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PubMed2004

Pharmacokinetics and pharmacodynamics of safinamide, a neuroprotectant with antiparkinsonian and anticonvulsant activity.

OBJECTIVE: This paper describes the pharmacokinetics and the pharmacodynamics, in terms of monoamino oxidase type B (MAO-B) inhibition, in male healthy volunteers of orally administered safinamide, a new neuroprotectant that in experimental models has demonstrated strong anticonvulsant and antiparkinson activities. METHODS: Four clinical trials covering the dose range of 25-10,000 microg/kg were carried out to describe pharmacokinetics, pharmacodynamics and tolerability of safinamide, administered in single or repeated dose regimen to steady state, including a food interaction trial. All the above trials were carried out after the Ethics Committee's approval and signature of the consent form by the volunteers. In single dose trials blood sampling covered a 24 h-period in pharmacodynamic trials, 48 h-period in pharmacokinetic trials. In the case of repeated dose regimen to steady state a pre-dose sample was drawn on the first six study days, whereas the curve was explored on the 7th study day, prolonging blood sampling over a 48 h-period after the last dosing. Safinamide level was determined in plasma by a very sensitive and specific LC-MS-MS method, with a low limit of quantification of 0.5 ng/ml of plasma. Pharmacokinetic analysis was carried out with non-compartmental method and, in one case, also with the two-compartmental method. Monoamine oxidase activity of both types A and B (MAO-A and MAO-B) was determined in plasma at different times (MAO-B) and correlated to safinamide levels, or in urine (MAO-A). RESULTS: Pharmacokinetics of safinamide proved to be linearly and proportionally related to the administered doses. The absorption of safinamide was rapid with peak plasma concentrations ranging from 2 to 4 h. Food prolonged the rate and did not affect the extent of absorption of safinamide. In repeat dose regimen once daily, the steady state was reached on the 5th study day with a marginal accumulation factor of 1.5-1.7. The drug was cleared with a t(1/2) of about 22 h. Safinamide reversibly inhibited MAO-B enzyme. Full inhibition was observed with single doses >/= 600 microg/kg, and a relevant, dose dependent, progressive inhibition was encountered with doses starting from 25 microg/kg. Even at the highest single dose of 10 mg/kg no evidence of MAO-A inhibition was observed. CONCLUSION: Enteral absorption of the drug is linear and proportional to the doses administered. The drug is cleared from the body with a t(1/2) of approximately equal to 22 h, without producing any clinically relevant accumulation at steady state. The MAO-B inhibitory activity, without affecting MAO-A, is useful to prevent a dopamine bioinactivation in patients suffering from Parkinson's disease. Safinamide tolerability in the four clinical trials proved to be good.

Adolescent↗
PubMed2006

Medicolegal analysis of 100 malpractice claims against bariatric surgeons.

BACKGROUND: Very few studies have addressed malpractice litigation specific to bariatric surgery. This study was designed to analyze litigation trends in bariatric surgery to prevent further lawsuits and improve patient care. METHODS: A total of 100 consecutive bariatric lawsuits were reviewed by a consortium of experienced bariatric surgeons and an attorney specializing in medical malpractice. RESULTS: Of the 100 lawsuits, 45% were reviewed for defense attorneys. The mean patient age was 40 years (range 18-65), 75% were women, 81% had a body mass index of <60, 31% were diabetic, and 38% had sleep apnea. Of the surgeons, 42% had <1 year of experience, and 26% had done <100 cases. Although 69% of the physicians were members of the American Society of Bariatric Surgery, only 22% had detailed consent forms. The surgical procedures were performed between 1997 and 2005 and included Roux-en-Y gastric bypass (78% total, 33% open, and 45% laparoscopic), vertical banded gastroplasty (3%), minigastric bypass (6%), biliopancreatic diversion/duodenal switch (4%), and revision (9%). Of the 100 cases, 32% involved an intraoperative complication and 72% required additional surgery. The most common adverse events initiating litigation were leaks (53%), intra-abdominal abscess (33%), bowel obstruction (18%), major airway events (10%), organ injury (10%), and pulmonary embolism (8%). From these injuries, 53 patients died, 28% had a full recovery, 12% had a minor disability, and 7% had major disabilities. Evidence of potential negligence was found in 28% of cases. Of these cases, 82% resulted from a delay in diagnosis and 64% from misinterpreted vital signs. CONCLUSIONS: This study found that leaks and delayed diagnosis were the most common cause of litigation. Even experienced bariatric surgeons should understand the most common errors made by others to prevent complications and avoid litigation.

