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中华妇幼临床医学杂志(电子版) ›› 2021, Vol. 17 ›› Issue (02) : 171 -180. doi: 10.3877/cma.j.issn.1673-5250.2021.02.008

所属专题： 文献；

论著

去甲肾上腺素与去氧肾上腺素防治剖宫产术分娩椎管内麻醉所致低血压的Meta分析
陈紫君, 黄瀚†()   
  • 收稿日期:2020-11-11 修回日期:2021-03-15 出版日期:2021-04-01
  • 通信作者: 黄瀚

Comparison of norepinephrine and phenylephrine for preventing and treating intraspinal anesthesia induced hypotension during cesarean section: a Meta-analysis

Zijun Chen, Han Huang†()   

  • Received:2020-11-11 Revised:2021-03-15 Published:2021-04-01
  • Corresponding author: Han Huang
  • Supported by:
    Major Research and Development Support Plan of Chengdu Science and Technology Bureau(2019-YFYF-00108-SN)
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引用本文：

陈紫君, 黄瀚. 去甲肾上腺素与去氧肾上腺素防治剖宫产术分娩椎管内麻醉所致低血压的Meta分析[J]. 中华妇幼临床医学杂志(电子版), 2021, 17(02): 171-180.

Zijun Chen, Han Huang. Comparison of norepinephrine and phenylephrine for preventing and treating intraspinal anesthesia induced hypotension during cesarean section: a Meta-analysis[J]. Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition), 2021, 17(02): 171-180.

目的

对去甲肾上腺素(NE)与去氧肾上腺素(PE)，防治剖宫产术分娩中椎管内麻醉(IA)所致低血压的有效性和安全性进行Meta分析。

方法

采用Cochrane系统评价法，计算机检索PubMed、Embase、Medline和Cochrane Central Register of Controlled Trials等英文数据库，以及中国知网(CNKI)、中国生物医学文献数据库(CBM)、维普中文科技期刊数据库及万方数据知识服务平台，手工检索相关会议资料、论文集中，关于比较剖宫产术中使用NE与PE防治IA后低血压的随机对照试验(RCT)。文献检索时间设定为自数据库建库至2020年6月。由2位研究者按照本研究设定的检索策略，独立筛选文献、提取资料，并评价纳入RCT的偏倚风险后，采用RevMan 5.3软件进行Meta分析。NE和PE预防剖宫产术中IA后低血压的主要结局指标为产妇低血压发生率及新生儿脐动脉血血气分析pH值，次要结局指标为产妇的高血压、心动过缓、心动过速、恶心和呕吐发生率，以及新生儿生后1、5 min Apgar评分，脐动脉血氧分压(PaO2)、二氧化碳分压(PaCO2)和碱剩余等。各研究间异质性采用Q检验进行分析，同时采用I2值对异质性大小进行定量评价。利用Mantel-Haenszel(M-H)法计算风险比(RR)或危险差(RD)及其95%CI，采用逆方差(IV)法计算均数差(MD)及其95%CI，模型均采用随机效应模型。

结果

①共计12篇文献(12项RCT)纳入本研究，产妇为1 590例，新生儿为1 647例。②对纳入文献的方法学质量评价结果显示，高和低质量文献分别为8、2篇，其余2篇无法评价。③本研究主要结局指标的Meta分析结果显示，2组产妇低血压发生率(RR＝1.031，95%CI：0.925～1.149，P＝0.58)与2组产妇分娩新生儿脐动脉血pH值(MD＝0.003，95%CI：-0.002～0.009，P＝0.28)比较，差异均无统计学意义(P>0.05)。④次要结局指标的Meta分析结果显示，2组产妇心动过缓发生率(RR＝0.454，95%CI：0.327～0.629，P<0.001)和2组产妇分娩新生儿PaO2(MD＝0.736，95%CI：0.033～1.440，P＝0.04)比较，差异有统计学意义(P<0.05)。而2组产妇高血压发生率(RD＝-0.008，95%CI：-0.039～0.023，P＝0.62)，心动过速发生率(RD＝ -0.001，95%CI：-0.059～0.056，P＝0.96)，恶心呕吐发生率(RR＝0.933，95%CI：0.714～1.220，P＝0.61)，以及2组产妇分娩新生儿脐动脉PaCO2(MD＝ -0.359，95%CI：-1.113～0.396，P＝0.35)、碱剩余(MD＝0.179，95%CI：-0.107～0.465，P＝0.22)，生后1、5 min Apgar评分(1 min：RD＝-0.001，95%CI：-0.015～0.013，P＝0.89；5 min：RD＝0.006，95%CI：-0.003～0.016, P＝0.18)比较，差异均无统计学意义(P>0.05)。

