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עמוד בית Thu, 14.11.19

July 2006


Focus
H. Liss
 Background: A publication bias exists towards positive results in studies funded by pharmaceutical companies.

Objectives: To determine whether drug studies in the pulmonary/allergy literature also demonstrate a publication bias towards more favorable results when a pharmaceutical company funds the study.

Methods: We reviewed all original articles published in seven pulmonary and allergy journals between October 2002 and September 2003. Included in the review were studies of inhaled corticosteroids (oral or nasal), long- or short-acting bronchodilators, or leukotriene receptor antagonists. Articles with funding from a pharmaceutical company and/or one or more authors employed by a pharmaceutical company were considered pharmaceutical company-sponsored studies. The remaining studies were considered not sponsored by a pharmaceutical company. Results were compared to ascertain whether positive results were obtained more frequently in the company-sponsored studies.

Results: Of the 100 articles included in this review 63 were considered pharmaceutical company-sponsored research. Results favorable for the drugs studies were significantly more common in those funded by a pharmaceutical company (98% vs. 32%).

Conclusions: In the pulmonary and allergy literature, as in other fields, there is a publication bias towards positive results in pharmaceutical company-sponsored research.

Original Articles
I. Topilski, O. Rogowski, A. Glick, S. Viskin, M. Eldar and B. Belhassen
 Background: Atrioventricular nodal reentry tachycardia is the most frequent cause of regular, paroxysmal supraventricular tachycardia. Radiofrequency ablation of the slow pathway has been recommended as first-line therapy for curing AVNRT[1].

Objectives: To report a 14 year experience of RFA[2] of the slow pathway in patients with AVNRT treated in our laboratory.

Methods: A total of 901 consecutive patients (aged 9–92, mean 50.8 ± 18.2 years) underwent RFA of the slow pathway. All patients had sustained AVNRT induced with or without intravenous administration of isoproterenol. A standard electrophysiologic method with three diagnostic and one ablation catheter was used in 317 patients (35.2%); in the remaining 584 patients (64.8%), only two electrode catheters (one diagnostic, one ablation) were used ("two-catheter approach").

Results: Catheter ablation of the slow pathway abolished AVNRT induction in 877 patients (97.3%). In 14 patients (1.6%) the procedure was discontinued while in 10 (1.1%) the procedure failed. In 864 patients (95.9%) there were no complications. Transient or permanent AV block occurred during the procedure in 31 patients (3.4%), of whom 8 (0.9%) eventually required pacemaker insertion (n=7) or upgrade of a previously implanted VVI pacemaker (n=1) during the month following the procedure. The number of catheters used did not significantly affect the rate of results or complications of the ablation procedure. The success and complication rates remained stable over the years, although a significant trend for increased age and associated heart disease was observed during the study period.

Conclusions: The results of this single-center large study, which included patients with a wide age range, showed results similar to those of previous studies. The use of a "two-catheter approach" (one diagnostic and one ablation) was as effective and safe as a multi-catheter approach.


 





[1] AVNRT = atrioventricular nodal reentry tachycardia

[2] RFA = radiofrequency ablation


D. Starobin, M.R. Kramer, A. Yarmolovsky, D. Bendayan, I. Rosenberg, J. Sulkes and G. Fink
 Background: Different exercise tests are used to evaluate the functional capacity in chronic obstructive pulmonary disease. The cardiopulmonary exercise test is considered the gold standard, but the 6 minute walk and the 15 step exercise oximetry tests are considerably less expensive.

Objectives: To determine whether reliable data could be obtained at lower cost.

Methods: The study sample consisted of 50 patients with mild to severe stable COPD]1[. All underwent pulmonary function test and the cardiopulmonary exercise test, 6 minute walk and 15 step exercise oximetry test as part of their regular follow-up visit. Functional capacity was graded according to each test separately and the functional capacities obtained were correlated.

Results: The results showed that most of the patients had severe COPD according to pulmonary function tests (mean forced expiratory volume in the first second 46.3 ± 19.9% of predicted value). There was a good correlation between the cardiopulmonary exercise test and the 6 minute walk functional capacity classes (r = 0.44, P = 0.0013). We did not find such correlation between the 15 step exercise oximetry test and the cardiopulmonary exercise test (r = 0.07, P = 0.64).

Conclusions: The study shows that the 6 minute walk is a reliable and accurate test in the evaluation of functional capacity in COPD patients.