Adolescent↗
PubMed2004

Pregnancy after kidney transplantation: an evidence-based approach.

Despite the relatively little space for transplantation in most medical schools, this issue is considered interesting by the students both for its clinical and ethical implications. The students were asked to choose a particular aspect of nephrology for a 2-hour case discussion. They chose the case of a 35-year-old female, kidney transplant recipient now 1.5 years postoperatively, who was coming to seek advice about pregnancy. The aim of the present work is to report an integration between narrative and evidence-based medicine (EBM) approaches. The search strategy was developed within a multidisciplinary working group, two of whose members were also masters in the methodology of systematic revisions. The first step in the discussion was the identification of ethical and methodological problem. In a rapidly developing field, books are unlikely to be able to give updated information. One needs to interact with electronic databases. In this context, no randomized controlled trial on pregnancy is expected. The evidence is likely to be heterogeneous. Prenatal care delivery differs around the world in part related to attitudes toward pregnancy, which depend upon religion and traditions. The second step was the definition of the search strategy. The third step, was selecting and cataloging the evidence. The titles and abstracts retrieved by the search strategy (272 items) were examined to identify full papers to be retrieved. The evidence retrieved was screened for the type of paper (reviews, primary studies, case reports, case series) and for the authors to give an indirect idea of duplicate publication bias. Teaching a complex and ever-changing subject, such as kidney transplantation, is a difficult task. The case of a young woman seeking information on the probability to undergo a successful pregnancy was particularly likely to exemplify the importance of being aware of the biases of the book-based information and on the need to interact with the internet. The search strategy developed by the working group of postgraduate trainees allowed students to have a direct experience with the complexity of the field. This preliminary study, as the basis for development of a checklist informed consent form on pregnancy in kidney transplantation, may give a first rough quantification of the work needed by a physician who wants to have a direct idea of the odds and risks of pregnancy in kidney transplant patients.

Evidence-Based Medicine↗
PubMed2005

The effects of yellow fever immunization (17DD) inadvertently used in early pregnancy during a mass campaign in Brazil.

BACKGROUND: This study describes the consequences of the inadvertent immunization of pregnant women during a mass vaccination campaign in the Campinas region of the state of São Paulo, Brazil, in February and March 2000. The study was carried out by the Women's Comprehensive Healthcare Center (CAISM), at the State University of Campinas (UNICAMP). The objective of the study was to evaluate the possible effects of the vaccine on pregnancy and conceptus, and to assess congenital infection resulting from immunization. METHODS: Pregnant women who received the YF vaccine were identified at primary health clinics and referred to the study site, a public reference, high-risk clinic, serving 42 towns in a region with a population of 3,000,000. A 12-month serological follow-up for newborns (PRNT), and an examination to detect congenital abnormalities was offered to pregnant women, who signed a consent form. In a sub-sample of women who were delivered at the study site, additional exams were proposed: neonatal fontanel ultrasound, funduscopy, audiometry, neuro-pediatric follow-up until 12 months of age, and IgM detection at birth. Fifteen blood samples from placentas and umbilical cords were tested for PCR. FINDINGS: A total of 480 pregnant, immunized women were identified, who had received the vaccine at a mean of 5.7 weeks (95% CI 5.2-6.2) of gestation. The great majority of women were unaware of their pregnancy at the time they were vaccinated, and only 46.7% were counseled to avoid immunization if pregnant. After a minimum 6-week interval, 98.2% pregnant women were IgG positive. A total of 19.6% of women reported mild adverse events (headache, fever or myalgia). No IgM antibodies were detected at birth and no placental or umbilical cord blood was positive according to PCR. The frequency of malformations (2.3% or 7/304 babies), miscarriages (2.5% or 11/441 pregnancies), stillbirths (0.7%) and premature delivery (7.8%) was similar to that found in the general population. At 12 months follow-up, 7% of samples were reactive to PRNT. However, after 12 months, only one child was seropositive. INTERPRETATION: Contrary to a previous study, maternal seroconversion was very high when immunization was carried out in early pregnancy. Vaccine applied during the first trimester does not appear to cause malformations, complications to the central nervous system, nor adverse perinatal results as represented by premature deliveries or perinatal deaths. The 12-month serological follow-up is inconclusive and should be extended to 24 months. Evaluation of the risk of miscarriage was hindered by late presentation at the study clinic.