结论

采取剖宫产术分娩产妇，采用NE和PE预防其IA后低血压的疗效相当，但是NE较PE所致产妇心动过缓发生率更低，二者对分娩新生儿的妊娠结局方面影响无差异。

关键词: 去甲肾上腺素, 脱氧肾上腺素, 剖宫产术, 麻醉, 产科, 低血压, 血气分析, 系统评价, 女(雌)性
Objective

To compare safety and efficacy of norepinephrine (NE) and phenylephrine (PE) in preventing and treating hypotension during cesarean section.

Methods

The English databases including PubMed, Embase, Medline and Cochrane Central Register of Controlled Trials, and Chinese databases including China National Knowledge Infrastructure (CNKI), China Biology Medicine (CBM), VIP and Wanfang Databases were electronically searched to collect randomized controlled trial (RCT) to compare the safety and efficacy of NE and PE in preventing and treating hypotension after IA. In addition, relevant conference papers were also searched manually. Retrieval time ranged from database inception to June 2020.The methodological quality and data extraction of the included studies were assessed independently by two reviewers following the Cochrane guidelines, then Meta-analysis was conducted by using RevMan 5.3 software. The main evaluation indexes included incidence of maternal hypotension and pH value of neonates. The secondary evaluation indexes included incidence of maternal hypertension, bradycardia, tachycardia, nausea and vomiting, and 1, 5 min Apgar score after birth, arterial partial pressure of oxygen (PaO2), arterial partial pressure of carbon dioxide (PaCO2), base excess of neonates. Q test was used to evaluate the heterogeneity of the treatment and I2 was used to quantitatively analyze the heterogeneity.The origin of heterogeneity would be searched in case of I2>50%. Risk ratio (RR) or risk difference (RD) with 95%CI were calculated with Mentel-Haenszel (M-H) method, while mean difference (MD) with 95%CI were calculated with inverse variance (IV) method.

Results

①A total of 12 RCTs which met the inclusion and exclusion criteria were included into this Meta-analysis, including 1 590 and 1 647 neonates. ②The methodological quality evaluation results of 12 RCT showed that there were 2 low-quality RCT and 8 high-quality RCT, and the remaining 2 couldn′t be evaluated. ③Meta-analysis of the main evaluation indexes showed that there were no differences between two groups in the incidence of maternal hypotension (RR=1.031, 95%CI: 0.925-1.149, P=0.58) or neonatal umbilical arterial pH values (MD=0.003, 95%CI: -0.002-0.009, P=0.28). ④Meta-analysis of the secondary evaluation indexes showed the following. NE was associated with lower incidence of bradycardia (RR=0.454, 95%CI: 0.327-0.629, P<0.001) and a slightly increased umbilical arterial PaO2 (MD=0.736, 95%CI: 0.033-1.440, P=0.04). There were no difference in incidence of maternal hypertension (RD=-0.008, 95%CI: -0.039-0.023, P=0.62), tachycardia (RD=-0.001, 95%CI: -0.059-0.056, P=0.96), nausea and vomiting (RR=0.933, 95%CI: 0.714-1.220, P=0.61), and umbilical arterial PaCO2(MD=-0.359, 95%CI: -1.113-0.396, P=0.35), base excess (MD=0.179, 95%CI: -0.107-0.465, P=0.22) or 1, 5 min Apgar score after birth (1 min: RD=-0.001, 95%CI: -0.015-0.013, P=0.89; 5 min: RD=0.006, 95%CI: -0.003-0.016, P=0.18).

