含砷中药复方青黄散治疗骨髓增生异常综合征患者血砷浓度及安全性分析

目的 观察含砷中药复方青黄散治疗骨髓增生异常综合征(myelodysplastic syndromes,MDS)患者体内血砷浓度及临床安全性.方法 采用原子荧光光谱仪测定45例接受复方青黄散(复方青黄散组)治疗的MDS患者服药后不同时间血砷浓度,并与47例服用青黄散(青黄散组)及20例健康人(正常对照组)进行比较,通过分析毒副作用及脏器功能评价复方青黄散临床安全性.结果 复方青黄散组治疗前血砷浓度与正常对照组比较,差异无统计学意义(P=0.450),治疗后1个月血砷浓度则显著升高(P<0.001);复方青黄散组治疗后1、3、6个月血砷浓度比较,差异无统计学意义(P=0.240).复方青黄散组总体毒副作用发生率及消化道毒副作用发生率均低于青黄散组(χ2值分别为4.720、4.650,P值分别为0.030、0.034).腹痛腹泻患者血砷浓度低于无腹痛腹泻患者(P=0.020).复方青黄散组治疗前分别有21例心肌酶偏高、10例肝功能异常及4例肾功能异常;治疗后6个月,分别有7例心肌酶、6例肝功能及1例肾功能恢复正常,无新增心肌酶、肝功能以及肾功能异常病例.结论 含砷中药复方青黄散治疗MDS,砷可被有效吸收入血液,血砷浓度维持稳定;毒副作用较青黄散小,无心肝肾功能损伤.

Analysis of blood arsenic concentration and safety of arsenic-containing compound Qinghuang powder in patients with myelodysplastic syndrome

Objective To analyze the blood arsenic concentration and the safety of compound Qinghuang powder(compound QHP)in patients with myelodysplastic syndrome(MDS).Methods A total of 45 MDS patients received treatment with compound QHP (the treatment group, n=45). The concentration of blood arsenic in different time was determined by atomic fluorescence spectrometry. The clinical safety of compound QHP was evaluated by analyzing the symptoms of adverse reaction and organ function. The comparison were MDS patients with Qinghuang powder (QHP group, n=47) and healthy people. Results There was no significant difference of the blood arsenic concentration between the treatment group and the healthy control group (P=0.450),while after the treatment for 1 month those concentrations significantly increased (P=0.000). There were no significant difference between the blood arsenic concentration after treatment for 1, 3, and 6 months (P=0.240). The incidence of adverse reaction in the treatment group was significantly lower than that in QHP group(χ2=4.720, P=0.030). The incidence of adverse reactions in the digestive tract was significantly lower in the treatment group than that in QHP group (χ2=4.650, P=0.034). The blood arsenic concentration of patients with abdominal pain diarrhea was significantly lower than those without abdominal pain diarrhea (P=0.020). Before treatment in the compound QHP group, there were 21 cases with increased myocardial enzymes, 10 cases with abnormal liver function and 4 cases with renal dysfunction, respectively. After treatment at 6th month, these indicators returned to normal with 7 cases of myocardial enzymes, 6 cases of liver function and 1 case of renal function, respectively. There was no new case with abnormal myocardial enzymes, liver function and renal dysfunction, respectively. Conclusions Arsenic could be absorbed in the digestive tract into blood in MDS patients after treatment with arsenic-containing compound QHP, and the blood arsenic concentration remained stable during the course of treatment. The adverse reactions were mainly mild gastrointestinal symptoms, but no heart, liver or renal function damage was observed. The incidence of abdominal pain diarrhea in patients treated with compound QHP was significantly lower than that with QHP.