Intraspinal administration of morphine hydrochloride combined with low doses of bupivacaine in hemorrhoidectomy: a clinical randomized trial.

BACKGROUND: Intrathecal local anesthetics, associated or not to opioids, is commonplace in anorectal surgery, but it is unknown which is the option with the best risk-benefit ratio. The main aim was to assess whether the combination of morphine (50 mcg) with low-dose bupivacaine (3 mg) in an intradural solution has a better analgesic short-term effect than bupivacaine alone at standard doses (5 mg) in hemorrhoidectomy. METHODS: Sixty-six patients of any sex were randomly assigned to two alternative treatments and 63 patients were considered valid for analysis. Hyperbaric bupivacaine 3 mg combined with 50 mcg of intradural morphine hydrochloride (BUP-MOR group) was compared with 5 mg hyperbaric bupivacaine (BUP group). The primary outcome was pain evaluated through a visual analog scale (from 0 to 100 mm) at 24 hours post-surgery. The proportion of patients requiring rescue analgesia, and those presenting with motor blockade and other adverse events was also compared between the two groups. RESULTS: BUP-MOR group showed a higher efficacy than BUP group in the visual analog scale at 24 hours postsurgery (15±12 vs. 33±22 mm; P<0.001). Also, BUP-MOR group presented a lower percentage of patients who needed rescue analgesia at resuscitation room (6.7% vs. 24.2%; P=0.08) and a lower proportion of patients who had motor blockade (23.3% vs. 51.5%; P=0.02), while they presented a non-significant increased incidence of urinary retention (23.3% vs. 9.0%; P=0.17). CONCLUSIONS: The addition of intradural morphine allows a reduction in the dosage of local anesthetic improves short-term postoperative analgesia and is associated with less motor blockade.

[The ethical aspects of population screening programme of rare diseases]. / Recomendaciones sobre los aspectos éticos de los programas de cribado de población para enfermedades raras.

The Committee on Ethics of the Instituto de Investigación de Enfermedades Raras (CEIIER) of the Spanish National Institute of Health Carlos III, presents this article dealing with ethical guidelines regarding the implementation of screening population programmes with special emphasis on genetic screening. After a critical review it has been addressed 24 recommendations concerning 14 topics: evaluation of the opportunity of the programme, including ethical analysis besides scientific evidences and cost/benefits issues; the need to differentiate between research and public health intervention and to built a specific and comprehensive programme; the creation of an interdisciplinary working group which control its implementation and prepare a protocol including justification, development, therapeutic or preventive actions and follow-up activities; the review of the programme by an independent Ethical committee; the guarantee of the voluntary, universal and equitable population access, which requires sufficient information on the programme and their specific relevant facts, as incidental detection of heterozygous state in minors in newborn screening and the relevance of non directive genetic counselling specially in prenatal screening offered to pregnant women; considerations regarding future uses of samples for research purposes; total quality and periodic programme evaluation; guarantee of personal data confidentiality and the conflict of interest statement of the members of all the Committees involved in the programme.

[Recommendations on the ethical aspects of specimen collections and human biobanks for biomedical research purposes]. / Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica.

The collecting and storing of human biospecimens and associated data are a historical fact in medicine, but the biobank is a very recent concept. The advent of new technologies making it possible to store all types of specimens, including cells capable of staying alive outside the human body for an indefinite length of time, and to obtain scientific data of all types, including genetic information, has opened up a whole new realm of possibilities for research. All of the above has led to complex ethical issues coming to fore concerning the specimen donors, the researchers handling the specimens and society as a whole. This document is aimed at providing some recommendations to serve as a guideline and encourage responsible deliberation among all those involved, thus contributing to society's recognition and trust in the forthrightness of the research and the solidary end purposes thereof. A total of nineteen recommendations have been drafted concerning the following aspects: Biobank organization and operation, degree of specimen identification, data management guarantees, consent for taking part in research and for the incorporation of specimens into the biobank, the right to know and the right not to know, consent for transferring specimens to third parties, specimen harvesting in deceased individuals, management of the pre-existing biospecimen collections, title to and commercialization of specimens and research findings and resulting payback benefiting the community.

[The use of anxiolytic and hypnotic drugs in Spain (1995-2002)]. / Utilización de ansiolíticos e hipnóticos en España (1995-2002).

BACKGROUND: Recent studies have revealed a rise in the use of anxiolytic and hypnotic drugs as well as the improper use thereof in Western countries. This study is aimed at ascertaining the pattern of use of anxiolytic and hypnotic drugs in Spain within the 1995-2002 period. METHODS: The data related to the use of medications was taken from the Ministry of Health and Consumer Affairs' ECOM (Medicinal Products Consumption) database, which includes information on the use of medications delivered through the community pharmacies and reimbursed by the National Health System. The data are expressed in Defined Daily Doses per 1,000 inhabitants per day. RESULTS: The use of anxiolytic and hypnotic drugs rose from 39.71 Defined Daily Doses per 1,000 inhabitants per day in 1995 to 62.02 in 2002. Throughout the period under study, benzodiazepines having a medium-range half-life (8-24 h.) were those most used, especially lorazepam, alprazolam and lormetazepam. The active ingredient having shown the greatest drop in use was flunitrazepam. CONCLUSIONS: Although the use of anxiolytic and hypnotic drugs has undergone a considerable rise in recent years in Spain, the pattern of use has shown no major changes.

[Trends in antibiotic consumption in Spain, 1985-2000]. / Evolución del consumo de antibióticos en España, 1985-2000.

BACKGROUND: The purpose of this study was to analyse the trend in antibiotics consumption to draw on the National Health System (NHS) over the last 16 years in Spain and its different Autonomous Communities (AC). MATERIAL AND METHOD: Consumption data for all antibiotics used in Spain, either alone or in fixed-dose combinations, were obtained using the database ECOM. This database includes all the packages sold through retail pharmacies and reimbursed by the NHS. Data are expressed as defined dairy doses per 1,000 inhabitants per day (DHD), in accordance with the methodology recommended by the World Health Organization. Demographic data were provided by the National Institute of Statistics. RESULTS: In 1985 the overall consumption of antibiotics was 21.9 DHD, while in 2000 it was 20.4 DHD. It was possible to distinguish three phases over the study period. The first phase lasts until 1989, where a mild decreasing trend was observed (1.1 DHD; 5.0%), mainly due to the fall of fixed-dose combinations of antibiotics and the association of sulfamethoxazole-trimethoprim. The second phase, lasting until 1996, was characterized by a generalized increase in the consumption in all AC, with an average of 2.3 DHD (+ 11.1%), ranging from 0.4 to 4.6 DHD; this increase was mainly due to the marketing of new macrolides, cephalosporins and quinolones. Finally, there was a third phase beginning in 1996, where the consumption of antibiotics came into a sustained and generalized decline, ranging from 0.5 to 5.1 DHD, and depending on the AC (national average 2.7 DHD, 11.7% lower than that in 1996). This latter trend was mainly due to the fall of wide-spectrum penicillins. Differences between AC regarding the level of consumption were huge over the study period, although the pattern of use was quite similar. There was, for instance, a difference of 10.4 DHD between Región de Murcia and Islas Baleares in 2000, or 9.9 DHD between the former and Madrid in the same year. CONCLUSIONS: The consumption of antibiotics in Spain and all its AC has declined since 1996, probably related to the campaigns launched by public administrations to promote the rational use of these agents. The main subgroup involved in this trend is wide-spectrum penicillins. Differences in antibiotics use between AC are too big to be accounted for by different epidemic patterns and, therefore, should be analysed further.