Lancet Respir Med:间充质干细胞用于耐药结核安全性良好

2014-01-10 佚名 丁香园

多药耐药(MDR)和广泛耐药(XDR)结核病,常常与患者的免疫功能紊乱、及治疗效果不佳相关。对于此类结核病,人们迫切需要能有新的治疗选择。此前研究显示,间充质干细胞(MSC)具有免疫调节作用,采用自体骨髓间充质干细胞辅助治疗,可以将患者机体内的慢性炎症转化为有益的免疫反应,并进而改善其临床预后。 为了评估输注自体骨髓间充质干细胞作为肺结核辅助疗法的安全性,来自瑞典斯德

多药耐药(MDR)和广泛耐药(XDR)结核病,常常与患者的免疫功能紊乱、及治疗效果不佳相关。对于此类结核病,人们迫切需要能有新的治疗选择。此前研究显示,间充质干细胞(MSC)具有免疫调节作用,采用自体骨髓间充质干细胞辅助治疗,可以将患者机体内的慢性炎症转化为有益的免疫反应,并进而改善其临床预后。

为了评估输注自体骨髓间充质干细胞作为肺结核辅助疗法的安全性,来自瑞典斯德哥尔摩市卡罗林斯卡学院实验医学系的Markus J Maeurer教授及其同事进行了一项研究,研究结果在线发表于2014年1月9日的The Lancet Respiratory Medicine 杂志上。

研究纳入30位年龄在21-65岁的白俄罗斯肺结核患者,均经微生物学检测确诊为MDR或XDR结核病,无其他恶性病变,或肺及胸膜以外的活动性结核。排除妊娠、合并艾滋病病毒、乙型肝炎病毒、丙型肝炎病毒感染或具有双重感染的患者。

所有患者均在其抗结核药物治疗开始后的4周内,接受一个单剂量自体骨髓间充质干细胞治疗(目标剂量为1×10⁶细胞/每公斤体重)。研究的主要终点是治疗的安全性。

评价指标包括:①MSC输注相关事件;②6个月观察期内与潜在传染病恶化有关的任何结核相关事件(主要通过结核分枝杆菌培养和显微镜检查结果的转换来监测);③任何由临床、及血液、生化指标变化所定义的其他不良事件。根据研究方案,在MSC输注后的六个月内,受试者每个月均需对其它不良事件进行1次评估。

结果显示,治疗中最常见的不良事件为1级或2级事件,具体包括:胆固醇水平增高(14/30例),恶心(11/30例),淋巴细胞减少或腹泻(10/30例)等。未见严重不良事件报告。

出现两个一过性的3级事件,一例病人出现了血浆钾离子浓度的一过性增加,另一例病人则出现了γ-谷氨酰转肽酶的一过性升高。

结论认为:采用骨髓间充质干细胞作为结核病辅助治疗是安全的,可以进一步探讨其与标准药物治疗方案联合用于MDR或XDR结核患者的治疗问题。骨髓间充质干细胞辅助疗法仍需在有对照的2期临床试验中,评估其对受试者免疫反应、临床效果、和微生物效果方面的影响。

原文出处

Aliaksandr Skrahin, Raija K Ahmed, Giovanni Ferrara, Lalit Rane, Thomas Poiret, Yaninaz Isaikina.Autologous mesenchymal stromal cell infusion as adjunct treatment in patients with multidrug and extensively drug-resistant tuberculosis: an open-label phase 1 safety trial.The Lancet Respiratory Medicine Jan 09, 2014

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    2014-05-15 howi
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    2014-01-11 120.192.83.198

    免疫抑制还是促进?

    0

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近日,来自英国医学研究委员会临床试验分会的Phillips等人认为相对于标准的6个月抗结核治疗方案来说,在治疗非空洞性肺结核时可以将治疗疗程缩短为4个月。其研究结果刊登在2013年6月份的国际肺结核与肺部疾病(The International Journal of Tuberculosis and Lung Disease)杂志上,但是香港卫生署结核与胸部疾病服务中心的Kwok-Chiu Cha