El uso de adhesivo tisular de albúmina-glutaraldehído sérico bovino (BioGlue (R)) para el cierre del lecho tumoral después de una nefrectomía parcial abierta / The use of bovine serum albumin-glutaraldehyde tissue adhesive (BioGlue (R)) for tumor bed closure following open partial nephrectomy

Objetivos: Informar sobre los resultados del uso del adhesivo tisular de albúmina-glutaraldehído sérico bovino (BioGlue(R)) para el cierre del lecho tumoral en cirugía abierta de preservación de nefronas (CCN). Materiales y métodos: La cohorte incluyó a 255 pacientes con masa renal que se sometieron a CCN abierta. Se utilizó abordaje mediante lumbotomía, con hipotermia in situ y enucleación del tumor. Para el cierre del lecho tumoral utilizamos el sellante BioGlue(R) para el relleno del lecho tumoral, sin suturar los bordes. Resultados: La media de edad de los pacientes fue de 65,4 años. El 5,1% de los pacientes tenía insuficiencia renal crónica preoperatoria. El diámetro medio de la masa renal fue de 4,2 ± 1,6cm y la puntuación media de nefrometría R.E.N.A.L fue 8,0 ± 1,6. El tiempo medio de isquemia fue 21,8±7,6. La pérdida de sangre media estimada fue de 42 ± 82ml, y solo 2 pacientes requirieron transfusión de sangre. Se registraron pérdida de orina y pseudoaneurisma en 2 pacientes y en uno, respectivamente. Ninguna de las operaciones se convirtió a nefrectomía radical. El cambio medio entre la eGFR postoperatoria y preoperatoria (Δ = -1,7 ml/min) fue insignificante en un seguimiento medio de 30,1 ± 29,6 meses. La tasa de supervivencia libre de recurrencia a 10 años fue del 99%, y la tasa de supervivencia global a 10 años fue del 85%. Conclusiones: El uso de BioGlue(R) para hemostasia después de CCN es una alternativa factible y segura a la sutura clásica. Su uso permite un resultado funcional satisfactorio y podría reducir potencialmente el tiempo de isquemia

Objectives: To report the results of the use of Bovine Serum Albumin-Glutaraldehyde tissue adhesive (BioGlue(R)) for tumor bed closure in open nephron-sparing surgery (NSS). Materials and methods: The cohort included 255 patients with enhancing renal mass who underwent open NSS. We used open flank approach, with in-situ hypothermia and enucleation of the tumor. For tumor bed closure, we used the BioGlue(R) sealant for tumor bed filling, without suturing the edges. Results: Mean patients' age was 65.4 years. 5.1% of patients had pre-operative chronic renal failure. Mean renal mass diameter was 4.2 ± 1.6cm and mean R.E.N.A.L nephrometry score was 8.0 ± 1.6. Mean ischemia time was 21.8 ± 7.6. Mean estimated blood loss was 42 ± 82ml and only two patients required blood transfusion. Urine leak and pseudo-aneurysm were recorded in two and one patient, respectively. None of the operations were converted to radical nephrectomy. The average change between post-operative and pre-operative eGFR (Δ = -1.7ml/min) was insignificant in a mean follow-up of 30.1 ± 29.6 months. The 10-year recurrence-free survival rate was 99% and the 10-year overall survival rate was 85%. Conclusions: The use of BioGlue(R) alone for hemostasis after NSS is a feasible and safe alternative to classical suturing. Its use enables satisfactory functional outcome and could potentially reduce ischemia time

The use of bovine serum albumin-glutaraldehyde tissue adhesive (BioGlue®) for tumor bed closure following open partial nephrectomy. / El uso de adhesivo tisular de albúmina-glutaraldehído sérico bovino (BioGlue®) para el cierre del lecho tumoral después de una nefrectomía parcial abierta.

