Biological Characteristics Of Chinese Medical Evidence Of Myelodysplastic Syndrome And Its Response To Treatment With Compound Qing Huang San

Clinical Study I Myelodysplastic Syndrome:Spleen and Kidney Deficiency,Toxic and Stagnant Evidence Study on the biological characteristics of Qi-Yin deficiency and toxin-stasis blockageObjective.To provide a reference basis for the objectification of Chinese medical evidence of MDS by comparing the differences in the biological characteristics of spleen-kidney two-deficiency and toxin-stasis blocking evidence(hereafter referred to as the spleenkidney two-deficiency group)and qi-yin two-deficiency and toxin-stasis blocking evidence(hereafter referred to as the qi-yin two-deficiency group)in myelodysplastic syndrome(MDS).Methods.One hundred and twenty patients with MDS were selected from the Department of Hematology,Xiyuan Hospital,Chinese Academy of Traditional Chinese Medicine,including 80 patients in the Spleen and Kidney Two Deficiency group and 40 patients in the Qi and Yin Two Deficiency group.The gender,age,peripheral blood cell count[neutrophil(ANC),hemoglobin(HGB)and platelet(PLT)count],bone marrow primitive cell ratio,karyotype,subtype,IPSS-R prognostic risk stratification,second-generation gene sequencing(NGS)and serum iron metabolism indexes[serum iron(SI),serum ferritin(SF),total iron binding capacity(TIBC),unsaturated iron binding capacity(UIBC),transferrin(TRF)and transferrin saturation(TS)].Firstly,the differences in biological characteristics between the two groups of patients with different evidence types were compared by univariate analysis;secondly,the indicators in the univariate analysis P<0.05 were included in the logistic regression model for multi-factor analysis,and logistic regression analysis was applied to further identify the difference indicators;finally,the area under the ROC curve(AUC)was applied to analyze the relevant biological indicators for the identification of TCM evidence types detection value.Results.1 Univariate analysis showed that PLT counts were significantly higher in the spleenkidney deficiency group[91.5(46,204.5)vs.48.5(26,89.25),P<0.05],the proportion of patients with intermediate/poor/very poor karyotype was significantly higher(32.5%vs.12.5%,P<0.05),and the IPSS-R prognostic risk was significantly higher in the spleen-kidney deficiency group compared with the qi-yin deficiency group[32.5%vs.15%,P<0.05].The proportion of patients stratified as high/very high risk was significantly higher(32.5%vs.15%,P<0.05),the number of mutations was significantly higher[1.81(1,2.75)vs.1.41(1,1.95),P<0.05],the frequency of mutations in the RNA shear group was significantly higher(30%vs.12.5%,P<0.05),and SF levels were significantly higher[1472.9(425.18,2366.8)vs 653.05(234.11,1516.58),P<0.05],significantly lower TIBC levels[45.78(38.25,50.81)vs 47.09(43.15,59.44),P<0.05],and significantly lower TRF levels[2.14(1.80,2.25)vs.2.25(2.08,2.87),P<0.05].The ANC count[1.25(0.8,2.23)vs 1.31(0.67,2.90)],HGB count(77.76 ± 20.41 vs 89.58±25.67),percentage of bone marrow primitive cells[2.65%(0.97%,6.0%)vs 1.75%(0.75%,4.75%)],subtypes,various mutation frequency,the proportion of patients with good(6.25%vs 5%)and poor(42.5%vs 27.5%)genetic prognostic significance,SI levels(28.32 ± 12.94 vs 28.53± 12.63),UIBC levels[17.65(3.6,22.25)vs 18.62(7.55,27.78)]and TS[82.45(41.44,91.81)vs.64.3(38.77,90.30)]were not significantly different(P>0.05).2 Multivariate logistic regression analysis showed that high PLT counts(OR 0.994,95%CI:0.99-0.999,P<0.05),number of multiple mutations(OR 0.660,95%CI:0.439-0.991,P<0.05)and the presence of RNA shear group mutations(OR 5.589,95%CI:1.513-20.644,P<0.05)were independent discriminatory factors for the spleen-kidney deficiency group.3 Using the spleen and kidney two-deficiency group as the study target,a total of eight biological indicators with significant differences in univariate analysis(P<0.05),PLT count,karyotype,IPSS-R prognostic risk stratification,number of gene mutations,presence of RNA shear group mutations,SF,TIBC,and TRF,were independently analyzed by ROC curves,and the AUCs were less than 0.7;eight biological indicators The AUC of the combined ROC curve analysis reached 0.83,suggesting that the application of a single biological index to determine whether the patients were in the spleen-kidney deficiency group was generally effective independently,while the combination of multiple biological indexes was effective.Conclusion.The important biological characteristics that distinguish the evidence of spleenkidney deficiency and toxic stasis from that of qi-yin deficiency and toxic stasis in MDS patients are PLT count,karyotype,IPSS-R prognostic risk stratification,number of gene mutations,presence of RNA shear group mutations,SF,TIBC and TRF.among them,PLT count,number of gene mutations and presence of RNA shear group mutations can be used to discriminate the two groups The TCM patterns were independently discriminated.Compared with single biological indexes,the combined use of multiple indexes is more effective for the differentiation of MDS patients’ TCM patterns,and the above biological features can be combined to assist in the differentiation of MDS patients’ TCM patterns in clinical