Israel Medical Association Journal

Background: Pulmonary disease is the most frequent cause of morbidity and mortality in cystc fibrosis patients. New techniques such as non-invasive positive pressure ventilation have resulted in prolongation of life expectancy in CF[1] patients with end-stage lung disease.

Objectives: To determine the role of NIPPV[2] in CF patients awaiting lung transplantation.

Methods: Between 1996 and 2001 nine CF patients (5 females) with end-stage lung disease were treated with bi-level positive airway pressure ventilation in the "spontaneous" mode.

Results: The patients' mean age at initiation of BiPAP[3] was 15 years (range 13–40 years) and the mean duration of BiPAP usage was 8 months (range 3–16 months). Four patients underwent successful lung transplantation, three patients died while awaiting transplantation, and the remaining two are still on NIPPV while waiting for transplantation. Patients' body mass index increased significantly (P < 0.05) during BiPAP therapy (from 16.1 to 17.2 kg/m²). Blood pH, p_aCO₂, and bicarbonate improved significantly (from 7.31 to 7.38, 90.8 to 67.2 mmHg, and 48.9 to 40.3 mEq/L, respectively). Pulmonary function tests were not affected by BiPAP usage. The patients experienced a significant alleviation in morning headaches and improvement in quality of sleep (P < 0.003). There were no major complications during BiPAP usage.

Conclusions: We demonstrated that long-term NIPPV can stabilize and improve physiologic parameters such as ventilation, arterial blood gases and body mass index, as well as subjective symptoms such as sleep pattern, daily activity level, and morning headaches in CF patients with end-stage lung disease. Further prospectively controlled studies are needed to evaluate the potential of BiPAP therapy and its influence on morbidity and mortality in the post-lung transplantation period.

Background: The management of diabetes in preschool children poses unique difficulties for both the families and the medical team.

Objective: To test the feasibility and safety of insulin pump therapy in the 1–6 year age group in order to improve quality of life and metabolic control.

Methods: The study group comprised 15 type 1 diabetic children aged 1–6 years old (mean ± SD, 3.8 ± 1.2 years) from three diabetes centers. Insulin pump therapy was applied for 12 months. Data, including insulin dose, hemoglobin A1c, hypoglycemic events, as well as scores on the Diabetes Quality of Life Measure Questionnaire and the Diabetes Treatment Satisfaction Questionnaire, were collected and compared with the multiple daily injections treatment prior to entry into the study.

Results: HbA1c[1] was measured at the beginning of the study and at 2, 4, 8 and 12 months later; the respective levels (mean ± SD) were 8.82 ± 0.98, 8.45 ± 1.05, 8.37 ± 0.85, 8.32 ± 0.71, 8.18 ± 0.90%. HbA1c measurements after 12 months were significantly lower than at the beginning of the study (P < 0.05). There were no significant differences in insulin dose and the total number of hypoglycemic events. In both the DQOL[2] and DTSQ[3] scales there were significant differences in scores in favor of the insulin pump period (43.7 ± 8.0 versus 33.7 ± 7.9, P < 0.001; and 10.9 ± 2.3 versus 14.5 ± 2.3, P < 0.001), respectively.

Conclusions: For very young diabetic children, insulin pump therapy improves quality of life and is feasible and safe. It should be considered as an optional mode of therapy for this age group.

Background: Eyes scheduled for posterior segment surgery may have cataract, which obscures the visualization of the retina. Surgery may be carried out either by a two-step procedure: i.e., removal of the cataract followed later by posterior segment surgery; or it may be done in a single session: i.e., combined surgery of both the anterior and posterior segments.

Objective: To evaluate the outcomes of combined surgery by phacoemulsification and vitrectomy.

Methods: We retrospectively reviewed the records of 42 patients with coexisting cataract and vitreoretinal disease who underwent combined surgery by phacoemulsification and pars plana vitrectomy at one session.

Results: Indications for surgery were vitreous hemorrhage in 71.4%, retinal detachment in 11.9%, macular hole in 11.9%, and epiretinal membrane in 4.8%. There were no significant intraoperative complications.The main early postsurgical complications were fibrinous formation in 11.9%, elevated intraocular pressure in 23.8%, and recurrent vitreous hemorrhage in 9.5%. There were a few late complications related to phacoemulsification: posterior synechia in 9.5%, posterior capsular opacification in 7.1%, and dislocating intraocular lens in 4.8%. Recurrent retinal detachment occurred in five eyes and rubeoisis iridis in one. Visual acuity was improved in 85.8%, stable in 7.1% and worse in 7.1%.

