ABSTRACT: Micafungin (FK463) is a new lipopeptide compound (echinocandin) with activity against Aspergillus and Candida species. This study evaluated the safety and efficacy of micafungin in patients with proven or probable invasive aspergillosis (IA).
A multinational, non-comparative study was conducted to examine proven or probable (pulmonary only) Aspergillus species infection in a wide variety of patient populations. The study employed an open-label design utilizing micafungin alone or in combination with another systemic antifungal agent. Criteria for IA and therapeutic responses were judged by an independent panel.
Of the 331 patients enrolled, only 225 met diagnostic criteria for IA as determined by the independent panel and received at least one dose of micafungin. Patients included 98/225 who had undergone hematopoietic stem cell transplantation (HSCT) (88/98 allogeneic), 48 with graft versus host disease (GVHD), and 83/225 who had received chemotherapy for hematologic malignancy. A favorable response rate at the end of therapy was seen in 35.6% (80/225) of patients. Of those only treated with micafungin, favorable responses were seen in 6/12 (50%) of the primary and 9/22 (40.9%) of the salvage therapy group, with corresponding numbers in the combination treatment groups of 5/17 (29.4%) and 60/174 (34.5%) of the primary and salvage treatment groups, respectively. Of the 326 micafungin-treated patients, 183 (56.1%) died during therapy or in the 6-week follow-up phase; 107 (58.5%) deaths were attributable to IA.
Micafungin as primary or salvage therapy proved efficacious and safe in high-risk patients with IA, although patient numbers are small in the micafungin-only groups.
The Journal of infection 12/2006; 53(5):337-49. · 4.13 Impact Factor
ABSTRACT: Thoracic epidural analgesia (TEA) is an established technique for postoperative pain relief after major abdominal surgery. However it is still under discussion whether pre-incisional TEA can reduce postoperative pain perception or postoperative analgesic consumption.
The present prospective, randomized, double-blind study was performed to investigate the effects of intra- and postoperative TEA vs only postoperative TEA using ropivacaine 0.375% in 30 women scheduled for major abdominal tumour surgery. Prior to induction of general anesthesia patients received an epidural bolus of 10 mL saline in Group I (GI) and 10 mL ropivacaine 0.375% in Group II (GII) followed by an infusion of 6 mL x hr(-1) of the respective solution during surgery. Postoperatively all patients received an epidural infusion of 6 mL x hr(-1) ropivacaine 0.375% during 24 hr followed by patient controlled epidural analgesia for the next 72 hr. Operative data, dynamic pain scores, consumption of local anesthetics and standardized supplemental analgesics were analyzed.
No difference was seen between groups with respect to the amount of required postoperative local anesthetics and supplemental analgesics, pain scores and side effects during the first 96 hr following surgery except a reduction of intraoperative sufentanil consumption (GI: 143.2 +/- 52.6 vs GII: 73.3 +/- 32.6 microg, P < 0.001).
Intraoperative TEA with ropivacaine 0.375% did not significantly reduce the amount of analgesics required after major abdominal gynecological tumour surgery.
Canadian Journal of Anaesthesia 50(6):568-73. · 2.35 Impact Factor
ABSTRACT: We tested the hypothesis that an opioid-free local anesthetic alone is able to provide comparable analgesia to the opioid supplemented epidural application of local anesthetics using thoracic epidural catheters after major abdominal surgery.
In a prospective, randomized, and double-blind study, we have compared the analgesic efficacy and side effects of ropivacaine 0.375% (group R) versus bupivacaine 0.125% in combination with sufentanil 0.5 microg/mL(-1) (group B/S) via a thoracic epidural catheter for a duration of 96 hours after major abdominal surgery in 30 gynecologic tumor patients. Piritramide was given for breakthrough pain. Assessments were performed every 12 hours after start of the epidural infusion using continuous (first 24 hours) and patient-controlled epidural analgesia (PCEA) (24 to 96 hours).
No differences were seen in demographic and perioperative data. Dynamic pain scores (visual analog scale [VAS] values) were comparable between groups during mobilization (group R v group B/S: 24 hours: 40 +/- 30 v 36 +/- 14, P =.9; 48 hours: 46 +/- 33 v 42 +/- 25, P =.93; 72 hours: 42 +/- 24 v 48 +/- 26, P =.78; 96 hours: 42 +/- 25 v 29 +/- 28, P =.49) and on coughing during the whole study period. Hemodynamics, intensity of motor block (Bromage scale), and side effects like nausea, vomiting, pruritus, and bladder disfunction also did not differ between groups.
The present study shows that thoracic epidural infusion of ropivacaine 0.375% provides comparable pain relief and incidence of side effects after major abdominal gynecologic surgery as bupivacaine 0.125% in combination with 0.5 microg/mL(-1) sufentanil and may therefore represent an alternative in epidural pain management.
Regional Anesthesia and Pain Medicine 27(4):367-73. · 4.08 Impact Factor