健脾生血颗粒单用或联合补铁制剂对比单用补铁制剂治疗儿童缺铁性贫血疗效和安全性的Meta分析
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摘要
目的:系统评价健脾生血颗粒单用或联合补铁制剂对比单用补铁制剂治疗儿童缺铁性贫血的疗效和安全性,为临床治疗儿童缺铁性贫血提供循证参考。方法:计算机检索PubMed、Embase、Medline、Scifinder、Cochrane图书馆、中国期刊全文数据库、维普网、万方数据,检索时限均为自建库起至2018年11月,收集健脾生血颗粒单用或联合补铁制剂(试验组)对比单用补铁制剂(对照组)治疗儿童缺铁性贫血疗效和安全性的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取,并用Cochrane系统评价员手册5.1.0进行质量评价后,采用Rev Man 5.3统计软件对总有效率、痊愈率、血红蛋白(HB)、平均红细胞体积(MCV)、红细胞平均血红蛋白量(MCH)、血清铁(SI)、血清铁蛋白(SF)升高水平和不良反应发生率进行Meta分析。结果:共纳入19项RCT,合计2 259例患者。Meta分析结果显示,试验组患者总有效率[OR=6.73,95%CI(4.68,9.68),P<0.001]、痊愈率[OR=2.51,95%CI(2.06,3.06),P<0.001]、HB升高水平[MD=8.91,95%CI(6.13,11.68),P<0.001]、MCV升高水平[MD=9.13,95%CI(5.32,12.95),P<0.001]、MCH升高水平[MD=2.95,95%CI(1.75,4.15),P<0.001]、SI升高水平[MD=3.66,95%CI(2.77,4.55),P<0.001]、SF升高水平[MD=10.82,95%CI(9.18,12.45),P<0.001]、不良反应发生率[OR=0.49,95%CI(0.33,0.71),P=0.000 2]均优于对照组,差异均有统计学意义。结论:健脾生血颗粒单用或联合补铁制剂对比单用补铁制剂在治疗儿童缺铁性贫血时,可提高患者总有效率、痊愈率和HB、MCV、MCH、SI、SF水平,降低不良反应发生率。
OBJECTIVE:To systematically review the efficacy and safety of Jianpi shengxue granule alone or combined with iron supplement versus iron supplement alone in the treatment of iron deficiency anemia in children,and to provide evidence-based reference for iron deficiency anemia in children. METHODS:Retrieved from PubMed,Embase,Medline,Scifinder,Cochrane library,CJFD,VIP and Wanfang database during database establishment to Nov. 2018,RCT about efficacy and safety of Jianpi shengxue granule alone or combined with iron supplement(trial group) versus iron supplement alone(control group) in the treatment of iron deficiency anemia in children were collected. After the data were extracted from clinical studies that met the inclusion criteria,and the quality was evaluated with Cochrane System Evaluator Manual 5.1.0,Meta-analysis was conducted by using Rev Man 5.3 statistical software for total response rate,cure rate,the levels of hemoglobin(HB),mean corpuscular volume(MCV),mean corpuscular hemoglobin(MCH),serum iron(SI),serum ferritin(SF) elevation,the incidence of ADR.RESULTS:Totally 19 RCTs were enrolled,involving 2 259 patients. Results of Meta-analysis showed that total response rate[OR=6.73,95%CI(4.68,9.68),P<0.001],cure rate [OR=2.51,95%CI(2.06,3.06),P<0.001],HB increased levels [MD=8.91,95%CI(6.13,11.68),P<0.001],MCV increased levels [MD=9.13,95%CI(5.32,12.95),P<0.001],MCH increased levels [MD=2.95,95% CI(1.75,4.15),P<0.001],SI increased levels [MD=3.66,95% CI(2.77,4.55),P<0.001],SF increased levels [MD=10.82,95%CI(9.18,12.45),P<0.001] and the incidence of ADR [OR=0.49,95%CI(0.33,0.71),P=0.000 2] in trial group were all better than control group,with statistical significance. CONCLUSIONS:Jianpi shengxue granule alone or combined with iron supplement versus iron supplement alone can improve total response rate,cure rate,the levels of HB,MCV,MCH,SI and SF in children with iron deficiency anemia,and also decrease the incidence of ADR.
