无线镇痛泵系统临床应用效果观察

The effects of clinical application of the wireless analgesic pump and its management system

目的评价无线镇痛泵系统是否具有预期的安全性和有效性。方法术后需自控镇痛患者（ASAⅠ～Ⅱ级）144例，纯随机分2组，试验组72例，采用无线镇痛泵系统；对照组72例，采用ZZB全自动注药泵。以首次量＋持续给药＋自控给药行静脉自控镇痛（patient-controlled vein analgesia，PCIA）48h。配方：芬太尼12μg·kg^-1·d^-1＋氟哌利多5mg＋生理盐水至150ml。参数：首次量5ml、持续量2．5ml／h，单次量3ml／次，锁定时间8min。观察：①患者年龄、性别、体重及术前体温、心率、呼吸、血压。②应用数字疼痛评分法（mumeric rating scales，NRS），分别于PCIA后4、24、48h评价患者的疼痛程度；③患者按压自控键的总次数；④患者按压自控键的有效次数；⑤观察患者在使用早期（4h内）有无寒战、发热、恶心、呕吐、呼吸抑制等副作用及其他不良事件。结果胸外科、泌尿科、骨科及普外科手术患者共144例，两组患者年龄、性别、体重及术前T、Hr、R、BP，差异均无统计学意义（P〉0．05）。试验组4、24、48h患者的NRS分别为（1．3±1．4）分，（1．6＋1．5）分，（1．3±1．4）分；对照组4、24、48h患者的NRS分别为（1．3±1．3）分，（2．1±1．8）分，（1．7±1．7）分，两组间比较差异无统计学意义（P〉0．05）。患者按压自控键的总次数，试验组（6±10）次，对照组（5＋13）次；有效次数，试验组为（2±4）次，对照组（3±6）次，丽组间差异无统计学意义（P〉0．05）。患者在使用早期无副作用及其他不良事件。结论无线镇痛泵系统能安全地用于各种急慢性疼痛个体化治疗及其他需持续或间断给药，以维持一定的血药浓度的疾病治疗。

Objective To assess the safety and efficacy of the wireless analgesic pump system. Methods 144 patients （ASAⅠ-Ⅱ）, receiving postoperative patient-controlled vein analgesia （PCIA） for 48 h, were randomly divided into two groups： the test group （n=72）, using the wireless analgesic pumps system, and the control group（n=72）, using type ZZB analgesic pump. The settings were as follows： loading dose 5 ml, background infusion 2.5 ml/h, bolus 3 ml, lockout time 8 rain, and the prescription were as follows： fentanyl 12 ug·kg^-1·d^-1, droperidol 5 mg admixed with NS to reach 150 ml. Outcome variables： （1） Age, weight, sex, and preoperative T, Hr, RR, BP, （2） pain rating NRS when using PCIA for 4, 24, 48 h, （3） the number of all attempts, （4） the number of successful delivery, （5） Shivering, fever, nausea, vomiting, respiratory depression and other adverse effects in first 4 h. Results 144 patients underwent thoracic, urology, orthopedics, and general surgery. No difference in age, weight, sex, and preoperative T, Hr, RR, BP were found between two groups （P〉0.05）. The pain rating NRS are 1.3±1.4, 1.6±1.5 and 1.3±1.4 in test group and 1.3±1.3, 2.1±1.8 and 1.7±1.7 in control group at 4, 24,48 h. There was no difference between two groups （P〉0.05）. The number of all attempts is 6±10 in test group and 5±13 in control group; the number of successful delivery is 2±4 in test group and 3±6 in control group during 48 h, which were no difference between two groups （P〉0.05）. Patients did not have any adverse effect in early phase. Conclusion The wireless analgesic pump and its management system were safe for individual treating a variety of acute or chronic pain and other treatment requiring continuing or intermittent injection to maintain a certain plasma concentration.