Israel Medical Association Journal

Background: Previous data showed that new recombi­nant hepatitis B virus vaccine, which contains the S-protein component of the HBV surface together with the Pre-S₁ and Pre-S₂, is considerably more immunogenic than a second-generation recombinant I-IBV vaccine.

Objectives:To compare the immunogenicity and safety of a novel recombinant HBV vaccine S1, Pre-S₁ and Pre-S₂ protein components of the hepatitis B surface antigen - Bio­TM

Hep^TM 10 לg dose, to a licensed vaccine containing only the S-protein component - Engerix-B, 20 לg dose.

Methods: A prospective randomized study included 524 adults - 260 in the Bio-Hep group and 264 in the Engerix-B group. Both vaccines were administered in a three-dose regimen given at 0, 1 and 6 months, and adverse events were recorded on a diary card 5 days after each vaccination. lmmunogenicity was tested by measuring anti-hepatitis B surface antibody.

Results: One month after the third injection, 98% of the BioHep^TM subjects were found to be seroprotected vs. 85.1% of the Engerix-B group. In addition, the geometric mean titers were 2,203 mlU/ml and 326 mlU/ml in the Bio-Hep-B and Engerix-B groups respectively. An immunogenic advantage of Bio-Hep-B was suggested by the rapid onset of antibody response - 66.5% were seroconverted one month after the first injection as compared to 19.3% in the Engerix-B group. No unexpected adverse events were observed, and the recorded events were mild in both groups.

Conclusions: BioHepTM, a novel recombinant HBV vaccine containing 5, Pre-S₁ and Pre-S₂ protein components. at a lower dose, is safe and more immunogenic than the conventional HBV vaccine that contains only S protein.

Background: Classic Kaposi's sarcoma is a rare tumor with an indolent behavior. Local therapy is not applicable in disseminated cutaneous disease. Patients with advanced disease are usually treated with systemic chemotherapy.

Objectives: To assess the effectiveness and toxicity of  single-agent vinblastine in the treatment of disseminated and recurrent Kaposi's sarcoma.

Methods: Ten patients with wide cutaneous spread of classic Kaposis sarcoma were treated with single-agent vinblastine, 6 mg/m² intravenously once every 2 weeks. Vinblastine was continued for 2 months after achieving a maximal response.

Results: The male:female ratio was 2.3:1, and median age 64 years (range 50-79 years). The median number of involved nodules in the skin was 34. The overall response rate was 90%, 5 with complete response (50%) and 4 with partial response (40%). Complete responders had a longer duration of response than partial responders: 41.2 vs. 14.8 months. The median survival of all patients was 33 months. Side effects were minimal and tolerable.

Conclusions: Vinblastine is very effective in the treatment of extensive classic Kaposi's sarcoma, and results in a high response rate, long survival and disease-free survival with tolerable toxicity.

Background: Autism is a pervasive developmental dis­order. The incidence rate and other related epidemiological characteristics of the Israeli population are not available.

Objectives: To assess the incidence rate of autism in the Haifa area and to compare family characteristics with previous reports from other countries.

Methods: We approached facilities in the Haifa area that are involved with the diagnosis and treatment of autism. The study group comprised children born between 1989 and 1993. Records of the children were scrutinized and 69% of the mothers were interviewed. Live-birth cohorts of the same years were employed for incidence computation.

Results: An incidence rate of 1/1000 was derived. Male to female ratio was 4.2:1. Pregnancy and perinatal periods were mostly uneventful. A low prevalence of developmental and emotional morbidity was reported for family members.

Conclusions: The epidemiological characteristics found in the Haifa area are similar to those reported from non-Israeli communities. This finding supports an underlying biological mechanism for this disorder. These data can be used for future trend analyses in Israel.
 

