Intravenous dolasetron mesilate in the prevention of postoperative nausea and vomiting in females undergoing gynecological surgery

STUDY OBJECTIVE: To evaluate a range of doses of intravenous (i.v.) dolasetron mesilate, in preventing postoperative nausea and vomiting (PONV). DESIGN: Double-blind, placebo-controlled, randomized, multicenter trial. SETTING: Ten hospitals and/or surgical centers. PATIENTS: 281 women undergoing gynecologic surgery with general anesthesia. INTERVENTIONS: Patients received one of four single, i.v. doses of dolasetron mesilate (12.5 mg, 25 mg, 50 mg, and 100 mg) or placebo administered following cessation of anesthesia. MEASUREMENTS AND MAIN RESULTS: Patients were monitored for 24 hours following study drug administration. The antiemetic efficacy of each dolasetron mesilate dose was evaluated by recording the number and timing of emetic episodes, and the effects on nausea were assessed by use of visual analog scales (VAS). Safety was assessed by adverse event reports, clinical laboratory tests, electrocardiographic (ECG) measurements, and monitoring vital signs. Complete responses (patients with no emetic episodes and no escape antiemetic medication requirements in 24 hours) were achieved by 54% in the 12.5-mg, 67% in the 25-mg, and 59% in both the 50-mg and 100-mg dolasetron mesilate dose groups, and by 43% in the placebo group. Nausea VAS assessments demonstrated that dolasetron-treated patients were significantly (p = 0.048) more likely to report no nausea (VAS score < 5 mm) than those in the placebo group. Adverse events reported generally were mild in intensity, and there were no clinically significant changes in laboratory tests, vital signs, or ECG parameters. CONCLUSIONS: Dolasetron was effective and well tolerated for the prevention of PONV in female patients undergoing gynecologic surgery with general anesthesia.     

Arterial oxygen desaturation during non-sedated diagnostic upper gastrointestinal endoscopy

We studied oxygen saturation (SaO2) using a pulse oximeter in 120 patients undergoing non-sedated diagnostic upper gastrointestinal endoscopy. The baseline SaO2 was 98.3 +/- 1.0%. During the procedure, absence of oxygen desaturation (SaO2 > or = 95%) was found in 56%, mild oxygen desaturation (95% > SaO2 > or = 90%) in 35%, and severe oxygen desaturation (SaO2 < 90%) in 9%. Age (p = 0.56), gender (p = 0.47), smoking (p = 0.35), hemoglobin level (p = 0.52), body mass index (p = 0.27), or total endoscopy time (p = 0.72) was not related to the degree of oxygen desaturation. These results suggest that oxygen desaturation is frequently observed during non-sedated diagnostic upper gastrointestinal endoscopy although severe oxygen desaturation, which may induce rare but serious cardiopulmonary events, is not common. Furthermore, we cannot predict in which patients desaturation will occur. We therefore recommend continuous monitoring of arterial oxygenation in all patients during the procedure.     

The feasibility of epidural anesthesia without endotracheal intubation for abdominal surgery in patients with collagen diseases

BACKGROUND/AIMS: Patients with collagen diseases are generally regarded as high-risk surgical candidates. MATERIAL AND METHODS: To evaluate the feasibility of epidural anesthesia and to determine the risk factors in abdominal surgery for patients with collagen diseases, 20 patients with collagen diseases who underwent elective abdominal surgery were examined for their surgical outcomes and clinical characteristics. Among the 20 cases, 12 received epidural anesthesia alone without endotracheal intubation, 3 received general anesthesia only, 4 received general anesthesia with epidural anesthesia and one received lumbar anesthesia. RESULTS: Only one patient receiving epidural anesthesia died after operation. The mortality in patients receiving epidural anesthesia was 8.3% (1/12) while the overall mortality was 5.0% (1/20). No significant difference was observed either in the mortality or incidence of postoperative complications among the 4 groups according to the method of anesthesia. Patients with a dysfunction of the vital organs more often had postoperative complications than those without a dysfunction of the vital organs (p = 0.043). CONCLUSIONS: Although only a small number of patients were included in this study, these results suggested that 1) elective abdominal surgery can be as safely performed under epidural anesthesia alone as with general anesthesia even for patients with collagen diseases, and 2) the patients with collagen diseases, who preoperatively showed a dysfunction of the vital organs, might be at a higher risk for abdominal surgery.     

