A placebo-controlled comparison of the effects on sexual functioning of bupropion sustained release and fluoxetine.

BACKGROUND: Many antidepressants are associated with sexual dysfunction, a side effect that may lead to patients' dissatisfaction and noncompliance with treatment. OBJECTIVE: This study compared the efficacy, tolerability, and effects on sexual functioning of bupropion sustained release (bupropion SR) and the selective serotonin reuptake inhibitor fluoxetine. METHODS: In this multicenter, randomized, double-blind, double-dummy, parallel-group study, patients with recurrent major depression were treated with bupropion SR 150 to 400 mg/d, fluoxetine 20 to 60 mg/d, or placebo for up to 8 weeks. Depression and sexual-functioning status were assessed by site-specific trained investigators at weekly clinic visits; tolerability was assessed primarily by monitoring adverse events. RESULTS: Four hundred fifty-six patients participated in the study, 150 receiving bupropion SR, 154 fluoxetine, and 152 placebo. The majority of patients in each group completed the study (63% each, bupropion SR [n = 94] and fluoxetine [n = 97]; 67%, placebo [n = 102]). Bupropion SR and fluoxetine were similarly effective in the treatment of depressive symptoms. Beginning at week 2 and continuing throughout the study, significantly more fluoxetine-treated patients experienced orgasm dysfunction than did patients receiving bupropion SR or placebo (P < 0.001); similar results were seen in patients defined as clinical responders (> or =50% decrease from baseline in 21-item Hamilton Rating Scale for Depression [HAM-D] total score) (P < 0.001) and in those experiencing remission of depression (HAM-D total score <8) (P < 0.05). At various time points, worsened sexual functioning, sexual desire disorder, sexual arousal disorder, and dissatisfaction with sexual functioning in those satistied at baseline were more frequently associated with fluoxetine treatment than with bupropion SR or placebo. Both active treatments were well tolerated. CONCLUSIONS: Bupropion SR and fluoxetine were similarly effective and well tolerated in the treatment of depression. Fluoxetine, however, was more frequently associated with sexual dysfunction compared with bupropion SR. Bupropion SR may be an appropriate initial choice for the treatment of depression in patients concerned about sexual functioning.

Sexual dysfunction associated with the treatment of depression: a placebo-controlled comparison of bupropion sustained release and sertraline treatment.

This study compared the sexual functioning effects as well as the safety and efficacy of bupropion sustained release (bupropion SR) and sertraline. Three hundred sixty-four patients with normal sexual functioning and recurrent major depression were treated with bupropion SR (150-400 mg/day), sertraline (50-200 mg/day), or placebo for 8 weeks in this randomized, double-blind, multicenter study. Patients' depression, sexual functioning, and overall safety were assessed at regular clinic visits. Significantly (P < 0.05) more patients treated with sertraline experienced orgasm dysfunction compared with patients treated with bupropion SR or placebo. Bupropion SR, but not sertraline, was statistically significantly superior to placebo in improving scores on all depression scales by the end of the study. Headache occurred with similar frequency in all groups. Gastrointestinal disturbances occurred more frequently with sertraline; insomnia and agitation occurred more frequently with bupropion SR. Small decreases in mean weight were seen with both active treatments; the placebo group experienced a minor increase in mean weight. Both bupropion SR and sertraline were generally well tolerated, although sertraline was more often associated with sexual dysfunction. Bupropion SR, but not sertraline, was statistically superior to placebo in relieving depression by the end of the study. Bupropion SR may offer advantages over sertraline in treating depressed patients concerned with sexual functioning.

Classroom peer acceptance, friendship, and victimization: distinct relational systems that contribute uniquely to children's school adjustment?

The proposition that relationships make differential (i.e., unique, redundant, contingent) contributions to adjustment was examined by investigating the linkages between children's participation in different types of peer relationships (i.e., friendship, peer acceptance, peer victimization) and their adjustment to school. Relationship measures were gathered for 5- to 6-year-old children (105 males, 95 females) twice during kindergarten (i.e., fall and spring) and were correlated with adjustment indicators at each time of assessment and used to predict changes in school adjustment over time. Examination of the relative associations between the relationship measures and children's adjustment revealed evidence of both unshared (i.e., unique) and shared (i.e., redundant) linkages, depending on the form of adjustment examined. These findings suggest that adjustment may be influenced by the diverse experiences (i.e., provisions) that children encounter in different forms of relationship, and that certain types of relationships may have greater or lesser adaptive significance depending on the adjustment outcome examined.

