The safety of ranitidine bismuth citrate in controlled clinical studies

Ranitidine bismuth citrate (Pylorid, Tritec) is a novel drug which heals peptic ulcers and when co-prescribed with either clarithromycin or amoxycillin eradicatesHelicobacter pylori. In controlled clinical studies it was well-tolerated when given alone or when co-prescribed with either antibiotic. Data from 20 clinical studies are reported in this analysis of safety with almost 5000 patients having received ranitidine bismuth citrate (200, 400, or 800 mg twice daily). The incidence of adverse events reported with this new drug, either alone or with an antibiotic, was not different from or lower than in patients given placebo and was independent of the dose of ranitidine bismuth citrate tested. Most commonly reported events (>1% of patients) were upper respiratory tract infection, constipation, diarrhoea, nausea and vomiting, dizziness, and headache, the latter being the only event reported by >2% of patients who received ranitidine bismuth citrate alone. Adverse events considered by the clinical investigator to be adverse reactions occurred with a similar frequency amongst patients given ranitidine bismuth citrate (8%), ranitidine hydrochloride (6%), or placebo (6%). The incidence of adverse reactions was greater when co-prescribed with amoxycillin (11%) or clarithromycin (20%) although it was not different from that noted with the antibiotics alone. Serious adverse events were reported in similar proportions of patients given placebo, ranitidine bismuth citrate alone or with an antibiotic, and ranitidine hydrochloride (range: <1-2%). The safety profile of ranitidine bismuth citrate was thus comparable to that of ranitidine hydrochloride (Zantac), a drug with a well-established record of safety in clinical use.     

Manic Psychosis and Catatonia Stemming from Systemic Lupus Erythematosus: Response to ECT

A 27-year-old woman with severe psychosis and mania associated with systemic lupus erythematosus was successfully treated with electroconvulsive therapy. Cyclophosphamide was given as an adjuvant. The use of electroconvulsive therapy in patients with lupus and psychiatric disorders is discussed.     

The effect of unilateral internal carotid arterial occlusion upon contralateral duplex study: criteria for accurate interpretation.

To determine the influence of unilateral internal carotid arterial occlusion (ICO) on Doppler frequency spectral analysis (DFSA) of the patent contralateral carotid artery, a retrospective review of 154 patients between July 1987 and December 1991 with angiographically confirmed ICO was performed, correlating duplex and arteriographic findings in a blinded fashion. Biplane arteriograms and bilateral carotid artery duplex studies that used a 5.0 MHz Doppler probe with a 1.5 mm3 sample volume at a 60 degree angle of insonation were performed on all patients. Each carotid artery was categorized by the severity of stenosis as quantified by arteriography: 1% to 15% (n = 41); 16% to 49% (n = 48), 50% to 79% (n = 21), 80% to 99% (n = 34), and bilateral occlusion (n = 10). DFSA peak systolic frequencies were commonly exaggerated in the presence of contralateral ICO and use of standard criteria for DFSA interpretation overestimated bifurcation stenoses in 43 of 89 lesions (48.3%) when determining nonhemodynamically significant lesions (less than 50% diameter reduction) with a sensitivity of only 57.3% and specificity of 96.9%. Conversely, prediction of hemodynamically significant lesions (greater than 50% diameter reduction) with standard criteria had 96.9% sensitivity but only 57.3% specificity. Modification of these criteria to account for the velocity increase or "jet effect" in the ipsilateral carotid artery system increased the sensitivity and specificity to 97.8% in predicting nonhemodynamically and hemodynamically significant stenoses respectively. A Doppler frequency spectrum with a peak systolic frequency (PSF) greater than 4.0 kHz and end-diastolic frequency (EDF) less than 5 kHz with an "open window" distinguished lesions with less than 50% diameter reduction.(ABSTRACT TRUNCATED AT 250 WORDS)     

Defining the susceptibility of acne-prone and sensitive skin populations to extrinsic factors.

Acne-Prone Skin. Acne-prone skin appears to be more susceptible to certain extrinsic factors that can either exacerbate existing disease or generate new lesions. Awareness of the factors that could worsen or interfere with therapy is important. In addition, identification of patients with minimal acne who are prone to outbreaks from extrinsic factors and provision of relevant advice could prove beneficial to significant numbers of patients. Sensitive Skin. From the perspective of our research, the definition of sensitive skin is still evolving. Certain individuals may view sensitive skin as fashionable; however, clinicians and the people who work in the personal-care industry know that when certain materials are applied to the skin, some individuals report symptoms (burning, stinging, itching, a tight feeling) and sometimes show traditional signs of irritation. The reasons for sensitive skin in these individuals may be obvious, but many times the complaints and signs of irritation occur in individuals who appear to be normal. Using our ongoing work we would like to suggest that the label "sensitive skin" apply to the following four categories: 1. Those individuals with obvious skin disease. 2. Those individuals with subclinical (mild) or atypical clinical signs of disease. 3. Those individuals who have experienced past insults to the skin. 4. Those individuals who do not fit into one of the above three categories and appear to be "normal". To define sensitive skin fully we may need to perform full profiles of the skin of these patients. In addition to history and examination, a battery of noninvasive tests may be helpful.(ABSTRACT TRUNCATED AT 250 WORDS)