目的 对比益气维血片/胶囊联合铁剂与生血宝合剂/颗粒联合铁剂治疗贫血相关疾病的临床疗效。方法 选取2019-2021年全国6省市10家综合医院信息系统数据库中,接受诊疗超过1年的贫血相关疾病患者916例,根据治疗方法不同分为观察组和对照组,观察组采用益气维血片/胶囊联合铁剂＞30 d(n=514),对照组采用生血宝合剂/颗粒联合铁剂＞30 d(n=402),采用倾向性评分匹配(PSM)方法平衡观察组和对照组的基线特征,每组205例。有效性指标为治愈率[患者血红蛋白(Hb)恢复正常 1年的累计发生率]、有效率(Hb上升＞10 g/L 1年的累计发生率)、Hb恢复正常中位时间及Hb上升＞10 g/L中位时间;安全性指标为肝功能ALT、AST前后变化。结果 两组治愈率均为44.39%,无统计学差异;观察组有效率明显高于对照组(67.32% vs. 54.63%,P<0.01);两组中位Hb恢复正常时间、中位Hb上升＞10 g/L时间均相当,均未观察到中位复发时间。两组的ALT、AST值与用药前相比均无明显上升(P＞0.05)。结论 两组治愈率、治愈和起效时间无差别,具有较好的安全性,益气维血有效率显著优于生血宝,具有临床推广价值。
Abstract
Objective To compare the clinical efficacy of Yiqiweixue tablets/capsules combined with iron supplements and Shengxuebao combination/granules combined with iron supplements in the treatment of anemia-related diseases. Methods A total of 916 patients with anemia-related diseases who had received treatment of Yiqiweixue (n=514) and Shengxuebao (n=402) for more than 1 year were selected from the information system database of 10 general hospitals in 6 provinces and cities across China from 2019 to 2021. Propensity score matching (PSM) method was used to balance the baseline characters of the observation and control group. After PSM, 205 cases the observation group of Yiqiweixue tablets/capsules combined with iron for >30 days, while the control group of Shengxuebao combination/granules combined with iron for >30 days. The effectiveness indicators included cure rate (the cumulative incidence rate of patients whose hemoglobin (Hb) levels return to normal within one year),and efficacy rate (the cumulative incidence rate of patients whose Hb levels increase by more than 10g/L within one year), median time for Hb to return to normal and median time for Hb increase of more than 10 g/L. Safety indicators were changes of liver function ALT and AST. Results The cure rates of the two groups were 44.39%, with no statistically significant difference; the efficacy rate of the observation group was significantly higher than that of the control group (67.32% vs. 54.63%, P<0.01); both the median time for Hb to return to normal and the median time for Hb to increase by more than 10 g/L were not significantly different in two groups, and no median relapse time was observed. The ALT and AST values in both groups showed no significant increase after treatment (P>0.05). Conclusions There is no difference in cure rate, time to cure and onset of actio between the 2 groups. Both treatments showed no impacts on liver function, but Yiqiweixue has significantly higher effective rate than Shengxuebao,which can be recommended for clinical use.
关键词
益气维血 /
生血宝 /
铁剂 /
贫血相关疾病
Key words
Yiqiweixue /
Shengxuebao /
iron supplement /
anemia-related diseases
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] 中国营养学会“缺铁性贫血营养防治专家共识”工作组. 缺铁性贫血营养防治专家共识[J]. 营养学报, 2019, 41(5): 417-426.
[2] Bellakhal S,Ouertani S,Antit S,et al. Iron deficiency anemia: clinical and etiological features[J].La Tunisie Medicale, 2019, 97(12):1389-1398.
[3] Dahlerup J, Lindgren S, Moum B. Järnbrist och järnbristanemi är globala hälsoproblem [Iron deficiency and iron deficiency anemia are global health problems]. Lakartidningen, 2015,112: 1-3.
[4] 唐 庆,谭 晨,裴学军,等. 从脾胃论治缺铁性贫血的探讨[J]. 世界中医药, 2018, 13(7): 1809-1812.
[5] 齐利丽,何 苗,朱丽红,等. 中西医结合治疗妊娠合并缺铁性贫血的Meta分析[J]. 山东中医杂志, 2020, 39(7): 669-677, 683.
