ABSTRACT
BACKGROUND: Postoperative nausea and vomiting (PONV) remain significant clinical problems for patients, especially nausea. The D2-antagonist droperidol was popular for prophylaxis until safety concerns limited its use. In early testing, APD421 (amisulpride for i.v. injection), a D2/D3-antagonist, has shown promising antiemetic efficacy at very low doses. We conducted a randomized, double-blind, dose-finding study to investigate APD421 in PONV prophylaxis. METHODS: Adult surgical patients with ≥2 Apfel risk factors for PONV undergoing surgery expected to last ≥1 h and receiving standard inhalation anaesthesia were randomized to receive placebo or one of three doses of APD421 (1, 5, or 20 mg) as a single i.v. administration at anaesthesia induction. The primary endpoint was PONV (vomiting/retching or antiemetic rescue) in the 24 h period after surgery. RESULTS: Two hundred and fifteen patients received study drug, 92% female and 60% with ≥3 risk factors. Groups were well balanced for baseline characteristics and risk factors. The PONV incidence was 37/54 [69%; 90% confidence interval (CI), 57-79%] in the placebo group; 28/58 (48%; 90% CI, 37-60%) with 1 mg APD421 (P=0.048); 20/50 (40%; 90% CI, 28-53%) with 5 mg (P=0.006); and 30/53 (57%; 90% CI, 44-68%) with 20 mg (P>0.1). APD421 at 5 mg also significantly improved vomiting, rescue medication use, and nausea rates. The safety profile of APD421 was similar to that of placebo at all doses, with no significant central nervous system (CNS) or cardiac side-effects. CONCLUSIONS: APD421 given i.v. before surgery is safe and effective at reducing PONV in moderate/high-risk adult surgical patients. The optimal dose tested was 5 mg.
Subject(s)
Antiemetics/therapeutic use , Dopamine Antagonists/therapeutic use , Postoperative Nausea and Vomiting/prevention & control , Sulpiride/analogs & derivatives , Adult , Aged , Aged, 80 and over , Amisulpride , Anesthesia, Inhalation/methods , Antiemetics/administration & dosage , Antiemetics/adverse effects , Dopamine Antagonists/administration & dosage , Dopamine Antagonists/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Injections, Intravenous , Male , Middle Aged , Postoperative Period , Preanesthetic Medication/methods , Sulpiride/administration & dosage , Sulpiride/adverse effects , Sulpiride/therapeutic use , Treatment Outcome , Young AdultABSTRACT
BACKGROUND: Secondary AA amyloidosis is a classical complication of rheumatismal or chronic infectious diseases. Psoriasis is a rare cause of secondary amyloidosis with only around thirty cases reported in the literature. CASE REPORT: A 62 year-old man exhibited cutaneous lesions of psoriasis for six years complicated by articular involvement over the past year. The occurrence of an isolated proteinuria revealed renal and hepatic AA amyloidosis. Treatment with methotrexate (Méthrotrexate), enalapril (Renitec) and colchicine (Colchicine) was initiated and led to a stabilization of the proteinuria for two years. DISCUSSION: In psoriatic patients, secondary amyloidosis mainly complicates the arthritic diseases of prolonged progression. Our case report is original in the rapid onset of amyloidosis after the first articular signs. The clinical manifestations of secondary amyloidosis are related to renal or gastrointestinal involvement. Prognosis is usually poor. Treatment of secondary amyloidosis is difficult and relies on systemic treatment. Colchicine may be helpful.
