他喷他多速释剂用于缓解拇囊炎术后中重度急性疼痛有效性和安全性的Meta分析
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摘要
目的:系统评价他喷他多速释剂(Tap IR)用于缓解拇囊炎术后中重度急性疼痛的有效性与安全性,为临床合理用药提供循证参考。方法:计算机检索PubMed、Medline、Cochrane图书馆、中国知网、维普数据库、万方数据库、美国临床试验网数据库,收集Tap IR(试验组)对比羟考酮速释剂或安慰剂用于缓解拇囊炎术后中重度急性疼痛的随机对照试验(RCT)。筛选文献、提取资料并采用改良Jadad量表评价文献质量后,采用Rev Man 5.3软件进行Meta分析。结果:共纳入6项RCT,共计2 378例患者。Meta分析结果显示,试验组患者48 h疼痛缓解总值(TOTPAR_(48))显著高于对照组[MD=35.60,95%CI(27.31,43.88),P<0.000 01]。亚组分析结果显示,试验组中使用50 mg[MD=28.68,95%CI(18.18,39.17),P<0.00 001]、75 mg[MD=39.97,95%CI(34.21,45.73),P<0.00 001]、100 mg[MD=38.50,95%CI(1.46,75.54),P=0.04]患者的TOTPAR_(48)显著高于对照组;试验组中使用75 mg患者的TOTPAR_(48)显著高于使用50 mg者[MD=9.04,95%CI(4.31,13.77),P=0.000 2]。两组患者补救药物使用率(URM)比较差异无统计学意义[RR=1.23,95%CI(0.84,1.80),P=0.29];亚组分析结果显示,试验组中使用75 mg患者的URM显著低于使用50mg者[RR=0.62,95%CI(0.41,0.94),P=0.02]。试验组患者48 h疼痛强度差总值(SPID_(48))显著低于对照组[MD=-18.96,95%CI(-37.28,-0.64),P=0.04];亚组分析结果显示,试验组中使用75 mg患者的SPID48显著高于使用50 mg者[MD=21.66,95%CI(8.93,34.39),P=0.000 9]。两组患者总体疼痛印象改变值(PGIC)比较差异无统计学意义[RR=0.95,95%CI(0.88,1.03),P=0.23];亚组分析结果显示,试验组中使用75 mg患者的PGIC显著高于使用50 mg者[RR=1.07,95%CI(1.01,1.13),P=0.02],显著低于使用100 mg者[RR=0.86,95%CI(0.77,0.97),P=0.01]。试验组患者恶心、呕吐、便秘、头晕、头痛发生率均显著低于对照组(P<0.05)。结论:Tap IR用于缓解拇囊炎术后中重度急性疼痛的疗效与安全性均较好,且75 mg可能为其最佳用药剂量。
OBJECTIVE:To systematically evaluate the efficacy and safety of Tapentadol immediate-release preparation(Tap IR) for relieving severe acute pain after brachiocephalic arteritis,and to provide evidence-based reference for rational drug use.METHODS:Retrieved from PubMed,Medline,Cochrane library,CNKI,VIP,Wanfang database and American clinical trialdatabase,randomized controlled trials(RCTs) about Tap IR(trial group) versus Oxycodone immediate-release preparation or placebo for relieving severe acute pain after brachiocephalic arteritis were collected. After literature screening,data extraction and literature quality evaluation with modified Jadad scale,Meta-analysis was conducted by using RevMan 5.3 software. RESULTS:A total of 6 RCTs were included,involving 2 378 patients. Results of Meta-analysis showed that 48 h total pain relief value(TOTPAR_(48))of trial group was significantly higher than control group [MD=35.60,95%CI(27.31,43.88),P<0.000 01]. Results of sub-group analysis showed that TOTPAR48 of trial group using Tap IR 50 mg [MD=28.68,95%CI(18.18,39.17),P<0.00 001],75 mg [MD=39.97,95% CI(34.21,45.73),P<0.000 01] and 100 mg[MD=38.50,95% CI(1.46,75.54),P=0.04] were significantly higher than control group;TOTPAR48 of patients who received Tap IR 75 mg were significantly higher than patients who received Tap IR 50 mg [MD=9.04,95% CI(4.31,13.77),P=0.000 2]. There was no statistical significance in the utilization rate of rescue medicine(URM)between 2 groups [RR=1.23,95% CI(0.84,1.80),P=0.29]. Subgroup analysis showed that URM in patients who received Tap IR 75 mg was significantly lower than those receiving Tap IR 50 mg [RR=0.62,95%CI(0.41,0.94),P=0.02]. The total difference of 48 h pain intensity(SPID_(48))in trial group was significantly lower than control group [MD=-18.96,95%CI(-37.28,-0.64),P=0.04]. Subgroup analysis showed that SPID_(48) in patients who received Tap IR 75 mg was significantly higher than those receiving Tap IR 50 mg [MD=21.66,95%CI(8.93,34.39),P=0.000 9]. There was no statistical significance in the total change of pain impression(PGIC) between 2 groups [RR=0.95,95% CI(0.88,1.03),P=0.23]. Subgroup analysis showed that PGIC in patients who received Tap IR 75 mg was significantly higher than those receiving Tap IR 50 mg [RR=1.07,95%CI(1.01,1.13),P=0.02] but significantly lower than those receiving Tap IR 100 mg [RR=0.86,95%CI(0.77,0.97),P=0.01]. The incidence of nausea,vomiting,constipation,dizziness and headache in trial group were significantly lower than control group(P<0.05). CONCLUSIONS:Tap IR shows good therapeutic efficacy and safety for severe acute pain after brachiocephalic arteritis,and the efficacy of Tap IR might be better when the dose of Tap IR is 75 mg.
