| Buprenorfina transdérmica en el manejo del dolor no oncológico y oncológico - resultados de estudio multicéntrico en Polonia. |
Transdermal buprenorphine in the treatment of cancer and non-cancer pain - the results of multicenter studies in Poland.
Przeklasa-Muszyńska A, Dobrogowski J.
Department of Pain Research and Treatment, Chair of Anesthesiology and Intensive Therapy, Medical College, Jagiellonian University, Śniadeckich 10, PL 31-531 Kraków, Poland. aprzemusz@wp.pl
Pharmacol Rep. 2011;63(4):935-48.
Abstract
This was a multicenter, non-interventional, post-marketing study that aimed to evaluate the analgesic activity, safety of use, safety profile and adverse drug reactions of transdermal buprenorphine (Transtec 35, 52.5 and 70 μg/h) during the treatment of moderate to severe chronic cancer and non-cancer pain. The study was performed in Poland by 339 doctors. The study involved 4,030 general practice outpatients (managed by primary care physicians), pain therapy center patients, specialist outpatient clinic patients as well as patients treated in inpatients units. The recruitment process began in September of 2007, and the study was completed in October of 2008. The study has been reported to the Central Register of Clinical Trials in Poland; it was also in accordance with the requirements of the Polish Pharmaceutical Law in force. The objective of the study was to evaluate the efficacy, safety of use and application of transdermal buprenorphine in patients with moderate to severe cancer pain and in patients with severe, non-malignant pain in the course of other diseases. Patients were enrolled if their pain was not well-controlled after using non-opioid analgesics. Another objective of the study was to monitor adverse drug reactions of transdermal buprenorphine reported by patients or noted by the doctors during the study visits. This first such multicenter study in Poland has confirmed high efficacy and good tolerability of buprenorphine and, therefore, confirmed its usefulness in the treatment of moderate to severe cancer pain as well as in the treatment of severe pain in patients with non-cancer pain that cannot be effectively treated with non-opioid analgesics.
http://www.if-pan.krakow.pl/pjp/pdf/2011/4_935.pdf |
| Efectos endócrinos y conductuales de la buprenorfina transdérmica en mujeres con dolor en diferentes edades reproductivas. |
Endocrine and behavioural effects of transdermal buprenorphine in pain-suffering women of different reproductive ages.
Aurilio C, Ceccarelli I, Pota V, Sansone P, Massafra C, Barbarisi M, Pace MC, Passavanti MB, Bravi F, Aloisi AM.
Second University of Naples, Department of Anaesthesiological, Surgical and Emergency Sciences, Naples, Italy.
Endocr J. 2011 Dec 27;58(12):1071-8. Epub 2011 Sep 22.
Abstract
Chronic pain is a common problem in clinical practice and women are affected more often than men. Morphine is often used for long-term pain relief, but it induces side effects including endocrine alterations. The aim of the present study was to assess the behavioural and hormonal effects of transdermal buprenorphine in women suffering from persistent non-malignant pain. Hormones (LH, FSH, total and free testosterone, estradiol, cortisol) and pain measures (visual analogue scale, McGill Pain questionnaire, present pain intensity test) were evaluated at baseline and after 1, 3 and 6 months. Subjects were recruited in the Second University of Naples Pain Research Centre. Eighteen chronic pain women were included in the study, divided into pre- and post-menopausal groups. A transdermal buprenorphine patch (Buprenorphine TDS, 35 µg/h) was administered every 72 h. As expected, buprenorphine administration led to a decrease in pain intensity and no side effects suggestive of hypogonadism were recorded. Pain measures decreased at the first control visit (T1) in both groups. Total and free testosterone were not reduced by treatment (they tended to increase in both groups) while cortisol progressively recovered from the quite low levels detected at the beginning of treatment. These data confirm that buprenorphine is a safe and effective drug for pain relief in women. It is free from the adverse effects on gonadal hormones frequently associated with other opioid treatments. The lack of opioid-induced effects on gonadal hormones (i.e. hypogonadism) is important to guarantee safe long-term pain treatment.
http://www.jstage.jst.go.jp/article/endocrj/58/12/1071/_pdf
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