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PubMed1979

Carcinogenic risk of products used in the pharmaceutical and related industries.

The pharmaceutical industry is perhaps most subject to rules and regulations in the majority of countries. Legislation in France in this regard is flexible and relatively easily adaptable; in addition, the pharmaceutical industry has established its own ground rules. One of these requires that a product be harmless under normal conditions of use; carcinogenicity checks are only mandatory under certain conditions. If they were to be made compulsory, a less unwieldy test system would be required. The use to which a product is put should be taken into consideration in regulating it.

Aerosols↗
PubMed1994

Antibodies to hepatitis C virus in human immunoglobulins: clinical meaning and diagnostic difficulties in children undergoing bone marrow transplant.

Anti-HCV antibodies were detected in 11 children undergoing BMT. All of them had received intravenous immunoglobulins (Ig) at a dose of 500 mg/kg every 2 weeks for the first 100 days post-BMT. Antibody titers appeared after the first dose and became undetectable between 1 and 6 months after the last dose of Ig. Detection of anti-HCV antibodies in these multitransfused patients raised doubts about their clinical significance. The clearance of antibody titers in the ensuing months, negativity of HCV RNA in the serum of the patients and the presence of anti-HCV in some batches of the commercial preparations administered supported the diagnosis of a passive transfer of antibodies and that true HCV infection could be ruled out. Routine screening of donors with the most sensitive tests and exclusion of anti-HCV positive sera from plasma pools should be mandatory. The presence of anti-HCV in these products has important clinical implications, leading to more expensive and time-consuming diagnostic procedures.

Bone Marrow Transplantation↗
PubMed1995

[The predictive value for major arrhythmic events of ventricular arrhythmias, particularly nonsustained ventricular tachycardias, in the subacute phase of a fibrinolyzed infarct. An analysis of GISSI-2 data. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico].

BACKGROUND: The relationship between ventricular arrhythmias (VA) in the subacute phase of a myocardial infarction (MI) and subsequent major arrhythmic events, i.e. sustained ventricular tachycardia (SVT) and sudden death (SD), is well known. The importance of left ventricular dysfunction in the same context is also well established. The vast majority of the data in the literature come from the prefibrinolytic era and/or are derived from limited data bases. MATERIALS, METHODS AND RESULTS: We examined the large, uniform GISSI-2 population of acute fibrinolysed myocardial infarctions in order to evaluate the significance and predictive power of VA detected by Holter monitoring during the subacute phase. Particular attention was paid to the occurrence of nonsustained ventricular tachycardias (NSVT) since their role is still uncertain, so it is hard to assess the utility of invasive measures such as programmed electrical stimulation (PES). Left ventricular function was evaluated by mono-, and two-dimensional echocardiography. Holter monitoring was available in 8,676 patients; a six-month follow-up, as regards mortality was completed in 8,552 patients (98.5%) and, as regards SVT incidence, in 7.713 (88.9%). During the follow-up 256 patients died (3%), 84 out of them suddenly (1%). Twenty-six [corrected] patients out of 7,713 (0.3%) experienced one or more SVT. The relationship between VA, left ventricular dysfunction and major arrhythmic events was evaluated by odds ratios (OR) and their confidence intervals (CI). Odds ratios for the combined end-point (SD and/or SVT) was 4.49 (CI 95% 2.69-7.51) if the Holter showed > 10 VEB/hour; 2.34 (CI 1.48-3.68) if couplets were present; 3.26 (1.52-6.99) if NSVT were present; 3.02 (2.02-4.50) if any complex ventricular arrhythmia was detected. Left ventricular disfunction seemed to exert a more powerful influence: OR 9.80 (CI 5.75-16.69) for SD and/or SVT. Any arrhythmic parameter had very low positive (< or = 3%) and very high (approximately 99%) negative predictive power. Multivariate analysis (Cox Model) including major prognostic factors confirmed the independent prognostic value of frequent VA (RR 2.75; 95% CI 1.58-4.79), couplets (RR 1.91; CI 1.28-2.86); complex VA (RR 2.02; CI 1.36-3.00). NSVT, after adjusting for the selected risk factors, was not independently associated with a worse prognosis. CONCLUSIONS: Ventricular arrhythmias detected by Holter monitoring during the subacute phase of a MI still have prognostic significance for major arrhythmic events in the fibrinolytic era. The presence of NSVT triples the risk of SD and/or SVT in the six months after an acute MI, but loses any predictive power in a multivariate analysis. Only 6.6% of the patients showed one or more episodes of NSVT in the Holter recording. If the ongoing clinical trials, MUSTT and MADIT, will confirm the usefulness of PES in such patients, the benefit will be confirmed to a very small proportion of the patients at risk of specific diagnostic tests. The positive predictive power of VA is very low and it is therefore mandatory to add other non-invasive variables to the screening to identify the subgroups at greatest risk. On the other hand the very high (99%) negative predictive power of VA and left ventricular dysfunction enables us to identify a large population of infarcts with a negligible risk, who need no further sophisticated investigations. From the point of view of the cost/benefit evaluation this seems to be an outstanding result.