practice.Clinical Study ⅡTherapeutic Response of Myelodysplastic Syndrome with Spleen and Kidney Deficiency and Toxic Stasis Blockage Evidence and Qi and Yin Deficiency and Toxic Stasis Blockage Evidence to Compound Qing Huang SanObjective.To investigate the clinical significance of the differentiation and treatment of MDS by comparing the therapeutic response of patients in the spleen-kidney two deficiency group and the qi-yin two deficiency group of MDS to the application of the evidencebased formula of Qinghuang San.Methods.An observational study was conducted to include 58 patients with MDS treated with compound Qinghuang San from October 2020 to December 2022,including 38 patients in the spleen-kidney two deficiency group and 20 patients in the qi-yin two deficiency group,who received compound Qinghuang San for 6 months(2 courses of treatment),and to analyze the therapeutic response of patients in the spleen-kidney two deficiency group and the qi-yin two deficiency group to compound Qinghuang San.Results.1 Changes in blood cell counts of patients in both groups before and after treatment1.1 HGB counts before and after treatment in the two groupsComparing the changes in HGB counts before and after treatment between patients in the spleen-kidney two-deficiency group and the qi-yin two-deficiency group,the results showed that the overall patient HGB counts were significantly higher after treatment compared with those before treatment(90.88±20.67 vs.79.85±22.13,P<0.05),and the patients in the spleen-kidney two-deficiency group had significantly higher HGB counts(92.61±19.04 vs.76.21±There was no significant difference in HGB counts between the patients in the qi-yin deficiency group(87.60±23.62 vs.86.76±25.94,P>0.05).1.2 PLT counts before and after treatment in the two groupsComparing the changes in PLT counts before and after treatment between patients in the spleen and kidney deficiency group and the qi and yin deficiency group,the results showed that compared with the pre-treatment period,PLT counts were significantly higher in the overall patients after treatment[84.50(43.75,127.00)vs 67.50(31.50,127.25),P<0.05],and PLT counts were significantly higher in patients in the spleen and kidney deficiency group[103.50(66.25,194.50)vs.90.50(49.50,145.25),P<0.05],and PLT counts were significantly higher in patients in the qi-yin deficiency group[47.00(30.00,95.50)vs.32.50(18.50,68.25),P<0.05].There was no significant difference in the improvement between the two groups(P>0.05).1.3 ANC counts before and after treatment in the two groupsComparing the changes in ANC counts of patients in the spleen-kidney deficiency group with those in the qi-yin deficiency group before and after treatment,the results showed that the overall patient ANC counts significantly increased after treatment compared with those before treatment[1.52(0.88,2.49)vs.1.24(0.53,2.03),P<0.05],and the patients in the spleen-kidney deficiency group had significantly higher ANC counts[1.36(0.70,2.34 There was no significant difference in the ANC counts of patients in the qi-yin deficiency group[1.61(0.99,3.48)vs.1.52(0.88,2.49),P>0.05].2 Changes in red blood cell infusion volume before and after treatment in the two groupsComparing the erythrocyte infusion volume(U)of patients in the spleen-kidney deficiency group and the qi-yin deficiency group before and after treatment,the results showed that the overall patient’s erythrocyte infusion volume decreased significantly after treatment compared with that before treatment[0(0,0)vs 0(0,2),P<0.05],and the erythrocyte infusion volume of patients in the spleen-kidney deficiency group decreased significantly[0(0,0)vs 0(0,2),P<0.05],and the qi-yin The erythrocyte infusion volume of patients in the two deficiency groups was significantly decreased[0(0,1.5)vs 0(0,2),P<0.05].There was no significant difference in the decrease in red blood cell transfusion volume between the two groups(P>0.05).3 Hematological improvement in the two groups A comparison of the hematological improvement of patients in the spleen-kidney two-deficiency group and the qi-yin two-deficiency group showed that the rate of red system reaction was significantly higher in patients in the spleen-kidney two-deficiency group compared with the qi-yin two-deficiency group(50%vs.20%,P<0.05).There was no significant difference in platelet response(13%vs 10%)and neutrophil response(15%vs 10%)between the two groups(P>0.05).4 Safety evaluationNo abnormal liver,kidney,and cardiac functions were observed in 58 patients,and no andrographis-related adverse reactions such as abdominal pain and diarrhea were observed.Conclusion.Compared with patients with Qi-Yin deficiency and toxic stasis obstruction,patients with Spleen-Kidney deficiency and toxic stasis obstruction had a worse prognosis,but compound Qinghuang San improved HGB count and ANC count more significantly in patients with Spleen-Kidney deficiency and toxic stasis obstruction,and had a higher red system response rate.It is suggested that the compound Qinghuang San has therapeutic selectivity for patients with spleen-kidney deficiency and toxin-stasis obstruction,and it is beneficial to identify and treat patients with MDS in clinical practice for more precise drug use.