除湿止痒软膏治疗轻度婴儿期特应性皮炎的有效性及安全性多中心临床研究

Efficacy and safety of Chushizhiyang ointment for the treatment of mild atopic dermatitis in infants： a multicenter clinical study

目的 评价除湿止痒软膏治疗轻度婴儿期特应性皮炎的有效性和安全性。方法 采用随机、开放、阳性药物平行对照的多中心研究方法，共入组婴儿期特应性皮炎患儿204例，其中试验组103例外用除湿止痒软膏，阳性对照组101例外用丁酸氢化可的松乳膏，评估治疗前及治疗第7天和14天患儿湿疹面积及严重度指数（EASI）改善情况、患儿生活质量改善情况及不良事件和不良反应的发生情况。结果 全分析集分析结果显示，两组患儿经治疗后疾病严重程度均明显缓解。试验组98例，基线、7 d和14 d时EASI值分别为2.47 ± 4.04、0.92 ± 1.25、0.39 ± 1.04，7 d和14 d分别与基线值比较，经配对秩检验，T值分别为-1 666和-1 793，均P 〈 0.001，差异有统计学意义；对照组101例，基线、7 d和14 d时EASI值分别为2.13 ± 2.01、0.85 ± 1.58、0.45 ± 1.65，7 d和14 d分别与基线比较，T值分别为-1 951和-1 941，均P 〈 0.001，差异有统计学意义；试验组与对照组间治疗前、治疗第7天和第14天比较，差异均无统计学意义。7 d随访时，试验组有效率为47.96%（47例），对照组为55.44%（56例）；治疗第14天，试验组为79.59%（78例），对照组为84.16%（85例），经独立样本秩和检验，均P 〉 0.05，差异无统计学意义。试验组不良事件发生率为2.90%（3例），以红斑瘙痒、脱屑为主；对照组发生率为6.90%（7例），以色素减退、毛细血管扩张、脱屑、色素沉着为主，两组差异无统计学意义（P＞0.05）。结论 除湿止痒软膏治疗轻度婴儿期特应性皮炎疗效确切，安全性、耐受性好，可为轻度婴儿期特应性皮炎的治疗选择方案之一。

Objective To evaluate the efficacy and safety of Chushizhiyang ointment for the treatment of mild atopic dermatitis in infants. Methods A multicenter, randomized, open, active-controlled clinical trial was conducted. A total of 204 infants with atopic dermatitis were enrolled and randomly divided into 2 groups to be topically treated with Chushizhiyang ointment （test group, n = 103） and hydrocortisone butyrate cream （control group, n = 101）, respectively, for 2 weeks. The improvement of eczema area and severity index （EASI） scores and quality of life was evaluated at 7 days and 14 days after the treatment, so was the incidence of adverse events and adverse reactions. Results Ninety-eight infants in the test group and 101 in the control group were included in the full analysis set, which revealed that the disease severity significantly decreased after the treatment in both groups. The EASI scores at the baseline and on days 7 and 14 were 2.47 ± 4.04, 0.92 ± 1.25 and 0.39 ± 1.04 respectively in the test group, as well as 2.13 ± 2.01, 0.85 ± 1.58 and 0.45 ± 1.65 respectively in the control group. Furthermore, the test group and control group both showed that EASI scores on days 7 and 14 significantly decreased compared with those at the baseline （the test group： T = -1 666, -1 793, respectively, both P 〈 0.001; the control group： T = -1 951, -1 941, respectively, both P 〈 0.001）. No significant differences in EASI scores at the baseline or on days 7 and 14 were observed between the test group and control group （all P 〉 0.05）. The response rates in the test group and control group were 47.96% （47/98） and 55.44% （56/101） respectively on day 7, as well as 79.59% （78/98） and 84.16% （85/101） respectively on day 14, and there were also no significant differences between the two groups （both P 〉 0.05）. The adverse reactions mainly manifested as erythema, itching and scaling in the test group, as well as hypopigmentation, telangiectasia, scaling and hyperpigmentation in the control group. No significant difference in the incidence of adverse events was found between the test group （2.9%, 3/103） and control group （6.9%, 7/101）. Conclusion Chushizhiyang ointment shows definite efficacy for mild atopic dermatitis in infants with good safety and tolerability, and can be a teatment option for mild atopic dermatitis in infants.