Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia.
Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia.
复制标题
DOI：
10.2147/jpr.s30861
复制
发表时间：
2012-01-01
影响因子：
2.7
通讯作者：
Candiotti, Keith A
中科院分区：
文献类型：
--
作者：
Bergese, Sergio D;Ramamoorthy, Sonia;Candiotti, Keith A
背景：布比卡因脂质体是局麻药布比卡因的一种新型制剂，旨在提供长时间的术后镇痛。该分析检查了 10 项随机、双盲脂质体布比卡因临床研究中反映的累积疼痛评分所反映的汇总疗效数据，其中研究药物通过局部伤口浸润给药。 方法：在 10 项局部伤口浸润研究中，共有 823 名患者暴露于脂质体布比卡因，在 5 项手术中剂量范围为 66 mg 至 532 mg 设置; 446 名患者接受盐酸布比卡因（剂量：75-200 mg），190 名患者接受安慰剂。手术后 72 小时内对疗效指标进行评估。结果：总体而言，45% 的患者为男性，19% 的患者年龄≥65 岁。在对 72 小时累积疼痛强度评分的分析中，在评估的 19 个治疗组中，脂质体布比卡因的疼痛评分低于对照组，在 17 个治疗组中的 5 个治疗组中，与盐酸布比卡因相比，具有统计学显着差异（P < 0.05）。这些结果得到了其他疗效指标结果的支持，包括首次使用阿片类药物救援药物的时间、避免阿片类药物救援药物的患者比例、术后阿片类药物救援药物的总消耗量以及患者/护理人员对术后镇痛的满意度。脂质体布比卡因的局部浸润导致布比卡因的全身血浆水平显着升高，这种水平可以持续96小时；给予脂质体布比卡因后，布比卡因的全身血浆水平与局部疗效不相关。脂质体布比卡因和盐酸布比卡因通常具有良好的耐受性。结论：基于对多种疗效指标的综合分析，脂质体布比卡因似乎是长期减少软组织和骨科手术后疼痛的潜在有用的治疗选择。
BACKGROUND: Liposome bupivacaine is a novel formulation of the local anesthetic bupivacaine, designed to provide prolonged postsurgical analgesia. This analysis examined pooled efficacy data as reflected in cumulative pain scores from 10 randomized, double-blind liposome bupivacaine clinical studies in which the study drug was administered via local wound infiltration.METHODS: A total of 823 patients were exposed to liposome bupivacaine in 10 local wound infiltration studies at doses ranging from 66 mg to 532 mg in five surgical settings; 446 patients received bupivacaine HCl (dose: 75-200 mg) and 190 received placebo. Efficacy measures were assessed through 72 hours after surgery.RESULTS: Overall, 45% of patients were male and 19% were ≥65 years of age. In the analysis of cumulative pain intensity scores through 72 hours, liposome bupivacaine was associated with lower pain scores than the comparator in 16 of 19 treatment arms assessed, achieving statistically significant differences compared with bupivacaine HCl (P < 0.05) in five of 17 treatment arms. These results were supported by results of other efficacy measures, including time to first use of opioid rescue medication, proportion of patients avoiding opioid rescue medication, total postsurgical consumption of opioid rescue medication, and patient/care provider satisfaction with postoperative analgesia. Local infiltration of liposome bupivacaine resulted in significant systemic plasma levels of bupivacaine, which could persist for 96 hours; systemic plasma levels of bupivacaine following administration of liposome bupivacaine were not correlated with local efficacy. Liposome bupivacaine and bupivacaine HCl were generally well tolerated.CONCLUSION: Based on this integrated analysis of multiple efficacy measures, liposome bupivacaine appears to be a potentially useful therapeutic option for prolonged reduction of postsurgical pain in soft tissue and orthopedic surgeries.