Health Sciences Center, Stomatology Department, Autonomous University of Aguascalientes, Aguascalientes, Mexico.
Health Sciences Center, Autonomous University of Aguascalientes, Aguascalientes, Mexico.
Pharmacol Res Perspect. 2024 Dec;12(6):e70033. doi: 10.1002/prp2.70033.
The primary objective of the present review was to report the safety profile of oral ketorolac in adults using the systematic review and meta-analysis methodology based on clinical trials. The present study is a PRISMA-based systematic review and risk ratio (RR) meta-analysis of the adverse events reported in clinical trials that used oral ketorolac; the review includes 50 clinical trials. The RR for the comparison of a single intake of oral ketorolac versus placebo, including all types of adverse events, was RR = 2.59, IC95% (1.5102; 4.4360) with p = 0.02, the RR for the comparison of a multiple intakes of oral ketorolac versus placebo for all types of adverse events was RR = 1.39, IC95% (0.95; 2.05) with p = 0.093, the RR for the comparison of a single intake of oral ketorolac versus active drugs for all types of adverse events was RR = 0.61, IC95% (0.49; 0.77) with p < 0.0001, the RR for the comparison of multiple intakes of oral ketorolac versus active drugs for all types of adverse events was RR = 0.78, IC95%(0.65; 0.93) with p = 0.006. Multiple intakes of 5, 10, or 20 mg of oral ketorolac, in treatment over 1-10 days, do not increase the risk of adverse events compared to placebo and show a tendency to reduce the risk of adverse events compared to active drugs. When a single intake of ketorolac (5, 10, 20, or 30 mg) is compared to a placebo, the risk increases only for trivial and mild adverse events.
本综述的主要目的是使用基于临床试验的系统评价和荟萃分析方法报告成人口服酮咯酸的安全性概况。本研究是一项基于 PRISMA 的系统评价和风险比 (RR) 荟萃分析，对使用口服酮咯酸的临床试验报告的不良事件进行分析；该综述包括 50 项临床试验。比较单次口服酮咯酸与安慰剂（包括所有类型的不良事件）的 RR 为 RR=2.59，95%CI（1.5102；4.4360），p=0.02，比较多次口服酮咯酸与安慰剂（所有类型的不良事件）的 RR 为 RR=1.39，95%CI（0.95；2.05），p=0.093，比较单次口服酮咯酸与活性药物（所有类型的不良事件）的 RR 为 RR=0.61，95%CI（0.49；0.77），p<0.0001，比较多次口服酮咯酸与活性药物（所有类型的不良事件）的 RR 为 RR=0.78，95%CI（0.65；0.93），p=0.006。5、10 或 20mg 口服酮咯酸多次给药，治疗 1-10 天，与安慰剂相比，不会增加不良事件的风险，并且与活性药物相比，有降低不良事件风险的趋势。当单次给予酮咯酸（5、10、20 或 30mg）与安慰剂相比时，仅轻微和轻度不良事件的风险增加。
