A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.

BACKGROUND: Allergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately. Oxymetazoline has a rapid onset of action, but its use should be limited to 3-5 days. OBJECTIVE: The study aimed to evaluate the safety and effectiveness of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily in patients with AR in a real-world clinical setting. METHODS: The study was a prospective, open-label, single-arm, multicenter, real-world observational study conducted in patients with AR for a period of 28 days. Patients (n = 388) with a diagnosis of AR were treated with a combination of FF + OXY nasal spray. Total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total symptom score (TSS) were documented at baseline and at the end of study period. The overall effectiveness of treatment with FF + OXY was rated by the investigators as very good/good/satisfactory/poor (4-point Likert scale) for each patient. RESULTS: Treatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS, from 7.18 ± 3.38 at baseline to 0.20 ± 0.84 (p < 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 (p < 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 (p < 0.001) at 28 days respectively. With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported. CONCLUSION: The fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg was effective in relieving the nasal congestion and reduction of TNSS, TOSS and TSS in patients suffering from AR. The combination was safe and well tolerated with no rebound congestion throughout the treatment period.

Effect of sodium arsenite on reproductive organs of female Wistar rats.

The present study was performed to investigate the subchronic effect of sodium arsenite on female Wistar rats. Mature female rats were divided into 4 groups of 12 animals each. Group I received distilled water, whereas the other 3 groups received sodium arsenite at 10, 30, and 50 µg/L doses for 60 days through drinking water. Half of the animals from each group were dissected after 30 days and the remaining after 60 days. A disruption in estrous cycle was observed with prolonged diestrous and metestrous phases. A significant increase in ovarian surface epithelium and follicular atresia was observed in treated rats (p ≤ .05). A significant decrease (p ≤ .05) in the uterine myometrium was observed. A significant increase (p ≤ .05) in the levels of lipid peroxidation along with decrease in the activities of antioxidant enzymes was observed. The results revealed that subchronic exposure of sodium arsenite causes degenerative changes in reproductive organs and induces oxidative stress in female rats.

Assessment of genotoxic potential of arsenic in female albino rats at permissible dose levels.

BACKGROUND: Arsenic is a wide spread environmental contaminant and has been recognized as a genotoxic element which is of major public health concern. AIM: The present study evaluates the genotoxic potential of arsenic at low permissible dose levels. MATERIALS AND METHODS: Forty-eight mature female rats were divided into four groups of 12 animals each. Group I animals received distilled water and served as control. Group II-IV animals received sodium arsenite dissolved in distilled water continuously for a period of 60 days at the dose of 10, 30 and 50 µg/L (ppb) respectively. Six rats from each group were sacrificed after 30 days of arsenic exposure and the remaining animals were sacrificed after 60 days. Liver was excised from the sacrificed animals to study the probable advent signs of carcinogenicity measured through microsomal degranulation test. Assessment of mutagenic potential of arsenic was evaluated through chromosomal aberrations observed in the bone marrow cells. RESULTS: The levels of RNA and proteins decreased significantly (P ≤ 0.01) in all the three doses administered along with an increase in % microsomal degranulation in hepatic fraction when compared to control at both 30 and 60 days time period. A dose-dependent increase in chromosome aberrations like fragmentation, breakage has been observed in all the treated animals. CONCLUSION: The results of present study revealed that chronic exposure of arsenic even at its low permissible dose limits results in carcinogenic and mutagenic effects which emphasize its genotoxic possibility.

Total phenolic contents and free radical scavenging activities of different extracts of seabuckthorn (Hippophae rhamnoides) pomace without seeds.

In this study, 100% methanolic extract (ME), 70% aqua-methanolic extract (AME) and 100% aqueous extract of seabuckthorn byproduct were used to evaluate antioxidant activity. The total phenolic contents were high in AME (84.28 ± 1.58 mg of Gallic Acid Equivalent (GAE)/gm of extract) compared to other extracts. All the extracts scavenged different in vitro radicals in a concentration-dependent manner. The IC(50) values were lowest in AME for 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) diammonium salt, 2,2-diphenyl-1-picrylhydrazyl, superoxide and nitric oxide radicals, while ME had lowest values for hydroxyl radicals. The reducing power of the extracts increased in a dose-dependent manner and was highest in AME. The findings of this study revealed that seabuckthorn pomace without seed is one of the important resources as an antioxidant for food, pharmaceuticals, cosmetic or nutraceutical industries.