Abortion, Spontaneous↗
PubMed1997

Baseline characteristics of patients in the coronary artery bypass graft (CABG) Patch Trial.

BACKGROUND: Patients with left ventricular dysfunction who undergo coronary artery bypass graft (CABG) surgery frequently have late sudden cardiac death. The CABG Patch Trial is a prospective, randomized, multicenter clinical trial that randomized patients at high risk at the completion of CABG surgery to implantation of an epicardial implantable cardioverter defibrillator (ICD) or to no antiarrhythmic treatment. The trial was designed to determine whether prophylactic implantation of an ICD at the time of CABG surgery would result in a lower total mortality in long-term follow-up. METHODS: Patients undergoing CABG surgery were eligible for the trial if they were younger than 80 years, had a left ventricular ejection fraction less than 0.36, and had an abnormal signal averaged electrocardiogram. Patients with a history of sustained ventricular tachycardia or ventricular fibrillation were excluded from the trial. All patients were scheduled to undergo follow-up at 3-month intervals until 42 months after surgery. RESULTS: Randomization of patients in the trial ended in February 1996. During the recruitment period 71,855 patients were screened, 1,422 were eligible, 1,055 were enrolled (signed consent forms), and 900 patients (76% of eligible patients) were randomized. The mean age of the 446 patients in the ICD group was 64 years versus 63 years for the 454 patients in the control group. A total of 87% of the participants in the ICD group were men versus 82% in the control group (p = NS). Most of the patients had a history of hypertension (55%), smoking (78%), and hypercholesterolemia (54%). Half of the patients had clinical heart failure, and the mean ejection fraction for both patient groups was 0.27 +/- 0.06. No difference was seen in the history of myocardial infarction (83%), congestive heart failure (50%), or atrial (11%) or ventricular (17%) arrhythmias between the two groups. Major clinical characteristics (age, sex, number of previous infarctions, incidence of heart failure, and mean left ventricular ejection fraction) were almost identical to those found in another ICD primary prevention trial, the Multicenter Automatic Defibrillator Implantation Trial (MADIT). CONCLUSIONS: A high risk sample of patients was enrolled in The CABG Patch Trial, as shown by examination of their baseline characteristics.

Adult↗
PubMed2001

International prospective evaluation of scintimammography with technetium-99m sestamibi: interim results.

OBJECTIVE: The purpose of this study is to evaluate the validity and reliability of scintimammography with technetium-99m (99mTc)-labeled sestamibi as an adjunct radiodiagnostic agent in the diagnosis of breast cancer. METHODS: This is a multicenter prospective cohort clinical trial that was initiated in June 1999 and will terminate May 2001. All patients with a physical or mammographic finding visiting any of the participating clinics are enrolled in the study. Patients who are younger than 18 years, pregnant, not willing to sign the consent form, or who have undergone an invasive procedure on the breast 30 days or less before scintimammography are excluded. At the time of the first interim report, 633 patients had been recruited from six Canadian centers. To date complete data have been collected for 530 patients. RESULTS: The mean (SD) age of the patients is 56 (12) years with a range between 24 and 85. There were 122 (23%) of the women in the sample who were postmenopausal and 36 (7%) who were perimenopausal. Breast density was graded as dense for 127 (24%), normal for 260 (50%), and fatty for 138 (26%). Of the 530 women in the study 156 (29%) had a palpable mass at physical examination. The mammographic results were classified as 76 (14%) breast imaging reporting and data system (BIRADS) 5, 60 (11%) BIRADS 4, 70 (13%) BIRADS 3 and the remaining BIRADS 2 or 1. The scintimammography results were positive for 118 (23%) of the patients and negative for 412 (78%). The histopathology showed malignant breast disease for 66 (12.5%) of the patients in the sample. Sensitivity and specificity of scintimammography for the detection of breast cancer was estimated 90.9% and 87.5%, respectively. A positive predictive value (PPV) of 50.8% with a negative predictive value of 98.5% and an accuracy of 87.5% were calculated. The PPV is interpreted as the posttest probability of disease given a positive test result. In this sample the pretest probability of disease would be best estimated by the prevalence of disease, which is equal to 12.5%. A positive scintimammography result would change the estimated probability to 51%, which is equivalent to a 400% change from the pretest value. Therefore a positive scintimammography result significantly increases our ability to predict the presence of malignant disease in this population. CONCLUSION: The interim results of the present study suggest that scintimammography with 99mTc-sestamibi is accurate and potentially useful as an adjunct to mammography for the detection of breast cancer.

