益髓生血颗粒治疗血红蛋白H病随机对照临床研究  

Randomized Controlled Trial of Yisui Shengxue Granule in Treating HbH Disease

作　　者：王文娟[1] 方素萍[2] 刘咏梅[2] 吴志奎[2] 张新华[3] 刘文军[2] 李敏[2] 王荣新[3] 罗瑞贵[3] 李平萍[3] 

机构地区：[1]首都医科大学中医药学院,北京100069 [2]中国中医科学院广安门医院,北京100053 [3]中国人民解放军第303医院,广西南宁530021

出　　处：《中国中医药信息杂志》2014年第5期21-24,共4页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：国家自然科学基金重大研究计划(90409003);国家自然科学基金(81173167);国家重点基础研究发展计划(2010CB530406)

摘　　要：目的评价益髓生血颗粒治疗血红蛋白H病(HbH病)的临床疗效。方法采用随机、单盲、安慰剂平行对照方法,将入选的59例HbH患者随机分为益髓生血颗粒组(27例)和安慰剂对照组(32例),分别予益髓生血颗粒和安慰剂口服,疗程3个月。治疗前后分别检测2组患者血红蛋白(Hb)浓度、红细胞计数(RBC)、网织红细胞百分比(Ret),对患者的中医证候进行量化评分,评价中医疗效及西医疗效。结果益髓生血颗粒组治疗后Hb、RBC明显提高(P<0.01,P<0.05),中医证候总积分明显降低(P<0.01),西医总有效率为77.8%(有效21例,无效6例),中医总有效率为90.9%(有效20例,无效2例)。安慰剂对照组Hb、RBC无明显改善(P>0.05),中医证候总积分降低不明显(P>0.05),西医总有效率为15.6%(有效5例,无效27例),中医总有效率为36.0%(有效9例,无效16例)。益髓生血颗粒组在升高Hb、降低中医证候总积分以及中西医疗效方面均明显优于安慰剂对照组(P<0.01)。结论益髓生血颗粒治疗HbH病能有效改善患者贫血程度,减轻临床症状。Objective To evaluate the therapeutic effect of Yisui Shengxue Granule in treating patients with HbH disease. Methods A randomized, single-blinded, placebo-controlled trial was conducted. A total of 59 patients with HbH disease were randomized to receive either Yisui Shengxue Granule （Yisui Shengxue Granule group, 27 cases） or placebo （control group, 32 cases） orally for 3 months. Before and after treatment, blood parameters （Hb, RBC, Ret） were examined, the TCM syndromes were measured, the therapeutic effect of TCM and western medicine were analyzed. Results After treatment, the level of Hb and RBC in Yisui Shengxue Granule group were improved （P〈0.01, P〈0.05）, the total score of TCM syndrome was lowered （P〈0.01）, the total efficiency of western medicine was 77.8% （21 of effective cases, 6 of invalid cases）, and the total efficiency of TCM was 90.9%（20 of effective cases, 2 of invalid cases）. The level of Hb and RBC in control group had no obvious improvement compared with those before treatment （P〉0.05）, the total score of TCM syndrome had no significant decrease （P〉0.05）, the total efficiency of western medicine was 15.6%（5 of effective cases, 27 of invalid cases）, the total efficiency of TCM was 36.0%（9 of effective cases, 16 of invalid cases）. Yisui Shengxue Granule group was superior to the control group in elevating Hb, reducing the total score of TCM syndrome, and in the therapeutic effect of western medicine and TCM （P〈0.01）. Conclusion Yisui Shengxue Granule can effectively improve the degree of anemia, alleviate the clinical symptoms of patients with HbH disease.

关 键 词：Α-地中海贫血 血红蛋白H病 益髓生血颗粒 随机对照试验 

分 类 号：R259.569[医药卫生—中西医结合]