Comparing hand-held computers and paper diaries for haemophilia home therapy: a randomized trial

Treatment of severe haemophilia with factor concentrates is by self-infusion in the home. Adherence to record keeping on paper diaries is poor. A randomized-controlled trial compared adherence with record keeping of paper diaries with hand-held computers. Forty-one individuals with severe haemophilia, were randomized to hand-held computers (n = 22) or paper diaries (n = 19) and followed for 6 months. About 86.2% (679 of 788) of infusions by patients in the computer group were in compliance with the data submission schedule compared with only 48.3% (358 of 741) of infusions by patients using paper diaries (P < 0.0001). The time intervals between infusions and the receipt of data were shorter in the computer group (median 0.25 vs. 25 days respectively, P < 0.0001). Reminder phone calls by the clinic were made less frequently to users of hand-held computers than to users of paper diaries (median one vs. five times, P < 0.0001). Accuracy of data was similar for both methods. Compliance with hand-held computers was superior to paper diaries. The clinic received data from hand-held computers mostly on the same day, and nurses could thereby provide clinical advice more effectively. Although hand-held computers did not result in increased accuracy, errors could be detected and corrected more rapidly. Electronic data can more easily be verified, analysed and summarized than that from paper diaries.     

Prospective, Double-Blind, Randomized, Parallel-Group, Dose-Ranging Study of Botulinum Toxin Type A in Men with Glabellar Rhytids

BACKGROUND: The effective dose for treating glabellar lines with botulinum toxin type A in men has not been studied adequately. OBJECTIVE: To compare the safety, efficacy, and duration of response of four doses of botulinum toxin type A on glabellar rhytids in men. METHODS: Eighty men were randomized to receive a total dose of either 20, 40, 60, or 80 U of botulinum toxin type A (BOTOX, BOTOX Cosmetic, or Vistabel, Allergan, Inc., Irvine, CA, USA) in the glabellar area. Glabellar lines were assessed at rest and maximum frown by a trained observer at baseline, 2 and 4 weeks, and monthly thereafter. Patients provided self-evaluations at the same visits. Adverse events were monitored throughout. RESULTS: The 40, 60, and 80 U doses of botulinum toxin type A were consistently more effective in reducing glabellar lines than the 20 U dose (duration, peak response rate, improvement from baseline). There was a dose-dependent increase in both the response rate at maximum frown and the duration of effect assessed by the trained observer. In addition, the participants reported a dose-dependent reduction in the ability to frown, improvement in their global assessment, and increased feelings of attractiveness, self-confidence, and satisfaction. The incidence of adverse events was not increased with higher doses. CONCLUSION: Male participants with glabellar rhytids benefit from starting doses of at least 40 U of botulinum toxin type A.     

Supply and demand in cerebral energy metabolism: the role of nutrient transporters.

Glucose is the obligate energetic fuel for the mammalian brain, and most studies of cerebral energy metabolism assume that the majority of cerebral glucose utilization fuels neuronal activity via oxidative metabolism, both in the basal and activated state. Glucose transporter (GLUT) proteins deliver glucose from the circulation to the brain: GLUT1 in the microvascular endothelial cells of the blood-brain barrier (BBB) and glia; GLUT3 in neurons. Lactate, the glycolytic product of glucose metabolism, is transported into and out of neural cells by the monocarboxylate transporters (MCT): MCT1 in the BBB and astrocytes and MCT2 in neurons. The proposal of the astrocyte-neuron lactate shuttle hypothesis suggested that astrocytes play the primary role in cerebral glucose utilization and generate lactate for neuronal energetics, especially during activation. Since the identification of the GLUTs and MCTs in brain, much has been learned about their transport properties, that is capacity and affinity for substrate, which must be considered in any model of cerebral glucose uptake and utilization. Using concentrations and kinetic parameters of GLUT1 and -3 in BBB endothelial cells, astrocytes, and neurons, along with the corresponding kinetic properties of the MCTs, we have successfully modeled brain glucose and lactate levels as well as lactate transients in response to neuronal stimulation. Simulations based on these parameters suggest that glucose readily diffuses through the basal lamina and interstitium to neurons, which are primarily responsible for glucose uptake, metabolism, and the generation of the lactate transients observed on neuronal activation.     

