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·循证药学·
妊娠中晚期使用帕罗西汀对母婴安全性影响的Meta分析 Δ
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卢丽清 ,万 宁,季 波,袁 进,温惠英,萧伟斌(中国人民解放军南部战区总医院临床药学科,广州
510010)
中图分类号 R969.3;R971+.43 文献标志码 A 文章编号 1001-0408(2023)03-0361-05
DOI 10.6039/j.issn.1001-0408.2023.03.20
摘 要 目的 系统评价妊娠合并抑郁症患者妊娠中晚期使用帕罗西汀对母婴的安全性,为临床合理使用该药提供参考。方法
计算机检索 Cochrane Library、PubMed、Embase、维普网、中国知网、万方数据库和 SinoMed数据库,并进行手工检索,收集关于妊
娠中晚期使用帕罗西汀对比使用其他类5-羟色胺选择性重摄取抑制剂(SSRI)的抑郁症患者的随机对照研究或者观察性研究,检
索时限均为建库起至 2022 年 8 月。利用 Cochrane 系统评价员手册 5.1.0 或纽卡斯尔-渥太华质量评估表(NOS)进行文献质量评
价,采用RevMan 5.4.1软件进行Meta分析。结果 最终共纳入9项观察性研究,NOS评分均为高等质量。对其中8项队列研究进
行Meta分析。结果显示,妊娠中晚期使用帕罗西汀的母婴不良妊娠结局总发生率[RR=0.99,95%CI(0.89,1.10),P=0.87]以及产
妇不良妊娠结局总发生率[RR=0.98,95%CI (0.87,1.10),P=0.69]、早产发生率[RR=0.89,95%CI (0.43,1.83),P=0.75]均低于妊
娠中晚期使用其他SSRI,但差异均无统计学意义;妊娠中晚期使用帕罗西汀的新生儿并发症总发生率高于妊娠中晚期使用其他
SSRI,但差异也无统计学意义[RR=1.02,95%CI (0.82,1.29),P=0.84]。有1项研究报道帕罗西汀组新生儿肺动脉高压发生率高
于其他 SSRI 组(0.4% vs. 0.3%)。结论 妊娠中晚期使用帕罗西汀与使用 SSRI 相比安全性相当,但需警惕新生儿肺动脉高压的
发生。
关键词 帕罗西汀;妊娠中晚期;妊娠并发症;不良妊娠结局;Meta分析
Effects of paroxetine on the safety of mothers and infants in the second and third trimesters of pregnancy:
a meta-analysis
LU Liqing,WAN Ning,JI Bo,YUAN Jin,WEN Huiying,XIAO Weibin(Dept. of Clinical Pharmacy, General
Hospital of Southern Theatre Command, Guangzhou 510010, China)
ABSTRACT OBJECTIVE To systematically evaluate the safety of paroxetine in the treatment of pregnant patients with
depression in the second and third trimesters of pregnancy, and provide reference for rational clinical use of it. METHODS
Retrieved from Cochrane Library, PubMed, Embase, VIP, CNKI, Wanfang database and SinoMed database, by manual search,
randomized controlled studies or observational studies were collected on depression patients who were given paroxetine vs. selective
serotonin reuptake inhibitor (SSRI) in the second and third trimesters of pregnancy during the inception to Aug. 2022.
Methodological qualities of the included studies were assessed by Cochrane Handbook 5.1.0 or Newcastle-Ottawa Scale (NOS).
Meta-analysis was performed with RevMan 5.4.1 software. RESULTS Finally, 9 observational studies were included, and all
included studies were of high quality in NOS scale. Meta-analysis was performed on 8 cohort studies. Meta-analysis showed that the
total incidence of adverse pregnancy outcomes of mothers and infants [RR=0.99, 95%CI(0.89,1.10),P=0.87], total incidence of
maternal adverse pregnancy outcomes [RR=0.98, 95%CI (0.87,1.10), P=0.69] and premature birth [RR=0.89, 95%CI (0.43,
1.83), P=0.75] in the second and third trimesters of pregnancy were lower than that with other SSRI, without statistical
significance. The incidence of neonatal complications with paroxetine in the second and third trimesters of pregnancy was higher
than that with other SSRI, but the difference was not statistically significant [RR=1.02, 95%CI (0.82,1.29), P=0.84]. One study
reported that the incidence of neonatal pulmonary hypertension in paroxetine group was higher than that in other SSRI group (0.4%
vs. 0.3%). CONCLUSIONS The safety of peroxetine in the second and third trimesters of pregnancy is comparable with that of
other SSRI, but it is necessary to be alert to the occurrence of
Δ 基金项目 国家自然科学基金青年科学基金项目(No.81703804);
neonatal pulmonary hypertension.
广州市科技计划项目(No.202002030446)
*第一作者 主管药师,硕士。研究方向:临床药学。电话:020- KEYWORDS paroxetine; second and third trimesters of
88686925。E-mail:491677244@qq.com pregnancy; pregnancy complications; adverse pregnancy
# 通信作者 副主任药师,博士。研究方向:临床药学。电话:020- outcome; meta-analysis
88686925。E-mail:78930718@qq.com
中国药房 2023年第34卷第3期 China Pharmacy 2023 Vol. 34 No. 3 · 361 ·