Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial.

IF 7.5 3区医学 Q1 MEDICINE, GENERAL & INTERNAL Chinese Medical Journal Pub Date : 2024-11-06 DOI:10.1097/CM9.0000000000003133

Shengde Li, Anxin Wang, Lin Shi, Qin Liu, Xiaoling Guo, Kun Liu, Xiaoli Wang, Jie Li, Jianming Zhu, QiuYi Wu, QingCheng Yang, Xianbo Zhuang, Hui You, Feng Feng, Yishan Luo, Huiling Li, Jun Ni, Bin Peng

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Abstract

Background: Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke.

Methods: This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days.

Results: There were 57 and 60 patients in the ANP and placebo groups finally included respectively for modified intention-to-treat analysis. The median age was 66 years, and the median NIHSS score at baseline was 12. The changes in cerebral infarct volume at day 14 were 0.3 mL and 0.4 mL in the ANP and placebo groups, respectively (median difference: -7.1 mL; interquartile range [IQR]: -18.3 to 2.3 mL, P = 0.30). The changes in cerebral edema volume of the ANP and placebo groups on day 14 were 11.4 mL and 4.0 mL, respectively (median difference: 3.0 mL, IQR: -1.3 to 9.9 mL, P = 0.15). The rates of SAE within 90 days were similar in the ANP (3/57, 5%) and placebo (7/60, 12%) groups (P = 0.36). Changes in serum mercury and arsenic concentrations were comparable. In patients with large artery atherosclerosis, ANP reduced the cerebral infarct volume at 14 days (median difference: -12.3 mL; IQR: -27.7 to -0.3 mL, P = 0.03).

Conclusions: ANP showed a similar safety profile to placebo and non-significant tendency to reduce cerebral infarct volume in patients with moderate-to-severe stroke. Further studies are warranted to assess the efficacy of ANP in reducing cerebral infarcts and improving clinical prognosis.

Trail registration: Clinicaltrials.gov, No. NCT04475328.

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中重度急性缺血性脑卒中患者服用安宫牛黄丸的安全性和有效性（ANGONG TRIAL）：随机双盲安慰剂对照试点临床试验。

背景：临床前研究表明，安宫牛黄丸（ANP）可减少脑梗死和水肿体积。本研究旨在探讨安宫牛黄丸是否能安全地减少中重度急性缺血性脑卒中患者的脑梗塞和水肿体积：这项随机、双盲、安慰剂对照试验纳入了美国国立卫生研究院卒中量表（NIHSS）评分为10至20分的急性缺血性脑卒中患者。患者在发病后36小时内通过分块随机分配接受ANP或安慰剂（每天3克，共5天）治疗。主要结果是治疗14天后脑梗死和水肿体积的变化。主要安全性结果是90天内的严重不良事件（SAEs）：ANP 组和安慰剂组最终分别有 57 名和 60 名患者被纳入修正意向治疗分析。中位年龄为 66 岁，基线 NIHSS 评分中位数为 12 分。第 14 天时，ANP 组和安慰剂组的脑梗塞体积变化分别为 0.3 毫升和 0.4 毫升（中位数差异：-7.1 毫升；中位数差异：-7.1 毫升；中位数差异：-7.1 毫升；中位数差异：-7.1 毫升：中位差：-7.1 毫升；四分位间距 [IQR]：-18.3 至 2.3 毫升，P = 0.30）。第 14 天，ANP 组和安慰剂组的脑水肿体积变化分别为 11.4 mL 和 4.0 mL（中位数差异：3.0 mL，IQR：-1.3 至 9.9 mL，P = 0.15）。ANP 组（3/57，5%）和安慰剂组（7/60，12%）90 天内的 SAE 发生率相似（P = 0.36）。血清中汞和砷浓度的变化相当。在大动脉粥样硬化患者中，ANP可减少14天的脑梗塞体积（中位数差异：-12.3 mL；IQR：-27.7至-0.3 mL，P = 0.03）：结论：ANP的安全性与安慰剂相似，在减少中重度卒中患者脑梗死体积方面无显著趋势。有必要开展进一步研究，评估ANP在减少脑梗塞和改善临床预后方面的疗效：试验登记：Clinicaltrials.gov，编号：NCT04475328。

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来源期刊

Chinese Medical Journal 医学-医学：内科

CiteScore

9.80

自引率

4.90%

发文量

19245

审稿时长

6 months

期刊介绍： The Chinese Medical Journal (CMJ) is published semimonthly in English by the Chinese Medical Association, and is a peer reviewed general medical journal for all doctors, researchers, and health workers regardless of their medical specialty or type of employment. Established in 1887, it is the oldest medical periodical in China and is distributed worldwide. The journal functions as a window into China’s medical sciences and reflects the advances and progress in China’s medical sciences and technology. It serves the objective of international academic exchange. The journal includes Original Articles, Editorial, Review Articles, Medical Progress, Brief Reports, Case Reports, Viewpoint, Clinical Exchange, Letter,and News,etc. CMJ is abstracted or indexed in many databases including Biological Abstracts, Chemical Abstracts, Index Medicus/Medline, Science Citation Index (SCI), Current Contents, Cancerlit, Health Plan & Administration, Embase, Social Scisearch, Aidsline, Toxline, Biocommercial Abstracts, Arts and Humanities Search, Nuclear Science Abstracts, Water Resources Abstracts, Cab Abstracts, Occupation Safety & Health, etc. In 2007, the impact factor of the journal by SCI is 0.636, and the total citation is 2315.