Quantification of cytomegalovirus DNA by a fully automated real-time PCR for early diagnosis and monitoring of active viral infection in solid organ transplant recipients

BackgroundQuantification of cytomegalovirus (CMV) DNA by real-time PCR is currently considered an alternative diagnostic approach for the evaluation of active infection in transplant patients. The pp65 antigenemia assay has been used as reference test for monitoring active CMV infection and guiding preemptive therapy in transplant recipients. However, this assay suffers from some limitations: need for immediate processing of the samples, labour-intensive process, lack of standardization and subjective result interpretation.ObjectivesThe aim of this study was to evaluate the performance of a new commercially available real-time PCR assay coupled with a fully automated DNA extraction system (COBAS Ampliprep/COBAS Taqman CMV Test, Roche Diagnostics) for the detection of CMV-DNA in plasma comparing it with pp65 antigenemia assay for monitoring active CMV infection in solid organ transplant recipients (SOTRs).Study designA total of 266 consecutive samples from 45 SOTRs were monitored with pp65 antigenemia and in parallel with CMV-DNA quantitation by real-time PCR assay.ResultsFifty-eight samples resulted PCR-positive, 163 negative and for 45 samples the CMV-DNA values obtained were below the lower limit of quantification (<150 copies/ml); pp65 antigen was detected in 47 samples and resulted negative in 219 specimens. Concordance between the two evaluations was 76.7%; also a good correlation was observed (r = 0.718). Considering the existing treatment criteria based on pp65 antigenemia evaluation corresponding to pp65 levels ≥ 20 positive cells/200,000, preemptive therapy was administered to four asymptomatically infected patients. The corresponding cut-off value of CMV-DNA load calculated for discrimination between self-clearing infections and those requiring therapy was 2500 copies/ml (or 2275 IU/ml).ConclusionThe fully automated real-time PCR from Roche provided specific and sensitive results and represented a rapid and simple assay for the evaluation and monitoring of CMV infection in SOTRs. Further studies are required to validate the threshold level for the initiation of preemptive therapy.     

Efficacy and safety of anti-CD45–saporin as conditioning agent for RAG deficiency

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Experiences in US-Guided Percutaneous Radiofrequency Ablation of 44 Renal Tumors in 31 Patients: Analysis of Predictors for Complications and Technical Success

Purpose Preliminary clinical studies have shown the feasibility, safety, and efficacy of radiofrequency thermal ablation (RFA) of renal tumors, but only a few have analyzed the prognostic factors for technical success and there are no long-term results. Our objective was to statistically evaluate our mid-term results of percutaneous US-guided RFA in order to define predictors for complications and technical success. Methods We selected for treatment 44 tumors in 31 patients (24 with renal cell carcinoma, 7 with hereditary tumors, 15 with a solitary kidney), up to 5 cm in diameter. Results Eight adverse events occurred; 3 (6.8%) were major complications, successfully treated with interventional radiology procedures in 2 cases. Exophytic extension of the tumor was protective against complications (p = 0.040). Technical success was obtained in 38 lesions after one RFA session and in 39 (89%) after one more session, when possible. At the end of treatment, central extension was the only negative predictor for technical success (p = 0.007), while neither size >3 cm (p = 0.091) nor other prognostic factors were statistically significant. Conclusion US-guided percutaneous RFA can be proposed for non-central renal tumors up to 5 cm, also in patients without surgical contraindications, thanks to a low incidence of complications and a high success rate. Randomized controlled trials versus surgery are now needed to investigate long-term comparative results.     

3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot) in advanced prostate cancer: results from an Italian,open, multicenter trial

OBJECTIVES: To determine the endocrine effects, efficacy and tolerability of the 3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot; 'Zoladex' is a trade mark of the AstraZeneca group of companies) in the treatment of patients with advanced prostate cancer. METHODS: Between February 1996 and October 1997, this open, multicentre study enrolled 120 patients with locally advanced (T3/4) or metastatic (N+ or M1) disease, or an increase in prostate-specific antigen (PSA) level after radical prostatectomy. Patients received goserelin acetate 10.8-mg depot every 12 weeks until clinical progression or interruption for adverse events or other reasons. RESULTS: The mean testosterone concentrations were suppressed to the castration range (< or =2 nmol/l) after 4 weeks of treatment and remained suppressed throughout the study. In total, 99/115 (86%) patients had a serum PSA response, and the mean PSA value decreased significantly during treatment (p = 0.006). The mean PSA level at baseline was significantly lower in patients without disease progression compared to those who experienced disease progression (p = 0.0002). Goserelin acetate 10.8-mg depot was well tolerated and there were no injection site reactions. CONCLUSIONS: The goserelin acetate 10.8-mg depot is well tolerated with no injection site reactions. It produces PSA responses and provides reliable suppression of serum testosterone.     

