תוצאת חיפוש

The Israeli Pharmaceutical Market

Segev Shani, Joshua Shemer

Pharmaceutical Policy and Economics Unit, Israeli Center for Health Technology Assessment in Health Care, Gertner Institute for Epidemiology and Health Policy Research, Tel Hashomer and Sackler Faculty of Medicine, Tel Aviv University

The pharmaceutical market in Israel has undergone many major changes over the past 2 years. We detail measures taken with regard to drug prices and utilization, from 1992 until 1995, when the National Health Insurance Law was implemented. This provides an information base for marketing and dispensing of drugs, economic planning in the public health system, and for physicians and pharmacists in clinical practice.

The national expenditure on pharmaceuticals in 1994 was 9.4% of the annual national health expenditure. From this fact, and the number of registered drugs and the number of clinical trials conducted, it appears that our pharmaceutical market is quite diversified and well developed compared to other markets in the western world. This size advantage enables our sick funds to purchase drugs at much lower prices than the private sector.

Adjuvant Therapy of Large Bowel Carcinoma

G. Ezekiel, S. Walfisch, Y. Cohen*

Dept. of Oncology and Colorectal Unit, Soroka Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

The National Institutes of Health (NIH) held a consensus conference which recommended 5-FU and levamisole as adjuvant chemotherapy for colon cancer MAC (Modified Astler Coller) stage C.

From 1991-1994, 37 such patients diagnosed here were treated with 5-FU (intravenous dose of 450/mg/m²/d for 5 days and from day 29, once a week for 48 weeks) and oral levamisole (50 mg 3 times/d. for 3 days, every 2 weeks for a year), as suggested by NIH guidelines.

16 patients were males and 21 were females, mean age was 62 years and median 64. Cancer locations were: right colon (in 16, 43%), left colon (19, 51%), multiple colon primaries (2, 1%). 25 (68%) had 1-3 positive lymph nodes and 12 (32%) had 4 or more positive lymph nodes.

Only 20 (54%) finished treatment as prescribed. In the others, 1 or both drugs caused side-effects for which the drugs had to be stopped. 6 patients relapsed while on treatment.

The most common side-effects were diarrhea, stomatitis and bone marrow suppression. 3 were hospitalized due to neutropenic fever. 5-year actuarial survival of all patients was 61%; 5-year relapse-free survival was 61%; 5-year relapse-free survival of right versus left colon was 41% and 82%, respectively (p<0.01). There was no significant difference in 5-year survival of those with 1-3 positive lymph nodes as compared to those with 4 or more (62% and 56%, respectively). 5-year survival in those who finished or did not finish treatment (excluding those who stopped treatment because of progressive disease) was 83% and 70%, respectively (NS).

The 5-year survival of our series was similar to that of patients treated similarly elsewhere. The 5-FU and levamisole treatment was not tolerated well by our study population. It has recently been replaced in our service by a 5-FU and leucovorin regimen given for 6 months.

* Jules E. Harris Chair in Oncology.

Nephron-Sparing Surgery - Initial Experience with 50 Patients

Sarel Halachmi, Alexander Kastin, Boaz Moskovitz, Ofer Nativ

Urology Dept., Bnai Zion Medical Center, Haifa

During recent years the use of the new imaging techniques, ultrasonography and computerized tomography, has increased. The accessibility to these methods has changed the pattern of detection of renal lesions. Over 90% of renal masses are now discovered incidentally, while investigating nonurological symptoms. Therefor, most lesions are discovered in their early stages.

The gold-standard procedure for removing renal masses is radical nephrectomy, which ensures complete removal of an organ-confined lesion, but involves loss of functional tissue. This might be critical in patients with a single kidney, or reduced nephron function. There are several diseases characterized by multiple renal lesions, such as Von Hippel-Lindau and tuberous sclerosis in which radical treatment may lead to chronic dialysis in young patients.

Nephron-sparing surgery was developed in order to preserve as much functional tissue as possible while removing safely any suspicious renal lesion. This new technique, not involving radical surgery, should be evaluated in cases of renal tumors for its ability to achieve the same cancer cures rates. We present our experience with our first 50 patients who underwent nephron-sparing surgery for removal of renal lesions.
 

Propafenone Dose for Emergency Room Conversion of Paroxysmal Atrial Fibrillation

D. Antonelli, A. Darawsha, S. Rimbrot, N.A. Freedberg, T. Rosenfeld

Dept. of Cardiology and Emergency Room, Central Emek Hospital, Afula

Paroxysmal atrial fibrillation (AF), a frequent cause of repeated hospitalization, is effectively treated with propafenone. The time to conversion to sinus rhythm is a consideration when managing AF in the emergency room. We investigated the conversion rates of paroxysmal AF by 3 different oral propafenone (P) regimens, in terms of time to conversion.

