Barber F A, Gladu D E
Plano Orthopedic and Sports Medicine Center, Texas 75093, USA.
Arthroscopy. 1998 Sep;14(6):605-12. doi: 10.1016/s0749-8063(98)70057-x.
The analgesic effectiveness of ketorolac tromethamine was compared with hydrocodone and acetaminophen for pain from an arthroscopically assisted patellar-tendon autograft anterior cruciate ligament reconstruction. There were 125 patients evaluated in a double-blind, randomized, multicenter, and multidose study. A loading dose of parental ketorolac tromethamine was administered and subjects were later given two staged doses of the same "unknown" drug with pain evaluations conducted after each dose. For group 1, dose 1 consisted of ketorolac tromethamine 20 mg orally and dose 2 was ketorolac tromethamine 10 mg. For group 2, both dose 1 and dose 2 consisted of hydrocodone 10 mg plus acetaminophen 1,000 mg orally. Efficacy was evaluated by standard analgesic measures. Subjects treated as outpatients showed lower categorical pain intensity for ketorolac tromethamine than hydrocodone and acetaminophen at 1 hour (P=.03), 2 hours (P=.006), and 3 hours (P=.02); lower summed intensity differences for ketorolac tromethamine than hydrocodone and acetaminophen at 3 hours (P=.014) and 4 hours (P=.019); and better total pain relief for ketorolac tromethamine than hydrocodone and acetaminophen at 3 hours (P=.014) and 4 hours (P=.013). With an effective loading dose administered before the subsequent oral dosage, there was statistically better pain reduction with ketorolac tromethamine than with hydrocodone and acetaminophen. Moreover, ketorolac tromethamine was no more likely to cause digestive complaints than hydrocodone and acetaminophen. No bleeding problems were observed in either group. In the outpatient setting, ketorolac tromethamine controls postoperative pain better than hydrocodone and acetaminophen in the immediate postsurgery period.
将酮咯酸氨丁三醇的镇痛效果与氢可酮和对乙酰氨基酚用于关节镜辅助下髌腱自体移植前交叉韧带重建术后疼痛的效果进行了比较。在一项双盲、随机、多中心、多剂量研究中对125例患者进行了评估。给予一剂静脉注射酮咯酸氨丁三醇负荷剂量，随后受试者接受两剂相同的“未知”药物分阶段给药，每次给药后进行疼痛评估。对于第1组，第1剂为口服20 mg酮咯酸氨丁三醇，第2剂为10 mg酮咯酸氨丁三醇。对于第2组，第1剂和第2剂均为口服10 mg氢可酮加1000 mg对乙酰氨基酚。通过标准镇痛措施评估疗效。门诊治疗的受试者在1小时（P = 0.03）、2小时（P = 0.006）和3小时（P = 0.02）时，酮咯酸氨丁三醇组的分类疼痛强度低于氢可酮和对乙酰氨基酚组；在3小时（P = 0.014）和4小时（P = 0.019）时，酮咯酸氨丁三醇组的累计强度差异低于氢可酮和对乙酰氨基酚组；在3小时（P = 0.014）和4小时（P = 0.013）时，酮咯酸氨丁三醇组的总疼痛缓解情况优于氢可酮和对乙酰氨基酚组。在后续口服给药前给予有效负荷剂量后，酮咯酸氨丁三醇的疼痛减轻效果在统计学上优于氢可酮和对乙酰氨基酚。此外，酮咯酸氨丁三醇引起消化不适的可能性并不比氢可酮和对乙酰氨基酚更高。两组均未观察到出血问题。在门诊环境中，在术后即刻，酮咯酸氨丁三醇比氢可酮和对乙酰氨基酚能更好地控制术后疼痛。
