Israel Medical Association Journal

Background: Mite allergy is an indoor allergen responsible for most respiratory allergies in the western world. Environmental control can modify disease activity in these patients.

Objectives: To examine the benefit of the Plasma Cluster^® device (Sharp, Japan) for inactivating and removing mites from the environment of patients diagnosed with either mite‑sensitive perennial allergic rhinitis or mite‑sensitive allergic asthma.

Methods: Patients with AR[1] (n=30) or AA[2] (n=10) were enrolled into a prospective open observational 8 week study. The first 2 weeks involved initial evaluation, the following 4 weeks consisted of active usage of the device, and the last 2 weeks were designated for follow‑up. Symptom scores (recorded daily by patients and during visits by physicians) were recorded and analyzed.

Results: Patients with AR experienced a significant (P < 0.05) reduction in nasal discharge, post‑nasal drip, nasal congestion, nasal itching, watery eyes, itchy eyes, headache, itchy ears, night disturbances and an improvement in general well‑being during the last 2 days of the study compared to baseline. Patients with AA reported significant (P < 0.05) reduction in dyspnea, wheezing and the need to avoid dust mites. There was a significant (P < 0.05) improvement in mean peak expiratory flow rate at study closure compared to baseline.

Conclusions: Short-term usage of the Plasma Cluster^® device resulted in considerable clinical improvement and increased peak expiratory flow rate in patients with AR or AA. The findings of this pilot study warrant longer and controlled studies to determine the value of this device in the treatment of various allergic disorders.

Background: Subcutaneous allergen immunotherapy is effective in treating allergic airway disease. Disadvantages include immediate local and systemic adverse reactions and poor compliance.

Objectives: To obtain real-life efficacy and safety data through a prospective observational study of SIT[1] in the allergist's office.

Methods: We prospectively collected data from all patients with a diagnosis of allergic rhinitis and/or asthma and a specific immunoglobulin E-mediated sensitization to one or more aeroallergens who began SIT during the 2 year period 1 January 2005 to 31 December 2006. As part of the routine immunotherapy care patients were asked to complete a disease activity questionnaire before and yearly during the treatment. The primary outcome measure was the combined rhinitis and asthma symptoms scores. Data from patients completing at least 1 year of immunotherapy were analyzed.

Results: Altogether, 133 enrolled patients with a mean age of 22.7 years completed at least 1 year of SIT. The allergic rhinitis and asthma disease activity score decreased from a mean of 8.1 to 3.3 (rhinitis) and from 4.8 to 2.4 (asthma) on a 10 cm visual analogue scale after 1 year of SIT (P < 0.001 for all comparisons). Rhinitis medication use in all patients and asthma medication use in asthmatics decreased significantly. Mild local adverse reactions were almost universal. There were 11 patients (8%) who developed 14 immediate systemic, mild to moderate reactions. All reactions were successfully treated in the clinic; none required additional observation or hospitalization.

Conclusions: In the hands of experienced allergists subcutaneous allergy immunotherapy is a safe and efficacious option for patients with allergic rhinitis and asthma. 

Background: Locally delivered steroids by inhalers or nebulizers have been shown in small trials to be effective in acute asthma attack, but evidence-based data are insufficient to establish their place as routine management of adult asthma attacks.

Objectives: To determine the efficacy of nebulized compared to systemic steroids in adult asthmatics admitted to the emergency department following an acute attack.

Methods: Adult asthmatics admitted to the ED[1] were assigned in random consecutive case fashion to one of three protocol groups: group 1 – nebulized steroid fluticasone (Flixotide Nebules®), group 2 – intravenous methylprednisolone, group 3 – combined treatment by both routes. Objective and subjective parameters, such as peak expiratory flow, oxygen saturation, heart rate, and dyspnea score, were registered before and 2 hours after ED treatment was initiated. Steroids were continued for 1 week following the ED visit according to the protocol arm. Data on hospital admission/discharge rate, ED readmissions in the week after enrollment and other major events related to asthma were registered.

Results: Altogether, 73 adult asthmatics were assigned to receive treatment: 24 patients in group 1, 23 in group 2 and 26 in group 3. Mean age was 44.4 ± 16.8 years (range 17–75 years). Peak expiratory flow and dyspnea score significantly improved in group 1 patients compared with patients in the other groups after 2 hours of ED treatment (P = 0.021 and 0.009, respectively). The discharge rate after ED treatment was significantly higher in groups 1 and 3 than in group 2 (P = 0.05). All 73 patients were alive a week after enrollment. Five patients (20.8%) in the Flixotide treatment arm were hospitalized and required additional systemic steroids. Multivariate analysis of factors affecting hospitalization rate demonstrated that severity of asthma (odds ratio 8.11) and group 2 (OD[2] 4.17) had a negative effect, whereas adherence to chronic anti-asthma therapy (OD 0.49) reduced the hospitalization rate.