OBJECTIVES: To report the results of the use of Bovine Serum Albumin-Glutaraldehyde tissue adhesive (BioGlue®) for tumor bed closure in open nephron-sparing surgery (NSS). MATERIALS AND METHODS: The cohort included 255 patients with enhancing renal mass who underwent open NSS. We used open flank approach, with in-situ hypothermia and enucleation of the tumor. For tumor bed closure, we used the BioGlue® sealant for tumor bed filling, without suturing the edges. RESULTS: Mean patients' age was 65.4 years. 5.1% of patients had pre-operative chronic renal failure. Mean renal mass diameter was 4.2±1.6cm and mean R.E.N.A.L nephrometry score was 8.0±1.6. Mean ischemia time was 21.8±7.6. Mean estimated blood loss was 42±82ml and only two patients required blood transfusion. Urine leak and pseudo-aneurysm were recorded in two and one patient, respectively. None of the operations were converted to radical nephrectomy. The average change between post-operative and pre-operative eGFR (Δ=-1.7ml/min) was insignificant in a mean follow-up of 30.1±29.6 months. The 10-year recurrence-free survival rate was 99% and the 10-year overall survival rate was 85%. CONCLUSIONS: The use of BioGlue® alone for hemostasis after NSS is a feasible and safe alternative to classical suturing. Its use enables satisfactory functional outcome and could potentially reduce ischemia time.

Update in urethral stents.

Urethral stents were first introduced in 1988, and since then, they have undergone significant improvements. However, they did not gain a wide popularity and their use is limited to a small number of centers around the world. Urethral stents can be used in the entire urethra and for various and diverse indications. In the anterior urethra, it can be used to treat urethral strictures. In the prostatic urethra, they can be used for the treatment of prostatic obstruction, including benign, malignant and iatrogenic prostatic obstruction. Moreover, although not widely used, it can be also applied for the treatment of posterior urethral stricture and bladder neck contracture, usually resulting in urinary incontinence and the need for subsequent procedures. Our main experience are with Allium urethral stents, and as such, we provide the latest updates in urethral stents with special emphasis on the various types of Allium urethral stents: bulbar, prostatic and bladder neck stents.

Sutureless nephron-sparing surgery: use of albumin glutaraldehyde tissue adhesive (BioGlue).

OBJECTIVES: To determine the feasibility of using serum albumin glutaraldehyde tissue adhesive (BioGlue) to achieve hemostasis and prevent urine leakage during nephron-sparing surgery (NSS). METHODS: From February 1993 to April 2005, 174 NSS operations were performed for renal cell carcinoma at our institute. A total of 143 patients underwent NSS with the traditional suturing technique (suture group) and 31 patients underwent a sutureless BioGlue sealing-only procedure (BioGlue group). We compared the two groups for clinical and tumor characteristics and surgical outcome. RESULTS: The patient and tumor characteristics were similar in both groups. The average maximal tumor diameter was 4.21 cm (range 2.2 to 7) for the suture group and 3.67 cm (range 2 to 6.8) for the BioGlue group. The use of BioGlue reduced the mean warm ischemic time by 8.8 minutes (17.2 versus 26 minutes, P = 0.002). The mean estimated blood loss was 45.1 mL in the BioGlue group and 111.7 mL in the suture group (P = 0.001). Blood transfusion was required in 1 patient (3.2%) of the BioGlue group and 24 (17%) in the suture group (P = 0.014). None of the patients treated with BioGlue developed urinary fistula compared with three (2%) in the suture group. CONCLUSIONS: Albumin glutaraldehyde tissue adhesive (BioGlue) alone provided adequate hemostasis during NSS, significantly decreasing the blood loss and transfusion rate, as well as the renal ischemic and operative times. BioGlue was easy to use and safe for sealing the kidney during partial nephrectomy. Future prospective clinical trials are necessary to validate its role during renal surgery.

Effect of percutaneous nephrolithotripsy on renal function: assessment with quantitative SPECT of (99m)Tc-DMSA renal scintigraphy.

