Ustekinumab有两种治疗炎症性肠病(IBD)的替代药物维持间隔,每8周(Q8W)和每12周(Q12W)。本研究旨在评估IBD患者两种维持间隔的疗效和安全性。在PubMed上进行系统搜索,WebofScience,科克伦图书馆,EMBASE被执行。在不同随访时间点的两个间隔之间,将相对风险(RR)汇总为疗效和安全性结果。归类为短期(少于44周),中期(约92周),和长期(约152周)。共纳入14项研究,共1448名患者。与Q12W相比,Q8W在短期内没有显著提高临床缓解率(RR,0.99;95%CI,0.83-1.16),中期(RR,1.05;95%CI,0.91-1.20),和长期(RR,1.07;95%CI,0.91-1.26)。同样,短期临床反应不存在实质性差异(RR,1.00;95%CI,0.85-1.17),内镜缓解(RR,0.97;95%CI,0.26-3.69),和组织学改善(RR,1.13;95%CI,0.93-1.36)两个间隔之间。对于安全结果,短期任何不良事件的RR值,中等,长期为1.10(95%CI,1.00-1.21),1.14(95%CI,1.08-1.20),Q8W和Q12W的1.12(95%CI,1.07-1.17)。最后,我们得出的结论是,每8周和12周给予一次ustekinumab维持治疗在IBD患者的疗效结局方面具有相似的效果,在维持阶段,Q12W的大多数安全性结果明显更好。
Ustekinumab has two alternative drug maintenance intervals for inflammatory bowel disease (IBD), every 8 weeks (Q8W) and every 12 weeks (Q12W). The current study aimed at evaluating the comparative efficacy and safety of the two maintenance intervals in patients with IBD. A systematic search on PubMed, Web of Science, Cochrane Library, and EMBASE was carried out. The relative risk (RR) was pooled for efficacy and safety outcomes between the two intervals at various follow-up time points, categorized as short term (less than 44 weeks), medium term (about 92 weeks), and long term (about 152 weeks). A total of 14 studies with 1448 patients were included. Q8W didn\'t result in a remarkably higher proportion of clinical remission compared to Q12W at short term (RR, 0.99; 95% CI, 0.83-1.16), medium term (RR, 1.05; 95% CI, 0.91-1.20), and long term (RR, 1.07; 95% CI, 0.91-1.26). Similarly, no substantial differences exist at short term in clinical response (RR, 1.00; 95% CI, 0.85-1.17), endoscopic remission (RR, 0.97; 95% CI, 0.26-3.69), and histologic improvement (RR, 1.13; 95% CI, 0.93-1.36) between the two intervals. For safety outcomes, the RR values for any adverse events in the short, medium, and long term were 1.10 (95% CI, 1.00-1.21), 1.14 (95% CI, 1.08-1.20), and 1.12 (95% CI, 1.07-1.17) for Q8W versus Q12W. Finally, we conclude that
ustekinumab maintenance therapy administered every 8 and 12 weeks showed similar effectiveness in achieving efficacy outcomes in IBD patients, and most safety outcomes were significantly better for Q12W during the maintenance phase.