188 patients with onset of AF within 48 hours were treated with propafenone (P): 48 received 600 mg as a first oral dose followed after 8 hrs by 150 mg (Group A); 82 received 300 mg as a first dose, followed by the same dose 3 and again 8 hrs later (B); 58 received 150 mg every 3 hrs, up to a total dose of 600 mg (C). P was stopped when sinus rhythm was achieved.

Rates of conversion to sinus rhythm after 3 hrs in the 3 groups were: 46%, 41% and 26% respectively; after 8 hrs: 77%, 78% and 70%; and after 12 hrs: 81%, 84% and 76%. Treatment was discontinued in 8. There was excessive QRS widening (>25% of the basal value) in 1 in group A, 1 in group B and 2 in group C; wide-QRS tachycardia occurred in 4 in group B. In Group A there was a higher rate of early successful conversion, with a lower incidence of side-effects than with the other regimens.

Outcome in Fetuses with Increased Nuchal Translucency Thickness

Ron Maymon, Eli Dreazen, Yosi Tovbin, Zwi Weinraub, Arie Herman

Ultrasound Unit, Dept. of Obstetrics and Gynecology, Assaf Harofeh Medical Center, Zerifin and Sackler Faculty of Medicine, Tel Aviv University

Increased thickness of fetal nuchal translucency (TNT) measured at 10-14 weeks of gestation, may suggest underlying fetal chromosomal defects, structural abnormalities or genetic syndromes. We examined the relationship between increased TNT and pregnancy outcome, especially in fetuses with normal karyotypes.

1400 pregnant women underwent first trimester scanning and screening for chromosomal abnormalities and measurement of fetal TNT. 25 fetuses (2%) with increased TNT (>3 mm) were identified. 8 (30%) had an abnormal karyotype. Of these, 5 pregnancies were aborted, 3 ended in spontaneous abortions before karyotyping, and 2 were terminated, all before detailed cardiac scanning. There was a high association between increased TNT and karyotype abnormalities. The total incidence of favorable outcome in fetuses with normal chromosomal and cardiac features but enlarged TNT was 56%.

Combined Sclerotherapy and Surgery for Huge Cervical Lymphangioma

Zvi Steiner, Asher Pressman, Jorge Mogilner

Dept. of Pediatric Surgery, B'nei Zion Medical Center and Faculty of Medicine, Technion Institute of Technology, Haifa

Lymphangioma is a benign developmental anomaly of the lymphatic system located in about 40% of cases in the neck and usually completely resectable. In some cases it invades adjacent structures such as the larynx, pharynx, or tongue. In such cases it is almost impossible to resect completely, as this would endanger vital structures.

We describe a baby born with a huge cervical lymphangioma which invaded the tongue, larynx, pharynx and other cervical structures. He was treated with bleomycin and aethoxysklerol. The sclerotherapy shrank the lymphangioma considerably and it became resectable. At 2 years of age the cosmetic result is good and vital function, such as swallowing and facial expression, are preserved.

Accidental Severance of a Venous Catheter: Diagnostic and Therapeutic Approach

Harel Gilutz, Aharon Gavriel, Shmuel Yurfest

Cardiology, Heart and Lung, and Vascular Surgery Depts., Soroka Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheba

The most common invasive procedure performed in hospitals ithe insertion of a vascular access device. This procedure has the rare complication ofcatheter emboli. Accidental cutting of a peripheral catheter, the use of duplex ultrasound to locate the cut and the extraction of the catheter through a venesection is described. If peripheral extraction fails, percutaneous extraction or thoracotomy should be tried, in that order. The immediate precautions have an impact on the final results.

Home Palliative Care of Terminal Cancer Patients, with Family Feedback

Hana Arad, Hana Geva, Valery Rosin, Ruth Kibrik, Isaac Kersz

Home Care Unit of Kupat Holim Haklalit, HaEmek Medical Center, Afula and Quality Improvement Unit, Rambam Medical Center, Haifa

Palliative care of terminal cancer patients is one of the tasks of our Home Care Unit. Increasing hospitalization costs have brought forward the decision to treat them at home, assuming that they would prefer to return and die in their natural surroundings, among family.

Most of our patients are aged, recent immigrants from the Soviet Union, of low socioeconomic status; most live with their close families. Our care model combines social, cultural, economic, medical and nursing aspects. More patients choose to die at home, and that is where costs are minimal. Care management and characteristics of 44 terminal cancer patients, who died between January and October 1996, are described. Living with a family was not required for treatment at home. Length of care by the unit ranged from 1-48 weeks, with an average of 8.5 and a median of 6. 55% of patients were hospitalized, most (58%) for 5-9 days for noncancerous diseases, and then discharged home. 54% died at home, a third were hospitalized for 2-17 days before death. Compared to the average length of stay in palliative care oncology wards, 1044 days and more than NIS 500,000 were saved.

