There is moderate-quality evidence to support that dimethyl fumarate at a dose of 240 mg orally three times daily or twice daily reduces both the number of patients with a relapse and the annualised relapse rate over two years of treatment in comparison with placebo. However, the quality of the evidence to support the benefit in reducing the number of patients with disability worsening is low. There is no high-quality data available to evaluate the benefit on MRI outcomes. The common adverse effects such as flushing and gastrointestinal events are mild-to-moderate for most patients. Lymphopenia and leukopenia are uncommon adverse events but significantly associated with dimethyl fumarate. Both dosages of dimethyl fumarate have similar benefit and safety profile, which supports the option of low-dose administration. New studies of high quality and long-term follow-up are needed to evaluate the benefit of dimethyl fumarate on prevention of disability worsening and to observe the long-term adverse effects including progressive multifocal leukoencephalopathy.
No abstract
Background Delayed meconium evacuation is an important cause of intestinal dysfunction in preterm infants. There are many methods to induce defecation in preterm infants: however, the effects are controversial. Finding a new intervention method to promote meconium evacuation in premature infants is necessary. Therefore, in the proposed study, the effectiveness of breast milk enema on complete meconium evacuation and time to achieve full enteral feeding will be investigated in preterm infants. Methods/design The study is a randomized, open-label, parallel-group, and single-center clinical trial. A total of 294 preterm infants will be recruited and stratified based on gestational age. Then, the infants will be assigned in a randomized block design to the intervention and control groups with a 1:1 ratio. Preterm infants in the control and intervention groups will receive saline enema and breast milk enema, respectively. The primary outcomes will be the time to achieve complete meconium evacuation from birth and time to achieve full enteral feeding from birth in preterm infants. The secondary outcomes will include hospitalization days, body weight at discharge, duration of total parenteral nutrition, cholestasis, and adverse events. Discussion The results of this trial will determine whether breast milk enema shortens the time to complete meconium evacuation and the time to achieve full enteral feeding in extremely preterm and preterm infants. Furthermore, the study results may provide a new, safe, inexpensive, and easy-to-use intervention to effectively evacuate meconium in preterm infants. Trial registration ISRCTN Registry ISRCTN17847514. Registered on September 14, 2019
This study aims at researching the content of hepatitis B virus (HBV) DNA in the breast milk of the mothers carrying HBV and investigating the effects of different feeding methods on mother-to-child transmission (MTCT) of HBV. Methods: All infants were voluntarily chosen by their mothers and divided into breastfeeding group and formula-feeding group, which were divided into three subgroups, respectively: HBV-DNA negative (HBV-) group, low viral load (LVL) group and high viral load (HVL) group. Results: HBV load in colostrum and mature milk were both significantly lower than in serum (P < 0.001). The positive rate of HBV-DNA in colostrum was positively correlated with HBV load in serum, significantly higher than that of the HBV-Group in colostrum in the LVL Group (P < 0.05), and the HVL Group was significantly higher than the LVL Group (P < 0.001). The analysis of risk factors of HBV infection in infants showed that breast-feeding and HBsAg positive in colostrum did not increase the risks of HBV infection of infants (P > 0.05). Conclusion: Breast-feeding is safe for infants with HBV-infected mothers who receive active immunization combined with passive immunization. As well, breast-feeding will neither increase the risks of HBV infection for infants nor weaken their immunity to HBV. However, breast-feeding shall be cautiously applied to pregnant women with high viral load.
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