Adult↗
PubMed2002

Role of nitric oxide and bcl-2 family genes in the regulation of human endometrial apoptosis.

OBJECTIVE: To investigate the role of nitric oxide (NO) and death regulatory genes, bcl-2 and bax, in human endometria apoptosis. DESIGN: Expression of bcl-2, bax, NO synthases (NOS), and the apoptotic effect of L-arginine on endometrial explants in vitro. SETTING: Prospective study. PATIENT(S): Thirty-seven eumenorrheic women. INTERVENTION(S): Endometrial samples were obtained with Pipelle suction curette after women signed institutional informed consent forms. MAIN OUTCOME MEASURE(S): DNA fragmentation (TUNEL), immunohistochemistry, and reverse transcription polymerase chain reaction. RESULT(S): Apoptosis was detected in mid and late secretory endometria. L-arginine induced an increase in apoptosis in stroma (threefold), glands (eightfold), and surface epithelia (fourfold) in proliferative but not secretory endometria explants. Immunostaining of Bcl-2 was almost absent in the secretory endometria, whereas Bax increased in the stroma at the end of the menstrual cycle, coincident to the decrease in the bcl-2/bax mRNA relative ratio (P<.05) observed in secretory endometria. CONCLUSION(S): The induction of DNA fragmentation by L-arginine on proliferative endometria suggests that NO may be involved in the endometrial apoptotic process, whose control may be related predominantly to the changes of Bcl-2 expression.

Adult↗
PubMed2003

Factors associated with disposition of cryopreserved reproductive tissue.

OBJECTIVE: To study patient characteristics associated with the preferences for the disposition of cryopreserved semen and embryos in the event of death or divorce. DESIGN: Retrospective exploratory study. SETTING: Tertiary care academic medical center. PATIENT(S): One hundred twelve men banking sperm, 54 female patients (partners of men banking sperm) undergoing in vitro fertilization (IVF), and 112 women undergoing IVF who were not partners of men banking sperm. INTERVENTION(S): Male patients banking sperm and couples undergoing IVF completed a standard consent form detailing their desired dispositions (disposal or release to a surviving party) of cryopreserved sperm and embryos in the event of death or divorce. MAIN OUTCOME MEASURE(S): Effect of marital status, age, reason for sperm banking, infertility diagnosis, partner status (single or significant-other partner) on sperm, and embryo disposition choice. RESULT(S): In the event of death, married men were 5.5 times more likely to release banked sperm to a surviving party than were single men. The estimated odds of giving sperm to a survivor were 1.07 times greater with every 1-year increase in age. The choice of sperm disposal was significantly related to the banking reason for the case of banking prior to chemotherapy and/or radiation for malignancy. In the case of male death, the decisions of couples undergoing IVF for embryo disposition agreed with choices of male patients for sperm disposition approximately 33% of the time more often than by chance alone. CONCLUSION(S): Decisions surrounding disposition of cryopreserved sperm are significantly associated with marital status, age, and reason for banking sperm. Respective choices of sperm and embryo disposition in couples undergoing IVF were similar in the situation of male death.

Adolescent↗
PubMed1998

Characteristics and attitudes of parents of children born with the use of assisted reproductive technology.

