Objective To assess the efficacy and safety of different dosages of oxycodone plus acetaminophen for treating acute pain after oral surgery,in order to provide a reasonable dosage of combination in clinic. Methods Randomized controlled trials ( RCTs ) on effect of combination of oxycodone plus acetaminophen on pain relief after oral operation were searched from the following data-bases:PubMed,EMbase,MEDLINE ( Ovid) ,the Cochrane Library,CNKI,and WANFANG from the date of their establishment to January 2015. The data of RCTs meeting the inclusive criteria were extracted according to Cochrane methods by two reviewers independently,and after the quality was evaluated and cross-checked,meta-analyses were conducted using RevMan 5.2 software. Results A total of 11 studies in 10 literatures involving 1 028 patients were included and were designated to 3 different dosage groups (5 mg/325 mg,10 mg/650 mg,10 mg/1 000 mg,respectively). The results of Meta-analyses showed that pain remission rate was significantly higher in the 3 different dosages of oxycodone plus acetaminophen groups than in the placebo group (RR5 mg/325 mg=3.35,95%CI [1.74,6.45],I2=38%,P=0.000 3;RR10 mg/650 mg=6.88,95%CI [4.00,11.83],I2=0%,P<0.000 01;RR10 mg/1 000 mg=4.94,95%CI [3.23,7.56],I2=81%,P=0.005). In additional,the RR of oxycodone 10 mg/acetaminophen 650 mg and placebo groups for pain remission rate was higher than that of the other 2 dosages groups,moreover,more studies were enrolled and its low heterogeneity led to high reliability. Usage rate of remedial painkillers was significally lower in oxycodone plus acetaminophen groups than in the placebo group (RR5mg/325mg=0.71,95%CI [0.60, 0.85],P<0.000 01;RR10mg/650mg=0.50,95%CI [0.41,0.61],P<0.000 01;RR10mg/1000mg=0.77,95%CI [0.66,0.90],P=0.001) ,In addition, the RRs of usage rate in oxycodone 10 mg/acetaminophen 650 mg and placebo groups were significantly lower than the other 2 dosages groups. Incidence rates of adverse effects were similar in the 3 different dosages groups and higher than that of the placebo group. However,the adverse events were generally described as mild to moderate in severity and rarely led to drug withdrawal according to all reports in the studies ( only one event ) . Conclusion The present study showed that combination of oxycodone plus acetaminophen can provide better analgesia in acute pain after oral surgery with high safety. In addition,combination of oxycodone 10 mg plus paracetamol 650 mg may be better for acute pain relief after oral surgery.%目的：系统评价不同剂量羟考酮/对乙酰氨基酚组合药物缓解口腔手术后急性疼痛的有效性和安全性，以期为临床提供合理的药物剂量组合。方法计算机检索PubMed、EMbase、MEDLINE( Ovid)、Cochrane图书馆、中国知网( CNKI)、万方数据库等电子数据库，查找羟考酮/对乙酰氨基酚组合药物对口腔手术后疼痛治疗的随机对照试验( RCT)，检索时间均从建库至2015年1月。对符合纳入标准的 RCT，由两位评价员按 Cochrane 系统评价的方法，独立进行资料提取、质量评价并交叉核对后，采用 RevMan 5.2版软件进行 Meta 分析。结果系统评价共纳入10篇文献的11项研究，合计患者1028例，羟考酮/对乙酰氨基酚分为3种剂量(5 mg/325 mg、10 mg/650 mg、10 mg/1000 mg)进行系统评价。结果显示：有效性方面，以上3种剂量组合的羟考酮/对乙酰氨基酚口腔手术后急性疼痛缓解率均明显优于安慰药组(RR5 mg/325 mg＝3.35，95％CI[1.74，6.45]，I2＝38％，P＝0.0003；RR10 mg/650 mg＝6.88，95％CI[4.00，11.83]，I2＝0％，P<0.00001；RR10 mg/1000 mg＝4.94，95％CI[3.23，7.56]，I2＝81％，P＝0.005)，其中羟考酮/对乙酰氨基酚(10 mg/650 mg)剂量组与安慰药组疼痛缓解率的RR值较其他2种剂量组合更高，且其纳入研究例数较多，研究的异质性低，可靠性高；另外羟考酮/对乙酰氨基酚组补救止痛药物使用率明显低于安慰药组(RR5mg/325mg＝0.71，95％CI[0.60，0.85]，P<0.00001；RR10 mg/650 mg＝0.50，95％CI[0.41，0.61]，P<0.00001；RR10 mg/1000 mg＝0.77，95％CI[0.66，0.90]，I2＝81％，P＝0.001)，其中羟考酮/对乙酰氨基酚(10 mg /650 mg)剂量组与安慰药组补救止痛药使用率的RR值较其他2种剂量组合更低。安全性方面：3种剂量组合羟考酮/对乙酰氨基酚发生率相似且均高于安慰药组，但不良反应程度一般为轻中度，且极少例数(仅1例)因不良反应而停药。结论羟考酮/对乙酰氨基酚组合药物在缓解口腔手术后急性疼痛效果良好，安全性较高。羟考酮/对乙酰氨基酚(10 mg/650 mg)的剂量组合可能更适合用于口腔手术后急性疼痛缓解。
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