背景:尽管体外研究和小型随机对照试验的结果表明,大竹红景天注射液(DZHJTI)对急性缺血性卒中(AIS)具有积极作用,它们在常规临床实践中的普遍性仍有待确立。
目的:本研究的主要目的是评估DZHJTI治疗AIS的有效性,从基线到门诊随访的卒中相关神经功能缺损的变化,死亡率,随后的血管事件,残疾,和真实世界临床环境中的中医证候。通过监测不良事件或生命体征和实验室参数的重大变化,我们还旨在评估DZHJTI的安全性。
方法:这种前瞻性,多中心队列研究计划在中国30家医院的症状出现14天内招募2000名AIS患者。符合条件的患者将在开始药物治疗后随访6个月。主要结果将是美国国立卫生研究院卒中量表评分从基线到门诊随访的变化。次要结果包括总死亡率,中风复发,新发主要血管事件,全球残疾,并在6个月内改善中医证候。不良事件或生命体征和实验室参数的临床显着变化,不管严重程度如何,将在试验期间进行记录,以评估DZHJTI的安全性。增强的逆倾向加权估计器将用于减少变异性并提高平均治疗效果估计的准确性。
结果:临床试验注册于2022年10月获得批准,参与者的招募和注册于2022年11月开始。这项研究的结果预计将在2025年发表,同行评审的健康相关研究期刊。
结论:这项真实世界的队列研究首次评估DZHJTI治疗AIS的有效性和安全性。它可能提供额外的临床证据,包括响应的持续时间,长期药物有效性,和亚组疗效数据。研究结果对于寻求AIS最佳治疗的临床医生和患者将是有价值的,并可能导致更好地使用DZHJTI并改善患者预后。
背景:ITMCTRITMCTR2022000005;http://tinyurl.com/554ns8m5。
■DERR1-10.2196/52447。
BACKGROUND: Although results from in vitro studies and small randomized controlled trials have shown positive effects of Dazhu hongjingtian injection (DZHJTI) on acute ischemic stroke (AIS), their generalizability to routine clinical practice remains to be established.
OBJECTIVE: The primary aim of this study is to evaluate the effectiveness of DZHJTI treatment for AIS with regard to changes in the stroke-related neurological deficit from baseline to outpatient follow-up, mortality, subsequent vascular events, disability, and traditional Chinese medicine syndrome in real-world clinical settings. By monitoring for adverse events or significant changes in vital signs and laboratory parameters, we also aim to assess the safety of DZHJTI.
METHODS: This prospective, multicenter cohort study plans to enroll 2000 patients with AIS within 14 days of symptom onset from 30 hospitals across China. Eligible patients will be followed up for 6 months after initiating medication treatments. The primary outcome will be the change in the National Institute of Health Stroke Scale score from baseline to outpatient follow-up. The secondary outcomes include overall mortality, stroke recurrence, new-onset major vascular events, global disability, and improvement of traditional Chinese medicine syndrome in 6 months. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of DZHJTI. An augmented inverse propensity weighted estimator will be used to reduce variability and improve accuracy in average treatment effects estimation.
RESULTS: The clinical trial registration was approved in October 2022, and the recruitment and enrollment of participants started in November 2022. The study\'s outcomes are expected to be published in 2025 in reputable, peer-reviewed health-related research journals.
CONCLUSIONS: This real-world cohort study is the first to assess the effectiveness and safety of DZHJTI in treating AIS. It may provide additional clinical evidence, including the duration of response, long-term drug effectiveness, and subgroup efficacy data. The study results will be valuable for clinicians and patients seeking optimal treatment for AIS and could lead to better use of DZHJTI and improved patient outcomes.
BACKGROUND: ITMCTR ITMCTR2022000005; http://tinyurl.com/554ns8m5.
UNASSIGNED: DERR1-10.2196/52447.