Drug and Alcohol Rehabilitation: SAMITAL(®) Improves Chemo/radiotherapy-Induced Oral Mucositis in Patients With Head and Neck Cancer: Results of a Randomized, Placebo-Controlled, Single-Blind Phase II Study.

SAMITAL(®) improves chemo/radiotherapy-induced oral mucositis in patients with head and neck cancer: results of a randomized, placebo-controlled, single-blind Phase II study.

Filed under: Drug and Alcohol Rehabilitation

Support Care Cancer. 2012 Sep 4;
Pawar D, Neve RS, Kalgane S, Riva A, Bombardelli E, Ronchi M, Petrangolini G, Morazzoni P

PURPOSE: This randomised, placebo-controlled single-blind trial investigated the safety and efficacy of SAMITAL®, a formulation of highly standardised botanical extracts, in the treatment of chemo/radiotherapy-induced oral mucositis (OM) in patients with head and neck cancer. METHODS: Patients received SAMITAL® or placebo four times daily for up to 50 days during scheduled chemo/radiotherapy. Severity of OM was monitored according to a modified WHO severity scale, and pain and quality-of-life assessments were based on the effect of symptoms of OM on relevant daily activities, according to a visual analogue scale. RESULTS: Mean scores for the severity of OM were significantly (p?HubMed – drug


Increased frequency of integrons and ?-lactamase-coding genes among extraintestinal Escherichia coli isolated with a 7-year interval.

Filed under: Drug and Alcohol Rehabilitation

Antonie Van Leeuwenhoek. 2012 Sep 4;
Mokracka J, Oszy?ska A, Kaznowski A

We analyzed the level of antimicrobial resistance, and the presence of integrons and ?-lactamase-coding genes in 69 clinically relevant Escherichia coli strains originating from extraintestinal infections isolated in 1999-2001 and 2008-2010. Comparison of the two groups showed significant differences in drug resistance frequency, and the presence of integron and ?-lactamase-coding genes. The frequency of resistance to all antimicrobials beside imipenem, streptomycin, piperacillin/tazobactam, and sulfamethoxazole increased significantly, especially towards aminoglycosides, ?-lactams and fluoroquinolones. Similarly, we noticed an increase in the number of strains with integrons from 31.6 to 80.7 %. The presence of integrase genes was associated with elevated frequency of resistance to each antimicrobial tested besides imipenem, piperacillin/tazobactam and ceftazidime. The presence of integrons was also associated with multidrug resistance phenotype. The genetic content of integrons comprised genes determining resistance toward aminoglycosides, sulfonamides and trimethoprim. Moreover, we noticed a significant increase in the frequency of bla (CTX-M) ?-lactamases, with appearance of bla (CTX-M-15) variant and newer plasmid-encoded ?-lactamases like CMY-15 and DHA. The emergence of strains resistant to several classes of antimicrobials and carrying integrons, ESBL and AmpC ?-lactamase-coding genes may predict the spread of isolates with limited treatment options.
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Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus: Insight from the 4-year results of the CREATE study.

Filed under: Drug and Alcohol Rehabilitation

Catheter Cardiovasc Interv. 2012 Sep 4;
Li Y, Han Y, Zhang L, Jing Q, Wang X, Yan G, Ma Y, Wang G, Wang S, Chen X, Yang L, Zhu G, Liu H, Jiang T

BACKGROUND: Diabetes mellitus is an independent predictor of adverse clinical events after drug-eluting stent implantation. OBJECTIVES: To evaluate the long-term clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in diabetic versus non-diabetic patients. METHODS: A total of 2077 “all comers”, including 440 (21.2%) diabetic patients and 1637 (78.8%) non-diabetic patients, were prospectively enrolled in the CREATE study at 59 centers in 4 countries. The recommended antiplatelet regimen was clopidogrel and aspirin for 6 months followed by chronic aspirin therapy. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR). RESULTS: Diabetic patients had higher risks of all-cause death (8.2% vs. 3.4%, p <0.001) and cardiac death (4.1% vs. 1.4%, p < 0.001) compared with non-diabetic patients at 4 years. The rates of non-fatal MI (0.2% vs. 0.9%, p = 0.218), TLR (2.0% vs. 2.8%, p = 0.357), MACE (5.9% vs. 4.4%, p = 0.227) and overall stent thrombosis (1.6% vs. 1.6%, p = 0.932) were not significantly different between diabetic and non-diabetic patients. A landmark analysis showed that prolonged clopidogrel therapy (> 6 months) was not beneficial in reducing the cumulative hazards of MACE either in diabetic or non-diabetic patients (log rank p = 0.810). CONCLUSIONS: Biodegradable polymer-based sirolimus-eluting stents for the treatment of diabetic patients had a similar clinical event rate at 4 years compared with non-diabetic patients, except for a higher mortality rate. © 2012 Wiley Periodicals, Inc.
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