 





[1] COPD = chronic obstructive pulmonary disease


Y. Turgeman, P. Levahar, I. Lavi, A. Shneor, R. Colodner, Z. Samra, L. Bloch and T. Rosenfeld
 Background: Adult calcific aortic stenosis is a well-known clinical entity but its pathophysiology and cellular mechanism have yet to be defined.

Objectives: To determine whether there is an association between the presence and severity of adult calcific aortic stenosis and Chlamydia pneumoniae seropositivity

Methods: Forty adult patients (23 women, 17 men) were divided into three groups according to echocardiographic aortic valve area: Group A – 7 symptomatic subjects (age 67 ± 7 years) with normal aortic valve and normal coronary angiogram, Group B – 16 patients (age 73 ± 6) with moderate ACAS[1] (AVA[2]> 0.8 £ 1.5 cm2), and Group C – 17 patients (age 76 ± 7) with severe ACAS (AVA £ 0.8 cm2). We tested for immunoglobulins M, G and A as retrospective evidence of C. pneumoniae infection using the micro-immunofluorescence method. Past C. pneumoniae infection was defined by IgG titer > 16 £ 512.

Results: No patients in Group A showed positive Ig[3] for C. pneumoniae. IgM was not detected in any of the patients with ACAS (groups B and C) while 2 of 17 patients (12%) in group C showed IgA for the pathogen. High titers of IgG were found in 14 of 33 (42%) of the patients with moderate or severe ACAS: 5 of 16 (31%) in group B and 9 of 17 (53%) in group C (P = 0.2). Both groups had the same prevalence of coronary artery disease (66%). AVA was lower in IgG-seropositive patients than in the seronegative group (0.88 ± 0.3 cm2 vs. 1.22 ± 0.4 cm2, respectively, P = 0.02).

Conclusions: Past C. pneumoniae infection may be associated with a higher prevalence and greater severity of ACAS.


 





[1] ACAS = adult calcific aortic stenosis

[2] AVA = aortic valve area

[3] Ig = immunoglobulin


A. Leibovitz, M. Lidar, Y,. Baumoehl, A. Livneh and R. Segal

Backgound: Colchicine is widely used for treating gout and familial Mediterranean fever. However, studies in animal models have reported ill effects of colchicine on the central nervous system, including cognitive function.

Objectives: To evaluate the cognitive status of elderly FMF[1] patients on long-term colchicine treatment.

Methods: The study group consisted of 55 FMF patients aged 74 ± 5, attending an FMF outpatient clinic and receiving colchicine treatment for 25.1 ± 8.9 years. The Mini-Mental State Examination was used for cognitive evaluation. Patients' scores were compared with accepted age- and education-adjusted cutoff scores, population-based norms, and scores of a matched control group of 56 subjects.

Results: Individually, all colchicine-treated FMF patients scored well above the age- and education-corrected cutoff scores. Overall, there was a large difference, 5.0 ± 1.6, from the expected cutoff points, in favor of the study group scores (P < 0.001). The individual scores of the control group were also above the cutoff points, however with a lower but still statistically significant difference (3.71 ± 1.15 points, P < 0.001). Compared to population-based norms adjusted by age and education, the study group had significantly higher mean MMSE[2] scores (27.2 ± 2.2 vs. 25.5 ± 2.4, P < 0.001). The control group’s scores were also somewhat higher than expected, but not significantly so.

Conclusions: Our results do not support the view that prolonged colchicine treatment may be associated with cognitive impairment. On the contrary, it is possible that long-term colchicine treatment may even confer protection against cognitive decline in patients with FMF.


 





[1] FMF = familial Mediterranean fever

[2] MMSE = Mini-Mental State Examination


M. Katz Leurer, E. Be'eri and D. Zilbershtein
 Background: There is a growing demand for respiratory rehabilitation services for children dependent on tracheostomy and/or chronic mechanical ventilation. Discharging these patients home following their rehabilitation can be an arduous process.

Objectives: To define the length of time required to rehabilitate and discharge these patients, and to identify predictors of a prolonged or failed discharge process.

Methods: We conducted a retrospective chart review of patients admitted to the Respiratory Rehabilitation Unit at Alyn Hospital, Jerusalem, over a 4 year period.

Results: Of the 48 patients identified, 31 (64.7%) were eventually discharged, 13 (27.1%) remained hospitalized long-term, and 4 (8.3%) died during their hospitalization. The median length of hospitalization was 10 months: 6 months for purposes of rehabilitation therapy, and 4 months thereafter to resolve the logistics of discharge. Specific family characteristics – an unemployed father (odds ratio = 4.6, P = 0.02) and an additional family member with a disability (OR[1] = 5.8, P = 0.03) – as well as ongoing mechanical ventilation at the time of discharge (OR = 5.5, P < 0.01) were found to positively correlate with a prolonged or failed discharge process.

