小剂量青黄散联合补肾健脾中药治疗低增生性骨髓增生异常综合征的临床观察

Effect of Treatment for Hypocellular Myelodysplastic Syndromes by a Low Dose Qinghuang Powder Combined with Chinese Drugs for Shen Supplementing and Pi Invigorating: a Clinical Observation

目的观察小剂量青黄散加补肾健脾中药治疗低增生性骨髓增生异常综合征(hypo-MDS)的临床疗效。方法选择2011年11月—2012年12月在中国中医科学院西苑医院血液科门诊就诊的hypoMDS患者33例,采用自身前后对照的方法,口服青黄散每日0.4 g、补肾健脾汤药每日1剂及司坦唑醇片每日3次,每次2 mg等治疗;3个月为1个疗程,共2个疗程,每个疗程结束后及时评价疗效。治疗前、治疗3个月后及治疗6个月后分别抽取静脉血进行血常规检查,观察指标主要有中性粒细胞绝对计数(ANC),血红蛋白(Hb)及血小板(PLT)等。结果试验完成31例。治疗后3个月,ANC,Hb及PLT计数均较治疗前升高(P<0.05);治疗后6个月,Hb及PLT较治疗前升高(P<0.01,P<0.05),ANC较治疗前差异无统计学意义(P>0.05);治疗6个月后Hb较治疗3个月升高(P<0.01),ANC及PLT则差异无统计学意义(P>0.05);治疗3个月,血液学进步、稳定、进展例数分别为:13例(41.9%)、15例(48.4%)、3例(9.7%);治疗6个月后分别为:18例(58.1%)、7例(22.6%)、6例(19.3%);治疗后3个月与治疗后6个月疗效比较差异无统计学意义(P>0.05);疗效与hypo-MDS患者年龄及病程无相关性(P>0.05)。结论以小剂量青黄散加补脾益肾中药为主的综合治方案对hypo-MDS具有确切的临床疗效,疗效与患者病程长短、年龄无明显相关性。

Objective To observe the clinical efficacy of a low dose Qinghuang Powder( QP) combined with Chinese drugs for Shen supplementing and Pi invigorating( CDSSPI) in treatment of hypocellular myelodysplastic syndromes( hypo- MDS). Methods Totally 33 hypo- MDS patients enrolled in this study came from outpatient clinics between November2011 and December 2012. A self- control method was used in this study. Patients took QP( 0. 4 g per day) combined with CDSSPI( one dose per day),and Stanozolol Tablet( 2 mg each time,three times per day),3 months as one therapeutic course,a total of 2 courses. The clinical efficacy was evaluated timely at the end of each therapeutic course. The venous blood was withdrawn before treatment,at month 3 and 6 after treatment. Changes of neutrophils( ANC),hemoglobin( Hb),and platelet( PLT) were mainly observed. Results Totally 31 patients in this study finished the treatment. Three months after treatment ANC,Hb,and PLT increased more than before treatment(P < 0. 05). Six months after treatment Hb and PLT increased(P < 0. 01,P < 0. 05),but with no statistical difference in ANC(P > 0. 05). Hb increased higher at month 6 after treatment than at month 3 after treatment(P < 0. 01),but with no statistical difference in ANC or PLT(P > 0. 05). After3- month treatment the number of hematologic progress,stability,disease progression were: 13 cases( 41. 9%),15 cases( 48. 4%),and 3 cases( 9. 7%),respectively; after 6- month treatment the number of hematologic improvement,stability,and disease progression were: 18 cases( 58. 1%),7 cases( 22. 6%),6 cases( 19. 3%),respectively. There was no significant difference between 3- month efficacy and 6- month efficacy(P > 0. 05). There was no correlation between the efficacy and ages of hypo- MDS patients or the efficacy and courses of hypo- MDS patients(P > 0. 05). Conclusions A low dose QP combined with CDSSPI showed confirmative efficacy in treatment of hypo- MDS. But the efficacy had little correlation with ages and courses of hypo- MDS patients.