定清片联合健脾补肾活血解毒方治疗骨髓增生异常综合征的临床研究

Clinical efficacy and safety of Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney,Detoxification and Vigoration of Blood Circulation in treatment of myelodysplastic syndrome

目的观察定清片联合健脾补肾活血解毒方治疗骨髓增生异常综合征的临床效果及安全性。方法收集2012年5月至2013年4月在上海中医药大学附属岳阳中西医结合医院诊断骨髓增生异常综合征及中医辨证属脾肾亏虚、瘀毒内蕴证患者60例,随机进入治疗组和对照组,各30例。对照组采用十一酸睾酮或沙利度胺或环孢素等西医基础治疗,结合健脾补肾活血解毒方,必要时结合DA(柔红霉素+阿糖胞苷)或CAG(阿糖胞苷+阿克拉霉素+粒细胞集落刺激因子)化疗方案治疗;治疗组采用定清片联合健脾补肾活血解毒方治疗。2组分别予以3个月药物治疗,比较患者西医、中医疗效及不良反应情况。结果西医疗效观察,治疗组部分缓解8例,进步11例,无效11例,总有效率为63.4%;对照组部分缓解12例,进步10例,无效8例,总有效率为73.2%;2组总有效率差异无统计学意义(P>0.05)。在中医证候疗效方面,治疗组显著3例,有效17例,无效9例,加重1例,总有效率为66.7%;对照组无显著病例,有效7例,无效15例,加重8例,总有效率为11.7%;治疗组总有效率显著高于对照组(P<0.05)。在安全性评价中,治疗组患者肝肾功能异常发生率低于对照组,差异有统计学意义(6.7%vs 30.0%,P<0.05)。结论定清片联合健脾补肾活血解毒方与西医常规治疗联合治疗方案治疗骨髓增生异常综合征的临床疗效相当,但中医证候疗效方面定清片联合治疗方案明显更优。2种治疗方法均具有一定的安全保障,但定清片联合健脾补肾活血解毒方治疗的安全性更优。

Objective To observe the clinical efficacy and safety of Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney,Detoxification and Vigoration of Blood Circulation in the treatment of myelodysplastic syndrome(MDS).Methods Sixty patients with MDS and TCM syndrome of spleen and kidney deficiency,stasis and toxin internal accumulation diagnosed at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from May 2012 to April 2013 were selected and randomly divided into a treatment group and a control group,with 30 cases in each group.The patients in the control group were treated with Testosterone Undecanoate,Thalidomide,or Cyclosporine,combined with Prescription of Invigorating Spleen and Kidney,Detoxification and Vigoration of Blood Circulation,or combined with DA or CAG chemotherapy if necessary.Patients in the treatment group were treated with Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney,Detoxification and Vigoration of Blood Circulation.After 3 months of medication,the clinical efficacy of TCM and Western medicine,and the adverse reactions of the two groups were compared.Results In terms of the efficacy for Western medicine,in the treatment group there were 8 cases of partial remission,11 cases of disease improvement,and 11 cases of ineffectiveness,with an effective rate of 63.4%;in the control group,there were 12 cases of partial remission,10 cases of disease improvement,and 8 cases of ineffectiveness,with an effective rate of 73.2%.The effective rate did not differed statistically between the two groups(P>0.05).In terms of the efficacy for TCM syndrome,in the treatment group,there were 3 cases of remarkable improvement,17 cases of improvement,9 cases of ineffectiveness,and 1 case of aggravation,with a total effective rate of 66.7%;in the control group,there was no case of remarkable improvement,7 cases of improvement,15 cases of ineffectiveness,and 8 case of aggravation,with a total effective rate of 11.7%.The total effective rate of the treatment group was statistically significant higher than that of the control group(P<0.05).The incidence of abnormal liver and kidney function in the treatment group was significantly lower than that of the control group(6.7%vs 30.0%,P<0.05).Conclusion The clinical efficacy of Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney,Detoxification and Vigoration of Blood Circulation in the treatment of MDS is equivalent to that of conventional Western medicine combined with Prescription of Invigorating Spleen and Kidney,Detoxification and Vigoration of Blood Circulation,but the curative effect on TCM syndrome is obviously better.Although the two treatments are both safe,Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney,Detoxification and Vigoration of Blood Circulation for MDS treatment has a better safety profile.