Bowel function during pain therapy with oxycodone/naloxone prolonged-release tablets in patients with advanced cancer.

BACKGROUND: The World Health Organization (WHO) step-III opioids are often required right from the start of pain therapy in order to achieve sufficient symptom control. Bowel dysfunction, particularly constipation, is one of the most frequent and persistent side effects of opioid therapy, and it is known to cause considerable distress in many patients. The aim of the study was to evaluate whether patients with advanced cancer and moderate to severe cancer pain will benefit from treatment with oxycodone/naloxone prolonged-release tablets (OXN), with particular regard to constipation. MATERIAL AND METHODS: In this exploratory, non-randomised, open-label, mono-centre study we evaluated the bowel function in palliative care patients treated with OXN. During the treatment phase patients were titrated up to an adequate pain control. The Bristol Stool Form Scale (BSFS) (type 1-7) and Bowel Function Index (BFI) (0-100) were used to assess consistency and frequency of bowel movements. Global patient satisfaction was assessed with Patient Global Impression of Change Scale (PGIC) (1-7). STATISTICS: mean ± SD, significance p<0.05. RESULTS: Twenty-six patients [10 male patients (38.5%)] were included; mean age 70.6 ± 14.0 years, length of stay 22.6 ± 21.2 days. At admission all patients had opioid-induced constipation. During the observation period of 14 days the daily mean dose of OX was 36.2 ± 17.2 mg and of N 15.4 ± 5.3 mg. In five cancer patients pain control was not sufficient under the approved maximum total daily dose of 40/20 mg OXN; therefore switching to hydromorphone. BFI improved significantly in 21 patients (72.4 ± 17.0 vs. 36.8 ± 13.4) (p<0.0001); stool consistency (BSFS) improved from type 2.0 ± 0.7 to 4.9 ± 1.0 (p<0.0001). PGIC at discharge was 1.9 ± 0.8. DISCUSSION: Patients with OXN treatment throughout the whole study phase showed a clinically relevant improvement in pain intensity and bowel function as well as increased satisfaction. Well-known disadvantages of laxative treatment might be spared or even circumvented under OXN treatment, if appropriate.

Impact of cafedrine/theodrenaline (Akrinor® ) on therapy of maternal hypotension during spinal anesthesia for Cesarean delivery: a retrospective study.

AIM: Maternal hypotension is the most frequent complication in spinal anesthesia for Cesarean delivery. Malperfusion of the foetus and nausea and vomiting of the mother are hallmarks of maternal hypotension. In this retrospective data analysis and anesthesia protocols we have investigated to explore the effects of therapeutic interventions for hypotension with cafedrine/theodrenaline (Akrinor® ) during spinal anesthesia for elective Cesarean section. METHODS: In a retrospective study anesthesia charts of 173 parturients undergoing spinal anesthesia for Cesarean delivery with 10mg hyperbaric bupivacaine + 5 µg sufentanil were reviewed for 30 min after onset of hypotension with respect to blood pressure, heart rate, respiration rate, as well as APGAR scores and umbilical arterial pH. Maternal data were compared to baseline values recorded and documented immediately before placing the spinal anesthesia in the operating room. The cohort was divided into two groups according to their hemodynamic response to spinal anesthesia: 117 parturients had a drop of systolic blood pressure to <120 mmHg or <80% of baseline blood pressure and were therefore treated with Akrinor® (cafedrine/theodrenaline; treatment group); 56 patients remained within the specified limits (non-treatment group). Maternal cardiovascular parameters and newborn outcome between the groups were compared. RESULTS: Both groups were comparable with regard to baseline characteristics. In the treatment group one minute after the first application of cafedrine (43 mg)/theodrenaline (2.2 mg) mean systolic blood pressure raised from 108.6 mmHg to 117.2 mmHg (P=0.0004), mean of maximal changes of systolic blood pressure after the first application of Akrinor® was 21.3 mmHg. Blood pressure levels of the non-treatment group were regained in the treatment group 8 min after hypotension onset and remained at that level until the end of 30 min observation. No clinically relevant changes of heart rate were detectable. While mean APGAR score one minute post partum was significantly higher in the treatment group (8.9±1.2 vs. 8.4±1.1 P=0.043), mean umbilical arterial cord pH was 7.3±0.1 and APGAR scores 5 and 10 minutes postpartum did not differ significantly. CONCLUSION: The results of this study confirm a rapid and sustained increase in blood pressure after application of Akrinor® for treatment of sympathicolysis induced hypotension. No negative impact of Akrinor® on umbilical arterial cord pH and APGAR scores was observed.