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1.
Cell Tissue Bank ; 2024 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-38489016

RESUMO

Demineralized bone matrix (DBM) has been regarded as an ideal bone substitute as a native carrier of bone morphogenetic proteins (BMPs) and other growth factors. However, the osteoinductive properties diverse in different DBM products. We speculate that the harvest origin further contributing to variability of BMPs contents in DBM products besides the process technology. In the study, the cortical bone of femur, tibia, humerus, and ulna from a signal donor were prepared and followed demineralizd into DBM products. Proteins in bone martix were extracted using guanidine-HCl and collagenase, respectively, and BMP-2 content was detected by sandwich enzyme-linked immunosorbent assay (ELISA). Variability of BMP-2 content was found in 4 different DBM products. By guanidine-HCl extraction, the average concentration in DBMs harvested from ulna, humerus, tibia, and femur were 0.613 ± 0.053, 0.848 ± 0.051, 3.293 ± 0.268, and 21.763 ± 0.344, respectively (p < 0.05), while using collagenase, the levels were 0.089 ± 0.004, 0.097 ± 0.004, 0.330 ± 0.012, and 1.562 ± 0.008, respectively (p < 0.05). In general, the content of BMP-2 in long bones of Lower limb was higher than that in long bones of upper limb, and GuHCl had remarkably superior extracted efficiency for BMP-2 compared to collagenase. The results suggest that the origin of cortical bones harvested to fabricate DBM products contribute to the variability of native BMP-2 content, while the protein extracted method only changes the measured values of BMP-2.

2.
Sci Rep ; 14(1): 5867, 2024 03 11.
Artigo em Inglês | MEDLINE | ID: mdl-38467756

RESUMO

To illustrate the surgical technique and explore clinical outcomes of the reconstruction for the malignant and metastatic bone tumour of proximal femur with metallic modular intercalary prosthesis. Sixteen patients who underwent modular intercalary prosthetic reconstruction after tumour resection were included from April 2012 and October 2020. Prosthesis and screws parameters, resected bone length and residual bone length, clinical outcomes and survivorship were analyzed. All patients were followed up for an average of 19 months (range 1-74). In our series, 12 patients died of the progression of the primary disease at the final follow-up. The cumulative survivorship since the treatment of proximal femoral metastasis was 78.6% (11 patients) at 6 months and 38.5% (5 patients) at 1 year. The mean MSTS score was 22.25 ± 4.55 among all patients. There were no cases of loosening or breakage of the prostheses, plates or screws, despite the various measurements of prostheses and residual bones. Modular intercalary prosthetic reconstruction was an effective method for malignant tumour of the proximal femur, including the advantages of providing early pain relief, quickly restoring postoperative function, required a short operation time, and preserving the adjacent joints.


Assuntos
Neoplasias Ósseas , Fêmur , Humanos , Resultado do Tratamento , Fêmur/patologia , Extremidade Inferior , Implantação de Prótese/métodos , Neoplasias Ósseas/patologia , Estudos Retrospectivos
3.
BMC Musculoskelet Disord ; 25(1): 141, 2024 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-38355520

RESUMO

BACKGROUND: Anemia is a common complication of total hip arthroplasty (THA). In this study, we evaluated the preoperative risk factors for postoperative anemia after THA and developed a nomogram model based on related preoperative and intraoperative factors. METHODS: From January 2020 to May 2023, 927 THA patients at the same medical center were randomly assigned to either the training or validation cohort. The correlation between preoperative and intraoperative risk factors and postoperative anemia after THA was evaluated using univariate and multivariate logistic regression analysis. A nomogram was developed using these predictive variables. The effectiveness and validation for the clinical application of this nomogram were evaluated using the concordance index (C-index), receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis (DCA). RESULTS: Through univariate and multivariate logistic regression analysis, 7 independent predictive factors were identified in the training cohort: Lower body mass index (BMI), extended operation time, greater intraoperative bleeding, lower preoperative hemoglobin level, abnormally high preoperative serum amyloid A (SAA) level, history of cerebrovascular disease, and history of osteoporosis. The C-index of the model was 0.871, while the AUC indices for the training and validation cohorts were 84.4% and 87.1%, respectively. In addition, the calibration curves of both cohorts showed excellent consistency between the observed and predicted probabilities. The DCA curves of the training and validation cohorts were high, indicating the high clinical applicability of the model. CONCLUSIONS: Lower BMI, extended operation time, increased intraoperative bleeding, reduced preoperative hemoglobin level, elevated preoperative SAA level, history of cerebrovascular disease, and history of osteoporosis were seven independent preoperative risk factors associated with postoperative anemia after THA. The nomogram developed could aid in predicting postoperative anemia, facilitating advanced preparation, and enhancing blood management. Furthermore, the nomogram could assist clinicians in identifying patients most at risk for postoperative anemia.


