RESUMO
BACKGROUND: Skin prick testing is the most important diagnostic tool to detect immunoglobulin E-mediated allergic diseases. With increase in the number of allergy tests performed in India, it is imperative to know the potency of indigenous extracts in comparison with U.S. Food and Drug Administration (USFDA)-approved extracts. METHODS: A randomized comparison trial of Indian manufactured and USFDA-approved extracts of Dermatophagoides pteronyssinus (DP) and Dermatophagoides farinae (DF) was done at Christian Medical College & Hospital, Vellore, India from April 2014 to June 2015, to compare the skin test reactivity of indigenous allergen extracts of dust mites against validated allergen. Study enrollment included 197 patients with allergic disorders that showed sensitivity to dust mite during routine allergy skin testing. Study participants were tested with varying dilutions of DP and DF indigenous extracts along with USFDA-approved allergens in a blinded fashion. Results were recorded, and statistical significance was calculated using the Friedman rank sum test. RESULTS: Using the Friedman rank sum test with a Tukey adjustment for multiple comparisons, we found that the extracts in each dilution were significantly different (P < .0001). The full strength indigenous extracts, B-DF (DF allergen standard extract from Bioproducts and Diagnostics, India) and C-DF (DF allergen extract from Creative Diagnostics, India) extracts, had mean wheal sizes of 7.69 (standard deviation [SD] 9.91) and 31.01(SD 51.04), respectively. The full strength S-DF (DF allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) had a mean wheal size of 109.97 (SD 162.73), which was significantly higher (P < .0001) than both the indigenous extracts. For each of the dilutions, the S-DF mean wheal size was significantly greater than that of the corresponding B-DF and C-DF wheal sizes. The full strength indigenous C-DP (DP allergen extract from Creative Diagnostics, India) had mean wheal size of 39.37 (SD 51.74). The full strength standard S-DP (DP allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) extract had a mean wheal size of 167.66 (SD 270.80), which was significantly higher (P < .0001) than the indigenous C-DP extract. Similar differences were seen across all dilutions. CONCLUSION: The indigenous extracts have significantly lower potency compared to USFDA-approved extracts; hence, there is an urgent need for policy makers to institute stringent criteria for standardization of antigens in India.
RESUMO
In this study, the acute and subchronic toxicity effect of the Syzygium aqueum leaf extract (SA) was evaluated. For the acute toxicity study, a single dose of 2000 mg/kg of the SA was given by oral-gavage to male Sprague-Dawley (SD) rats. The rats were observed for mortality and toxicity signs for 14 days. In the subchronic toxicity study the SA was administered orally at doses of 50, 100, and 200 mg/kg per day for 28 days to male SD rats. The animals were sacrificed at the end of the experiment. The parameters measured including food and water intake, body weight, absolute and relative organ weight, blood biochemical tests and histopathology observation. In both the acute and subchronic toxicity studies, SA did not show any visible signs of toxicity. There were also no significant differences between the control and SA treated rats in terms of their food and water intake, body weight, absolute and relative organ weight, biochemical parameters or gross and microscopic appearance of the organs. There were no acute or subchronic toxicity observed and our results indicate that this extract could be devoid of any toxic risk. This is the first in vivo study reported the safety and toxicity of SA.
RESUMO
Trichosanthes cucumerina Linn. is one of the medicinal plants that is often used in Sri Lankan traditional systems of medicine for the preparation of formulations to treat a variety of disease conditions. However, the toxic effects of T. cucumerina are not known. The aims of the present study were to (a) standardize hot water (HWE) and cold ethanolic (CEE) extracts of T. cucumerina aerial parts, and (b) evaluate toxic potential of the plant extracts. Both extracts were standardized by developing their densitograms and HPLC fingerprints and determination of physico chemical parameters such as total ash, water soluble ash and acid insoluble ash. Administration of the HWE or CEE to mice did not result in acute or chronic toxic effects as evident from their effects on (a) liver and kidney functions and (c) hematological parameters and (d) fertility of male or female mice.In conclusion, the results of this study have revealed that standardized extracts of T. cucumerina at the doses tested do not produce any serious toxic side effects.
Trichosanthes cucumerina Linn. Es una de las plantas comunmente utilizadas en el sistema de medicina tradicional de Sri Lanka, en la preparación de formulaciones para el tratamiento de diversas enfermedades. Debido a que los efectos tóxicos de T. cucumerina no se conocen, los objetivos de este estudio fueron: (a) estandarizar los extractos obtenidos con agua caliente (EAC) y con etanol frío (EEF), y (b) evaluar la toxicidad de ambos extractos. Ambos extractos fueron estandarizados por obtención de sus densitogramas y huella digital con HPLC. Adicionalmente se determinaron parámetros fisicoquímicos, tales como: cenizas totales, cenizas solubles en agua y cenizas solubles en ácido. La administración de EAC y EEF a ratones no mostró efectos tóxicos agudos ni crónicos. Las funciones renales, hepáticas, estudios hematológicos y de fertilidad en machos y hembras fueron normales. Se concluye que los extractos estandarizados de T. cucumerina, a las dosis ensayadas no producen ningún efecto tóxico.
