BackgroundOsteomyelitis is a challenging infection that can involve 4–6 weeks of intravenous (IV) antibiotics. Dalbavancin, approved for acute bacterial skin and skin structure infections, has potent activity against gram-positive pathogens. This study assessed the efficacy and safety of dalbavancin as a 2-dose regimen for osteomyelitis.MethodsThis study was a randomized, open-label, comparator-controlled trial in adults with a first episode of osteomyelitis defined by clinical symptoms, radiologic findings, and elevated C-reactive protein. Patients were randomized 7:1 to dalbavancin (1500 mg IV on days 1 and 8) or standard of care (SOC) for osteomyelitis (oral or IV) per investigator judgment for 4–6 weeks. The primary endpoint was clinical response at day 42, defined as recovery without need for additional antibiotics in the clinically evaluable (CE) population. Clinical response was also assessed at day 21, 6 months, and 1 year.ResultsEighty patients were randomized to dalbavancin (n = 70) or SOC (n = 10). All had baseline debridement; Staphylococcus aureus was the most common pathogen (60% of patients). Clinical cure at day 42 was seen in 65/67 (97%) and 7/8 (88%) patients in the dalbavancin group and SOC group in the CE population, respectively. Clinical response was similar in the dalbavancin group at day 21 (94%), 6 months, and 1 year (96%). Treatment-emergent adverse events occurred in 10 patients in the dalbavancin group; no patient discontinued treatment due to an adverse event.ConclusionsA 2-dose regimen of weekly dalbavancin is effective and well tolerated for the treatment of osteomyelitis in adults.Clinical Trials RegistrationNCT02685033.
The problem of improving the results of surgical care for patients with mechanical jaundice syndrome as a complication of pancreaticobiliary cancer and chronic pseudotumor pancreatitis is still being discussed. Purpose - to improve the results of radical surgical care for patients with pancreaticobiliary cancer and chronic pseudotumour pancreatitis complicated by mechanical jaundice syndrome. Materials and methods. The results of surgical treatment of 272 patients with mechanical jaundice syndrome were analyzed. The main group included 112 patients who were treated with our own developed prognostic and therapeutic algorithm. The comparison group included 160 patients who underwent preoperative preparation outside this algorithm. Results. Almost all the patients in the main group had single nucleotide genetic mutations in the PRSS 1 (Arg122His), SPINK 1 (Asn34Ser), TNF (G308A) and CFTR (Phe508del) genes. In patients of the main group, according to ultrasound elastography, the density of pathological focus for pancreatic cancer was 7.5±0.8 units, and for chronic pseudotumour pancreatitis - 5.6±0.5 units (p<0.05). The most significant differences were observed in the frequency of pancreaticodigestive anastomosis failure (2=6.95; p=0.008) and in the frequency of bleeding in the postoperative period (2=4.29; p=0.004). The amount of life-threatening postoperative complications was 42 (37.5%) cases in the main group and 102 (63.8%) cases in the comparison group (2=18.22; df=1; p<0.0001). In the main group 7 (6.3%) patients died, in the comparison group - 19 (11.9%). Conclusions. Prevention of the development of immediate postoperative complications in patients with focal pathology of the pancreatobiliary zone against the background of mechanical jaundice is achieved by combining molecular genetic studies with the determination of the patient's phenotype, ultrasound fibroelastography and mathematical modelling of patient status. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.
Особенности течения острого тонзиллита у военнослужащих в зависимости от сезона Резюме. В статье проведен анализ литературы относительно острого тонзиллита у военнослужащих и представлены собст-венные данные об особенностях течения острого тонзиллита у последних. Features of acute tonsillitis in the servicemen depending on the season Abstract. The article deals with an analysis of the literature on acute tonsillitis in military personnel and presents own data on the features of the course of acute tonsillitis in the servicemen.
