Abstract:

Objective　To observe the effect of Fuyuan Xingnao Decoction combined with edaravone for patients with type 2 diabetes mellitus (T2DM) and cerebral infarction. Methods　Ninety-eight patients with T2DM and cerebral infarction treated at Shaanxi Provincial Hospital of Traditional Chinese Medicine from May 2023 to May 2024 were selected for the randomized controlled trial, and were divided into a control group and a study group by the random number table method, with 49 cases in each group. There were 29 males and 20 females in the control group; they were (56.92±9.36) years old; the course of diabetes was (12.39 ± 3.05) years; the course of cerebral infarction was (15.82±4.01) h. There were 27 males and 22 females in the study group; they were (57.88±10.07) years old; the course of diabetes was (13.12 ± 3.03) years; the course of cerebral infarction was (16.98±4.13) h. The control group took conventional treatment and edaravone, while the study group took conventional treatment, edaravone, and Fuyuan Xingnao Decoction, for 2 weeks. The neurological function, daily living ability, glucose metabolism indicators, inflammatory factors, hemorheological indicators, and endothelial function indicators before and after the treatment, clinical efficacies, and medication safety were compared between the two groups. The statistical analysis on the data was performed using t test and χ² test. Results　After the treatment, the score of National Institutes of Health Stroke Scale (NIHSS), fasting blood glucose (FBG), 2-hour postprandial blood glucose (2hPBG), glycated hemoglobin (HbA1c), fasting insulin (FINS), homeostasis model assessment-insulin resistance index (HOMA-IR), interleukin-6 (IL-6), soluble intercellular adhesion molecule-1 (sICAM-1), tumor necrosis factor-α (TNF-α), high sensitivity C-reactive protein (hs-CRP), plasma viscosity, whole blood high shear viscosity, whole blood low shear viscosity, hematocrit, endothelin-1 (ET-1), and homocysteine (Hcy) were lower than those before the treatment in both groups (all P<0.05), and the above indicators in the study group were lower than those in the control group [6.14±2.28 vs. 10.39±3.16, (6.52±0.93) mmol/L vs. (7.18±1.06) mmol/L, (9.41±1.56) mmol/L vs. (10.35±1.62) mmol/L, (6.24±0.86)% vs. (6.85±0.92)%, (10.31±3.02) mU/L vs. (11.64±3.05) mU/L, 2.99±0.62 vs. 3.71±0.75, (6.68±2.13) ng/L vs. (9.31±2.36) ng/L, (250.89±31.65) ng/mL vs. (274.16±30.87) ng/mL, (5.07±1.43) ng/L vs. (7.12±2.24) ng/L, (7.25±2.19) mg/L vs. (9.82±2.76) mg/L, (1.57±0.16) mPa·s vs. (2.16±0.13) mPa·s, (4.27±0.41) mPa·s vs. (5.52±0.49) mPa·s, (8.09±2.07) mPa · s vs. (9.96±2.12) mPa·s, (37.85±2.47)% vs. (41.94±3.52)%, (50.86±7.18) ng/L vs. (63.49±9.22) ng/L, and (12.53±1.08) μmol/L vs. (16.94±1.27) μmol/L] (t=7.635, 3.276, 2.926, 3.391, 2.169, 5.179, 5.791, 3.684, 5.400, 5.106, 20.033, 13.695, 4.418, 6.658, 7.566, and 18.517; all P<0.05). After the treatment, the Barthel index (BI) score and nitric oxide (NO) level were higher than those before the treatment in both groups (all P<0.05), and the above indicators in the study group were higher than those in the control group [79.45±5.76 vs. 70.10±5.93 and (9.16±1.13) μmol/L vs. (7.91±1.05) μmol/L] (t=7.917 and 5.672; both P<0.05). The total clinical effective rate of the study group was higher than that of the control group [95.92% (47/49) vs. 81.63% (40/49); χ²=5.018; P<0.05]. There was no statistical difference in the total incidence rate of adverse reactions between the two groups (P>0.05). Conclusion　Fuyuan Xingnao Decoction combined with edaravone for patients with T2DM and cerebral infarction can significantly regulate their glucose metabolism, reduce the levels of inflammatory factors, improve their hemorheology, neurological function, and daily living ability, and protect their vascular endothelial function.