Arrhythmias, Cardiac↗
PubMed1996

[Using a computer for accessing information in environmental medicine].

Decisions or statements about the health effects of "pollutants" are often based on not exactly known exposure conditions and/or doubtful cause-effect relationships. Even searches in international databases will not always give adequate answers or produce new problems for the specialist in environmental medicine because the information may be contradictory or leave a wide scope for interpretation, perhaps requiring detailed specialized knowledge (e.g. mutagenicity testing, immunotoxicological parameters etc.). In situations like these, inter-disciplinary working is the mandatory condition. Therefore electronic communication systems might be used to resolve problems, because they provide access to well-presented knowledge of competent colleagues. However, the fundamental concept of such mailbox system for environmental medicine requires active participation by all its users who should contribute to its files and not remain passive, i.e. only call for information.

Computer Communication Networks↗
PubMed1997

The diagnosis by fine needle aspiration biopsy of hydatid cyst of the pancreas.

We describe a case of pancreatic hydatid cyst in which the definitive diagnosis was made at fine needle aspiration cytology. The most common site of hydatid cyst is the liver (65%), followed by the lungs (25%). The hydatid cyst of the pancreas is rare since it accounts for less than 1% of the various sites of hydatid disease. The diagnosis may be difficult when the presentation is that of an unexplained epigastric mass or cyst, despite suggestive radiological and ultrasonographic features. Modern serology tests are positive in up to 80% of the abdominal hydatid cysts. It is mandatory to obtain a fine needle aspiration biopsy for definite diagnosis and for appropriate treatment planning. Surgical removal of the hydatid cyst still remains the most effective treatment.

Biopsy, Needle↗
PubMed1996

Reevaluation of growth hormone (GH) secretion in 69 adults diagnosed as GH-deficient patients during childhood.

At present, the most appropriate method for diagnosing GH deficiency (GHD) in adults remains unclear. Recently, it has been demonstrated that GHD in adults can be identified by insulin tolerance test (ITT). Moreover, it has been described that the GHRH plus pyridostigmine (GHRH+PD) test is more accurate than an arginine, glucagon, levodopa, or GHRH test to diagnose GHD in adults. In the current study, firstly we reevaluated GH secretion by the GHRH+PD test in adults previously diagnosed as GH deficient in childhood. The study included 69 patients and 38 healthy subjects. After the GHRH+PD test, the patients and the healthy subjects had peak GH levels of 10.6 +/- 11.2 and 56.7 +/- 28.1 micrograms/L, respectively (P < 0.001). The patients were divided into two groups, responder patients and nonresponder patients, considering an arbitrary cut-off of 10 micrograms/L as the GH peak after the GHRH+PD test. Thirty-nine patients had GH peak below 10 micrograms/L (1.9 +/- 1.7 micrograms/L), whereas the remaining 30 patients above 10 micrograms/L (21.6 +/- 8.] micrograms/L; P < 0.001). Secondly, we compared the GHRH+PD test and the ITT in diagnosing GHD. Twenty-one of the 39 patients with a GH peak below 10 micrograms/L and 29 of the 30 patients with a GH peak above 10 micrograms/L after the GHRH+PD test underwent an ITT. The GH peak after insulin administration was 2.1 +/- 1.7 micrograms/L in nonresponder patients and 21.1 +/- 9.3 micrograms/L in responder patients after the GHRH+PD test (P < 0.001). Three of the responder patients to the GHRH+PD test were identified as GH deficient by the ITT. The relative diagnostic accuracies of the two tests to discriminate GH-deficient patients from healthy subjects were similar (ITT vs. GHRH test: sensitivity, 100%, specificity, 90%; GHRH+PD vs. ITT; sensitivity, 88%; specificity, 100%). In conclusion, in adults previously diagnosed as GH deficient, it is mandatory to reevaluate GH secretion. GHRH+PD and/or ITT are able to diagnose GHD in adults with similar accuracies. Taking into account the potential side-effects of the ITT, however, the GHRH+PD test is the most reliable and safe test to accurately diagnose GHD status in adults.