Assuntos
Anemia , Artroplastia de Quadril , Transtornos Cerebrovasculares , Osteoporose , Humanos , Anemia/diagnóstico , Anemia/epidemiologia , Anemia/etiologia , Artroplastia de Quadril/efeitos adversos , Hemoglobinas , Nomogramas , Estudos Retrospectivos , Redução de Peso
4.
Medicine (Baltimore) ; 102(45): e35943, 2023 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-37960744

RESUMO

To explore the early clinical value of enhanced recovery after surgery (ERAS) with interscalene brachial plexus block (ISB) for arthroscopic rotator cuff repair (ARCR). We enrolled 240 patients who underwent arthroscopic rotator cuff repair, randomly divided into 3 groups (n = 80 each). Groups A, B, and C underwent only surgery, surgery + ERAS, and ISB + surgery + ERAS, respectively. We analyzed the clinical data and postoperative indicators for the 3 patient groups. Group comparisons of clinical data and postoperative indicators revealed no significant differences in clinical characteristics (P > .05). Group C showed superior Visual Analog Scale scores at 0-6 and 6-24 hours postoperatively (P < .05), and the shortest length of hospital stay (LOS) (P < .05). At 6 weeks and 3 months postoperatively, Constant-Murley shoulder score and University of California-Los Angeles scores were better in Groups B and C than in Group A (P < .05). Joint swelling was more common in Group A than in Groups B and C (P < .05) but with no significant difference in the incidence of postoperative stiffness (P > .05). ERAS can relieve postoperative pain, shorten LOS, and help restore shoulder joint mobility, thereby reducing postoperative swelling. ISB + ERAS optimized pain control and allowed a shorter LOS, but had similar effects on early functional recovery and complications.


Assuntos
Bloqueio do Plexo Braquial , Lesões do Manguito Rotador , Humanos , Anestésicos Locais , Artroscopia/efeitos adversos , Bloqueio do Plexo Braquial/efeitos adversos , Dor Pós-Operatória/prevenção & controle , Dor Pós-Operatória/etiologia , Manguito Rotador/cirurgia , Lesões do Manguito Rotador/cirurgia , Lesões do Manguito Rotador/complicações , Resultado do Tratamento
5.
Cell Tissue Bank ; 24(1): 203-210, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35831637

RESUMO

At present, the commonly used allogeneic bone powder in the clinic can be divided into nondemineralized bone matrix and demineralized bone matrix (DBM). Commonly used demineralizers include acids and ethylene diamine tetraacetic acid (EDTA). There may be some diversities between them. Also, the size of the bone particle can affects its cell compatibility and osteogenic ability. We produced different particle sizes i.e., < 75, 75-100, 100-315, 315-450, 450-650, and 650-1000 µm, and treated in three ways (nondemineralized, demineralized by EDTA, and demineralized by HCl). Scanning electron microscopy showed that the surface of the samples in each group was relatively smooth without obvious differences. The results of specific surface area and porosity analysis showed that they were significantly higher in demineralized bone powder than in nondemineralized bone powder, however, there was no significant difference between the two decalcification methods. The content of hydroxyproline in nondemineralized bone powder and EDTA-demineralized bone powder had no statistical difference, while HCl-demineralization had statistical significance compared with the former two, and the content increased with the decrease of particle size. The protein and BMP-2 extracted from HCl demineralized bone powder were significantly higher than that from nondemineralized bone powder and EDTA demineralized bone powder, and there were differences among different particle sizes. These results suggested the importance of demineralization mode and particle size of the allogenic bone powder and provided guidance for the choice of the most appropriate particle size and demineralization mode to be used in tissue bioengineering.