OBJECTIVE:To systematically evaluate the efficacy and safety of Tapentadol immediate-release preparation(Tap IR) for relieving severe acute pain after brachiocephalic arteritis,and to provide evidence-based reference for rational drug use.METHODS:Retrieved from PubMed,Medline,Cochrane library,CNKI,VIP,Wanfang database and American clinical trialdatabase,randomized controlled trials(RCTs) about Tap IR(trial group) versus Oxycodone immediate-release preparation or placebo for relieving severe acute pain after brachiocephalic arteritis were collected. After literature screening,data extraction and literature quality evaluation with modified Jadad scale,Meta-analysis was conducted by using RevMan 5.3 software. RESULTS:A total of 6 RCTs were included,involving 2 378 patients. Results of Meta-analysis showed that 48 h total pain relief value(TOTPAR_(48))of trial group was significantly higher than control group [MD=35.60,95%CI(27.31,43.88),P<0.000 01]. Results of sub-group analysis showed that TOTPAR48 of trial group using Tap IR 50 mg [MD=28.68,95%CI(18.18,39.17),P<0.00 001],75 mg [MD=39.97,95% CI(34.21,45.73),P<0.000 01] and 100 mg[MD=38.50,95% CI(1.46,75.54),P=0.04] were significantly higher than control group;TOTPAR48 of patients who received Tap IR 75 mg were significantly higher than patients who received Tap IR 50 mg [MD=9.04,95% CI(4.31,13.77),P=0.000 2]. There was no statistical significance in the utilization rate of rescue medicine(URM)between 2 groups [RR=1.23,95% CI(0.84,1.80),P=0.29]. Subgroup analysis showed that URM in patients who received Tap IR 75 mg was significantly lower than those receiving Tap IR 50 mg [RR=0.62,95%CI(0.41,0.94),P=0.02]. The total difference of 48 h pain intensity(SPID_(48))in trial group was significantly lower than control group [MD=-18.96,95%CI(-37.28,-0.64),P=0.04]. Subgroup analysis showed that SPID_(48) in patients who received Tap IR 75 mg was significantly higher than those receiving Tap IR 50 mg [MD=21.66,95%CI(8.93,34.39),P=0.000 9]. There was no statistical significance in the total change of pain impression(PGIC) between 2 groups [RR=0.95,95% CI(0.88,1.03),P=0.23]. Subgroup analysis showed that PGIC in patients who received Tap IR 75 mg was significantly higher than those receiving Tap IR 50 mg [RR=1.07,95%CI(1.01,1.13),P=0.02] but significantly lower than those receiving Tap IR 100 mg [RR=0.86,95%CI(0.77,0.97),P=0.01]. The incidence of nausea,vomiting,constipation,dizziness and headache in trial group were significantly lower than control group(P<0.05). CONCLUSIONS:Tap IR shows good therapeutic efficacy and safety for severe acute pain after brachiocephalic arteritis,and the efficacy of Tap IR might be better when the dose of Tap IR is 75 mg.
引文
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[8]DANIELS S,CASSON E,STEGMANN JU,et al.A randomized,double-blind,placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IRand oxycodone IR for acute pain[J].Curr Med Res Opin,2009,25(6):1551-1561.