Phosphodiesterase Type 5 Inhibitor Treatment for Erectile Dysfunction in Patients with End-Stage Renal Disease Receiving Dialysis or After Renal Transplantation

IntroductionThe phosphodiesterase type 5 (PDE5) inhibitors are generally well tolerated and effective for treating erectile dysfunction (ED), including in patients with significant comorbidity. Because of this benign safety profile, investigators have used PDE5 inhibitors to treat patients with ED and severe renal disease or those who have received renal transplants.AimTo assess safety and efficacy of PDE5 inhibitors in patients receiving dialysis or renal transplants.Main Outcome MeasuresErectile function as assessed by the International Index of Erectile Function (IIEF) and Global Assessment Questions; adverse events (AEs).MethodsWe reviewed published studies of PDE5 inhibitors in patients receiving dialysis or renal transplants.ResultsIn double-blind, placebo-controlled studies in patients receiving dialysis or renal transplants, sildenafil significantly improved erectile function as assessed by the IIEF, and 75–85% of patients reported improved erectile function on Global Assessment Questions; efficacy was more variable in less well-controlled studies. In >260 patients undergoing dialysis who received sildenafil in clinical studies, there were only six reported discontinuations because of AEs (headache [N=3], headache and nausea [N=1], gastrointestinal [N=1], and symptomatic blood pressure decrease [N=1]). In approximately 400 patients with renal transplants who received sildenafil, only three patients discontinued because of AEs. Vardenafil improved IIEF scores of up to 82% of renal transplant recipients in randomized, controlled studies (N=59, total), with no reported discontinuations because of AEs. Limited data also suggest benefit with tadalafil.Conclusions.ED is common in patients undergoing renal dialysis or postrenal transplant and substantially affects patient quality of life. Sildenafil and vardenafil appear to be efficacious and well tolerated in patients receiving renal dialysis or transplant. Lasaponara F, Sedigh O, Pasquale G, Bosio A, Rolle L, Ceruti C, Timpano M, Negro CLA, Paradiso M, Abbona A, Segoloni GP, and Fontana D. Phosphodiesterase type 5 inhibitor treatment for erectile dysfunction in patients with end-stage renal disease receiving dialysis or after renal transplantation. J Sex Med 2013;10:2798–2814.     

Early insertion of inflatable prosthesis for intractable ischemic priapism: our experience and review of the literature

A cohort of 20 patients with delayed priapism who underwent treatment at the Emergency Department of our academic referral centers between January 2002 and April 2010 was studied. Of these, 16 cases suffered from a low-flow priapism. A total of 6 cases were managed non-surgically, 10 required shunt surgery, and of these 5 were treated by early penile prosthesis surgery. Prostheses were easily implanted in all patients with a mean operative time of 94 min. No intraoperative complications and no infection were registered. All patients with an inflatable prosthesis complained a reduction in penile sensibility that lasted 3 months. All patients were satisfied with the results of surgery (International Index of Erectile Function Questionnaire-5, Q5 mean value 4), and all were successfully engaging in satisfactory sexual intercourses. No significant loss of penile length, neither apical erosion nor extrusion was recorded. Early insertion of a penile prosthesis is a simple and safe procedure in patients with ischemic priapism, which failed to respond to conservative management. Early insertion of a prosthesis helps to maintain adequate penile length, resolve priapism and, in the long term, it results in high satisfaction rates.     

Factors predicting outcomes of microwave ablation of small hepatocellular carcinoma

Purpose

The aim of our study was to evaluate factors influencing effectiveness of percutaneous microwave ablation (MWA) in patients with small hepatocellular carcinoma (HCC) (<3 cm).

Materials and methods

Between December 2007 and August 2015, 49 patients with 65 previously histological typed HCC were treated in a total of 61 sessions. Tumours were subdivided into central (>3 cm from the capsule) (n = 22) and peripheral (<3 cm from the capsule) (n = 43). Imaging follow-up was performed at 1, 3, 6, and 12 months after treatment, then annually. Mean follow-up period was 18 months (range 1–55). Location of the lesion, age, sex, and underlying disease of the patients was analyzed and related with efficacy.

Results

Technical success was obtained in all cases. Residual disease was registered in 21 lesions (32.3 %): 13 were peripheral and 8 were central. Twelve of them were retreated with percutaneous MWA. Local recurrence was recorded in 8 lesions (12.3 %): 5 were retreated with MWA. No significant difference in terms of effectiveness was observed in lesions located in a central position and those situated in the peripheral position. Age, sex, and underlying disease not influenced results. Only one major complication was observed. The rate of minor complications was 24.5 %. Mortality at 30 days was 0 %.

Conclusions

Our results encourage the role of MWA in the treatment of small HCC. More numerous series and randomized studies are necessary to state the role of MWA and to select cases in which MWA may be more effective and safer than RFA.

     

Bone and hormones. Estrogens and antiestrogens: action on osteoporosis

ESTROGEN INSUFFICIENCY: Estrogens play a cardinal role in bone tissue in women. Estrogen insufficiency leads to accelerated bone loss within 5 to 8 years after menopause. HORMONE SUBSTITUTION THERAPY: Substitution therapy prevents postmenopausic bone loss (lumbar vertebrae, hip, radius) and reduces the risk of osteoporotic fracture. Cohort studies have demonstrated that women given hormone substitution therapy for at least 7 years have a significantly higher bone density than untreated women. Although still controversial, it would appear that the risk of breast cancer increases with prolonged use of hormone substitution therapy. SERM: Observations in patients given tamoxifen, an antiestrogen used in the treatment of breast cancer, have led to the concept of selective estrogen receptor modulators (SERM), a new class of compounds with estrogen agonistic or antagonistic activity, depending on the tissue. Among these molecules, raloxifen has reached advanced clinical testing phases. Phase III trials have demonstrated that raloxifen can prevent bone loss and reduce the risk of vertebral fractures while reducing total cholesterol and LDL-cholesterol in menopaused women without stimulating the endometrium. SERMs are a promising alternative to hormone substitution therapy for the treatment of menopaused women.