Effects of carteolol and timolol on plasma lipid profiles in older women with ocular hypertension or primary open-angle glaucoma.

PURPOSE: To determine the effect on serum lipid levels of carteolol hydrochloride 1.0% or timolol maleate 0.5% given twice a day to women age 60 years and older with primary open-angle glaucoma or ocular hypertension. METHOD: We included 112 patients in this double-masked, randomized, multicenter trial. Fasting clinical laboratory studies were evaluated at baseline and at 12 weeks. Patients were instructed not to change their dietary, alcohol consumption, or exercise habits during the study. RESULTS: For the carteolol group, the high-density lipoprotein (HDL) and total cholesterol/high-density lipoprotein (TC/HDL) ratio at baseline of 50.1 +/- 1.5 mg/dl and 4.7 +/- 0.2 changed by the 12-week visit to 51.3 +/- 1.9 mg/dl (P = .25) and 4.6 +/- .02 (P = .47), respectively. For the timolol maleate group, the baseline HDL and TC/HDL ratio of 53.6 +/- 2.2 mg/dl and 4.4 +/- 0.2 changed to 50.2 +/- 1.9 mg/dl (P < .001) and 4.7 +/- 0.2 (P = .001), respectively, at the 12-week visit. Carteolol patients showed no significant change from baseline, whereas the HDL (P < .001) and TC/HDL ratio decreased (P = .001) significantly in the timolol maleate group. There also was a significant difference in the change from baseline at 12 weeks between carteolol and timolol maleate groups for the HDL and TC/HDL ratio (P = .01 and .012, respectively). No differences in TC, low-density lipoprotein (LDL), or triglycerides (TG) or in changes from baseline were observed between groups at 12 weeks (P > .05). At 12 weeks, no differences were observed between carteolol and timolol maleate groups in intraocular pressure or safety (P > .05), except that patients given carteolol demonstrated fewer solicited ocular symptoms (P = .007). CONCLUSIONS: Carteolol appears to be neutral in its effect on serum lipid levels, whereas timolol maleate adversely affects the HDL and TC/HDL ratio in women age 60 years and older with ocular hypertension or primary open-angle glaucoma.

A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis.

OBJECTIVE: To evaluate the effects of loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis. DESIGN: Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration. PARTICIPANTS: A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated. INTERVENTION: All patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days. MAIN OUTCOME MEASURES: Bulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured. RESULTS: A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0-3 scale) and itching (3.4 vs. 3.0 units on a 0-4 scale) over the first 2 weeks. The treatment effect by these measures was -0.5 and -0.4 units in favor of LE (P < or = 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively). Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment. CONCLUSIONS: Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo.

A controlled evaluation of the efficacy and safety of loteprednol etabonate in the prophylactic treatment of seasonal allergic conjunctivitis. Loteprednol Allergic Conjunctivitis Study Group.

PURPOSE: To evaluate the efficacy and safety of loteprednol etabonate 0.5% as prophylactic treatment for the ocular signs and symptoms of seasonal allergic conjunctivitis. METHODS: In this randomized, double-masked, placebo-controlled, parallel study, 293 adults with history of seasonal allergic conjunctivitis were treated with either loteprednol etabonate or vehicle (placebo) four times daily, beginning before the onset of the allergy season and continuing for 6 weeks. The primary efficacy measure was a primary composite score (sum of itching and bulbar conjunctival injection scores). Supportive efficacy measures were the investigator global assessment and a secondary composite score (sum of tearing, erythema, chemosis, and discomfort scores), all calculated during the 21-day peak pollen season. RESULTS: The proportion of patients who never developed moderate or severe signs and symptoms of allergy during the peak pollen season in the loteprednol etabonate treatment group was greater than that in the placebo group. For the primary composite score, this efficacy criterion was reached by 94% of patients (136/145) in the loteprednol etabonate group and 78% of patients (111/143) in the placebo group (P = .001). The magnitude of effect was similar for the investigator global assessment (86% [118/138] vs 64% [87/137]; P < .001) and, although not statistically significant, the secondary composite score (77% [112/145] vs 68% [97/143]; P = .092). None of the loteprednol etabonate-treated patients had an intraocular pressure increase of 10 mm Hg or more, whereas two placebo patients did. CONCLUSIONS: Loteprednol etabonate is generally effective in prophylaxis of seasonal allergic conjunctivitis and has an acceptable safety profile.

Comparative evaluation of the short-term bactericidal potential of a steroid-antibiotic combination versus steroid in the treatment of chronic bacterial blepharitis and conjunctivitis.

The effects of four days' treatment with topical Maxitrol (neomycin sulphate 3500 IU/mL, polymyxin-B sulphate 6000 IU/mL with dexamethasone 0.1%) were compared with those of Maxidex (dexamethasone 0.1% alone) in a double-masked study in 111 patients with bacterial blepharitis or conjunctivitis, 95 of whom were evaluable for efficacy. The majority of patients (N = 80) had chronic blepharitis. Maxitrol treatment resulted in a significantly greater reduction (90%) in bacterial counts and bacterial eradication (50%) compared with Maxidex (34% and 17% respectively). Maxitrol treatment also produced a significantly greater reduction in conjunctival discharge than did Maxidex, while the treatments were equally effective in alleviating other ocular signs and symptoms. It was concluded that use of a fixed dose combination steroid-antibiotic product was more effective for bacterial control and therapeutic efficacy in the treatment of chronic blepharitis and conjunctivitis patients than treatment with steroid alone. However, in the long-term treatment of chronic blepharitis the well-known toxic problems of neomycin sulphate have to be taken into account.

