A drug experience registry

The Drug Exerience Registry is a system for the recording and filing of drug-related patient events in a readily retrievable form. The purpose of the registry is to accumulate information on adverse drug reactions, unusual therapeutic successes of failures, and other experiences that may be useful for education, research or promotion of rational drug therapy. Data are recorded on case report forms which are categorized by organ-disease system affected, the clinical event and involved drug(s). These are then filed in the clinical event file along with literature synopses that serve as guides in evaluating the incidents and determining proper therapy. A drug file serves as a cross index to the clinical event file and allows one to quickly locate clinical events involving a drug. Both files contain sufficient hospital data to allow later retrieval of additional information if needed.     

Erythropoietic protoporphyria. Hepatic implications

Repetitive behaviors of six autistic children were observed under two conditions of background illumination. During two sessions, the room was illuminated by fluorescent light and during two other sessions, by equal intensity incandescent light. Subjects spent significantly more time engaged in repetitive behavior under fluorescent light. Previous research suggested that these findings were related to the flickering nature of fluorescent ilumination. Practical and theoretical implications were discussed. Further experimentation was suggested to assess relationships between flickering illumination and arousal.     

Medical sculpture: a valuable aid to patient rehabilitation

Silicone rubber is the most satisfactory material for cosmetic prostheses. It has a soft, lifelike texture, is easily worked and easily colored and is strong enough to withstand frequent application and removal. Examples of patients referred to the medical sculptor include those with congenital defects of one or both ears, loss of the nose or an eye and orbit due to cancer surgery, loss or absence of fingers or parts of the hand and those who have had radical breast surgery.     

Phase I clinical study of the recombinant oncotoxin TP40 in superficial bladder cancer

Many previous studies evaluating various hormone levels in males with subnormal semen analyses were performed when the normal semen parameters were considerably higher than now. This study evaluated sera levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), total testosterone (TET), free TET, and prolactin (PRL) in 60 males with oligospermia and decreased motility according to recent World Health Organization standards. Three separate groups were evaluated: group 1, motile density (MD) < 5 x 10(6)/mL (but not azoospermia); group 2, 5 < or = MD < 10 x 10(6)/mL; group 3, MD > 10 x 10(6)/mL, but % motility < 30%. There were no significant differences in mean FSH levels between groups. Overall FSH was increased in 47.1% of the cases. In contrast, mean LH levels were normal in all three groups. Only 17.3% of the entire group had elevated LH levels. The TET level was below normal in 32.3% of the entire group, with a fairly equal distribution between the three groups. Overall, only 7.8% had elevated PRL levels, with the highest percentage found in group 3 (22.2%). Only a small minority of patients with increased FSH had low TET levels compared to 48.0% of those with normal FSH. These data demonstrate that when using the lower semen parameters, the most common serum hormone abnormality is increased FSH; men with MD < 5 x 10(6)/mL do not have a higher incidence of elevated FSH than those with higher MDs.(ABSTRACT TRUNCATED AT 250 WORDS)     

Sonoclot analysis

Assessment of perioperative bleeding disorders, especially those related to platelet dysfunction, remains a clinical challenge. The management of the bleeding patient in the operating theatre or on the postoperative ward is often empirical with little scientific basis. Much of the reason for this is that conventional clotting studies are not immediately available and there is a perceived urgency, particularly among trainee doctors, to treat bleeding disorders without first establishing the exact nature of the coagulopathy. SCT provides useful information on platelet function, particularly in patients after cardiopulmonary bypass, and has enabled practitioners to rationalize the management of bleeding disorders and not expose their patients to the risks of unnecessary transfusion of blood products. Undoubtedly further studies are required before this instrument can be used reliably in the clinical setting but it may prove to be a useful addition to the available techniques for monitoring perioperative bleeding disorders.     

Prophylactic and therapeutic efficacy of an avian antitoxin in ricin intoxication

This study was designed to demonstrate the efficacy in animals of a ricin antitoxin consisting of purified avian antibodies. Antitoxins consisting of avian antibodies have significant advantages when compared to conventional mammalian (e.g. horse) antibodies; (a) avian antibodies do not fix human complement, eliminating associated inflammatory reactions, and, (b) avian antibodies can be manufactured more economically. Ricin toxoid was injected into laying hens followed by collection of eggs bearing hyperimmune immunoglobulin. Immunoglobulin was extracted from yolks and purified by immunoaffinity chromatography. In a mouse model for toxin neutralization it was shown that immunoaffinity purified ricin antibodies could prevent ricin lethality. Furthermore, it was shown that passive antibody treatment leads to active ricin immunization in animals given lethal ricin doses. Highly purified avian antibodies, as developed in this study, should offer enhanced clinical effectiveness, greater safety, and reduced manufacturing costs when compared to other technologies.     

Acute vision loss resulting from complications of ethanol abuse

A dynamic digital brain phantom was created from the MRI to evaluate visually the relationship between the noise and the error in the parameter estimates in the PET kinetic analysis. This phantom incorporates the noise level depending on administration dose, camera efficiency and the data acquisition schedule. We simulated a serial dynamic scan with 18F-FDG or 11C-flumazenil, assuming 2-tissue 3-parameter model and 1-tissue 2-parameter model, respectively, and the sampling schedule was determined according to the clinical examination. The noise in the tissue time activity curve in FDG had a peak in the first minute and decreased thereafter, whereas the noise increased gradually in the flumazenil study after the initial peak due to radioactivity decay. We examined the relationship between the noise level and the error in the parameter estimates. Both mean absolute differences between true and estimated values and standard deviation became large, and the quality of the parametric images became poor with increasing noise level. This simulation was compared with human tissue time activity curves and parametric images, which were obtained with 100 MBq administration dose in FDG study and 430 MBq in flumazenil study. We inferred that the noise level in the human study was 10-20% in FDG, and 20-40% in flumazenil, and the error in the estimated parameter of K-complex in FDG study was about 20%, that of DV in flumazenil study was 2%.     

Immunoassay of human Neisseria meningitidis serogroup A antibody

An enzyme immunoassay is described which quantitates antibodies to Neisseria meningitidis serogroup A capsular polysaccharide in human sera. Modifications of a previously developed two-day assay by Carlone et al. were made to permit analysis in one day and to be compatible with automation. The allowable variations in assay conditions and the areas in which stringent control must be maintained for consistent assay performance are described. Antigen-coating parameters, the kinetics of primary and secondary antibody incubation steps, the buffer compositions, including detergents, serum requirements, and the need for blocking steps were examined. Our modified one-day assay showed excellent agreement with the standardized method of Carlone, with a correlation coefficient between the two methods of 0.989. This assay is adaptable within a permissible range of parameters thus facilitating the implementation of the standardized assay. This will maximize the consistency of results from serum analysis for conjugate vaccine trials related to serotype A Neisseria meningitidis.