Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients

Background. Hypertensive haemodialysis patients may be at a high risk for cardiovascular events. This study was undertaken to ascertain whether the calcium channel blocker amlodipine reduces mortality and cardiovascular events in these high-risk patients

Randomised controlled trial with medical leeches for osteoarthritis of the knee

OBJECTIVES: To evaluate the possible efficacy of medical leeches (Hirudo medicinalis) in the treatment of patients with active osteoarthritis of the knee. DESIGN: Unblinded, randomised controlled trial with outpatients in a crossover design with single interventions of either leeches or transcutaneous electrical nerve stimulation (TENS) as comparator. MAIN OUTCOME MEASURES: Change in Lequesne's combined index for pain and function and change (L.I.) and overall assessment of complaints by visual analog scale (VAS). Cross-over at day 42, with further observation period of 21 days. RESULTS: 52 out of 72 screened patients were randomised (intent to treat) to initial treatment with either eight leeches (group 1: 27 patients) or TENS (group 2: 25 patients). Due to phase effects, confirmatory evaluation had to be restricted to the first period. Between days 0 and 21, we observed highly significant (p<0.001) improvements for means of Lequesne's index from 12.07 to 9.37 and for VAS from 5.89 to 4.16cm for leeches, but no significant differences for TENS. Effect size as group difference was -2.50 for L.I. (95% confidence interval -3.88 to -1.11), resp. -1.86cm for VAS (95% confidence interval -2.85 to -0.87cm). 12 patients (5 group1, 7 group 2) did not finish the trial, mostly due to non-compliance (6). No serious adverse effects were observed. CONCLUSIONS: Single leech therapy showed significant, relevant and sustaining effects, comparable to other trials with leeches. The method deserves further research, esp. into mechanisms of possible specific effects and optimization of dosing by number of leeches and possible repeats. Copyright © 2011 Elsevier Ltd. All rights reserved

Sorafenib, but not sunitinib, induces regulatory T cells in the peripheral blood of patients with metastatic renal cell carcinoma

Induction of regulatory T cells (Treg) is an important mechanism leading to tolerance against tumors. Increased levels of Treg have been described in renal cell carcinoma (RCC) patients and seem to correlate with an adverse outcome. Our study aimed to analyze the influence of sorafenib and sunitinib on the frequency of Treg in patients with metastatic RCC (mRCC). Treg were analyzed by flow cytometry in the peripheral blood (PB) of patients (n=19) with histologically confirmed mRCC under treatment with either sunitinib (50 mg/d, n=11) or sorafenib (800 mg/d, n=8). Blood samples were taken before treatment and during the first, second, and third months of therapy. Flow cytometric analysis of PB mononuclear cells was performed using fluorochrome-labeled antibodies against CD3, CD4, CD25, and FOXp3. During the first month of therapy, patients treated with sorafenib showed a significant increase in FOXp3CD3CD4CD25 Treg (13.5 vs. 36.3% of gated cells, P=0.02, or 0.35 vs. 0.49% of total cells) and the ratio FOXp3 T cells/FOXp3 T cells (0.16 vs. 0.56 of gated cells, P=0.02). These elevated levels persisted throughout the treatment period. There was no influence of sunitinib on the frequency of Treg in our cohort of patients. Sorafenib, but not sunitinib, leads to an early and sustained increase in Treg in PB of mRCC patients. In immunoresponsive tumors such as RCC, immunological effects of kinase inhibitors are particularly relevant for the design of combination trials with immunotherapeutic agents. Our study suggests that sorafenib should be avoided in such a therapeutic setting

Laparoscopic temporary clipping of uterine artery during laparoscopic myomectomy

Purpose: Our aim is to study the feasibility and effect of bilateral laparoscopic temporary occlusion of uterine arteries by special vascular clamps on blood loss during laparoscopic myomectomy. Methods: Of 166 women with symptomatic uterine myomas necessitating surgical intervention who wished to retain their uteri, 80 underwent laparoscopic uterine artery clipping and myomectomy (experimental group) and 86 received laparoscopic myomectomy only (control group). Main outcome measures were operating time, number and weight of leiomyomas, blood loss, Doppler examination of the uterine arteries and complications of procedure. Results: In the experimental group the median hemoglobin drop measured on day 3 postoperatively was 1.2 g/dl. In the control group the mean hemoglobin drop measured on day 3 postoperatively was 1.45 g/dl. The time needed to put the clips in place (the time from the opening of the retroperitoneum and the positioning of the clips) varied between 6 and 40 min. No patient required blood transfusion. There were no conspicuous complications. Conclusion: The use of the clips has proved to be statistically effective in reducing hemoglobin loss during laparoscopic myomectomy. © 2012 Springer-Verlag

Prognostic value of multimarker analysis in stage III colorectal cancer: one step forward towards an individualized therapy decision

Background: Recently, we have analyzed new prognostic markers in colorectal cancer including neuroendocrine dif- ferentiation, overexpression of the sialyl-Lexantigen, over- expression of the peripheral benzodiazepine receptor (PBR), BAX protein expression and p53 mutational status. The pre- dictive power of all markers in combination has not yet been evaluated. Patients and Methods: Between 1989 and 1991, 48 consecutive patients underwent surgery for stage III col- orectal cancer at our hospital. All patients received a com- plete 5-year follow-up. Paraffin-embedded tumor samples were analyzed for all 5 markers. Multivariate discriminant analysis was performed to determine the prognostic value of all markers in combination. Results: Based on these prog- nostic markers a mathematical discriminant function was obtained. This function allowed to correctly predict the further course of disease in 77% of the patients specificity: 83.3%, sensitivity: 70.8%). The discriminant function was confirmed in another group of 19 patients. Single marker analysis allowed the prediction of the further course of disease only in 58–70%. Conclusion: Our study shows that in colorectal cancer, multimarker analysis is superior to unimarker analysis in predicting prognosis. The derived discriminant function allows patient tratification according to risk. Therefore, a multimarker analysis provides a rationale for future individualized risk-adapted therapies in stage III colorectal cancer