【摘要】 目的:观察健脾生血颗粒在真实世界中治疗妊娠期、儿童及成人缺铁性贫血的疗效与安全性特征。方法:采用病例系列研究方法,计划前瞻性竞争性纳入34家医院2000年1月至2000年1月门诊病例1 000例,其中,妊娠期缺铁性贫血病例(妊娠组)600例,儿童缺铁性贫血病例(儿童组)150例、成人缺铁性贫血病例(成人组)250例,按照药品说明书规定用法用量给予健脾生血颗粒治疗1个月。治疗前后均进行血常规、肝肾功能检查,并进行中医证候评分,记录不良反应发生情况。结果:共竞争性纳入1 055例,妊娠组脱落3例,儿童组脱落24例,成人组脱落17例,其中资料完整可以评价的共1 011例:妊娠组623例,儿童组130例,成人组258例。经过1个月健脾生血颗粒治疗,除了儿童组MCHC外,所有组别的受试者Hb、MCH、MCHC、RBC、HCT及MCV等与治疗前比较,均有显著升高,并具有统计学意义(P<0.05)。妊娠组、儿童组、成人组中医证候评分减分率分别为78.87%、74.02%、77.12%,组间比较无统计学意义(P>0.05);总有效率分别为96.15、93.08、92.64%,组间比较无统计学意义(P>0.05)。其中,妊娠组入组前经过其他贫血药物治疗无效的,入组前经过其他贫血药物治疗不能耐受的,与初治患者间分层比较,有效率均无统计学意义(P>0.05)。不良事件发生率分别为7.06%、5.38%、6.98,无1例肝肾功能异常情况发生,不良事件发生率组间比较无统计学意义(P>0.05)。结论:健脾生血颗粒治疗1个月可达到良好疗效和安全性。更多还原

【Abstract】 Objective: To observe the effectiveness and safety of Jianpishengxue Granule in the treatment of iron deficiency anemia( IDA) of children,adults and pregnancy in the real world. Methods: A case series study was conducted for treating IDA. 1000 cases from 34 hospitals from January 2000 were planned to enroll in this study,including 600 cases in pregnancy group,150 cases in children group and 250 cases in adult group. All of the patients were given Jianpishengxue Granule for 1 month in accordance with the drug instructions. Routine blood test,liver and kidney function tests were carried out before treatment. TCM syndrome score and adverse reactions were recorded before and after the treatment. Results: A total of 1 055 cases were enrolled competitively while there were only 1011 cases( 623 cases in pregnancy group,130 cases in children group,258 cases in adult group) which were evaluate,due to 3,24,and 17 cases were dropped out in pregnancy group,children group and adult group respectively. After 1 month’ treatment,in addition to the children’s group,MCHC,Hb,MCH,MCHC,RBC,HCT and MCV of all cases were significantly higher than that before treatment( P < 0. 05). The reduction rate of total TCM syndrome score of pregnancy group,children group,and adult group were 78. 87%,74. 02% and 77. 12% respectively. And there was no significant difference between the three groups( P > 0. 05). The total effective rate was 96. 15,93. 08 and 92. 64% respectively,and there was no significant difference between the three groups( P > 0. 05). Through stratified comparison with the pregnancy group,no significant differences were founded in the patients between ineffective after treatment of the other anemia drugs,which could not be tolerated after treatment with the other anemia drugs,and the initial treatment of patients. The incidence of adverse reactions in all groups was less than 8%,and no case of liver and renal dysfunction occurred. And there was no significant difference between the three groups( P > 0. 05). Conclusion: 1 month treatment of Jianpishengxue Granule may achieve a good curative effect and safety.更多还原