FIL SSF intraocular lens opacification after pars plana vitrectomy with gas tamponade for traumatic lens luxation and retinal detachment: a case report and literature review.

BACKGROUND: To report a case of sutureless scleral-fixated hydrophilic intraocular lens (FIL SSF IOL, Soleko, Italy) opacification following pars plana vitrectomy surgery using sulfur hexafluoride (SF6) for traumatic lens luxation associated with retinal detachment. CASE PRESENTATION: A 77-year-old woman was referred to our emergency department after blunt trauma in her right eye. At the ophthalmic evaluation, visual acuity was hand movement, biomicroscopy showed pseudoexfoliation syndrome and a traumatic lens luxation in the vitreous chamber. The patient underwent pars plana vitrectomy, subluxated cataract explantation, and FIL SSF IOL implant. During surgery, an inferior retinal detachment was encountered, requiring 20% SF6 gas tamponade. No adverse events were encountered. One month postoperatively, visual acuity (BCVA) improved to 0,3 logMAR. At the 3-month follow-up, the patient presented with BCVA of 0,5 logMAR, and biomicroscopy showed a minimal IOL opacification. Six months postoperatively, BCVA decreased to 1.0 logMAR, and diffuse, IOL opacification was noted at slit lamp examination. The patient refused any other surgical intervention for IOL exchange. CONCLUSIONS: Although hydrophilic IOL opacification gas related is known, to the best of our knowledge, this is the first case reported in the literature of FIL SSF IOL opacification after pars plana vitrectomy with gas tamponade for retinal detachment.

Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans.

BACKGROUND: Dihydroergotamine (DHE), a proven migraine treatment, currently has product labeling warning against concomitant use of CYP3A4 inhibitors because of potential drug interactions. However, no reported studies of such interactions with DHE administered by any route are available. METHODS: The pharmacokinetics (PK) of MAP0004, an investigative inhaled DHE formulation, were assessed in human subjects with and without CYP3A4 inhibition by ketoconazole to evaluate the potential for drug interaction, elevation of DHE levels, and increased adverse effects. RESULTS: After MAP0004 alone vs. MAP0004 plus ketoconazole, the DHE maximum concentrations (C(max)) and area-under-the-curve (AUC(0-48) and AUC(0-∞)) were not statistically significantly different nor was the C(max) of the primary metabolite, 8'-OH-DHE. A difference in 8'-OH-DHE AUCs was observed between MAP0004 with and without ketoconazole; however, the concentrations were very low. MAP0004 was well tolerated after both treatments. CONCLUSIONS: This study demonstrated that CYP3A4 inhibition had little to no effect on DHE PK after MAP0004 administration, apparently because of its high systemic and low gastrointestinal bioavailability. CYP3A4 inhibition slowed elimination of the metabolite 8'-OH-DHE, but concentrations were too low to be pharmacologically relevant.

Heated lidocaine/tetracaine patch (Synera, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access.

BACKGROUND: We compared the lidocaine/tetracaine patch [Synera (USA), Rapydan (Europe)], a novel heat-aided patch using a eutectic mixture of lidocaine 70 mg and tetracaine 70 mg, with a eutectic mixture of lidocaine 25 mg ml(-1) and prilocaine 25 mg ml(-1) (EMLA Cream). The agents were administered at different time periods for local topical anaesthesia before a vascular access procedure. METHODS: In this double-blind, paired study, 82 adult volunteers were randomized to receive the lidocaine/tetracaine patch on one anticubital surface and lidocaine/prilocaine cream on the other concurrently for 10, 20, 30, or 60 min before a vascular access procedure. Subjects rated pain intensity using a 100 mm visual analogue scale (VAS). Skin reactions and adverse events were also evaluated. RESULTS: Median VAS scores were significantly lower for the lidocaine/tetracaine patch than for lidocaine/prilocaine cream in the 10 min (P=0.010), 20 min (P=0.042), and 30 min (P=0.001) application groups. The lidocaine/tetracaine patch was associated with significantly more erythema than lidocaine/prilocaine cream at 20, 30, and 60 min, whereas lidocaine/prilocaine cream produced more blanching than the lidocaine/tetracaine patch at 30 and 60 min. Two subjects reported nausea and faintness associated with the vascular access procedure; one was withdrawn from the study. CONCLUSIONS: The lidocaine/tetracaine patch provided effective anaesthesia with an application time as short as 10 min and was better than lidocaine/prilocaine cream at all application times shorter than 60 min, demonstrating a substantial improvement in time to onset of anaesthesia. The lidocaine/tetracaine patch provided an important alternative to lidocaine/prilocaine cream for topical local anaesthesia.

Bioequivalence of liquid and freeze-dried recombinant human follicle-stimulating hormone.

OBJECTIVE: The bioequivalence and tolerability of freeze-dried and liquid formulations of recombinant human follicle-stimulating hormone (r-hFSH) filled-by-mass were assessed in a crossover, open-label, randomised, single-centre, phase I bioequivalence study. METHODS: Following pituitary down-regulation with the gonadotrophin-releasing hormone agonist goserelin, healthy adult volunteers (18years-45years of age) received single subcutaneous injections of r-hFSH , 300 IU, from freeze-dried and liquid formulations in random order, separated by a 7-day washout period. Blood was obtained over 144 h for pharmacokinetic analysis. MAIN OUTCOME MEASURES: These were peak serum FSH concentrations (Cmax,), time to peak concentration (Tmax) and area under the concentration-time curve from zero to the last measurable concentration (AUCJ), local and systemic tolerability. RESULTS: Of 44 volunteers who underwent down-regulation, 39 (18 men, 21 women) completed the study. Cmax and AUClast were similar with the freeze-dried (mean 9.51 IU/L and 844 IU.h/L, respectively) and liquid (mean 8.99 IU/L and 841 IUh/L, respectively) formulations, whereas T was significantly higher with the liquid formulation (median 12h vs 15h, p = 0.0183). The 90% confidence intervals for the ratio of the treatment means for Cnw and AUC,=, were within the pre-defined bioequivalence range of 0.8-1.25. CONCLUSION: Both formulations were well tolerated with regard to both systemic and local adverse events. The freeze-dried and liquid formulations of r-hFSH are bioequivalent and show no significant differences in tolerability. Thus, the liquid formulation is expected to provide comparable efficacy and tolerability to the freeze-dried formulation in clinical use.

