Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, PR China.
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, PR China; Institute for Brain, Disorders, Beijing University of Chinese Medicine, Beijing, PR China.
J Stroke Cerebrovasc Dis. 2024 May;33(5):107649. doi: 10.1016/j.jstrokecerebrovasdis.2024.107649. Epub 2024 Feb 25.
Naoxueshu oral liquid is the only approved drug for acute treatment of cerebral hemorrhage in China. It has been used widely for the treatment of acute ischemic stroke and acute hemorrhagic stroke. However, safety and efficacy data on the early use of Naoxueshu oral liquid are lacking. The main purpose of this study is to observe the benefit and safety of early use of Naoxueshu oral liquid (< 72 h of cerebral hemorrhage) and offer evidence into the potential superiority of Naoxueshu oral liquid in patients with hemorrhagic stroke, and its healthcare costs.
This registration study for the prevention and treatment of cerebral hemorrhage using Naoxueshu oral liquid will be a quantitative, prospective, multicenter, observational clinical registry study. We aim to register 2000 patients with cerebral hemorrhage within 7 days of disease onset. This study will be an observational study and not interfere with the medication regimen of participants. Hence, we will not allocate patients. The main observation indicators will be the hematoma volume and the proportion of reduction 14 days post-cerebral hemorrhage (or at hospital discharge), onset of new stroke (ischemic stroke, hemorrhagic stroke) within 12 months of disease onset, independence in everyday life activities (modified Rankin Scale score ≤ 2), total cost during hospitalization, and treatment costs.
This registration study will offer strong evidence for the efficacy and safety of Naoxueshu oral liquid for the prevention and treatment of cerebral hemorrhage, particularly with regard to early use (72 h after onset). It will offer evidence into the potential advantages of Naoxueshu oral liquid in patients with hemorrhagic stroke, including healthcare costs.
脑血疏口服液是中国唯一批准用于急性脑出血治疗的药物。它已广泛用于治疗急性缺血性卒中和急性出血性卒中。然而，缺乏脑血疏口服液早期使用（脑出血发病后 72 小时内）的安全性和疗效数据。本研究的主要目的是观察早期使用脑血疏口服液（脑出血发病后 72 小时内）的获益和安全性，并为脑出血患者提供脑血疏口服液潜在优势的证据，包括其医疗成本。
本研究是一项使用脑血疏口服液防治脑出血的注册研究，是一项定量、前瞻性、多中心、观察性临床注册研究。我们计划在脑出血发病后 7 天内登记 2000 例脑出血患者。本研究将是一项观察性研究，不会干扰参与者的用药方案。因此，我们不会对患者进行分配。主要观察指标将是脑出血发病后 14 天（或出院时）的血肿体积和减少比例、发病后 12 个月内新发卒（缺血性卒、出血性卒）、日常生活活动能力独立（改良 Rankin 量表评分≤2）、住院总费用和治疗费用。
本注册研究将为脑血疏口服液在脑出血的预防和治疗中的疗效和安全性提供有力证据，特别是在早期使用（发病后 72 小时内）方面。它将为脑出血患者使用脑血疏口服液的潜在优势提供证据，包括医疗成本。
