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Pilot Study to Evaluate Compliance and Tolerability of Cranberry Capsules in Pregnancy for the Prevention of Asymptomatic Bacteriuria

机译:评估蔓越莓胶囊在孕妇中预防无症状细菌尿的依从性和耐受性的初步研究

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摘要

>Objectives: To evaluate the compliance with and tolerability of daily cranberry capsule ingestion for asymptomatic bacteriuria (ASB) prevention in pregnancy.>Design: A total of 49 pregnant women from two sites were randomly assigned to cranberry or matching placebo, two doses daily, at gestational ages less than 16 weeks. Patients were followed monthly for urinary tract infection until delivery. Up to seven monthly visits were scheduled for each patient. Delivery data were evaluated.>Results: Of 38 evaluable patients, the mean compliance rate over the study period was 82% (range, 20%–100%). This compliance rate and the 74% of patients achieving good (≥75%) compliance were similar between those who received cranberry capsules and placebo. Compliance evaluation revealed that most patients stopped capsule consumption after 34–38 weeks of participation. Multivariate logistic regression and longitudinal analysis showed a significant interaction time effect with cranberry treatment. However, cranberry consumption was not a significant predictor of gastrointestinal intolerance or study withdrawal. Although 30% of patients withdrew for various reasons, only 1 withdrew because of intolerance to the cranberry capsules. Loss to follow-up was mostly due to provider change (9 of 49 [18%]) and therapy disinterest (4 of 49 [8%]). Seven cases of ASB occurred in 5 patients: 2 of 24 (8%) in the cranberry group and 3 of 25 (12%) in the placebo group. No cases of cystitis or pyelonephritis were observed.>Conclusion: One third of pregnant women could not complete the study protocol for various reasons. Compliance with and tolerability of cranberry capsule ingestion appear good; these capsules provide a potentially effective means to prevent ASB in pregnancy. Further studies with large samples are necessary to confirm the findings.
机译:>目标:评估每日摄入蔓越莓胶囊对预防孕妇无症状菌尿(ASB)的依从性和耐受性。>设计:共有来自两个地点的49名孕妇在胎龄小于16周时,随机分配给小红莓或相配的安慰剂,每天两次。每月随访患者的尿路感染直至分娩。每位患者计划最多进行七个月访视。评估了分娩数据。>结果:在38例可评估患者中,研究期间的平均依从率为82%(范围为20%–100%)。接受酸果蔓胶囊和安慰剂的患者之间的依从率和74%的患者达到良好(≥75%)依从性相似。依从性评估显示,大多数患者在参与34-38周后停止服用胶囊。多元逻辑回归分析和纵向分析显示,酸果蔓处理具有显着的相互作用时间效应。然而,蔓越莓的摄入量不是胃肠道不耐受或研究退出的重要预测指标。尽管30%的患者因各种原因退出治疗,但只有1名患者由于对蔓越莓胶囊的耐受性而退出治疗。随访损失主要是由于提供者变更(49人中的9人[18%])和对治疗无兴趣(49人中的4人[8%])。 7例ASB发生在5例患者中:蔓越莓组为24例中的2例(8%),安慰剂组为25例中的3例(12%)。没有观察到膀胱炎或肾盂肾炎的病例。>结论:出于各种原因,三分之一的孕妇无法完成研究方案。摄入蔓越莓胶囊的顺应性和耐受性良好;这些胶囊为预防ASB妊娠提供了潜在的有效手段。为了证实发现,有必要对大量样品进行进一步研究。

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