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升血宁片治疗和预防缺铁性贫血的有效性和安全性:一项系统评价与荟萃分析

The efficiency and safety of Shengxuening tablet on treating and preventing iron deficiency anemia: A systematic review and meta-analysis.

作者信息

Zhang Yanyu, Lv Yan, Sun Yan, Li Yumeng, Wang Dehao, Niu Jicong, Zhao Pei, Zhang Mei, Wang Mingjing, Liu Weiyi, Hu Xiaomei

机构信息

Department of Hematology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

Graduate School, China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

Front Pharmacol. 2022 Nov 3;13:1029641. doi: 10.3389/fphar.2022.1029641. eCollection 2022.

DOI:10.3389/fphar.2022.1029641
PMID:36408243
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9669986/
Abstract

Iron deficiency anemia (IDA) is a public health problem worldwide. Shengxuening Tablet (SXN) has been used for the treatment of various types of anemia, attaining high efficacy. To evaluate the safety of SXN as well as its preventive and therapeutic efficacy against IDA across different population groups. PubMed, Embase, Web of Science, the Cochrane Library, the China Knowledge Network, the China Biomedical Literature Database, the Wanfang Data Knowledge Service Platform, and the China Science and Technology Journal Database was searched for relevant clinical trials through June 2022 and a systematic review and meta-analysis of the identified studies was undertaken. A total of 39 trials involving 4,562 cases were included in the meta-analysis. The total efficiency of SXN was superior than the control group in improving red blood cell (RBC) count [SMD = 1.31, 95% CI (0.7, 1.91), < 0.0001], hemoglobin (Hb) [SMD = 1.11, 95% CI (0.75, 1.46), < 0.00001], mean corpuscular volume (MCV) [SMD = 0.5, 95% CI (0.33, 0.68), < 0.00001], total serum iron (SI) levels [SMD = 1.87, 95% CI (1.3, 2.44), < 0.00001], and transferrin saturation (TSAT) levels [SMD = 2.07, 95% CI (1.86, 2.27), < 0.00001]. Besides, the total effects of SXN to improve mean corpuscular hemoglobin (MCH) [SMD = 0.12, 95% CI (-0.16, 0.4), = 0.41], mean corpuscular hemoglobin concentration (MCHC) [SMD = 0.03, 95% CI (-0.18, 0.24), = 0.77], hematocrit (HCT) [SMD = 0.65, 95% CI (-0.25, 1.55), = 0.16], and serum ferritin (SF) levels [SMD = 0.59, 95% CI (-0.67, 1.85), = 0.36] and reduce the total iron binding capacity (TIBC) [SMD = 0.34, 95% CI (-0.07, 0.74), = 0.1] was comparable to that of iron supplementation. SXN significantly raised the total effective rates of IDA [risk ratio (RR) = 1.06, 95% CI (1.02, 1.09), = 0.0005] and was associated with fewer adverse events [RR = 0.24, 95% CI (0.18, 0.31), < 0.00001], fewer adverse pregnancy outcomes [RR = 0.34, 95% CI (0.2, 0.57), < 0.0001], and lower anemia recurrence rates during pregnancy [RR = 0.29, 95% CI (0.1, 0.84), = 0.02]. Regarding prevention, the effects of SXN to maintain the RBC count, Hb level and other IDA-related parameters were comparable to that of control group and SXN reduced the risk of IDA incidence during pregnancy. SXN demonstrated promising efficacy in the treatment and prevention of IDA and outperformed routine iron formulations in terms of safety, thus rendering SXN a reliable treatment option for IDA. https://www.crd.york.ac.uk/prospero/, identifier: CRD42022353247.

摘要

缺铁性贫血(IDA)是一个全球性的公共卫生问题。升血宁片(SXN)已被用于治疗各种类型的贫血,疗效显著。为了评估SXN在不同人群中对IDA的安全性及其预防和治疗效果。通过检索PubMed、Embase、Web of Science、Cochrane图书馆、中国知网、中国生物医学文献数据库、万方数据知识服务平台和中国科技期刊数据库,查找截至2022年6月的相关临床试验,并对纳入的研究进行系统评价和荟萃分析。荟萃分析共纳入39项试验,涉及4562例病例。SXN在提高红细胞(RBC)计数[标准化均数差(SMD)=1.31,95%置信区间(CI)(0.7,1.91),P<0.0001]、血红蛋白(Hb)[SMD = 1.11,95% CI(0.75,1.46),P < 0.00001]、平均红细胞体积(MCV)[SMD = 0.5,95% CI(0.33,0.68),P < 0.00001]、血清总铁(SI)水平[SMD = 1.87,95% CI(1.3,2.44),P < 0.00001]和转铁蛋白饱和度(TSAT)水平[SMD = 2.07,95% CI(1.86,2.27),P < 0.00001]方面,总有效率优于对照组。此外,SXN在改善平均红细胞血红蛋白(MCH)[SMD = 0.12,95% CI(-0.16,0.4),P = 0.41]、平均红细胞血红蛋白浓度(MCHC)[SMD = 0.03,95% CI(-0.18,0.24),P = 0.77]、血细胞比容(HCT)[SMD = 0.65,95% CI(-0.25,1.55),P = 0.16]和血清铁蛋白(SF)水平[SMD = 0.59,95% CI(-0.67,1.85),P = 0.36]以及降低总铁结合力(TIBC)[SMD = 0.34,95% CI(-0.07,0.74),P = 0.1]方面的总体效果与铁补充剂相当。SXN显著提高了IDA的总有效率[风险比(RR)=1.06,95% CI(1.02,1.09),P = 0.0005],且不良事件较少[RR = 0.24,95% CI(0.18,0.31),P < 0.00001],不良妊娠结局较少[RR = 0.34,95% CI(0.2,0.57),P < 0.0001],孕期贫血复发率较低[RR = 0.29,95% CI(0.1,0.84),P = 0.02]。在预防方面,SXN维持RBC计数、Hb水平和其他与IDA相关参数的效果与对照组相当,且SXN降低了孕期IDA发病风险。SXN在IDA的治疗和预防方面显示出有前景的疗效,并且在安全性方面优于常规铁制剂,因此使SXN成为IDA的可靠治疗选择。https://www.crd.york.ac.uk/prospero/,标识符:CRD42022353247

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