A Clinical Trial During the COVID-19 Pandemic: The Effects of Traditional preparation "Kiogan(奇應丸)" on Patients with Ischemic Stroke and its Safety
蔡金川1,2,*戴逸承3王浩洸4陳冠佐5王軍5
吳明遠5林致廷2,5朱劭昂4,6,7林原禾5徐靖翔5
1義大大昌醫院中醫科，高雄，台灣
2義守大學學士後中醫學系，高雄，台灣
3義大醫院神經科，高雄，台灣
4義大醫院神經外科，高雄，台灣
5義大癌治療醫院中醫科，高雄，台灣
6義守大學醫學院，高雄，台灣
7義守大學資訊工程學系，高雄，台灣
【摘要】
腦中風是全球人口死亡與失能的主要原因，即使存活後通常會遺留不同
程度的神經功能障礙，造成病人與家屬極大的經濟負擔及照護壓力。在常規治
療外，開發具潛能的療法深具意義。團隊以此進行研究探討「奇應丸｣對缺血性
腦中風患者的臨床療效及使用後的安全性評估(EMRP37108N)。
方法：研究採取非盲式實驗，缺血性中風急性發病個案住院期間在常規治療下
投與樋屋奇應丸（以下簡稱奇應丸），與同時期醫院中風資料庫交叉比對缺血
性腦中風神經學量表評估。並針對急性期住院試驗期間肝腎功能的變化以及床
病程症狀質性報告評估其安全性。另外應用網絡藥理學採掘大數據來釐清奇應
丸治療上與安全性的可能代謝機轉。
結果：巴式量表評估中，實驗組改善程度優於對照組，但無達統計意義；在整
體功能狀態量表mRS方面實驗組改善程度優於對照組並達到統計顯著差異。
個案肝臟發炎指數GPT上升，實驗組有減緩趨勢，但無達統計意義；腎臟功能
【關鍵詞】缺血性腦中風 ； 樋屋奇應丸 ； 臨床試驗 ； 巴氏量表 ； 肝腎毒性 ； 網路藥理學
【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 (奇應丸) " 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 疫情下的臨床試驗— 奇應丸對缺血性中風患者臨床之療效 和安全性評估