Adult↗
PubMed1985

Patients with an acoustic neurinoma examined with a tilting room.

Patients with acoustic neurinomas do not usually show vertigo or spontaneous nystagmus, suggesting a gradual decrease of vestibular function with adequate compensation. Seventeen patients with acoustic neurinoma were examined to test their postural control. Examination in the tilting room showed a visual dominance in postural control with these patients irrespective of involvement of the central vestibular system. The subjective horizon was determined in addition to routine audiovestibular examination, to be informed about the compensation process. When routine audiovestibular examination points to an acoustic neurinoma, a pathological subjective horizon favours the diagnosis, although this is not mandatory. The combination of tilting room and stabilometry is superior in detecting visual dominance to the standard Romberg test.

Humans↗
PubMed1995

Systematic underestimation of treatment effects as a result of diagnostic test inaccuracy: implications for the interpretation and design of thromboprophylaxis trials.

Many clinical trials that have assessed strategies for the prevention of deep vein thrombosis have employed diagnostic tests that are less accurate than venography. The correct interpretation of these trials has been the subject of considerable debate. This paper attempts to quantify the likely effects of the use of inaccurate diagnostic tests (in particular fibrinogen scanning) on the validity and precision of estimates of treatment effects. It is shown that, if there is no difference in the rate of misclassification of deep vein thrombosis between study and control groups, then treatment effects will tend to be systematically underestimated in trials that only use inaccurate diagnostic tests. However, for trials in which there are no false positive diagnoses, such as those employing venography, the estimate of relative treatment effects will be unbiased. This phenomenon is demonstrated empirically by data from randomised trials of antiplatelet therapy. The implications of these findings are two-fold. First, so long as the accuracy of the test is the same in study and control groups, positive trial results cannot be ascribed to diagnostic test inaccuracy. Second, unbiased estimates of relative treatment effects can be obtained by using cheap, practicable and non-invasive screening tests that are supplemented by venographic assessment of positive test results. This would facilitate the conduct of much larger randomised trials than has generally been possible when mandatory venography was used; if future trials randomised some thousands of patients and employed confirmatory venography then they would provide both unbiased and precise estimates of relative treatment effects.

Clinical Trials as Topic↗
PubMed2007

Can we ensure the safe use of known human teratogens?: The iPLEDGE test case.

Minimising the public health burden of isotretinoin-induced teratogenicity has been a challenge for 24 years, the duration of availability of isotretinoin in the US for the treatment of severe, recalcitrant nodular acne. Although the teratogenicity of this drug is well known and risk-management programmes had been implemented, preventable fetal exposures continued to occur, largely as a result of the lack of sufficient controls within the programmes themselves. The manufacturers of isotretinoin implemented a new risk-management programme, iPLEDGE, in March 2006. iPLEDGE is a comprehensive distribution system that includes mandatory registration of patients, healthcare providers, pharmacies, and wholesalers. It allows real-time linkage of pregnancy-test results for verification prior to the dispensing of isotretinoin. Although the challenges of implementing a closed distribution system for a very widely used medication have been extensive, the potential public health benefits from preventing fetal exposure to isotretinoin are substantial.