Orthostatic hypotension with syncope--a problem of hypertensive therapy in the aged

STUDY OBJECTIVE: To assess the efficacy of the "laryngeal lift" maneuver in improving laryngoscopic visualization to facilitate endotracheal intubation. DESIGN: Blinded study. SETTING: Operating room at Meridia Huron Hospital. PATIENTS: 305 patients receiving general anesthesia for elective surgery requiring intubation. (Five patients were eliminated from the study because we elected to intubate these patients awake and sedated.) INTERVENTIONS: Following induction of anesthesia and paralysis with muscle relaxants, laryngoscopic views of each patient were evaluated by the laryngoscopist before and after the laryngeal lift was performed by an anesthesiologist assisting the laryngoscopist. Each patient served as his or her own control group. The anesthesiologist was blinded to the results obtained by the laryngoscopist. All Grade I laryngoscopic views were eliminated (198 patients). Five patients were eliminated on the basis of obesity or atlantoaxial subluxation. The laryngeal lift was performed on the remaining 102 patients, representing Grade II to Grade V laryngoscopic views. MEASUREMENTS AND MAIN RESULTS: A modification of the original classification of laryngoscopic views by Cormack and Lehane was used: Grade I = full view of glottis; Grade II = only posterior commissure visible; Grade III = arytenoids visible; Grade IV = epiglottis visible; Grade V = no glottic structure visible. In 98 of 102 cases (96%), the maneuver improved visualization by at least 1 grade. There was no evidence of change in the 4 remaining cases. CONCLUSIONS: The laryngeal lift should be part of the anesthesiologists' armamentarium in helping the laryngoscopist who is faced with Grades II, III, IV, and V laryngoscopic views to enhance visualization of the larynx and thus facilitate endotracheal intubation.     

Two year maintenance treatment of duodenal ulcer disease with ranitidine 150 mg: a prospective multicentre randomised study. GEMUD (Groupe d'Etude de la Maladie Ulcéreuse Duodénale)

Maintenance treatment of duodenal ulcer (DU) with ranitidine 150 mg/day was compared with placebo in a two year prospective multicentre randomised study. Three hundred and ninety nine patients were included (mean age: 44.7 years, M/F ratio = 2.47/1; 37.6% of smokers) in placebo (n = 202) and ranitidine (n = 197) groups. Efficacy was assessed by the length of time to the first ulcer pain attack (with or without endoscopic confirmation) or DU complication. One hundred and fourteen patients of 399 (28.6%) had incomplete follow up. Actuarial survival curves of patients without ulcer pain (26 and 53% at two years in placebo and ranitidine groups, respectively) were significantly different (p < 0.0001). Endoscopies were performed depending on physicians' decision (mainly where there was severe pain or complication). Patients without relapses from endoscopy were more frequent in the ranitidine group (83%) than in the placebo group (47%, p < 0.0001). A greater incidence of complications, mainly bleeding, was also seen in the placebo group (13 complications v two in the ranitidine group, p < 0.002). No factor predicting DU relapse was identified. No important side effect was encountered. Ranitidine 150 mg/day is effective and well tolerated in preventing ulcer pain attacks and DU complications for up to two years.     

Dexpanthenol nasal spray as an effective therapeutic principle for treatment of rhinitis sicca anterior

BACKGROUND: Controlled clinical studies on medical treatment of rhinitis sicca anterior have not yet been published. Therapy recommendations are based on experiences but not on results of controlled clinical studies. The aim of this study was to examine the efficacy and tolerance of a new form of application of Dexpanthenol in physiologic saline solution (Nasicur). PATIENTS AND METHODS: A randomized comparison of parallel groups was performed. One group was treated with the nasal spray while the control group received a placebo. The assessment of nasal breathing resistance and the extent of crust formation according to scores were defined as target parameters. Statistical analysis was carried out according to Wilcoxon at alpha < or = 0.05. RESULTS: Forty-eight outpatients diagnosed with rhinitis sicca anterior were included in this study. Twenty-four received the medication, and 29 were treated with a placebo. The superiority of the dexpanthenol nasal spray in comparison to the placebo medication was demonstrated for both target parameters as clinically relevant and statistically significant. The placebo spray showed clinical improvement of the other treatment outcome parameters. Dexpanthenol nasal spray showed no statistically significant difference in comparison to placebo. The clinically proven efficacy is emphasized by good tolerance of both treatments which was validated by the objective rhinoscopy findings. Good compliance was confirmed. CONCLUSION: The result of the controlled clinical study confirms that the dexpanthenol nasal spray is an effective medicinal treatment of rhinitis sicca anterior and is more effective than common medications.     

