生血合剂环孢菌素治疗慢性再障临床对照研究

A Clinical Control Study of Treating Chronic Aplastic Anemia Patients with ShengXue Mixture or Cyclosporine

目的:研究健脾补肾活血中药复方生血合剂治疗慢性再生障碍性贫血(CAA)的疗效和安全性,并比较CAA不同中医证型患者的疗效差异。方法:纳入62例CAA患者分为治疗组32例和对照组30例,治疗组患者辨证分为脾肾阳虚型(9例)和脾肾阴虚型(23例),脾肾阳虚型患者服用生血合剂1号,脾肾阴虚型患者服用生血合剂2号,对照组服用环孢菌素A(CsA),两组均配合支持治疗,治疗6月后,进行疗效观察和安全性评价。结果:治疗组、对照组在临床疗效、外周血象/骨髓象改善方面比较无明显差异(P>0.05),但治疗组在中医证候改善方面明显优于对照组(P<0.05),且生血合剂发生不良反应也明显少于CsA。脾肾阳虚型患者在临床疗效、血象改善方面优于脾肾阴虚型(P<0.05)。结论:生血合剂治疗CAA疗效与CsA相似,但在中医证候改善方面,生血合剂则明显优于CsA,且生血合剂治疗未见明显不良反应。CAA脾肾阳虚型治疗效果优于脾肾阴虚型,提示CAA"阳虚易治,阴虚难调"。

Objective：This study aims to determine the efficacy and safety of Chinese materia medica prescription ShengXue mixture in treating Chronic Aplastic Anemia Patients,and to compare the differences of therapeutic effects with respect to different patterns of CAA patients.Methods：62 patients with CAA were included and divided into an experimental group（32 patients） and a control group（30 patients）.In the experimental group,according to syndrome differentiation,the patients were then divided into spleen and kidney Yang-deficiency（9 patients）,spleen and kidney Yin-deficiency（23 patients）.ShengXue mixture 1,ShengXue mixture 2 and cyclosporin A（CsA） were administered respectively to the patients in spleen and kidney Yang-deficiency group,spleen and kidney Yin-deficiency group and control group,all of which received supportive medical care.After 6 month,we observed therapeutic effects and safety of different treatments.Results：In terms of clinical therapeutic effects,effects indicated by peripheral blood routine examination and bone marrow smear,no significant difference existed in both experimental and control groups（P〉0.05）.While syndromes in the experimental group were much greater improved than that in the control group（P〈0.05）,and adverse reaction observed in the experimental group was much less than that in the control group.Therapeutic effects and blood routine examination showed a greater improvement in the cases of spleen and kidney Yang-deficiency than those of spleen and kidney Yin-deficiency.Conclusion：Therapeutic effects of ShengXue mixture and CsA in treating CAA are similar to each other.But as to syndrome improvement,ShengXue mixture is superior to CsA without obvious side effects.Therapeutic effect in the treatment of CAA with spleen and kidney Yang-deficiency is superior to that with spleen and kidney Yin-deficiency,which also suggests that ＂It’s much easier to cure the cases with Yang deficiency than those with Yin deficiency＂.