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甲氨蝶呤联合米非司酮治疗异位妊娠效果的回顾性队列研究
Δ
刘 翌 ,杨志勇 ,王齐尔 ,谢运飞 (1.成都大学附属医院药剂科,成都 610081;2.成都大学附属医院妇产
1*
1
3 #
2
科,成都 610081;3.四川省医学科学院/四川省人民医院核医学科,成都 610072)
中图分类号 R97;R714.22 文献标志码 A 文章编号 1001-0408(2023)04-0471-05
DOI 10.6039/j.issn.1001-0408.2023.04.17
摘 要 目的 探讨甲氨蝶呤(MTX)注射液联合米非司酮片治疗异位妊娠的效果。方法 采用回顾性队列研究方法,收集2013年
1月1日-2021年12月31日在成都大学附属医院就诊的异位妊娠患者资料。单独给予MTX注射液的为对照组,给予MTX注射
液联合米非司酮片的为暴露组。采用倾向性评分匹配(PSM)法均衡两组基线变量,比较匹配后队列的结局指标。结果 纳入125
例患者,其中对照组 68 例,暴露组 57 例。经 PSM 后,各组有 46 例匹配成功。暴露组和对照组的治疗有效率分别为 73.91% 和
63.04%、药品不良反应(ADR)发生率分别为21.74%和13.04%,均无显著差异(P>0.05)。两组患者组内治疗前后血清β-HCG值
对比均显著下降(P<0.05),但两组患者治疗后血清β-HCG值及其恢复正常的时间、再次妊娠、再次异位妊娠、再次宫内妊娠的间
隔时间均无显著差异(P>0.05)。暴露组的B超妊娠包块平均直径治疗前后差值、临床症状缓解时间和住院时间均显著大于对照
组(P<0.05),但住院期间的药品费用和住院总费用并未显著增加(P>0.05)。MTX 单剂方案组和多剂方案组的治疗有效率、
ADR 发生率无显著差异(P>0.05),单剂方案组的住院时间、药品费用、住院总费用均显著少于多剂方案组(P<0.05)。结论
MTX注射液联合或不联合米非司酮片都能有效治疗异位妊娠,有效性和安全性相当。联合治疗可以促进包块缩小,且对住院费
用和再次妊娠情况无明显影响。MTX单剂方案和多剂方案治疗效果相当,但多剂方案增加了住院时间和住院费用。
关键词 甲氨蝶呤;米非司酮;倾向性评分匹配;异位妊娠;再次妊娠;疗效;经济性
Retrospective cohort study on the efficacy of methotrexate combined with mifepristone in the treatment of
ectopic pregnancy
LIU Yi ,YANG Zhiyong ,WANG Qier ,XIE Yunfei(1. Dept. of Pharmacy, the Affiliated Hospital of Chengdu
2
1
1
3
University, Chengdu 610081, China;2. Dept. of Obstetrics and Gynecology, the Affiliated Hospital of Chengdu
University, Chengdu 610081, China;3. Dept. of Nuclear Medicine, Sichuan Academy of Medical Sciences &
Sichuan Provincial People’s Hospital, Chengdu 610072, China)
ABSTRACT OBJECTIVE To investigate the efficacy of Methotrexate (MTX) injection combined with Mifepristone tablets in
the treatment of ectopic pregnancy. METHODS A retrospective cohort study method was used to collect data on patients with
ectopic pregnancy who visited the Affiliated Hospital of Chengdu University from January 1, 2013 to December 31, 2021. Control
group was given MTX injection alone, and exposure group was given MTX injection combined with Mifepristone tablets. Baseline
variables were balanced between the two groups using a propensity score matching (PSM), and the outcomes of the matched
cohorts were compared. RESULTS A total of 125 patients were included, involving 68 in the control group and 57 in the exposure
group. After PSM, 46 cases in each group were successfully matched. There was no significant difference in the treatment response
rate and the incidence of adverse drug reaction (ADR) between the exposure group and the control group, which were 73.91% and
63.04%, 21.74% and 13.04% (P>0.05). Compared with before treatment, serum levels of β-HCG were all significantly decreased
in 2 groups after treatment (P<0.05); there was no significant difference in the serum level of β-HCG after treatment, the time to
return to normal, the interval time of second pregnancy, second ectopic pregnancy and second intrauterine pregnancy between 2
groups (P>0.05). The mean diameter difference of B-ultrasound pregnancy mass before and after treatment, duration of clinical
symptom remission and length of hospital stay in the exposure group were significantly higher than those in the control group (P<
0.05), but drug costs during hospitalization and total hospitalization costs were not significantly increased (P>0.05). There were
no significant difference between single-dose group and multi-
Δ 基金项目 四川省医学会青年创新科研课题(No.Q21066);成都
dose group of MTX in the treatment response rate and the
药学会赞邦药学科研基金项目(No.202103)
incidence of ADR (P>0.05). The hospitalization time, drug
*第一作者 主管药师,硕士。研究方向:临床药学。电话:028-
86432423。E-mail:liuyi21223@sina.com cost and total cost of the single dose group were significantly
# 通信作者 主管药师,博士。研究方向:临床药学、中药药理学、 less than those of the multi-dose group (P<0.05).
放射药学。电话:028-87393445。E-mail:xyfsub@126.com CONCLUSIONS MTX injection combined with or without
中国药房 2023年第34卷第4期 China Pharmacy 2023 Vol. 34 No. 4 · 471 ·