复方青黄散治疗骨髓增生异常综合征的临床效果、安全性及其与血砷浓度的 相关性

目的 分析复方青黄散治疗骨髓增生异常综合征(MDS)的临床效果、安全性及其与血砷浓度的关系.方法 40例MDS患者给予复方青黄散治疗,于治疗后6、9个月分析临床疗效、安全性及其与血砷浓度的关系.结果 治疗6个月时,血液学进步率32.5%(13/40),总有效率87.5%(35/40).21例患者治疗前依赖输血,治疗后6例(28.5%)完全脱离输血,6例(28.5%)输血量减少50%以上;中性粒细胞由治疗前的(0.50±0.13)×109/L上升到(0.93±0.33)×109/L(t=4.130,P=0.0008),血红蛋白由(71.06±14.82)g/L上升到(80.41±27.35)g/L(t=2.233,P=0.0321),治疗前后血小板计数差异无统计学意义(P>0.05).治疗9个月时,76.2%(16/40)的患者摆脱输血或输血量减少50%以上;血小板计数由治疗前的(45.04±24.38)×109/L上升到(60.65±29.46)×109/L(t=2.241,P=0.0335).40例患者治疗1、3、6个月时消化道不良反应发生率分别为12.5%(5/40)、10.0%(4/40)、5.0%(2/40),均为轻度.12例治疗前肝功能异常患者中,6例治疗后恢复正常,6例明显减轻,无新增肝功能异常病例.10例治疗前心肌酶增高患者中,1例治疗后恢复正常,9例明显减轻,无新增心肌酶增高病例.治疗前后均未见肾功能指标异常病例.患者治疗前血砷浓度(7.71±5.65)μg/L,低于治疗1、3、6个月时血砷浓度(29.27±9.07)μg/L、(27.79±10.18)μg/L、(31.98±12.55)μg/L,均P<0.0001],治疗1、3、6个月时血砷浓度维持稳定(P>0.05).治疗有效组血砷浓度(33.48±12.56)μg/L]高于无效组(21.46±6.00)μg/L](t=2.089,P=0.035).治疗第1个月时有12.5%(5/40)的患者发生轻度消化道不良反应,血砷浓度(16.93±1.80)μg/L]低于未发生不良反应者(31.78±1.39)μg/L](P<0.0001);治疗3、6个月时消化道不良反应发生率逐渐降低,血砷浓度逐渐提高.结论 复方青黄散治疗MDS疗效显著,消化道不良反应轻微,无需停药,对心、肝、肾脏器功能无损伤.减轻消化道不良反应及维持有效血砷浓度是复方青黄散治疗MDS有效的关键.

Clinical efficacy and safety of compound Qinghuang powder for treatment of myelodysplastic syndromes and its association with blood arsenic concentration

Objective To analyze the clinical efficacy and safety of compound Qinghuang powder (compound QHP) for treatment of myelodysplastic syndromes (MDS) and its association with blood arsenic concentration (BAC). Methods 40 patients with MDS were treated with compound QHP, and the clinical efficacy, safety, and its association with BAC were evaluated after treatment for 6, 9 months, respectively. Results After treatment for 6 months, the rate of hematology improvement was 32.5 % (13/40), and the effective rate was 87.5%(35/40). 21 cases depended on the blood transfusion before treatment, after treatment 6 cases completely got rid of blood transfusion and the blood transfusion of another 6 cases was decreased by more than 50 %. The absolute neutrophil count was increased from (0.50±0.13)×109/L to (0.93±0.33)×109/L (t= 4.130, P= 0.0008). The hemoglobin content was increased from (71.06±14.82) g/L to (80.41±27.35) g/L (t= 2.233, P= 0.0321). After treatment for 9 months, 76.2 % (16/40) of the patients got rid of blood transfusion or blood transfusion reduction was more than 50%. The platelet count was increased from (45.04 ± 24.38)×109/L to (60.65±29.46)×109/L (t= 2.241, P= 0.0335). The incidence of abdominal pain and diarrhea after treatment for 1, 3 and 6 months were 12.5 % (5/40), 10.0 % (4/40) and 5.0 % (2/40), respectively, all belonging to mild level . Before treatment , there were 12 patients with abnormal liver function , including 6 cases back to normal after treatment, and 6 cases of significantly relieved, without new case with abnormal liver function. Before treatment, there were 10 cases with abnormal myocardial enzymes, including 1 cases back to normal after treatment and 9 cases significantly relieved, without new case with abnormal myocardial enzymes. No patient with abnormal renal function was observed before and after treatment. The BAC was (7.71±5.65) μg/L before treatment, which was significantly lower than that of 1, 3 and 6 months (29.27±9.07)μg/L, (27.79 ±10.18) μg/L and (31.98 ±12.55) μg/L respectively, all P< 0.0001]. There was no significant change of BAC among the patients after treatment for 1, 3 and 6 months (P> 0.05). The BAC in efficacy group (33.48 ±12.56) μg/L] was significantly higher than that in non-efficacy group (21.46 ±6.00) μg/L] (t=2.089, P=0.035). 12.5% (5/40) of the patients had mild gastrointestinal side effects after treatment for 1 month, while the BAC of them (16.93 ±1.80) μg/L] was significantly lower than that in patients without gastrointestinal side effects (31.78±1.39 ) μg/L, P<0.0001]. The occurrence rate of abdominal pain and diarrhea was decreased after treatment for 3 and 6 months, while the BAC was increased gradually. Conclusions Compound QHP is effective in the treatment of MDS with mild adverse reactions. There is no damage to the heart, liver, and renal function. Besides, it shows that reducing the gastrointestinal adverse reactions and maintaining the effective concentration of BAC play a significant role in the effect of compound QHP in the treatment of MDS.