Conclusions: Phacoemulsification performed at the time of posterior segment surgery enables good visualization during the vitrectomy, facilitates surgery, and is associated with only minor complications. In cases with cataract and vitreoretinal diseases, combined surgery by phacoemulsification and vitrectomy in one session may be considered.
 

Background: Complementary and alternative medical care has gained increasing popularity in western societies in recent years.

Objectives: To provide a cross-sectional and temporal (2000 vs. 1993) analysis of the use of complementary and alternative medicine in Israel.

Methods: The subjects studied represented the Israeli Jewish urban population aged 45–75 years. Full sit-down interviews were conducted with 2,003 respondents in 1993 and 2,505 respondents in 2000.

Results: For 1993, 6% of the population reported on consultations with CAM[1] providers during the previous year. For 2000, that proportion increased to 10%. Being a woman, having higher education, enjoying better economic status, being younger, living in a big city, and being dissatisfied with specialists’ care were all positively related to the use of non-conventional medicine, particularly in 2000. In both years, more than 50% of the consultations were with acupuncturists and homeopaths. However, chiropractors have doubled their market shares, and lower back pain became the leading problem for which care was sought. The main reason for consulting CAM was a reluctance to use too many drugs or to undergo an invasive procedure. However, a significant proportion of the users continue to use conventional medicine concurrently. Seventy-five percent in 2000 and 60% in 1993 reported that the treatment helped.

Conclusions: Between 1993 and 2000, CAM in Israel changed from an infant industry into a mainstream medical commodity, reflected in both prevalence and different patterns of consumption.

Background: The treatment of osteoporosis among postmenopausal women represents a major public health challenge since long-term therapy is needed to prevent fractures and chronic disability.

Objectives: To assess compliance with osteoporosis drug therapy among Israeli postmenopausal women treated with either a bisphosphonate (alendronate) or a selective estrogen receptor modulator (raloxifene); to identify factors affecting compliance among these patients; and to compare adherence to the treatment in these two groups.

Methods: Our study included 178 consecutive patients aged 67.41 ± 8.52 years who were treated for osteoporosis with alendronate or raloxifene in the Metabolic Bone Diseases Unit. All the patients received supplement with calcium carbonate 1,500 mg and 600 IU vitamin D daily. Compliance was assessed at a clinic visit 6 months after starting therapy.

Results: The dropout rate was 23% (41 patients): 20 patients (31%) in the raloxifene group and 21 (18%) in the alendronate group (P = 0.0041). The main reasons for dropout were side effects and/or non-compliance, 16 and 24 patients (39% and 58.53%), respectively. The most frequent side effect was abdominal pain in 9 patients (42.8%) who discontinued alendronate use. The reasons for non-compliance were a fear of side effects and high drug price in 6 (30%) and 4 (20%) patients respectively in the raloxifene group, and inconvenience caused by medication use in 3 (14.3%) patients in the alendronate group. Logistic regression analysis of factors that may influence compliance included age, previous fractures, family history of osteoporosis, bone density T-score less than -2.5, and presence and number of concomitant diseases. Age was the only statistically significant parameter in this model: 67.8 ± 8.8 in non-compliant versus 64.11 ± 7.4 in compliant patients (P = 0.029).

Conclusion: At least 20% of the patients discontinued chronic treatment for osteoporosis during the initial 6 months of therapy. The main reasons were gastrointestinal side effects in the alendronate group, and fear of side effects and high drug price in the raloxifene group. Older age was the only statistically significant factor influencing compliance.

The human placenta is the interface between the mother and fetus in the uterus. Until recently it was generally believed that the uterus provides a protective environment for the fetus. It is now accepted that any chemical substance, including any therapeutic agent, administered to a mother is able to permeate across the placental barrier. Unfortunately, the placental transfer of substances and their distribution in the placenta is not well established. Understanding the structure of placental transporters and their function may serve as the ideal tool for drug development and the cure of mother and fetus during pregnancy.
 

Background: Cardiac surgery is being performed with increasing frequency in patients aged 80 years and older.