PURPOSE: To measure the effect of PCNL on global and regional renal function using quantitative single-photon emission CT (SPECT) measurement of Tc-dimercaptosuccinic acid (DMSA) uptake by the kidneys (QDMSA). PATIENTS AND METHODS: A series of 47 male and 41 female patients with a mean age of 47 +/- 16 years were studied by sequential QDMSA examinations before and 1.5 to 24 months after PCNL. Among the 67 patients (76%) in whom PCNL was performed using upper- or lower-pole access, the function of the affected and nonaffected poles of the treated kidney was calculated separately. RESULTS: There was no statistically significant difference in the uptake by the treated kidneys before versus after PCNL (11.9% +/- 5% v 11.6% +/- 5%; t = 0.9; P = 0.368). The total functional volume of the treated kidney was slightly decreased, from 235 cc +/- 62 cc to 224 cc +/- 59 cc (t = 2.7; P = 0.011). The percent of the injected isotope dose per cubic centimeter of tissue of the treated kidney was not affected (0.051 +/- 0.02 v 0.053 +/- 0.02; t = 0.86; P = 0.296). Regional assessment revealed a statistically significant decrease in the functional volume at the PCNL port of entry (91 cc +/- 30 cc v 82 cc +/- 27 cc; t = 2.64; P = 0.013). Regarding the percent of the injected dose per cubic centimeter of renal tissue, no statistically significant difference was found between the area of the kidney that underwent PCNL and the untreated area of the same kidney (0.049 +/- 0.02 v 0.05 +/- 0.02; t = 0.693; P = 0.494). The function of the contralateral kidneys remained unchanged (13.4% +/- 5.2% v 13.6% +/- 4.8%; t = 0.68; P = 0.5). CONCLUSIONS: Despite the statistically significant decrease in the functional volume of the surgically treated region, neither total percent uptake nor percent of injected dose were reduced significantly. Further studies with long-term follow-up of treated kidneys are required.

[Does percutaneous nephrolithotripsy (PCNL) affect renal function: assessment with quantitative spect of Tc 99M-DMSA (QDMSA) renal scintigraphy].

PURPOSE: The study aimed to quantitatively investigate the effect of PCNL on global and regional function using quantitative single photon emission computerized tomography (SPECT) measurement of Tc-dimercaptosuccinic acid (DMSA) uptake by the kidneys (QDMSA). METHODS: Seventy nine patients with nephrolithiasis undergoing PCNL were studied by sequential QDMSA examination. There were 42 (53%) males and 37 (47%) females with mean age of 47 +/- 16 years. The initial study was conducted before PCNL procedure and the follow-up studies were performed 1.5-24 months after PCNL. Among 60 of the 79 (76%) patients, in whom PCNL was performed using upper or lower pole access, regional renal function of affected and non-affected pole of operated kidney was calculated separately. RESULTS: There was no statistically significant difference between the uptake of treated kidney before and after PCNL procedure (11.9% +/- 5% vs 11.6% +/- 5%; t = 0.9, p = 0.368). The total renal functional volume of treated kidney was to be slightly decreased from 235cc +/- 62cc to 224cc +/- 59cc (t = 2.7; p = 0.011). The percent of injected dose per ml.. of renal tissue of treated kidney was not affected statistically (0.051 +/- 0.02 vs 0.053 +/- 0.02; t = 0.86, p = 0.296). In the assessment of the regional renal function of treated kidney, a statistically significant decrease in the functional renal volume was revealed at the part which underwent PCNL procedure (91cc +/- 30cc vs 82cc +/- 27cc; t = 2.64, p = 0.013). Regarding percent of injected dose per ml. of renal tissue, no statistically significant difference was found between the part of treated kidney, which underwent PCNL and non-affected area of the same kidney (0.049 +/- 0.02 vs 0.05 +/- 0.02; t = 0.693, p = 0.494). The function of contralateral kidney remained unchanged (13.4% +/- 5.2% vs 13.6% +/- 4.8%; t = 0.68, p = 0.5). Function volume, neither total percent uptake, nor percent of injected dose per ml. of renal tissue were reduced significantly. Further studies with long term follow-up of treated kidney are required.

