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עמוד בית
Thu, 18.07.24

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July 2006
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.

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


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


T. Hershcovici, T. Chajek-Shaul, T. Hasin, S. Aamar, N. Hiller, D. Prus and H. Peleg
June 2006
R. Rosenberg, S. Vinker, J. Yaphe and S. Nakar
 Background: Maintaining a death register and holding staff discussions about patients who died can aid the physician in audit and research, which will lead to improved care of the terminally ill and the bereaved and to the development of prevention strategies. These issues are important for students and residents as well.

Objectives: To review the value of mortality-case discussions in primary care clinics, particularly teaching clinics.

Methods: The clinic death register, instituted in 1998, includes age, gender, cause of death, place of death, relevant illnesses, and support provided to the patient before the death. In the half-yearly sessions, the data are reviewed, and individual cases that had an emotional impact on the staff, or information that can bring about changes in future care are discussed by the clinic staff and trainees.

Results: In our clinic 233 deaths occurred during a 6 year period (1998–2003). The crude all-cause mortality rate was 7.1/1000. The median age was 80 years old. Neoplastic causes were slightly more frequent than cardiovascular causes of death. Only 15% died at home; 20% lived alone and 70% lived with a spouse or family members before the death. Topics discussed in the mortality review meetings include identifying pre-suicidal patients, when to hospitalize the sick elderly, dealing with the anger of bereaved families, and ensuring proper home care for terminal patients.

Conclusions: We recommend keeping a death register and conducting mortality review sessions in order to improve the quality of care, emotional support of the staff, and training students and residents about the complex issues surrounding the death of patients.

H. Desatnik, Z. Habot-Wilner, A. Alhalel, I. Moroz, J. Glovinsky and J Moisseiev
 Background: The major cause of visual impairment in diabetic patients is macular edema. The failure of laser photocoagulation in a large subgroup of patients with clinically significant diabetic macular edema has prompted interest in other treatment methods.

Objectives: To evaluate the long-term efficacy and safety of an intravitreal injection of triamcinolone acetonide for clinically significant diabetic macular edema.

Methods: In a retrospective case series 31 diabetic patients with persistent, recurrent or diffuse clinically significant diabetic macular edema received a single 4 mg (0.1 ml) intravitreal triamcinolone acetonide injection and were followed for at least 6 months. The main outcome measures evaluated were classified as primary: visual acuity and central macular thickness, and secondary: intraocular pressure and cataract progression. Statistical analyses included Student’s t-test, chi-square test and the McNamar test.

Results: Best visual acuity results were observed 2.6 ± 2.4 months post-injection. At that time the mean foveal thickness had decreased by 37% from a baseline of 455 ± 100 to 288 ± 99 µ (P < 0.001) and the mean visual acuity improved from 6/42 to 6/23 (P < 0.001). Final mean visual acuity after an average of 10 ± 1.8 months follow-up (range 6–13 months) was identical to the baseline, although mean foveal thickness was still significantly lower than the initial thickness (368 ± 166 vs. 455 ± 100 µ, P < 0.01). Statistical analysis did not identify any pre-injection prognostic factors for improved visual acuity. The only complications that occurred were elevated intraocular pressure in 42% of patients and cataract progression in 21%. There was no endophthalmitis.

Conclusions: Intravitreal injection of triamcinolone acetonide for clinically significant diabetic macular edema is effective in reducing foveal thickness and improving visual acuity in the short term. Longer follow-up revealed that visual acuity returned to pre-injection values, even though a modest decrease in the foveal thickness persisted. Further studies are needed to evaluate the long-term efficacy in conjunction with laser photocoagulation treatment.

A. Ekka-Zohar, Y. Zitser-Gurevich, M. Mandel, I. Weiss-Salz, S. Nir, E. Mor, R. Nakash, H. Merhav, R. Bruck and E. Simchen
Background: There is a dearth of organs for liver transplantation in Israel. Enhancing our understanding of factors affecting graft survival in this country could help optimize the results of the transplant operation.




Objectives: To report 3 years national experience with orthotopic liver transplantation, and to evaluate patient and perioperative risk factors that could affect 1 year graft survival.

Methods: The study related to all 124 isolated adult liver transplantations performed in Israel between October 1997 and October 2000. Data were abstracted from the medical records. One-year graft survival was described using the Kaplan-Meier survival curve and three multivariate logistic regression models were performed: one with preoperative case-mix factors alone, and the other two with the addition of donor and operative factors respectively.