Background. The issues of predicting and finding ways to avoid the origin of intraand early postoperative complications in patients with focal diseases of the biopancreatoduodenal area complicated by mechanical jaundice, reducing perioperative mortality in this challenging category of patients remain very relevant. The purpose of the work is to determine the optimal measures of the immediate results of pancreatoduodenal resection improving in patients with focal diseases of the biliopancreatoduodenal area complicated by mechanical jaundice. Materials and methods. The study reveals the analysis of the results of surgical treatment of 272 patients with focal pathology of the biliopancreatoduodenal area complicated by mechanical jaundice syndrome. Oncopathology of the biliopancreatoduodenal zone was diagnosed in 101 (90.2 %) patients of the main group and 117 (73.1 %) patients of the comparison group. Chronic pseudotumoral pancreatitis was detected in 11 (9.8 %) patients of the main and 43 (26.9 %) patients of the comparison group. The first (main group) included 112 patients who underwent risk modelling and preoperative preparation according to the original algorithm by performing mathematical modelling and genetic analysis involving conservative measures of detoxification and decompression of the biliary tract. The comparison group is represented by 160 patients prepared only by conservative therapy, and decompression of biliary hypertension was not performed. Results. Assessing the quality of preoperative care was guided by the dynamics of changes in the mental status of patients, indicators of cytolytic and cholestatic syndromes. According to the original algorithm, more significant positive changes were achieved in the main group than the comparison group due to the preoperative preparation. The number of points on the MoCA scale before surgery in the main and comparison groups was 24.9 ± 3.2 and 22.8 ± 2.4, respectively. According to the results of the DSST test, patients were distributed as follows – 40.2 ± 3.8 and 23.6 ± 2.6 points in the main and comparison groups (p < 0.05). We compared the dynamics of the level of total bilirubin. Significant differences began to be observed from the third day – 185.1 ± 2.4 μmol/l against 258.4 ± 2.9 μmol/l, on the fifth day – 163.2 ± 2.6 μmol/l against 222.2 ± 3.8 μmol/l, and finally on the eve of surgery – 112.3 ± 2.7 μmol/l against 198.3 ± 3.3 μmol/l in patients of the main group and the comparison group, respectively (p < 0.05). We assessed the dynamics of ALT activity under conditions of different types of preoperative care. We found that on the seventh day the differences persisted, gained reliability and amounted to 119 ± 12 U/l and 157 ± 14 U/l in the main group and in the comparison group, respectively (p < 0.05). The difference in the levels of AST activity between the compared groups became significant and began to gain reliability from the 5th day 124 ± 13 U/l against 150 ± 11 U/l in the main and comparison groups, respectively (p < 0.05). On the eve of surgery (PDR), the difference between the indicators of ASTactivity was also significant – 81 ± 7 U/l against 114 ± 7 U/l in the main group and the comparison group, respectively (p < 0,05). Regarding AP levels, on the 3rd day of observation its content in both groups decreased to 440.9 ± 2.1 and 550.7 ± 1.4 U/l (p < 0.05). On the 5th day of observation, the values of the indicator were even smaller, and in the main group there was a more significant decrease in the activity of AP (up to 223.2 ± 2.7 U/l) compared with the comparison group (up to 350.3 ± 1.1 U/l) (p < 0.05). Finally, on the eve of PDR, the activity of AP was 104.8 ± 1.3 U/l in the main group, and 270.8 ± 1.9 U/l in the comparison group (p < 0.05). The differences in GGT activity became more significant on the 5th day – 403 ± 29 U/l against 446 ± 35, and gained reliability on the 7th day – 304 ± 21 U/l against 374 ± 26 U/l in the main group and the comparison group, respectively. (p < 0.05). On the eve of the PDR, a further decrease in the indicator retained its reliability of 271 ± 29 U/l in the main group against 348 ± 33 U/l in the comparison group (p < 0.05). The number of life-threatening postoperative complications in the main group was 42 (37.5 %) cases, and in the comparison group – 102 (63.8 %) cases. Thus, in terms of the frequency of postoperative complications, the comparison group was significantly ahead of the main one (c2 = 18.22 df = 1 p < 0.0001). Postoperative mortality in the main group was 6.3 %, and in the comparison group – 11.9 %. Conclusions. One of the main ways to prevent postoperative complications is a clear stratification of risk factors taking into account the main parameters of the pathological condition of patients with mechanical jaundice in the preoperative stage, which is possible through the combined use of mathematical modelling and unique laboratory and instrumental methods – genetic analysis and ultrasound elastography.
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