Objective: To evaluate the intraoperative and late complications of osteoplastic sinus surgery with fat obliteration with long-term magnetic resonance imaging (MRI) follow-up. Methods: The operative records of all patients who underwent osteoplastic frontal sinus surgery with fat obliteration between January 1, 1986 and December 31, 1997 were reviewed and the postoperative clinical course and magnetic resonance imaging (MRI) scans were analyzed if available. MRI analyses revealed that changes in the distribution of fatty and fibrous tissue, the development of necrosis or oil cysts, recurrences, inflammatory complications, and mucoceles were time-dependent occurrences. Results: Eightytwo operative records were evaluated and 59 patients were followed 1 to 12 years after surgery. Eighty-six MRI scans in 51 patients were available for analysis. The most frequent intraoperative complications were exposure of orbital fat (19.5%), unintentional fracture of the anterior wall (19.5%), incorrect placement of the anterior wall (17%), and dural injury (9.8%). Persistent changes of the frontal contour (embossment, depression) occurred in 10.2% and the esthetic result was unfavorable in 5.1% of the cases. Mucoceles could be detected in 5 of 51 cases (9.8%). The amount of adipose tissue detectable in the last scan was less than 20% in the majority of cases (53%), and more than 60% in only 18% of the cases. The amount of adipose tissue decreased significantly with time (the median half-life was 15.4 mo). Conclusions: Osteoplastic frontal sinus surgery with fat obliteration is very useful and successful in patients in whom the frontal sinus is not accessible via an endonasal approach or the natural drainage cannot be reestablished. MRI is currently the most valuable diagnostic tool to evaluate the frontal sinus after obliteration with adipose tissue. The method has some limitations with regard to detection of small recurrent mucoceles and differentiating vital adipose tissue from fat necroses in the form of oil cysts. In these difficult cases, long-term MRI follow-up is necessary. Key Words: Frontal sinus surgery, osteoplastic flap operation, frontal sinus obliteration, fat transplantation, magnetic resonance imaging, frontal sinus mucocele.
This meta-analysis of open-label studies provides confidence that reductions of around 50% of risk for nocturnal hypoglycaemia can be achieved with using glargine instead of NPH.
AimsThis analysis evaluated HbA1c-adjusted hypoglycemia risk with glargine versus neutral protamine Hagedorn (NPH) over a 5-year study in patients with Type 2 diabetes mellitus (T2DM). Clinical significance was assessed using number needed to harm (NNH) to demonstrate the risk of one additional patient experiencing at least one hypoglycemic event.MethodsIndividual patient-level data for symptomatic documented hypoglycemia and HbA1c values from a 5-year randomized study comparing once-daily glargine (n = 513) with twice-daily NPH (n = 504) were analyzed. Symptomatic hypoglycemia was categorized according to concurrent self-monitoring blood glucose levels and need for assistance. Hypoglycemic events per patient-year as a function of HbA1c were fitted by negative binomial regression using treatment and HbA1c at endpoint as independent variables. An estimate of NNH was derived from logistic regression models.ResultsThe cumulative number of symptomatic hypoglycemia events was consistently lower with glargine compared with NPH over 5 years. Compared with twice-daily NPH, once-daily glargine treatment resulted in significantly lower adjusted odds ratios (OR) for all daytime hypoglycemia (OR 0.74; p = 0.030) and any severe event (OR 0.64; p = 0.035), representing a 26% and 36% reduction in the odds of daytime and severe hypoglycemia, respectively. Our model predicts that, if 25 patients were treated with NPH instead of glargine, then one additional patient would experience at least one severe hypoglycemic event.ConclusionsThis analysis of long-term insulin treatment confirms findings from short-term studies and demonstrates that glargine provides sustained, clinically meaningful reductions in risk of hypoglycemia compared with NPH in patients with T2DM.
To investigate the combined analgesic and spasmolytic effect of dipyrone, 104 patients suffering from "severe" or "excruciating" colic pain due to a confirmed calculus in the upper urinary tract were randomized to receive i.v. either 2.5 g dipyrone (36 patients), 100 mg tramadol (35 patients), or 20 mg butylscopolamine (33 patients) in a multicentre, observer-blind, parallel-group study conducted in 8 German centres. The three treatment groups were homogeneous when analyzed by age, sex, height, and baseline pain intensity. Dipyrone was significantly more effective than tramadol in reducing pain for the primary endpoint, pain intensity differences (PID) at 20, 30, and 50 min after drug administration, and was significantly more effective than butylscopolamine at 30 and 50 min for the secondary efficacy endpoint, pain intensity differences on a categorical scale. Dipyrone had the highest SPID0-2 h of the three drugs (P < 0.05). Only 5 patients receiving dipyrone needed "rescue" medication as compared with 13 patients given tramadol and 11 patients receiving butylscopolamine. Adverse events were observed in 4 patients receiving butylscopolamine and in 1 patient each given dipyrone and tramadol. "Distinct" pain relief as assessed on a visual analogue scale (VAS) is a reliable method of determining the onset of analgesic action in the colic pain model.
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