首页|期刊导航|中国临床药理学杂志|自体富血小板凝胶联合噻吗洛尔对糖尿病足溃疡术后的临床研究

自体富血小板凝胶联合噻吗洛尔对糖尿病足溃疡术后的临床研究OA

Clinical trial on autologous platelet-rich gel combined with timolol in the treatment of postoperative diabetic foot ulcer

中文摘要英文摘要

目的 观察自体富血小板凝胶(APG)联合噻吗洛尔滴眼液对糖尿病足溃疡术后患者的临床疗效和安全性.方法 将我院内分泌科就诊并接受手术治疗的糖尿病足溃疡患者依据术后治疗方式的差异分为对照组和试验组.对照组用APG治疗,创面清洁消毒后,均匀涂抹APG(厚度约0.5~1.0 cm),外层覆盖凡士林油纱和无菌纱布,每周给药1次,疗程4 w;试验组在对照组的基础上联合使用马来酸噻吗洛尔滴眼液治疗,将药液直接滴敷于覆盖APG凝胶的内层纱布表面,每平方厘米创面1滴,待药液吸收后覆盖外层敷料,每2 d给药1次,疗程4 w.比较2组患者的临床疗效、创面情况、血清炎症相关指标、血管新生指标、创面胶原蛋白和足背动脉血流情况,并进行安全性评价.结果 本研究共纳入80例患者,对照组42例、试验组38例.治疗后,试验组的临床总有效率为86.84%(33例/38例),显著高于对照组的66.67%(28例/42例)(P<0.05).治疗后,试验组和对照组的创面面积分别为(5.96±1.56)和(6.86±1.84)cm2,创面深度分别为(0.56±0.08)和(0.62±0.13)cm,创面症状评分(TIME)分别为(3.84±0.79)和(4.26±0.96)分,创面愈合时间分别(57.18±9.52)和(64.26±11.37)d,血清网膜素-1(Omentin-1)水平分别为(899.04±86.77)和(853.56±80.25)ng·L-1,细胞间黏附因子1(ICAM-1)水平分别为(211.03±31.73)和(230.25±36.92)μg·L-1,内皮抑素(Endostatin)水平分别为(38.84±4.73)和(42.05±5.29)ng·L-1,血管生成因子(VEGF)水平分别为(100.60±12.11)和(93.93±9.92)ng·mL-1,血小板衍生生长因子(PDGF)水平分别为(85.58±9.15)和(80.50±8.13)ng·mL-1,碱性成纤维生长因子(bFGF)水平分别为(84.33±12.26)和(78.16±10.64)ng·mL1,Ⅰ型胶原蛋白水平分别为(2.77±0.70)和(2.36±0.63)mg·mL-1,Ⅲ型胶原蛋白水平分别为(2.52±0.75)和(2.09±0.62)mg·mL-1,足背动脉血管内径分别为(2.03±0.33)和(1.85±0.29)mm,峰值流速分别为(0.79±0.17)和(0.68±0.15)m·s-1,血流量分别为(21.55±4.30)和(19.38±3.89)mL·min-1;上述指标在2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01).试验组的药物不良反应有局部瘙痒、局部干燥和轻微刺痛,对照组有局部轻微刺激感和轻度红肿.试验组和对照组的药物不良反应总发生率分别为7.89%(3例/38例)和7.14%(3例/42例),在统计学上差异无统计学意义(P>0.05).结论 糖尿病足溃疡术后患者实施APG联合噻吗洛尔滴眼液治疗临床疗效确切,可以有效促进创面愈合,缩短愈合时间,同时能减轻炎症反应,促进血管新生及创面胶原蛋白沉积,利于足部血运改善,且安全性良好.