Acne Vulgaris↗
PubMed2006

Segmental study of the median nerve versus comparative tests in the diagnosis of mild carpal tunnel syndrome.

OBJECTIVE: The aims of this study were to analyze normative data of nerve conduction studies (NCS) by optimal transformations, and compare the utility of electrodiagnostic tests in detecting mild carpal tunnel syndrome (CTS). METHODS: In 131 hands of patients with mild CTS and 136 hands of controls, the segmental study of the median nerve between the digit-palm and palm-wrist segments, and the median-to-ulnar and median-to-radial comparative tests were performed. Normal limits were derived by calculating the mean+/-2 standard deviations of the optimally transformed data of the controls. The specificity, sensitivity, and misclassification rate were calculated to evaluate the utility of each test. RESULTS: All tests had high specificities, ranging from 98.5 to 100%. The distoproximal latency ratio (DPLR) of the median nerve showed the highest sensitivity and the difference between the median and radial sensory latencies (D1M-D1R) the second highest, but there was no statistical difference between them. The difference between the median and ulnar mixed nerve latencies in the palm-to-wrist segment (PM-PU) showed the lowest sensitivity. Misclassification rates of the DPLR, D1M-D1R, and PM-PU were 6.9, 3.8, and 6.1%, respectively. CONCLUSIONS: Optimal transformation of NCS data is mandatory to diminish the effect of skewness and enhance the diagnostic accuracy. As compared to the comparative tests, the segmental study of the median nerve is more easily applied and yields higher sensitivity in detecting mild CTS. SIGNIFICANCE: With a high diagnostic yield and easy application, the segmental study of the median nerve may routinely be used to evaluate patients with mild CTS.

Adult↗
PubMed2004

Avoidance of animal experiments in the new EU Chemicals Regulation - opportunities and problems from the point of view of animal welfare.

On 29 October 2003, the European Commission forwarded the "Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) on Persistent Organic Pollutants" to the European Parliament and the Council for adoption under the so-called co-decision procedure. From the point of view of animal welfare it is to be welcomed that it is envisaged better to protect humans and the environment from unknown risks through chemical substances. However, in order to ensure that this goal can be met, extensive amendments to the proposed draft are requested: Instead of continuing to perform animal tests, relevant and reliable non-animal testing strategies should be implemented. Before considering testing, all existing data must be made available, shared and evaluated. This request should be enforced in the new Regulation through an adequate mandatory system. Data requirements must be tailored to the specific substance, to ensure that only such information is collected that is necessary for its safe handling by workers and consumers. Missing data should be determined with non-animal test methods. Finally, the European Union and its Member States are called to provide adequate funding for alternative method research without delay and to call for tenders on those information-gaps that currently prevent the implementation of an entirely non-animal testing strategy, so that such new methods will be available in time for application under the REACH system.

Animal Experimentation↗
PubMed1995

[HIV testing in Denmark in 1993: were the tests relevant?].

In order to describe HIV-testing activity among adults in Denmark, a cross-sectional study was designed using an anonymous questionnaire, which was forwarded with all HIV-test results in a given two-week period in 1993. Notified first-time identified HIV-positive cases were used for comparisons. The response rate was 50%. A total of 996 women and 834 men were included, among whom 68% of men and 62% of women were classified as having a behaviour that put them at increased risk for acquiring HIV, p < 0.02. Women were younger than men, p < 0.001. Around 1/3 of both men and women had previously been HIV-tested, a proportion that increased with increasing risk for HIV, p < 0.00001 for trend. HIV-tested adults were younger and less frequently living in the Copenhagen area than the first-time identified HIV-infected persons reported to the mandatory national HIV-surveillance system. The overall HIV prevalence was 0.3%, being 0.5% among men and 0.2% among women. Estimates showed that the yearly number of first-time identified HIV-infections among tested homo/bisexual men per 10(5) men were 100 times as high as among the heterosexual population. Also, 12% of Danish homo/bisexual men had an HIV test per year, a proportion that was 2.3% among adult women and 1.8% among adult heterosexual men without i.v. drug use. The yearly test-activity decreases with increasing age among both men and women. In conclusion, studies among the HIV-tested population along with results from systematic surveillance of first-time identified HIV-infections are useful in order to estimate the frequency and the relevancy of HIV testing in the entire population. Also, these results may help when planning national information campaigns.

