再生方治疗低危骨髓增生异常综合征临床研究

目的：观察中药再生方治疗治疗低危MDS的疗效及安全性。方法2008年2月至2010年7月低危MDS60例，按WHO诊断和分型，其中RA12例，RCMD42例，RAS2例，MDS-U 4例。随机分为再生方组与对照组，每组30例。再生方组应用再生方，水煎服，日一剂。对照组给予司坦唑醇，2 mg，3次/d，口服，或十一酸睾丸酮40 mg，2次/d，口服。治疗期间患者如有感染发热及时应用抗菌药物，贫血严重或出血明显时输注红细胞悬液或血小板，并统计血细胞输注数量。结果再生方组完全缓解3例、部分缓解3例、血液学改善14例，总有效率66 T．7％。对照组部分缓解2例、血液学改善9例，总有效率36．7％。2组疗效比较差异有统计学意义（χ2＝5．41， P ＜0．05）。细胞形态观察，中药再生方治疗低危MDS，可以使红系病态造血减轻。再生方组红细胞输注量为（15±10）U，对照组为（22±15）U，2组比较红细胞输注量差异有统计学意义（ t ＝2．18， P ＜0．05）。再生方组血小板输注量为（6±4）U（1人份为1 U），对照组为（13±6）U，2组比较差异有统计学意义（ t ＝2．31， P ＜0．05）。再生方组4例发生不良反应，发生率为13．3％，均为轻微的消化道反应，未发现肝肾功能损害。对照组30例有20例发生各种不良反应，发生率为66．7％。2组不良反应发生率差异有统计学意义（χ2＝17．78， P ＜0．01）。结论再生方治疗低危MDS有较好疗效，有效率高于雄性激素类药物，并减少红血细胞和血小板输注，无严重不良反应。形态学观察再生方可改善红系病态造血，使红细胞和血红蛋白显著改善。

Therapeutic effect and safety of regeneration formula on low-risk myelodysplastic syndromes

Objective To observe the therapeutic effect and safety of regeneration formula on low-risk myelodysplastic syndromes （ MDS） .Methods Sixty patients with low-risk MDS who were inpatients or outpatients from February 2008 to July 2010 were enrolled in the study ,including 12 cases of RA ,42 cases of RCMD ,2 cases of RAS,4 cases of MDS-U according to the criterion of diagnosis and typing of WHO .These patients were randomly divided into treatment group （ n =30） and control group （ n =30）.The patients in treatment group were treated with regeneration formula which was decocted in water for oral dose ,one dose a day ,however ,the patients in control group were treated with stanozolol ,2mg once,3 times a day.The patients were given antibacterials in case of infectious fever,and they were injected with red cell suspension or platelets in case of sever anemia or obvious hemorrhage ,meanwhile the transfusion amount of red cell suspension or platelets was calculated .Results The total effective rates in treatment group and control group were 66.7%,36.7%,respectively,there was a significant difference between two groups （ P 〈0.05 ）.Cell morphous observation results showed that erythron dyshaematopoiesis was relieved in treatment group .There was a significant difference in transfusion amount of red cell suspension between two groups （ P 〈0.05）,so was in transfusion amount of platelets （ P 〈0.05）.The adverse reactions were taken place in 4 patients of treatment group , and the incidence rate was 20%, but these adverse reactions were all mild digestive tract reaction ,and no injury of liver and kidney was found .However the adverse reactions were taken place in 20 patients of control group ,and the incidence rate was 66.7%,there was a significant difference between two groups （ P 〈0.01）.Concluison The regeneration formula is effective in treating low-risk MDS,and its effective rate is higher than that of stanozolol ,furthermore,which can reduce the transfusion amount of red cell suspension or platelets , without severe adverse reactions .The regeneration formula can also improve erythron dyshaematopoiesis ,as a result,improve obviously red blood cells and hemoglobin .