Superficial temporal artery laceration. A complication of skull tong traction.

Complications associated with the use of skull tongs are not uncommon. We report a case of superficial temporal artery injury as a complication of Gardner-Wells tong application. Chronic recurrent episodes of pulsatile bleeding from the pin site necessitated arterial ligation to control the bleeding.

Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. Effect of patient characteristics on lovastatin-induced changes in plasma concentrations of lipids and lipoproteins.

BACKGROUND: Lovastatin produces consistent dose-related reductions in plasma levels of low density lipoprotein (LDL) cholesterol along with variable decreases in triglycerides and increases in high density lipoprotein (HDL) cholesterol. Patient characteristics from the Expanded Clinical Evaluation of Lovastatin (EXCEL) study were examined to determine their association with the magnitude of lovastatin-induced changes in these lipids and lipoproteins. METHODS AND RESULTS: After a baseline period consisting of dietary therapy, 8,245 patients with moderate hypercholesterolemia were randomized to five groups that received 48 weeks of treatment with either placebo or daily doses of lovastatin ranging from 20 to 80 mg. By use of linear statistical models, 20 different patient characteristics were examined for modification of the dose-dependent responses observed. For LDL cholesterol, the following were associated with enhanced lowering (p less than 0.05; percent changes are placebo-corrected, adjusted mean changes from baseline for the 80-mg/day lovastatin group): full drug compliance (-41.9%) versus 80% compliance (-20.3%); an age of 65 (-43.4%) versus 45 years (-38.1%) for women; white race (-40.9%) versus black race (-38.0%); and 4.5-kg weight gain (-42.6%) versus 4.5-kg weight loss (-37.9%). Similar relations for enhanced triglyceride lowering were found with older age and weight gain. Patients with initially low HDL cholesterol (less than 0.91 mmol/l) and high triglycerides (greater than 2.26 mmol/l) had enhanced responses for these parameters: placebo-corrected percent changes at 80 mg/day were -27.4% for triglycerides and +12.3% for HDL cholesterol. CONCLUSIONS: Overall, patient characteristics had very little impact of clinical importance on the dose-dependent LDL cholesterol lowering found with lovastatin. In patients with initially high levels of triglycerides and low levels of HDL cholesterol, the elevation of HDL cholesterol produced by lovastatin appears to be enhanced.

Expanded clinical evaluation of lovastatin (EXCEL) study results: III. Efficacy in modifying lipoproteins and implications for managing patients with moderate hypercholesterolemia.

In the multicenter, double-blind EXCEL (Expanded Clinical Evaluation of Lovastatin) study the efficacy of lovastatin in modifying plasma lipids and lipoproteins in 8,245 participants with moderate primary hypercholesterolemia was evaluated. Patients were randomly assigned to 48 weeks of treatment with diet and placebo or diet and lovastatin 20 or 40 mg once a day, or 20 or 40 mg twice a day. At all of these dosages, lovastatin produced substantial dose-dependent reductions in low-density-lipoprotein (LDL)-cholesterol levels, averaging 24% (20 mg/day) to 40% (80 mg/day). The magnitude of the effect of this lipoprotein was further reflected by the percentage of patients who achieved National Cholesterol Education Program (NCEP) goals. In the absence of coronary artery disease (CAD) or two other CAD risk factors, the LDL-cholesterol goal of 4.14 mmol/L (160 mg/dL) was attained by 22% of patients in the placebo group and between 81% (20 mg/day) and 96% (80 mg/day) of those treated with lovastatin. For those with CAD or at least two other CAD risk factors, the LDL-cholesterol goal of 3.36 mmol/L (130 mg/dL) was attained by 4% of placebo patients and between 38% (20 mg/day) and 83% (80 mg/day) of those treated with lovastatin. Lovastatin also increased high-density-lipoprotein cholesterol (7-10%) and decreased triglycerides (10-19%) in a dose-dependent manner. Thus, when used as an adjunct to a prudent diet, lovastatin produces favorable changes in the entire lipoprotein profile and is a highly effective agent for managing patients with primary hypercholesterolemia.