Assuntos
Osso e Ossos , Transplante de Células-Tronco Hematopoéticas , Tamanho da Partícula , Pós/análise , Ácido Edético , Matriz Óssea/química , Osteogênese , Técnica de Desmineralização Óssea
7.
J Pharm Biomed Anal ; 208: 114437, 2022 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-34735992

RESUMO

ZL-01 is a novel dual-prodrug which shows promise to be an antiviral candidate for hepatitis C virus. Here we have established a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of ZL-01 and its four metabolites (M1, M7, M8, and M9) in rat plasma with special consideration of ex vivo ZL-01, M1, and M7 stability. Several factors affecting the stability were investigated. EDTA and citric acid solution (1 M) were added to plasma to maintain the stability of analytes. The protein-precipitation method was selected with acetonitrile containing sofosbuvir as internal standard (IS). Adequate separation of ZL-01 and its metabolites was achieved on XSelect HSS T3 (3.5 µm, 4.6 × 150 mm) column by a gradient-elution with a mobile phase consisting of 0.1% formic acid and acetonitrile at a flow rate of 0.5 mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode to monitor the precursor-to-product ion transitions of m/z 599.2→418.5 for ZL-01, m/z 529.7→398.2 for M1, m/z 330.5→182.0 for M7, m/z 260.3→112.1 for M8, m/z 261.3→113.2 for M9 and m/z 530.4→243.4 for IS. The calibration curves exhibited good linearity (r>0.997) for all components. The lower limit of quantitation (LLOQ) was in the range of 1-2 ng/mL. The intra-day and inter-day precisions (RSD) at three different levels were both less than 10.2% and the accuracies (RE) ranged from -3.7-7.6%. The matrix effect and extraction recovery of them ranged from 84% to 110.3% and 88.3-106.3%. This LC-MS/MS method for the simultaneous quantitation of ZL-01 and its metabolites was developed successfully and applied in the pharmacokinetic studies of these in rats. Pharmacokinetic results indicated ZL-01 would be metabolized rapidly and M8 might be the main metabolites after oral absorption.


Assuntos
Pró-Fármacos , Espectrometria de Massas em Tandem , Animais , Cromatografia Líquida , Nucleotídeos , Plasma , Ratos , Reprodutibilidade dos Testes
8.
ANZ J Surg ; 92(1-2): 140-145, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34636468

RESUMO

BACKGROUND: The surgical management of left-sided malignant large bowel obstruction (MLBO) is associated with high morbidity and mortality. Recently, self-expandable metallic colonic stent (SEMS) and transanal decompression tube (TDT) used as a 'bridge to surgery' (BTS) have been widely used. This study aims to compare the clinical outcomes and oncological safety of SEMS and TDT as BTS to transform MLBO into elective surgery. METHODS: Between February 2013 and March 2019, 62 patients with MLBO received SEMS (n = 32) or TDT (n = 30), and elective one-stage surgery later. We evaluated decompression efficiency and oncological safety in selective operation in TDT and SEMS groups, including preoperative preparation time, surgical approach, number of lymphatic dissection and vascular invasion, ulcer formation and histopathological findings of resected specimens. RESULTS: The preoperative preparation time in the SEMS group was shorter than that of the TDT group (P < 0.05). However, there was no significant difference between the groups in postoperative length of hospital stay (P > 0.05). The number of vascular invasions in the TDT group was less than that in the SEMS group (P < 0.05). Furthermore, the risk of wound abscess and ulcer formation in the TDT group was significantly lower than that in the SEMS group (P < 0.05). CONCLUSION: Our findings suggest that SEMS is associated with a relatively poor oncological outcome and the placement of TDT as BTS in MLBO patients may be a better alternation.


Assuntos
Neoplasias Colorretais , Obstrução Intestinal , Stents Metálicos Autoexpansíveis , Canal Anal , Neoplasias Colorretais/complicações , Neoplasias Colorretais/terapia , Descompressão/métodos , Humanos , Obstrução Intestinal/complicações , Obstrução Intestinal/terapia , Estudos Retrospectivos , Stents Metálicos Autoexpansíveis/efeitos adversos , Resultado do Tratamento
9.
Zhongguo Gu Shang ; 34(12): 1182-5, 2021 Dec 25.
Artigo em Chinês | MEDLINE | ID: mdl-34965639