Objective To observe the clinical efficacy and safety of autologous platelet-rich gel(APG)combined with timolol eye drops in postoperative patients with diabetic foot ulcer.Methods Patients with diabetic foot ulcers who were admitted to the department of endocrinology of our hospital and underwent surgical treatment were divided into control group and treatment group based on postoperative intervention protocols.In control group,wounds were cleaned and disinfected,then evenly covered with 0.5-1.0 cm thick APG,dressed with petrolatum gauze and sterile gauze once weekly for 4 weeks.The treatment group received the same APG treatment combined with timolol maleate eye drops(one drop per square centimeter of wound surface dripped on the inner gauze over APG);dressing was applied after absorption,administered once every two days for 4 weeks.Compare the clinical efficacy,wound progress,serum inflammatory markers,angiogenesis indicators,wound collagen,blood flow in the dorsalis pedis artery and safety between the two groups.Results This research included 80 participants,among whom 42 were allocated to control group and 38 to treatment group.After treatment,the treatment group achieved a total clinical efficacy rate of 86.84%(33 cases/38 cases),this outcome was markedly superior to the control group's 66.67%(28 cases/42 cases),and the inter-group difference was statistical significance(P<0.05).After treatment,the wound area in treatment group and control group were(5.96±1.56)and(6.86±1.84)cm2,respectively;wound depth were(0.56±0.08)and(0.62±0.13)cm,respectively;wound symptom scores(TIME)were(3.84±0.79)and(4.26±0.96)points,respectively;wound healing time was(57.18±9.52)and(64.26±11.37)days,respectively;the serum omentin-1 levels were(899.04±86.77)and(853.56±80.25)ng·L-1,respectively;the intercellular adhesion molecule-1(ICAM-1)levels were(211.03±31.73)and(230.25±36.92)μg·L-1,respectively;the endostatin levels were(38.84±4.73)and(42.05±5.29)ng·L-1,respectively;the vascular endothelial growth factor(VEGF)levels were(100.60±12.11)and(93.93±9.92)ng·mL-1,respectively;the platelet-derived growth factor(PDGF)levels were(85.58±9.15)and(80.50±8.13)ng·mL-1,respectively;the basic fibroblast growth factor(bFGF)levels were(84.33±12.26)and(78.16±10.64)ng·mL-1,respectively;the type Ⅰ collagen levels were(2.77±0.70)and(2.36±0.63)mg·mL-1,respectively;the type Ⅲ collagen levels were(2.52±0.75)and(2.09±0.62)mg·mL-1,respectively;dorsalis pedis artery inner diameter were(2.03±0.33)and(1.85±0.29)mm,respectively;peak flow velocity were(0.79±0.17)and(0.68±0.15)m·s-1,respectively;blood flow were(21.55±4.30)and(19.38±3.89)mL·min-1,respectively.The differences of the above indicators between the two groups were all statistically significant(P<0.05,P<0.01).Regarding adverse drug reactions,the treatment group had local pruritus,local dryness and mild stinging;the control group had mild local irritation,and mild redness and swelling.The total incidence of adverse drug reactions in treatment group and control group were 7.89%(3 cases/38 cases)and 7.14%(3 cases/42 cases),respectively,with no statistically significant difference between the two groups(P>0.05).Conclusion For patients with diabetic foot ulcers following surgery,the combination therapy of APG and timolol eye drops demonstrates definite clinical efficacy.It effectively promotes wound healing,shortens healing time,alleviates inflammatory responses,enhances angiogenesis and collagen deposition in the wound,and contributes to the improvement of pedal blood supply,all with a favorable safety profile.

王崇贤;崔利娜;李俊

郑州大学第二附属医院内分泌科,河南郑州 450000郑州大学第二附属医院内分泌科,河南郑州 450000郑州大学第二附属医院内分泌科,河南郑州 450000

医药卫生

自体富血小板凝胶噻吗洛尔滴眼液糖尿病足溃疡网膜素血管新生胶原蛋白

autologous platelet-rich geltimolol eye dropdiabetic foot ulceromentin-1angiogenesiscollagen

《中国临床药理学杂志》 2026 (7)

914-919,6

10.13699/j.cnki.1001-6821.2026.07.003

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