Comparison of sulfasalazine and placebo in the treatment of reactive arthritis (Reiter's syndrome). A Department of Veterans Affairs Cooperative Study

OBJECTIVE: To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective in the treatment of reactive arthritis (ReA) that has been unresponsive to nonsteroidal antiinflammatory drug (NSAID) therapy. METHODS: One hundred thirty-four patients with ReA who had failed to respond to NSAIDs were recruited from 19 clinics, randomized (double-blind) to receive either SSZ or placebo, and followed up for 36 weeks. The definition of treatment response was based on joint pain/tenderness and swelling scores and physician and patient global assessments. RESULTS: Longitudinal analysis revealed improvement in the patients taking SSZ compared with those taking placebo, which appeared at 4 weeks and continued through the trial (P = 0.02). At the end of treatment, response rates were 62.3% for SSZ treatment compared with 47.7% for placebo treatment. The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints. CONCLUSION: SSZ at a dosage of 2,000 mg/day is well tolerated and effective in patients with chronically active ReA.     

Fluticasone propionate aqueous nasal spray is safe and effective for children with seasonal allergic rhinitis

INTRODUCTION: Fluticasone propionate aqueous nasal spray, a new topical corticosteroid preparation, is effective when given as 200 micrograms once daily in patients (> 12 years of age) with seasonal allergic rhinitis. STUDY OBJECTIVE: To evaluate the efficacy and safety of fluticasone proprionate aqueous nasal spray in children aged 4 to 11 years with seasonal allergic rhinitis. STUDY DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel-group. PATIENTS: Two hundred fifty children aged 4 to 11 years with moderate-to-severe nasal symptoms, a positive skin test reaction to a late-summer or autumn allergen, a history of seasonal allergic rhinitis, and documentation of an unsatisfactory response to conventional treatment. INTERVENTIONS: Children were randomly assigned to receive fluticasone propionate, either 100 micrograms or 200 micrograms, or placebo, given by intranasal spray once daily in the morning for 14 days. MEASUREMENTS AND RESULTS: Severity of nasal symptoms (obstruction, rhinorrhea, itching, and sneezing) was recorded on visual analog scales by investigators at weekly visits and by patients (or adult guardian) daily in the evening. According to investigator and patient ratings, both fluticasone propionate 100 micrograms/d and 200 micrograms/d lowered total nasal symptom scores when compared with placebo. Both dosages of fluticasone propionate were more effective than placebo on the basis of investigator-rated overall clinical evaluation of efficacy at the end of treatment, with significant improvement (as opposed to moderate or mild improvement, no change or worsening) noted in 21% to 29% of the active-treatment groups vs 9% in the placebo group. There were no significant differences between the two fluticasone propionate dosages in any efficacy measurement. Morning plasma cortisol concentrations and frequency of drug-related adverse events were similar in the fluticasone propionate and placebo groups. CONCLUSION: In children as young as 4 years, 100 micrograms of fluticasone propionate aqueous nasal spray given once daily is as effective as 200 micrograms given once daily, the usual adult dose for the treatment of seasonal allergic rhinitis. Both fluticasone propionate dosages were well tolerated and neither dosage appears to interfere with the hypothalamic-pituitary-adrenal axis in children.     

