目的:系统评价盐酸羟考酮缓控释片治疗中重度癌痛的有效性和安全性。方法:计算机检索PubMed、Web of Sci-ence、Embase、Cochrane Library、CBM、中国知网、VIP、万方等数据库，检索时限为建库至2023年3月25日。纳入盐酸羟考酮缓控释片(试验组)对比同类药物(对照组)用于治疗中重度癌痛的随机对照试验。采用Cochrane偏倚风险评价手册对纳入的文献进行质量评价，运用RevMan 5。3和Stata 17。0软件进行Meta分析。结果:共纳入70项RCT，共计6 449例患者。70篇文献按照对照组所用药物的不同，分组进行Meta分析。Meta分析结果显示，试验组患者的疼痛有效缓解率均显著高于对照组，盐酸曲马多缓释片[RR=1。12，95％CI(1。08，1。17)，P＜0。01]、硫酸吗啡缓控释片[RR=1。16，95％CI(1。12，1。20)，P＜0。01]、美沙酮片[RR=1。13，95％CI(1。03，1。25)，P=0。01]、氨酚羟考酮片[RR=1。09，95％CI(1。01，1。19)，P=0。03]。在药物安全性方面，试验组患者的便秘、恶心、呕吐、头晕等不良反应发生率低于对照组硫酸吗啡缓控释片(P＜0。05)，部分不良反应发生率(头晕、恶心及呼吸抑制)低于对照组氨酚羟考酮片(P＜0。05)，而与对照组盐酸曲马多缓释片和美沙酮片相比，不良反应发生率差异无统计学意义(P＞0。05)。结论:盐酸羟考酮缓控释片镇痛效果相比同类药物盐酸曲马多缓释片、硫酸吗啡缓控释片、美沙酮片、氨酚羟考酮片具有明显优势，且不增加药物不良反应，安全性良好。
Systematic evaluation of the safety and effectiveness of oxycodone hydrochloride slow controlled release tablets for moderate-severe cancer pain
OBJECTIVE Systematic evaluation of the efficacy and safety of oxycodone hydrochloride extended release tablets for moderate-to-severe cancer pain.METHODS Computerized searches of the databases of PubMed,Web of Science,Embase,Cochrane Library,Chinese BioMedicine(CBM),CNKI,VIP and Wanfang were performed with a time limit of March 25,2023 from inceptions.Randomized controlled trials(RCTs)comparing oxycodone hydrochloride extended release tablets(test group)with similar drugs(control group)for moderate-to-severe cancer pain were included.Cochrane Handbook for the Evaluation of Risk of Bias was utilized for evaluating the quality of the included literature and Meta-analysis performed with RevMan 5.3 and Stata 17.0 software.RESULTS A total of 70 RCTs were retrieved with 6449 patients.Meta-analysis was performed according to the drugs used in control group.Meta-analysis revealed that effective pain relief rate of trial group was significantly higher than that of control group:tramadol hydrochloride extended-release tablets[RR=1.12,95％CI(1.08,1.17),P＜0.01],morphine sulfate extended-release tablets[RR=1.16,95％CI(1.12,1.20),P＜0.01],methadone tablets[RR=1.13,95％CI(1.03,1.25),P=0.01]and aminophenol oxycodone tablets.[RR=1.09,95％CI(1.01,1.19),P=0.03].In terms of drug safety,the incidence of constipation,nausea,vomiting and dizziness was lower in test group than that of morphine sulfate extended-release tablets in control group(P＜0.05);the incidence of some adverse reactions(dizziness,nausea & respiratory depression)was lower than that of aminophenol oxycodone tablets in control group(P＜0.05).Yet the difference in the incidence of adverse reac-tions as compared with tramadol hydrochloride extended-release tablets and methadone tablets in control group had no statistical significance(P＞0.05).CONCLUSION Oxycodone hydrochloride extended-release tablets offers obvious advantages over simi-lar drugs tramadol hydrochloride extended-release tablets,morphine sulfate extended-release tablets,methadone tablets and amino phenol oxycodone tablets in terms of analgesia.Without a higher incidence of adverse reactions,it has a decent safety profile.
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