无针注射器瘢痕疙瘩内注射糖皮质激素的疗效研究

摘要

Objective To compare the efficacy of intralesional glucocorticoid injection with a needle-free injector versus an ordinary injector for the treatment of keloid. Methods A total of 60 patients with keloid were enrolled and randomly divided into two groups by using a random number table to receive intralesional injection of compound betamethasone with a needle-free injector(n=31)or an ordinary injector(n=29). The injection was given at a dose of 0.2 ml/cm3 once every 3 weeks for 3 sessions. Parameters for therapeutic efficacy were assessed, adverse reactions were recorded, and clinical pictures were taken before and after each treatment. Statistical analysis was carried out by the Mann-Whitney U test and chi-square test with the SPSS 19.0 software. Results Compared with the ordinary injector group, the needle-free injector group showed significantly different injection time during the first and second treatment (U=299.000, 773.500, respectively, both P=0.000), as well as duration of pain after the first injection(U=730.000, P=0.003). After three sessions of treatment, there was a significant difference in the volume, height, hardness of keloid, scores for pain, itching and appearance, and number of injection points between the needle-free injector group and ordinary injector group (U=295.000, 336.500, 264.000, 464.000, 451.500, 308.000, 233.500, P=0.001, 0.007, 0.000, 0.041, 0.043, 0.003, 0.001, respectively). No significant differences were observed in the incidence of adverse reactions between the two groups(all P>0.05). Moreover, the interval for lesion recurrence was significantly shorter in the needle-free injector group(11.8 days, 95%CI:10.96-12.6 days)than in the ordinary injector group(21.2 days, 95%CI:13.96-28.45 days). Conclusion Compared with the ordinary injector, the needle-free injector shows better efficiency for the treatment of keloid with decreased difficulty in injection and improved compliance in patients.%目的：比较无针注射器与普通注射器瘢痕疙瘩内注射糖皮质激素的疗效。方法瘢痕疙瘩患者60例分为无针注射器组31例，普通注射器组29例。两组均使用复方倍他米松注射液进行皮损内注射，注射剂量0．2 ml/cm3，均为3周1次，连续3次。收集入组病例每次治疗前后参数数据、不良反应观察指标和每次治疗前后临床照片。采用Mann-Whitney检验、χ2检验等对两组参数数据进行统计学分析。结果第1次和第2次注射时间、第1次注射后疼痛时间Mann-Whitney检验U值分别为299．000、773．500、730．000，P值分别为0．000、0．000、0．003，其差异有统计学意义。3次治疗后体积、高度、硬度、痛觉、痒觉、外观评价、注射点数Mann-Whitney检验U值分别为295．000、336．500、264．000、464．000、451．500、308．000、233．500，P值分别为0．001、0．007、0．000、0．041、0．043、0．003、0．001，其差异均有统计学意义。两组3次治疗后不良反应发生率比较，差异无统计学意义（均P>0．05）。无针注射器组皮损反跳临界时间11．8 d（95％CI：10．96~12．6 d）比普通注射器组皮损反跳临界时间21．2 d （95％CI：13．96~28．45 d）短。结论无针注射器治疗瘢痕疙瘩与普通注射器相比，疗效好，又可以降低注射难度，提高患者治疗依从性。