Jina Pharmaceuticals Inc., Libertyville, IL, USA.
Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India.
Drug Res (Stuttg). 2021 Jul;71(6):302-306. doi: 10.1055/a-1388-5415. Epub 2021 Mar 8.
Antihyperglycemic activity of Thymoquinone (TQ) was evaluated in diabetic mouse model and patients.
TQ (50 mg/kg) was orally administered daily for 21 days in combination with metformin in diabetic mice and a reduction on blood glucose level was monitored. In human, a 90-day randomized study was carried out in 60 Type 2 Diabetes mellitus patients to evaluate safety and efficacy of TQ administration with metformin in a 3-arm study. Patients in arm 1 (T1) received 1 tablet of metformin SR 1000 mg and 1 tablet of TQ 50 mg once daily. The second arm (T2) patients received 1 tablet of metformin SR 1000 mg and 2 tablets of TQ 50 mg once daily. Patients in arm 3 (R) received 1 tablet of metformin SR 1000 mg only.
The diabetic mice treated with combination of TQ and metformin showed significant decrease in blood sugar compared to those treated with only metformin. In patients who completed the study, the glycated hemoglobin (HbA1c) values in T1, T2 and R decreased after 3 months from 7.2, 7.2 and 7.3 to 6.7, 6.8, and 7.1, respectively. A greater reduction in Fasting Blood Glucose and Post Prandial Blood Glucose was also observed in T1 and T2 arms compared to R.
At dose levels of 50 and 100 mg of TQ combined with a daily dose of 1000 mg Metformin demonstrated a reduction in the levels of HbA1c and blood glucose compared to the standard treatment of diabetic patients with metformin alone.
评估姜酮（TQ）在糖尿病小鼠模型和患者中的降血糖活性。
在糖尿病小鼠中，TQ（50mg/kg）每日口服给药 21 天，并与二甲双胍联合使用，监测血糖水平降低情况。在人体中，对 60 名 2 型糖尿病患者进行了为期 90 天的随机研究，以评估在 3 臂研究中使用二甲双胍联合 TQ 给药的安全性和疗效。第 1 臂（T1）患者每天接受 1 片二甲双胍控释片 1000mg 和 1 片 TQ 50mg；第 2 臂（T2）患者每天接受 1 片二甲双胍控释片 1000mg 和 2 片 TQ 50mg；第 3 臂（R）患者仅接受 1 片二甲双胍控释片 1000mg。
与仅用二甲双胍治疗的小鼠相比，用 TQ 和二甲双胍联合治疗的糖尿病小鼠血糖显著下降。完成研究的患者中，T1、T2 和 R 组的糖化血红蛋白（HbA1c）值在 3 个月后分别从 7.2、7.2 和 7.3 降至 6.7、6.8 和 7.1。与 R 组相比，T1 和 T2 组的空腹血糖和餐后血糖也有更大程度的降低。
与单独使用二甲双胍治疗糖尿病患者的标准治疗相比，TQ 联合 50 和 100mg 剂量的二甲双胍每日剂量可降低 HbA1c 和血糖水平。