A telephone survey examined families' satisfaction with various components of care. 92% were satisfied with the home treatment. 79%-82% felt that the nurse and doctor of the team met their needs and expectations. Half the families were satisfied with the treatment of pain. Families in which treatment was 24 weeks or more were generally less satisfied than those with shorter treatment at home. We learned that an early entry into treatment is necessary; hospital referral criteria should consider to a greater extent the coping ability of families; nursing aid hours should be increased and professional emotional support added; additional pain control methods should be used. All these would strengthen families, improve quality of care, and contribute to additional savings by decreasing hospital stay.

Prognostic Implications in Pediatric Head Injuries

Gideon Paret, Ron Ben Abraham, Susana Berman, Amir Vardi, Rami Harel, Yossi Manisterski, Zohar Barzilay

Depts. of Pediatric Intensive Care and of Anesthesiology and Intensive Care, Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine, Tel Aviv University

An unselected series of 200 consecutive cases of major head trauma in children aged 6 months to 16 years, seen during 4 years, was studied. Injuries were due to road accidents (40%), falls (30.5%) and other causes (29.5%), and were assessed clinically and by cranial CT.

On admission the Glasgow Coma Score ranged from 4.72-11.65 and in addition to pupillary responses and brain stem reflexes, was a significant predictor of outcome. Brain edema, midline shift, intracranial hemorrhage and also hyperglycemia, hypokalemia and coagulopathy, were associated with poor outcome. While 17% died, 53% were discharged in good functional condition.

Early identification of clinical features related to prognosis can help the caring team provide maximal support for patient and family.

Information Provided for Informed Consent in Clinical Trials

Avishay Sella

Genitourinary Medical Oncology Unit, Dept. of Oncology, Rabin Medical Center (Beilinson Campus), Petah Tikva, and Sackler Faculty of Medicine, Tel Aviv University

The Helsinki Declaration contains recommendations guiding physicians who conduct clinical trials. One is that the requirement for informed consent is essential for approval of a trial. An important component of the informed consent doctrine is that all data required for the participant's decision must be provided. We analyze data of a therapeutic trial, and define 12 data components outlined in, or directly derived from the Helsinki Declaration.

61 instances of informed consent for therapeutic clinical trials from various fields of medicine, from 1994 to 1997, were analyzed. In each the presence of the 12 components was evaluated.

The data demonstrated that there were only 5 components cited in most cases of informed consent: trial objectives, methods, treatment plan, risks, and the option of withdrawing. Benefit to the participant was mentioned in half the cases, while only limited information was provided about other components such as life-threatening and unpredictable risks, and alternative treatment.

Examples of informed consent from 1997 showed statistical improvement since 1994 in the data concerning trial objectives, methods, risks and alternative therapy. Informed consent documents of international multicenter trials compared with local trials showed statistical improvement in the data components of the trial objectives, methods, and risks, including those of potentially life-threatening and unpredictable risks, and alternative therapy. Analysis of informed consent showed that not all components required for a comprehensive decision regarding participation in a clinical trial are included. These data emphasize the need to design a structured informed consent protocol in which all the required data components are specifically outlined for potential participants.

1000 Cardiac Catheterizations in Congenital Heart Disease

Benjamin Zeevi, Galit Bar-Mor, Michael Berant

Cardiac Catheterization Unit, Schneider Children's Medical Center, and Sackler School of Medicine, Tel Aviv University

Over the past 15 years, percutaneous therapeutic cardiac catheterization has become increasingly important in the treatment of congenital heart disease. We describe our experience in 1000 such catheterizations between 1993-1997. 55% were in 1-12-year-olds; only 20% were in patients younger than 1 year old and 11.3% were in adults with congenital heart defects. In about 50% it was at least a second cardiac catheterization. Overall, there were 425 therapeutic cardiac catheterizations, increasing from 33% in the first 200 procedures, to 63% in the last 200.

We performed 30 different types of therapeutic catheterizations: 23.3% were valvular dilations, 21.4% vessel angioplasties, 36.9% closure procedures, 9.2% electrophysiological procedures, and 9.2% miscellaneous. In 31.3% of therapeutic catheterizations we used 12 new procedures. Minor complications occurred in 8.5% and major in 0.6%; most complications were successfully treated or were self-limited and there was no residual damage.

In this report the current role of each type of major catheterization is discussed on the basis of our experience. Further development of technology for lesions not amenable to currently available transcatheter methods, and longer follow-up for current techniques will consolidate the role of therapeutic cardiac catheterization in congenital heart disease.