Objectives: To examine the long and short-term results of surgery in this age group.

Methods: We retrospectively investigated 202 consecutive patients aged 80 years or older who underwent cardiac surgery between 1991 and 1999. Ninety-six operations (48%) were urgent.

Results: The study group comprised 140 men (69%) and 62 women (31%) with a mean age of 82.1 years (range 80–89). Preoperatively, 120 patients (59%) had unstable angina, 37 (18%) had left main coronary artery disease, 22 (11%) had renal failure, 17 (8.5%) had a history of stroke, and 13 (6.5%) had previous cardiac surgery. Hospital mortality for the whole group was 7.4%. Postoperative complications included: re-exploration for bleeding in 15 (7.4%), stroke in 8 (4%), sternal wound infection in 3 (1.5%), low cardiac output in 17 (8.4%), new Q wave myocardial infarction in 5 (2.5%), renal failure in 17 (8.5%), and atrial fibrillation in 71 (35%). The actuarial survival for patients discharged from the hospital was 66% at 5 years and 46% at 8 years. The type of surgical procedure was significantly associated with increased early mortality (coronary artery bypass grafting only in 2.9%, CABG[1] + valve in 16.1%, valve only in 16.7%; P = 0.01). Significant predictors (P < 0.05) for late mortality included type of surgical procedure, congestive heart failure, and postoperative low cardiac output.

Conclusions: When appropriately applied in selected octogenarians, cardiac surgery can be performed with acceptable mortality and good long-term results.

Background: Sulfur mustard and VX are potent chemical warfare agents that penetrate rapidly through the skin, causing severe prolonged injuries and sometimes death.

Objectives: To develop a topically applied pretreatment that will act as a barrier and prevent the absorption of these agents through the skin, reducing morbidity and saving life.

Methods: Several formulations were developed and tested in preclinical animal studies in pigs. The protecting cream was applied as a single application (0.5–1 ml/100 cm²) prior to exposure (10 minutes to 12 hours) to sulfur mustard or VX. Assessment of sulfur mustard-induced skin damage was based on clinical and histologic evaluations. When tested against VX, clinical signs and blood cholinesterase activity were monitored. At the final stage of development, safety studies were conducted in animals and in human volunteers.

Results: The formulation that gave the best results, coded IB1 (under patent application), provided significant protection against a 1 hour exposure to sulfur mustard (droplets or vapor). All the pigs pretreated with IB1 cream survived a 1–4 hour challenge of 2xLD₅₀ VX and did not exhibit any overt clinical signs. Protection was exhibited even when the cream was applied 12 hours (single application) prior to exposure. IB1 was found to be non-irritating in animals and humans. No adverse effects were found in a Phase I clinical study in young healthy volunteers when the cream was applied to around 20% of the skin surface (results presented elsewhere).

Conclusions: IB1 cream has been shown to be a safe and effective topical skin protectant against the chemical warfare agents sulfur mustard and VX.

Background: About 40% of patients with infective endocarditis will require surgical treatment. The guidelines for such treatment were formulated by the American College of Cardiology and American Heart Association in 1998.

Objectives: To examine our experience with surgical treatment of infective endocarditis in light of these guidelines.

Methods: Surgery was performed in 59 patients with infective endocarditis between 1990 and 1999. The patients' mean age was 48 years (range 13–80). The indications for surgery were hemodynamic instability, uncontrolled infection, and peripheral embolic events. The surgical treatment was based on elimination of infection foci and correction of the hemodynamic derangement. These objectives were met with valve replacement in the majority of patients. Whenever conservative surgery was possible, resection of vegetation and subsequent valve repair were performed and the native valve was preserved.

Results: Six patients (10%) died perioperatively from overwhelming sepsis (n=3), low cardiac output (n=2) and multiorgan failure (n=1). The mean hospital stay was 15.6 days. Of 59 patients, 47 (80%) underwent valve replacement and in 11 (19%) the surgical treatment was based on valve repair. After 1 year of follow up, there was no re-infection.

Conclusion: The new guidelines for surgical treatment of infective endocarditis allow better selection of patients and timing of surgery for this aggressive disease, which consequently decreases the mortality rate. Valve repair is feasible and is preferred whenever possible. According to the new guidelines, patients with neurologic deficit in our series would not have been operated upon, potentially decreasing the operative mortality to 7%.