Experimental evaluation of a new self-expanding patent ductus arteriosus occluder in a canine model.

PURPOSE: A new self-expanding patent ductus arteriosus (PDA) occluder was designed. MATERIALS AND METHODS: Percutaneous closure of surgically created aortopulmonary shunts was attempted in 19 dogs. The occlusion device consisted of a nitinol wire frame tightly woven into a cylinder with a flat retention disc. A polyester-filled frame was used in the last six procedures. A 6-F introducing sheath was advanced across the aortopulmonary conduit into the descending thoracic aorta. The prosthesis (attached on a stiff delivery cable) was advanced through the introducing sheath. The retention disc was first released in the descending thoracic aorta, then the cylindrical device frame was expanded within the conduit by withdrawing the sheath. RESULTS: Subtotal misplacement into the descending aorta occurred in one procedure (overall technical success rate, 95%), and one animal died before the 1-week follow-up. Complete angiographic shunt closure was achieved in seven of 18 (39%) animals at 30 minutes, 12 of 17 (71%) animals at 1 week, 14 of 17 (82%) animals at 1 month, and 11 of 12 (92%) animals at 3 months. Significantly higher 30-minute closure rates occurred with polyester-filled occluders compared with nonfilled occluders (five of five [100%] vs one of 13 [15%]; P = .002). Persistent shunt at 3 months occurred in only one nonfilled device (6%). In the remaining 16 animals, both orifices of the shunt were covered by a smooth glistening neoendothelium at postmortem examination. CONCLUSION: This device combines the advantages of small delivery system, easy placement, self-centering, and repositionability. Immediate shunt closure can be reliably accomplished with the polyester-filled prosthesis.

Friendship quality as a predictor of young children's early school adjustment.

The purpose of this study was to develop a method for assessing young children's perceptions of classroom friendships and to determine whether these perceptions were associated with their adjustment during the transition to grade school. Subscales tapping 5 friendship processes (e.g., validation, aid, disclosure of negative affect, exclusivity, conflict) were extracted from a 24-item friendship interview that was individually administered to 82 kindergarten children (M age = 5.61) who possessed a reciprocated and stable "best" friend in their classroom. Children's reports of the investigated friendship processes were found to be reliable, and processes such as perceived validation and conflict predicted children's satisfaction with their friendships, and the stability of these relationships. Perceived conflict in friendships was associated with multiple forms of school maladjustment for boys, including higher levels of school loneliness and avoidance and lower levels of school liking and engagement. For both boys and girls, validation and aid forecasted gains in perceived support from classmates, and aid also predicted improvements in children's school attitudes. Perceived exclusivity in friendships was associated with lower levels of achievement. These findings, and others reported in this article, are consistent with the hypothesis that the relational features of children's classroom friendships yield psychological benefits or costs (e.g., provisions) that, in turn, affect their development and adjustment.

Tracheal vascular response to hypertonic and hypotonic solutions.

One of the major roles of the upper respiratory mucosa is to humidify inspired air. This function requires the coordinated activity of respiratory epithelium and mucosal vasculature. It has been difficult to study this relationship in vivo. In the present study, we investigated the effects of osmolarity on the vessel diameter of mucosal vessels via a specially constructed chamber that allows direct visualization of the rat trachea microvasculature. With use of an anesthetized and instrumented rat preparation, the luminal surface of the dorsal wall of the trachea was superfused with physiological solutions at 37 degrees C. The osmolarities were varied by removing or adding NaCl or mannitol (200, 290, and 500 mosM). The mucosal vessels dilated when the airway surface was superfused with hypertonic solutions and constricted when superfused with hypotonic solution. The largest changes occurred in the arterioles (51 +/- 5.6 microns diam), which constricted by 10 +/- 2.18 microns (P = 0.0001) when exposed to a 200 mosM solution and dilated by 11 +/- 1.55 microns (P = 0.0001) when exposed to a 500 mosM NaCl-enriched solution. Smaller changes of similar pattern were seen in venules. The changes in vessel diameter were readily reversible upon replacement of the hypo- or hypertonic solutions by an isotonic solution. We conclude that increase or decrease of solution osmolarity on the epithelial surface of the trachea can regulate diameter of mucosal blood vessels.