Expanded clinical evaluation of lovastatin (EXCEL) study results. II. Assessment of the human lens after 48 weeks of treatment with lovastatin.

The crystalline lenses of hypercholesterolemic patients were assessed before and after 48 weeks of treatment with lovastatin or placebo to determine the effect of lovastatin on the human lens. Patients were given a biomicroscopic (slit-lamp) examination of the lens, and a previously validated, standardized classification system was used to describe the findings. A total of 8,245 patients were randomly assigned in equal numbers to treatment with placebo or lovastatin 20 or 40 mg once or twice daily in this double-blind, parallel-group study. Statistical analyses of the distribution of cortical, nuclear and subcapsular opacities at 48 weeks, adjusted for age and presence of an opacity at baseline, showed no significant differences (p less than 0.01) between the placebo and lovastatin-treated groups. Visual acuity assessments at week 48 were also not found to have significantly different distributions among treatment groups. Moreover, no significant differences were found among the groups in the frequencies of greater than or equal to 2-line worsening in visual acuity with concurrent progression in lenticular opacity, cataract extraction, or any spontaneously reported adverse ophthalmologic experience. No evidence was found for an effect of lovastatin on the human lens after 48 weeks of treatment.

Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. I. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia.

In the Expanded Clinical Evaluation of Lovastatin (EXCEL) Study, a multicenter, double-blind, diet- and placebo-controlled trial, we evaluated the efficacy and safety of lovastatin in 8245 patients with moderate hypercholesterolemia. Patients were randomly assigned to receive placebo or lovastatin at a dosage of 20 mg once daily, 40 mg once daily, 20 mg twice daily, or 40 mg twice daily for 48 weeks. Lovastatin produced sustained, dose-related (P less than .001) changes as follows (for dosages of 20 to 80 mg/d): decreased low-density lipoprotein-cholesterol level (24% to 40%), increased high-density lipoprotein-cholesterol level (6.6% to 9.5%), decreased total cholesterol level (17% to 29%), and decreased triglyceride level (10% to 19%). The National Cholesterol Education Program's low-density lipoprotein-cholesterol level goal of less than 4.14 mmol/L (160 mg/dL) was achieved by 80% to 96% of patients, while the less than 3.36 mmol/L (130 mg/dL) goal was achieved by 38% to 83% of patients. The difference between lovastatin and placebo in the incidence of clinical adverse experiences requiring discontinuation was small, ranging from 1.2% at 20 mg twice daily to 1.9% at 80 mg/d. Successive transaminase level elevations greater than three times the upper limit of normal were observed in 0.1% of patients receiving placebo and 20 mg/d of lovastatin, increasing to 0.9% in those receiving 40 mg/d and 1.5% in those receiving 80 mg/d of lovastatin (P less than .001 for trend). Myopathy, defined as muscle symptoms with a creatine kinase elevation greater than 10 times the upper limit of normal, was found in only one patient (0.1%) receiving 40 mg once daily and four patients (0.2%) receiving 80 mg/d of lovastatin. Thus, lovastatin, when added after an adequate trial of a prudent diet, is a highly effective and generally well-tolerated treatment for patients with moderate hypercholesterolemia.

Menstrual patterns and progesterone circulating levels following different procedures of tubal occlusion.

This study was undertaken to assess the effects of different tubal occlusion procedures on ovarian function. Three groups of subjects randomized to tubal occlusion by laparoscopy and Yoon ring (24 subjects), minilaparotomy and Yoon ring (19 subjects) and minilaparotomy and Pomeroy (22 subjects), and one separate control group of 26 healthy subjects not using any form of contraception were studied in a prospective design. The characteristics of the menstrual patterns were studied for one year after sterilization. Determination of the circulating progesterone levels were made on days 15, 20 and 25 of menstrual cycles initiated 1, 3, 6 and 12 months following the tubal ligation. In the analysis of the bleeding pattern there was a statistically significant difference in the mean segment length and in the longest bleeding-free interval in the subjects who had been sterilized by minilaparotomy with Yoon ring, when compared to the other two study groups and to the control group. However, the magnitude of this difference in number of days was not considered clinically significant. There was no statistically significant difference in the percentage of ovulatory cycles within the study and the control groups, or when the results of the study groups were compared with each other or to the control group.