Gastrointestinal endoscopy in high-risk patients

In America more than 100,000 high-risk patients/year have conditions normally evaluated by gastrointestinal endoscopy. This review analyzes the safety and efficacy of gastrointestinal endoscopy in high-risk patients. Endoscopy during pregnancy raises the unique issue of fetal safety. The safety of esophagogastroduodenoscopy (EGD) during pregnancy has been examined in a case-controlled study of 83 patients, a mailed survey of 73 patients, and case reports. The safety of sigmoidoscopy during pregnancy has been examined in a case-controlled study of 45 patients, a mailed survey of 26 patients, and case reports. These studies suggest that EGD and sigmoidoscopy are not contraindicated during pregnancy. For example, EGD should be performed for significant upper gastrointestinal bleeding. The safety of colonoscopy during pregnancy is inadequately analyzed. In a study of 34 EGDs performed within 3 weeks of myocardial infarction, no endoscopic complications occurred in 26 clinically stable patients with uncomplicated myocardial infarction. However, 3 major endoscopic complications occurred in 8 clinically unstable patients. In a study of 9 sigmoidoscopies within 3 weeks of myocardial infarction, no sigmoidoscopic complications occurred in 7 clinically stable patients. Several studies have shown that EGD, sigmoidoscopy, or colonoscopy is safe in patients with advanced HIV infection. AIDS patients should generally be endoscoped with the same aggressiveness as other patients. However, endoscopy may be unwise in any terminal patient. No complication occurred in 60 patients undergoing EGD within 3 weeks of esophageal, gastric, or duodenal surgery. One minor complication occurred in 36 patients undergoing sigmoidoscopy within 3 weeks of colonic surgery. These results suggest that EGD or sigmoidoscopy is not contraindicated within 3 weeks of gastrointestinal surgery. No complications occurred in 53 chronic obstructive pulmonary disease patients undergoing EGD. EGD appears to be safe in chronic obstructive pulmonary disease patients without severe hypoxemia or acute bronchospasm. Emergency EGD can be performed in patients with severe hypoxemia after endotracheal intubation.     

Diarrhea as initial manifestation of medullary thyroid carcinoma

HISTORY AND CLINICAL FINDINGS: For 15 months a 52-year-old business man had been suffering from chronic diarrhoea which had persisted even after exophthalmic hyperthyroidism (Grave's disease) had been diagnosed and adequately treated. Physical examination on admission revealed no abnormalities, in particular no sign of hyperthyroidism. INVESTIGATIONS AND DIAGNOSIS: Repeated stool examinations failed to demonstrate any infectious organisms. Upper gastrointestinal endoscopy and ileaocoloscopy were normal, as were biopsies. Persistence of the diarrhoea during a fasting test and the bulky stools suggested a secretory cause. Among various hormonal tests the calcitonin concentration was found to be greatly raised (4572 ng/l, normal 10 < ng/l). Ultrasound demonstrated a thyroid tumour and cytological examination of a fine-needle biopsy revealed a medullary carcinoma. TREATMENT AND COURSE: After total thyroidectomy with bilateral neck dissection the patient was free of any symptoms: the diarrhoea ceased immediately after the operation and the calcitonin concentration became nearly normal. CONCLUSIONS: Signs of chronic secretory diarrhoea suggest the possibility of an endocrinally active tumour. Search for a medullary carcinoma of the thyroid with measurement of the serum calcitonin level should be among the diagnostic procedures.     

Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy

BACKGROUND: Conventional treatment for painful peripheral diabetic neuropathy is largely symptomatic and often ineffective, with unacceptable side-effects. We tested electrical spinal-cord stimulation for the management of chronic neuropathic pain. METHODS: Ten diabetic patients who did not respond to conventional treatment (mean age 51 [SD 9.3] years, six with type II diabetes, mean duration of diabetes 12 [6.3] years, mean duration of neuropathy 5 [2.1] years) were studied. The electrode was implanted in the thoracic/lumbar epidural space. Immediate neuropathic pain relief was assessed by visual analogue scale (VAS) after connecting the electrode, in a random order, to a percutaneous electrical stimulator or to a placebo stimulator. Exercise tolerance was assessed on a treadmill. FINDINGS: Eight subjects had statistically significant pain relief with the electrical stimulator (p < 0.02) and were therefore converted to a permanent system. Statistically significant relief of both background and peak neuropathic pain was achieved at 3 months (n = 7, p = 0.016), at 6 months (n = 7, p = 0.03), and at the end of the study (14 months, n = 7, background pain p = 0.06, peak pain p = 0.03). One patient died 2 months after the start of the study of unrelated cause while continuing to benefit from treatment and another patient ceased to benefit at 4 months. McGill pain questionnaire scores with the stimulator turned off did not change significantly from baseline scores, indicating that the severity of the underlying pain was unaltered. However, with the stimulator turned on, there was a statistically significant (p < 0.05) improvement in all four components of the score, by the end of the study. At the end of the study, six patients continued to gain significant pain relief and used the stimulator as the sole treatment for their neuropathic pain. For example, median background and peak pain scores at the end of study, were, respectively, 77 and 81 with the stimulator off and 23 and 20 with the stimulator on. Exercise tolerance significantly improved at 3 months (n = 7, median % increase 85 [IQR, 62-360], p = 0.015) and at 6 months (n = 6, 163 [61-425], p = 0.0007). Electrophysiological tests, vibration perception-threshold, and glycaemic control were unchanged. INTERPRETATION: Electrical spinal-cord stimulation offers a new and effective way of relieving chronic diabetic neuropathic pain and improves exercise tolerance. The technique should be considered in patients with neuropathic pain who do not respond to conventional treatment.     

