再造生血胶囊对骨髓增生异常综合征低危患者外周血象的影响

目的观察再造生血胶囊对骨髓增生异常综合征(MDS)低危患者外周血象的影响及血液学改善情况。方法采用随机对照、多中心竞争入组方式筛选全国6家三级甲等中医医院MDS低危患者117例,最终纳入有效病例98例,其中治疗组69例、对照组29例。治疗组予再造生血胶囊,每次5粒,每日3次,口服;对照组予复方皂矾丸,每次8粒,每日3次,口服。治疗期间2组延续既往基础治疗,随症支持治疗。2组均连续治疗3个月。比较2组治疗前后外周血血红蛋白(HGB)、红细胞、红细胞平均血红蛋白含量(MCV)、血小板、白细胞、中性粒细胞绝对值(NEUT)水平,观察血液学改善情况。结果与本组治疗前比较,治疗组治疗后红细胞、HGB明显升高(P<0.01),MCV明显下降(P<0.05),对照组NEUT水平升高(P<0.05)。治疗组红细胞和血红蛋白、血小板、中性粒细胞改善率分别为52.17%、44.92%、50.72%,对照组分别为51.72%、41.38%、51.72%,2组比较差异无统计学意义(P>0.05)。2组治疗过程中患者基本生命体征、肝肾功能均正常。治疗组1例、对照组2例出现轻度腹痛,停药后自愈。结论再造生血胶囊可提高MDS低危患者外周血红细胞、HGB水平,复方皂矾丸可提高中性粒细胞水平。长期应用再造生血胶囊可能提高红系血液学改善疗效、减少血液成分输注,长期应用复方皂矾丸可预防感染。

Effects of Zaizao Shengxue Capsules on Peripheral Blood in Low-risk Patients with Myelodysplastic Syndrome

Objective To observe the effects of Zaizao Shengxue Capsules on the peripheral blood of low-risk patients with myelodysplastic syndrome(MDS)and the improvement of hematology.Methods Totally 117 low-risk patients screened by 6 tertiary Class A TCM medical units nationwide were selected as the research subjects,and clinical trials were conducted through randomized controlled,multi-center competition enrollment methods.Finally,98 valid cases were included,including 69 in the treatment group and 29 in the control group.The treatment group was given 5 Zaizao Shengxue Capsules,3 times a day,orally;the control group was given 8 saponin pills,3 times a day,orally.During the treatment period,the two groups received the previous basic treatment,followed by supportive treatment.Both groups were treated continuously for 3 months.The changes of HGB,RBC,MCV,PLT,WBC,NEUT in peripheral blood before and after treatment were compared between the two groups,and the improvement of hematology was observed.Results Compared with before treatment,RBC and HGB in the treatment group increased significantly(P<0.01),MCV decreased significantly(P<0.05),and NEUT level in the control group increased(P<0.05).The improvement rates of red blood cells and hemoglobin,platelets,and neutrophils in the treatment group were 52.17%,44.92%,and 50.72%,respectively,while those in the control group were 51.72%,41.38%,and 51.72%,respectively,without statistical significance(P>0.05).The basic vital signs and liver and kidney functions of the patients in the two groups were normal during treatment.1 case in the treatment group and 2 cases in the control group recovered spontaneously after stopping medication due to mild abdominal pain.Conclusion Zaizao Shengxue Capsules can improve the levels of peripheral RBC and HGB in patients with low-risk MDS;Compound Zaofan Pills can improve the effect of neutrophils.It is speculated that the long-term clinical application of Zaizao Shengxue Capsules may improve the level of erythropoiesis and improve the efficacy of blood,and reduce the transfusion of blood components.Long-term clinical application of Zaofan Pills may have the effect of preventing infection.