鞘内药物输注系统复合用药与单独用药比较治疗难治性疼痛疗效及安全性的Meta分析

EFFICACY AND SAFETY OF IDDS OPIOID COMBINED WITH ADJUVANT DRUG VERSUS OPIOID ALONE IN THE TREATMENT OF REFRACTORY PAIN:A META - ANALYSIS

摘要:

目的：系统评价鞘内药物输注系统（Intrathecal drug delivery system, IDDS）复合用药与单独用药比较治疗难治性疼痛的有效性和安全性。方法：计算机检索PubMed、Web of Science、OVid、CBM、CNKI、万方数据库、VIP数据库，搜索有关IDDS复合用药与单独用药比较治疗难治性疼痛的随机对照试验（RCTs），检索时限从建库至2020年4月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险，采用RevMan 5.1软件进行Meta分析。结果：共纳入7个RCT，包括438例患者，均为癌性相关难治性疼痛患者。Meta分析结果显示：IDDS用药后第1天疼痛评分[SMD=-3.16,95%CI(-5.89,-0.42),P=0.02]、用药后1周疼痛评分 [SMD=-0.67,95%CI(-0.91,-0.43),P＜0.00001]、用药后1周吗啡使用量 [MD=-2.30,95%CI(-3.52,-1.07),P=0.0002]、恶心呕吐发生率 [RR=0.65,95%CI(0.45,0.92),P=0.01]、瘙痒发生率[RR=0.44,95%CI(0.21,0.96),P=0.04]方面，复合用药组优于单独用药组，差异具有统计学意义；IDDS用药后第3天疼痛评分[SMD=-0.36,95%CI(-1.75,1.02),P=0.61]、便秘[RR=0.86,95%CI(0.49,1.53),P=0.62]、幻觉[RR=0.33,95%CI(0.05,2.07),P=0.24]、尿储留[RR=1.06,95%CI(0.60,1.86),P=0.85]的差异无统计学意义。结论：当前证据表明，IDDS复合用药治疗难治性疼痛的疗效和安全性优于单独用药。且IDDS复合用药可以减少阿片类药物使用量，进而减少不良反应发生。受纳入研究数量和质量限制，上述结论尚待更高质量研究进一步验证。

Abstract:

objectives: To systematically review the Efficacy and safety of IDDS opioid combined with adjuvant drug versus opioid alone in the treatment of refractory pianpain.Method:PubMed、Web of Science、OVid、CBM、CNKI、WanFang Data、VIP databases were electronically searched to collect randomized controlled trials (RCTs) of the efficacy and safety of IDDS opioid combined with adjuvant drug versus opioid alone in the treatment of refractory pianpain from inception to Apr 2020. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.1 software.Results:A total of 7 RCTs involving 438 patients were included,all of them are cancer-relative refractory pain. The results of meta-analysis showed that:IDDS combine group was superior to alone group in the pain score 1on day 1 after IDDS [SMD=-3.16,95%CI(-5.89,-0.42),P=0.02]、the pain score on 1 week after IDDS [SMD=-0.67,95%CI(-0.91,-0.43),P＜0.00001] 、the usage of morphine on 1 week after IDDS [MD=-2.30,95%CI(-3.52,-1.07),P=0.0002]、the incidence of nausea and vomiting [RR=0.65,95%CI(0.45,0.92),P=0.01]、the incidence of pruritue [RR=0.44,95%CI(0.21,0.96),P=0.04].there were no statistical difference between IDDS combine group and alone group in the pain score on 3th day after IDDS [SMD=-0.36,95%CI(-1.75,1.02),P=0.61]、the incidence of constipation [RR=0.86,95%CI(0.49,1.53),P=0.62]、illusion[RR=0.33,95%CI(0.05,2.07),P=0.24]、urinary retention[RR=1.06,95%CI(0.60,1.86),P=0.85].conclusions:Current evidence shows that IDDS opioid combined with adjuvant drug is more effective and safer than opioid alone for refractory pianpain,and IDDS combine group can reduce the usage of opioid drug,thus reducing the incidence of adverse reactions.Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.