Patient-controlled sedation and analgesia, using propofol and alfentanil, during colonoscopy: a prospective randomized controlled trial

BACKGROUND AND STUDY AIMS: Patient-controlled sedation (PCS) enables titration of dosage to an individual's requirements and is potentially useful in colonoscopy. The aim was to compare the value of patient-controlled sedation, using propofol and alfentanil, with that of intravenous diazemuls and pethidine during colonoscopy. PATIENTS AND METHODS: Following randomization, 66 patients undergoing colonoscopy received either an intravenous bolus of pethidine (50 mg) and diazemuls (10-20 mg) prior to colonoscopy or were connected to an infusion pump containing propofol (10 mg/ml) and alfentanil (25 microg/ml). Patients self-administered 0.5 ml boluses as often as they required. Pain and sedation score were recorded by a nurse specialist and on a patient questionnaire. An anaesthetist was present throughout the procedure. RESULTS: PCS provided lighter sedation (median sedation score, 3 versus 4; P=0.0001), less analgesia (median pain score, 1 versus 0; P=0.004), a smaller maximum fall in systolic blood pressure (23 mmHg versus 33 mmHg; P=0.02) and a faster recovery time (median 10 min versus 40 min; P=0.0001), irrespective of the dose administered, compared with a diazemuls-pethidine combination. The duration of the procedure was unaffected. All patients were satisfied with their level of sedation. CONCLUSIONS: Patient-controlled sedation is an effective alternative to premedication with narcotic/benzodiazepine combinations during colonoscopy.     

Effect of nicotine nasal spray on smoking cessation. A randomized, placebo-controlled, double-blind study

BACKGROUND: Nicotine replacement therapies have proved to be of value in smoking cessation. However, not all smokers can use the nicotine gum or nicotine patch owing to side effects. In addition, the absorption of nicotine from these formulas is slow compared with smoking. A nicotine nasal spray delivers nicotine more rapidly. The objective of this study was to evaluate the efficacy and safety of the nicotine nasal spray for smoking cessation. METHODS: Subjects were recruited through advertisements in newspapers and among patients referred to the smoking cessation clinic at Sahlgren's Hospital, G?teborg, Sweden. Two hundred forty-eight smokers were treated in small groups with eight counseling sessions over 6 weeks. At their first group session, subjects were randomized to a group receiving nicotine spray (n = 125), 0.5 mg of nicotine per single spray, or to a placebo group (n = 123). The procedure was double blind. Success rates were measured up to 12 months. The nonsmoking status was verified by expired carbon monoxide less than 10 ppm. RESULTS: Significantly more subjects in the nicotine group were continuously abstinent for 12 months than in the placebo group (27% vs 15%; odds ratio, 2.16; 95% confidence interval, 1.15 to 4.12). Ten of the 34 abstinent subjects in the nicotine group used the spray for 1 year. Mild or moderate side effects were rather frequent for both sprays, but they were significantly more for the nicotine spray. Subjects with high scores (> 7) on Fagerstr?m's tolerance questionnaire had a significantly lower success rate with placebo than with the nicotine spray. For subjects with low scores, there was no difference. CONCLUSION: Nicotine nasal spray in combination with group treatment is an effective aid to smoking cessation.     