Preservative-free influenza vaccine.

OBJECTIVE: To investigate the immunogenicity of and tolerance towards the preservative-free inactivated influenza vaccine Begrivac. METHODS: In this prospective, single-centre, non-controlled study, efficacy was evaluated by the change in influenza antibody titre from baseline to 21 days following vaccination. The safety variables included post-injection reactions and adverse events. Blood samples were taken on day 21 and the antibody titre assayed by haemagglutination inhibition test. RESULTS: All three of the European efficacy requirements for influenza vaccines are satisfied by the new preservative-free vaccine described in this report. The mean geometric increase in titre and the proportion of vaccination responders were greater in patients of the adult group than in the elderly. Thus for strain A/Beijing/262/95 66% of subjects seroconverted and 28% showed a significant increase in antibody titre (total 94%), compared to a total of 45 patients (76%) in the elderly group. For strain A/Sydney/5/97 the corresponding figures were total 55 (90%) adult and 47 (80%) elderly, and for B/Beijing/184/93 46 (75%) adult and 31 (53%) elderly. Sixty four subjects (53%) reported adverse events, mainly local reactions at the injection site such as pain, erythema and induration, and systemic reactions such as headache and fatigue. CONCLUSIONS: The absence of preservative in this novel vaccine preparation does not have any detectable impact on its efficacy or safety and tolerability profile.

Acute liver injury related to the use of niperotidine.

BACKGROUND/AIMS: H2-receptor antagonists are widely used for the therapy of peptic disease, since they ensure a protracted and intense inhibition of gastric acidity. Niperotidine (piperonyl-ranitidine) is a new H2 blocking agent recently proposed for clinical use. METHODS: Twenty-five cases of acute hepatitis associated with the use of niperotidine were reported in Italy between March and August 1995. Intercurrent viral infections, recent drug and alcohol consumption and blood transfusions were excluded as causes. RESULTS: All patients showed an increase in the parameters of liver cell injury and the clinical symptoms of acute hepatitis. After withdrawal of the drug, all patients showed a good outcome, except one who developed a fulminant hepatitis and died from digestive tract bleeding. CONCLUSIONS: The absence of other causes of acute liver injury suggests that the observed liver injury may be a niperotidine-adverse reaction. Moreover, the lack of a relationship between the dose of the drug and the degree of liver damage, the variable latent period and the rarity and unpredictability of the injury are suggestive of an idiosyncratic reaction.

Peritoneal mesothelioma in recurrent familial peritonitis.

A 39-year-old man had a 2-year history of fatigue, weight loss, drug-resistant ascites, and decreased intestinal motility. During adolescence he began to suffer frequent episodes of acute benign peritonitis that spontaneously subsided at age 35. The fact that his younger brother was taking colchicine for the same symptoms led us to diagnose familial Mediterranean fever (FMF). The medical workup revealed uniform thickening of the intestinal wall with no signs of amyloidosis. Exploratory laparotomy revealed diffuse peritoneal mesothelioma that proved to be unresponsive to chemotherapy. There was no history of asbestos exposure. It is probable that the chronic peritoneal inflammation was responsible for the development of this tumor, although in almost all cases of FMF this phenomenon causes only limited peritoneal fibrosis or, less commonly, encapsulating peritonitis. A computerized search of the literature indicates that this is the second report of peritoneal mesothelioma associated with FMF.

Pancreatic juice 90K and serum CA 19-9 combined determination can discriminate between pancreatic cancer and chronic pancreatitis.

OBJECTIVES: Differential diagnosis of pancreatic cancer versus chronic pancreatitis may be difficult. The aim of this study is to determine whether a group of tumor-associated antigens could differentiate between the two pathologies. METHODS: CA 19-9, TAG-72, CAR-3, and a newly discovered antigen termed "90K" were determined in the serum and in the pancreatic juice of 19 patients with pancreatic cancer, 20 patients with chronic pancreatitis, and seven controls with lithiasis of extrapancreatic bile ducts. RESULTS: The serum antigen levels of all three markers except 90K were significantly higher in pancreatic cancer than in chronic pancreatitis. High correlations were found between serum CA 19-9 and both TAG-72 and CAR-3. 90K did not correlate with other markers. In pancreatic juice, only 90K values were significantly higher in chronic pancreatitis than in pancreatic cancer, and only 90K and CA 19-9 were significantly correlated. At the stepwise discriminant analysis, serum CA 19-9 and pancreatic juice 90K had independent diagnostic roles. Used in combination, they correctly identified 84.2% of pancreatic cancer and 90% of chronic pancreatitis. CONCLUSIONS: These data suggest that pancreatic juice 90K and serum CA 19-9 can discriminate between chronic pancreatitis and pancreatic cancer. The data further support the complementary use of tumor-associated antigens along with other diagnostic tools.