated 1-year RFS rate of pestilent toxicity syndrome was 87.0%;while there were 5 patients(22.7%)occurred recurrence and the estimated 1-year RFS rate of was 63.2%with the other syndrome’s patients.There were significant differences both in the estimated 1-year OS rate and the estimated 1-year RFS rate between the two syndromes of patients(P<0.05).In general,the long-term curative effect of pestilent toxicity syndrome was better than that of the deficiency syndrome.Conclusion In the treatment of AML with HHT as the main chemotherapy regimen,there was no significant difference in the complete remission rate between the pestilent toxicity syndrome and the deficiency syndrome.But,in the curative effect of TCM and the long-term curative effect,the pestilent toxicity syndrome was better than the deficiency syndrome.Furthermore,both in the degree of myelosuppression and the incidence of major adverse reactions caused by chemotherapy,the pestilent toxicity syndrome was less than the deficiency syndrome.All the above results suggested that HHT treatment response and prognosis of patients with pestilent toxicity syndrome were better than those with deficiency syndrome,which was consistent with the risk stratification results of leukemia cytogenetics and molecular biology indicators.This paper provides a reference basis for clinical prediction of treatment response and prognosis of AML patients to HHT. |