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补肾益髓法治疗β地中海贫血的随机对照试验

[Treatment of beta-thalassemia with Bushen Yisui therapy: a randomized controlled trial].

作者信息

Wu Zhi-kui, Liu Yong-mei, Zhang Xin-hua, Liu Wen-jun, Li Min, Wang Rong-xin, Chai Li-min, Wang Wen-juan, Zhang Chong, Huang You-wen, Chen Yu-ying, Lu Xin-xia

机构信息

Department of Molecular Biology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.

出版信息

Zhong Xi Yi Jie He Xue Bao. 2007 Mar;5(2):137-40. doi: 10.3736/jcim20070207.

DOI:10.3736/jcim20070207
PMID:17352867
Abstract

OBJECTIVE

To investigate the efficacy and safety of Yisui Shengxue Granule (YSSXG), a compound traditional Chinese herbal medicine, in treating beta-thalassemia.

METHODS

A randomized single-blinded trial was designed. Sixty patients with beta-thalassemia were divided into two groups: 30 patients in YSSXG-treated group and 30 in placebo parallel-control group. The patients in the two groups were assigned to receive either YSSXG or placebo for three months. The patients' symptoms and their blood indexes such as hemoglobin (Hb), red blood cell (RBC), reticulocytes (Ret) and fetal hemoglobin (HBF) were examined before and after the treatment. Meanwhile, the liver and spleen were examined with B-mode ultrasound.

RESULTS

In the YSSXG-treated group, the blood indexes (Hb, RBC, Ret and HBF) and the symptoms of the patients were improved after three-month treatment, with statistical significance compared to those before treatment (P<0.01); hepatauxe and splenomegaly were also relieved (P<0.05) and no adverse reactions were monitored. In the placebo parallel-control group, no significant improvement of the blood indexes and symptoms, as well as the hepatauxe and splenomegaly had been found (P>0.05).

CONCLUSION

YSSXG demonstrates obvious clinical efficacy and no adverse reactions in treating beta-thalassemia.

摘要

目的

探讨复方中药益髓生血颗粒(YSSXG)治疗β地中海贫血的疗效和安全性。

方法

设计一项随机单盲试验。将60例β地中海贫血患者分为两组:益髓生血颗粒治疗组30例,安慰剂平行对照组30例。两组患者分别接受益髓生血颗粒或安慰剂治疗3个月。治疗前后检查患者症状及其血液指标,如血红蛋白(Hb)、红细胞(RBC)、网织红细胞(Ret)和胎儿血红蛋白(HBF)。同时,用B超检查肝脏和脾脏。

结果

益髓生血颗粒治疗组治疗3个月后,患者血液指标(Hb、RBC、Ret和HBF)及症状均有改善,与治疗前比较有统计学意义(P<0.01);肝肿大和脾肿大也得到缓解(P<0.05),且未监测到不良反应。安慰剂平行对照组血液指标、症状以及肝肿大和脾肿大均无明显改善(P>0.05)。

结论

益髓生血颗粒治疗β地中海贫血临床疗效明显,且无不良反应。

相似文献

1
[Treatment of beta-thalassemia with Bushen Yisui therapy: a randomized controlled trial].补肾益髓法治疗β地中海贫血的随机对照试验
Zhong Xi Yi Jie He Xue Bao. 2007 Mar;5(2):137-40. doi: 10.3736/jcim20070207.
2
Clinical observation on YiSuiShengXueGranule on treating 156 patients with beta-thalassemia major and the molecular mechanism study.益髓生血颗粒治疗156例重型β地中海贫血的临床观察及分子机制研究
Biol Pharm Bull. 2007 Nov;30(11):2084-7. doi: 10.1248/bpb.30.2084.
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[Clinical observation of Yisui Shengxue Granule in treating 25 patients with hemoglobin H disease].益髓生血颗粒治疗25例血红蛋白H病的临床观察
Zhong Xi Yi Jie He Xue Bao. 2008 Feb;6(2):153-6. doi: 10.3736/jcim20080209.
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[Clinical observation on effects of Yisui Shengxue Granule in treating 156 patients with beta-thalassemia].益髓生血颗粒治疗156例β地中海贫血患者疗效的临床观察
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2006 Apr;26(4):352-4.
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[Effects of yisui shengxue granules on expressions of alpha-hemoglobin stabilizing protein and erythroid transcription factor GATA-1 mRNAs in bone marrow of patients with beta-thalassemia].益髓生血颗粒对β地中海贫血患者骨髓中α-血红蛋白稳定蛋白及红系转录因子GATA-1 mRNA表达的影响
Zhong Xi Yi Jie He Xue Bao. 2006 May;4(3):247-50. doi: 10.3736/jcim20060305.
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Genomewide DNA Methylation Responses in Patients with β-Thalassemia Treated with Yisui Shengxue Granules ().益髓生血颗粒治疗β-地中海贫血患者全基因组 DNA 甲基化反应()。
Chin J Integr Med. 2019 Jul;25(7):490-496. doi: 10.1007/s11655-018-2777-9. Epub 2018 May 3.
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[Effect of yisui shengxue granule on gene expression in children with beta-thalassemia].
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2005 Jul;25(7):591-4.
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Effect of Yisui Shengxue Granule () on the oxidative damage of erythrocytes from patients with hemoglobin H disease.益髓生血颗粒对血红蛋白 H 病患者红细胞氧化损伤的影响。
Chin J Integr Med. 2012 Sep;18(9):670-5. doi: 10.1007/s11655-012-1202-z. Epub 2012 Aug 31.
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Molecular mechanism of yisui shengxue granule, a complex chinese medicine, on thalassemia patients suffering from hemolysis and anemia of erythrocytes.益髓生血颗粒治疗地中海贫血溶血性贫血及红细胞贫血症的分子机制。
Evid Based Complement Alternat Med. 2014;2014:213782. doi: 10.1155/2014/213782. Epub 2014 Dec 10.
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Zhongguo Dang Dai Er Ke Za Zhi. 2012 May;14(5):344-9.

引用本文的文献

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Foetal haemoglobin inducers for reducing blood transfusion in non-transfusion-dependent beta-thalassaemias.诱导胎儿血红蛋白生成以减少非输血依赖型β-地中海贫血的输血。
Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD013767. doi: 10.1002/14651858.CD013767.pub2.
2
Natural Remedies for the Treatment of Beta-Thalassemia and Sickle Cell Anemia-Current Status and Perspectives in Fetal Hemoglobin Reactivation.治疗β地中海贫血和镰状细胞贫血的天然疗法——胎儿血红蛋白再激活的现状与展望
Int Sch Res Notices. 2014 Oct 2;2014:123257. doi: 10.1155/2014/123257. eCollection 2014.
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Molecular mechanism of yisui shengxue granule, a complex chinese medicine, on thalassemia patients suffering from hemolysis and anemia of erythrocytes.
益髓生血颗粒治疗地中海贫血溶血性贫血及红细胞贫血症的分子机制。
Evid Based Complement Alternat Med. 2014;2014:213782. doi: 10.1155/2014/213782. Epub 2014 Dec 10.