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早期流产的心理影响及患者对治疗的满意度:期待治疗与米索前列醇治疗的随机对照试验比较。

Psychological impact of early miscarriage and client satisfaction with treatment: comparison between expectant management and misoprostol treatment in a randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö, Sweden.

Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.

出版信息

Ultrasound Obstet Gynecol. 2021 Nov;58(5):757-765. doi: 10.1002/uog.23641. Epub 2021 Oct 13.

Abstract

OBJECTIVES

To compare the short- and long-term emotional distress (grief, anxiety and depressive symptoms) after early miscarriage and satisfaction with treatment between women randomized to expectant management vs vaginal misoprostol treatment.

METHODS

This was a preplanned analysis of data collected during a randomized controlled trial comparing expectant management with misoprostol treatment in women with early anembryonic or embryonic miscarriage and vaginal bleeding. If the miscarriage was not complete on day 31 after inclusion, surgical evacuation was recommended. The main outcomes were levels of anxiety and grief, depressive symptoms and client satisfaction with the treatment, which were assessed using the following validated psychometric self-assessment instruments: Spielberger State-Trait Anxiety Inventory (STAI, Form Y), Perinatal Grief Scale (PGS), Montgomery-Åsberg Depression Rating Scale (MADRS-S; self-reported version) and Client Satisfaction Questionnaire (CSQ-8). All women were assessed at four timepoints: on the day of randomization, on the day when the miscarriage was judged to be complete, and at 3 months and 14 months after complete miscarriage. The psychometric and client satisfaction scores were compared between the misoprostol group and the expectant-management group at each assessment. Analysis was performed by the intention-to-treat principle.

RESULTS

Ninety women were randomized to expectant management and 94 to misoprostol treatment. The psychometric and client satisfaction scores were similar in the two treatment groups at all assessment timepoints. At inclusion, 41% (35/86) of the women managed expectantly and 37% (34/92) of those treated with misoprostol had a STAI-state score of > 46 ('high level of anxiety'), and 9% (8/86) and 10% (9/91), respectively, had symptoms of moderate or severe depression (MADRS-S score ≥ 20). In both treatment groups, symptom scores for anxiety and depression were significantly higher at inclusion than after treatment and remained low until 14 months after complete miscarriage. Grief reactions were mild in both groups, with a median PGS score of 40.0 at 3 months and 37.0 at 14 months after complete miscarriage in both treatment groups. Four women treated with misoprostol and two women managed expectantly had a PGS score of > 90 (indicating deep grief) 3 months after complete miscarriage, while one woman managed expectantly had a PGS score of > 90 14 months after complete miscarriage. Women in both treatment groups were satisfied with their management, as indicated by a median CSQ-8 score of > 25 at each assessment. More than 85% of participants in each of the two groups reported that they would recommend the treatment they received to a friend.

CONCLUSIONS

The psychological response to and recovery after early miscarriage did not differ between women treated with misoprostol and those managed expectantly. Satisfaction with treatment was high in both treatment groups. Our findings support patient involvement when deciding on the management of early miscarriage. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

摘要

目的

比较早期流产后短期和长期的情绪困扰(悲伤、焦虑和抑郁症状)以及接受期待管理与阴道米索前列醇治疗的女性对治疗的满意度。

方法

这是一项对一项随机对照试验数据的预先计划分析,该试验比较了期待管理与米索前列醇治疗早期胚胎或胚胎流产伴阴道出血的女性。如果在纳入后第 31 天流产仍未完全,建议进行手术清除。主要结局为焦虑和悲伤、抑郁症状和患者对治疗的满意度,使用以下经过验证的心理测量自评量表评估:斯皮尔伯格状态-特质焦虑量表(STAI,Y 型)、围产期悲伤量表(PGS)、蒙哥马利-阿斯伯格抑郁评定量表(MADRS-S;自评版)和患者满意度问卷(CSQ-8)。所有女性在四个时间点进行评估:随机分组当天、判断流产完全当天,以及完全流产后 3 个月和 14 个月。在每个评估中,比较米索前列醇组和期待管理组之间的心理测量和患者满意度评分。分析按照意向治疗原则进行。

结果

90 名女性被随机分配至期待管理组,94 名女性被随机分配至米索前列醇治疗组。在所有评估时间点,两组的心理测量和患者满意度评分均相似。纳入时,41%(35/86)接受期待管理的女性和 37%(34/92)接受米索前列醇治疗的女性 STAI 状态评分>46(“高度焦虑”),分别有 9%(8/86)和 10%(9/91)出现中度或重度抑郁症状(MADRS-S 评分≥20)。在两组治疗中,焦虑和抑郁症状评分在治疗后均显著低于纳入时,且在完全流产后 14 个月仍保持较低水平。两组的悲伤反应均较轻,完全流产后 3 个月和 14 个月时 PGS 评分中位数分别为 40.0 和 37.0。完全流产后 3 个月,4 名接受米索前列醇治疗的女性和 2 名接受期待管理的女性 PGS 评分>90(表明严重悲伤),而 1 名接受期待管理的女性 PGS 评分>90 14 个月后流产。两组女性对其治疗均满意,每个评估的 CSQ-8 评分中位数均>25。每组均有超过 85%的参与者表示会向朋友推荐他们接受的治疗。

结论

接受米索前列醇治疗与接受期待管理的女性在早期流产后的心理反应和恢复方面没有差异。两组患者对治疗的满意度均较高。我们的研究结果支持在决定早期流产的管理时考虑患者的意见。© 2021 作者。约翰威立父子出版公司代表国际超声协会在妇产科超声发表。

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