纳米微针透皮技术联合郑氏新伤软膏贴敷治疗急性踝关节扭伤的临床研究  

A clinical study of nano-microneedles assisted transdermal technology combined with external application of Zheng’s Xinshang(郑氏新伤)ointments for treatment of acute ankle sprain

作　　者：周杰[1] 熊小明[1] 何本祥[2] 孙育良 ZHOU Jie;XIONG Xiaoming;HE Benxiang;SUN Yuliang(Sichuan Provincial Orthopedics Hospital,Chengdu 610041,Sichuan,China;Chengdu Sport University,Chengdu 610041,Sichuan,China)

机构地区：[1]四川省骨科医院,四川成都610041 [2]成都体育学院,四川成都610041

出　　处：《中医正骨》2021年第2期20-25,共6页The Journal of Traditional Chinese Orthopedics and Traumatology

摘　　要：目的:探讨纳米微针透皮技术联合郑氏新伤软膏贴敷治疗急性踝关节扭伤的临床疗效和安全性。方法:将80例急性踝关节扭伤患者随机分为2组,每组40例。软膏贴敷组采用郑氏新伤软膏贴敷治疗,每晚贴敷8~10h,共2周;联合治疗组在贴敷郑氏新伤软膏前先采用纳米微针透皮技术治疗,每晚1次,每次3min,共2周。分别于治疗前、治疗结束后记录并比较2组患者足踝部周径、踝部疼痛视觉模拟量表(visual analogue scale,VAS)评分及Kofoed踝关节评分,并观察并发症发生情况。结果:①足踝部周径。治疗前2组患者足踝部周径比较,差异无统计学意义[(35.08±2.39)cm,(34.93±2.44)cm,t=0.278,P=0.782];治疗结束后,联合治疗组患者足踝部周径小于软膏贴敷组[(28.63±1.40)cm,(30.18±1.60)cm,t=-4.626,P=0.000],2组患者足踝部周径均小于治疗前(t=17.338,P=0.000;t=14.162,P=0.000)。②踝部疼痛VAS评分。治疗前2组患者踝部疼痛VAS评分比较,差异无统计学意义[(7.08±1.14)分,(7.05.±1.13)分,t=-0.308,P=0.758];治疗结束后,联合治疗组患者踝部疼痛VAS评分低于软膏贴敷组[(2.03±0.73)分,(3.10±1.17)分,t=-4.467,P=0.000],2组患者踝部疼痛VAS评分均低于治疗前(t=-5.591,P=0.000;t=-5.690,P=0.000)。③Kofoed踝关节评分。治疗前2组患者Kofoed踝关节评分比较,差异无统计学意义[(50.18±5.49)分,(50.23±5.26)分,t=-0.042,P=0.967];治疗结束后,联合治疗组患者Kofoed踝关节评分高于软膏贴敷组[(89.95±1.74)分,(82.18±1.88)分,t=19.205,P=0.000],2组患者Kofoed踝关节评分均高于治疗前(t=-40.124,P=0.000;t=-37.709,P=0.000)。④综合疗效。治疗结束后,联合治疗组优15例、良18例、及格6例、差1例,软膏贴敷组优9例、良16例、及格11例、差4例;联合治疗组的综合疗效优于软膏贴敷组(Z=-2.100,P=0.036)。⑤并发症发生情况。2组患者均未出现药物过敏反应;联合治疗组2例遗留踝关节轻微疼痛,软膏贴敷组7例遗留踝关�Objective:To explore the clinical curative effects and safety of nano-microneedles-assisted transdermal technology combined with external application of Zheng’s Xinshang(郑氏新伤)ointments for treatment of acute ankle sprain(AAS).Methods:Eighty AAS patients were randomly divided into monotherapy group and combination therapy group, 40 cases in each group.All patients were treated with external application of Zheng’s Xinshang(郑氏新伤)ointments, 8-10 hours every night for consecutive 2 weeks;and the nano-microneedles-assisted transdermal technology was used before external application of Zheng’s Xinshang ointments in combination therapy group, once every night for 3 minutes at a time.The ankle circumferences, ankle pain visual analogue scale(VAS)scores and Kofoed ankle scores were recorded and compared between the 2 groups before the treatment and after the end of the treatment respectively, and the complications were observed.Results:There was no statistical difference in ankle circumferences between the 2 groups before the treatment(35.08±2.39 vs 34.93±2.44 cm, t=0.278,P=0.782).The ankle circumferences were smaller in combination therapy group compared to monotherapy group after the end of the treatment(28.63±1.40 vs 30.18±1.60 cm, t=-4.626,P=0.000).The ankle circumferences were smaller after the end of the treatment compared to pre-treatment(t=17.338,P=0.000;t=14.162,P=0.000).There was no statistical difference in ankle pain VAS scores between the 2 groups before the treatment(7.08±1.14 vs 7.05.±1.13 points, t=-0.308,P = 0. 758). The ankle pain VAS scores were lower in combination therapy group compared to monotherapy group after the end of the treatment( 2. 03 ± 0. 73 vs 3. 10 ± 1. 17 points,t =-4. 467,P = 0. 000). The ankle pain VAS scores were lower after the end of the treatment compared to pre-treatment( t =-5. 591,P = 0. 000;t =-5. 690,P = 0. 000). There was no statistical difference in Kofoed ankle scores between the 2 groups before the treatment( 50. 18 ± 5. 49 vs 50. 23 ± 5. 26

关 键 词：踝关节 扭伤和劳损 投药 皮肤 纳米透皮技术 郑氏新伤软膏 临床试验 

分 类 号：R684.7[医药卫生—骨科学]