Conclusions: Our study cohort showed the advantage of nebulized steroid fluticasone versus systemic corticosteroids in adult asthmatics managed in the ED following an acute attack. Both these and previous results suggest that nebulized steroids should be used, either alone or in combination with systemic steroids, to treat adults with an acute asthma attack.

Background: Iron deficiency is the most common single cause of anemia worldwide. Treatment consists of improved nutrition along with oral, intramuscular or intravenous iron administration.

Objectives: To describe the efficacy and adverse effects of intravenous iron sucrose therapy in a group of children with iron deficiency anemia who did not respond to oral iron therapy.

Methods: We conducted a prospective investigation of 45 children, aged 11 months to 16 years, whose oral iron therapy had failed. The children attended the Pediatric Ambulatory Care Unit where they received intravenous iron sucrose infusion.

Results: Forty-four of the 45 patients were non-compliant. Nine had Helicobacter pylori gastritis and 16 patients suffered from intestinal malabsorption from different causes. Before treatment, the blood mean hemoglobin concentration was 7.43 g/dl (range 5–10.1 g/dl). Fourteen days after treatment the mean hemoglobin concentration increased to 9.27 g/dl (SD 1.23) and 6 months later to 12.40 g/dl (SD 1.28). One patient demonstrated a severe side effect with temporary and reversible reduced blood pressure during treatment.

Conclusions: These preliminary data suggest that administration of intravenous iron in pediatric patients is well tolerated and has a good clinical result, with minimal adverse reactions.

There has been a paradigm shift in the treatment of rheumatoid arthritis in recent years. Early and aggressive treatment with good control of disease activity has improved the prognosis of the disease, however, there is significant variability in the response of patients to different therapeutic agents. Hence it is essential to find the predictors of response to a drug at baseline so that we can avoid the delay in achieving remission and improve the outcome. Here we review the literature on available predictors for treatment response in general and specifically for methotrexate and biological agents. We also look at specific scores or indices that can help predict the response in individual patients.

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.

Objectives: To establish the impact of breast MRI on women undergoing testing in our institution.

Methods: We analyzed 82 cases that underwent MRI between January 2001 and April 2003. Analysis appraised the clinical impact of MRI testing in cases where medical summaries were available.

Results: Studies were categorized into five indications: a) screening in high risk women (n=7), b) search for primary disease in the presence of disease (n=5), c) monitoring of chemotherapy (n=2), d) postoperative assessment of tumor bed (n=9), and e) diagnostic/characterization of primary or recurrent breast cancer (n=59). Results were defined as negative, positive or no impact on clinical management. MRI testing had a positive impact in 62 cases, affecting measurable change in 9 cases. Benefit was seen in screening, diagnosis and postoperative cases. In 15 cases, MRI stimulated investigations.

Conclusion: MRI is a valuable tool in breast imaging and affects management. Further trials are necessary to define clearly the role of MRI and to ascertain whether in cases where beneficial impact on management is noted, there is ultimate impact on outcome. 

Objectives: To use pelvic fractures as a test case for the efficiency of the Israeli trauma system, as reflected in the experience of our medical center.

Methods: Data were obtained from the medical charts of all cases of pelvic fractures admitted to our medical center between 1987 and 1999. We obtained demographic data, information on the cause of injury, fracture classification, co-injuries and Injury Severity Score, treatment strategies, and mortality rate.

Results: Altogether, 808 patients with pelvic injuries were treated in our medical center. The most common cause of injury was motor vehicle accidents (51%). Pelvic fractures without acetabular involvement were diagnosed in 58% of patients and isolated acetabular fractures in 32%, while 10% sustained combined injuries to the pelvic ring and the acetabulum. The overall rate of operative stabilization was 34%. The majority of patients had associated injuries, mostly additional musculoskeletal injuries. Altogether, 13% were referred from Level II/III trauma centers. We observed an increase in the total number of local admissions, in the percentage of referred patients and in the percentage of operated patients during the study period. The observed mortality rate was 5%.

Conclusions: Our results show a more than twofold increase in the percentage of referred patients following the designation of a Level I trauma center. These referrals result not only from the designation as a Level I trauma center, but also from the presence of a dedicated team of pelvic fracture specialists, available 24 hours a day. In addition, a larger percentage of patients undergo surgery for internal fixation of pelvic fractures, in accordance with current worldwide trends.

Objectives: To evaluate the sensitivity, specificity, accuracy, and positive and negative predictive values of FNAB[1] in cases of a solitary thyroid nodule.

Methods: The preoperative FNAB results of 170 patients who underwent thyroidectomy due to a solitary thyroid nodule were compared retrospectively with the final postoperative pathologic diagnoses.

