ABSTRACT
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 trial database， 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 （TOTPAR48） 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 （SPID48） 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 SPID48 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.