Thermo-chemotherapy for intermediate or high-risk recurrent superficial bladder cancer patients.

BACKGROUND: The purpose of this study was to evaluate the efficacy of combined local hyperthermia and intravesical mitomycin-C (MMC) in a selected group of patients with intermediate or high-risk recurrent transitional cell carcinoma (TCC) of bladder. PATIENTS AND METHODS: Forty-seven patients with multiple or recurrent Ta or T1 TCC of the bladder were treated with intravesical MMC and local hyperthermia of the bladder wall. Patients were treated with either a prophylactic protocol (40 mg MMC) after complete transurethral resection of all tumours or with an ablative protocol (80 mg MMC) in patients with viable tumours. RESULTS: Thirty-two patients were eligible for analysis. The prophylactic protocol was administered to 22 patients. After a mean follow-up of 289 days, 20 patients (91%) were recurrence free. Two patients (9%) had tumour recurrence after a mean period of 431 days. The ablative protocol was administered to 10 patients. Complete tumour ablation was achieved in eight patients (80%) after a mean follow up of 104.5 days. CONCLUSIONS: Our efficacy and safety results confirm those reported in previously published studies, suggesting the promising value of this combined treatment modality for both prophylactic and ablative patients. The ablative protocol offers an alternative therapy for a selected patient population for whom no other treatment option exists.

How accurate is helical CT volumetric assessment in renal tumors?

The aim of this study was to evaluate the accuracy of tumor size measurement on CT studies of renal tumors. Sixteen patients with tumors of the kidneys were imaged by helical CT prior to surgery. Assessment of tumor volume was made by two radiologists on the CT images with the summation of area method, then compared with the resected specimen water displacement volume. Intra- and interobserver agreement for CT measurements were also assessed. There were substantial differences between the CT volume measurement compared with the tumor post-operative volume (mean of differences 30.05+/-91.6, 95%CI: 31.45-91.55). The inter- and intraobservation agreements for tumor measurement by CT was found to be satisfactory (ANOVA: p < 0.0001; t-test: p < 0.05). The CT volumetric measurement by area summation is a method with good inter- and intraexamination reproducibility but not an accurate technique for tumor volume assessment.

Prognostic score for patients with localized renal cell carcinoma treated by nephrectomy.

OBJECTIVE: To evaluate the feasibility of using combined clinical and histomorphometric features to construct a prognostic score for the individual patient with localized renal cell carcinoma. PATIENTS AND METHODS: We studied 39 patients with pT1 and pT2 RCC who underwent radical nephrectomy between 1974 and 1983. Univariate and multivariate analyses were used to determine the association between various prognostic features and patient survival. RESULTS: The most important and independent predictors of survival were tumor angiogenesis (P = 0.009), nuclear DNA ploidy (P = 0.0071), mean nuclear area (P = 0.013), and mean elongation factor (P = 0.0346). Combination of these variables enabled prediction of outcome for the individual patient at a sensitivity and specificity of 78% and 89%, respectively. CONCLUSION: Our results indicate that no single parameter can accurately predict the outcome for patients with localized RCC. Combination of neovascularity, DNA content and morphometric shape descriptors enabled a more precise stratification of the patients into different risk categories.

Bladder cancer--genetic overview.

BACKGROUND: This article review the serial genetic changes which are responsible to the initiation and progression of bladder cancer. Knowledge of the exact genetic alteration has a direct implication on the development of knew more sensitive and specific tool for an early diagnosis and better prognosis calculations. CONCLUSION: Bladder cancer develop and progress through a series of genetic alterations. Understanding of the genetic mechanisms which lead to malignant transformation gave rise to the development of various genetic mechanisms which lead to malignant transformation gave rise to the development of various genetic tools providing better ability of early detection and more accurate prognosis prediction.

Bone anchored sling for the treatment of post-prostatectomy incontinence.

