It is a life-threatening condition in newborns.
Current recommendations advocate the use of targeted monotherapy hypertension research journal abbreviation a first-line approach for the treatment of Persistent Pulmonary Hypertension of the Newborn PPHN. In case of an inadequate clinical response to treatment, an addition of a second or third agent is considered. PAH is usually managed with a phosphodiesterase 5 inhibitor or an endothelin receptor blocker.
There are limited pediatric studies that address questions like which class of therapy should be initiated first or if a combination should be initiated hypertension research journal abbreviation.
With this background, the present study was initiated to compare the efficacy, safety, and tolerability of bosentan as an adjuvant to sildenafil and sildenafil alone in PPHN.
Results A total of 40 patients were enrolled in the study. PPHN was most commonly seen in the 29 Mean duration of symptoms was The participants were randomized to two groups.
Group A consisted of total 25 participants that received both bosentan and sildenafil and group B hypertension research journal abbreviation 15 participants that vélemények a magas vérnyomás kezeléséről sildenafil alone.
Both groups were comparable in terms of birth weight and present weight, consanguinity, and mode of delivery. PASP in group A was PASP on the third and seventh day in group A were There were two deaths each in both groups.
Two participants in Group A developed liver function abnormalities. None of the participants in Group B had adverse effects. Conclusion Most common clinical manifestations were nonspecific. Cardiovocal syndrome was common in PPHN. We conclude that oral sildenafil treatment is a safe, simple and effective treatment for persistent pulmonary hypertension in newborn.
Combination of bosentan with sildenafil is more effective and safe in reducing pulmonary artery PA pressures in high-risk patients with PPHN. It is a common problem in the neonate and is associated with significant morbidity and mortality [ 12 ]. PPHN occurs in approximately 1. The principal goal of PPHN treatment is selective pulmonary vasodilatation.
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Various modalities of PPHN treatment include Ventilation strategies and pulmonary vasodilators like nitric oxide, prostacyclin analogues, phosphodiesterase inhibitors, and endothelin antagonists [ 3 ]. Although the above treatments approved for PAH in adults have shown favorable effects in children, pediatric treatment decisions largely depend on results from evidence-based adult studies and the experience of clinicians. But they are expensive therapeutic modalities associated with technical difficulties in developing countries.
So alternative less expensive treatments are being sought [ 4 ].
Bosentan is a dual endothelin receptor antagonist that has been established in double-blind, placebo-controlled studies in adults with PAH [ 56 ] and in children over 3 years of age [ 7 ]. Recent studies have emphasized that oral bosentan may be a safe and effective treatment to improve oxygenation in neonates with PPHN.
Sildenafil is a phosphodiesterase inhibitor type 5 PDE5 that has been shown to selectively reduce pulmonary vascular resistance. Several case reports and controlled studies document improved oxygenation and echo cardio-graphic evidence of reduced pulmonary arterial pressures following the administration of Sildenafil therapy in newborns that had PPHN.
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This study was designed to assess the efficacy, safety, and tolerability of bosentan as an adjuvant to sildenafil and sildenafil alone in PPHN. This was a prospective, randomized, interventional, open-label and comparative study. A consecutive series of 40 patients were enrolled in this study. The exclusion criteria included children with cyanotic congenital heart disease, bleeding disorders and liver dysfunction.
Patients who met the inclusion and exclusion criteria were included in the study. PAH history included the date of the first presentation, date of diagnosis, demographic profile, clinical manifestations, and functional signs.
These were documented in a case report form. The participants were randomized based on computer-generated numbers [ 9 ] into Group A or Group B. Group A participants received both bosentan and sildenafil; and Group B only sildenafil. Sildenafil was administered via a nasogastric tube or orally at a starting dose of 0. The dose of sildenafil was increased stepwise by 0. Hemodynamic parameters were documented at inclusion, at 3rd day, and 7th day hypertension research journal abbreviation completion hypertension research journal abbreviation treatment.
The evaluation of efficacy was based on the reduction of Pulmonary Artery Systolic Pressure PASP from baseline to the 3rd and 7th day of post-drug therapy. Patients were monitored for ADR like hypotension, gastric intolerance, bleeding or pulmonary hemorrhage daily during the administration of study therapy by active surveillance.
Serum bilirubin, liver enzymes, alkaline phosphatase, serum creatinine, serum electrolytes and complete blood count were performed twice 3rd and 7th day of the drug therapy.
Statistical methods The data were analyzed by using SAS Descriptive statistics such as mean and standard deviation SD for continuous variables and percentage for categorical variables was determined. Univariate and multivariate analysis were employed to draw significant inference.
A p-value of 0.
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Results Demographic profile A total of 40 participants were enrolled in the study. There were 13 The mean age at presentation was 2. The mean birth weight of participants in Group A was 2.
The weight at presentation was 4. The gender distribution is shown in Fig. Figure 1.