A Clinical Trial During the COVID-19 Pandemic: The Effects of Traditional preparation "Kiogan(奇应丸)" on Patients with Ischemic Stroke and its Safety
蔡金川1,2,*戴逸承3王浩洸4陈冠佐5王军5
吴明远5林致廷2,5朱劭昂4,6,7林原禾5徐靖翔5
1义大大昌医院中医科，高雄，台湾
2义守大学学士後中医学系，高雄，台湾
3义大医院神经科，高雄，台湾
4义大医院神经外科，高雄，台湾
5义大癌治疗医院中医科，高雄，台湾
6义守大学医学院，高雄，台湾
7义守大学资讯工程学系，高雄，台湾
【摘要】
脑中风是全球人口死亡与失能的主要原因，即使存活後通常会遗留不同
程度的神经功能障碍，造成病人与家属极大的经济负担及照护压力。在常规治
疗外，开发具潜能的疗法深具意义。团队以此进行研究探讨「奇应丸｣对缺血性
脑中风患者的临床疗效及使用後的安全性评估(EMRP37108N)。
方法：研究采取非盲式实验，缺血性中风急性发病个案住院期间在常规治疗下
投与 屋奇应丸（以下简称奇应丸），与同时期医院中风资料库交叉比对缺血
性脑中风神经学量表评估。并针对急性期住院试验期间肝肾功能的变化以及床
病程症状质性报告评估其安全性。另外应用网络药理学采掘大数据来厘清奇应
丸治疗上与安全性的可能代谢机转。
结果：巴式量表评估中，实验组改善程度优於对照组，但无达统计意义；在整
体功能状态量表mRS方面实验组改善程度优於对照组并达到统计显着差异。
个案肝脏发炎指数GPT上升，实验组有减缓趋势，但无达统计意义；肾脏功能
【关键词】缺血性脑中风 ； 屋奇应丸 ； 临床试验 ； 巴氏量表 ； 肝肾毒性 ； 网路药理学
【Summary】
Objectives: Stroke is a leading cause of global mortality and disability. Even survived, varying degrees of neurological impairments often persist, constituting adult disabilities majorly. This results in significant economic burdens and caregiving pressures for patients and their families. Beyond conventional medications, the exploration of promising therapies, including traditional medicine or repurposing existing drugs, holds significance and in need profoundly. So we conducted a clinical study in the efficacy and safety of "Hiya Kiogan (奇应丸) " on ischemic stroke subjects (EMRP 37108N, June 10, 2020 to March 2, 2023). Methods: The study adopted a non-blinded experimental design, where subject received Kiogan Pill in addition to routine medication during hospitalization. Cross-matching was performed with stroke databases from the same period in hospitals for comparison. The Stroke Scales were included for evaluation. Safety assessment encompassed qualitative reporting of clinical course symptoms and the functions of liver and kidney. Additionally, we applied network pharmacology to mine big data, aiming to analyze and elucidate the relevant metabolic mechanisms of Kiogan on ischemic stroke. Results: The results showed that the experimental group exhibited a superior in the Barthel Index compared to the control group. However the statistical differences need further investigation. In the preliminary investigation, there was a decline in GPT, but not significant statistically. Both eGFR and Creatinine showed no adverse deterioration, and safety assessments were consistently positive. The insights gained from network pharmacology contribute to elucidating the underlying mechanisms, specifically the correlation with hepatic and renal metabolism. Conclusions: This study conclude Hiya Kiogan pills possess a positive effect on the acute recovery of ischemic stroke patients and present a positive safety profile. Further investigation to Hiya Kiogan pills therapy’s efficacy and safety is warranted for double-blind randomized controlled trial.
282.2COVID19 疫情下的临床试验─ 奇应丸对缺血性中风患者临床之疗效 和安全性评估