Intrahospital Transport of Critically Ill Children

Gideon Paret, Ron Ben Abraham, Oshrat Yativ, Amir Vardi, Zohar Barzilay

Dept. of Pediatric Intensive Care and of Anesthesiology, Sheba Medical Center, Tel Hashomer and University of Tel Aviv

Prospective evaluation of intrahospittransportation of 33 critically ill children to and from the pediatric intensive care unit was conducted over the course of a month. Factors contributing to risk of transport were assessed.

There were 33 children (25 boys and 8 girls), 3 days to 15 years of age. Reasons for admission included: disease and trauma in 19, and status post operation in 11. The pretransport PRISM score was 4.84. 22 children (66.6%) were being mechanically ventilated and 10 (30.3%) were being treated with amines. Transport time ranged from 8-150 minutes. 15 of the transports (45.4%) were urgent and a special intensive care team escorted 22 (66.6%). Equipment mishaps and physiolog-ical deterioration occured in 12 (36.3%) and 11 (30.3%) of the cases, respectively. The use of amines, mechanical ventilation, longer transport time and high PRISM score were all associated with physiological deterioration on transport.

Laparoscopy for Common Bile Duct Stones

Ibrahim Matter, Moshe Wald, Shmuel Eldar

Depts. of Surgery and Urology, B'nai-Zion Medical Center, Haifa

We performed 75 laparoscopic cholecystectomies during July and September 1996. In 3 men and 4 women, aged 32-87 years, there was obstructive jaundice caused by choledocholithiasis. During laparoscopy in the jaundiced patients, calculi were identified by cholangioscopy and intra-operative cholangiography. They were washed into the duodenum (confirmed cholangiographically) after intravenous glucagon injections and dilation of the papilla of Vater.

Serum bilirubin and liver enzyme levels returned to normal within a few days. There was no operative or postoperative morbidity, nor any biliary-related systemic complications. Average postoperative hospitalization was 3 days.

Pelvic Floor Exercise and Biofeedback in Genuine Stress Incontinence

D. Gordon, D. Luxman, Y. Sarig, A. Groutz

Women and Children's Division, Liss Hospital, Sourasky-Tel Aviv Municipal Medical Center and Sackler Faculty of Medicine, Tel Aviv University

Stress urinary incontinence is a medical and social problem. In the past decade there has been increased awareness of this condition and the number of those affected who seek help is increasing. Treatment is usually surgical - elevation of the bladder neck. Pelvic floor exercise is an accepted conservative treatment modality used for mild to moderate cases that have not yet completed their families.

We present our results in 30 women, aged 28-71 years, av. 49% with genuine stress incontinence treated with pelvic floor exercise and biofeedback. 14 patients (46.7%) were completely cured and 15 (50%) were improved. In only 1 was there no improvement.

Our results show significant improvement in the duration and intensity of pelvic floor contractions after treatment. Pelvic floor exercise with biofeedback is a very important treatment modality, requiring a highly motivated patient and a physiotherapist specialized in pelvic floor exercise.

Treatment of Retroperitoneal Sarcoma

Dina Lev-Chelouche, Subhi Abu-Abeid, Mordechai Gutman, Yoram Kluger, Moshe Michovitch, Isaac Meller, Moshe Inbar, Joseph M. Klausner

Depts. of Surgery B, Orthopedic Oncology and Oncology, Tel Aviv - Sourasky Medical Center (Affiliated with Sackler Faculty of Medicine, Tel Aviv University)

Soft tissue sarcomas are exceedingly rare, making up less than 1% of all solid malignancies. In the retroperitoneum, they tend to be large when diagnosed and are a therapeutic challenge to the surgical oncologist. Our experience with 51 patients with retroperitoneal sarcomas operated on during the past 4 years is presented. 37 were primary and 26 presented as recurrent tumors. The group included many different histological sub-types, the majority being high grade tumors.

Complete resection was achieved in 84%, necessitating extensive surgery, but was not possible in 8 patients (16%) who underwent partial resection or biopsy only. There was 1 perioperative fatality (2%). 18 (35%) suffered complications, all of which were reversible. The estimated 5-year survival in the complete resection group is 40%, while none of those who underwent partial resection survived more than 2 years. There was significantly better survival in patients with primary, low grade sarcomas which were smaller than 8 cm, compared to those with high-grade, recurrent sarcomas larger than 8 cm. Local recurrence developed in 8 patients of the complete resection group (18%), 2 months to 3 years after surgery.

These data show that despite the concept of retroperitoneal sarcomas as being aggressive, invasive tumors with a poor prognosis, the prognosis is not unusually bad. With proper surgical technique, resectability may be high, with improved overall survival.