Captopril-stimulated renal vein renin measurements in the diagnosis of atherosclerotic renovascular hypertension.

The diagnostic utility of post-captopril renal vein renin (RVR) measurements was quantitated in 43 patients (mean age 62, range 41 to 77 years) undergoing aortography to rule out renovascular hypertension (RVHT), and then compared with that of pre-captopril RVR measurements. Four patterns of post-captopril RVR secretion were defined: 1) unilateral hypersecretion (stenotic/peripheral [S/P] > 2.0) and contralateral suppression (C/P) (< 1.25) (n = 12); 2) bilateral hypersecretion (S/P > 2.0, C/P > 1.25) (n = 14); 3) bilateral suppression (peripheral plasma renin activity [PRA] < 1.0 ng/mL/h) (n = 12); and 4) "normal" (RVR/PRA < 2.0 bilaterally) (n = 5). Using the radiologic findings as the definitive test, the sensitivity and specificity of post-captopril RVR measurements in detecting unilateral or bilateral renal artery stenoses (85% or greater of lumen) was 61 and 96%, and 92 and 90%, respectively, a significant improvement compared with those of pre-captopril RVR measurements (44 and 62%, and 17 and 93%, respectively). Post-captopril RVR measurements facilitated the diagnosis of both hypersecretion and, when present, contralateral suppression of renin, and therefore, are useful in the diagnosis of atherosclerotic RVHT, and in planning its treatment. However, confirmation by more extensive prospective studies, including treatment outcome, is needed.

Hemolytic effect of the Amplatz thrombectomy device.

PURPOSE: The hemolytic effect of the Amplatz thrombectomy device (ATD) was evaluated in nine dogs and in nine patients. MATERIALS AND METHODS: The device was activated for 1-2 minutes in the abdominal aorta, inferior vena cava, or femoral artery of nine dogs. The device was activated for 1-4 minutes in the nine patients in occluded lower extremity bypass grafts (n = 5), native superficial femoral artery (n = 1), a pulmonary artery embolus (n = 1), a portocaval shunt (n = 1), and an iliac vein stent (n = 1). Patients were examined for laboratory evidence of hemolysis following mechanical thrombectomy. RESULTS: In all dogs haptoglobin level decreased, free hemoglobin level in the plasma increased, and hemoglobinuria was present. There was no change in renal function. The level of haptoglobin decreased and the level of plasma free hemoglobin increased in eight patients, with hemoglobinuria detected in one. More hemolysis was observed in the animals than in the patients. CONCLUSION: The ATD has a definite transient hemolytic effect. Until further studied, it should not be used in children and should be used with caution in patients who are anemic, hypoxemic, or have potentially reversible renal insufficiency. Activation time should be monitored closely because hemolysis probably increases with increasing activation time.

Mechanical thrombectomy: results of early experience.

PURPOSE: To evaluate the clinical application of a mechanical thrombectomy device in occluded lower extremity arteries and bypass grafts. MATERIALS AND METHODS: A mechanical thrombectomy device was used in five patients with acutely occluded lower extremity bypass grafts (n = 2) or superficial femoral arteries (n = 3). RESULTS: The thrombus was completely removed in three cases (two bypass grafts and one native superficial femoral artery). In two of the patients with occlusions in the native superficial femoral artery, the thrombus was partially removed. In these two patients, the aspirate demonstrated a more fibrous thrombus that was not easily fragmented. In one of these two patients, the coagulum was thought to be embolic from the heart. CONCLUSION: The thrombectomy device works well in recent thromboses, particularly in polytetrafluoroethylene grafts in which organization does not occur. Its efficacy in chronically occluded vessels is not certain.

