温经通络散治疗糖尿病下肢血管病变的临床疗效及安全性观察

Clinical Observation on the Efficacy and Safety of Wenjing Tongluo San(温经通络散) in the Treatment of Diabetic Lower Extremity Vascular Disease

目的:观察温经通络散治疗寒凝经脉证糖尿病下肢血管病变(LEAD)的临床疗效及安全性。方法:将80例LEAD患者随机分为对照组和治疗组各40例,对照组以西医常规治疗,治疗组在对照组的基础上加用温经通络散治疗。观察患者治疗前后临床症状(静息痛、下肢感觉异常、间歇性跛行)、Hb A1c、ABI以及双侧股动脉、腘动脉、足背动脉血流速的改变。结果:治疗组临床疗效、中医证候疗效均优于对照组,差异均有统计学意义(P<0.05);治疗组患者Hb A1c、ABI、腘动脉、足背动脉血流速改善均优于对照组;两组治疗后股动脉血流速度比较,差异无统计学意义(P>0.05);治疗期间,治疗组1例患者出现皮肤瘙痒,对照组未见明显不良反应。结论:温经通络散封包热熨治疗LEAD(寒凝经脉证),可有效改善患者临床症状、改善中医证候、降低Hb A1c、提高ABI及改善下肢血流速度。

Objective： To observe the clinical efficacy and safety of Wenjing Tongluo San （温经通络散, WJTSS） in the treatment of diabetic lower extremity vascular disease. Methods： A total of 80 patients were randomly divided into treatment group and control group, each of 40 cases. Both groups were treated with conventional treatment. The treatment group were additionally treated with WJTSS, four weeks for one course. The clinical symptoms （rest pain, paresthesia, intermittent claudication）, TCM syndrome, HbAlc, ABI and bilateral femoral artery, popliteal artery, dorsalis pedis artery blood flow changes were observed and analyzed before and after one course. Results： The clinical efficacy, TCM syndrome, HbAlc, ABI, popliteal artery, dorsalis pedis artery blood flow changes in the treatment group were significantly higher than the control group （P〈0.05）; The total effective rate of femoral artery blood flow velocity has no significant difference in two groups （P〉0.05）; During treatment, the treatment group of 1 patients with skin itching, the control group had no obvious side effect showed. Conclusion： Effect of WJTSS in the treatment of patients with LEAD （syndrome of cold coagulation meridians） is affirmed for clinical symptom, TCM syndromes, decreased HbA1c, increased ABI and improved lower limb blood flow velocity.