RESUMO

OBJECTIVE: To evaluate the clinical efficacy of local infiltration anesthesia of ropivacaine combined with compound betamethasone for postoperative analgesia in patients with hallux valgus. METHODS: From September 2019 to December 2020, 48 patients with hallux valgus were treated surgically. According to different postoperative analgesia methods, the patients were divided into combined local infiltration group and intravenous analgesia pump group. There were 24 cases, in the combined local infiltration group including 2 males and 22 females;the age ranged from 21 to 78 years old, with an average of (58.3±7.7) years old;soft tissue release and chevron osteotomy were performed in 15 cases and metatarsophalangeal joint fusion in 9 cases;immediately after operation, 20 ml of ropivacaine combined with compound betamethasone mixed diluent was used for local infiltration anesthesia once. There were 24 patients in intravenous analgesia pump group, including 3 males and 21 females;the age ranged from 23 to 81 years old, with an average of(56.8±8.3) years old;soft tissue release and Chevron osteotomy were performed in 17 cases and metatarsophalangeal joint fusion in 7 cases;immediately after operation, intravenous analgesia pump was used for analgesia. The basic flow was 2 ml / h;the self control dose was 0.5 ml;and the locking time was 15 min. Visual analogue scale (VAS) was recorded at 12, 24, 48 and 72 hours after operation;and the VAS was recorded at 24 hours after operation. The occurrence of adverse drug reactions at 0 to 12 hours, 12 to 24 hours and 24 to 48 hours after operation were recorded;and the healing of incision was recorded. RESULTS: All patients were followed up, and the duration ranged from 14 to 17 days, with a mean of (14.60±0.92) days. There was significantdifference in VAS at 12, 24 and 48 hours between the combined local infiltration group and the intravenous analgesia pump group(P<0.05). There was no significant difference in VAS between the two groups 72 hours after operation (P>0.05). There was no significant difference in the number of adverse drug reactions between the two groups at 0 to 12 hours after operation (P>0.05);there was significant difference in the number of adverse drug reactions 12 to 24 hours after operation (P<0.05). No adverse drug reactions occurred in both groups 24 to 48 hours after operation. There was no significant difference in the grade of knife edge healing between the two groups after suture removal (P>0.05). CONCLUSION: Compared with intravenous analgesia pump group, ropivacaine combined with compound betamethasone can significantly reduce postoperative wound pain without increasing adverse drug reactions, and does not increase wound infection.


Assuntos
Analgesia , Joanete , Hallux Valgus , Adulto , Idoso , Idoso de 80 Anos ou mais , Anestesia Local , Estudos de Viabilidade , Feminino , Hallux Valgus/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/tratamento farmacológico , Adulto Jovem
10.
Orthop Surg ; 13(5): 1540-1545, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34086401

RESUMO

OBJECTIVES: To describe the technique of the aorta balloon occlusion, and evaluate the blood loss in lumbar spine tumor surgery assisted by aortic balloon occlusion, and to observe the balloon-related complications. METHODS: Six patients with lumbar spine tumor underwent resuscitative endovascular balloon occlusion of the aorta prior to tumor resections in our institution between May 2018 to January 2021. Medical records including demographic, diagnosis, tumor location, surgical approach, intraoperative blood loss, surgical duration, and perioperative balloon-related complication were evaluated retrospectively. RESULTS: This series included four males and two females, with a median age of 50 years (range 22 to 69). Of these, three primary tumors were plasmacytoma, giant cell tumor of bone, and osteosarcoma, while recurrence of undifferentiated pleomorphic sarcoma (UPS), recurrence of giant cell tumor of bone (GCT), and metastatic thyroid cancer were diagnosed in cases 1, 6, and 2, respectively. L2 was involved in cases 1 and 5. L3 was involved in case 6. L4 was involved in case 2, 3, and 6. L5 was involved in case 4. One-stage total en bloc resection surgery (TES) was accomplished in all patients; of this series, signal anterior approach was conducted in case 1, signal posterior approach was utilized in cases 2, 3, and 6, while combined anterior and posterior approach was performed in cases 4 and 5. The median intraoperative blood loss was 1683 mL and ranged from 400 to 3200 mL with a median surgical duration of 442 min and a range from 210 to 810 min. During the perioperative period, no serious balloon-related complications occurred. CONCLUSIONS: Endovascular balloon occlusion of the aorta successfully controls intraoperative exsanguination, contributing to a more radical tumor resection and a low rate of tumor cell contamination in lumbar tumor surgery.