Knowledge on the pathophysiology of irritable bowel syndrome has evolved, beginning with disturbances in motility to visceral hypersensitivity, and ultimately to alterations in brain-gut bi­directional communication, where neurotransmitters such as serotonin play a key role. Recently, a multicomponent disease model that integrates all these alterations was proposed. This model is divided into physiological, cognitive, emotional and behavioral components that explain the gastrointestinal as well as the constitutional symptoms. In recent years there has been an explosion of research together with new developments in pharmacological treatments for lBS that support each compo­nent of this model. This review presents recent data in favor of these alterations in IBS.

Background: Information is lacking on the effects of hormone replacement therapy in women with diabetes, especially during moderate chronic hyperglycemia.

Objectives: To study the effects of HRT on the lipid profile and the low density lipoprotein subclass distribution in women with type 2 diabetes under satisfactory and non-satisfactory glycemic control.

Methods: Fifty-four postmenopausal women after a 6 week run-in diet were randomized to receive either placebo(HbAlc <8%, n=13 HbAlc >8%, n=17) or HRT (HbAlc<8%, n=11 HbAlc >8%, n=13) for 12 weeks. HRT consisted of cyclical conjugated estrogens 0.625 mg/day plus medrogestone 5 mg/day. At the beginning and at the end of each treatment period the LDL subclass distribution was estimated by density gradient ultracentrifugation.

Results: At the baseline and during the study, the HbAlc level was significantly higher in hyperglycemic patients than in the near-normoglycemic controls (baseline 10.2±2.9 vs. 6.5±0.7%, P<0.01). They showed a trend for higher total and LDL cholesterol, triglycerides and lower high density lipoprotein-cholesterol compared to near-normoglycemic con­trols, as well as significantly higher triglyceride concentrations in very low density lipoprotein, intermediate density lipoprotein and LDL-1 particles and cholesterol content in LDL-1 and -2 particles. HRT decreased LDL-cholesterol in both groups. In the normoglycemic patients a small increase in HbAlc was observed (6.5±0.7 vs. 7.4+1%, P=004). In all cases, HRT did not modify the proportion of LDL represented by denser LDLs.

Conclusions: HRT did not modify the LDL subclass distribution, even in the presence of moderate chronic hyperglycemia in women with type 2 diabetes.

Background: Both diagnostic and therapeutic options in the management of iatrogenic false aneurysms have changed dramatically in the last decade, with surgery being required only rarely.

Objective: To describe our experience, techniques and results in treating pseudoaneurysms at a large medical center with frequent arterial interventions. We emphasize upper limb lesions.

Materials and Methods: We reviewed the data of all consecutive patients diagnosed by color-coded duplex Doppler between August 1992 and July 1998 as having upper limb and lower limb pseudoaneurysms (mainly post- catheterization). We accumulated 107 false aneurysms (mainly post- catheterization lesions): 5 were upper limb lesions and 102 were groin aneurysms.

Results: In the lower limb cases 94 of the 102 lesions were not operated upon (92.1%). Seventy lower limb cases were treated non-operatively by ultrasound-guided compression obliteration with a 95.7% success rate (67 cases). Two cases were treated by  percutaneous thrombin injection (2%) and 23 by observation only (22.5%). Altogether 12 patients underwent surgery (11.2%): 4 upper extremity and 8 lower extremity cases. None of the lower limb group suffered serious complications regardless of treatment, but all five upper limb cases did, four of them necessitating surgical intervention. Three of the five upper limb cases had a grave outcome with severe or permanent or neurological damage.

Conclusion: Most post- catheterization pseudoaneurysms can be managed non-surgically. False aneurysms in the upper extremity are rare, comprising less than 2% of all lesions. However, upper extremity pseudoaneurysms present a potentially more serious complication and require early diagnosis and prompt intervention to minimize the high complication rate and serious long-term sequelae. Prevention can be achieved by proper puncture technique and site selection, and correct post-procedure hemostatic compression with or without an external device. Some upper limb lesions are avoidable if the axillary artery is not punctured.
 

Background: Secundum atrial septal defect is a common congenital heart defect that causes right heart volume overload and produces symptoms usually after the third decade of life. Treatment until the last few years has been open heart surgery.