OBJECTIVE:To systematically review the efficacy and safety of Jianpi shengxue granule alone or combined with iron supplement versus iron supplement alone in the treatment of iron deficiency anemia in children,and to provide evidence-based reference for iron deficiency anemia in children. METHODS:Retrieved from PubMed,Embase,Medline,Scifinder,Cochrane library,CJFD,VIP and Wanfang database during database establishment to Nov. 2018,RCT about efficacy and safety of Jianpi shengxue granule alone or combined with iron supplement(trial group) versus iron supplement alone(control group) in the treatment of iron deficiency anemia in children were collected. After the data were extracted from clinical studies that met the inclusion criteria,and the quality was evaluated with Cochrane System Evaluator Manual 5.1.0,Meta-analysis was conducted by using Rev Man 5.3 statistical software for total response rate,cure rate,the levels of hemoglobin(HB),mean corpuscular volume(MCV),mean corpuscular hemoglobin(MCH),serum iron(SI),serum ferritin(SF) elevation,the incidence of ADR.RESULTS:Totally 19 RCTs were enrolled,involving 2 259 patients. Results of Meta-analysis showed that total response rate[OR=6.73,95%CI(4.68,9.68),P<0.001],cure rate [OR=2.51,95%CI(2.06,3.06),P<0.001],HB increased levels [MD=8.91,95%CI(6.13,11.68),P<0.001],MCV increased levels [MD=9.13,95%CI(5.32,12.95),P<0.001],MCH increased levels [MD=2.95,95% CI(1.75,4.15),P<0.001],SI increased levels [MD=3.66,95% CI(2.77,4.55),P<0.001],SF increased levels [MD=10.82,95%CI(9.18,12.45),P<0.001] and the incidence of ADR [OR=0.49,95%CI(0.33,0.71),P=0.000 2] in trial group were all better than control group,with statistical significance. CONCLUSIONS:Jianpi shengxue granule alone or combined with iron supplement versus iron supplement alone can improve total response rate,cure rate,the levels of HB,MCV,MCH,SI and SF in children with iron deficiency anemia,and also decrease the incidence of ADR.
引文
[1]陈娜,辛亚芳,王茜,等.小儿缺铁性贫血的治疗及临床预后分析[J].世界最新医学信息文摘,2018,18(88):190-192.
[2]郎海燕,陈信义,杨文华.缺铁性贫血中医药防治康复一体化专家共识[J].中华中医药杂志,2018,33(8):3487-3492.
[3]国家药典委员会.中华人民共和国药典:四部[S]. 2015年版.北京:中国医药科技出版社,2015:1374-1375.
[4]孙莉.健脾生血颗粒治疗慢性肾衰竭肾性贫血的临床研究[D].武汉:湖北中医学院,2006.
[5]马海侠.健脾生血颗粒治疗婴幼儿缺铁性贫血的疗效观察[J].儿科药学杂志,2006,12(3):54-55.
[6]康雅媛.健脾生血颗粒治疗婴幼儿缺铁性贫血70例[J].中国中医药科技,2009,16(2):152.
[7]陈春宝,王敏,卢伟.健脾生血颗粒治疗儿童缺铁性贫血疗效观察[J].现代中西医结合杂志,2010,19(2):191-192.
[8]熊霖,何粒立,施映映.健脾生血颗粒治疗小儿缺铁性贫血34例临床观察[J].云南中医中药杂志,2013,34(11):49-50.
[9]刘常基.健脾生血颗粒治疗小儿缺铁性贫血56例临床疗效观察[J].中国民族民间医药,2013,22(16):68.
[10]孙艳.健脾生血颗粒治疗婴幼儿缺铁性贫血50例临床观察[J].中国现代医生,2015,53(3):127-129.
[11]黄冠.小儿健脾补血颗粒治疗小儿缺铁性贫血的疗效观察[J].基层医学论坛,2015,19(32):4485-4486.
