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目的:考察APA-BCCS对中重度癌症疼痛的疗效,评价其临床应用的安全性及实用性。方法:采用多中心自身对照方法,80例(中度32,重度48)首先接受镇痛西药治疗,然后接受APA-BCCS蛛网膜下腔注射加/减镇痛西药。结果:西药镇痛CR、PR、MR、RR和ORR率分别为2.5%、22.5%、35.0%、25.0%和60.0%;注射后第14天,CR20.0%、PR 65.0%、MR 12.5%、RR 85.0%和ORR97.5%,差异有统计学意义。中、重度疼痛起效时间分别为0.5~4.5及0.5~5.0 d、中位1.5及2.5 d,缓解持续9.0~130及2.5~130 d、中位分别为66、52 d。注射APA-BCCS后,45.0%患者可停用镇痛药,50.0%患者仅需使用半量或降一级的镇痛药,即95.0%患者可从APA-BCCS治疗中获益。APA-BCCS对生命体征、血常规、肝肾功能和心电图等无明显影响,未出现严重不良反应事件,未发现依赖、成瘾和滥用之潜在可能性。80.0%被调查者认同APA-BCCS镇痛效果及其可操作性。结论:APA-BCCS具有长效、高效和相对安全等特点,由于该技术是一种新的镇痛方法,还有待于上市后进一步观察。
Objective: To investigate the curative effect of APA-BCCS on moderate-severe cancer pain and to evaluate its safety and practicability in clinical application. Methods: A multicenter self-control study was conducted in 80 patients (moderate 32, severe 48) receiving first-aid western medicine and then APA-BCCS subarachnoid plus western medicine. Results: The CR, PR, MR, RR and ORR rates of analgesia were 2.5%, 22.5%, 35.0%, 25.0% and 60.0% respectively. On the 14th day after injection, CR20.0%, PR 65.0%, MR 12.5% , RR 85.0% and ORR 97.5%, the difference was statistically significant. The onset time of moderate and severe pain ranged from 0.5 to 4.5 and from 0.5 to 5.0 d respectively, with a median duration of 1.5 and 2.5 days. The duration of moderate and severe pain lasting from 9.0 to 130 and from 2.5 to 130 days was 66 and 52 days, respectively. After the injection of APA-BCCS, 45.0% of the patients can stop the analgesics, 50.0% of the patients only need to use half or one dose of analgesics, that is, 95.0% patients can benefit from the treatment of APA-BCCS. APA-BCCS had no significant effect on vital signs, blood tests, liver and renal function, electrocardiogram, etc. There were no serious adverse reactions and no potential dependence, addiction and abuse were found. 80.0% of respondents agree with APA-BCCS analgesic effect and its maneuverability. Conclusion: APA-BCCS is long-lasting, effective and relatively safe. Due to the new analgesic method, APA-BCCS remains to be further observed after its launch.