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

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例遗留踝关节轻微疼痛,因不影响日常生活,均未给予特殊处理。2组并发症发生率比较,差异无统计学意义(χ²=2.003,P=0.157)。结论: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,能缓解疼痛、减轻肿胀和改善关节功能,其疗效优于单纯郑氏新伤软膏贴敷治疗,但两者安全性相当。

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

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 points,t =-0. 042,P = 0. 967). The Kofoed ankle scores were higher in combination therapy group compared to monotherapy group after the end of the treatment( 89. 95 ± 1. 74 vs 82. 18 ± 1. 88 points,t = 19. 205,P = 0. 000). The Kofoed ankle scores were higher after the end of the treatment compared to pre-treatment( t =-40. 124,P =0. 000;t =-37. 709,P = 0. 000). After the end of the treatment,15 patients obtained an excellent result,18 good,6 fair and 1 poor in combination therapy group;while 9 patients obtained an excellent result,16 good,11 fair and 4 poor in monotherapy group. The combination therapy group surpassed the monotherapy group in the total clinical curative effects( Z =-2. 100,P = 0. 036). No drug hypersensitivity reactions were found in the 2 groups. The residual mild ankle pain was found in 2 patients in combination therapy group and 7 patients in monotherapy group,and no special treatment were performed for noneffects on daily living. There was no statistical difference in complication incidences between the 2 groups( χ2= 2. 003,P = 0. 157). Conclusion: The combination therapy of nano-microneedles-assisted transdermal technology and external application of Zheng’s Xinshang( 郑氏新伤) ointments can relieve the ankle pain,reduce the ankle swelling and improve the ankle function in treatment of AAS,and it surpasses the monotherapy of external application of Zheng’s Xinshang( 郑氏新伤)ointments in the clinical curative effects,while they are similar to each other in safety.