[12]郝连欣,马云涛.健脾生血颗粒治疗婴幼儿缺铁性贫血的临床效果观察[J].临床合理用药杂志,2018,11(7B):82-83.
[13]赖鹏程,沈朝霞.健脾生血颗粒治疗小儿缺铁性贫血临床研究[J].儿科药学杂志,2014,20(4):36-38.
[14]陈冰蓉,沈丽萍,胡国华.健脾生血颗粒治疗婴幼儿缺铁性贫血75例临床观察[J].中医儿科杂志,2015,11(5):47-49.
[15]苑赟,裴学军.健脾生血颗粒治疗小儿缺铁性贫血临床疗效观察[J].世界中医药,2017,12(10):2315-2317.
[16]吴冬梅,周娟娟,徐佳妮,等.健脾生血颗粒联合推拿治疗小儿营养性缺铁性贫血[J].吉林中医药,2018,38(7):849-852.
[17]严芳芝.健脾生血颗粒联合富马酸亚铁治疗小儿缺铁性贫血90例疗效观察[J].中医儿科杂志,2014,10(4):42-45.
[18]刘玉静.健脾生血颗粒联合富马酸亚铁对缺铁性贫血患儿的改善效果[J].实用中西医结合临床,2017,17(12):35-37.
[19]邓玉清.对比单纯应用富马酸亚铁与联合健脾生血颗粒治疗小儿缺铁性贫血的临床疗效[J].北方药学,2016,13(2):92-93.
[20]王湘宁,朱天河.健脾生血颗粒联合富马酸亚铁治疗小儿缺铁性贫血[J].中国现代药物应用,2018,12(14):139-141.
[21]肖贞,吴卫照.富马酸亚铁单独治疗与联合健脾生血颗粒治疗小儿缺铁性贫血的疗效[J].中国医学创新,2018,15(1):140-142.
[22]杨劲.健脾生血颗粒联合富马酸亚铁治疗小儿缺铁性贫血临床观察[J].中外女性健康研究,2018(14):73-74.
[23]张长忠.健脾生血颗粒联合蛋白琥珀酸铁口服溶液对缺铁性贫血患儿血清SF Hb SI水平变化及生活质量的影响[J].中国药物与临床,2018,18(1):22-25.
[24]中华儿科杂志编辑委员会,中华医学会儿科学分会血液学组,中华医学会儿科学分会儿童保健学组.儿童缺铁和缺铁性贫血防治建议[J].中华儿科杂志,2008,46(7):502-504.
[25]梁海英.小儿缺铁性贫血经琥珀酸亚铁和硫酸亚铁治疗的临床效果对比探讨[J].中国医院用药评价与分析,2016,16(S1):95.
[26]郑丽娟.右旋糖酐铁口服液治疗儿童缺铁性贫血疗效观察[J].临床合理用药杂志,2018,11(8A):89-90.
[27]赵刚,张雪琼,裴学军,等.健脾生血颗粒(片)治疗各型贫血作用解析[J].世界中医药,2017,12(2):474-476.
[28]马薇,姚新颖,侯丽,等.“健脾生血”治疗缺铁性贫血理论依据及应用研究[J].中国临床医生,2014,42(9):85-87.
[29]赵刚,屈文,肖飞,等.健脾生血颗粒对围产期大鼠的毒性研究[J].中国药房,2017,28(16):2190-2193.
[2]郎海燕,陈信义,杨文华.缺铁性贫血中医药防治康复一体化专家共识[J].中华中医药杂志,2018,33(8):3487-3492.
[3]国家药典委员会.中华人民共和国药典:四部[S]. 2015年版.北京:中国医药科技出版社,2015:1374-1375.
[4]孙莉.健脾生血颗粒治疗慢性肾衰竭肾性贫血的临床研究[D].武汉:湖北中医学院,2006.
[5]马海侠.健脾生血颗粒治疗婴幼儿缺铁性贫血的疗效观察[J].儿科药学杂志,2006,12(3):54-55.
[6]康雅媛.健脾生血颗粒治疗婴幼儿缺铁性贫血70例[J].中国中医药科技,2009,16(2):152.