Dose-Ranging Study of Botulinum Toxin Type A in the Treatment of Glabellar Rhytids in Females

OBJECTIVE: To compare the efficacy, safety, and duration of effect of four doses of botulinum toxin type A in the treatment of glabellar rhytids in females. DESIGN: Double-blind, randomized, parallel-group, dose-ranging trial followed by an open-label extension. SETTING: Private dermatologic clinic. SUBJECTS: Eighty female subjects with moderate to severe wrinkles at maximum frown entered the study. The first 40 subjects completing the double-blind phase entered the open-label extension. INTERVENTION: Random administration of 10, 20, 30, or 40 U botulinum toxin type A in divided doses. Open-label trial: 30 U botulinum toxin type A at the same sites in divided doses. MAIN OUTCOME MEASUREMENTS: Trained observer and subject assessments of wrinkle severity at maximum frown and repose using the Facial Wrinkle Scale (0 = none to 3 = severe), subject satisfaction, and adverse events. Follow-up monthly for up to 1 year postinjection. RESULTS: Relapse rates and responder rates revealed benefits lasting 3 to 6 months or longer. Objectively, 10 U of botulinum toxin type A was significantly less effective than 20, 30, or 40 U. The relapse rate at 4 months was significantly higher in the 10 U group (83%) versus 40, 30, or 20 U (28%, 30%, and 33%, respectively). Subject satisfaction was high in all groups. Duration of effect and response rates were sustained during the open-label extension. Adverse effects were mild and infrequent. CONCLUSION: Twenty to 40 U botulinum toxin type A doses were significantly more effective at reducing glabellar lines than 10 U. Most subjects experienced benefits for 3 to 4 months; some subjects demonstrated effect for up to 12 months.     

Single-Center, Double-Blind, Randomized Study to Evaluate the Efficacy of 4% Lidocaine Cream versus Vehicle Cream During Botulinum Toxin Type A Treatments

BACKGROUND: Botulinum toxin type A (BTX-A) injections are overwhelmingly safe and effective treatment in cosmetic treatment, but some patients are apprehensive about pain associated with injection. OBJECTIVE: To determine whether preprocedural application of lidocaine 4% topical anesthetic cream to the injection site will reduce pain on injection of BTX-A for the treatment of crow's feet. METHODS: Twenty-four participants receiving bilateral injections for crow's feet were enrolled. Subjects were randomized to one of four study groups. Prior to BTX-A injection, group 1 (n = 6) received lidocaine 4% cream on the right side of the face and vehicle cream on the left side of the face; group 2 (n = 6) received vehicle cream on the right side and lidocaine 4% on the left side; group 3 (n = 6) received lidocaine 4% on both sides; and group 4 (n = 6) received vehicle cream on both sides. RESULTS: We observed a statistically significant reduction in subject-reported procedural pain in participants pretreated with lidocaine 4% on both sides of the face compared with controls. CONCLUSION: Lidocaine 4% cream is effective in reducing the pain associated with BTX-A injection for crow's feet. We encourage further study to clarify the optimal use of topical anesthetics in the practice of cosmetic dermatology.     

Low-artifact intravascular devices: MR imaging evaluation

Flow-phantom magnetic resonance (MR) imaging, with use of both spin-echo (SE) and gradient-echo (GRE) techniques at 1.5 T, was performed on the percutaneous Greenfield (beta-III titanium alloy [TMA wire]), Amplatz (MP32-N alloy), and Simon nitinol filters and TMA wire facsimiles of the bird's nest, Gunther, new retrievable, and Amplatz vena caval filters. SE imaging allowed detection of thrombi as small as 5 X 5 mm trapped within the percutaneous Greenfield, Simon nitinol, and TMA-wire facsimile filters; with the MP32-N Amplatz filter, a larger volume of thrombus (10 X 20-mm clots) was necessary for clot detection. GRE imaging allowed detection of intraluminal tilting of the percutaneous Greenfield and facsimile Amplatz (TMA-wire) filters. GRE imaging was useful for demonstrating postfilter turbulence due to clots, which was greatest for the Amplatz filter. Imaging of facsimile vascular devices made of tantalum or TMA wire did not cause the severe "black-hole" MR artifacts typical of the stainless-steel devices. SE and GRE imaging were very useful for determining caval patency in two patients with previously placed Mobin-Uddin filters. Noninvasive MR evaluation of blood vessels in the presence of a variety of low-artifact intravascular devices appears feasible.