OBJECTIVE: To explore the medical issues, attitudes, concerns, and choices that parents have about their children born with the use of assisted reproductive technology (ART). DESIGN: Retrospective and prospective survey. SETTING: An academic medical center and a private practice. PATIENT(S): Participants who conceived and were delivered of infants in two ART programs. INTERVENTION(S): A total of 373 patients were mailed an anonymous survey, a consent form, and the Parent Child Relationship Inventory. The rate of response was approximately 49% for clinic A and 33% for clinic B. MAIN OUTCOME MEASURE(S): Pregnancy outcomes and attitudes about parenting. RESULT(S): Respondents' major concerns during pregnancy revolved around miscarriage and the infant's health; complications occurred in 38.9% of first pregnancies. Parents believed that their children were more appreciated, that their children were not emotionally different, that ART did not create ongoing medical or emotional problems, and they were not overprotective as parents. Gender differences were statistically significant on attitudinal variables. CONCLUSION(S): Parents had concerns about pregnancy. Overall, men and women felt positive about ART and their parenting. The ART experience is associated with complex choices, attitudes, and emotions.

Attitude↗
PubMed1997

Body fat and water changes during pregnancy in women with different body weight and weight gain.

OBJECTIVE: To determine the fat deposited during pregnancy in women gaining according to recommendations of the Institute of Medicine and the relationship of weight gain to fat gain in women of different starting weights (classified by their body mass index). METHODS: A cohort study of healthy, nonsmoking women, 18-36 years of age, identified during prenatal visits at three hospital clinics and one birthing center in New York City. From a pool of 432 eligible volunteers who signed a consent form, body composition measurements were performed on 200 women at weeks 14 (+/-2) and 37+ of pregnancy, and bone mineral mass was measured at 2-4 weeks postpartum. Body fat was estimated with a model that used total body water, weight, and density and bone mineral mass. RESULTS: In women gaining as recommended by the Institute of Medicine, fat gains during pregnancy for women underweight, normal weight, overweight, or obese before pregnancy were 6.0 +/- 2.6 kg, 3.8 +/- 3.4 kg, 3.5 +/- 4.1 kg, and -0.6 +/- 4.6 kg, respectively. Higher weight gain increased fat gain. Body water gain was not different among the four prepregnancy weight groups. CONCLUSION: Recommended weight gain should not cause obesity in any weight group. Underweight women will normalize their body composition if they gain as recommended, whereas obese women will have little or no change in body fat. A majority of women do not gain as recommended during pregnancy.

Adipose Tissue↗
PubMed1998

Incidence of perihepatic adhesions in ectopic gestation.

OBJECTIVE: To compare the incidence of perihepatic adhesions in patients undergoing surgery for ectopic pregnancy with the incidence in patients undergoing elective laparoscopic sterilization. Fitz-Hugh-Curtis syndrome is a perihepatitis that usually occurs as a complication of pelvic inflammatory disease. Perihepatic adhesions may be an aftereffect of the acute hepatic episode, and because the cause of ectopic gestation is thought to be salpingitis, women with an ectopic gestation may also have a higher prevalence of coexisting perihepatic adhesions. METHODS: We reviewed charts of 97 women who had undergone laparoscopy or laparotomy for ectopic pregnancy (study group) and 116 women who had laparoscopic sterilization (control group). We recorded all perihepatic, pelvic, or abdominal adhesions that were documented at the time of surgery. Medical histories and sites of adhesions in the two groups were compared. RESULTS: The incidence of perihepatic adhesions was 14% in the study group compared with 3% in the control group (P < .01). For the total patient population, a history of pelvic infection correlated positively with the presence of perihepatic adhesions (P < .01), and the study (ectopic) group had a higher incidence of previous pelvic infection. CONCLUSION: Compared with control subjects, significantly more women with ectopic pregnancies had perihepatic adhesions. In women who have history of pelvic infection or ectopic pregnancy, physicians should inquire about long-term right upper quadrant pain. The inclusion of lysis of perihepatic adhesions in the preoperative consent form may be useful.

Adult↗
PubMed2002

Conductive keratoplasty for the correction of low to moderate hyperopia: 1-year results on the first 54 eyes.