Photodynamic therapy (PDT) and photodiagnosis (PD) using endogenous photosensitization induced by 5-aminolevulinic acid (ALA): current clinical and development status.

Exogenous provision of 5-aminolevulinic acid (ALA) to many tissues results in the accumulation of sufficient quantities of the endogenous photosensitizer protoporphyrin IX (PpIX) via the heme biosynthetic pathway, to produce a photodynamic effect when exposed to activating light. Therefore, ALA may be considered the only current photodynamic therapy (PDT) agent in clinical development that is a biochemical precursor of a photosensitizer. Topical ALA application, followed by exposure to activating light (ALA PDT), has been reported effective for the treatment of a variety of dermatologic diseases including cutaneous superficial and nodular basal cell carcinoma, Bowen's disease, actinic (solar) keratoses, and T cell lymphoma. Local internal application of ALA has also been used for selective endometrial ablation in animal model systems and, in human clinical studies, it has shown selective formation of PpIX within the endometrium. PpIX induced by ALA application has also been used as a fluorescence detection marker for photodiagnosis (PD) of cancer and dysplastic conditions of the urinary bladder and other organs. Systemic, oral administration of ALA has been used for ALA PDT of superficial head and neck cancer, various gastrointestinal cancers, and the condition known as Barrett's esophagus. This paper reviews the current clinical and development status of ALA PDT and PD.

The investigation of psychoanalytic theory by means of the experimental method.

Psychoanalysis has been criticized for its lack of a quantitative research tradition and its resulting reliance on the case history method for its data. While the in-depth observation of a small group of cases has an important place in the development of science, particularly in the hypothesis generating phase, it is argued that the testing of psychoanalytic hypotheses must depend on research methods that allow for more stringent control and replication. Five studies that utilize a true experimental design and that examine psychoanalytically significant topics are described. Special problems confronting the psychoanalytic experimenter are discussed. It is hoped that this article will stimulate those investigators who have an interest in testing psychoanalytic principles to design future studies that are rigorous in their methodology.

Two methods of assessing narcissism: comparison of the Narcissism-Projective (N-P) and the Narcissistic Personality Inventory (NPI).

Students in Introductory Psychology (N = 75) were administered the Narcissism-Projective (N-P), which asks subjects to describe two TAT cards and two early childhood memories. Protocols were scored using criteria adapted from the DSM-III section that describes the narcissistic personality disorder. On the basis of these ratings, the high and low narcissists (N = 16) were chosen for further study. These subjects were interviewed by an experienced clinician who was unaware of their performance on the N-P. The interviewer rated each subject as either a high or low narcissist. After the interview, the subject was administered the Narcissistic Personality Inventory (NPI). Results indicate a statistically significant relationship between the interview assessment of narcissism and the N-P (p less than .01), the NPI (p less than .05), and the NPI factor of self-absorption/self-admiration (p less than .05). The limitations and implications of these data are discussed. It is concluded that both measures demonstrate promise as instruments useful in the rigorous scientific investigation of significant clinical and theoretical issues related to narcissism.

An experimental investigation of Kernberg's and Kohut's theories of narcissism.

This article presents data from a double-blind experimental study of the comparative validity of specific premises of Kernberg's and Kohut's theories of narcissism. The Narcissistic Personality Inventory (NPI) was administered to 70 undergraduates. Thirteen of the 14 most narcissistic subjects (from the NPI data) participated in three experimental sessions during which the subject was exposed to one of three subliminal stimuli administered tachistoscopically. Each of the experimental stimuli represented an aspect of Kernberg's or Kohut's clinical theory of narcissism. A third stimulus contained neutral content and served as a control. After each tachistoscopic administration, the Narcissism-Projective (N-P) and the Self Focus Sentence Completion (SFSC), measures designed to assess narcissism and egocentricity, were administered. Results indicate that the Kernberg stimulus demonstrated a significant effect on the subject's narcissism and egocentricity (p less than .01). The stimulus that represented Kohut's theory did not demonstrate any statistically significant effect. It is concluded that methodologically rigorous investigations of psychoanalytical questions of theoretical and clinical significance are possible and necessary.

Considerations in the treatment of the adult blind patient.

This paper contends that blindness is not a single clinical determinant, but, rather, that there are two groups of blind people for whom the treatment considerations are quite different. For those congenitally blind, lack of vision can cause developmental difficulties, e.g., impairments in human attachment, object permanence, and self-representation. For those who later acquire blindness, the premorbid psychodynamics and object relationships are most important in understanding the person's reactions to his/her disability. Two adult cases are presented to illustrate these phenomena in the context of psychotherapy.

Leprosy downgrading reaction associated with griseofulvin.

A dramatic alteration from clinically subpolar tuberculoid leprosy toward subpolar lepromatous leprosy was observed during griseofulvin therapy in a 29-year-old man, despite apparently normal cell-mediated immunity. To our knowledge, this is the first reported case of a downgrading reaction associated with griseofulvin. It is possible that this reaction was due to inhibition of polymorphonuclear leukocyte chemotaxis by griseofulvin.