闭环反馈自动给药分娩镇痛泵用于分娩镇痛的临床研究

Clinical application of intelligent patient-controlled pump for labor analgesia

目的评价闭环反馈自动给药分娩镇痛泵（简称智能自控镇痛泵）用于分娩镇痛的临床效果及对母婴的影响。方法选择要求分娩镇痛的初产妇120例，采用随机数字表法分为两组（每组60例）：智能自控镇痛泵组（I组）和传统自控镇痛泵组（T组），两组均采用硬膜外阻滞分娩镇痛，首剂量给予0．1％罗哌卡因＋0．5mg／L舒芬太尼混合液12ml，镇痛起效后，I组和T组分别应用智能自控镇痛泵和传统自控镇痛泵进行分娩镇痛。两种自控镇痛泵基本参数设置为：背景剂量5ml／h，患者自控镇痛（patient controlled analgesia，PCA）剂量5ml，锁定时间15min。智能自控镇痛泵每1小时评估一次，若产妇按压次数为0，则下一小时背景剂量减少5ml，最小背景速度以0．1ml／h输注；若产妇按压次数为1、2，则下一小时背景剂量不变；若产妇按压次数≥3，则下一小时背景剂量增加5ml，每小时镇痛药物极限量为30ml。两组均于第二产程结束后关闭镇痛泵。记录产妇镇痛前（T0）、镇痛后15min（T1）、镇痛后30min（T2）、镇痛后2h（B）、宫口开全（T4）、第二产程用力分娩时（B）的VAS评分，分娩方式，第二产程时间，总产程时间，总镇痛时间，镇痛药物总用量，每小时用药量，第二产程用力分娩时的局部麻醉药背景输注速率，爆发痛发生率，新生儿lmin、5minApgar评分，新生儿体重及镇痛副作用和产妇满意度等。结果最终纳入产妇113例，I组57例，T组56例。与T组比较，I组爆发痛发生率和宫口开全时VAS评分降低（P〈0．05），I组镇痛满意度和第二产程用力分娩时背景输注速率增加（P〈0．05），但并没有增加第二产程时间；两组产妇镇痛药物用量、分娩方式、第二产程时间、总镇痛时间、新生儿出生时体重差异无统计学意义（P〉0．05）。结论智能自控镇痛泵用于分娩镇痛效果确切，爆发痛发生率降低且不增加镇痛药物用量及副作用发生率，产妇满意度高，对母婴是安全的。

Objective To evaluate the efficiency of intelligent patient-controlled pump for labor analgesia, and its influence on mothers and neonates. Methods One hundred and twenty primiparas were randomly divided into two groups（n=60）, respectively utilizing intelligent（group I） and traditional（group T） patient-controlled pumps to deliver 0.1% ropivacaine plus 0.5 mg/L sufentanil for constant epidural analgesia. Both groups received an initial bolus of 12 ml analgesic solution, and the basic pump settings were 5 ml/h, 5 ml, 15 min for basal infusion rate, bolus dose, and lock time, respectively. In group T, the basic pump settings were used. In group I, the doses of analgesics were adjusted once every hour to meet patients demands for adequate analgesia. The pumps were stopped by the end of the second stage of labor. The follow outcome measures, including the VAS scores before maternal analgesia（T0）, 15 min （T1）, 30 min （T2）, 2 h （T3） after analgesia, the full cervical dilatation（T4）, and forced delivery at the second stage of labor（T5）, delivery mode, the time of the second stage of labor, total duration of labor, total analgesia time, the usage of analgesics, hourly dosage, local anesthetic background infusion rate at delivery, the number of breakthrough pain, 1 min, 5 min Apgar score of the neonatal, the neonatal weight, side-effects as well as the maternal satisfaction, were recorded. Results We analyzed valid data from 113 parturie nt women （57 in group I and 56 in group T）. Compared with group T, the VAS score at full cervical dilatation and the incidence of breakthrough pain in group I were significantly decreased （P〈0.05）, the infusion rate of analgesics during forced labor in group I was increased with better analgesia （P〈0.05）, there was no significant difference between two groups in, the usage of analgesics, the duration of labor, the mode of delivery, the condition of neonates, and the incidence of side-effects as well. Conclusions The intelligent patient-controlled analgesia pump is effective for labor analgesia. It lowers incidence of breakthrough pain and improves maternal satisfaction without increasing the dosage of analgesics and the risk of side-effects.