Mifepristone in Italy: the case of a drug trapped between ethics and clinical practice

In Italy mifepristone is not yet marketed. Gynaecologists in our hospital asked to use this medication as a less traumatic method for voluntary abortions. We followed the standard procedure defined by the Italian Health Ministry (IMH) for purchasing drugs from abroad but encountered several unexpected barriers. Starting from this case, this paper is aimed at identifying these barriers which we found to be not only professional, but also ethical, religious and moral.     

Free insulin-like growth factor-I and cognitive function in older persons living in community.

CONTEXT: Increasing evidences from experimental and human studies suggest that the activity of the growth hormone (GH/insulin-like growth factor-I) axis may contribute to the age-related cognitive decline and poor cognition in late life. OBJECTIVE: The aim of the present study was to evaluate the relationship of total serum free IGF-I and its binding protein-3 with cognitive performance in older persons aged 80 years or older. DESIGN: Data are from baseline evaluation of the ilSIRENTE study (n=353). Cognitive performance was evaluated using five items enclosed in the Minimum Data Set for Home Care assessment form: short-term memory, procedural memory, cognitive skills in daily decision making, verbal expression, comprehension. Free insulin-like growth factor-I (free IGF-I) and IGF-binding protein-3 (IGFBP-3) in blood were measured. Analysis of covariance (ANCOVA) was used to examine the relationship between cognitive impairment and the serum free IGF-I and IGFBP-3 concentrations, after adjustment for potential confounding variables. RESULTS: After adjustment for potential confounders, which included age, gender, education, cerebrovascular disease, ischemic heart disease, congestive heart failure, hypertension, diabetes, depression, Parkinson diseases, thyroid diseases, smoking status, alcohol abuse, body mass index, and number of medications, individuals with verbal expression problems (n=20) and individuals with comprehension problems (n=24) had a significantly lower serum levels of readily dissociable IGF-I than participants without cognitive impairments. The serum IGFBP-3 presented the same behavior of free IGF-I. CONCLUSION: The present study suggests that among old-old subjects living in the community lower levels of total serum free IGF-I and IGFBP-3 are associated with impairment of cognitive performance. This finding suggests that the GH/IGF-I axis may play an important role in the age-related decline of cognitive performance.     

Fibrosis of gastric cardia after endoscopic sclerosis. Mechanism for control of experimental reflux?

Endoscopic sclerosis of the gastric cardia (ESGC) prevents experimental gastroesophageal reflux (GER) without changes in lower esophageal sphincter (LES) pressure and length. This study was performed to define the histologic appearance of the esophagus and stomach one year after ESGC. Four dogs were studied one year after ESGC with morrhuate sodium; ESGC had been performed at six sites, 1-3 cm distal to the esophagogastric junction. All animals had stable weight and eating habits at sacrifice. Light microscopy of the cardia and LES included morphometry of wall thickness (mm) and assessment of fibrosis (- to ). The esophagus had minimal changes; the gastric cardia had focal fibrosis, maximal on the greater curve, without any change difference in wall thickness. ESGC results in fibrosis of the gastric cardia, without significant changes in the esophagus. These changes prevent GER, possibly by preventing the initiation of a reflux event.     

Using polymerase chain reaction to human papillomavirus in oral and pharyngolaryngeal carcinomas

Purpose: Increasingly, evidence has shown that human papillomavirus (HPV) plays a role in the induction of certain carcinomas. The presence of HPV sequences in 56 previously untreated oral and pharyngolaryngeal carcinomas was examined by the polymerase chain reaction (PCR).Materials and Methods: After DNA extraction, samples underwent 40 replication cycles with specific oligonucleotide primers corresponding to sequences from the E6 open-reading frame of HPV-6b, HPV-16, and HPV-18. To determine the E6 genomic integration, positive samples were processed with specific primers for the corresponding HPV L1 genes. Genomic HPV DNA cloned into PBR 322 was used as positive control.Results: HPV E6 DNA of the 6b and 16 types was detected in 14 patients (25%). The L1 gene was not present.Conclusion: Detected HPV E6 DNA might be integrated into the cell genome in the positive cases as indicated by the absence of the L1 gene-coding for the viral capside. Histological and clinical parameters, such as tumor location, degree of differentiation, stage, recurrence, and survival rates, were unrelated to the presence of HPV.     