PURPOSE: This ongoing study evaluates the safety and efficacy of a new minimally invasive sling procedure for treating post-prostatectomy incontinence. MATERIALS AND METHODS: A total of 16 men 56 to 74 years old (mean age 67) underwent the procedure using the Straight-In bone anchoring system. Time after prostatectomy was 1.5 to 5 years (mean 2.5). Of the 16 patients 14 had urodynamically confirmed stress urinary incontinence, while 2 had mixed incontinence with stress incontinence and detrusor instability. The procedure is performed with the patient in the lithotomy position using a perineal approach. Four miniature bone screws with pre-attached pairs of No. 1 polypropylene sutures are placed directly into the medial aspect of the inferior rami of the pubic bone. A pair of bone anchors is placed just below the symphysis on each side, and the second pair is inserted 3 to 4 cm. lower. To support the bulbar urethra a gelatin coated polyethylene terephthalate trapezoid shaped sling or cadaveric fascia lata is tied to the pubic bone using the 4 pairs of sutures attached to the bone anchors. Urethral resistance is increased to 30 to 50 cm. water above baseline pressure. RESULTS: Followup was 4 to 20 months (mean 12.2). Of the 14 men with the preoperative urodynamic diagnosis of genuine stress incontinence 12 were cured of incontinence, defined as subjectively dry with no or only 1 pad used daily for security without any episode of leakage, while 2 were improved subjectively with a decrease of 50% or more in pads daily. Two other patients with the preoperative diagnosis of mixed urinary incontinence were improved. Postoperatively urodynamic study in these patients revealed resolved stress incontinence but persistent urge urinary incontinence. They responded to anticholinergics and are completely dry. Intraoperative and postoperative complications were minimal with no erosion, infection or osseous complications. CONCLUSIONS: This new minimally invasive male sling procedure is safe and efficacious. Adjusting sling tension by measuring urethral resistance results in a low rate of over correction and failure. Further experience is needed to establish this procedure as treatment for post-prostatectomy incontinence.

Long-term follow-up of the in-flowtrade mark intraurethral insert for the treatment of women with voiding dysfunction.

OBJECTIVE: The aim of the current study is to report the long-term follow-up of women treated with the In-Flowtrade mark device for periods longer than 1 year. Abstract METHODS: The efficacy of the intraurethral insert was evaluated in 92 women. Data regarding their urodynamic diagnosis, complications and satisfaction were collected. RESULTS: Early and late discontinuation of the device use was recorded in 52 patients (56.5%) and 19 patients (20.6%), respectively. Twenty-one patients (22.8%) are now being followed for more than 1 year with a follow-up time of 12-44 months (mean 24.6). Complications include device migration into the bladder (4 patients), asymptomatic bacteriuria (15 patients), and symptomatic urinary tract infections (4 cases, 1 of them pyelonephritis). In the 3 women who were sexually active before treatment, the use of the device did not preclude sexual intercourse, although mild dyspareunia was reported in 1 patient. Two patients complained of episodic inconvenience between their legs during walking. All patients were satisfied with the device and preferred it to previous treatment modalities used. The reasons for early and late discontinuation of treatment are described and discussed. CONCLUSIONS: The In-Flowtrade mark intraurethral insert can serve as a long-term treatment for the management of women with voiding difficulties. Women who continue treatment for a prolonged time are satisfied with the device use. Further studies comparing this treatment with other modalities are needed to support the role of the In-Flowtrade mark device in the management of women with voiding dysfunction.

Kidney function after radical nephrectomy: assessment by quantitative SPECT of 99mTc-DMSA uptake by the kidneys.