[7]陈春宝,王敏,卢伟.健脾生血颗粒治疗儿童缺铁性贫血疗效观察[J].现代中西医结合杂志,2010,19(2):191-192.
[8]熊霖,何粒立,施映映.健脾生血颗粒治疗小儿缺铁性贫血34例临床观察[J].云南中医中药杂志,2013,34(11):49-50.
[9]刘常基.健脾生血颗粒治疗小儿缺铁性贫血56例临床疗效观察[J].中国民族民间医药,2013,22(16):68.
[10]孙艳.健脾生血颗粒治疗婴幼儿缺铁性贫血50例临床观察[J].中国现代医生,2015,53(3):127-129.
[11]黄冠.小儿健脾补血颗粒治疗小儿缺铁性贫血的疗效观察[J].基层医学论坛,2015,19(32):4485-4486.
[12]郝连欣,马云涛.健脾生血颗粒治疗婴幼儿缺铁性贫血的临床效果观察[J].临床合理用药杂志,2018,11(7B):82-83.
[13]赖鹏程,沈朝霞.健脾生血颗粒治疗小儿缺铁性贫血临床研究[J].儿科药学杂志,2014,20(4):36-38.
[14]陈冰蓉,沈丽萍,胡国华.健脾生血颗粒治疗婴幼儿缺铁性贫血75例临床观察[J].中医儿科杂志,2015,11(5):47-49.
[15]苑赟,裴学军.健脾生血颗粒治疗小儿缺铁性贫血临床疗效观察[J].世界中医药,2017,12(10):2315-2317.
[16]吴冬梅,周娟娟,徐佳妮,等.健脾生血颗粒联合推拿治疗小儿营养性缺铁性贫血[J].吉林中医药,2018,38(7):849-852.
[17]严芳芝.健脾生血颗粒联合富马酸亚铁治疗小儿缺铁性贫血90例疗效观察[J].中医儿科杂志,2014,10(4):42-45.
[18]刘玉静.健脾生血颗粒联合富马酸亚铁对缺铁性贫血患儿的改善效果[J].实用中西医结合临床,2017,17(12):35-37.
[19]邓玉清.对比单纯应用富马酸亚铁与联合健脾生血颗粒治疗小儿缺铁性贫血的临床疗效[J].北方药学,2016,13(2):92-93.
[20]王湘宁,朱天河.健脾生血颗粒联合富马酸亚铁治疗小儿缺铁性贫血[J].中国现代药物应用,2018,12(14):139-141.
[21]肖贞,吴卫照.富马酸亚铁单独治疗与联合健脾生血颗粒治疗小儿缺铁性贫血的疗效[J].中国医学创新,2018,15(1):140-142.
[22]杨劲.健脾生血颗粒联合富马酸亚铁治疗小儿缺铁性贫血临床观察[J].中外女性健康研究,2018(14):73-74.
[23]张长忠.健脾生血颗粒联合蛋白琥珀酸铁口服溶液对缺铁性贫血患儿血清SF Hb SI水平变化及生活质量的影响[J].中国药物与临床,2018,18(1):22-25.
[24]中华儿科杂志编辑委员会,中华医学会儿科学分会血液学组,中华医学会儿科学分会儿童保健学组.儿童缺铁和缺铁性贫血防治建议[J].中华儿科杂志,2008,46(7):502-504.
[25]梁海英.小儿缺铁性贫血经琥珀酸亚铁和硫酸亚铁治疗的临床效果对比探讨[J].中国医院用药评价与分析,2016,16(S1):95.
[26]郑丽娟.右旋糖酐铁口服液治疗儿童缺铁性贫血疗效观察[J].临床合理用药杂志,2018,11(8A):89-90.
[27]赵刚,张雪琼,裴学军,等.健脾生血颗粒(片)治疗各型贫血作用解析[J].世界中医药,2017,12(2):474-476.
[28]马薇,姚新颖,侯丽,等.“健脾生血”治疗缺铁性贫血理论依据及应用研究[J].中国临床医生,2014,42(9):85-87.
[29]赵刚,屈文,肖飞,等.健脾生血颗粒对围产期大鼠的毒性研究[J].中国药房,2017,28(16):2190-2193.