探讨瑞芬太尼静脉自控分娩镇痛作为舒芬太尼联合罗哌卡因硬膜外分娩镇痛补充方式的安全性和有效性。

选择2014年6～12月于上海市第一妇婴保健院分娩并自愿要求分娩镇痛的427例产妇为研究对象。根据产妇自愿选择的分娩镇痛方式，将其分为研究组(n＝159，采用瑞芬太尼静脉自控分娩镇痛)与对照组(n＝268，采用舒芬太尼联合罗哌卡因硬膜外自控分娩镇痛)。本组427例产妇均为美国麻醉医师协会(ASA)评级Ⅰ～Ⅱ级、单胎、足月妊娠、初产妇及自愿接受分娩镇痛的经阴道试产产妇。研究组瑞芬太尼静脉自控分娩镇痛泵液为20 μg/mL瑞芬太尼，首次剂量为0.4 μg/kg，背景剂量为0.04 μg/(kg·min)，患者自控镇痛(PCA)剂量为0.4 μg/kg，镇痛泵锁定时间为3 min。对照组采用舒芬太尼联合罗哌卡因硬膜外自控分娩镇痛，选择L₂～L₃椎间隙正中入路硬膜外穿刺置管，泵液为0.3 μg/mL舒芬太尼＋0.068%罗哌卡因，首次剂量为6～8 mL，背景剂量为6～8 mL，PCA剂量为5 mL，镇痛泵锁定时间为20 min。两组产妇娩出胎儿时，即刻抽取胎儿脐动脉(UA)血1 mL进行血气分析。观察并记录两组产妇镇痛前，镇痛起效时，镇痛1、2及3 h后血压、心率、呼吸频率及经皮脉搏血氧饱和度(SpO₂)等生命体征指标，视觉模拟评分量表(VAS)评分及Ramsay评分，两组镇痛起效时间，第一、二、三产程时间，催产素使用情况，是否为产钳助产或转为剖宫产，新生儿出生1及5 min时Apgar评分，UA血气分析情况，不良反应发生情况，以及产妇及其家属对分娩镇痛效果满意度评价。对两组上述指标进行统计学比较。本研究遵循的程序符合上海市第一妇婴保健院人体试验委员会制定的伦理学标准，得到该委员会批准，分组征得受试对象知情同意，并与之签署临床研究和分娩镇痛知情同意书。

①两组产妇年龄、体重、身高、人体质量指数及孕龄等基本临床资料比较，差异均无统计学意义(P>0.05)。②两组产妇镇痛前，镇痛起效时，镇痛1、2及3 h后的平均动脉压、心率、呼吸频率及SpO₂比较，差异均无统计学意义(P>0.05)。③研究组产妇镇痛起效时间为(1.0±0.1)min，明显短于对照组的(15.7±1.9)min，并且差异有统计学意义(t＝126.408，P＝0.000)。研究组产妇镇痛起效时Ramsay评分为(2.4±0.6)分，显著高于对照组的(1.9±0.4)分，并且差异有统计学意义(t＝10.599，P＝0.000)；镇痛1 h后，研究组产妇Ramsay评分为(2.3±0.4)分，亦显著高于对照组的(1.9±0.4)分，差异亦有统计学意义(t＝10.722，P＝0.000)；两组产妇镇痛前、镇痛2及3 h后的Ramsay评分比较，差异均无统计学意义(P>0.05)。镇痛起效时，镇痛1、2及3 h后，研究组VAS评分均显著高于对照组，并且差异均有统计学意义(P<0.05)。镇痛1 h后，研究组VAS评分呈上升趋势，对照组各时间点的VAS评分相对稳定。④两组产妇阴道分娩率，总产程，第一、二及三产程时间，产钳助产率，转剖宫产率及催产素使用率比较，差异均无统计学意义(P>0.05)。两组产妇呕吐及皮肤瘙痒等不良反应发生率比较，差异亦均无统计学意义(P>0.05)；研究组产妇头晕发生率为22.0%(31/141)，显著高于对照组的1.8%(4/228)，并且差异有统计学意义(χ²＝41.535，P＝0.000)；研究组产妇下肢麻木发生率为0.7%(1/141)，显著低于对照组的6.6%(15/228)，并且差异亦有统计学意义(χ²＝7.236，P＝0.007)。⑤两组产妇所产新生儿出生1及5 min时Apgar评分、出生1 min时Apgar评分≤8分所占比例、UA血pH值及剩余碱水平比较，差异均无统计学意义(P>0.05)。⑥研究组及对照组产妇总满意率分别为94.3%(150/159)与95.1%(255/268)，二者比较，差异无统计学意义(χ²＝0.13，P＝0.714)。研究组及对照组产妇家属总满意率分别为95.0%(151/159)与96.3%(258/268)，二者比较，差异亦无统计学意义(χ²＝0.42，P＝0.518)。

瑞芬太尼静脉自控分娩镇痛具有操作简便、创伤小、起效快的优势。瑞芬太尼背景剂量为0.04 μg/(kg·min)，PCA剂量为0.4 μg/kg分娩镇痛方式，对产妇及新生儿安全，虽然分娩镇痛效果不如舒芬太尼联合罗哌卡因硬膜外自控分娩镇痛确切及稳定，但产妇及家属满意度较高。在加强产妇和胎儿持续监护下，瑞芬太尼静脉自控分娩镇痛，可作为舒芬太尼联合罗哌卡因硬膜外自控分娩镇痛的有效补充。

To compare the effect of remifentanil parturient-controlled intravenous analgesia and sufentanil combined ropivacaine parturient-controlled epidural analgesia in labor, in order to assess the safety and feasibility of remifentanil patient-controlled intravenous analgesia in labor.