UNLABELLED: To determine the function of the remaining contralateral kidney after the removal of a functioning kidney, 30 consecutive patients (18 men, 12 women; average age, 67 y; age range, 34-87 y) who were undergoing unilateral radical nephrectomy were evaluated by sequential quantitative 99mTc-dimercaptosuccinic acid (DMSA) SPECT (QDMSA) studies. METHODS: The 30 patients were undergoing radical nephrectomy for renal tumors. The first study was done before surgery. Follow-up studies were performed 2-23 mo after surgery. Clinical evaluations and determinations of serum creatinine level were performed at the same time as the QDMSA studies. RESULTS: The relative contribution of the resected kidneys to the global renal function before surgery was 43.2% +/- 7.3%. After surgery the uptake of the remaining kidney increased from 13.4% +/- 4.0% to 18.3% +/- 5.8% (t = 5.7; P = 0.0000). The relative function of the remaining kidney increased from 56.8% +/- 7.1% to 79.1% +/- 23.6% (t = 4.9; P < 0.0001) of the global renal function before nephrectomy. Increases in the renal volume (from 211 +/- 62 cm3 to 229 +/- 68 cm3; t = 4.5; P = 0.0001) and in the percentage injected dose per cubic centimeter (%ID/cm3) of the remaining kidney (from 0.066 +/- 0.02 % ID/cm3 to 0.085 +/- 0.03 %ID/cm3; t = 4.6; P = 0.0001) were associated with this change. Nine patients had 2 follow-up studies performed 3-4 mo after surgery and 12-14 mo after surgery. The volume of the remaining kidney (209.22 +/- 46.20 cm3 versus 217.88 +/- 58.85 cm3; t = 0.962; P = 0.364), the %ID/cm3 (0.09 +/- 0.016 %ID/cm3 versus 0.093 +/- 0.025 %ID/cm3; t = 0.362; P = 0.726), and the percentage uptake (19.26% +/- 4.45% versus 20.11% +/- 7.01%) did not change significantly between these 2 QDMSA studies. CONCLUSION: The results of this study suggest that adaptive changes causing hyperfunction of the remaining kidney may occur after nephrectomy of a functioning kidney in adults. These changes occur soon after surgery, persist for at least 1 y, and are evident on QDMSA studies.

Does long-term itraconazole prophylaxis result in in vitro azole resistance in mucosal Candida albicans isolates from persons with advanced human immunodeficiency virus infection? The National Institute of Allergy and Infectious Diseases Mycoses study group.

The effects of prolonged itraconazole exposure on the susceptibility of Candida albicans isolates to itraconazole and fluconazole have not been well characterized. A recent placebo-controlled study of long-term itraconazole antifungal prophylaxis in persons with advanced human immunodeficiency virus infection afforded the opportunity to address this question. Mucosal Candida sp. isolates were obtained from subjects who developed oropharyngeal or esophageal candidiasis, and in vitro susceptibilities of the last isolate obtained at removal from the study as a prophylaxis failure were compared in itraconazole and placebo recipients. More subjects in the placebo group (74 of 146 [51%]) than in the itraconazole group (51 of 149 [34%]) developed mucosal candidiasis (P = 0.004). A total of 112 isolates were recovered from 56 of the 74 (76%) subjects with mucosal candidiasis assigned to the placebo group, compared to 97 isolates from 45 of the 51 (88%) subjects in the itraconazole group. C. albicans accounted for 98% of isolates in the placebo group and 89% of isolates in the itraconazole group. The itraconazole MIC at which 50% of the isolates tested were inhibited (MIC(50)) for last-episode isolates from the itraconazole group was 0.125 microg/ml compared to 0.015 microg/ml for the placebo group subjects, P = 0.0001. The MIC(50) of fluconazole for the last isolates from the itraconazole group was 1.5 microg/ml compared to 0.5 microg/ml for the placebo subjects (P = 0.005). A lower proportion of isolates recovered from subjects on itraconazole therapy were classified as susceptible to itraconazole (63%) compared to isolates from the placebo group (96%) (P = 0.001). Similarly, a lower proportion of C. albicans isolates from subjects on itraconazole therapy were susceptible to fluconazole (78%) compared to isolates from the placebo group (96%) (P = 0.01). Also, the proportion of isolates that were not fully susceptible to itraconazole or fluconazole was greater in patients assigned to the itraconazole group than the placebo group (itraconazole susceptibility, 37 and 4%, respectively (P = 0.001); fluconazole susceptibility, 23 and 4%, respectively (P = 0.01). In conclusion, long-term itraconazole prophylaxis in patients with AIDS is associated with reduction in susceptibility to itraconazole and cross-resistance to fluconazole.