Key words:

Type 2 diabetes mellitus, Cerebral infarction, Fuyuan Xingnao , Decoction, Edaravone

摘要：

目的　观察复元醒脑汤联合依达拉奉治疗2型糖尿病（type 2 diabetes mellitus，T2DM）合并脑梗死患者的效果。方法　选取2023年5月至2024年5月陕西省中医医院收治的98例T2DM合并脑梗死患者进行随机对照试验。采用随机数字表法将其分为对照组和研究组，各49例。对照组男29例，女20例，年龄（56.92±9.36）岁，糖尿病病程（12.39±3.05）年，脑梗死病程（15.82±4.01）h。研究组男27例，女22例，年龄（57.88±10.07）岁，糖尿病病程（13.12±3.03）年，脑梗死病程（16.98±4.13）h。对照组给予常规治疗+依达拉奉，研究组给予常规治疗+依达拉奉+复元醒脑汤，均治疗2周。比较两组治疗前后神经功能、日常生活能力、糖代谢指标、炎症因子、血液流变学指标、血管内皮功能指标，临床疗效和用药安全性。采用t检验、χ²检验对数据进行统计学分析。结果　治疗后，两组美国国立卫生研究院脑卒中量表（National Institutes of Health Stroke Scale，NIHSS）评分、空腹血糖（fasting blood glucose，FBG）、餐后2 h血糖（2-hour postprandial blood glucose，2hPBG）、糖化血红蛋白（glycated hemoglobin，HbA1c）、空腹胰岛素（fasting insulin，FINS）、胰岛素抵抗指数（homeostasis model assessment-insulin resistance index，HOMA-IR）、白细胞介素-6（interleukin-6，IL-6）、可溶性细胞间黏附因子-1（soluble intercellular adhesion molecule-1，sICAM-1）、肿瘤坏死因子α（tumor necrosis factor-α，TNF-α）、超敏C反应蛋白（high sensitivity C-reactive protein，hs-CRP）、血浆黏度、全血高切黏度、全血低切黏度、红细胞压积、内皮素-1（endothelin-1，ET-1）、同型半胱氨酸（homocysteine，Hcy）均低于治疗前（均P<0.05），研究组上述指标均低于对照组［（6.14±2.28）分比（10.39±3.16）分、（6.52±0.93）mmol/L比（7.18±1.06）mmol/L、（9.41±1.56）mmol/L比（10.35±1.62）mmol/L、（6.24±0.86）%比（6.85±0.92）%、（10.31±3.02）mU/L比（11.64±3.05）mU/L、2.99±0.62比3.71±0.75、（6.68±2.13）ng/L比（9.31±2.36）ng/L、（250.89±31.65）μg/L比（274.16±30.87）μg/L、（5.07±1.43）ng/L比（7.12±2.24）ng/L、（7.25±2.19）mg/L比（9.82±2.76）mg/L、（1.57±0.16）mPa·s比（2.16±0.13）mPa·s、（4.27±0.41）mPa·s比（5.52±0.49）mPa·s、（8.09±2.07）mPa·s比（9.96±2.12）mPa·s、（37.85±2.47）%比（41.94±3.52）%、（50.86±7.18）ng/L比（63.49±9.22）ng/L、（12.53±1.08）μmol/L比（16.94±1.27）μmol/L］（t=7.635、3.276、2.926、3.391、2.169、5.179、5.791、3.684、5.400、5.106、20.033、13.695、4.418、6.658、7.566、18.517，均P<0.05）。治疗后，两组Barthel指数（Barthel index，BI）评分、一氧化氮（nitric oxide，NO）水平均高于治疗前（均P<0.05），研究组上述指标均高于对照组［（79.45±5.76）分比（70.10±5.93）分、（9.16±1.13）μmol/L比（7.91±1.05）μmol/L］（t=7.917、5.672，均P<0.05）。研究组临床总有效率高于对照组［95.92%（47/49）比81.63%（40/49）；χ²=5.018，P<0.05］；两组不良反应总发生率差异无统计学意义（P>0.05）。结论　复元醒脑汤联合依达拉奉可明显调节T2DM合并脑梗死患者糖代谢，降低炎症因子水平，改善血液流变学，保护血管内皮功能，并可改善患者神经功能与日常生活能力。

关键词:

2型糖尿病, 脑梗死, 复元醒脑汤, 依达拉奉