To investigate the value of anorexiant medications as an adjunct to other forms of weight control therapy, we studied 121 people in a 34-week, double-blind clinical trial of 60 mg extended-release fenfluramine plus 15 mg phentermine resin versus placebo added to behavior modification, caloric restriction, and exercise. Participants weighed 130% to 180% (154% +/- 1.2%, mean +/- SEM) of ideal body weight (1983 Metropolitan Life tables) and were in good health. By week 34, participants receiving active medication lost an average of 14.2 +/- 0.9 kg, or 15.9% +/- 0.9% of initial weight (n = 58), versus a loss of 4.6 +/- 0.8 kg or 4.9% +/- 0.9% of initial weight by subjects taking placebo (n = 54; p less than 0.001). On visual analog scales, participants rated fenfluramine plus phentermine as more helpful than placebo (50.3 +/- 0.5 versus 20.3 +/- 0.3) and not bothersome (fenfluramine plus phentermine, 17.4 +/- 0.3 versus 13.5 +/- 0.2). Blood pressure decreased and pulse remained unchanged in both groups. Dry mouth was the most common adverse effect in subjects receiving fenfluramine plus phentermine; all adverse effects decreased after 4 weeks. Only nine participants left the study in the first 34 weeks. Two subjects from each group left the study as a result of adverse effects. Overall, fenfluramine plus phentermine used in conjunction with behavior modification, caloric restriction, and exercise aided weight loss and continued to be efficacious for 34 weeks.
Background:The Truview EVO2(C) laryngoscope (TL) is a recently introduced optical device designed to provide an unmagnified anterior image of the glottic opening and allow indirect laryngoscopy.Aim:This study is designed to determine whether the TL is a better alternative to the Macintosh laryngoscope (ML) for routine endotracheal intubations in patients with usual airway characteristics.Methods:We compared the Truview EVO2(C) and MLs in 140 elective surgical patients requiring general anaesthesia and intubation in a prospective crossover fashion. The two blades were compared in terms of Cormack and Lehane grades, time required for intubation, anaesthetists’ assessment of ease of intubation, intubation difficulty score, attempts at intubation, success rate, soft tissue damage and arterial oxygen saturation during laryngoscopy. The Student t test and Chi-square test were used to determine the statistical significance of parametric data and categorical data, respectively.Results:The Truview EVO2(C) blade provided a better laryngoscopic view than the Macintosh blade as suggested by improved Cormack and Lehane grades (in 48 patients), but required a longer time for intubation than the Macintosh blade (34.1 vs. 22.4 s), i.e., an improved view at the cost of longer mean intubation time. In spite of lower intubation difficulty scores, Truview EVO2(C) was considered as difficult to use on subjective assessment by the anaesthesiologist when compared with Macintosh. There was no difference observed between the two groups in attempts at intubation, success rate, soft tissue damage and arterial oxygen saturation during laryngoscopy.Conclusion:We opine that although Truview provides a better laryngoscopic view than Macintosh in difficult cases, it does not have an extra benefit over Macintosh otherwise, further indicating the need for more experience with the use of a Truview laryngoscope.
Between weeks 34 and 104, we explored different schema for administering fenfluramine plus phentermine in open-label fashion. At week 34, the original placebo group participants began taking fenfluramine plus phentermine (placebo-to-active group). Those receiving fenfluramine plus phentermine between weeks 6 and 34 either continued to receive medication or began targeted intermittent therapy. Participants who did not lose 10% of initial weight received an augmented dose (60 mg fenfluramine plus 30 mg phentermine. The placebo-to-active group lost an additional 9.1 +/- 0.8 kg (mean +/- SEM) in the period from week 34 to week 60. At week 60, they were assigned to either continue medication, intermittent therapy, or augmented therapy. More than 68% (83) of the original participants completed up to study week 104. At that point, overall weight loss was 10.8 +/- 0.7 kg (11.6 +/- 0.8% of initial weight); participants who continued to receive fenfluramine plus phentermine lost 11.6 +/- 0.8 kg, participants receiving intermittent therapy lost 11.6 +/- 1.3 kg, and participants receiving augmented therapy lost 6.5 +/- 1.5 kg. Although 41% of the participants complained of dry mouth, neither serious adverse effects nor evidence of medication abuse appeared. There were 29 dropouts in the period from weeks 34 to 104. Sixteen of those were related to medication (adverse effects, lack of efficacy, and fear of medication). Overall, fenfluramine plus phentermine used in conjunction with behavior modification, caloric restriction, and exercise continued to be efficacious for up to 2 years.
To clarify further the suggested influence of menstrual cycle phase on platelet alpha 2-adrenoceptors, we carried out cross-sectional studies in 77 subjects in a clinical trial of weight control strategies. Blood samples were drawn at baseline and after 6 weeks of diet, behavior modification, and exercise, a program that resulted in a mean weight loss of 4.5 kg. For the analyses, 42 premenopausal women were divided into four groups according to the week of menstrual cycle at the time of blood sampling. At baseline, there was no significant difference in mean platelet alpha 2-adrenoceptor numbers among the four groups. At week 6 accompanying the weight loss, there was a significant increase in the platelet alpha 2-adrenoceptor number for all groups. Despite the fact that the women were at a different phase of the menstrual cycle than at baseline, there was again no significant difference in mean platelet alpha 2-adrenoceptor number. Mean baseline platelet alpha 2-adrenoceptor number in the premenopausal women (113.7 +/- 5.5 fmol/mg protein) did not differ from values in 12 postmenopausal women (113.7 +/- 12.0 fmol/mg protein), four women with hysterectomies (105.9 +/- 8.9 fmol/mg protein), or 19 men (101.8 +/- 6.2 fmol/mg protein). Numbers at 6 weeks also did not differ. We conclude that the menstrual cycle has minimal effects on platelet alpha 2-adrenoceptor number and should not confound clinical studies of platelet alpha 2-adrenoceptors.
Despite antiseptic precautions, postoperative infectious morbidity remains a possible complication in most surgical procedures. This persistent risk of infection remains the main impetus for antibiotic prophylaxis. It has been reported that one third of hospital antibiotic use is for perioperative prophylactic indication^.^^ l6 The Joint Commission on Hospital Accreditation and infectious disease experts have urged monitoring of perioperative prophylactic antibiotics to detect inappropriate use.Although some early studies1, 33 l1 failed to demonstrate the efficacy of antibiotic prophylaxis in surgery, a large number of recent, well-controlled studies4, 8* 93 l2 have shown perioperative prophylaxis to be valuable. The failure of earlier studies in this regard has been attributed to lack of controls and inappropriate doses, dosing intervals, and timing of prophyla xi^.^, Studies with positive results suggest that prophylactic antibiotics should be administered before or during the procedures when contamination may occur rather than after surgery, and in therapeutic doses on a rational schedule rather than the low and irregular doses used in early studies.
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