帕瑞昔布钠注射液用于胆囊切除患者术后镇痛的临床研究

Clinical trial of parecoxib sodium injection in the treatment of postoperative analgesia in patients with cholecystectomy

目的观察帕瑞昔布钠注射液用于胆囊切除患者术后镇痛的临床疗效及安全性。方法将310例胆囊切除术患者随机分为对照组和试验组,每组155例。对照组于缝皮前5 min予以0.5%布比卡因10 m L,局部注射;试验组于缝皮前5 min予以帕瑞昔布钠40 mg,静脉推注。比较2组患者的视觉模拟评分(VAS)、P物质(SP)和5-羟色胺(5-HT),以及药物不良反应的发生情况。结果术后,试验组和对照组的VAS分别为(3.84±0.53)和(4.61±0.61)分,SP分别为(165.83±23.58)和(207.72±27.56)μg·L^(-1),5-HT分别为(679.25±92.58)和(763.98±99.10)μg·L^(-1),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应主要有皮肤瘙痒、恶心呕吐、上腹部不适和嗜睡。试验组和对照组的总药物不良反应发生率分别为14.84%和27.74%,差异有统计学意义(P<0.05)。结论帕瑞昔布钠注射液用于胆囊切除患者术后镇痛的临床疗效确切,其能显著降低患者的SP和5-HT水平,且安全性较好。

Objective To observe the clinical efficacy and safety of parecoxib sodium injection in the treatment of postoperative analgesia in patients with cholecystectomy. Methods A total of 310 patients with cholecystectomy were randomly divided into control and treatment groups with 155 cases per group. Control group was given 0. 5% bupivacaine 10 m L,local injection,5 min before surgical suture. Treatment group was given parecoxib sodium 40 mg,intravenous push,5 min before surgical suture. The visual analogue scale（ VAS） scores,substance P（ SP）,5-hydroxytryptamine（ 5-HT） and adverse drug reactions were compared between two groups. Results After surgery,the main indexes in treatment and control groups were compared： VAS scores were（ 3. 84 ± 0. 53） and（ 4. 61 ± 0. 61）,SP were（ 165. 83 ± 23. 58） and（ 207. 72 ± 27. 56） μg · L^（-1）,5-HT were（ 679. 25 ± 92. 58） and（ 763. 98 ± 99. 10） μg·L^（-1）,the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions of two groups were skin pruritus,nausea, vomiting,upper abdominal discomfort and lethargy. The total incidences of adverse drug reactions in treatment and control groups were 14. 84% and 27. 74% with significant difference（ P〈0. 05）.Conclusion Parecoxib sodium injection has a definitive clinical efficacy and safety in the treatment of postoperative analgesia in patients with cholecystectomy,which can significantly reduce the levels of SP and 5-HT.