Results: Of the 124 liver transplantations performed, 32 failed (25.8%). The 1 year survival was lower than rates reported from both the United States and Europe, but the difference was not significant. Of the preoperative risk factors, recipient age ≥ 60 years, critical condition prior to surgery, high serum bilirubin and serum hemoglobin ≤ 10 g/dl were independently associated with graft failure, adjusting for all the other factors that entered the logistic regression equation. Extending the model to include donor and operative factors raised the C-statistic from 0.79 to 0.87. Donor age ≥ 40, cold ischemic time > 10 hours and a prolonged operation (> 10 hours) were the additional predictors for graft survival. A MELD score of over 18 was associated with a sixfold increased risk for graft failure (odds ratio = 6.5, P = 0.001).

Conclusions: Graft survival in Israel is slightly lower than that reported from the U.S. and Europe. Adding donor and operative factors to recipient characteristics significantly increased our understanding of 1 year survival of liver grafts.

S. Eilat-Tsanani, A. Merom, S. Romano, A. Reshef, I. Lavi and H. Tabenkin
 Background: Postpartum depression is a well-known phenomenon that occurs in about 10% of births and affects the quality of life of the mother as well as the family. As in other cases of depression, under-diagnosis of PPD[1] may keep patients from getting proper care and increase their physical and emotional distress.

Objectives: To identify patients with PPD and to describe their consultation patterns with primary care physicians for themselves and their babies.

Methods: Using a telephone survey and the Edinburgh Postnatal Depression Scale questionnaire we identified PPD in a sample of women who gave birth in HaEmek Medical Center. We also assessed the extent to which the women consulted with family physicians, gynecologists and/or pediatricians.

Results: The survey included 574 women, of whom 9.9% were diagnosed with PPD. There was a higher rate of PPD among Arab compared to Jewish women, among women with a prior history of depression, among women whose pregnancy was unplanned, among those who described the course of pregnancy as “difficult,” and among women who described their general health as “not good.” Women with PPD consulted more with family physicians and pediatricians. The reasons for the consultations are physical and emotional. There were cases of somatization manifested directly by the mother or indirectly through the baby.

Conclusions: Women with PPD have higher consultation rates than those without. By asking a few simple questions it is possible to identify a significant proportion of women with PPD.


 





[1] PPD = postpartum depression


May 2006
O. Hochwald, E. Bamberger and I. Srugo

The Israel Ministry of Health’s epidemiology department reported a record number of 1564 new pertussis cases in 2004. This brings the incidence rate to 23 per 100,000 population, indicating a marked increase in the prevalence of pertussis, from 1–3/100,000 in 1998, 9 in 2001, to 14 in 2003. The rate of atypical pertussis presentations in vaccinated patients, the decline in pertussis immunity post-vaccination, and the decreased awareness of potential infections in the adult population make the diagnosis of pertussis difficult and contribute to the rising incidence. In this article we review the current literature in order to increase awareness of the occurrence of pertussis in children as well as adults, discuss the laboratory diagnostic methods being used, and report the currently recommended means of treating the disease.

L. Moerman, A. Leventhal, P.E. Slater, E. Anis, R. Yishai and E. Marva

Background: Pertussis is the only vaccine-preventable disease that has re-emerged in Israel. The reported crude incidence of the disease increased 16-fold since 1998.

Objectives: To describe the epidemiology of pertussis and to explain the substantial increase in reported pertussis incidence in Israel in recent years.

Methods: Crude and specific pertussis incidence by age, patient immunization status, hospitalization rate and national immunization coverage rate were calculated from information provided by the public health offices of the Ministry of Health.

Results: The reported crude incidence of pertussis increased from 1–2/100,000 in 1994–98 to 23/100,000 in 2004. The trend was observed in all age groups, being most prominent in infants under age 1 year and in children aged 5–14. The incidence of pertussis was substantially higher in unvaccinated and partly vaccinated compared to fully vaccinated persons. Fifteen percent of notified cases were hospitalized, but in infants under age 1 year the hospitalization rate was 50%. National pertussis immunization coverage by age 2 years was stable during the last 10 years.

Conclusions: There are several possible explanations for the re-emergence of pertussis in Israel. The most plausible reason seems to be the waning of vaccine-induced immunity in face of infrequent natural exposure to the infectious agent and lack of a pertussis vaccine booster dose after age 1.
 

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