Adult↗
PubMed2006

Protean clinical manifestations and diagnostic challenges of human brucellosis in adults: 16 years' experience in an endemic area.

A prospective study was carried out to elucidate the clinical, epidemiological and laboratory features of human brucellosis. A total of 26 948 blood samples (from adults aged 15 years and above) were screened for serological evidence of brucellosis over a period of 16 years. The slide agglutination/Rose Bengal plate agglutination test gave positive results in 517 patients, of which 509 had detectable titres by the standard tube agglutination test (SAT). The diagnosis of brucellosis was documented in 495 (1.8 %) patients based on diagnostic titres (> or = 1 : 160, 490 cases) and rising titres from insignificant titres (four cases) by serology and for one case by blood-culture isolation alone. Blood cultures were carried out in 345 cases, of which 191 cases (55.3 %) yielded Brucella melitensis. In 77/79 cases undertaken for follow up, there was a steady fall in 2-mercaptoethanol (2ME) agglutination titres along with clinical improvement (P < 0.01). SAT titres remained detectable in most cases for a longer period in spite of an effective antimicrobial therapy and clinical recovery. A substantial number of patients (84.2 %) presented with fever, this being the only complaint in 51.1 % of the cases. Complications were present in 8.8 % of the patients (arthritis excluded): this included the unusual complications of hydrocele (two cases), Stevens-Johnson syndrome (one case) and urinary tract infection (one case). Brucella agglutinins were demonstrated in synovial, testicular, hydrocele and cerebrospinal fluids. There was no clinical suspicion of brucellosis in 439 cases (88.7 %) and the diagnosis was made only by routine serology. A two-drug regimen for 42-84 days with a follow-up 2ME test resulted in lower levels of relapse. These results suggest that, in endemic areas of the world, it should be mandatory to screen routinely for brucellosis due to protean clinical manifestations.

Adolescent↗
PubMed2005

IL-1beta in bronchial lavage fluid is a non-invasive marker that predicts the viability of the pulmonary graft from the non-heart-beating donor.

BACKGROUND: Viability testing of the pulmonary graft retrieved from the non-heart-beating donor (NHBD) is mandatory for successful outcome after lung transplantation. Functional assessment by ex vivo reperfusion, however, remains a cumbersome procedure. In this study, therefore, we wanted to investigate the possible value of the proinflammatory cytokines interleukin-1beta (IL-1beta) and tumor necrosis factor-alpha (TNF-alpha) measured in bronchial lavage fluid (BLF) in predicting functional outcome of the pulmonary graft after reperfusion. METHODS: Domestic pigs (29.9 +/- 0.56 kg) were sacrificed and divided in 5 groups (n = 5/group). In the non-ischemic group (NHBD-0), the heart-lung block was explanted immediately. In the other groups the animals were left untouched with increasing time intervals (1 hour = NHBD-1; 2 hours = NHBD-2; 3 hours = NHBD-3). Thereafter both lungs were cooled topically via chest drains up to a total ischemic interval of 4 hours. Finally, in the heart-beating donor group lungs were flushed and stored for 4 hours (4 degrees C) [HBD]. BLF samples were taken from the right lung in all groups after explantation for measurement of IL-1beta and TNF-alpha and the left lung was prepared for evaluation in an isolated reperfusion circuit. Haemodynamic, aerodynamic and oxygenation parameters were measured. Wet-to-dry weight ratio (W/D) was calculated after reperfusion. RESULTS: Graft function deteriorated with increasing time intervals after death. A strong correlation was found between the increase of IL-1beta concentration measured in BLF and the increase in pulmonary vascular resistance (r = 0.80), mean airway pressure (r = 0.74) and wet-to dry weight ratio (r = 0.78); (p < 0.0001, for all parameters). No significant differences in TNF-alpha levels in BLF were observed amongst groups (p = 0.933). CONCLUSIONS: IL-1beta in BLF prior to reperfusion correlated well with graft function and may therefore be a useful, non-invasive marker that can predict the viability of the pulmonary graft from the NHBD.

