RESUMEN
Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome is a severe adverse drug reaction characterized by skin rash, fever, lymph node enlargement, and single or multiple organ involvement. Prompt diagnosis and withdrawal of the offending drug reduce mortality. We report a case of DRESS syndrome along with a review of the literature. We identified the case as DRESS syndrome based on the skin rash, fever, eosinophilia, and liver and kidney involvement. According to the European Registry of Severe Cutaneous Adverse Reactions to Drugs and Collection of Biological Samples (RegiSCAR), our patient had a score of 6. Drug rash with eosinophilia and systemic symptoms syndrome is a severe form of drug reaction with the potential for significant morbidity and mortality. Human leukocyte antigens (HLA) screening may be performed to prevent disease in susceptible patients. Steroids in a tapering dose are helpful in the resolution of symptoms.
RESUMEN
Efficacy and safety of 2 herbal products--E-MA-H at 2 dose levels, low (HLD) and high (HHD), and E-MA-HP (HP) capsules--versus placebo (PL) was evaluated in subjects with male sexual dysfunction. Males aged 21-60 with erectile dysfunction, premature ejaculation, or other form of sexual dysfunction were studied in this triple-blind, randomized, placebo-controlled, parallel-groups trial. Subjects received any one of the following 4 interventions: E-MA-H 2 capsules at night (HLD) for 60 days; E-MA-H 2 capsules twice daily for 30 days, followed by 2 capsules at night for 30 days (HHD); E-MA-HP (HP) 2 capsules twice daily for 60 days; or placebo (PL) 2 capsules twice daily for 60 days. All dosage regimens were standardized to 2 capsules twice daily by using 2 matching placebo capsules as the morning dose for HLD and on days 31-60 for HHD. Efficacy outcome measures were the international index of erectile function; index for premature ejaculation; erectile dysfunction inventory of treatment satisfaction; subjects' and investigators' global assessment. Safety was assessed through adverse events; hematology; blood chemistry. Of 148 subjects enrolled, 1 was excluded from analysis; data on the intention-to-treat population of 147 (PL = 36, HLD = 38, HHD = 37, HP = 36) were analyzed. There was a significant (P < 0.01) increase in the total international index of erectile function score (mean ± SEM) in subjects receiving HLD (16.28 ± 1.39), HHD (15.40 ± 1.22), and HP (18.55 ± 1.36) compared with PL (6.83 ± 1.52). The same pattern was seen with increase in index for premature ejaculation scores: HLD (9.68 ± 1.17), HHD (10.27 ± 1.05), HP (11.36 ± 1.20) versus PL (3.77 ± 1.04). There was no significant difference in effect among the active treatment groups. The incidence of adverse events was similar in all the groups. Laboratory evaluations did not show any clinically significant abnormality in any of the groups. Treatment with HLD, HHD, and HP is well tolerated, and more effective than placebo (P < 0.01), in subjects with erectile dysfunction, premature ejaculation, and other forms of sexual dysfunction.
Asunto(s)
Disfunción Eréctil/tratamiento farmacológico , Fitoterapia/métodos , Extractos Vegetales/uso terapéutico , Disfunciones Sexuales Fisiológicas/tratamiento farmacológico , Adulto , Cápsulas , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Eyaculación/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Fitoterapia/efectos adversos , Extractos Vegetales/administración & dosificación , Extractos Vegetales/efectos adversos , Resultado del Tratamiento , Adulto JovenRESUMEN
The efficacy and safety of a polyherbal preparation E-OA-07 was compared against placebo in patients with moderate to severe symptoms of osteoarthritis (OA) of the knee, in a double-blind, randomized, parallel groups study. Male or female subjects with American Rheumatism Association functional class II/III and Kellgren Lawrence grade 2 or 3 OA of the knee, who had moderate to severe OA symptoms as recorded by a score of at least 60 on the modified version of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, and an overall pain score of at least 70 mm on a 100 mm Visual analogue (VAS) scale were studied. Subjects received 2 capsules of E-OA-07 or placebo twice daily for 12 weeks and paracetamol up to 2 gm per day as rescue medication. Efficacy outcome measures were WOMAC and VAS scores, functional tests for joint mobility and gait, consumption of rescue medication, investigator's global assessment and subjects' opinion. Safety was assessed through incidence of adverse events and subject's assessment of tolerability. After 12 weeks of treatment, there was a significant reduction of WOMAC scores in the E-OA-07 group as compared with placebo (P < 0.01). Mean (±SEM) reductions in WOMAC scores of pain, stiffness, and physical function for E-OA-07 versus placebo were 8.86 (1.77) versus 2.50 (0.76), 3.00 (0.65) versus 0.75 (0.45), and 30.00 (5.22) versus 10.87 (2.18). Significant between-group differences were also observed for VAS scores of pain and stiffness. The symptom alleviating effect of E-OA-07 persisted over a follow-up period of 4 and 6 weeks as VAS pain and stiffness scores continued to remain statistically lower (P < 0.01) in the E-OA-07 group than placebo. Subject's opinion was significantly greater in favor of E-OA-07 than placebo, whereas both groups received favorable responses from investigator. Consumption of rescue medication and tolerability ratings were similar between the 2 groups. One E-OA-07 subject was hospitalized due to accidental fall and withdrawn from the study. No other serious adverse event occurred. The effect of E-OA-07 in relieving moderate to severe symptoms of OA of the knee is well tolerated, superior, and more persistent than placebo.