OBJECTIVE: To document the 1-year postoperative clinical results of the safety, efficacy, and stability of conductive keratoplasty (CK) to correct low to moderate hyperopia. DESIGN: Prospective, nonrandomized, self-controlled trial. PARTICIPANTS: Five surgeons at four centers performed CK on the first 54 eyes of a multicenter, 2-year clinical trial. Treated eyes had +0.875 to +4.00 diopters (D) of hyperopia and < or =0.75 D of cylinder. The nature of this procedure was explained to all participating patients who signed informed consent forms prior to undergoing the procedure. INTERVENTION: Low energy, high-frequency current was applied directly into the peripheral corneal stroma through a delivery tip inserted at 16 or more treatment spots. An early nomogram was used for the first 54 eyes with an intended refraction of plano. MAIN OUTCOME MEASURES: Data from all 54 eyes were analyzed for safety and stability. A subset of 30 of the 54 eyes was found that had been treated with the appropriate number of spots with the early nomogram. These eyes were categorized as current nomogram eyes; the data for these eyes were analyzed for efficacy and predictability, as well as stability and safety. All patients reported on satisfaction and quality of vision after surgery. RESULTS: Preoperatively, the manifest refractive spherical equivalent refraction (MRSE) of the 30 current nomogram eyes was +1.57 D. At 1 year postoperatively, uncorrected visual acuity was 20/20 or better in 57% of the eyes and 20/40 or better in 93%. The MRSE was within 0.50 D in 46%, within +/-1.00 D in 93%, and within +/-2.00 D in 100%. No eye lost > or =2 lines of best spectacle-corrected visual acuity at 1 year postoperatively nor had an induced cylinder of > or =2.00 D. The MRSE changed a mean of 0.25 D +/- 0.43 between 3 and 6 postoperative months, 0.16 D +/- 0.38 between 6 and 9 postoperative months, and 0.07 D +/- 0.38 between 9 and 12 postoperative months. Refractive stability appeared to be attained by 6 months postoperatively. CONCLUSIONS: Conductive keratoplasty appears to be safe, effective, and stable for correcting low to moderate spherical hyperopia. Stability appeared by the 6-month follow-up visit. For the eyes treated with the current CK nomogram, uncorrected visual acuity, predictability, and stability are as good as or better than those obtained with hyperopic laser in situ keratomileusis or noncontact laser thermal keratoplasty.

Adult↗
PubMed1995

Ten-year refractive and visual results of radial keratotomy.

PURPOSE: The authors evaluated the 10-year refractive and visual acuity results of a cohort of patients who underwent radial keratotomy (RK). METHODS: A prospective cohort study was begun in 1980 of 198 consecutive myopic eyes of patients who were to undergo RK surgery. Patients were at least 18 years of age with myopia between 1.75 and 10 diopters. All patients signed consent forms. Refraction, uncorrected visual acuity (UVA), and best corrected visual acuity (BCVA) were the main outcomes evaluated at 10 years. RESULTS: Mean refraction at 10 years was -0.12 D, compared with -0.43 D at 5 years. Fifty-seven percent of eyes had UVA of at least 20/40 at 10 years, compared with 55% at 5 years. Improvement in UVA between 5 and 10 years occurred most frequently in eyes with most preoperative myopia and most surgery. Eighty-five percent of eyes had BCVA of at least 20/25 at 10 years, compared with 81% at 5 years. Women had significantly less myopia then men before surgery (P < 0.01), yet had similar UVA and worse BCVA. At 10 years, women had similar refraction but worse UVA and BCVA than men. CONCLUSIONS: Radial keratotomy was shown to be effective 10 years later. Some refractive and acuity changes occurred between 5 and 10 years follow-up, but these were mainly normal physiologic changes that occur with aging. Women had poorer vision than men before RK surgery and less beneficial results after surgery.

Adult↗
PubMed1980

Improving emergency department care of the sexual assault victin.

Victims of sexual assault face the multiple threats of disease, unwanted pregnancy, psychological trauma, and physical injury, which are further complicated by a comprehensive police investigation. An organized approach to the care of victims of sexual assault is presented, including guidelines for patient care and a discussion of police investigations, written consent forms, and physical evidence recovery kits. We recommend that the care of victims, from arrival in the emergency department until rehabilitation, be coordinated by a nurse. This specially trained individual serves as a liaison between the patient and the health professionals and police team.