Conclusions:  Hospitalization in a pediatric respiratory rehabilitation unit may be prolonged for both medical and non-medical reasons, with the process of discharge home being particularly difficult in certain subsets of patients. A proactive discharge policy by hospitals, improved community support services, and legislation defining the rights of home-ventilated children may facilitate more efficient discharge home of these patients.


 





[1] OR = odds ratio


I. Arad, M. Baras, B. Bar-Oz and R. Gofin
 Background: Maternal transport, rather than neonatal transport, to tertiary care centers is generally advocated. Since a substantial number of premature deliveries still occur in hospitals with level I and level II nurseries, it is imperative to find means to improve their outcome.

Objectives: To compare the neonatal outcome (survival, intraventricular hemorrhage and bronchopulmonary dysplasia) of inborn and outborn very low birth weight infants, accounting for sociodemographic, obstetric and perinatal variables, with reference to earlier published data.

Methods: We compared 129 premature infants with birth weights of 750–1250 g delivered between 1996 and 2000 in a hospital providing neonatal intensive care to 99 premature babies delivered in a referring hospital. In the statistical analysis, variables with a statistical significant association with the outcome variables and dissimilar distribution in the two hospitals were identified and entered together with the hospital of birth as explanatory variables in a logistic regression.

Results: Accounting for the covariates, the odds ratios (outborns relative to inborns) were 0.31 (95% confidence interval = 0.11–0.86, P = 0.03) for mortality, 1.37 (95%CI[1] = 0.64–2.96, P = 0.42) for severe intraventricular hemorrhage, and 0.86 (95%CI = 0.38–1.97, P = 0.78) for bronchopulmonary dysplasia. The odds ratio for survival without severe intraventricular hemorrhage was 1.10 (95%CI = 0.55–2.20, P = 0.78). Comparing the current results with earlier (1990–94) published data from the same institution showed that mortality decreased in both the outborn and inborn infants (OR[2] = 0.23, 95%CI = 0.09–0.58, P = 0.002 and 0.46; 95%CI = 0.20–1.04, P = 0.06, respectively), but no significant change in the incidence of severe intraventricular hemorrhage or brochopulmonary dysplasia was observed. Increased survival was observed also in these infants receiving surfactant, more so among the outborn. The latter finding could be attributed to the early, pre-transport surfactant administration, implemented only during the current study.

Conclusions: Our data suggest that very low birth weight outborn infants may share an outcome comparable with that of inborn babies, if adequate perinatal care including surfactant administration is provided prior to transportation to a tertiary center.


 





[1] CI = confidence interval

[2] OR = odds ratio


Reviews
S.W. Moses, M. David, E. Goldhammer, A. Tal and S. Sukenik
D. Rimar, Y. Rimar and Y. Keynan
 Today, more than 10 years and 2000 articles since human herpesvirus 8 was first described by Chang et al., novel insights into the transmission and molecular biology of HHV-8[1] have unveiled a new spectrum of diseases attributed to the virus. The association of HHV-8 with proliferative disorders – including Kaposi's sarcoma, multicentric Castleman disease and primary effusion lymphoma – is well established. Other aspects of HHV-8 infection are currently the subject of accelerated research. Primary HHV-8 infection may manifest as a mononucleosis-like syndrome in the immunocompetent host, or in various forms in the immunocompromised host. The association of HHV-8 with primary pulmonary hypertension was observed by Cool et al. in 2003, but six clinical trials evaluating the role of HHV-8 in pulmonary hypertension have not been able to replicate this intriguing observation. It has been speculated that HHV-8 may secondarily infect proliferating endothelium in patients with pulmonary hypertension. HHV-8 epidemiology, modes of transmission, new spectrum of disease and treatment are presented and discussed.







[1] HHV-8 = human herpesvirus 8


Case Communications
Imaging
הבהרה משפטית: כל נושא המופיע באתר זה נועד להשכלה בלבד ואין לראות בו ייעוץ רפואי או משפטי. אין הר"י אחראית לתוכן המתפרסם באתר זה ולכל נזק שעלול להיגרם. כל הזכויות על המידע באתר שייכות להסתדרות הרפואית בישראל. מדיניות פרטיות
ז'בוטינסקי 35 רמת גן, בניין התאומים 2 קומות 10-11, ת.ד. 3566, מיקוד 5213604. טלפון: 03-6100444, פקס: 03-5753303