| Objective:Compound Huangdai Tablet is a pure traditional Chinese medicine preparation,in which realgar is the sovereign drug and its main component is arsenic sulfide.In 2009,Fufang Huangdai Tablet obtained the New Drug Certificate from State Food and Drug Administration(Z20090053),and has become the first-line drug in Chinese guidelines for diagnosis and treatment of acute promyelocytic leukemia(2018).This study aims to analyze the adverse reactions and and the effect on heart,liver and kidney during using Compound Huangdai Tablet to treat acute promyelocytic leukemia(APL)based retrospective studies,summarize the management strategy,provide the basis of using Compound Huangdai Tablet safely and improve curative effect of treating APL.Methods:A study of 231 patients with APL treated at the 967th Hospital of the Chinese People Liberation Army from 1 January 1986 to 30 December 2017 was performed using a retrospective research.The indexes such as diverse reactions,blood routine,liver function,renal function,electrocardiogram before treatment,during treatment,at complete remission(CR)with Compound Huangdai Tablet were studied in order to analysis and summary of adverse reactions,the effects on liver,kidney,heart function during treatment with Compound Huangdai Tablet.Result:1、During remission-induction therapy with Compound Huangdai Tablets,the adverse reactions were abdominal pain,diarrhea,nausea,vomiting,constipation,rash,jaundice,itchy skin,eyelid edema,facial edema in which gastrointestinal reactions were the most common with 58.7%the incidence rate.Among gastrointestinal reactions,the primary manifestations were abdominal pain,diarrhea,nausea and vomiting,and the incidence rates were 29.00%,19.04%,5.63%,and 5.19%respectively.All adverse reactions was alleviated with symptomatic treatment.2、After treatment with Compound Huangdai Tablets,WBC of 90.4%of the patients with WBC≤10×10~9/L at the time of admission increased with different degrees at(10.4±5.7)d,of which WBC of 22.11%of patients exceeded 10×10~9/L up to 220×10~9/L,and decreased to normal level at(15.1±6.9)d after keep on treatment with Compound Huangdai Tablets.Before treatment,WBC of the patient with WBC>10×10~9/L fell to the normal level at(18.4±9.1)d.3、Before t remission-induction therapy with Compound Huangdai Tablets,The liver enzyme of 34 patients were abnormality and incidence rates was 14.72%,including 5 cases with ALT≥80U/L the highest value was346.0U/L in them;2 cases with AST≥80U/L,the highest value was 80.6.U/L in them.During treatment with Compound Huangdai Tablets or at CR,31 patients had liver enzyme abnormalities and the incidence rate was 13.42%,including 10 patients with ALT≥80U/L,the highest value was 256.0U/L in them;6 patients with AST≥80U/L The highest value is 93.7U/L in them.All patients with abnormal liver enzymes before and after treatment recovered to normal after the treatment for protecting liver.The ALT before and after treatment with Compound Huangdai Tablets was 19.2±6.2 U/L and23.8±7.9U/L respectively with statistically significant between them(P<0.05).The AST before and after treatment with Compound Huangdai Tablets was 16.5±5.8U/L and19.3±6.3U/L respectively without statistically signification between them(P>0.05).4、Before treatment with Compound Huangdai Tablets,Cr of 3 cases and BUN of a case exceeded the upper limit of the normal detection value respectively;Cr of 2 cases and BUN of 2 case fell the lower limit of the normal detection value respectively;and returned to normal during the treatment.The Cr before and after treatment with Compound Huangdai Tablets was 63.9±16.6μmol/Land 54.6±13.2μmol/L respectively without statistically signification between them(P>0.05)..The BUN before and after treatment with Compound Huangdai Tablets were 4.5±1.6mmol/L and 3.8±1.5mmol/L respectively without statistically signification between them(P>0.05).5、Before remission-induction therapy with Compound Huangdai Tablets,QT interval of 15.99%of patients exceeded 440ms,and 5 cases returned to normal at CR.During treatment or at CR,f them,5.50%of patients presented the prolonged QT interval exceeding440ms.These patients did received any treatment.The QT interval before and after treatment was 421.36±19.41ms and 419.39±26.44ms,respectively without significant difference between them(P>0.05).Conclusion:1、The main adverse reaction of Compound Huangdai Tablets are gastrointestinal reactions,which can be relieved with symptomatic treatment.2、During remission-induction therapy,Compound Huangdai Tablets,can cause a increased WBC from peripheral blood with different degrees but no similar to the appearance of retinoic acid syndrome occured.3、Compound Huangdai Tablets cause reversible liver dysfunction,mainly manifested as increased AST and ALT,and can be restored to normal after treatment for protecting.Compound Huangdai Tablet does not need to be reduced or stopped.4、During remission-induction therapy for APL,Compound Huangdai Tablet had had not the effect on renal function,obvious toxic effect on the heart.5、Compound Huangdai Tablets have fewer adverse reactions,less toxic side effects and high safety. |
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