PDF(Pubmed)
Abstract：
UNASSIGNED: The stability, efficacy, and safety of omalizumab at different doses and regimens for chronic spontaneous urticaria (CSU) are yet to be studied.
UNASSIGNED: A systematic review (SR) with meta-analysis (MA) and trial sequential analysis (TSA) was performed to assess the efficacy and safety of omalizumab in CSU.
UNASSIGNED: Randomised controlled trials (RCTs) of administering omalizumab versus placebo for CSU were searched. Random-effects MAs were performed using planned subgroup analyses. TSA was performed to control for the risk of random errors and assess the stability of our MA results. Publication bias was visually assessed using a contour-enhanced funnel plot and the trim-and-fill method. The quality of RCTs was assessed using the Cochrane Risk of Bias Tool 2.
UNASSIGNED: Twelve studies met the inclusion criteria. Omalizumab had remarkable effects on the patient percentage of the weekly urticaria activity score is zero (UAS = 0) [RR 4.64, 95% CI (3.38, 6.37)], percentage of no angioedema-burdened days [MD 3.15, 95% CI (0.10, 6.19], patient percentage of UAS ≤6 [RR 3.05, 95% CI (2.46, 3.78)], and patient percentage of the weekly itch severity score minimally important difference (ISS7 MID) [RR 1.50, 95% CI (1.36, 1.66)]. Omalizumab was well tolerated across studies [RR 0.98, 95% CI (0.90, 1.08)]. TSA confirmed the above results, except for \"the percentage of no angioedema-burdened day\".
UNASSIGNED: Among the different doses and courses assessed, omalizumab (300 mg, 12 weeks) can be recommended as an effective treatment for patients with CSU. However, whether omalizumab improves angioedema requires further investigation. The clinical management of angioedema accompanying CSU requires further attention.
UNASSIGNED: A systematic review (SR) with meta-analysis (MA) and trial sequential analysis (TSA) was performed to assess the efficacy and safety of omalizumab in CSU.
UNASSIGNED: Randomised controlled trials (RCTs) of administering omalizumab versus placebo for CSU were searched. Random-effects MAs were performed using planned subgroup analyses. TSA was performed to control for the risk of random errors and assess the stability of our MA results. Publication bias was visually assessed using a contour-enhanced funnel plot and the trim-and-fill method. The quality of RCTs was assessed using the Cochrane Risk of Bias Tool 2.
UNASSIGNED: Twelve studies met the inclusion criteria. Omalizumab had remarkable effects on the patient percentage of the weekly urticaria activity score is zero (UAS = 0) [RR 4.64, 95% CI (3.38, 6.37)], percentage of no angioedema-burdened days [MD 3.15, 95% CI (0.10, 6.19], patient percentage of UAS ≤6 [RR 3.05, 95% CI (2.46, 3.78)], and patient percentage of the weekly itch severity score minimally important difference (ISS7 MID) [RR 1.50, 95% CI (1.36, 1.66)]. Omalizumab was well tolerated across studies [RR 0.98, 95% CI (0.90, 1.08)]. TSA confirmed the above results, except for \"the percentage of no angioedema-burdened day\".
UNASSIGNED: Among the different doses and courses assessed, omalizumab (300 mg, 12 weeks) can be recommended as an effective treatment for patients with CSU. However, whether omalizumab improves angioedema requires further investigation. The clinical management of angioedema accompanying CSU requires further attention.
摘要：
■稳定性，功效,不同剂量和方案的奥马珠单抗治疗慢性自发性荨麻疹(CSU)的安全性尚待研究.
■进行了系统评价（SR）和荟萃分析（MA）和试验序贯分析（TSA），以评估奥马珠单抗在CSU中的疗效和安全性。
■对CSU给予奥马珠单抗与安慰剂的随机对照试验（RCT）进行了检索。使用计划的亚组分析进行随机效应MA。进行TSA以控制随机误差的风险并评估我们的MA结果的稳定性。使用轮廓增强漏斗图和修剪填充方法对出版偏差进行视觉评估。使用Cochrane偏差风险工具2评估随机对照试验的质量。
■12项研究符合纳入标准。奥马珠单抗对每周荨麻疹活动评分为零的患者百分比有显著影响(UAS=0)[RR4.64,95%CI(3.38,6.37)],无血管性水肿负担天数的百分比[MD3.15，95%CI（0.10，6.19]，UAS≤6的患者百分比[RR3.05，95%CI（2.46，3.78）]，和患者每周瘙痒严重程度评分最低重要差异（ISS7MID）的百分比[RR1.50，95％CI（1.36，1.66）]。奥马珠单抗在所有研究中耐受性良好[RR0.98，95%CI(0.90，1.08)]。运输安全管理局证实了上述结果，除了“没有血管性水肿负担的一天的百分比”。
■在评估的不同剂量和疗程中，奥马珠单抗（300毫克，12周）可以推荐作为CSU患者的有效治疗方法。然而,奥马珠单抗是否能改善血管性水肿需要进一步研究.伴随CSU的血管性水肿的临床处理需要进一步关注。
■进行了系统评价（SR）和荟萃分析（MA）和试验序贯分析（TSA），以评估奥马珠单抗在CSU中的疗效和安全性。
■对CSU给予奥马珠单抗与安慰剂的随机对照试验（RCT）进行了检索。使用计划的亚组分析进行随机效应MA。进行TSA以控制随机误差的风险并评估我们的MA结果的稳定性。使用轮廓增强漏斗图和修剪填充方法对出版偏差进行视觉评估。使用Cochrane偏差风险工具2评估随机对照试验的质量。
■12项研究符合纳入标准。奥马珠单抗对每周荨麻疹活动评分为零的患者百分比有显著影响(UAS=0)[RR4.64,95%CI(3.38,6.37)],无血管性水肿负担天数的百分比[MD3.15，95%CI（0.10，6.19]，UAS≤6的患者百分比[RR3.05，95%CI（2.46，3.78）]，和患者每周瘙痒严重程度评分最低重要差异（ISS7MID）的百分比[RR1.50，95％CI（1.36，1.66）]。奥马珠单抗在所有研究中耐受性良好[RR0.98，95%CI(0.90，1.08)]。运输安全管理局证实了上述结果，除了“没有血管性水肿负担的一天的百分比”。
■在评估的不同剂量和疗程中，奥马珠单抗（300毫克，12周）可以推荐作为CSU患者的有效治疗方法。然而,奥马珠单抗是否能改善血管性水肿需要进一步研究.伴随CSU的血管性水肿的临床处理需要进一步关注。