Adolescent↗
PubMed2002

[Recovery of lung function after laparoscopic cholecystectomy: the role of postoperative pain].

OBJECTIVES: Lung function has been shown to deteriorate after laparoscopic cholecystectomy (LC). The present study evaluated 1) the rate of recovery after LC, and 2) the pathogenic role of postoperative pain in functional deterioration. DESIGN: Lung function was measured 24 hours before LC, upon hospital discharge (48-72 h after LC), and 10 days later. All patients received metamizol after LC until discharge (2 g every 6 h i.v.). Half the patients (analgesia group) received tramadol (150 mg i.m.) 30 minutes before lung function testing on the day of hospital discharge. The remaining patients constituted the control group. PATIENTS: Twenty healthy subjects (53 4 years old) undergoing LC for gall bladder removal. All signed informed consent forms. Measures and outcomes: Patient characteristics and preoperative lung function results were similar in both groups. LC duration and postoperative course were also similar in both groups. All were discharged without complications within 72 hours after LC. Lung function upon discharge (FVC, FEV1, TLC, PaO2 and AaPO2) had deteriorated in both groups (p<0.001). Deterioration was less marked in the analgesia group (p < 0.05). Ten days later, lung function had normalized for all subjects. CONCLUSIONS: These results indicate that after LC, 1) lung function is still abnormal when the patient is discharged from hospital, 2) lung function has fully recovered within 10 days, and 3) postoperative pain contributes significantly to temporary deterioration in lung function.

Adult↗
PubMedDate not supplied

Clinical efficacy and safety of a depigmented and glutaraldehyde polymerized therapeutic vaccine of Parietaria judaica.

BACKGROUND: The inhalation of Parietaria judaica pollen is a common cause of allergic respiratory diseases in the Mediterranean area. The objective of this study was to investigate the safety and clinical efficacy of a chemically modified (depigmented and glutaraldehyde-polymerized) vaccine of Parietaria judaica. METHODS AND RESULTS: Thirty patients with a well-documented clinical history of seasonal rhinitis and clinical sensitivity to Parietaria judaica pollen were included in a randomized trial during 12 months. The study was conducted following good clinical practices and appropriate consent forms were signed. Patients were divided into 2 groups of 15 individuals; group A received the modified extract and group C did not receive specific immunotherapy. Any adverse event was recorded to assess safety. Symptom scores, symptomatic medication use and the results of specific nasal challenges (before and after 12 months of treatment) were recorded to evaluate clinical efficacy. The treatment schedule consisted of an incremental phase of 5 injections and a maintenance dosage of 0.5 ml per month. Each patient received 14 injections during this period. All the patients completed the trial and no adverse reactions related to immunotherapy were recorded. A significant difference (p < 0.001) in symptom scores and overall use of symptomatic medication was observed between the two groups, being both scores lower in group A. No significant differences in nasal sensitivity existed before treatment among the 2 groups. However, after 12 months, a significant difference (p < 0.05) was observed only in group A patients, who showed a significant improvement in specific nasal challenges. CONCLUSIONS: Immunotherapy with depigmented and glutaraldehyde-polymerized extract of Parietaria judaica pollen is safe and effective to treat patients with allergic rhinitis and clinical sensitivity to this pollen.

Adult↗
PubMed2006

[Male and female sterilization techniques: Summary of ANAES assessments (May 2005)].

