脉管复康片联合贝前列素钠治疗血栓闭塞性脉管炎的临床研究

Clinical study on Maiguan Fukang Tablets combined with beraprost sodium in treatment of thromboembolic vasculitis

目的研究脉管复康片联合贝前列素钠联合治疗血栓闭塞性脉管炎患者的有效性与安全性。方法选取2016年6月—2017年6月在西安市中医医院治疗的血栓闭塞性脉管炎患者116例,随机分成对照组和治疗组,每组各58例。对照组患者口服贝前列素钠片,1片/次,3次/d;治疗组患者在对照组基础上口服脉管复康片,8片/次,3次/d。两组患者均连续治疗1个月。观察两组患者临床疗效,同时比较治疗前后两组患者踝肱指数、最大行走距离、炎症因子水平和不良反应情况。结果治疗后,对照组和治疗组临床有效率分别为81.03%和94.83%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者的踝肱指数和最大行走距离均显著升高(P<0.05),且治疗后治疗组上述指标均高于对照组(P<0.05)。治疗后,两组白细胞介素-6(IL-6)和肿瘤坏死因子-α(TNF-α)水平均显著降低(P<0.05),且治疗后治疗组IL-6和TNF-α水平明显低于对照组(P<0.05)。治疗期间,治疗组患者的药物不良反应发生率显著低于对照组患者,两组比较差异具有统计学意义(P<0.05)。结论脉管复康片联合贝前列素钠治疗血栓闭塞性脉管炎临床临床好,安全性高,具有一定的临床推广应用价值。

Objective To study the efficacy and safety of Maiguan Fukang Tablets combined with beraprost sodium in treatment of thromboembolic vasculitis. Methods Patients（116 cases） with thromboembolic vasculitis in Xi’an Hospital of TCM from June 2016 to June 2017 were randomly divided into control and treatment groups, and each group had 58 cases. Patients in the control group were po administered with Beraprost Sodium Tablets, 1 tablet/time, three times daily. Patients in the treatment group were po administered with Maiguan Fukang Tablets on the basis of the control group, 8 tablets/time, three times daily. Patients in two groups were treated for 1 month. After treatment, the clinical efficacy was evaluated, and the ankle-brachial index, maximum walking distance, inflammatory factor levels and adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups was 81.03% and 94.83% respectively, and there were differences between two groups（P 〈 0.05）. After treatment, the ankle-brachial indexes and maximum walking distance in two groups were significantly increased（P 〈 0.05）, and these indexes in the treatment group after treatment were significantly higher than those in the control group（P 〈 0.05）. After treatment, the IL-6 and TNF-α levels in two groups were significantly decreased（P 〈 0.05）, and the IL-6 and TNF-α levels in the treatment group after treatment were significantly lower than those in the control group（P 〈 0.05）. During the treatment, the adverse reaction rates in the treatment group was significantly lower than that in the control group, with significant difference between two groups（P 〈 0.05）. Conclusion Maiguan Fukang Tablets combined with beraprost sodium has significant clinical efficacy and high safety in treatment of thromboembolic vasculitis, which has a certain clinical application value.