Control of the mucosal microcirculation in the upper respiratory tract.

This study was designed to investigate the regulatory mechanisms of the mucosal microvascular network in the upper respiratory tract. Tracheal mucosal circulation was observed using a specially constructed chamber that allowed direct microscopic visualization of mucosal arterioles. Solutions of increasing hypertonicity (500 and 900 mOsm) applied to the tracheal epithelium resulted in increasing dilation of the underlying mucosal arterioles (p < 0.001). N(omega)-nitro-L-arginine methyl ester (L-NAME, 1 mmol/L), a specific inhibitor of nitric oxide synthesis, added to a hypertonic solution inhibited dilation of mucosal arterioles (p < 0.001). Addition of the substrate for nitric oxide synthesis, L-arginine (0.6 mmol/L) to the hypertonic solution containing L-NAME resulted in dilation of mucosal arterioles once again. These data demonstrate that nitric oxide is a crucial mediator in the response of mucosal arterioles to the hypertonic stimulus presented to the epithelial surface of the trachea. Further elucidation of the control of the mucosal microcirculation in the upper respiratory tract could be implemented in new treatment for pathologic processes of the upper respiratory tract such as mucosal congestion and edema.

Thermal ablation of the gallbladder.

Gallbladder ablation by means of injection of hot contrast medium was attempted in 13 dogs. Room temperature contrast medium was injected into the gallbladders of two additional dogs (controls). After midline laparotomy was performed to expose the gallbladder, temperature probes were placed in the liver adjacent to the gallbladder, and on the surface and in the lumen of the gallbladder. A 7-F catheter with multiple side holes was placed into the gallbladder. The cystic duct was clamped during the procedure. After injection of boiling contrast medium, the mean temperature in the gallbladder lumen was 80 degrees C; in the adjacent liver, 43.5 degrees C; and on the gallbladder surface, 45.8 degrees C. After the procedure, the cystic duct was unclamped, temperature probes and catheter were removed, and the laparotomy was closed in standard fashion. In the hot contrast medium group, one dog each was sacrificed at 2, 4, 8, and 12 weeks, and at 6 months. Six animals were sacrificed at 1 year. The gallbladder was completely ablated in 11 of 13 animals in the hot contrast medium group. One dog was sacrificed at 8 days because of bile leakage, and another was sacrificed at 17 days because of gallbladder rupture. The two control animals were sacrificed at 12 and 13 weeks, and their gallbladders were normal at that time.

Percutaneous enterostomy with the Cope suture anchor.

Eighty-two percutaneous enterostomies were performed at three institutions with the Cope suture anchor for stomach or jejunal wall stabilization during alimentation tube placement. The anchors were successfully placed into the stomach or jejunum in 81 cases. Early in the series, two anchors were misplaced, with no sequelae. There were no other complications at the time of placement. In all successful cases, excellent immobilization of the viscus was achieved. Tract dilation and tube placement were easily performed, and there were no guidewire or tube dislodgments.

Double-lumen needle for percutaneous ureteral pressure-flow studies.

Ureteral perfusion studies in patients without preexisting renal access currently must be intermittently interrupted for intrarenal pressure measurement. A double-lumen needle has been successfully placed in four patients (two with native and two with transplanted kidneys). This permits simultaneous perfusion and intrarenal pressure monitoring yet maintains the safety and ease of use of a single skinny needle.

Experience with the Amplatz retrievable vena cava filter.

The Amplatz retrievable inferior vena cava filter was designed to be used as either a permanent indwelling filter or a short-term, percutaneously removable filter. The authors placed 52 filters in 52 patients. No deaths occurred as a result of filter placement or usage. Follow-up in 42 (81%) patients included inferior vena cavography (n = 31), computed tomography (n = 4), duplex ultrasound (n = 4), and autopsy (n = 3). Inferior vena cava thrombosis was found in seven (17.5%) of the 40 previously nonobstructed venae cavae studied. Two patients with caval thrombosis required a second filter to prevent embolization of thrombus that had extended to the lung side of the first filter. No clinically evident pulmonary emboli after filter placement have been noted. Six filters were successfully retrieved or repositioned percutaneously. The relatively high rate of caval thrombosis with extension above the filter may be due to a higher trapping efficiency or to filter geometry. The role of this filter in the treatment of deep venous thrombosis and pulmonary emboli is unclear.

