Kemper K, Horwitz R I, McCarthy P
Department of Pediatrics, Yale University, New Haven, Connecticut.
Pediatrics. 1988 Oct;82(4):631-8.
Neonatal jaundice is one of the most common problems leading to prolonged hospitalization of the newborn. Therefore, an effective low-risk, low-cost therapy reducing hospitalization is highly desirable. Plain dried agar, an extract of seaweed, is low cost and low risk; it can bind bilirubin in the gut, decreasing its enterohepatic circulation, thereby decreasing serum levels. Because of conflicting conclusions in the studies of agar's effectiveness in the prevention and treatment of neonatal jaundice, a meta-analysis of their methodologies was done. Criteria for assessing prospective controlled therapeutic trials of agar were established in six areas: hypothesis and clinical outcome, patient selection, treatment group allocation, therapeutic maneuver, use of cotherapies, and data analysis. Nine prospective clinical trials of agar therapy were evaluated using these six criteria. The seven studies with negative conclusions regarding agar's efficacy failed to meet the criteria in several categories: patient selection, therapeutic maneuver, use of cotherapies, or data analysis. All of the studies, including the positive studies, were at risk for biased treatment allocation. Although the pooled data analysis suggests that prophylactic agar treatment is associated with reduced peak serum bilirubin levels, this observation must be interpreted cautiously in light of heterogenous patient populations and the methodologic problems described. Based on this meta-analysis, agar therapy for neonatal jaundice can neither be recommended nor rejected. The methodologic analysis gives clear guidance for future research concerning the effectiveness of agar in treating neonatal jaundice and provides a model for meta-analysis of other prospective trials in pediatrics.
新生儿黄疸是导致新生儿住院时间延长的最常见问题之一。因此,非常需要一种有效的低风险、低成本疗法来减少住院时间。普通干琼脂是一种海藻提取物,成本低且风险小;它可以在肠道中结合胆红素,减少其肠肝循环,从而降低血清水平。由于关于琼脂在预防和治疗新生儿黄疸有效性的研究结论相互矛盾,因此对其方法进行了荟萃分析。在六个方面确定了评估琼脂前瞻性对照治疗试验的标准:假设与临床结果、患者选择、治疗组分配、治疗措施、联合治疗的使用以及数据分析。使用这六个标准对九项琼脂治疗的前瞻性临床试验进行了评估。七项关于琼脂疗效得出阴性结论的研究在几个类别中未达到标准:患者选择、治疗措施、联合治疗的使用或数据分析。所有研究,包括得出阳性结果的研究,都存在治疗分配偏倚的风险。尽管汇总数据分析表明预防性琼脂治疗与降低血清胆红素峰值水平有关,但鉴于患者群体的异质性和所描述的方法学问题,这一观察结果必须谨慎解释。基于这项荟萃分析,既不能推荐也不能拒绝使用琼脂治疗新生儿黄疸。方法学分析为未来关于琼脂治疗新生儿黄疸有效性的研究提供了明确指导,并为儿科其他前瞻性试验的荟萃分析提供了一个模型。