逐瘀通脉胶囊联合法舒地尔对2型糖尿病下肢动脉硬化闭塞症患者疗效及应激状态的影响

Effect of Zhuyu Tongmai capsule combined with Fasudil on the curative effect and stress state of patients with arteriosclerosis obliterans in lower extremities with type 2 diabetes mellitus

目的:探讨逐瘀通脉胶囊联合法舒地尔对2型糖尿病(T2DM)下肢动脉硬化闭塞症(ASO)患者疗效及应激状态的影响。方法:将100例T2DM合并ASO患者分为研究组(50例)和对照组(50例),对照组采用法舒地尔治疗,研究组采用逐瘀通脉胶囊联合法舒地尔治疗,对比两组治疗前后动脉硬化指标[踝肱指数(ABI)、足背动脉血流量]、血流变指标[血浆黏度、全血黏度(低切)、全血黏度(高切)]、凝血功能指标[血浆凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、血浆纤维蛋白原(FIB)]、氧化应激指标[丙二醛(MDA)、超氧化物歧化酶(SOD)、硫氧还蛋白(TRX)、髓过氧化物酶(MPO)活性]、跛行距离,观察两组疗效和安全性。结果:研究组治疗后ABI、足背动脉血流量、跛行距离高于对照组[(0. 99±0. 16)vs(0. 81±0. 12),(0. 79±0. 27)vs(0. 57±0. 09)m/(s·cm^2),(569. 93±135. 34)vs(415. 72±112. 28)m/10 min],差异具有统计学意义(P<0. 05)。研究组治疗后血浆黏度、全血黏度(低切)、全血黏度(高切)、FIB低于对照组[(2. 00±0. 26)vs(2. 31±0. 32)mPa/s,(13. 79±1. 27)vs(20. 57±2. 05)mPa/s,(8. 93±0. 34)vs(11. 72±1. 28)mPa/s,(2. 73±0. 35)vs(3. 49±0. 43)g/L,P<0. 05],PT、APTT高于对照组[(12. 85±2. 63)vs(11. 93±1. 74)s,(42. 95±5. 36)vs(36. 95±4. 38)s,P<0. 05]。研究组治疗后MDA、TRX、MPO低于对照组[(2. 10±0. 96)vs(4. 31±1. 32)mmol/L,(48. 93±10. 34)vs(78. 72±12. 28)ng/mL,(72. 85±15. 63)vs(96. 03±12. 14)U/L,P<0. 05],SOD高于对照组[(163. 79±21. 27)vs(110. 57±12. 05)nU/mL,P<0. 05]。研究组总有效率高于对照组(94. 00%vs 80. 00%,χ~2=13. 025,P<0. 05),两组不良反应率(6. 00%vs 10. 00%,χ~2=1. 035,P>0. 05)对比无差异。结论:逐瘀通脉胶囊联合法舒地尔可显著改善T2DM合并ASO患者临床症状,改善下肢局部血液循环,抑制应激反应,疗效确切,安全性高。

Objective: To investigate the effect of Zhuyu Tongmai capsule, a traditional Chinese medicine,combined with Fasudil on the efficacy and stress status of patients with type 2 diabetes mellitus(T2DM) lower extremity arteriosclerosis obliterans(ASO).Methods: One hundred patients with T2 DM combined with ASO were divided into study group(50 cases) and control group(50 cases).The control group was treated with fasudil. The study group was treated with Zhuyu Tongmai capsule and Fasudil. Atherosclerosis indicators, such as Ankle brachial index(ABI) and foot arterial blood flow, blood rheological parameters, such as plasma viscosity, whole blood viscosity(low cut),whole blood viscosity(high cut), coagulation function indices, such as Plasma prothrombin time(PT), activated partial thromboplastin time(APTT), plasma fibrinogen(FIB), oxidative stress indicators, such as malondialdehyde(MDA), superoxide dismutase(SOD), Thioredoxin(TRX), myeloperoxidase(MPO) activity, and lameness distance were used to observe the efficacy and safety of the two groups.Results: After treatment, ABI, dorsal artery blood flow, and lameness distance were higher in study group than those in control group as(0. 99±0. 16) vs(0. 81±0. 12),(0. 79±0. 27) vs(0. 57±0. 09) m/(s · cm^2),(569. 93±135. 34) vs(415. 72±112. 28) m/10 min,respectively(all P<0. 05). After treatment, plasma viscosity, whole blood viscosity(low cut), whole blood viscosity(high cut),FIB were lower than in control group as(2. 00± 0. 26) vs(2. 31± 0. 32) mPa/s,(13. 79± 1. 27) vs(20. 57±2. 05)mPa/s,(8. 93±0. 34) vs(11. 72±1. 28) mPa/s,(2. 73±0. 35) vs(3. 49±0. 43) g/L,respectively(all P<0. 05), PT and APTT were longer than in control group as(12. 85 ± 2. 63) vs(11. 93± 1. 74) s and(42. 95± 5. 36) vs(36. 95± 4. 38) s, respectively(both P<0. 05). After treatment, MDA, TRX, and MPO of the study group were lower than those of control group [(2. 10±0. 96) vs(4. 31± 1. 32) mmol/L,(48. 93± 10. 34) vs(78. 72± 12. 28) ng/mL,(72. 85± 15. 63) vs(96. 03 ± 12. 14) U/L, respectively, P<0. 05], SOD was higher than control group as(163. 79 ±21. 27) vs(110. 57± 12. 05) nU/mL(both P<0. 05). The total effective rate of the study group was higher than that of the control group(94. 00% vs 80. 00%, χ~2=13. 025, P<0. 05). There was no difference in the adverse reaction rate(6. 00% vs 10. 00%, χ~2=1. 035, P>0. 05) between the two groups.Conclusion: Zhuyu Tongmai Capsules combined with Fasudil can significantly change the clinical symptoms of T2DM patients with ASO, improve the local blood circulation of lower extremities, suppress the stress response, and have a definite curative effect with high safety.