羟考酮缓释片和吗啡即释片在中重度癌痛滴定中疗效及安全性比较的Meta分析

目的 评价羟考酮缓释片与吗啡即释片在中重度癌痛患者滴定中的疗效及安全性。方法计算机检索中国知识基础设施工程（CNKI）、中文科技期刊全文数据库（VIP）、万方数字化期刊全文库（Wanfang），以及结合手工检索。纳入羟考酮缓释片与吗啡即释片用于中重度癌痛滴定的前瞻性随机对照试验（RCT），对纳入研究进行方法学偏倚风险评价，并对纳入研究的数据进行Meta分析。结果 根据纳入标准，共纳入12项 RCT，合计1131例患者。Meta分析结果显示：（1）1 h疼痛缓解率方面，羟考酮缓释片组显著优于吗啡即释片组，差异有统计学意义（RR=3.16， 95％CI：1.64～6.08， P=0.0006）；（2）4 h内疼痛缓解率方面，羟考酮缓释片组显著优于吗啡即释片组，差异有统计学意义（RR=2.44， 95％CI：1.49～3.97，P=0.0004）；（3）24 h疼痛缓解率方面，羟考酮缓释片组显著优于吗啡即释片组，差异有统计学意义（RR=1.13， 95％CI：1.04～1.24， P=0.005）；（4）滴定周期方面，羟考酮缓释片组较吗啡即释片组显著缩短，差异有统计学意义（MD=-0.77， 95％CI：-1.14～-0.40）， P＜0.0001）；（5）镇痛起效时间方面，羟考酮缓释片组较吗啡即释片组显著缩短，差异有统计学意义（MD=-29.63，95％CI：-45.54～-13.73，P=0.0003）；（6）便秘方面，羟考酮缓释片组显著低于吗啡即释片组，差异有统计学意义（RR=0.69，95％CI：0.52～0.92，P=0.01）；恶心呕吐方面，羟考酮缓释片组显著低于吗啡即释片组，差异有统计学意义（RR=0.57，95％CI：0.45～0.73， P＜0.00 001）；在其他不良反应方面比较未见差异有统计学意义（P＞0.05）。结论 羟考酮缓释片组在1 h、4 h内、24 h的疼痛缓解率及滴定周期和镇痛起效时间方面均显著优于吗啡即释片组，羟考酮缓释片可以更快速地完成剂量滴定，且便秘和恶心呕吐的发生率显著低于吗啡即释片，是中重度癌痛滴定的更好选择。

Meta-analysis of efficacy and safety of oxycodone hydrochloride sustained-release tablets and immediate-re-lease morphine tablets in the titration therapy on moderate to severe cancer pain

Objective To evaluate the efficacy and safety of oxycodone hydrochloride sustained-release tablets and immediate-release morphine tablets in the titration of patients with moderate or severe cancer pain. Methods China national knowledge infrastruc-ture(CNKI) full-text database, Chinese science and technology journal full-text database (VIP) and digital journal full-text database of Wanfang were searched. Oxycodone hydrochloride sustained-release tablets and immediate-release morphine tablets were included into the prospective randomized controlled trial ( RCT) of moderate to severe cancer pain titration. Methodological assessment of bias risk of the included studies has been performed. The meta analysis of the included studies has been carried out. Results According to the inclusion criteria, 12 RCTs involving 1131 patients were included and subgroup analysis were performed. Meta-analysis results showed that:(1) As for the 1 h pain relief rate, oxycodone hydrochloride sustained-release tablets was significantly better than immediate-release morphine tablets(RR=3. 16, 95%CI:1. 64-6. 08, P=0. 0006);(2) As for the 4 h pain relief rate, oxycodone hydrochloride sustained-release tab-lets was significantly better than immediate-release morphine tablets(RR=2. 44, 95%CI:1. 49-3. 97, P=0. 0004);(3) As for the 24 h pain relief rate, oxycodone hydrochloride sustained-release tablets was significantly better than immediate-release morphine tablets( RR=1. 13, 95%CI:1. 04-1. 24, P = 0. 005 ); ( 4 ) As for the titration cycles, oxycodone hydrochloride sustained-release tablets was significantly shorter than immediate-release morphine tablets ( MD=-0. 77, 95%CI:-1. 14--0. 40, P<0. 0001);( 5) As for the time to onset, oxycodone hydrochloride sustained-release tablets was significantly faster than immediate-release morphine tablets ( MD=-29. 63, 95%CI:-45. 54--13. 73, P=0. 0003);(6) In terms of adverse reactions, the incidence of constipation(RR=0. 69, 95%CI:0. 52-0. 92, P=0. 01), nausea and vomiting(RR=0. 57, 95%CI: 0. 45-0. 73, P<0. 000 01) of oxycodone hydrochloride sustained-release tablets were significantly lower than immediate-release morphine tablets;There was no significant difference in the comparison of other adverse reactions( P>0. 05) . Conclusion Oxycodone hydrochloride sustained-release tablets has significantly higher 1 h, 4 h and 24 h pain relief rates than immediate-release morphine tablets so that the titration can be completed faster. And it also has significantly shorter titration cy-cles and the time to onset. Oxycodone sustained-release tablets performs better than immediate-release morphine tablets in the treatment of moderate and severe cancer pain, and leads to less incidences of constipation, nausea and vomiting. Consequently, it will be a better medication choice for moderate or severe cancer pain titration.