Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial.
Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial.
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中西医结合治疗低危骨髓增生异常综合征所致贫血：随机安慰剂对照试验研究方案
DOI：
10.1186/s13063-021-05646-2
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发表时间：
2021-10-18
期刊：
影响因子：
2.5
通讯作者：
Luo M
中科院分区：
文献类型：
--
作者：
Zheng Q;Xu H;Song L;Yan Z;Sun M;Peng X;Jiang Y;Shi L;Zhang A;Wu Z;Lu J;Luo M
背景红细胞生成与铁稳态密切相关；低风险骨髓增生异常综合征(MDS)所致的贫血仍难以治疗。在过去的十年里，我们一直致力于利用中医药改善铁代谢的调节。以往的研究发现，中药益宫散可通过抑制炎症引起的海普西丁的过度表达，减少转铁蛋白的表达，促进细胞内铁的外向转移，改善贫血症状。本研究采用前瞻性、多中心、双盲、随机对照的临床试验方法，评价传统药物联合YGS与单纯传统药物治疗MDS的疗效，为临床提供科学依据。本研究共纳入60例患者，每组(常规药物+YGS和常规药物+安慰剂)各30例。每日两次口服药物，疗程3个 月。所有患者都将在整个3个月的时间内接受随访。主要结果是通过评估血液中的血红蛋白水平来衡量。通过对中医症状积分、铁代谢、海普西丁水平和炎症因子的评估来评估二次结局。以及其对低风险MD患者炎症因子和铁代谢的影响。试验注册中国临床试验注册中心(http://www.chictr.org.cn/)ChiCTR1900026774。注册于2019年10月21日。
BackgroundErythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions.MethodsA prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors.DiscussionThis trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS.Trial registrationChinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 . Registered on October 21, 2019.
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益公散汤对小鼠急性炎症模型铁稳态的影响
DOI：
10.1155/2016/2696480
发表时间：
2016
期刊：
Evidence-based complementary and alternative medicine : eCAM
影响因子：
--
作者：
Zheng Q;Guan Y;Xia L;Wang Z;Jiang Y;Zhang X;Wang J;Wang G;Pu Y;Xia J;Luo M
通讯作者：
Luo M
影响因子：
2.1
作者：
Braun, Thorsten;Fenaux, Pierre
通讯作者：
Fenaux, Pierre
在饮食中铁超负荷和急性炎症过程中对全身铁调节进行建模：肝素独立机制的作用。
影响因子：
4.3
作者：
Enculescu M;Metzendorf C;Sparla R;Hahnel M;Bode J;Muckenthaler MU;Legewie S
通讯作者：
Legewie S
影响因子：
2.7
作者：
Fozza, Claudio;Longinotti, Maurizio
通讯作者：
Longinotti, Maurizio
不稳定的血浆铁水平预测脊髓降临综合征的患者的存活率。
影响因子：
10.1
作者：
de Swart L;Reiniers C;Bagguley T;van Marrewijk C;Bowen D;Hellström-Lindberg E;Tatic A;Symeonidis A;Huls G;Cermak J;van de Loosdrecht AA;Garelius H;Culligan D;Macheta M;Spanoudakis M;Panagiotidis P;Krejci M;Blijlevens N;Langemeijer S;Droste J;Swinkels DW;Smith A;de Witte T;EUMDS Steering Committee
通讯作者：
EUMDS Steering Committee