Intracranial actinomycosis in juvenile patients Case report and review of the literature

A case of actinomycotic brain infection in a juvenile patient is described. Cases of actinomycosis affecting the head and neck are rare, particularly in juvenile patients. In this case complete resolution of the infection was achieved by means of surgical treatment and prolonged antibiotic therapy. The authors emphasize the importance of a combined approach for treatment of this unusual brain infection and stress the difficulties involved in the diagnosis of this pathology. Received: 3 November 1997     

Preoperative Chemotherapy Alone and Combined with Preoperative Radiotherapy in Small-Size Breast Cancer

Abstract: Breast conservation surgery is an effective and safe treatment for many breast carcinomas. It may be possible to further limit the extent of resection (or expand the indication for breast conservation) by the application of preoperative chemotherapy and radiotherapy. We explored the feasibility of this in a pilot study.
Seventy-three patients (mean age 48, 63% premenopausal) with confirmed breast cancer, less than 2.5 cm, received chemotherapy (Group A) or chemotherapy plus radiotherapy (Group B) prior to limited resection (tumorectomy). Axillary dissection was always performed. Results: In 6/31 (19%) Group A and 17/42 (40%) Group B patients the tumor was not palpable after preoperative treatment, with complete pathological remission in 1 and 3 cases respectively. Histologic grading, mitosis, cellular alteration, and cellularity evaluations indicated a consistently greater therapeutic effect with chemoradiotherapy than with chemotherapy alone.
In conclusion, radiotherapy appears useful in the preoperative treatment of breast cancer and its use in association with various drug combinations should be further explored.     

Effect of epidural anesthesia on colorectal anastomosis

PURPOSE: Epidural anesthesia is believed to benefit colorectal anastomotic blood flow because of the sympathetic blockade it produces. Our purpose is to measure with tonometry the effect of epidural anesthesia on colorectal anastomotic oxygenation. PATIENTS AND METHODS: Fifteen patients operated on for rectal cancer (radical anterior resection) were monitored postoperatively using tonometers placed in the stomach (celiac trunk), transverse colon (superior mesenteric artery), and the anastomotic area during the operation. An epidural catheter was placed at L1-2, and on the first postoperative day, 8 ml of bupivacaine (0.25 percent) was administered. The anesthetic effect extended up to T-4. Intramucosal pH (pHi) at the three locations was measured before, during, and after the epidural blockade. RESULTS: Gastric and transverse colon pHi increased during the epidural blockade from 7.35±0.01 to 7.41±0.01 and from 7.34±0.02 to 7.40±0.02, respectively. The anastomotic pHi decreased from 7.3±0.02 to 7.24±0.03 under the epidural and increased up to 7.34±0.02 after withdrawal of the effect on the following day. All pHi variations were statistically significant (P<0.05, paired Student'st-test and Wilcoxon's test), because it was the comparison between gastric and transverse colon pHi with the anastomotic pHi during the epidural (P<0.05, one-way analysis of variance and Kruskal-Wallis tests). None of the patients developed anastomotic or other complications. CONCLUSIONS: Epidural anesthesia with bupivacaine causes a significant decrease in the oxygenation-perfusion state of colorectal anastomosis in comparison with the increase in other areas of the digestive tract. Further studies need to be done to see if other epidural anesthetic-analgesic protocols also worsen colorectal anastomotic blood flow.Supported in part by a grant from the Spanish Society of Digestive Diseases, Madrid, Spain. All tonometric catheters and drugs were donated by the Clinic University Hospital of Valencia, Spain.Read at the meeting of The American Society of Colon and Rectal Surgeons, Seattle, Washington, June 9 to 14, 1996.