Premier Research Group, Ltd, Austin, TX 78666, USA.
Curr Med Res Opin. 2010 Oct;26(10):2375-84. doi: 10.1185/03007995.2010.515478.
Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is a rapidly absorbed formulation of diclofenac approved for the treatment of mild to moderate acute pain in adults (≥18 years of age). The objective of this study was to investigate the efficacy and safety of DPSGC 25 mg in a multicenter, randomized, double-blind, placebo-controlled study in patients experiencing pain following first metatarsal bunionectomy.
Patients experiencing a requisite level of pain (≥4 based on an 11-point numeric pain rating scale [NPRS]; 0 = no pain, 10 = worst pain possible) on the day following surgery were randomized to receive DPSGC 25 mg or placebo. Patients received a second dose (remedication) on request or at 8 hours postdose followed by additional doses every 6 hours through the end of postsurgery Day 4. Rescue medication (hydrocodone/acetaminophen) was available as needed after the second dose.
NCT00375934.
The primary efficacy endpoint was the average NPRS score over the 48 hour inpatient multiple-dose period.
DPSGC provided a significant improvement in mean 48 hour NPRS scores over placebo (3.29 vs 5.74, respectively; p < 0.0001), as well as for summed pain intensity difference (203.1 vs 86.6; p < 0.0001). Patients treated with DPSGC experienced a faster onset of meaningful pain relief compared with placebo (p = 0.0034). Rescue medication use on Day 1 and Day 2 was reduced in the DPSGC group compared with placebo (53.5% vs 92.1% on Day 1; 30.3% vs 67.3% on Day 2; p < 0.0001). DPSGC was well tolerated and no patients treated with DPSGC reported serious adverse events. As with any study, there are potential limitations including study design and patient population.
These results indicate that DPSGC reduced pain in patients who underwent bunionectomy and this novel formulation of diclofenac potassium may be a practical option for treating mild to moderate acute pain.
双氯芬酸钾充液软胶囊（DPSGC）是一种双氯芬酸的快速吸收制剂，适用于治疗成人（≥18 岁）轻度至中度急性疼痛。本研究的目的是在一项多中心、随机、双盲、安慰剂对照研究中，评估 DPSGC 25mg 治疗第一跖骨拇囊炎切除术后疼痛患者的疗效和安全性。
术后第一天疼痛程度达到一定水平（根据 11 点数字疼痛评分量表[NPRS]≥4；0=无痛，10=最痛）的患者被随机分为 DPSGC 25mg 或安慰剂组。患者按需或在给药后 8 小时接受第二次剂量（补救治疗），随后每 6 小时给予额外剂量，直至术后第 4 天结束。第二次剂量后，必要时可使用解救药物（氢可酮/对乙酰氨基酚）。
NCT00375934。
48 小时住院多次给药期间的平均 NPRS 评分。
与安慰剂相比，DPSGC 显著改善了平均 48 小时 NPRS 评分（分别为 3.29 和 5.74；p<0.0001）和疼痛强度总和差异（203.1 和 86.6；p<0.0001）。与安慰剂相比，接受 DPSGC 治疗的患者更快地获得有意义的疼痛缓解（p=0.0034）。与安慰剂组相比，DPSGC 组第 1 天和第 2 天的解救药物使用率降低（第 1 天分别为 53.5%和 92.1%；第 2 天分别为 30.3%和 67.3%；p<0.0001）。DPSGC 具有良好的耐受性，没有接受 DPSGC 治疗的患者报告严重不良事件。与任何研究一样，本研究存在潜在局限性，包括研究设计和患者人群。
这些结果表明，DPSGC 减轻了拇囊炎切除术患者的疼痛，这种新型双氯芬酸钾制剂可能是治疗轻度至中度急性疼痛的实用选择。