Objective: To review our early experience with transcatheter closure of ASD2 using the Amplatzer septal occluder.

Methods: Between November 1999 and February 2000, 20 children and young adults with a median age of 9.1 years (4.2-35.1 years) were referred for transcatheter closure of ASD2. Diagnosis was established by transthoracic echocardiography. Implantation was performed under general anesthesia through the femoral vein with the guidance of transesophageal echocardiography and fluoroscopy. Femoral arterial puncture was performed for blood pressure monitoring during the procedure. The device size chosen was similar to the balloon-stretched diameter of the ASD2.

Results: Implantation was completed successfully in 18 patients. Two patients were referred for elective surgery: one had an unsuitable anatomy for transcatheter closure by TEE in the catheterization laboratory and the device could not implanted properly, the other patient had a large multiperforated septal aneurysm that was retrieved. Mean ASD2 diameter by TTE and TEE was similar (13.9 + 3 mm, 13.4 + 3.5 mm) and mean stretched diameter was 18.3 + 4.3 mm. Mean Qp:Qs (pulmonary flow: systemic flow) was 2.2 + 0.6. Mean fluoroscopy time for the procedure was 14.8 + 4.8 minutes.

The patients were discharged the day after the procedure.

Four patients had a tiny leak immediately post-procedure, and none had a leak at one month follow-up. The only complication was a small pseudoaneurysm of the femoral artery in one patient, that resolved spontaneously.

Conclusion: Transcatheter closure of ASD2 with the Amplatzer septal occluder is a safe and effective alternative to surgical closure. Long-term outcome has to be evaluated.

Objective: To identify correlates for under-utilization of influenza immunization among the elderly.

Methods: A telephone survey was conducted among a random sample of patients aged 65 and over registered at a Jerusalem primary care community clinic. The 626 questionnaires were analyzed for associations of immunization receipt for the latest influenza season. Multivariate logistic regression was performed to identify independent correlates. Respondents were also asked what factors had influenced their decision about immunization.

Results: The most frequently reported influence on getting immunized was a physician's recommendation. Immunization was independently associated with the identity of the primary care physician (P0.0001) and with having visited the physician during the previous 3 months (P=0.0006). Immunization was more likely among persons who believed that it provides complete protection from influenza (P0.0001) and less likely among those who believed immunization can cause influenza (P0.0001). Higher immunization rates were also associated with being married (P=0.0031).

Conclusion: Through their influence on patient knowledge and the effect of their recommendation, primary care physicians play a pivotal role in determining immunization rates. Physicians should routinely discuss the effects of immunization and recommend it to the elderly.

Background: Tumor necrosis factor is associated with various local and systemic inflammatory sequelae following snakebite. Xanthine oxidase is a principal mediator of remote tissue injury (e.g., lungs, heart, liver).

Objective: To investigate in a snakebite-like animal model the as yet unexplored role of TNF and XO in mediating organ damage following snakebite.

Methods: Sprague-Dawley rats were injected intramuscularly with a non-lethal 500 g/kg dose of Vipera aspis venom (n=10) or saline (n=10). Blood pressure and heart rate were continuously monitored, TNF- was measured in the blood, and total XO + xanthine dehydrogenase activity was assessed in various tissues. Lung histology and permeability indices were analyzed.

Results: Venom injection caused a significant (P0.05) reduction in both heart rate and invasive arterial pressure. The blood circulating TNF levels were significantly higher in the intoxicated group (P0.05 vs. saline group), with changes seen at 30 minutes from intoxication in both groups. Total XO + XDH activity in the kidney, lung and liver of the venom-injected group was significantly (P0.05) higher than in the saline group, while the activity in the heart was similar.

Conclusions: The mediation of remote organ and hemodynamic changes following intramuscular injection of a non-lethal dose of Vipera aspis venom can be attributed partly to TNF and partly to XO. More research is needed to better understand the role of either compound and the time frame of their activity before specific antagonists can be introduced for snakebite management.