PIP: This study was undertake to assess the effects of different tubal occlusion procedures on ovarian function. 3 groups of subjects randomized to tubal occlusion by laparoscopy and Yoon ring (24 subjects), minilaparotomy and Yoon ring (19 subjects) and minilaparotomy and Pomeroy (22 subjects), and 1 separate control group of 26 healthy subjects not using any form of contraception were studied in a prospective design. The characteristics of the menstrual patterns were studied for 1 year after sterilization. Determination of the circulating progesterone levels were made on days 15, 20, and 25 of menstrual cycles initiated 1,3,6 and 12 months following the tubal ligation. In the analysis of the bleeding pattern there was a statistically significant difference in the mean segment length and in the longest bleeding-free interval in the subjects who had been sterilized by minilaparotomy with Yoon ring, when compared to the other 2 study groups and to the control group. However, the magnitude of this difference in number of days was not considered clinically significant. There was no statistically significant difference in the % of ovulatory cycles within the study and the control groups, or when the results of the study groups were compared with each other or to the control group. (Author's).

Regulation of intestinal blood flow with increased intraluminal pressure.

To better characterize the mechanisms which regulate intestinal blood flow (IBF), we studied the effects of gradual and rapid increases in intraluminal pressure (LP) in anesthetized canines. Polarographic measurements of hydrogen washout allowed repeated assessment of IBF (ml/min X g) in control (CL) and distended (DL) autoperfused small intestinal loops. In group I (n = 7) graded increases in LP (mm Hg) were produced by saline inflation. In group II (n = 4), IBF was measured before and after intraarterial aminophylline (adenosine blockade); LP was then rapidly raised to 24 mm Hg. IBF was unchanged by time (CL 0.64 +/- 0.24) or gradual distension (DL 0.65 +/- 0.28 at mean maximal LP = 26). Aminophylline did not change IBF at LP = 0. Rapid distension after adenosine blockade was accompanied by immediate increases in IBF (0.96 +/- 0.41, P less than 0.05) and decreased resistance (50 +/- 25% control). IBF is maintained despite gradual increases in luminal pressure. Blockade of adenosine, an intestinal vasodilator, does not inhibit this response; hyperemia associated with rapid distension is not impaired. We conclude that autoregulation of IBF during distension is not accomplished by an adenosine mediated metabolic mechanism.

Ovarian activity in the mare between latitude 15 degrees and 22 degrees N.

Ovarian activity, as measured by the presence of small (10-15 mm diam.), medium (15-30 mm) and large (greater than 30 mm) follicles, corpora haemorrhagica and corpora lutea (CL), was determined in a total of 3584 ovaries during 1 year using post-mortem specimens. There were significant correlations of the incidence of ovulated follicles (ovulations), large and medium follicles (P less than 0 . 001) and of the mean number of small follicles (P less than 0 . 05) per mare with respect to season. The yearly averages of ovulated, large and medium follicles were 30 . 1, 13 . 9 and 73 . 9%, respectively, and the mean number of small follicles per mare was 2 . 0. The mean incidence of inactive ovaries throughout the year was 21 . 2%. The adjusted sinusoidal curves remained above their own yearly average from April to October (ovulations), March to September (large follicles), February to September (medium follicles) and January to July (small follicles), and below its yearly average from March to September (inactive ovaries). The mean incidence of multiple ovulations was 11 . 9%. No significant differences were found between the activities of the right and left ovaries. It was concluded that the mare shows a seasonal reproductive pattern near the equator in the northern tropical zone.

Racial differences in normal values of proptosis.

Measurement of proptosis was made with a Luedde exophthalmometer by one experimenter in 402 black and 325 white adults without endocrine disease or obvious orbital pathologic conditions. Black subjects had significantly higher values of proptosis than white subjects. It is suggested that the following "upper limits of normal" be used when clinically estimating proptosis: 19 and 21 mm for white female and male patients, respectively; and 23 and 24 mm for black female and male patients, respectively.