乳果糖治疗妊娠期妇女便秘的随机、双盲、安慰剂对照多中心临床研究

目的 观察乳果糖治疗妊娠期妇女便秘的疗效及安全性。方法 本研究为多中心、随机、双盲、安慰剂对照临床研究，共观察63例便秘孕期妇女。试验为期3周，包括1周导入期，2周双盲治疗期。每日治疗剂量为早餐时服用乳果糖或安慰剂30ml，3d后可酌情调整为15或45ml。每例受试者在日记卡上记录每天便次并依照Bristol粪便量表记录相应便型。整个研究中还观察受试者治疗后出现的不良事件（TEAE）并随访至其分娩。结果治疗最后1周时，乳果糖组的平均粪便性状明显改善，与导入期相比，增加值明显高于安慰剂组（1．32比0．68，P=0．019），同期乳果糖组的有效率也高于安慰剂组（61．3％比46．9％）。治疗结束时，乳果糖组有更多的受试者有明显改善或改善（64．6％比50．5％）。同样在乳果糖组中，有更多的受试者对治疗表示非常满意或较为满意（61．3％比45．2％）。整个研究过程中，无一例严重TEAE发生。乳果糖组TEAE较安慰剂组常见[15（48．4％）比7（21．9％）]，但均为轻度胃肠道反应。两组最常见的TEAE在乳果糖组为恶心、呕吐症状[6（19．4％）]，安慰剂组为腹泻[2（6．3％）]。安慰剂组中有1例因TEAE（呕吐）退出研究。两组受试者的生命体征、体检和妊娠结局（新生儿体重、身高、APGAR评分）均无异常。结论 研究表明乳果糖为治疗妊娠期便秘的有效、安全药物。

Lactulose for the treatment of constipation in pregnant women: A randomized, double-blind, placebo-controlled, multicenter study

Objective To assess the efficacy and safety of lactulose in the treatment of constipation for pregnant women.Methods A three-week,prospective,randomized,double-blind,placebo-con- trolled,multicenter study was carried out in 63 pregnant women with constipation.After one-week run- in period,eligible subjects were randomized and allocated to either the lactulose group or the placebo group,with the daily treatment dosage of 30 ml which could be adjusted to 15 ml or 45 ml from day 3 if necessary.All the subjects were asked to record the daily defecation frequencies on their diary cards together with the consistency per bowel movement which was judged by the Bristol Stool Form Scale (BSFS).Also,the treatment emergent adverse events (TEAEs) were observed and the delivery results were followed up.Results The mean change in stool consistency from the run-in period to the last week of the treatment period in the lactulose group was significantly greater than that in the placebo group (1.32 vs 0.68,P=0.019).The responder rate in the last week of treatment was also higher with lac- tulose than placebo (61.3% vs 46.9%).More subjects in the lactulose group were judged as marked im- provement or improvement by the investigators (64.6% vs 50.0%),also a higher percentage of subjects in the lactulose group described themselves as very satisfied relief or fairly satisfied relief than in the pla- cebo group (61.3% vs 45.2%).There were no serious adverse events.TEAEs were more common in lactulose group than those in placebo group [15(48.4%) vs 7(21.9%)],but all events in the lactulose group were judged as mild by the investigators,which all involved in the gastrointestinal tract.The most commonly reported TEAEs were nausea and vomiting [6(19.4%)]in the lactulose group,and diarrhea [2(6.3%)] in the placebo group.No abnormal findings in the two groups regarding the vitals signs, physical examination and the outcome of the pregnancy (weight and height of the newborns,APGAR scores).Conclusion Overall,the results of the study indicate that lactulose is efficacious and safe for the treatment of constipation in pregnant women.