来自杂志 Frontiers in neurology 的文献。
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颜林林 (2023-05-11 22:05):
#paper doi:10.3389/fneur.2023.1036453 Frontiers in Neurology, 2023, Mechanism of Qihuang needle therapy in the management of tic disorders: a clinical trial protocol. 这是一篇关于针灸治疗方法开展注册临床试验的文章(在中国临床试验注册中心注册,编号:ChiCTR2200057723,网址:https://www.chictr.org.cn/showproj.html?proj=161252)。该临床试验于2022年3月至2023年9月期间开展,通过岐黄针对抽动障碍的儿童进行干预性治疗(预计入组干预组和对照组各20例),并随访患儿12周,除相关临床量表评估外,还采集外周血并通过质谱和ELISA实验测定其血浆中的代谢物和蛋白,以及采集粪便进行16S rRNA的微生物组分析,以期通过这些多组学数据来探索针灸治疗的作用机制。临床试验尚未结束,本文的投稿时间为2022年9月(历经半年至2023年4月接收),为提前公开详细披露其临床试验具体操作流程,因此仅有方法描述,而无结果数据。虽然很难想象代谢物、蛋白及肠道菌群等信息,要与针灸对神经类疾病治疗的作用机制该如何关联,但中医讲究整体系统论,万事万物皆有联系,既然在肉眼可见的解剖学水平难以建立直接联系,那间接通过不同多组学的尝试来观察和早期探索,或许也是一种不错的尝试。先期待下临床试验完成后的数据分析结果的公开发表吧。
Abstract:
Background: Qihuang needle therapy is a newly developed acupuncture therapy to treat tic disorders in clinical practice. However, the mechanism to reduce tic severity remains unknown. Changes in intestinal flora … >>>
Background: Qihuang needle therapy is a newly developed acupuncture therapy to treat tic disorders in clinical practice. However, the mechanism to reduce tic severity remains unknown. Changes in intestinal flora and circulation metabolites are perhaps the potential pathogenesis of tic disorders. As a result, we present a protocol for a controlled clinical trial using multi-omics analysis to probe the mechanism of the Qihuang needle in managing tic disorders.Methods: This is a matched-pairs design, controlled, clinical trial for patients with tic disorders. Participants will be allocated to either an experimental group or a healthy control group. The main acupoints are Baihui (GV20), Yintang (EX-HN3), and Jueyinshu (BL14). The experimental group will receive Qihuang needle therapy for a month, while the control group will receive no interventions.Expected outcomes: The change in the severity of the tic disorder is set as the main outcome. Secondary outcomes include gastrointestinal severity index and recurrence rate, which will be calculated after a 12-week follow-up. Gut microbiota, measured by 16S rRNA gene sequencing; serum metabolomics, assessed via LC/MS; and serum zonulin, assessed by enzyme-linked immunosorbent assay (ELISA), will be used as biological specimen analysis outcomes. The present study will investigate the possible interactions between intestinal flora and serum metabolites and the improvement of clinical profiles, which may elucidate the mechanism of Qihuang needle therapy for tic disorders.Trial registration: This trial is registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/). Registration number: ChiCTR2200057723, Date: 2022-04-14. <<<
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