京万红软膏和纳米银凝胶治疗糖尿病足溃疡的临床疗效比较研究

Comparison of clinical effects of Jing Wan Hong ointment and nano silver gel in treating diabetic foot ulcer

目的通过随机、对照方法对糖尿病足溃疡患者分别使用京万红软膏和纳米银凝胶进行治疗,比较两药的疗效。方法选取2015年7月至2018年5月在广东省人民医院(广东省医学科学院)接受治疗,满足入组标准的96例糖尿病足溃疡患者,按照随机对照表法进行分组,分为京万红软膏组和纳米银离子组,每组各48例。2组分别用京万红软膏或纳米银凝胶涂于创面治疗,药物厚达3 mm,隔日换药,治疗满16周或16周内任意时间点创面愈合,即试验完成。比较2组在治疗后第4、8、12、16周患者的视觉模拟评分法(VAS)评分、愈合例数、创面愈合时间,患者脉搏、心率、血压等生命体征。对数据行X^2检验和t检验。结果京万红软膏组VAS评分[(3. 09±1. 08)分]明显较纳米银离子组[(5. 83±1. 15)分]要低,差异有统计学意义(t=28. 25,P <0. 05);京万红软膏组与纳米银离子组患者在治疗后第8、12、16周愈合例数比较,差异均无统计学意义(X^2=0. 26、0. 71、0. 26,P=0. 77、0. 45、0. 77);京万红软膏组平均愈合时间[(72. 6±16. 2) d]与纳米银离子组平均愈合时间[(69. 8±21. 3) d]比较,差异无统计学意义(t=0. 37,P=0. 71);两组患者呼吸频率、心率和血压变化无异常。结论京万红软膏与纳米银凝胶均有促进糖尿病足慢性创面愈合的作用,京万红软膏作用疼痛更小,治疗更舒适。

Objective To compare the efficacy of Jing Wan Hong ointment and nano silver gel in treating patients with diabetic foot ulcer by random and control methods.MethodsAll patients were treated in Guangdong General Hospital (Guangdong Academy of Medical Sciences) from July 2015 to May 2018. Ninty-six patients with diabetic foot ulcer were divided into 48 cases of Jing Wan Hong oinment group and 48 cases of nano silver gel group according to random comparison table method. The two groups were treated with Jing Wan Hong ointment or nano silver gel. The topical medicine was 3 mm thick, dressing every other day. The wound healed at any time within 16 weeks, and the study was completed. Visual analogue score (VAS), healing cases, healing time, pulse, heart rate, blood pressure and other vital signs were compared between the two groups at 4th, 8th, 12th and 16th weeks after treatment. Data were processed with χ^2 test and t text.ResultsThe VAS score of Jing Wan Hong ointment group [(3.09±1.08) points] was significantly lower than that of nano silver gel group [(5.83± 1.15) points], and the difference was statistically significant (t=28.25, P<0.05). There was no difference in healing cases between Jing Wan Hong ointment group and nano silver gel group at 8th, 12th and 16th week (χ^2=0.26, 0.71, 0.26;P=0.77, 0.45, 0.77). The healing time of Jing Wan Hong ointment group was (72.6 ±16.2) d, and that of nano silver gel group was (69.8±21.3) d, there was no significant difference in healing time between the two groups (t=0.37, P=0.71). There was no abnormal change in respiratory rate, heart rate and blood pressure in the two groups.ConclusionsJing Wan Hong ointment and nano silver gel both can promote the healing of diabetic foot ulcer. Jing Wan Hong ointment has less pain and more comfortable treatment than nano silver gel.