Nicoline Wieringa

ACTIVITY OF GENTIAN VIOLET AND BRILLIANT GREEN AGAINST SOME MICROORGANISMS ASSOCIATED WITH SKIN INFECTIONS

The antimicrobial activity of gentian violet and brilliant green was tested against various strains of potential skin pathogens, by means of agar diffusion assay. The activity of both compounds was affected by pH. Gentian violet was found to be more active than brilliant green at pH 7.4, particularly against Pseudomonas aeruginosa. The spectrum of activity of gentian violet was not increased by the addition of brilliant green. An aqueous solution of gentian violet 0.5% turned out to be an adequate topical anti‐infective drug. The preparation is particularly suitable for primary health care in tropical developing countries, because it is cheap, chemically and physically stable, and easy to prepare.

Cardiovascular drugs: discrepancies in demographics between pre- and post-registration use

AbstractObjectives: To study discrepancies in demographic characteristics between patients participating in pre-registration phase III trials of cardiovascular drugs, registered in the Netherlands, and patient populations in daily practice representing the actual users of the drugs after registration. Methods: Comparison of age and sex distribution in registration files of 15 cardiovascular drugs [angiotensin-converting enzyme (ACE)inhibitors/angiotensin II receptor antagonists, calcium channel blockers, beta-adrenergic blocking agents, vasodilators, HMG-CoA reductase inhibitors and thrombolytics] with patients selected from a general practitioner (GP) registration database, who had received prescriptions for drugs from the therapeutic classes for the registered indications (hypertension, hypercholesterolaemia or angina pectoris) or were diagnosed with myocardial infarction. Moderate discrepancy was defined as more than 10% difference between the populations, large discrepancy by more than 20% difference. Clinical trials were also analysed by region of trial performance with respect to patient selection criteria, differences in male/female ratios and ethnic origin of patients. Results: Phase III clinical trials in registration files of drugs registered for hypertension, angina pectoris and myocardial infarction had a moderate to large under-representation of female patients. Patients aged more than 65 years, who accounted for more than 50% of drug use indicated for hypertension, angina pectoris and myocardial infarction, were under-represented in the clinical trials of drugs registered for all indications. Trials performed in North America included relatively fewer female patients compared with European trials, and showed different patterns in the ethnic origin between indications. Conclusions: Clinically relevant subgroups of cardiovascular patients are under-represented in pre-registration phase III trials. These findings concern major areas of cardiovascular diseases, i.e. hypertension, hypercholesterolaemia, angina pectoris and myocardial infarction. Widely used therapeutic classes of drugs are affected and regional differences in trial performance are present.

Positioning functional foods in an ecological approach to the prevention of overweight and obesity

To contribute to the social debate about the role of functional foods in the prevention of overweight and obesity using an ecological model to study the positioning of functional foods and their social implications. Positioning was conceptualized as the relative attention given to functional foods within the range of preventive strategies, and the way in which they address specific causes of overweight. A systematic review was conducted to identify (A) preventive strategies aiming at the individual; (B) technological approaches; and (C) environmental strategies. All strategies were further classified according to the nature of causes they refer to – either individual or environmental. In the prevention of overweight/obesity, an emphasis on strategies designed to change the quality of food products and supplies has developed. Technological strategies particularly relate to functional foods; however, while providing a new dimension to food products, they do not challenge the underlying lifestyles causing overweight. Furthermore, they also stress individual responsibility for overweight/obesity and technological solutions to it. From a societal perspective, the characteristics of functional foods indicate that they can only be expected to play a limited role in overweight/obesity prevention. The ecological approach suggests that other strategies targeting individual and social causes need to be developed and marketed equally well.

CONNECTING PRE-MARKETING CLINICAL RESEARCH AND MEDICAL PRACTICE Opinion-based Study of Core Issues and Possible Changes in Drug Regulation

A double glazing panel including a pleated blind within, and means for raising and lowering the blind. One embodiment includes an aperture in one of the glazing panels, a bolt with a hole through the center mounted in the aperture, and the blind control means passing through the bolt hole and further up and over a screen, if desired. Another embodiment provides routing the control means over the glazing housing, and any screen housing provided. The blind may be optionally mounted to one of the glazing panels to aid in cleaning.

Use of Cimetidine; Parallels and Discrepancies Between the Views of Drug Regulatory Agencies and Practicing Physicians*

SummaryThe use of cimetidine in general practice was studied in relation to the guidelines approved by the Dutch National Drug Regulatory Agency (DRA). National and regional figures showed that the frequency with which cimetidine was prescribed in general practice was greater than could be explained on the basis of approved indications alone. Analysis of its employment in 14 hypothetical cases suggested however, that general practitioners in The Netherlands chose their indications for cimetidine and the duration of cimetidine treatment according to the guidelines for its use approved by the DRA; only 12.7% of the prescriptions related to indications that had not been approved in The Netherlands, the most prominent finding being the case of a possible gastric carcinoma. It was estimated that less than half of all cimetidine prescriptions in general practice will be issued for indications approved by the Dutch DRA. Some discrepancy exists with regard to the dose employed; contrary to the recommendations of the DRA, the dose chosen varied little from indication to indication.

Comparative trials in registration files of cardiovascular drugs: Comparator drugs and dosing schemes.

Registration files of 13 cardiovascular drugs were analysed with respect to the number of double‐blind phase‐III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double‐blind trials used active comparator drugs. The majority of files included first‐choice reference drugs, but we also found trials in three files with lower dosing schemes of comparator drugs and four files which included only placebo or active controlled double‐blind trials. To allow a better interpretation of the information provided in European Public Assessment Reports, which are published for every product approved for marketing in the European Union, uniform reporting is recommended on basic details of trial design, such as comparator drugs used and dosing schemes.

THE SUITABILITY OF SOME PRESERVATIVES IN CHLOROQUINE PHOSPHATE SYRUP

In Third World countries chloroquine phosphate syrup is frequently prepared with chloroform as a preservative. Because of the toxic side effects of chloroform the suitability of a number of possible alternatives were investigated. If the chloroquine phosphate syrup is prepared as such, the combination of sorbic acid (1.5 g/l) and citric acid (2 g/l) is preferred. If, however, the chloroquine phosphate syrup is prepared from a stock solution of simple syrup, the relatively low pH may be undesirable, because it may negatively affect the stability or solubility of other medicinal compounds. For a stock solution of simple syrup the combination of methyl paraben (1.8 g/l) and propyl paraben (0.2 g/l) is preferred. Good care must be taken that a layer of condense water cannot be formed.