硬膜外舒芬太尼分娩镇痛的效应 随机、多中心研究

Efficacy and safety of epidural sufentanil for labor analgesia:a randomized multi-center study

目的采用随机、多中心方法探讨硬膜外舒芬太尼分娩镇痛的有效性和安全性。方法分娩单胎孕初产妇240例,自愿接受分娩镇痛,无产科及硬膜外阻滞禁忌证,年龄<35岁,孕周>37周,体重<100 kg,随机分为2组(n=120):舒芬太尼混合罗哌卡因组(S组)和芬太尼混合罗哌卡因组(F组)。当产妇宫口开至3 cm时,L2,3间隙硬膜外穿刺置管,S组硬膜外注射0．15％罗哌卡因和O．5μg·ml-1舒芬太尼混合液试验剂量5 ml,观察5 min确认导管在硬膜外腔后追加上述混合液5-10 ml,30 min后以0．1％罗哌卡因和0．5μg·ml-1舒芬太尼混合液行病人自控硬膜外镇痛。F组混合液以2μg·ml-1芬太尼替代0．5μg·ml-1舒芬太尼,其他用药情况均与S组同。两组PCA剂量均为6 ml,锁定时间均为15 min。于镇痛前、镇痛10、30、60 min行视觉模拟评分(VAS)和运动神经阻滞分级(采用改良Bromage分级法测定),记录镇痛起效时间、首次PCA时间、镇痛药物用量、低血压、镇痛不良反应、镇痛满意度、生命体征、产程、分娩方式及新生儿Apgar评分。结果与镇痛前比较,镇痛期间两组VAS评分降低(P<0．05),镇痛效果满意;镇痛10、30和60min两组收缩压和舒张压均降低(P<0．05),心率差异无统计学意义(P>0．05)。与F组比较,S组首次PCA时间延迟约14min,PCA用量和有效次数减少(P<0．05),S组皮肤瘙痒发生率增高(P<0．05)。PCA用量:舒芬太尼6μg,芬太尼36μg,用量比1:6。两组产后镇痛满意度优良率(分别为95％和93．5％)、镇痛起效时间、VAS评分、镇痛后催产素使用率、产后失血量、产程、剖宫产率、器械助产率及新生儿产后1、5 min Apgar评分差异均无统计学意义(P>0．05)。结论舒芬太尼混合罗哌卡因硬膜外分娩镇痛安全有效,舒芬太尼镇痛持续时间长于芬太尼,效价为芬太尼的6倍。

Objective To evaluate the efficacy and safety of epidural sufentanil for labor analgesia in a randomized multi-center study. Methods Two hundred and forty AgA Ⅰ or Ⅱ nulliparous parturients in active labor with a cervical dilatation of 3 cm were randomized to receive a loading dose of 10-15 ml of 0.15% ropivacaine with 0.5 μg·ml^-1 sufentanil （group S, n = 120） or 2 μg·ml^-1 fentanyl （group F, n = 120） followed by PCEA with 0.1% ropivacaine plus 0.5 μg·ml^-1 sufentanil （group S） or 2 μg· ml^-1 fentanyl （group F）. The PCA pump was programmed to deliver a bolus of 6 ml with a lockout interval of 15 min. （ 1 ） Pain was assessed using VAS （0 = no pain, 10 = worst pain）, （2） motor block was evaluated according to Bromage scale. （3） maternal vital signs and side effects and （4） neonatal Apgar score were recorded. Results VAS scores were significantly reduced after epidural medication in both groups. The analgesia was good and there was no significant difference in onset of analgesia and VAS scores after epidural medication between the two groups. The interval between the loading dose and the first bolus dose of PCEA was 14 rain longer in group S than in group F. The number of successfully delivered PCEA doses and the total volume of PCEA solution consumed were significantly greater in group F than in group S. The incidence of pruritus was significantly higher in group S than in group F.The consumption of sufentanil was 6 μg while that of fentanyl was 36 μg with a ratio of 1 ： 6. There was no significant difference in length of labor, percentage of cesarean section or instrumental delivery, oxytocin consumption and Apgar score. Patient satisfaction was equally high in both groups. Conclusion Epidural sufentanil combined with repivacaine provides good and safe labor analgesia. Sufentanil provides a longer duration of analgesia and has a potency ratio of 1：6 to fentanyl.