The Clinical Study To Treat APL With Professor Huang Shilin's Therapeutical Principle Of "Qu Xie Fu Zheng"

Objective:To inherit and summarize the academic experience and theory of professor Huang Shilin to treat acute promyelocytic leukemia(APL)with the therapeutical principle of "QU'XIE-FU-ZHENG".Methods:First,we traced the theory of "QU-XIE-FU-ZHENG".Second,the clinical experience of APL treated with the Traditional Chinese Medicine(TCM) of realgar natural indigo tablet(CRNIT)was inherited and summarized.The patients with APL was treated only with the CRNIT during induction remission, and the CRNIT and chemotherapy were administered alternatively during post remission.The indictors such as complete remission(CR)rate,relapse-free survival(RFS)rate and its influence factors,hemogram,liver and renal biochemical examination,creatine kinase(CK)and CK-MB,the indicators of disseminated intravascular coagulation(DIC),the PML-RARαfusion gene,the liver,gall,spleen and renal ultrasonography results,abnormality of electrocardiogram(ECG)and clinical symptoms were analysed.SPSS 11.5 software was used to analyze the date.Results:79 patients have received induction therapy with CRNIT(55 newly diagnosed,24 refractory or relapsed),the therapeutic effect of 77 patients can be calculated.97.4%(75/77)patients got CR after 44.4±14.0 days,and 94.7%(18/19)patients were in negative PCR status.During induction therapy,the indisposition rate of stomach intestine was 35.4%,and the alanine aminotransferase(ALT)and asparate aminotransferase(AST)levels were higher slightly than CRNIT treatment before.The abnormal rate of ALT(higher than nomal value)was 28.0%(p＜0.05)and AST(higher than the two times of the nomal value)was 9.3%(p＜0.05).Post remission,the ALT and AST were normal. Other biochemical indicators such as TBIL,DBIL,GLB,ALB,BUN,CR,CK,CK-MB were normal during induction threapy.The DIC rate were no siganificantly differences between before and after treatment.During induction therapy,the QTc span prolong slightly than treatment before,but didn't during post remission therapy.All these indictors' levels were normal during post remission therapy.The gall and renal ultrasonography results were normal,the abnormal rate of the liver and spleen ultrasonography results were no statistically differences between treatment before and during post remission.The PCR-negative rate in half year,one year,two year,three year and more than three year were 95.8%(23/24),94.7%(18/19),89.5%(17/19),100%(9/9), 71.4%(5/7).Kaplan-Meier estimate of 5-year,and 7,10-year RFS rates of newly diagnosed patients were 91.0%and equal to 87.0%,the 5,7,10-year RFS rates of refractory or relapsed patients were equal to 59.9%.The systematical therapy is the main factor to influence the RFS.Conclusion:1.Professor Huang developed the of "QU-XIE-FU-ZHENG" to treat the Acute Leukemia based on the Zhang Congzheng's theory that is "one's spirits will automatically recover when the evil was drived away".Its strategic point of the theory is to drive away the evil factor and doesn't do harm to healthy energy.The theory of"QU-XIE-FU-ZHENG" is the great development of TCM to treat AL.2.CRNIT originates with Professor Huang,which is the representative to reflect the theory,.has the high performance abilities to drive away evil and does not do harm to healthy energy.Its therapeutic effect on APL in clinical is specific, more than 95%patients with APL treated only with CRNIT from can get complete remission,it establish a favourable foundation for the patients with APL to get complete continuous remission,creates a new way to other AL to get complete remission and long term survival treated with TCM.3.CRNIT has no cross tolerance with chemotherapy,ATRA and As₂O₃.As a result,it provide another treatment with high therapeutic effect to induce the relapse or refractory APL,which has resistance to chemotherapy,ATRA and As₂O₃.4.CRNIT was taken as the main medicine in the post remission therapy,it makes a precedent to treat APL with compound Chinese materia medica in whole treatment. 5.Its predominance is taking the TCM as the main medicine and the complementation of TCM with western medicin,the survival span was significantly prolonged,and a opportunity for patients to get long term disease free survival and even to get healing well was provided.