From June to December 2014, a total of 427 cases of pregnant women who delivered in Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine and demanded for analgesia voluntarily were enrolled as research subjects. According to the analgesia method pregnant women chose for, they were divided into study group (n=159) who received remifentanil parturient-controlled intravenous analgesia and control group (n=268) who received sufentanil combined ropivacaine parturient-controlled epidural analgesia. All the 427 cases of pregnant women were grade Ⅰ-Ⅱ in American Society of Anesthesiologists (ASA), single birth, full term, received analgesia voluntarily and with vaginal trial delivery. The analgesia method in study group was with remifentanil 20 μg/mL, first dose of remifentanil: 0.4 μg/kg, background dose: 0.04 μg/(kg·min), patient controlled analgesia (PCA) dose: 0.4 μg/kg and lockout time: 3 minutes. While the analgesia method in control group was with sufentanil 0.3 μg/mL + 0.068% ropivacaine, background dose: 6~8 mL, PCA dose: 5 mL, and lockout time: 20 minutes. At the time fetus delivered out, 1 mL umbilical artery (UA) blood was exsanguinated immediately and did blood gas analysis. Blood pressure, heart rate, respiratory rate, hemoglobin oxygen saturation by pulse oximetry (SpO₂), visual analogue scale (VAS) score and Ramsay sedation score before analgesia, at the onset of analgesia, 1 hour, 2 hours and 3 hours after analgesia of two groups were recorded. The period of effective analgesia, the period of first, second, and third stage of labor, the use of oxytocin, forceps delivery rate, cesarean section rate, Apgar scores, UA blood gas analysis, adverse reactions, and the satisfaction of pregnant women and their families of two groups were also recorded. Statistical methods were analyzed between two groups among those indexes mentioned above. The study protocol was approved by the Ethical Review Board of Investigation in West China Second University Hospital, Sichuan University. Informed consent was obtained from each participant.

①There were no statistically significant differences between two groups among the age, body weight, body height, body mass index and gestational age and so on (P>0.05). ②There were no statistically significant differences between two groups among mean arterial pressure, heart rate, breathing rate and SpO₂ before analgesia, the onset of analgesia, 1 hour, 2 hours and 3 hours after analgesia (P>0.05). ③The analgesia onset time in study group was (1.0±0.1) minutes which was significantly shorter than that of (15.7±1.9) minutes in control group, and the difference was statistically different (t=126.408, P=0.000). The Ramsay sedation scores in study group at the onset of analgesia and 1 hour after analgesia were (2.4±0.6) score, (2.3±0.4) score which were significantly higher than those of (1.9±0.4) score, (1.9±0.4) score, respectively in control group, and both the differences were statistically significant (t=10.599, 10.722; P=0.000). While there were no statistical differences of Ramsay sedation scores before analgesia, 2 hours and 3 hours after analgesia between two groups (P>0.05). The VAS scores at the onset of analgesia and 1 hour, 2 hours and 3 hours after analgesia in study group were all higher than those in control group, and all the differences were statistically different (P<0.05). And the VAS score in study group was in an increasing trend 1 hour after analgesia, while the trend in control group was relatively stable. ④There were no statistical differences among the mode of delivery, labor process, forceps delivery rate, cesarean section rate and the rate of using of oxytocin between groups (P>0.05). There were no statistical differences between two groups in the incidences of vomiting and pruritus (P>0.05). 22.0% (31/141) patients in study group encountered dizziness, which was far higher than that in control group 1.8% (4/228) and the difference was statistically different (χ²=41.535, P=0.000). But the incidence of lower limb numbness in study group (0.7%, 1/141) was lower than that in control group (6.6%, 15/228), and the difference was also statistically significant (χ²=7.236, P=0.007). ⑤The Apgar score, the pH value and base excess level of UA blood gas analysis of the newborn infants between two groups were not statistically significant (P>0.05). ⑥Both two groups obtained high degree of satisfaction from pregnant women and their family, and both the differences between two groups were not statistically significant [pregnant women: 94.3% (150/159) vs 95.1% (255/268), χ²=0.13, P=0.714; their family: 95.0% (151/159) vs 96.3% (258/268), χ²=0.42, P=0.518].

Compared to traditional sufentanil combined ropivacaine parturient-controlled epidural analgesia in labor, remifentanil parturient-controlled intravenous analgesia is confirmed secure, effective and convenient. As an alternative mode of labor analgesia, remifentanil patient-controlled intravenous analgesia with background dose 0.04 μg/(kg·min) and PCA dose 0.4 μg/kg can be used under the precondition of ensuring one-to-one beside care, continuous monitoring, oxygen supply and preparation for neonatal resuscitation.