Animals↗
PubMed1997

Direct detection of Mycobacterium tuberculosis complex in nonrespiratory specimens by Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test.

The Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test (AMTDT) was adapted for the detection of Mycobacterium tuberculosis complex in 224 nonrespiratory specimens from 188 patients. The sensitivity and specificity of the AMTDT for such specimens, after resolution of discrepant results, were 85.7 and 100%, respectively. Pretreatment of nonrespiratory specimens with sodium dodecyl (lauryl) sulfate is mandatory to obtain consistent and reproducible AMTDT results. The use of 500 microliters of decontaminated specimen improves the sensitivity of the test. Because the AMTDT detects stable rRNA from noncultivable bacilli, it is not useful for monitoring patients receiving treatment.

Bacterial Typing Techniques↗
PubMed1995

Bicyclist head injury prevention by helmets and mandatory wearing legislation in Victoria, Australia.

After a decade of promotion and education, legislation for mandatory helmet wearing by bicyclists in Victoria was introduced on 1 July 1990. The legislation was a world first. Comparison of 1710 bicyclist casualties wearing and not wearing helmets has demonstrated that wearing helmets certified to the Australian Standard reduces the head injury risk by at least 39% and lessens head injury severity. Simulated impact testing of helmets has shown that they provide protection in most impacts including collisions involving a motor vehicle. Legislation for mandatory helmet wearing in Victoria has led to increased wearing rates and marked reductions in bicyclist fatalities and head injuries. The Victorian experience gives substantial support to the introduction of legislation for mandatory helmet wearing by bicyclists.

Accidents, Traffic↗
PubMed2006

Clinical utility of blood tests in elite athletes with short term fatigue.

OBJECTIVE: To determine, in a population of elite athletes at their initial presentation with tiredness or fatigue, whether a set of haematological and biochemical investigations enhances the diagnostic process over and above the information gained from clinical history and examination. METHODS: A sequential series of 50 elite athletes were studied at the initial consultation for a primary complaint of fatigue, tiredness, or a synonym thereof. A standardised clinical history, physical examination, and series of haematological and biochemical test were performed. The effects of the results of the blood tests on the diagnosis made after the clinical history and examination were examined. RESULTS: In only one case did the test results lead to an alteration in diagnosis. Physical examination did not provide any findings that would not have been suspected from the history, except for a number of incidental findings not relevant to the presenting symptom. DISCUSSION: In cases of short term fatigue in elite athletes, a thorough clinical history is mandatory. Physical examination is unlikely to reveal any findings not suspected from the history. Routine ordering of a panel of blood tests at the initial consultation should be discouraged. Unless specifically indicated by the history and examination, investigations are not required at the initial consultation.

Adolescent↗
PubMed2004

Refractive surgery in glaucoma.

PURPOSE OF REVIEW: The purpose of this review is to discuss the topics relevant to the topic of LASIK in glaucoma patients or suspects. The safety of LASIK and the implications of LASIK on glaucoma diagnostic testing are reviewed. RECENT FINDINGS: Most studies have found no change in the nerve fiber layer thickness or optic disc after LASIK. Several reports of steroid-induced glaucoma after LASIK have been published. Important new syndromes such as the interlamellar stromal cyst have been described. Most investigators, but not all, have found intraocular pressure to be lower after LASIK, most likely an artifact of measurement as a result of reduced central corneal thickness. SUMMARY: The safety of LASIK in patients with glaucoma has not been proved. However, based on the published literature, LASIK may be a viable option for some glaucoma patients. Although not an absolute contraindication, glaucoma is a relative contraindication, and careful patient education and life-long follow-up is mandatory. The clinician must be ever mindful of the important effects that LASIK may have on diagnostic testing.

Glaucoma↗