Parisa Darvish Mohammadi, Ahamadreza Ghalami Nobar, Elnaz Shaseb, Mohammadbagher Hosseini, Parvin Sarbakhsh, Manijeh Mostafa Gharabaghi,
Volume 28, Issue 0 (Supplementary 2024)
Abstract
Introduction: Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm infants, resulting from insufficient lung development and surfactant deficiency. Various natural and synthetic surfactants are used to treat RDS. Curosurf and bractant are two commonly used natural surfactants for this condition. This randomized clinical trial compared the efficacy of these two natural surfactants in preterm infants with RDS.
Methods and Materials: This clinical trial was conducted on 200 infants for eight months at the Neonatal Intensive Care Unit of AL-Zahra Hospital. Preterm infants weighing 2000 g and born 34 weeks of gestational age diagnosed with RDS were randomly assigned to receive either beractant (4 mg/kg every 6 hours) or curosurf (2.5 mg/kg every 12 hours). The primary outcome was a change in the fraction of inspired oxygen (FiO2) requirements. Additional outcomes, including the number of surfactant doses, duration of mechanical ventilation, length of hospital stay, and mortality rates, were assessed using statistical analysis.
Results: A total of 200 infants were included (100 per group). The reduction in FiO2 from baseline to final measurement was more significant in the beractant group (49.8% vs. 53.8%; p = 0.05) than the other group. The beractant group required fewer repeat surfactant doses than the curosurf group (22.2% vs. 45.5% for the 4th dose; p = 0.001). The length of hospital stay was shorter in the beractant group (15.48 days vs. 20.13 days; p = 0.01) than curosurf group, but mortality rates did not differ significantly between groups.
Conclusion and Discussion: The Iranian-produced beractant was at least as effective as curosurf in improving oxygenation and reducing the need for repeat surfactant doses in preterm infants with RDS. Beractant was also associated with shorter hospital stays, potentially making it a more
cost-effective treatment option. These findings support using beractants as an effective surfactant replacement therapy for RDS in preterm infants. However, further investigations with a broader sample size are needed to support the results.
Seyedeh Samin Aminzadeh, Samineh Beheshtirouy, Haleh Rezaee, Elnaz Shaseb,
Volume 28, Issue 0 (Supplementary 2024)
Abstract
Introduction: Atypical antipsychotics, or second-generation antipsychotics, are prescribed for psychiatric disorders. These agents aimed to decrease the extrapyramidal side effects of typical (first-generation) antipsychotics. However, metabolic side effects of atypical antipsychotics, such as weight gain, diabetes, and dyslipidemia, are non-negligible. This study aimed to assess the effect of empagliflozin, an antidiabetic agent with cardiovascular benefits, on the cardiometabolic side effects of atypical antipsychotics.
Methods and Materials: This pilot randomized clinical trial was conducted on 36 patients with psychiatric disorders. Patients were included if they were aged between 18 and 65 years, had confirmed mental disorders based on the DSM-V-TR criteria, received atypical antipsychotics within the past 6 months, and had stable weight (less than 5% change within the past 3 months). Pregnant and breastfeeding patients were excluded from the study. The participating patients were randomly assigned to 18 in the empagliflozin group and 18 in the control group. Patients in the empagliflozin group received empagliflozin 10 mg daily along with their routinely prescribed atypical antipsychotics for 12 weeks. Patients in the control group did not receive any extra medication. For all of the patients, cardiometabolic parameters were measured at baseline and the end of the 12-week study. These parameters included systolic and diastolic blood pressure (SBP and DBP), LDL, HDL, TG, FBS, body weight, body mass index (BMI), and waist circumference.
Results: Based on the results, the level of FBS was significantly decreased in the empagliflozin group (p = 0.033). Moreover, weight (p-value = 0.00), BMI
(p = 0.00), waist circumference (p = 0.00), and SBP (p = 0.043) were significantly improved in the intervention group (p = 0.05). There was no significant change in the empagliflozin group's DBP or TG, LDL, and HDL levels (p = 0.05). No significant difference was observed in cardiometabolic parameters in the control group, except for DBP.
Conclusion and Discussion: BMI, weight, and waist circumference were significantly decreased in patients who received empagliflozin. Moreover, empagliflozin use resulted in a significant reduction in SBP. The results of this study demonstrated that patients affected by psychiatric disorders might benefit from routine doses of empagliflozin to alleviate cardiometabolic side effects. To the best of our knowledge, this is the first clinical trial evaluating the efficacy of empagliflozin on cardiometabolic effects of atypical antipsychotics. The results support the two preclinical studies previously performed on rats.
