脉管Ⅱ号胶囊治疗下肢动脉硬化闭塞症的临床研究

Clinical Study on Vascular Capsule Ⅱ in the Treatment of Lower Extremities Arteriosclerosis Obliterans

目的观察脉管Ⅱ号胶囊治疗下肢动脉硬化闭塞症的临床疗效。方法将福建中医药大学附属人民医院2013年1月-2015年10月收治的120例下肢动脉硬化闭塞症患者随机分为空白组、对照组和治疗组。每组40例。空白组患者给予常规治疗,对照组患者在常规治疗的基础上每日口服西洛他唑,治疗组患者在常规治疗的基础上每日口服脉管Ⅱ号胶囊。3组患者分别于治疗前及治疗后14 d应用血管分析工作站进行脉搏体积容积描记(PvR),记录踝肱指数(Ankle Brachial Index,ABI),并通过肢体发凉、静息痛、间歇性跛行等指标来评价其临床疗效。结果治疗前空白组、对照组、治疗组的ABI及症状积分差异均无统计学意义(P均>0.05);治疗14 d后,与空白组相比,对照组、治疗组的ABI及症状积分差异均具有统计学意义(P均<0.05),但对照组和治疗组的ABI及症状积分差异无统计学意义(P>0.05)。结论与单纯常规治疗相比,脉管Ⅱ号胶囊在提高患者ABI,改善肢体发凉、静息痛、间歇性跛行、肢体酸胀、麻木等症状方面均具有明显优势;但与西洛他唑相比,两者在上述方面无明显差异。

Objective To observe clinical efficacy of Vascular Capsule Ⅱ in the treatment of arteriosclerosis obliterans of lower extremities.Methods One hundred and twenty patients with arteriosclerosis obliterans of lower extremities admitted into Fujian People＇s Hospital Affilialed with Fujian University of Traditional Chinese Medicine between January2013 and October 2015 were randomly divided into three groups;a blank group,a control group and a treatment group,40 patients in each group.The blank group was given the conventional treatment,the control group was given daily oral administration of cilostazol combined with the conventional treatment,while the treatment group was given daily oral administration of Vascular Capsule Ⅱ combined with the conventional treatment.For patients in each group,pulse volume recorder（PVR） was taken by using Peripheral Vascular System and the ankle brachial index（ABI） was recorded before the treatment and 14 days after the treatment respectively,and the clinical efficacy was evaluated by indicators including limb chill,rest pain and intermittent claudication,etc.Results There was no statistically significant difference between the three groups in terms of ABI value and symptom scores before the treatment（P 〉0.05）,while 14 days after the treatment,compared with the blank group,the ABI value and symptom scores in the control group and treatment group both showed statistically significant difference（P 〈0.05）,but there was no statistically significant difference between the control group and the treatment group in terms of ABI value and symptom scores（P〉0.05）.Conclusion Compared with the simple conventional treatment,Vascular Capsule II has remarkable advantages in improving ABI value,limb chill,rest pain,intermittent claudication,limb swelling and numbness and other symptoms,but it is not superior to oral cilostazol in terms of the above aspects.