Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand; Pharmacoepidemiology and Statistics Research Center (PESRC), Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.
Pharmacoepidemiology and Statistics Research Center (PESRC), Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand; Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
J Allergy Clin Immunol Pract. 2022 Jan;10(1):297-308. doi: 10.1016/j.jaip.2021.10.022. Epub 2021 Oct 22.
Recently, pharmacological treatment options for H1-antihistamine-refractory chronic spontaneous urticaria have increased dramatically; however, their effects on patient-reported outcomes, including health-related quality of life (HRQOL), remain unclear.
To compare the impact of these treatments on HRQOL among H1-antihistamine-refractory patients with chronic spontaneous urticaria.
We completed a comprehensive search of the available literature in the electronic databases, gray literature, and preprint reports up to April 19, 2021, with no language restrictions. The primary outcome for evaluation was a change in HRQOL from the baseline, and secondary outcomes included patient unacceptability and other patient-reported outcomes. We used a random-effects network meta-analysis and estimated differences in standardized mean differences (SMDs) and odds ratios with 95% CIs. Evidence-based synthesis was based on magnitudes of effect size, evidence certainty, ranking of treatment effects, and clinically meaningful improvement.
Twelve randomized controlled trials encompassing 1866 adolescent and adult patients were included. Our evidence synthesis analyses revealed that hydroxychloroquine (SMD, -1.00 [-1.61 to -0.39]), 72 mg ligelizumab (SMD, -0.66 [-0.96 to -0.35]), 240 mg ligelizumab (SMD, -0.67 [-0.98 to -0.37]), and 300 mg omalizumab (SMD, -0.53 [-0.67 to -0.39]) significantly improved HRQOL with a moderate beneficial effect. However, the use of hydroxychloroquine seems to be limited by a higher risk of patient unacceptability of treatment. Other secondary outcomes remain inconclusive based on the available evidence.
Both ligelizumab (72 or 240 mg) and 300 mg omalizumab appeared to be effective treatments for H1-antihistamine-refractory chronic spontaneous urticaria, because they were closely associated with improved HRQOL.
近来，针对 H1 抗组胺药难治性慢性自发性荨麻疹的药物治疗选择显著增加；然而，其对患者报告结局（包括健康相关生活质量[HRQOL]）的影响尚不清楚。
比较这些治疗方法对 H1 抗组胺药难治性慢性自发性荨麻疹患者 HRQOL 的影响。
我们全面检索了截至 2021 年 4 月 19 日电子数据库、灰色文献和预印本报告中的现有文献，无语言限制。主要评估结局为 HRQOL 从基线的变化，次要结局包括患者的不可接受性和其他患者报告结局。我们使用随机效应网络荟萃分析，并估计标准化均数差（SMD）和优势比的差异及其 95%置信区间。基于效应大小、证据确定性、治疗效果排名和临床有意义的改善，进行基于证据的综合评估。
共纳入 12 项包含 1866 名青少年和成年患者的随机对照试验。我们的证据综合分析显示，羟氯喹（SMD，-1.00 [-1.61 至-0.39]）、72 mg 利格司亭（SMD，-0.66 [-0.96 至-0.35]）、240 mg 利格司亭（SMD，-0.67 [-0.98 至-0.37]）和 300 mg 奥马珠单抗（SMD，-0.53 [-0.67 至-0.39]）显著改善 HRQOL，具有中度有益效果。然而，羟氯喹的使用似乎受到患者不可接受治疗风险较高的限制。其他次要结局的证据仍不明确。
利格司亭（72 或 240 mg）和 300 mg 奥马珠单抗似乎都是治疗 H1 抗组胺药难治性慢性自发性荨麻疹的有效方法，因为它们与 HRQOL 的改善密切相关。