Assuntos
Oclusão com Balão/métodos , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Endovasculares/métodos , Vértebras Lombares/irrigação sanguínea , Vértebras Lombares/cirurgia , Neoplasias da Coluna Vertebral/irrigação sanguínea , Neoplasias da Coluna Vertebral/cirurgia , Adulto , Idoso , Aorta , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
11.
Cell Prolif ; 54(4): e12989, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33609051

RESUMO

OBJECTIVES: Our aim was to investigate the prevalence and predictive variables of sarcopenia. METHODS: We recruited participants from the Peking Union Medical College Hospital Multicenter Prospective Longitudinal Sarcopenia Study (PPLSS). Muscle mass was quantified using bioimpedance, and muscle function was quantified using grip strength and gait speed. Logistic regression revealed the relationships between sarcopenia and nutritional, lifestyle, disease, psychosocial and physical variables. RESULTS: The prevalence of sarcopenia and sarcopenic obesity was 9.2%-16.2% and 0.26%-9.1%, respectively. Old age, single status, undernourishment, higher income, smoking, low physical activity, poor appetite and low protein diets were significantly associated with sarcopenia. Multiple logistic regression analysis showed that age was a risk factor for all stages of sarcopenia, and participants above 80 years were greater than fivefold more susceptible to sarcopenia, while lower physical activity was an independent risk factor. The optimal cut-off value for age was 71 years, which departs from the commonly accepted cut-off of 60 years. Female participants were greater than twofold less susceptible to sarcopenia than male participants. The sterol derivative 25-hydroxyvitamin D was associated with fourfold lower odds of sarcopenia in male participants. Several protein intake variables were also correlated with sarcopenia. Based on these parameters, we defined a highly predictive index for sarcopenia. CONCLUSIONS: Our findings support a predictive index of sarcopenia, which agglomerates the complex influences that sterol metabolism and nutrition exert on male vs female participants.


Assuntos
Proteínas/metabolismo , Sarcopenia/patologia , Esteróis/metabolismo , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Calcifediol/metabolismo , China/epidemiologia , Exercício Físico , Feminino , Humanos , Modelos Logísticos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Curva ROC , Fatores de Risco , Sarcopenia/epidemiologia , Fatores Sexuais , Testosterona/análise
12.
Medicine (Baltimore) ; 99(2): e18623, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31914042

RESUMO

BACKGROUND: The surgical management of acute malignant left-sided bowel obstruction is associated with high morbidity and mortality. Recently, transanal drainage tubes (DTs) and metallic stents (MSs) used as a "bridge to surgery" have become widely used decompression methods compared with emergency surgery. This study aims to evaluate the efficacy and safety of DTs and MSs for the decompression of acute left-sided malignant colorectal obstruction. METHODS: All studies were acquired from PubMed, Medline, Embase, CNKI and the Cochrane Library. The data were extracted by two of the coauthors independently and were analyzed with RevMan5.3. Mean differences (MDs), odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. The Cochrane Collaboration's risk of bias tool and the Newcastle-Ottawa scale were used to assess the risk of bias. RESULTS: Eleven studies, which included three randomized controlled trials (RCTs) and 8 observational studies, were assessed. The methodological quality of the trials ranged from low to moderate. The pooled results of the technical success rate showed that the difference was not statistically significant between the2 devises. The differences in clinical success rate, operative time and complications were statistically significant between MSs and DTs, and MSs were associated with a better clinical success rate, increased operative time and fewer complications. Sensitivity analysis proved the stability of the pooled results, and the publication bias was low. CONCLUSION: MS insertion for acute left-sided malignant bowel obstruction is effective and safe with a better technical success rate and with fewer complications than decompression using a DT, and MS insertion can avoid stoma formation. Moreover, MS insertion appears to be a useful treatment strategy for malignant colonic obstruction even if the lesion is located in the right colon. More large-sample, multicenter, high-quality RCTs are needed to verify the outcomes of this meta-analysis.


Assuntos
Neoplasias Colorretais/complicações , Drenagem/instrumentação , Obstrução Intestinal/etiologia , Obstrução Intestinal/cirurgia , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Complicações Pós-Operatórias/epidemiologia
13.
J Org Chem ; 83(21): 13121-13131, 2018 11 02.
Artigo em Inglês | MEDLINE | ID: mdl-30351938

RESUMO

A practical metal-free oxidative Ugi-type three-component assembly has been achieved efficiently, employing a tertiary-amine-derived iminium ion as an imine surrogate, N-hydroxyimide as an acid surrogate, and DEAD as an oxidant. This dual-surrogate Ugi variant proceeded with a broad substrate scope and desired functional group tolerance, leading to a wide range of N-alkyl- N-acyl aminophthalimide and N-alkyl- N-acylaminosuccinimide derivatives in good isolated yields.