Conclusions

Compared with PE, NE has similar efficacy in maintaining blood pressure during cesarean section. Besides, neonatal outcomes show no significant differences between NE group and PE group, and lower incidence of bradycardia appears in NE group.

Key words: Norepinephrine, Deoxyepinephrine, Cesarean section, Anesthesia, obstetrical, Hypotension, Blood gas analysis, Systematic review, Female
图1 文献筛选流程及结果
表1 纳入研究的12篇RCT的基本情况
纳入文献(第一作者，文献发表年) 国家及地区 组别 麻醉方案/产妇体位/麻醉平面/术中追加麻醉 2组防治措施 主要结果 定义
NE组 PE组 NE组 PE组
Wang[17]，2019 中国南京 56 55 SBA/左侧卧位/T5 L2～3或L3～4/0.5%重比重布比卡因2.0～2.2 mL 发生低血压时静脉推注NE 4 g 发生低血压时静脉推注PE 50 g 产妇收缩压与心率 ①②⑤⑥
Hasanin[9], 2019 埃及 60 63 SBA/坐位/T4 L3～4或L4～5/10 mg重比重布比卡因、20 g芬太尼 SBA后静脉输注NE 0.05 g/(kg·min)，低血压时提高静脉输注速率20%，并静脉推注PE 50 g或麻黄碱9 mg SBA后静脉输注PE 0.75 g/(kg·min)，低血压时提高静脉输注速率20%，并静脉推注PE 50 g或麻黄碱9 mg 产妇低血压发生率 ②⑤⑥
Vallejo[13], 2017 美国 43 38 SBA/坐位/T4 L3～4或L4～5/12～15 mg重比重布比卡因、0.2 mg吗啡、20 g芬太尼 SBA后静脉输注NE 0.05 g/(kg·min)，高血压时停止输注，低血压时静脉推注PE 100 g SBA后静脉输注0.1 g/ (kg·min)，高血压时停止输注，低血压时静脉推注PE 100 g 产妇所需要补救给予升压药的次数 ③⑤⑦
Ngan Kee[8], 2017 中国香港 49 52 SBA/右侧卧位/L3～4或L4～5/2.2 mL 0.5%/重比重布比卡因、15 g芬太尼 SBA后以30 mL/h静脉输注5 g/mL的NE，根据血压调整静脉输注速率 SBA后以30 mL/h的速率静脉输注100 g/mL的PE，根据血压调整静脉输注速率 产妇每次收缩压测量结果与基础血压差值的百分比的绝对值的中位数 ②⑤⑥
Dong[7], 2017 中国山东 62 64 腰硬联合/右侧卧位/T6 L2～3或L3～4/15 mg 0.5%等比重罗哌卡因 SBA后及发生低血压时静脉推注NE 10 g SBA后及发生低血压时静脉推注PE 50 g 产妇心动过缓发生率 ②⑤⑥
Ngan Kee[5], 2015 中国香港 49 52 SBA/右侧卧位/L3～4或L4～5/2.2 mL 0.5%重比重布比卡因、15 g芬太尼 SBA后以30 mL/h静脉输注5 g/mL的NE，根据血压调整静脉输注速率 SBA后以30 mL/h静脉输注100 g/mL PE，根据血压调整静脉输注速率 产妇CO ②⑤⑥
Mohta[14], 2019 爱尔兰 45 45 SBA/坐位/T6 L3～4/0.5%布比卡因2.2 mL或2.0 mL(身高<150 cm) 低血压时静脉推注NE 5 g 低血压时静脉推注PE 100 g 产妇心动过缓发生率 ②⑤⑧
Sharkey[16], 2019 加拿大 56 56 SBA/坐位/L3～4/ 13.5 mg 0.75%布比卡因、10 g芬太尼、100 g吗啡 血压低于基础水平时静脉推注NE 6 g 血压低于基础水平时静脉推注PE 100 g 产妇心动过缓发生率 ①④⑤⑥