Results: In cases of a solitary thyroid nodule, FNAB had a sensitivity of 79%, specificity of 98.5%, accuracy of 87%, and positive and negative predictive values of 98.75% and 76.6% respectively. All cases of papillary carcinoma diagnosed by FNAB proved to be malignant on final histology, while 8 of 27 cases of follicular adenoma detected by preoperative FNAB were shown to be malignant on final evaluation of the surgical specimen.

Conclusions: FNAB cytology reduces the incidence of thyroidectomy since this method has excellent specificity and sensitivity and a low rate of false-negative results. It proved to be cost-effective and is recommended as the first tool in the diagnostic workup in patients with thyroid nodules.

Background: Head lice move easily from head to head. The lack of safe, effective repellents leads to reinfestation.

Objectives: To test the efficacy of a slow-release citronella formulation as a repellent against the head louse.

Methods: During 4 months in 2003 a randomized, placebo-controlled double-blind clinical study was conducted in four elementary schools; 103 children were treated with the test formulation and 95 with a placebo.

Results: A significant difference was observed during the second examination 2 months later, when 12.0% of the children treated with the test repellent and 50.5% of those treated with placebo were infested with lice. A significant difference was also observed at the third examination 2 months later, when 12.4% of the children treated with the test repellent and 33.7% treated with placebo were infested. Overall, there were significant differences between those treated with the repellent and those treated with the placebo (15.4% and 55.1% respectively, P < 0.0001). Side effects were observed in 4.4% of children who disliked the odor of the formulation, and an additional 1.0% who complained of a slight itching and burning sensation.

Conclusions: Use of an effective repellent could significantly lower the incidence of reinfestations, which would lower expenditure on lice control, including pediculicides, combs and products for nit removal, and the time spent on treatment and removal of the nits.

Background: Head louse infestations are prevalent worldwide. Over the past 20-25 years, 15-20% of all children in Israel between 4 and 13 years of age have been infested with head lice; This is mainly due to the existence of ineffective pediculicides on the market.

Objective: To examine the pediculicidal efficacy and safety of a natural remedy (”Chick-Chack") and to compare it in an open clinical study with a known pesticide spray.

Methods: The natural remedy, which contains coconut oil, anise ail and ylang ylang oil:, was applied to the hair of infested.children three times at 5 day intervals. Each treatment lasted for 15 minutes. The control pediculicide was a spray, formulation containing permethrin, malathion, piperonyl butoxide, isododecane and propellant gas, which was applied twice for 10 minutes with a 10 day interva1 between applications.

Results: Of 940 Children, aged 6-14 years, from six schools in Jerusalem who were examined for head louse infestastion,199 (21:.2÷/) were infested with lice and eggs, while 164 (17.4% ) were infested only  with nits. Altogether, 119 children were randomly treated with either the natural remedy or the control product. Treatment was successful with the natural remedy  in 60 children (92.3%) and with the control pediculicide in 59 children (92.2%). There were no significant side effects associated with either formulation.

Conclusions: The natural remedy was very effective in controlling  louse infestations under clinical conditions and caused no serious side effects.
 

Background: Hyperlipidemia is a major risk factor for coronary heart disease. Reducing low density lipoprotein-cholesterol can significantly reduce the risk of CHD[1], but many patients fail to reach the target LDL-C[2] goals due to low doses of statins or low compliance.

Objectives: To treat high risk patients with atorvastatin in order to reach LDL-C goals (either primary or secondary prevention) of the Israel Atherosclerosis Society.

Methods: In this open-label study of 3,276 patients (1,698 of whom were males, 52%), atorvastatin 10 mg was given as a first dose, with follow-up and adjustment of the dose every 6 weeks. While 1,670 patients did not receive prior hypolipidemic treatment, 1,606 were treated with other statins, fibrates or the combination of both.

Results: After 6 weeks of treatment, 70% of the patients who did not receive prior hypolipidemic medications and who needed primary prevention reached target LDL-C levels. Interestingly, a similar number of patients on prior hypolipidemic treatment reached the LDL-C goals for primary prevention. The patients treated with other statins, fibrates or both did not reach the LDL-C treatment goals. Only 34% of all patients who needed secondary prevention reached the ISA[3] LDL-C target of 100 mg/dl. Atorvastatin proved to be completely safe; only two patients had creatine kinase elevation above 500 U/L, and another six had mild CK[4] elevation (<500 U/L). None of the patients had clinical myopathy, and only one had to be withdrawn from the study.

Conclusion: Atorvastatin is a safe and effective drug that enables most patients requiring primary prevention to reach LDL-C goal levels, even with a low dose of 10 mg. Patients in need of secondary prevention usually require higher doses of statins.

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