自体浓缩生长因子凝胶联合木丹颗粒治疗糖尿病足溃疡的临床研究

Clinical Observation on Treating Diabetic Foot Ulcers with A utologous Concentrated Growth Factor Gel Combined with Mudan Granules

目的 探讨自体浓缩生长因子凝胶联合木丹颗粒治疗糖尿病足溃疡的临床疗效。方法 选取2017年3月—2019年6月期间在岳阳市中医医院进行治疗的糖尿病足患者116例,按随机数字表法分为对照组和观察组,每组各58例。两组患者均予基础常规治疗,对照组加用木丹颗粒口服,观察组在对照组的基础上加用自体浓缩生长因子凝胶。治疗8周后,观察比较两组患者临床疗效、不良反应发生情况,治疗前后视觉模拟评分法(Visual analogue scoring, VAS)评分、间歇性跛行评分、下肢皮温和踝肱指数(Ankle-brachial index, ABI)等指标;检测两组患者治疗前后血浆C反应蛋白(C-reactive protein, CRP)、白细胞介素-1β(Interleukin-1β,IL-1β)和白细胞介素-10(Interleukin-10,IL-10)的表达水平。结果 治疗后观察组总有效率94.82%(55/58)明显高于对照组77.59%(45/58),差异有统计学意义(P<0.05)。治疗后两组患者VAS评分和间歇性跛行评分较治疗前降低,差异有统计学意义(P<0.05);且观察组患者VAS评分和间歇性跛行评分低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者皮温和ABI较治疗前升高,差异有统计学意义(P<0.05);且观察组患者皮温和ABI高于对照组,差异有统计学意义(P<0.05)。治疗后两组患者CRP、IL-1β表达水平较治疗前降低,IL-10表达水平较治疗前升高,差异有统计学意义(P<0.05);且观察组CRP和IL-1β表达水平低于对照组,IL-10表达水平高于对照组,差异有统计学意义(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(χ^(2)=0.152,P=0.697)。结论 自体浓缩生长因子凝胶联合木丹颗粒治疗糖尿病足溃疡确有良好疗效,值得临床推广应用。

Objective To observe the clinical efficacy of autologous concentrated growth factor gel combined with Mudan Granules in the treatment of diabetic foot ulcers.Methods A total of 116 patients with diabetic foot ulcers treated in Yueyang Hospital of Traditional Chinese Medicine from March 2017 to June 2019 were randomly assigned into a control group(n=58)and an observation group(n=58)with the random number table method.In addition to the conventional treatment,the control group received Mudan Granules and the observation group received autologous concentrated growth factor gel combined with Mudan Granules.The treatment lasted for 8 weeks,and then the clinical efficacy was evaluated and the adverse reactions were recorded.The visual analogue scale(VAS)score,intermittent claudication score,leg skin temperature,and ankle-brachial index(ABI)were compared between the two groups and between before and after treat-ment.The expression levels of C-reactive protein(CRP),interleukin-1β(IL-1β),and IL-10 in the plasma were de-termined before and after treatment.Results The total effective rate of the observation group was 94.82%(55/58),which was higher than that(77.59%,45/58)of the control group(P<0.05).After treatment,the VAS score and inter-mittent claudication score were lower than those before treatment(P<0.05),and the scores of the observation group were lower than those of the control group(P<0.05).The treatment in both groups increased the leg skin temperature and ABI(P<0.05),which were higher in the observation group than in the control group(P<0.05).The treatment down-regu-lated the expression levels of CRP and IL-1βand up-regulated the expression level of IL-10(P<0.05).Moreover,the observation group had lower expression levels of CRP and IL-1βand higher expression level of IL-10 than the con-trol group(P<0.05).The the incidence of adverse reactions showed no significant difference between the two groups(χ^(2)=0.152,P=0.697).Conclusion Autologous concentrated growth factor gel combined with Mudan Granules can al-leviate the clinical symptoms of diabetic foot ulcers,which is worthy of promotion in clinical practice.