Effect of inhibition of nitric oxide synthase on chronic tension-type headache: a randomised crossover trial

BACKGROUND: Studies in animals have shown that nitric oxide plays an important part in central sensitisation and that inhibitors of nitric oxide synthase (NOS) decrease sensitisation in models of persistent pain. The efficacy of inhibitors of NOS has not been tested in patients with tension-type chronic headache. We aimed to show whether N(G)-monomethyl-L-arginine hydrochloride (L-NMMA), an inhibitor of NOS, is effective in relieving pain in such patients. METHODS: We undertook a randomised double-blind, crossover trial of 16 patients with chronic-tension-type headache. Patients were assigned intravenous infusion of 6 mg/kg L-NMMA or placebo on 2 days separated by at least 1 week in a randomised order. Headache intensity was measured on a 100 mm visual analogue scale, and on a verbal rating scale at baseline and at 30 min, 60 min, and 120 min after start of treatment. The primary endpoint was reduction of pain intensity on the visual analogue scale by the active treatment compared with placebo. FINDINGS: L-NMMA reduced pain intensity on the visual analogue scale significantly more than placebo: 120 min after start of treatment, the mean pain score was decreased from 49 to 33 with L-NMMA and from 44 to 40 with placebo (p=0.01). Pain intensity on the verbal rating scale was also significantly lower for treatment with L-NMMA than for treatment with placebo (p=0.02). INTERPRETATION: Inhibition of NOS had an analgesic effect in chronic tension-type headache. Further tests are required before clinical application.     

Comparative study of the efficacy and tolerance of 2 types of colon cleansing

OBJECTIVE: To examine if (hypothesis): orally administered colon cleansing with 3 liters of balanced electrolyte/polyethylene glycol solution is superior to the standard method of bowel preparation with senna laxatives and sodium phosphate enemas. Study factors: 1st) Quality of colon cleansing estimated by the attending endoscopist. 2nd) Patient tolerance. METHODS: DESIGN: prospective randomized trial, blind to the endoscopist, comparing two methods of bowel preparation: group A received 3 L of the balanced electrolyte/polyethylene glycol solution the night before the procedure and group B was instructed to ingest 75 ml of a senna laxative the day before the colonoscopy and sodium phosphate enemas per rectum b.i.d. starting 2 days before the examination and again the morning of the procedure. Assessing criteria: 1st) Questionnaire filled by the attending endoscopist immediately after the completion of the colonoscopy. 2nd) Questionnaire filled by the patient the day after the procedure. PATIENTS: Inclusion criteria: all the patients addressed to our Unit for colonoscopy (18 patients refused to participate). Exclusion criteria: severe cardiovascular disease, decompensated diabetes mellitus and severe disease or neurological derangement that prevented collaboration (35 patients). Two hundred and sixteen patients were initially included, 110 in group A and 106 in group B; in 39 patients (18 in group A and 21 in group B) colonoscopy could not be completed for causes others than bowel preparation and were excluded for further evaluation by the endoscopist, thus, quality of bowel preparation was evaluated in 92 patients in group A and in 85 patients in group B; 83 patients (43 in group A and 40 in group B) did not answer the questionnaire, or did it incorrectly, thus, tolerance was evaluated in 67 patients in group A and in 66 patients in group B. RESULTS: In 2 patients in group A (2.2%) and in 9 patients in group B (10.6%) colonoscopy could not be completed because of solid stool (p = 0.045). Mucosal visualization was better in group A than in group B (p = 0.0108). A total of 11.9% of the patients in group A and 25.8% of the patients in group B found the preparation hard or very hard to tolerate (p = 0.0001), patients in this latter group presented more frequently abdominal cramps (p = 0.0004), and distress (p < 0.00001), and dizziness (p = 0.0031). Bad tolerance in group B was primarily due to the rectal enemas (p < 0.0001). CONCLUSIONS: Bowel preparation for colonoscopy with 3 L of orally administer balanced electrolyte/polyethylene glycol solution (PEG) results in a better colon cleansing and is better tolerated than the classical preparation consisting in oral purge and rectal enemas.     