Puthenveettil[15], 2019 印度 25 25 SBA/左侧卧位/T5 L3～4或L4～5/1.8 mL 0.5%重比重布比卡因、0.2 mL芬太尼 低血压时静脉推注NE 4 g 低血压时静脉推注PE 50 g 间断给药次数 ①④⑤⑥
Ngan Kee[12]，2017 中国香港 15 15 SBA/右侧卧位/T6 L3～4或L4～5/ 11 mg 0.5%重比重布比卡因、15 g芬太尼 低血压时静脉推注NE 8 g 低血压时静脉推注PE 100 g NE与PE的等效剂量 ⑥
Ngan Kee[18]，2020 中国香港 332 332 SBA或CSEA/足够的麻醉平面/不严格限制剂量的0.5%重比重布比卡因、芬太尼 不限制给药方式，给予NE 6 g/mL 不限制给药方式，PE 100 g/mL 新生儿动脉血血气分析pH值 ④⑦
Wang[19]，2020 中国南京 52 50 SBA/左侧卧位/T5 L3～4/15 mg 0.5%罗哌卡因 SBA后及低血压时静脉推注NE 8 g SBA后及低血压时静脉推注PE 100 g 产妇CO ②⑤⑥
图2 纳入研究文献的偏倚风险评价结果
表2 2组产妇及其分娩新生儿各项结局指标比较的Meta分析结果
结局指标 纳入研究文献 例数 异质性检验结果 效应模型 Meta分析结果
NE组 PE组 P值 I2(%) 效应量(95%CI) P值
主要结局指标                
  产妇低血压发生率 7篇[7,8,9,13,16,18,19] 647 652 0.65 0 随机 RR＝1.031(0.925～1.149) 0.58
  新生儿脐动脉血pH值 9篇[5,7,9,12,14,16,17,18,19] 730 728 0.22 25 随机 MD＝0.003(—0.002～0.009) 0.28
次要结局指标                
  产妇高血压发生率 8篇[7,8,9,13,14,15,16,17] 392 393 0.24 24 随机 RD＝—0.008(—0.039～0.023) 0.62
  产妇心动过缓 10篇[7,8,9,13,14,15,16,17,18,19] 773 777 0.11 37 随机 RR＝0.454(0.327～0.629) <0.001
  产妇恶心呕吐 10篇[7,8,9,13,14,15,16,17,18,19] 779 780 0.14 33 随机 RR＝0.933(0.714～1.220) 0.61
  产妇心动过速 3篇[15,16,17] 137 136 0.93 0 随机 MD＝—0.001(—0.059～0.056) 0.96
  新生儿脐动脉血PaO2 9篇[5,7,8,12,14,16,17,18,19] 670 679 0.33 12 随机 MD＝0.736(0.033～1.440) 0.04
  新生儿脐动脉血PaCO2 9篇[5,7,8,12,14,16,17,18,19] 730 728 0.77 0 随机 MD＝—0.359(—1.113～0.396) 0.35
  新生儿脐动脉血碱剩余 8篇[5,7,12,14,16,17,18,19] 670 665 0.41 3 随机 MD＝0.179(—0.107～0.465) 0.22
  新生儿生后1 min Apgar评分<7分 7篇[5,7,13,16,17,18,19] 687 667 1.00 0 随机 RD＝—0.001(—0.015～0.013) 0.89
  新生儿生后5 min Apgar评分<7分 7篇[5,7,13,16,17,18,19] 687 667 0.91 0 随机 RD＝0.006(—0.003～0.016) 0.18
图3 NE组(n＝647)与PE组(n＝652)产妇低血压发生率比较的Meta分析
图4 NE组(n＝730)与PE组(n＝728)产妇分娩新生儿脐动脉血血气分析中pH值比较的Meta分析
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