14.
Chin Med J (Engl) ; 131(3): 289-294, 2018 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-29363643

RESUMO

BACKGROUND: Pelvic floor peritoneum reconstruction is a key step in various standard resections for open radical rectal cancer. However, during endoscopic surgery, most surgeons do not close the pelvic floor peritoneum. This study aims to evaluate the efficacy of pelvic peritonization during laparoscopic Dixon surgery using an observational study. METHODS: A total of 189 patients, who underwent laparoscopic Dixon surgery at Tianjin Union Medical Center, China, were analyzed retrospectively. All of the cases were divided into two groups according to the differences of surgical procedure. The 92 patients in Group A (observation group) underwent pelvic peritonization and the 97 patients in Group B (control group) did not undergo this procedure. Postoperative complications were observed in the two groups, compared, and analyzed using the Chi-square or Fisher's exact test. RESULTS: The incidence of anastomotic leakage was significantly lower in Group A than in Group B (P = 0.014). A significant difference was found in the postoperative short-term (P = 0.029) and long-term (P = 0.029) ileus rates between the two groups, with Group A exhibiting a lower rate than Group B. Patients in Group A had significantly lower rates of postoperative infections than those in Group B (χ2 = 7.606, P = 0.006; χ2 = 4.464, P = 0.035). Patients in Group A had significantly lower rates of deep venous thrombosis than those in Group B (χ2 = 8.531, P = 0.003). CONCLUSIONS: Pelvic peritonization effectively reduces postoperative complications, such as anastomotic leakage, which warrants its increased use in laparoscopic surgery.


Assuntos
Peritônio/cirurgia , Neoplasias Retais/cirurgia , Idoso , Fístula Anastomótica/prevenção & controle , Feminino , Humanos , Íleus/prevenção & controle , Laparoscopia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/prevenção & controle , Período Pós-Operatório , Estudos Retrospectivos , Medição de Risco , Fatores de Tempo , Resultado do Tratamento
15.
J Antimicrob Chemother ; 69(12): 3379-86, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25151205

RESUMO

OBJECTIVES: Our purpose was to evaluate ertapenem versus ceftriaxone/metronidazole for prophylaxis of surgical site infections (SSIs) following elective colorectal surgery in Chinese adult patients. METHODS: Eligible Chinese adults aged 18-80 years scheduled to undergo elective colorectal surgery by laparotomy were randomized to receive a 30 min infusion of 1 g of ertapenem/metronidazole placebo or 2 g of ceftriaxone/500 mg of metronidazole within 2 h before initial incision. The study endpoint was the proportion of patients with successful prophylaxis at 4 weeks after treatment. The primary analysis was based on the evaluable population (PP population) and the pre-specified non-inferiority margin was set at -15%. ClinicalTrials.gov: NCT01254344. RESULTS: Of 599 patients randomized, 499 (251 ertapenem and 248 ceftriaxone) were eligible for inclusion in the PP population. The proportions of patients with successful prophylaxis in the ertapenem and ceftriaxone groups were 90.4% (227/251) and 90.3% (224/248), respectively. The difference in the proportion of successful outcomes was 0.1% (95% CI -5.2%, 5.5%). Unexplained antibiotic use was the most frequent reason for prophylaxis failure in both groups [ertapenem 4.8% (12/251), ceftriaxone 4.4% (11/248); difference 0.3%; 95% CI -3.6, 4.3]. Pathogen species isolated from SSI sources were consistent with previously conducted studies and the product package insert. The incidence of adverse events (AEs) was similar between the groups, with the most common AE being pyrexia [ertapenem 7.6% (22/290), ceftriaxone 5.7% (17/297)]. CONCLUSIONS: Ertapenem is as effective as ceftriaxone/metronidazole for SSI prophylaxis in patients undergoing elective colorectal surgery, and is well tolerated.


Assuntos
Antibacterianos/administração & dosagem , Antibioticoprofilaxia/métodos , Cirurgia Colorretal/efeitos adversos , Infecção da Ferida Cirúrgica/prevenção & controle , beta-Lactamas/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ceftriaxona/administração & dosagem , China , Cirurgia Colorretal/métodos , Método Duplo-Cego , Ertapenem , Feminino , Humanos , Infusões Intravenosas , Laparotomia/efeitos adversos , Laparotomia/métodos , Masculino , Metronidazol/administração & dosagem , Pessoa de Meia-Idade , Placebos/administração & dosagem , Resultado do Tratamento , Adulto Jovem
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