Gamma knife radiosurgery and albendazole for cerebral alveolar hydatid disease

We measured pharyngeal mucosal pressures at six different locations on the laryngeal mask airway (LMA) and tested the hypothesis that the efficacy of the seal is not related to pharyngeal mucosal pressure. Twenty anesthetized, paralyzed adult patients were studied. Microchip sensors were attached to the size 5 LMA at locations corresponding to the lateral and posterior pharynx, the hypopharynx, the pyriform fossa, the base of tongue, and the oropharynx. Mucosal pressures and airway sealing pressures were recorded during inflation of the cuff from 0 to 40 mL in 10-mL increments. The highest mean mucosal pressure was in the oropharynx (26 cm H2O), and the lowest was in the posterior pharynx (2 cm H2O). Mucosal pressures increased with increasing intracuff pressure and cuff volume, but the rate of increase varied among locations. Airway sealing pressure increased with increasing intracuff volume from 0 to 10 mL (P < 0.0001) and 10 to 20 mL (P = 0.0001), was unchanged from 20 to 30 mL, and decreased from 30 to 40 mL (P = 0.005). The airway sealing pressure was higher than pharyngeal mucosal pressure until the intracuff volume was > or =30 mL. There was no correlation between mucosal pressures and airway sealing pressure at any location. We conclude that the efficacy of the seal is not related to pharyngeal mucosal pressure. Pharyngeal mucosal pressures are generally lower than those considered safe for the tracheal mucosa during prolonged intubation. IMPLICATIONS: We measured pharyngeal mucosal pressures at six different locations on the laryngeal mask airway and showed that the efficacy of the seal is not related to pharyngeal mucosal pressure. Pharyngeal mucosal pressures are generally lower than those considered safe for the tracheal mucosa during prolonged intubation.     

Predominantly gastrointestinal symptoms and signs in 11 consecutive AIDS patients with gastrointestinal lymphoma: a multicenter, multiyear study including 763 HIV-seropositive patients

OBJECTIVES: Gastrointestinal lymphoma is a distinct subgroup of lymphoma in HIV-seronegative patients. This study analyzes whether gastrointestinal lymphoma similarly forms a distinct clinical subgroup in HIV-seropositive patients. METHODS: Case control study of medical records of 763 human immunodeficiency virus-seropositive patients admitted to three university hospitals from 1986 through 1992, including 22 with non-Hodgkin's lymphoma. Eleven patients (50%) had gastrointestinal lymphoma, and 11 controls had extraintestinal lymphoma. RESULTS: The clinical presentation in patients with gastrointestinal lymphoma was dominated by gastrointestinal symptoms and signs and gastrointestinal complications. Common symptoms and signs included: change in bowel habits, gross or occult blood per rectum, involuntary weight loss, abdominal pain, abdominal tenderness, peripheral lymphadenopathy, cachexia, and hepatosplenomegaly. Significant gastrointestinal complications during the presenting admission included gastrointestinal bleeding in five, intestinal obstruction in one, and dysphagia from an esophageal stricture in one. Subsequent complications included a walled-off perforating gastric ulcer in one and obstructive jaundice in one. In contrast, the control patients with extraintestinal lymphoma had significantly fewer gastrointestinal symptoms and gastrointestinal complications (p < 0.001 and p < 0.01, respectively, Fisher's exact test). Upper gastrointestinal series or barium enema identified lymphomatous gastrointestinal lesions in all seven patients undergoing these tests. The pathologic diagnosis was made from endoscopic biopsies in six of six patients undergoing panendoscopy, and two of three patients undergoing lower endoscopy. Tumor sites included stomach in six, colon in three, ileum in two, esophagus in two, and duodenum in one. Eight patients had extraintestinal lesions at diagnosis, including four with extraabdominal extranodal lesions. The outcome of gastrointestinal lymphoma was poor with all therapies (mean combined survival = 3.6 +/- 2.2 months), and was not significantly different from that for the controls (mean survival = 4.1 +/- 2.7 months, Student's t test). CONCLUSIONS: This study suggests that gastrointestinal lymphoma in AIDS shares the poor prognosis and aggressive features of extraintestinal lymphoma in AIDS, but has unique localizing features at presentation of predominantly gastrointestinal symptoms and signs, and frequent gastrointestinal complications.     