[6] 蓝 海,侯 丽,郎海燕,等. 常见血液病的中医分类与命名[J]. 中医杂志, 2019, 60(9): 750-753, 778.
[7] 中国中西医结合学会血液学专业委员会. 缺铁性贫血(萎黄病)中西医诊疗专家共识2023[J]. 中国中西医结合杂志, 2023, 43(7): 1-8.
[8] 周琦浩,朱里洁,童露露. 缺铁性贫血的中医证型及用药规律分析[J]. 湖南中医杂志, 2020, 36(4): 129-131.
[9] 寇艳婷,王 莹. 缺铁性贫血及其治疗的研究进展[J]. 中国现代医生, 2017, 55(23): 165-168.
[10] Rodrigues J P, Pinho R, Silva J, et al.. Appropriateness of the study of iron deficiency anemia prior to referral for small bowel evaluation at a tertiary center[J]. World J Gastroenterol, 2017, 23(24): :4444-4453.
[11] 张凤奎. 缺铁性贫血的现代认识与治疗进展[J]. 临床血液学杂志, 2023, 36(11): 763-767.
[12] 何亚萍. 益气维血胶囊联合琥珀酸亚铁片治疗妊娠期缺铁性贫血患者的临床疗效及其对铁代谢的影响[J]. 临床合理用药杂志, 2022, 15(12): 128-130.
[13] 张征帆,倪 瑛. 益气维血胶囊与蔗糖铁治疗缺铁性贫血的效果观察[J]. 健康研究, 2020, 40(2): 234-235.
[14] 沈 悌,赵永强. 血液病诊断及疗效标准(第4版)[M] . 北京: 科学出版社, 2018: 10.
[15] 俞朝野,张 承,杨 红,等.益气维血颗粒治疗缺铁性贫血30例临床观察[J].黑龙江中医药, 2003(6):2.
[16] 李 萌,陈 熹,续 畅,等.益气维血成方治疗缺铁性贫血临床疗效Meta分析[J].中国现代医生, 2018, 56(7):4.
[17] 任秀聪,游小红. 益气维血胶囊治疗妊娠期缺铁性贫血对患者Hb、SF、RBC及妊娠结局的影响[J]. 现代医学与健康研究电子杂志, 2020, 4(21): 85-87.
[18] 郎海燕,马 薇,张雅月. 益气维血胶囊联合琥珀酸亚铁片治疗缺铁性贫血的临床效果[J]. 临床合理用药杂志, 2021, 14(20): 8-11.
[19] 张晓艳. 益气维血胶囊联合右旋糖酐铁治疗妊娠期缺铁性贫血的临床效果[J]. 临床研究, 2024, 32(5): 119-122.
[20] 吕琳媛. 益气维血胶囊联合琥珀酸亚铁片治疗妊娠期缺铁性贫血临床观察[J]. 实用中医药杂志, 2024, 40(3): 478-480.
[21] 何 斌,杨宇飞,褚亚军,等. 生血宝合剂治疗非小细胞肺癌患者化疗后白细胞减少症210例多中心随机、双盲对照临床研究[J]. 中医杂志, 2017, 58(9): 763-767.
[22] 王延辉,沈蓓莉,曲青山,等. 生血宝合剂对慢性肾脏病3~5期(未透析)患者肾性贫血的影响[J]. 河南中医, 2019, 39(3): 434-437.
[23] 毕素娟,王 菲,陈秀琴,等. 生血宝合剂联合琥珀酸亚铁片治疗妊娠期缺铁性贫血的疗效及对铁代谢指标和妊娠结局的影响[J]. 现代生物医学进展, 2022, 22(9): 1687-1690, 1624.
[24] 陈晓峰,张一妙,朱丽红. 生血宝合剂的临床应用进展[J]. 中成药, 2024, 46(5): 1589-1593.
[25] 王俊茹,刘慧丽,郝俊兰,等. 益气维血胶囊联合复方硫酸亚铁治疗妊娠期缺铁性贫血的临床研究[J]. 现代药物与临床, 2023, 38(9): 2314-2317.
[26] 杨启明. 251名老年缺铁性贫血结果及益气维血胶囊的治疗效果分析[J]. 北方药学, 2023, 20(10): 138-139, 143.
PDF(1868 KB)
