盐酸奥洛他定治疗慢性自发性荨麻疹多中心、随机、双盲、平行对照临床研究

目的 评价盐酸奥洛他定治疗慢性自发性荨麻疹的疗效和安全性。 方法 多中心、随机、双盲、平行对照临床研究。试验组口服盐酸奥洛他定5 mg每日2次，对照组口服盐酸左西替利嗪及其模拟片5 mg每日2次。两组均连续服药28 d。以疗效指数作为主要指标，总体疗效评价及总有效率作为次要指标。 结果 3个研究中心共入选病例144例，可进行疗效分析病例为137例，其中试验组和对照组分别为70例、67例。ITT分析试验组治疗后第7天、第14天、第28天的总有效率分别为64.29%（45/70）、82.86%（58/70）、87.14%（61/70），对照组为56.72%（38/67）、74.63%（50/67）、77.61%（52/67），两组比较差异均无统计学意义（均P > 0.05）。治疗4周，试验组的疗效指数（82.67% ± 22.70％）高于对照组（70.51% ± 32.07％）（P ＜ 0.05）。试验组和对照组的不良反应发生率分别为33.80%（24/71）、27.94%（19/68）（P > 0.05），主要有嗜睡、口干、疲倦等。 结论 盐酸奥洛他定治疗慢性自发性荨麻疹安全有效。

Olopatadine hydrochloride for the treatment of chronic idiopathic urticaria: a multicentre,double-blind,randomized, parallel-group,controlled clinical trial

Zhai Zhifang*, Wei Yingbo, Lei Tiechi, Chen Xingping, Hu Ping, Chen Lan, Wei Ping, Tian Kaocong, Peng Bin, Hao Fei. *Department of Dermatology, Southwest Hospital, Third Military Medical University, Chongqing 400038, China Corresponding author: Hao Fei, Email: haofei62@medmail.com.cn 【Abstract】 Objective To evaluate the efficacy and safety of olopatadine hydrochloride for the treatment of chronic idiopathic urticaria （CIU）. Methods A multicentre, double-blind, randomized, parallel-group, controlled clinical trial was conducted. A total of 144 patients with CIU from 3 research centers were enrolled into this study, and randomly and equally divided into a test group and a control group. The test group administrated olopatadine hydrochloride 5 mg twice a day for 28 consecutive days, while the control group administrated levocetirizine hydrochloride 5 mg in the forenoon and a placebo tablet of olopatadine hydrochloride 5 mg in the afternoon for 28 consecutive days. The symptom score reducing index （SSRI） served as the primary outcome, and global assessment score for efficacy and total response rates as the secondary outcome. Results Totally, 137 patients completed the trial, including 70 in the test group and 67 in the control group. As intention-to-treat analysis showed, there were no significant differences in the total response rate between the test group and control group on day 7 （64.29% （45/70） vs. 56.72% （38/67）, P > 0.05）, 14 （82.86%（58/70） vs. 74.63%（50/67）, P > 0.05）, or 28 （87.14% （61/70） vs. 77.61% （52/67）, P > 0.05） after start of treatment. The SSRI was significantly higher in the test group than in the control group after 4 weeks of treatment （82.67% ± 22.70% vs. 70.51% ± 32.07%, P < 0.05）. In addition, no significant difference was observed in the incidence of adverse reactions between the test group and control group （33.80% （24/71） vs. 27.94% （19/68）, P > 0.05）, and adverse reactions mainly included lethargy, dry mouth, fatigue, etc. Conclusion Olopatadine hydrochloride is effective and safe for the treatment of CIU.