国产局部麻醉镇痛系统与进口静脉输注装置的镇痛效果和安全性比较

目的比较国产局部麻醉镇痛系统与进口静脉输注装置的镇痛效果和安全性。方法研究设计为两中心前瞻性随机对照试验。研究对象为2008年1至9月在北京大学第三医院和北京大学第一医院普通外科实施腹腔内或腹壁手术的患者。将患者按照随机区组法分为试验组与对照组,每组80例。试验组使用国产局部麻醉镇痛系统经伤17局部输注利多卡因,对照组使用进口静脉输注装置输注吗啡。观察2组术后24及48h视觉模拟评分（VAS）、患者对镇痛系统或装置的满意程度、是否使用镇痛药、使用镇痛系统或装置时是否出现不适感、是否影响活动、是否出现炎性反应或液体渗漏以及不良反应或不良事件的发生情况。结果试验组男47例,女33例,平均年龄（50．34-14．6）岁;对照组男48例,女32例,平均年龄（49．54-12．7）岁。2组受试者年龄、性别、身高、体重、手术类型及镇痛初始的VAS评分差异均无统计学意义（均P〉0．05）。术后24、48h2组患者VAS评分、使用镇痛系统或装置的满意程度、不适感、影响活动程度、炎性反应发生率的差异均无统计学意义（均P〉0．05）。但试验组出现局部渗液者（10例,12．5％）明显多于对照组（2例,2．5％）,差异有统计学意义（P〈0．05）。试验组局部渗液发生率较高的主要原因为局部麻醉镇痛系统输液导管放置部位不合适。结论国产局部麻醉镇痛系统与进口静脉输注装置均具有良好的术后镇痛效果与安全性。

Comparison of analgesic efficacy and safety between domestic local analgesia system and imported intravenous infusion analgesia device

Objective To compare the analgesic efficacy and safety between domestic disposable postoperative local anesthesia analgesic system and imported disposable intravenous infusion analgesia device. Methods A prospective, randomized, double-center controlled trial was conducted. The subjects who were underwent intra-abdominal or abdominal wall surgeries in Peking University Third Hospital and Peking University First Hospital from January to September 2008 were divided into the test group and the control group by randomized block method. Each group comprised 80 patients. The patients in the test group and the control group used domestic disposable postoperative local anesthetic analgesic system and imported disposable intravenous infusion analgesia device, respectively. Visual analogue scale （VAS）, satisfaction＇s degree to analgesic systems or device, whether analgesics were used, whether discomfort sensation appeared, whether activities were affected, whether inflammation or leakage of liquid occurred, and whether the adverse reactions or events happened were observed 24 and 48 hours after operation, respectively. Results The test group comprised 47 males and 33 females with average age （50.3 ± 14.6） years. The control zroup comprised 48 males and 32 females with average age （49.5 ± 12.7） years. There were no significant differences in age, gender, height, body weight, operation types and the initial analgesic VAS scores between the two groups 24 and 48 hours after operation （ P 〉 0.05 for all comparisons）. There were no significant differences in VAS scores, using of analgesic, degree of satisfaction＇s discomfort sensation, affecting of activity and incidence of inflammation between the two groups （ P 〉 0.05 for all comparisons）. The number of cases with leakage of liquid in the test group （10 cases, 12.5% ） was higher than that in the control group（ 2 cases, 2.5% ）, the difference was statistically significant（ P 〈 0.05 ）. The main reason of higher incidence of leakage of liquid in the test group was associated with improper location of infusion catheter of local anesthesia analgesic system. Conclusion Both domestic disposable postoperative local anesthesia analgesic system and imported disposable intravenous infusion analgesia device have favorable analgesic efficacy and safety.