Efficacy of two different ProMACE-CytaBOM derived regimens in advanced aggressive non-Hodgkin's lymphoma. Final report of a multicenter trial conducted by GISL

BACKGROUND AND OBJECTIVE: To compare the efficacy of ProME(Epidoxorubicin)CE-CytaBOM (PE-C) and ProMI(Idarubicin)CE-CytaBOM (PI-C) in the treatment of adult patients with aggressive non Hodgkin's lymphoma in a multicenter randomized controlled trial performed by 18 centers of the Italian Lymphoma Study Group (GISL). DESIGN AND METHODS: One hundred and twenty-eight and 122 patients were randomly assigned to receive either 6 courses of PE-C or PI-C, respectively. Some patients achieving complete remission with induction therapy participated in another randomized study comparing no further therapy versus maintenance therapy consisting of four blocks of two drugs. RESULTS: The rate of CRs was 62% and 64% for patients treated with PE-C and PI-C, respectively (p = 0.51). The 5-year relapse-free survival was 60% for PE-C and 53% for PI-C (p = 0.29). The estimated relapse-free disease survival rates at 4 years were 75% for patients in the consolidation group and 57% for those in the observation group (p = 0.11). Patients alive in first complete remission 4 years after study entry were estimated to be 39% in the PE-C arm and 38% in the PI-C arm (p = 0.90). The 3-year and 5-year estimated survival rates were 61% and 55% for the PE-C group and 56% and 47% for the PI-C group (p = 0.26). Fatal toxicities occurred in 7 patients (2.9%) with active disease and in 4 patients (1.7%) in complete remission. Stage (p = 0.04), bulky disease (p = 0.02), serum LDH (p = 0.0006), serum albumin (p = 0.0051), hemoglobin (p = 0.0011), performance status (p = 0.0001), International prognostic index (p < 0.0001) and the index proposed by the French group G.E.L.A. (p < 0.0001) were of prognostic value. In a multivariate analysis (Cox regression model) alternatively IPI alone or G.E.L.A. index plus performance status emerged as independent prognostic factors. INTERPRETATION AND CONCLUSIONS: The present study indicates that epirubicin and idarubicin in a combined chemotherapy regimen, have similar activities. The toxic profile also indicates the safety of both anthracyclines at the dosages employed, suggesting their possible dose escalation in a combined chemotherapy setting. PE-C and PI-C were both effective and feasible regimens in an outpatient setting, with acceptable cardiovascular toxicity. The trend toward a better outcome in patients undergoing consolidation therapy after the achievement of a complete remission, warrants further investigation.     

Double blind randomised controlled trial of effect of metoprolol on myocardial ischaemia during endoscopic cholangiopancreatography

OBJECTIVE: To evaluate the effect of metoprolol, a beta adrenergic blocking drug, on the occurrence of myocardial ischaemia during endoscopic cholangiopancreatography. DESIGN: Double blind, randomised, controlled trial. SETTING: University Hospital. SUBJECTS: 38 (two groups of 19) patients scheduled for endoscopic cholangiopancreatography. INTERVENTIONS: Metoprolol 100 mg or placebo as premedication two hours before endoscopy. MAIN OUTCOME MEASURES: Heart rate, arterial oxygen saturation by continuous pulse oximetry, ST segment changes during endoscopic cholangiopancreatography (an ST segment deviation > 1 mV was defined as myocardial ischaemia), electrocardiogram monitored continuously with a Holter tape recorder. RESULTS: All patients had increased heart rate during endoscopy compared with rate before endoscopy, but heart rate during endoscopy was significantly lower in the metoprolol group compared with the placebo group (P = 0.0002). Twenty one patients (16 placebo, 5 metoprolol; P = 0.0008) developed tachycardia (heart rate > 100/min) during the procedure, and 11 patients (10 placebo, 1 metoprolol; P = 0.003) developed myocardial ischaemia. One patient in the placebo group had an acute inferolateral myocardial infarction. In the 10 other patients with signs of myocardial ischaemia during endoscopy the ST deviation disappeared when the endoscope was retracted. In all patients myocardial ischaemia was related to increases in heart rate, and 10 of the 11 patients had tachycardia coherent with myocardial ischaemia. CONCLUSIONS: Metoprolol prevented myocardial ischaemia during endoscopic cholangiopancreatography, probably through lowering the heart rate. Thus, tachycardia seems to be a key pathogenic factor in the development of myocardial ischaemia during endoscopy.