[9]STEGMANN JU,WEBER H,STEUP A,et al.The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic(bunionectomy)surgery[J].Curr Med Res Opin,2008,24(11):3185-3196.
[10]JADAD AR,MOOR RA,CARROLL D,et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary?[J].Control Clin Trials,1996,17(1):1-12.
[11]DANIELS SE,UPMALIS D,OKAMOTO A,et al.A randomized,double-blind,phaseⅢstudy comparing multiple doses of tapentadol IR,oxycodone IR,and placebo for postoperative(bunionectomy)pain[J].Curr Med Res Opin,2009,25(3):765-776.
[12]LEE YK,KO JS,RHIM HY,et al.Acute postoperative pain relief with immediate-release tapentadol:randomized,double-blind,placebo-controlled study conducted in South Korea[J].Curr Med Res Opin,2014,30(12):2561-2570.
[13]Johnson&Johnson Pharmaceutical Research&Development,L.L.C.A trial to evaluate CG5503 efficacy and safety in acute pain after bunionectomy[EB/OL].(2011-10-03)[2018-03-13].https://www.clinicaltrials.gov/ct2/show/NCT00609466.
[14]Janssen-Cilag International NV.A study to evaluate the effectiveness and safety of tapentadol(CG5503)in the treatment of acute pain from bunionectomy compared with placebo[EB/OL].(2015-01-09)[2018-03-13].https://www.clinicaltrials.gov/ct2/show/NCT01813890.
[15]VORSANGER G,XIANG J,BIONDI D,et al.Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients[J].Pain Res Manag,2011,16(4):245-251.
[2]KEHLET H,JENSEN TS,WOOLF CJ.Persistent postsurgical pain:risk factors and prevention[J].Lancet,2006,367(9522):1618-1625.
[3]CARR DB,GOUDAS LC.Acute pain[J].Lancet,1999,353(9169):2051-2058.
[4]American Society of Anesthesiologists Task Force on Acute Pain Management.Practice guidelines for acute pain management in the perioperative setting:an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management[J].Anesthesiology,2012,116(2):248-273.
[5]WHEELER M,ODERDA GM,ASHBURN MA,et al.Adverse events associated with postoperative opioid analgesia:a systematic review[J].J Pain,2002,3(3):159-180.
[6]SCHUG SA,ZECH D,GROND S.Adverse effects of systemic opioid analgesics[J].Drug Saf,1992,7(3):200-213.
[7]TZSCHENTKE TM,CHRISTOPH T,KOGEL B,et al.(-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride(tapentadol HCl):a novel mu-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties[J].J Pharmacol Exp Ther,2007,323(1):265-276.
[8]DANIELS S,CASSON E,STEGMANN JU,et al.A randomized,double-blind,placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IRand oxycodone IR for acute pain[J].Curr Med Res Opin,2009,25(6):1551-1561.
[9]STEGMANN JU,WEBER H,STEUP A,et al.The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic(bunionectomy)surgery[J].Curr Med Res Opin,2008,24(11):3185-3196.
[10]JADAD AR,MOOR RA,CARROLL D,et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary?[J].Control Clin Trials,1996,17(1):1-12.
[11]DANIELS SE,UPMALIS D,OKAMOTO A,et al.A randomized,double-blind,phaseⅢstudy comparing multiple doses of tapentadol IR,oxycodone IR,and placebo for postoperative(bunionectomy)pain[J].Curr Med Res Opin,2009,25(3):765-776.
[12]LEE YK,KO JS,RHIM HY,et al.Acute postoperative pain relief with immediate-release tapentadol:randomized,double-blind,placebo-controlled study conducted in South Korea[J].Curr Med Res Opin,2014,30(12):2561-2570.
[13]Johnson&Johnson Pharmaceutical Research&Development,L.L.C.A trial to evaluate CG5503 efficacy and safety in acute pain after bunionectomy[EB/OL].(2011-10-03)[2018-03-13].https://www.clinicaltrials.gov/ct2/show/NCT00609466.
[14]Janssen-Cilag International NV.A study to evaluate the effectiveness and safety of tapentadol(CG5503)in the treatment of acute pain from bunionectomy compared with placebo[EB/OL].(2015-01-09)[2018-03-13].https://www.clinicaltrials.gov/ct2/show/NCT01813890.
[15]VORSANGER G,XIANG J,BIONDI D,et al.Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients[J].Pain Res Manag,2011,16(4):245-251.