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舒芬太尼舌下片系统用于术后疼痛管理的疗效与安全性:一项系统评价和Meta分析

Efficacy and safety of sufentanil sublingual tablet system in postoperative pain management: a systematic review and meta-analysis.

作者信息

Thangaraju Pugazhenthan, Varthya Shoban Babu, Venkatesan Sajitha, Tamilselvan Thangaraju, Singh Surjit

机构信息

Pharmacology, AIIMS Raipur, Raipur, India.

Pharmacology, AIIMS Jodhpur, Jodhpur, India.

出版信息

BMJ Support Palliat Care. 2023 Oct;13(e1):e20-e29. doi: 10.1136/bmjspcare-2020-002693. Epub 2021 Mar 2.

DOI:10.1136/bmjspcare-2020-002693
PMID:33653734
Abstract

BACKGROUND

Sufentanil sublingual tablet system (SSTS) is a recently approved formulation for postoperative pain management that has become popular due to its pharmacokinetic properties such as good bioavailability, rapid attainment of equilibrium and elimination without any metabolites, along with its pharmacodynamic properties such as rapid onset and effective pain reduction. It is also relatively well tolerated by patients.

OBJECTIVE

This is a quantitative analysis of the efficacy and safety of SSTS in patients with moderate to severe postoperative pain.

DESIGN

This is a systematic review and meta-analysis. Databases such as Cochrane Library, MEDLINE and EMBASE were searched for eligible articles.

SETTINGS

Randomised controlled trials published after 2000 in English language and which assessed at least one of the outcome measures of interest with pain intensity difference between 12 hours and a maximum of 96 hours.

PARTICIPANTS

Adults with moderate to severe postoperative pain and taking SSTS for pain management.

METHODS

Data were analysed using Review Manager (RevMan) V.5.3. Risk of bias (RoB) assessment was done using RoB-2 scale, and overall grading of evidence of each outcome was done using GRADEpro Guideline Development Tool.

RESULTS

Analysis of SSTS versus control indicates a statistically significant reduction in summed pain intensity difference at 12 hours (mean difference (MD)=-12.33 (95% CI -15.5 to -9.17), p<0.00001), summed pain intensity difference at 48 hours (MD=-43.57 (95% CI -58.65 to -28.48), p<0.00001), time-weighted total pain relief over 12 hours (MD=-4.77 (95% CI -6.28 to -3.27), p<0.00001) and pain intensity difference (MD=-0.73 (95% CI -1.00 to -0.46), p<0.00001) with SSTS, alongside high quality of evidence. Success of treatment as assessed by Patient Global Assessment (OR=4.01 (95% CI 2.74 to 5.89), p<0.00001) and Healthcare Professional Global Assessment (OR=4.46 (95% CI 3.03 to 6.56), p<0.00001) scoring at 72 hours was observed in a significantly high number of individuals using SSTS, with high quality of evidence. There was no difference in adverse events except for dizziness (RR=1.90, 95% CI 1.02 to 3.52). There was a significantly higher number of total adverse events in orthopaedic surgery in the SSTS group than in the comparator.

CONCLUSION

SSTS is effective in postoperative pain management in patients with moderate to severe pain. It also has good tolerability and high patient satisfaction.

PROSPERO REGISTRATION NUMBER

CRD42018115458.

摘要

背景

舒芬太尼舌下片系统(SSTS)是一种最近获批用于术后疼痛管理的制剂,因其具有良好的生物利用度、快速达到平衡且无代谢产物消除等药代动力学特性,以及起效迅速和有效减轻疼痛等药效学特性而受到欢迎。患者对其耐受性也相对较好。

目的

这是一项对SSTS用于中重度术后疼痛患者的疗效和安全性的定量分析。

设计

这是一项系统评价和荟萃分析。检索了Cochrane图书馆、MEDLINE和EMBASE等数据库以查找符合条件的文章。

设置

2000年后发表的英文随机对照试验,且评估了至少一项感兴趣的结局指标,疼痛强度差异在12小时至最长96小时之间。

参与者

患有中重度术后疼痛并服用SSTS进行疼痛管理的成年人。

方法

使用Review Manager(RevMan)V.5.3分析数据。使用RoB-2量表进行偏倚风险(RoB)评估,并使用GRADEpro指南制定工具对每个结局的证据进行总体分级。

结果

SSTS与对照组的分析表明,在12小时时总疼痛强度差异有统计学显著降低(平均差异(MD)=-12.33(95%置信区间-15.5至-9.17),p<0.00001),48小时时总疼痛强度差异(MD=-43.57(95%置信区间-58.65至-28.48),p<0.00001),12小时内时间加权总疼痛缓解(MD=-4.77(95%置信区间-6.28至-3.27),p<0.00001)以及疼痛强度差异(MD=-0.73(95%置信区间-1.00至-

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