Atheroablation with the Kensey catheter: a pathologic study.

The mode of action of the Kensey catheter, a new atheroablation device, was investigated. Fresh above-the-knee amputated legs were used for recanalization of the superficial femoral artery. The variables used were identical to those of clinical trials, including a rotational speed of 50,000 rpm and an injection rate of 40 mL/min. The debris produced by the catheter was studied cytologically, and the arterial segments were examined histologically. The particle size in the debris ranged from 1 to 2,000 microns. The softer plaques produced a fine fibrin dust background with long strips of intima ranging from 10 to 2,000 microns. Complicated calcified plaques produced larger background material (10-120 microns) but smaller strips of intima (50-800 microns). Dissections and perforations occurred. Some of the debris produced by the atheroablation process was used to embolize a canine heart and kidney. Small focal infarctions were found in the heart, and large and multiple infarcts were seen in the kidney. In clinical studies the debris appears to be tolerated in the lower extremities. Its safety in the kidney and heart are questioned.

Electrolysis for recanalization of urinary collecting system obstructions: a percutaneous approach.

Nine recent endourologic cases are presented that evidence percutaneous electrolysis and electrocautery as new and safe techniques for incising the urothelium. Electrolysis with balloon dilation was employed to remove stones sequestered behind infundibular and/or diverticular neck stenoses, to correct uretero-pelvic junction (UPJ) stenoses and strictures, and to recanalize a totally obstructed fibrotic UPJ.

Percutaneous removal of caliceal and other "inaccessible" stones: instruments and techniques.

Percutaneous removal of renal stones is becoming an established procedure, especially for stones lying free in the renal pelvis. However, some renal stones, particularly caliceal stones, are less accessible and require special techniques for removal. We discuss these techniques, which include 1) retrograde pyelography to facilitate a thorough understanding of caliceal anatomy and stone position in 3 dimensions, 2) approaches for accurate placement of a nephrostomy tract for straight-line access to the stone(s), 3) judicious use of percutaneous punctures above the 12th rib and secondary percutaneous tracts, and 4) skilled choice and use of a large variety of cutting, extracting and disintegrating instruments with endoscopic and/or fluoroscopic control. The flexible nephroscope is valuable especially to reach inaccessible areas, although its skilled use requires experience. Flexible endoscopy often is aided by pressure irrigation, an assistant and simultaneous fluoroscopic control.

Percutaneous removal of caliceal and other "inaccessible" stones: results.

Percutaneous removal of renal stones (percutaneous nephrolithotomy) is becoming an established procedure, especially for stones lying free in the renal pelvis. However, some renal stones, particularly caliceal stones, are less accessible and, therefore, more difficult by the percutaneous route. We removed percutaneously 95 caliceal or otherwise poorly accessible renal stones from 53 patients with a variety of techniques, including percutaneous puncture above the 12th rib, double or Y percutaneous nephrostomy tracts, rigid and flexible endoscopy, and intrarenal cutting with diathermy. Intravenously assisted local anesthesia was used exclusively in 89 per cent of the patients. Status free of stones was achieved in all but 1 patient who retained 2 small fragments. The average number of sessions was 1.89 and the average hospital stay was 7.9 days. Complications were minor except for 1 patient who required tertiary renal artery embolization for bleeding. Illustrative cases are presented. Virtually all renal stones can be removed percutaneously.

Failing arteriovenous dialysis fistulas: evaluation and treatment.

A total of 31 patients with 45 episodes of failing arteriovenous dialysis fistulas was studied. Fistula failure was usually due to venous and/or anastomotic stenosis, often in conjunction with thrombosis. Abnormalities were treated by percutaneous dilation and occasionally streptokinase infusion. Most complications and failures occurred either in patients with recently created fistulas or in those with multiple or long segment stenosis associated with thrombosis. Patients with a single nonobstructing stenosis were very successfully treated with percutaneous techniques, which are the treatment of choice for this condition.