Wu Zhuoxi, Zhao Peng, Peng Jing, Fang Liang, Ding Jinping, Yan Guangming, Wang Yang, Zhu Jing, Wang Dongting, Li Yang, Chen Zhengqiong, Zhang Qingling, Deng Qiangting, Duan Guangyou, Zuo Zhiyi, Li Hong
Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China.
Department of Anesthesiology, Chinese People's Liberation Army of China (PLA) No. 964 Hospital, Changchun, China.
Front Med (Lausanne). 2021 May 27;8:679159. doi: 10.3389/fmed.2021.679159. eCollection 2021.
Postpartum depression (PPD) is a severe psychiatric disorder. Its risk is associated with the cesarean section (CS). Currently, there are few early intervention strategies for these women with PPD who underwent CS. This was a parallel-group randomized controlled trial of singleton pregnant women who underwent elective CS in a tertiary referral hospital in China from October, 2017 to September, 2019. After operation, patients received randomly tramadol patient-controlled intravenous analgesia (PCIA; 4 mg/ml; TRA group), hydromorphone PCIA (0.04 mg/ml; HYD group), or ropivacaine patient-controlled epidural analgesia (PCEA; 1.5 mg/ml; ROP group) for 48 h in a 1:1:1 ratio. Total blinding during hospitalization was not feasible due to differences between the PCEA and PCIA treatments. All investigators who performed the follow-up were blinded to the group assignment. A total of 1,230 patients were enrolled for eligibility. Intention-to-treat analysis showed reduced incidence of PPD in the TRA group ( = 27 [6.6%]) than that in the HYD (10.2%, OR 1.62, 95% CI 0.982.68; = 0.059) and ROP groups (10.5%, OR 1.66, 95% CI 1.012.75; = 0.046) at 4 weeks post-operation, however, the difference was not statistically significant (Bonferroni corrected = 0.118, = 0.098, respectively). Subgroup analysis in high-risk women (preoperative Edinburgh Postpartum Depression Scale [EPDS] ≥10) showed a significantly lower incidence of PPD in the TRA group (16.5%) than in the HYD (32.6%) and ROP groups (30.9%) (Bonferroni corrected = 0.022 and = 0.038, respectively). The per-protocol analysis yielded similar results. Reported adverse events (AEs) were mostly mild. None of the women or infant discontinued treatment due to AEs. Tramadol PCIA after CS in high-risk women can help to reduce the risk of PPD at 4 weeks after elective CS. https://clinicaltrials.gov/ct2/show/NCT03309163?term=ETPPD&draw=2&rank=1; ClinicalTrials.gov (NCT03309163).
产后抑郁症（PPD）是一种严重的精神障碍。其风险与剖宫产（CS）有关。目前，对于这些接受剖宫产的产后抑郁症女性，几乎没有早期干预策略。这是一项平行组随机对照试验，研究对象为2017年10月至2019年9月在中国一家三级转诊医院接受择期剖宫产的单胎孕妇。术后，患者按1:1:1的比例随机接受曲马多患者自控静脉镇痛（PCIA；4mg/ml；TRA组）、氢吗啡酮PCIA（0.04mg/ml；HYD组）或罗哌卡因患者自控硬膜外镇痛（PCEA；1.5mg/ml；ROP组），持续48小时。由于PCEA和PCIA治疗存在差异，住院期间完全盲法不可行。所有进行随访的研究人员对分组情况均不知情。共有1230名患者符合纳入标准。意向性分析显示，术后4周时，TRA组PPD的发生率（=27[6.6%]）低于HYD组（10.2%，OR 1.62，95%CI 0.982.68；=0.059）和ROP组（10.5%，OR 1.66，95%CI 1.012.75；=0.046），然而，差异无统计学意义（经Bonferroni校正后，分别为=0.118，=0.098）。高危女性（术前爱丁堡产后抑郁量表[EPDS]≥10）的亚组分析显示，TRA组PPD的发生率（16.5%）显著低于HYD组（32.6%）和ROP组（30.9%）（经Bonferroni校正后，分别为=0.022和=0.038）。符合方案分析得出了类似结果。报告的不良事件（AE）大多为轻度。没有女性或婴儿因AE而停止治疗。高危女性剖宫产术后使用曲马多PCIA有助于降低择期剖宫产后4周时发生PPD的风险。https://clinicaltrials.gov/ct2/show/NCT03309163?term=ETPPD&draw=2&rank=1；ClinicalTrials.gov（NCT03309163）
