ABSTRACT
The genus Passiflora (Passifloraceae) comprises about 500 species. The Passiflora edulis stands out because of its economic and medicinal importance. It is widely planted in tropical and subtropical regions worldwide, especially in South America, the Caribbean, South Africa, and Asia. The aqueous extract of Passiflora edulis Sims f. edulis (Gulupa) leaves is used in traditional medicine for its soothing and tranquilizing effects on the central nervous system. Therefore, evaluating its safety for human use is a fundamental requirement to continue the development of new therapies within the framework of regulatory, preclinical, and clinical guidelines. Here, the sub-acute toxicity study was conducted following the Organization for Economic Cooperation and Development (OECD) guideline 407 for 28 days in Wistar albino rats. The study showed that 1000 mg/kg/day of the aqueous extract in 10 adult Wistar rats (five males and five females) was well tolerated. The hematological results are at normal levels. However, monocytopenia and eosinopenia were observed with a significant difference (P < 0,05) for both male and female rats treated with the aqueous extract of Passiflora edulis. The results show that liver and kidney function profiles were conserved. However, an increase in ALT is observed with significant differences between male and female rats treated with the extract compared to the controls. Study findings were limited to non-adverse histopathological results of a slightly increased incidence of focal periportal lymphocytic infiltrate in the liver and focal corticomedullary nephrocalcinosis in the kidney compared to control. Therefore, the aqueous extract of Passiflora edulis has a good safety profile in oral administration, was well tolerated, and did not cause any lethality or adverse effects in the sub-acute toxicity study in male and female rats. The NOAEL (no observed adverse effect level) for the 28-day subacute toxicity study was considered to be 1000 mg/kg.
ABSTRACT
BACKGROUND: Neurotrauma centers have developed management protocols on the basis of evidence obtained from literature analysis and institutional experience. This article reviews our institutional experience in the management of severe traumatic brain injury (TBI) at Simòn Bolivar Hospital, the district trauma center for Bogotá's north zone. METHODS: This is a case control study comparing a group of patients (n: 16) operated for severe TBI between January 2002 and July 2004 according to an institutional management protocol characterized by an early decompressive craniectomy (DC) approach versus a historical control group (n: 20) managed before the implementation of such protocol. Mortality and Glasgow Outcome Score (GOS) at 6 months were used as the main outcome variables. RESULTS: An early DC protocol implemented within 12 hours from injury in 16 patients with severe isolated TBI and a Marshall score between III or IV was associated with a lesser mortality than the conventional approach with ventriculostomy and Intensive Care Unit (ICU) management alone. The GOS was significantly better in the DC group (p=0.0002) than in the control group. CONCLUSION: The use of an early DC protocol for severe TBI patients (Glasgow Coma Scale <9) had a significantly improved outcome compared with the conventional approach with ventriculostomy and ICU management in Simòn Bolivar Hospital in Bogotá, Colombia.