The New England journal of medicine
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Randomized Controlled Trial Clinical Trial
The effects of treatment with recombinant human growth hormone on body composition and metabolism in adults with growth hormone deficiency.
In a double-blind, placebo-controlled trial, we studied the effects of six months of growth hormone replacement in 24 adults with growth hormone deficiency. Most of the patients had acquired growth hormone deficiency during adulthood as a consequence of treatment for pituitary tumors, and all were receiving appropriate thyroid, adrenal, and gonadal hormone replacement. The daily dose of recombinant human growth hormone (rhGH) was 0.07 U per kilogram of body weight, given subcutaneously at bedtime. ⋯ The basal metabolic rate, measured at base line and after one and six months of rhGH administration, increased significantly; the respective values were 32.4 +/- 1.4, 37.2 +/- 2.2, and 34.4 +/- 1.6 kcal per kilogram of lean body mass per day (P less than 0.001 for both comparisons). Fasting plasma cholesterol levels were lower (P less than 0.05) in the rhGH-treated group than in the placebo group, whereas plasma triglyceride values were similar in the two groups throughout the study. We conclude that growth hormone has a role in the regulation of body composition in adults, probably through its anabolic and lipolytic actions.
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Infants with birth weights under 750 g are disproportionately represented in perinatal mortality and morbidity rates. We reviewed the outcomes of 98 infants delivered at our perinatal center between July 1982 and June 1985 (period 1) whose lengths of gestation were 20 or more weeks and whose birth weights were under 750 g, and compared them with the outcomes of 129 such infants born between July 1985 and June 1988 (period 2). The frequency of cesarean section increased from 12 to 19 percent between the two periods. ⋯ When all live-born infants of less than 28 weeks' gestation were considered, only 8 percent of those born at 23 weeks survived, as compared with 16 percent of those born at 24 weeks, and 53, 63, and 72 percent of those born at 25, 26, 27 weeks, respectively. Thus, despite a tendency to perform more cesarean sections and active resuscitations, no improvement in the survival of babies with lengths of gestation below 25 weeks or birth weights under 750 g was observed. The probability of survival is very poor if the length of gestation is less than 24 weeks or the birth weight less than 600 g.
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Randomized Controlled Trial Clinical Trial
A trial of desmopressin (1-desamino-8-D-arginine vasopressin) to reduce blood loss in uncomplicated cardiac surgery.
Previous studies have suggested that desmopressin may reduce the bleeding diathesis that often complicates open-heart surgery. To pursue this question further, we performed a double-blind, randomized, placebo-controlled trial to determine whether the previously reported beneficial effect of desmopressin on hemostasis during complex cardiac surgery was applicable to all elective cardiac surgical procedures involving cardiopulmonary bypass. In 150 consecutive patients, most of whom underwent primary coronary-artery bypass grafting, we compared the effects of intravenous desmopressin (0.3 microgram per kilogram of body weight) with those of saline placebo on postoperative blood loss and the need to replace blood products. ⋯ Similarly, the levels of von Willebrand factor multimers increased uniformly in both groups. These findings may be consistent with a normal stress response of von Willebrand factor to major surgery and could explain our failure to detect a therapeutic effect of desmopressin. We conclude that the majority of patients who undergo elective cardiac surgery receive no hemostatic benefit from the use of desmopressin.
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Guidelines for medical practice can contribute to improved care only if they succeed in moving actual practice closer to the behaviors the guidelines recommend. To assess the effect of such guidelines, we surveyed hospitals and obstetricians in Ontario before and after the release of a widely distributed and nationally endorsed consensus statement recommending decreases in the use of cesarean sections. These surveys, along with discharge data from hospitals reflecting actual practice, revealed that most obstetricians (87 to 94 percent) were aware of the guidelines and that most (82.5 to 85 percent) agreed with them. ⋯ Furthermore, data on actual practice after the publication of the guidelines showed that the rates of cesarean section were 15 to 49 percent higher than the rates reported by obstetricians, and they showed only a slight change from the previous upward trend. We conclude that guidelines for practice may predispose physicians to consider changing their behavior, but that unless there are other incentives or the removal of disincentives, guidelines may be unlikely to effect rapid change in actual practice. We believe that incentives should operate at the local level, although they may include system-wide economic changes.
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Patients who undergo peripheral vascular surgery are at increased risk for postoperative cardiac events and are difficult to assess preoperatively because of limitations on their activity. We prospectively studied 176 consecutive eligible patients undergoing elective vascular surgery to determine the value in predicting a postoperative cardiac event of preoperative electrocardiographic monitoring to detect myocardial ischemia. Of the 176 patients, 32 (18 percent) had 75 episodes of monitored ischemic ST-segment depression preoperatively (of which 73 were asymptomatic), and 13 (7 percent) met strict criteria for major postoperative cardiac events, including 1 with a fatal myocardial infarction, 3 with nonfatal infarctions, 4 with unstable angina, and 5 with ischemic pulmonary edema. ⋯ In multivariate analyses, preoperative ischemia was the most significant correlate of postoperative cardiac events and remained a statistically significant independent correlate even after we had controlled for all other preoperative factors (multivariate relative risk, 24.4; 95 percent confidence interval, 6.8 to 88). These preliminary data suggest that preoperative electrocardiographic monitoring to detect episodes of myocardial ischemia is a useful method for assessing cardiac risk in patients who undergo elective vascular surgery. In particular, the absence of ischemia during monitoring indicates a very low risk.