A randomized trial of itraconazole in allergic bronchopulmonary aspergillosis.

BACKGROUND: Allergic bronchopulmonary aspergillosis is a hypersensitivity disorder that can progress from an acute phase to chronic disease. The main treatment is systemic corticosteroids, but data from uncontrolled studies suggest that itraconazole, an orally administered antifungal agent, may be an effective adjunctive therapy. METHODS: We conducted a randomized, double-blind trial of treatment with either 200 mg of itraconazole twice daily or placebo for 16 weeks in patients who met immunologic and pulmonary-function criteria for corticosteroid-dependent allergic bronchopulmonary aspergillosis. A response was defined as a reduction of at least 50 percent in the corticosteroid dose, a decrease of at least 25 percent in the serum IgE concentration, and one of the following: an improvement of at least 25 percent in exercise tolerance or pulmonary-function tests or resolution or absence of pulmonary infiltrates. In a second, open-label part of the trial, all the patients received 200 mg of itraconazole per day for 16 weeks. RESULTS: There were responses in 13 of 28 patients in the itraconazole group (46 percent), as compared with 5 of 27 patients in the placebo group (19 percent, P=0.04). The rate of adverse events was similar in the two groups. In the subsequent open-label phase, 12 of the 33 patients who had not had a response during the double-blind phase (36 percent) had responses, and none of the patients who had a response in the double-blind phase of the trial had a relapse. CONCLUSIONS: For patients with corticosteroid-dependent allergic bronchopulmonary aspergillosis, the addition of itraconazole can lead to improvement in the condition without added toxicity.

Relationship between prostate size and percent free prostate-specific antigen in patients with operable prostate cancer.

BACKGROUND: The free-to-total prostate-specific antigen ratio is the best marker for optimizing prostate cancer detection. The main problem with studies of percent free PSA is the variability of reported cutoff values. OBJECTIVES: To evaluate the influence of prostate size on the ratio of free to total PSA. METHODS: The study group included 58 patients (mean age 66.4 years) with clinically localized prostate cancer treated surgically at our institution. Total PSA and free PSA levels were measured by a solid phase enzyme immunoassay test (Hoffman-La Roche, Basel, Switzerland). The percent free PSA was compared with prostate size as determined from the surgical specimen. RESULTS: A direct relation was noted between prostate size and the percent free PSA value (r = 0.49, P = 0.0001). Mean percentage free PSA was 9% +/- 0.004 in men with normal-sized gland while in men with large prostate (> 60 g) the average percent free PSA was 15.9 +/- 0.09 (P = 0.001). CONCLUSIONS: In patients with prostate cancer the percent free PSA level is influenced by the gland size. The larger the prostate the higher the proportion of the free PSA. Such information may have influence on the recommendation for prostate biopsy in screening programs for early detection of prostate cancer.

Treatment of fluconazole-refractory oropharyngeal candidiasis with itraconazole oral solution in HIV-positive patients.

This open-label, multicenter trial evaluated the efficacy and safety of a new oral solution formulation of itraconazole in HIV+/AIDS patients with fluconazole-refractory oropharyngeal candidiasis. Seventy-four HIV+/AIDS patients with mycologically confirmed oropharyngeal candidiasis who failed fluconazole therapy (200 mg/day) were treated with 100 mg of itraconazole oral solution administered twice daily (200 mg/day) for 14 days. Patients who demonstrated an incomplete response to treatment were treated for an additional 14 days (28 days total). Clinical responders were eligible for participation in a separate 6-month maintenance protocol. If they declined further treatment, responders were monitored for 6 weeks posttreatment. The primary efficacy parameter was clinical response (i.e., no lesions or symptoms) at end of treatment. Fungal cultures were performed at baseline and at the end of treatment. Among the 74 patients who had mycologically confirmed, fluconazole-unresponsive, oropharyngeal candidiasis at baseline, 41 (55%) achieved a clinical response by day 28. The median time to response was 7 days (range, 7 to 28 days). Candida albicans was the most common pathogen isolated, either alone (62%) or in combination with another Candida species (31%). All 22 patients who entered the optional, off-therapy, 6-week follow-up phase relapsed; mean time to relapse was 13 days. Itraconazole oral solution was well-tolerated; adverse events were predominantly gastrointestinal disturbances. This trial demonstrates that itraconazole oral solution is a useful therapy in the treatment of HIV-infected patients with fluconazole-refractory oropharyngeal candidiasis.

