软坚清脉颗粒联合贝前列素钠片治疗血脉瘀阻证糖尿病足溃疡临床研究  

Clinical Study of Ruanjian Qingmai Granules Combined with Beraprost Sodium Tablets in the Treatment of Diabetes Foot Ulcer with Blood Stasis Syndrome

作　　者：徐磊[1] 周敏杰 刘哲 蔡文怡 王御震 曹烨民[1] 方豫东[1] 杨沁彤[1] XU Lei;ZHOU Minjie;LIU Zhe;CAI Wenyi;WANG Yuzhen;CAO Yemin;FANG Yudong;YANG Qintong(Shanghai Hospital of Integrated Traditional and Western Medicine,Shanghai,China 200082)

机构地区：[1]上海市中西医结合医院,上海200082

出　　处：《中国药业》2025年第9期109-112,共4页China Pharmaceuticals

基　　金：上海市卫生健康委员会科研项目[20224Y0387];上海市虹口区第二轮“国医强优”三年行动计划(2022-2024年)立项项目[HKGYQYXM-2022-07]。

摘　　要：目的探讨软坚清脉颗粒联合贝前列素钠片治疗血脉瘀阻证糖尿病足溃疡的临床疗效,以及对患者足部修复效果、足部微循环和炎性因子水平的影响。方法选取医院2020年1月至2023年1月收治的血脉瘀阻证糖尿病足溃疡患者116例,按随机数字表法分为观察组和对照组,各58例。两组患者均口服贝前列素钠片,观察组患者加用软坚清脉颗粒。两组患者均连续治疗4周。结果观察组总有效率为93.10%,显著高于对照组的74.14%(P<0.05);观察组患者溃疡愈合率为(79.43±6.32)%,显著高于对照组的(63.59±4.67)%(P<0.05)。治疗后,两组患者的溃疡面积、溃疡深度、中医证候积分、视觉模拟评分法(VAS)评分、C反应蛋白(CRP)、白细胞介素6(IL-6)和肿瘤坏死因子-α(TNF-α)水平均显著低于治疗前(P<0.05),经皮氧分压、创面血流量水平均显著高于治疗前(P<0.05),且观察组改善程度均显著优于对照组(P<0.05)。两组患者治疗期间均未出现明显不良反应。结论软坚清脉颗粒联合贝前列素钠片治疗血脉瘀阻证糖尿病足溃疡的临床疗效良好,能有效改善患者的足部微循环,降低炎性因子水平,且安全性良好。Objective To investigate the clinical efficacy of Ruanjian Qingmai Granules combined with Beraprost Sodium Tablets in the treatment of diabetes foot ulcer with blood stasis syndrome,and its effect on the patients'foot repair,foot microcirculation and inflammatory factor levels.Methods A total of 116 patients with diabetes foot ulcer with blood stasis syndrome admitted to the hospital from January 2020 to January 2023 were selected and divided into the observation group and the control group by the random number table,with 58 cases in each group.The patients in the two groups were orally administered with Beraprost Sodium Tablets,while the patients in the observation group received additional treatment with Ruanjian Qingmai Granules.Both groups were treated continuously for four weeks.Results The total effective rate in the observation group was 93.10%,which was significantly higher than 74.14%in the control group(P<0.05).The ulcer healing rate in the observation group was(79.43±6.32)%,which was significantly higher than(63.59±4.67)%in the control group(P<0.05).After treatment,the ulcer area,ulcer depth,traditional Chinese medicine(TCM)syndrome score,Visual Analog Scale(VAS)score,C-reactive protein(CRP),interleukin-6(IL-6),and tumor necrosis factor-α(TNF-α)levels in the two groups were significantly lower than those before treatment(P<0.05),while the transcutaneous oxygen pressure and wound blood flow in the two groups were significantly higher than those before treatment(P<0.05),and the improvement degree in the observation group was significantly better than that in the control group(P<0.05).No significant adverse reactions observed in the two groups during the treatment period.Conclusion Ruanjian Qingmai Granules combined with Beraprost Sodium Tablets have good clinical efficacy and safety in the treatment of diabetes foot ulcer with blood stasis syndrome,which can effectively improve the patients'foot microcirculation,and reduce the level of inflammatory factors.

关 键 词：软坚清脉颗粒 贝前列素钠片 血脉瘀阻证 糖尿病足 微循环 炎性因子 临床疗效 

分 类 号：R932[医药卫生—生药学] R285.6[医药卫生—药学]