OBJECTIVE: To summarize assessments carried out by ANAES on male and female sterilization techniques. The summary was requested by the French Health Directorate after the law authorizing sterilization as a means of contraception was passed. RESULTS (FEMALE STERILIZATION): (i) EFFICACY of tubal ligation, electrocoagulation, clips or rings: the annual pregnancy rate is 0-2% depending on the study, with no significant difference between techniques. No data were found on fimbriectomy. (ii) EFFICACY of a hysteroscopically placed micro-insert device: no pregnancies were observed in patients with bilateral tube obstruction diagnosed by hysterosalpingography at 3 or at 6 months after placement (placement rate: 87-89%). (iii) SAFETY of tubal ligation, electrocoagulation, clips or rings: (a) By approach: There was no difference in the incidence of major complications between laparoscopy and minilaparotomy but there were significantly fewer minor complications with laparoscopy than with minilaparotomy. There were significantly more major complications with culdoscopy than with minilaparotomy and significantly more minor complications than with laparoscopy. (b) By operative technique: major and minor complications were significantly more common with the Pomeroy technique than with electrocoagulation; the difference could be due to the approach used. No data were available on fimbriectomy. (iv) SAFETY of a hysteroscopically placed micro-insert device: there were 11 cases of myometrial or tubal perforation among 734 patients (with device displacement into the peritoneal cavity in 3 cases). RESULTS (MALE STERILIZATION): (i) EFFICACY: efficacy varied from 84% to 100% depending on the approach and the mode of vas deferens obstruction. There was no significant difference in efficacy according to approach (transcutaneous or scrotal). However, no conclusion could be drawn on the comparative efficacy of the occlusion techniques used from published data. (ii) SAFETY: the rate of postoperative complications was low, below 10% in most series. Complications were benign and only rarely necessitated surgical revision. CONCLUSION: The advantage of sterilization methods is that they lack any permanent contraindication. They should be presented as being generally irreversible. Fimbriectomy is not recommended for female sterilization. Laparoscopy is the preferred approach. Sterilization by hysteroscopic placement of a micro-insert device should be restricted to cases presenting a risk on laparoscopy; the technique should be re-assessed in 2006. The two approaches used for male sterilization are technically similar and do not seem to differ in efficacy. The Public Health Code states that "Fallopian tube or deferens duct ligation for contraceptive purposes is not allowed in minors" and that ligation "cannot be performed unless the adult involved has given his/her informed and motivated consent, expressed after taking into consideration clear, complete information on the consequences of the procedure". A waiting period of four months must follow the moment the decision to sterilize is taken and consent is given. An informed consent form must be signed. Sterilization in young or nulliparous women should be proposed with the greatest prudence and with many reservations.

Adolescent↗
PubMed2003

Use of abdominal aortic endovascular prostheses in France from 1999 to 2001.

BACKGROUND: Since the introduction of endovascular repair (EVR) for infrarenal abdominal aortic aneurysm (AAA), clinical evaluation has been under way in many countries throughout the world. The main purpose of this retrospective study was to determine outcome of EVR with aortic endovascular prostheses (AEPs) and to evaluate the extent to which French practitioners have complied with regulatory and clinical guidelines for the use of these trial devices. METHODS: This retrospective study was conducted by the French National Health Insurance Fund for Salaried Workers. Data were compiled on EVR procedures performed at health care institutions all over mainland France between June 1999 and May 2001. RESULTS: A total of 1012 AEPs were deployed for AAA repair in France during the study period. Only 151 (14.9%) of these EVR procedures were carried out within an approved investigational setting with informed patient consent. Only 149 of the 861 patients (17.3%, 95% confidence interval [CI], 14.9 to 19.9%) who underwent endovascular repair in noninvestigational settings signed informed consent forms. In 452 cases (46.5%), the diameter of the AAA was 50 mm or less. Complete outcome data for the first year were available for 891 patients (88%). Complications occurred in 177 of these patients (19.9%, 95% CI, 17.3 to 22.6%). There were a total of 47 deaths (5.3%, 95% CI, 3.9 to 6.9%), including 27 during the first 30 postoperative days. Other major events during the first year after AEP implantation were ruptured AAA in 5 patients, conversion to open operation in 15, and additional endovascular treatment in 52. Data on clinical surveillance were available for 987 patients (97.5%) with a mean follow-up of 345 days. Only 294 patients (29.8%, 95% CI, 27.0 to 32.7%) underwent complete imaging within the first month after AEP implantation. A total of 184 patients (18.6%, 95% CI, 16.3 to 21.2%) received no surveillance at all. CONCLUSION: This study shows the need for improvement in the clinical evaluation of new devices and medical technologies in France. Study findings also confirm the significant incidence of adverse outcomes and necessity for routine surveillance after EVR of AAA with AEP. However, risk/benefit analysis is difficult because most procedures were not carried out within a proper investigational context.

Adult↗