Continuous itraconazole treatment for onychomycosis and dermatomycosis: an overview of safety.

Over the past 10 years, itraconazole has been used to treat more than 34 million patients worldwide. We present a review of the safety of various continuous itraconazole schedules used in the treatment of dermatomycosis and onychomycosis. Data from controlled clinical trials and extensive post-marketing surveillance show that itraconazole has an impressive safety profile at a dose of 50-200 mg/day for 1-4 weeks for dermatomycosis and 200 mg/day for 3 months for onychomycosis. In addition, itraconazole is safe to use in diabetic patients with dermatomycosis or onychomycosis. Short-term, intermittent itraconazole regimens, which may offer additional benefits in terms of safety and cost, have now been introduced.

Safety of itraconazole pulse therapy for onychomycosis. An update.

After experience with more than 34 million patients over 10 years, the safety of itraconazole and its potential drug-drug interactions are well known. In clinical trials, the average incidence of adverse events with a 1-week pulse regimen was 18% in pooled safety data (n = 2,867); only 2.2% of patients dropped out. In direct comparative trials, the incidence of mild and reversible adverse effects was comparable for itraconazole and terbinafine (31% and 28%, respectively) during treatment. The rate of permanent withdrawal because of adverse events was 3.6% for itraconazole and 7.5% for terbinafine (P < .05). Itraconazole was significantly better tolerated as evaluated by the investigator and patients. The analysis of the elderly subpopulation showed that patients 65 and older tolerated itraconazole pulse well, with only 20% experiencing mild and reversible side effects (total group). In direct comparative trials, itraconazole also produced fewer adverse effects than terbinafine (13% vs 32%, respectively). As newer oral antifungal agents gain widespread use, clinicians need to be aware of their potential drug-drug interactions and their possibly serious adverse events. However, pooled data from the 1-week itraconazole pulse regimen indicated a favorable safety profile, and a dose increase to 400 mg had no impact on safety.

Renal function after tumor enucleation: assessment by quantitative SPECT of 99mTc-dimercaptosuccinic acid uptake by the kidneys.

UNLABELLED: The purpose of this study was to evaluate the amount of functioning renal mass removed and the amount of remaining individual renal function after tumor enucleation. METHODS: Renal functional volume, percentage injected dose (%ID) per cubic centimeter of renal tissue and individual renal uptake of 24 operated and 24 contralateral kidneys were studied by two sequential SPECT quantitations of 99mTc-dimercaptosuccinic acid (DMSA) uptake by the kidneys (QDMSA). The first study was before surgery and the second study was 1 to 6 mo (mean 3.5 mo) after surgery. Mean tumor size was 3.4 +/- 0.99 cm and all tumors were confined to the renal parenchyma (stages pT1 and pT2). RESULTS: In the operated kidneys, there was a statistically significant decrease in renal cortical volume (170 +/- 46 mL after surgery versus 207 +/- 45 mL before surgery, t = 6.2, P < 0.001) and individual renal uptake (10.3% +/- 3.0% after surgery versus 13.0% +/- 2.9% before surgery, t = 5.4, P < 0.001). There was no statistically significant change after surgery compared with before surgery in the %ID per cubic centimeter of renal tissue of the operated kidneys, and in the volume, %ID per cubic centimeter and uptake of the contralateral normal kidneys. CONCLUSION: The results suggest that QDMSA is a noninvasive method able to assess changes in separate renal function. The limited functioning parenchymal loss after tumor enucleation had no effect on the opposite kidneys.