A Multicenter, Double-Blind, Randomized, Noninferiority Comparison of 14 Days' Treatment with Oral Olopatadine 10 mg or Cetirizine 10 mg in Chinese Adults with Cutaneous Pruritus
机构：[a]Departments of Dermatology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences[b]Departments of Allergy, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences[c]Department of Dermatology, Xuan Wu Hospital, Capital Medical University, Beijing首都医科大学宣武医院[d]Department of Dermatology, Zhong Shan Hospital[e]Department of Dermatology,Hua Shan Hospital, Fu Dan University, Shanghai[f]Department of Dermatology, Second Affiliated Hospital of Zhong Shan University, Guangzhou[g]Department of Dermatology, General Hospital of Shen Yang Military District, Shenyang, PR China
Objectives: To assess whether olopatadine hydrochloride (OH) was noninferior to cetirizine in the treatment of cutaneous pruritus (CP). Patients and Methods: Patients with CP presenting at seven centers in China were randomly allocated to double-blind treatment with 5 mg of OH orally twice a day or cetirizine 10 mg orally once a day for 2 weeks. Patients were followed up on days 7 and 14. Noninferiority was predefined as a 20% maximum difference in the reduction of symptom score reducing indices (SSRI). Both intention-to-treat (ITT) and per-protocol populations were analyzed. Results: 174 patients (86 receiving OH and 88 cetirizine) were included in the ITT population. In the ITT population, the mean reduction in SSRI was 0.640 +/- 0.274 in the OH group and 0.603 +/- 0.289 in the cetirizine group. The one-sided 97.5% CI (-0.047) met the criteria for noninferiority. Noninferiority was also demonstrated for SSRI in the per-protocol population, with reductions of 0.640 +/- 0.271 with OH and 0.596 +/- 0.287 with cetirizine (97.5% CI -0.043). The total effectiveness rate (TER) was similar in the OH (90.0%) and cetirizine (80.0%) groups. The corresponding one-sided 97.5% CI (-1.0%) also demonstrated noninferiority. The incidence of adverse events was 47.1% in the OH group and 41.4% in the cetirizine group (p = 0.453). Conclusion: The efficacy of OH was noninferior to that of cetirizine in controlling itching indicating that it can be considered as a clinically relevant alternative therapy to cetirizine for the management of CP in adult Chinese patients. Copyright (C) 2013 S. Karger AG, Basel
第一作者机构：[a]Departments of Dermatology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
通讯作者：
通讯机构：[*1]Department of Dermatology, Peking Union Medical College Hospital Peking Union Medical College, Chinese Academy of Medical Sciences Beijing 100730 (PR China)
推荐引用方式(GB/T 7714)：
Tao Wang,Yuehua Liu,Jia Yin,et al.A Multicenter, Double-Blind, Randomized, Noninferiority Comparison of 14 Days' Treatment with Oral Olopatadine 10 mg or Cetirizine 10 mg in Chinese Adults with Cutaneous Pruritus[J].PHARMACOLOGY.2013,91(1-2):117-122.doi:10.1159/000345447.
APA：
Tao Wang,Yuehua Liu,Jia Yin,Shi Lian,Ming Li...&Shifa Zhang.(2013).A Multicenter, Double-Blind, Randomized, Noninferiority Comparison of 14 Days' Treatment with Oral Olopatadine 10 mg or Cetirizine 10 mg in Chinese Adults with Cutaneous Pruritus.PHARMACOLOGY,91,(1-2)
MLA：
Tao Wang,et al."A Multicenter, Double-Blind, Randomized, Noninferiority Comparison of 14 Days' Treatment with Oral Olopatadine 10 mg or Cetirizine 10 mg in Chinese Adults with Cutaneous Pruritus".PHARMACOLOGY 91..1-2(2013):117-122
