Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.
Breastfeed Med. 2021 Mar;16(3):245-250. doi: 10.1089/bfm.2020.0234. Epub 2020 Nov 17.
Mothers of many preterm babies are unable to produce sufficient milk for their babies during the prolonged hospitalization. Domperidone stimulates the release of prolactin, thereby increasing breast milk production. The primary outcome was to study the efficacy of domperidone in augmenting breast milk production in mothers with lactation failure (LF). The secondary outcomes included the effect of domperidone on prolactin levels, adverse effects of domperidone, and outcome on breastfeeding rates at discharge. This was a randomized, double-blinded, placebo-controlled trial where mothers with LF were either allocated domperidone (10 mg) or placebo, 2 tablets three times a day for 14 days. Milk volumes were recorded daily for 14 days. Serum prolactin levels were measured at the start and at day 7 of study. Out of 166 women eligible for the study, 119 (71.7%) mothers were able to increase their breast milk production without pharmacological treatment after being counseled on the advantages of human milk and proper breastfeeding management. Forty-seven mothers were finally enrolled in the study; 24 in the domperidone group (DG) and 23 in the placebo group (PG). Breast milk production increased from a baseline of 156 + 141.1 to 400.9 + 239.2 mL in the DG and increased from a baseline of 175.8 + 150.7 to 260.5 + 237.5 mL in the PG, after 14 days ( < 0.01). The prolactin levels in the DG and PG increased from 72.85 (22.2-167.15) and 42.33 (14.02-93.54) ng/mL, respectively, to 223.4 (49.79-280.2) ng/mL ( = 0.005) in the DG and 60.08 (14.31-132.14) ng/mL ( = 0.232) in the PG on the 7th day of treatment. No adverse effects were recorded. Ninety-five percent of babies in the DG were exclusively breastfeeding at hospital discharge, compared with 52.4% in the PG ( = 0.008). Domperidone treatment can result in an increase in breast milk production with no adverse effects. The study was registered with the Thai Clinical Trials Registry ID TCTR2020091008.
许多早产儿的母亲在长时间住院期间无法为婴儿提供足够的母乳。多潘立酮可刺激催乳素释放，从而增加母乳产量。主要结局是研究多潘立酮在增加泌乳失败（LF）母亲的母乳产量方面的功效。次要结局包括多潘立酮对催乳素水平的影响、多潘立酮的不良反应以及出院时母乳喂养率的结果。这是一项随机、双盲、安慰剂对照试验，将 LF 的母亲分为多潘立酮（10mg）组或安慰剂组，每天 3 次，每次 2 片，共 14 天。14 天内每天记录奶量。在研究开始和第 7 天测量血清催乳素水平。在符合研究条件的 166 名女性中，119 名（71.7%）母亲在接受有关人乳优势和正确母乳喂养管理的建议后，无需药物治疗即可增加母乳产量。最终有 47 名母亲入组研究；24 名入多潘立酮组（DG），23 名入安慰剂组（PG）。多潘立酮组的母乳产量从基线的 156+141.1 增加到 400.9+239.2ml，安慰剂组从基线的 175.8+150.7 增加到 260.5+237.5ml，14 天后（<0.01）。多潘立酮组和安慰剂组的催乳素水平分别从 72.85（22.2-167.15）和 42.33（14.02-93.54）ng/ml增加到治疗第 7 天的 223.4（49.79-280.2）ng/ml（=0.005）和 60.08（14.31-132.14）ng/ml（=0.232）。未记录到不良反应。多潘立酮组 95%的婴儿在出院时纯母乳喂养，而安慰剂组为 52.4%（=0.008）。多潘立酮治疗可增加母乳产量，且无不良反应。该研究已在泰国临床试验注册中心注册，注册号为 TCTR2020091008。
