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INTRODUCTION: The results from the phase 3 study that evaluated the efficacy and safety of tedizolid phosphate, an oxazolidinone drug, for the treatment of gram-positive ventilated hospital-acquired bacterial pneumonia (vHABP)/ventilator-associated bacterial pneumonia (VABP) compared with linezolid (VITAL study), have been previously reported. We conducted a subgroup analysis to report the data obtained from Japanese patients enrolled in this study. METHODS: Patients aged ≥18 years with vHABP/VABP likely to be caused by gram-positive cocci were randomized 1:1 to tedizolid phosphate 200 mg once daily for 7 days or linezolid 600 mg twice daily for 10 days. In both treatment groups, patients with concurrent gram-positive bacteremia were treated for 14 days. Primary efficacy endpoints were day 28 all-cause mortality (ACM) and investigator-assessed clinical response at test-of-cure (TOC) in the intention-to-treat population. Safety outcomes included assessment of treatment-emergent adverse events. RESULTS: Fifty-three Japanese patients were randomized at received study drug (tedizolid, n = 28; linezolid, n = 25). Demographics and characteristics were generally similar between treatment groups. Rates of day 28 ACM were 10.7% and 20.0% with tedizolid and linezolid, respectively (difference, 9.3%; 95% CI, -10.1 to 28.7). Rates of investigator-assessed clinical cure at TOC were 78.6% and 72.0% with tedizolid and linezolid, respectively (difference, 6.6%; 95% CI, -16.7 to 29.8). Tedizolid phosphate was generally well tolerated and no new safety concerns were observed in the Japanese subgroup. CONCLUSION: The results from this subgroup analysis suggest generally favorable efficacy and safety of tedizolid in adult Japanese patients with vHABP/VABP. (ClinicalTrials.gov identifier: NCT02019420).
Subject(s)
Oxazolidinones , Pneumonia, Bacterial , Pneumonia, Ventilator-Associated , Skin Diseases, Bacterial , Adolescent , Adult , Anti-Bacterial Agents/adverse effects , Bacteria , Double-Blind Method , Hospitals , Humans , Japan , Linezolid/adverse effects , Organophosphates , Oxazolidinones/adverse effects , Pneumonia, Bacterial/drug therapy , Pneumonia, Ventilator-Associated/drug therapy , Skin Diseases, Bacterial/drug therapy , Tetrazoles , Ventilators, MechanicalABSTRACT
Inappropriate antimicrobial therapy for surgical site infections (SSIs) can lead to poor outcomes and an increased risk of antibiotic resistance. A nationwide survey was conducted in Japan from 2018 to 2019 to investigate the antimicrobial susceptibility of pathogens isolated from SSIs. The data were compared with those obtained in 2010 and 2014-2015 surveillance studies. Although the rate of detection of extended-spectrum ß-lactamase producing strains of Escherichia coli was increased from 9.5% in 2010 to 23% in 2014-2015, the incidence decreased to 8.7% in 2018-2019. Although high susceptibility rates were detected to piperacillin/tazobactam (TAZ), the geometric mean MICs were substantially higher than to meropenem (2.67 vs 0.08 µg/mL). By contrast, relatively low geometric mean MICs (0.397 µg/mL) were demonstrated for ceftolozane/TAZ. Although the MRSA incidence rate decreased from 72% in the first surveillance to 53% in the second, no further decrease was detected in 2018-2019. For the Bacteroides fragilis group species, low levels of susceptibility were observed for moxifloxacin (65.3%), cefoxitin (65.3%), and clindamycin (CLDM) (38.9%). In particular, low susceptibility against cefoxitin was demonstrated in non-fragilis Bacteroides, especially B. thetaiotaomicron. By contrast, low susceptibility rates against CLDM were demonstrated in both B. fragilis and non-fragilis Bacteroides species, and a steady decrease in susceptibility throughout was observed (59.3% in 2010, 46.9% in 2014-2015, and 38.9% in 2018-2019). In conclusion, Japanese surveillance data revealed no significant lowering of antibiotic susceptibility over the past decade in organisms commonly associated from SSIs, with the exception of the B. fragilis group.
Subject(s)
Bacteroides fragilis , Surgical Wound Infection , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Humans , Japan/epidemiology , Microbial Sensitivity Tests , Surgical Wound Infection/drug therapy , Surgical Wound Infection/epidemiologyABSTRACT
BACKGROUND: Excrement containing antimicrobial-resistant bacteria (ARB) is discharged from the hospital sewage through wastewater treatment plants (WWTP) into rivers, increasing the antimicrobial resistance (AMR) burden on the environment. PURPOSE: We illustrate the contamination of hospital sewage tanks with ARB harboring antimicrobial resistance genes (ARGs) using comprehensive metagenomic sequencing. During the study period, we moved to a new hospital building constructed for renovation. Therefore, we investigated the difference in bacterial flora in the sewage tanks for each building with different departments, and the change in bacterial flora over time in new sewage tanks. Furthermore, we performed a comparative genome analysis of extended spectrum ß-lactamase (ESBL)-producing organisms (EPOs) from hospital sewage and clinical samples. Residual antibiotics in the sewage tank were also measured. METHODS: Metagenomic analysis was performed on the hospital sewage samples, followed by whole genome sequencing of EPOs. RESULTS: The bacterial composition of new sewage tanks was comparable with that of old tanks within 1 month after relocation and was instantly affected by excrement. The bacterial composition of sewage tanks in the old and new buildings, containing rooms where seriously ill patients were treated, was similar. Selection on CHROMagar ESBL allowed detection of EPOs harboring bla CTX-M and carbapenemase genes in all sewage tanks. One of the sewage Escherichia coli strain comprising ST393 harboring bla CTX-M-27 corresponded to the clinical isolates based on core genome analysis. Moreover, the levels of levofloxacin and clarithromycin in the hospital sewage were 0.0325 and 0.0135 µg/mL, respectively. CONCLUSION: Hospital sewage was contaminated with many ARB species, ARGs and residual antibiotics, which can cause a burden on WWTP sewage treatment. The bacterial flora in the sewage tank was rapidly affected, especially by the ward with seriously ill patients. AMR monitoring of hospital sewage may help detect carriers prior to nosocomial ARB-associated outbreaks and control the outbreaks.
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PURPOSE: To analyze the impact of postoperative remote infections (PRIs) on medical expenditure. METHODS: The subjects of this retrospective study were 338 patients who had undergone gastroenterological surgery at one of the 20 Japanese institutions within the Japan Society for Surgical Infection (JSSI) and mainly authorized as educational institutions. The patients were allocated to 169 pairs of those with a PRI (PRI (+) group) matched with those without a PRI (PRI (-) group). PRIs included pneumonia, urinary tract infection (UTI), catheter-associated blood stream infection (CA-BSI), and antibiotic-associated enteritis. RESULTS: SSI developed in 74 of the 338 patients (22 without PRI and 52 with PRI). The SSI incidence was significantly higher in the PRI (+) group (p < 0.001). The difference in the median postoperative length of hospital stay was 15 days, indicating a significant prolongation in the PRI (+) group (p < 0.001). The PRI (+) group also had a higher rate of inter-hospital transfer (p < 0.01) and mortality (p < 0.001). Similarly, the difference in median postoperative medical fees was $6832.3, representing a significant increase in the PRI (+) group (p < 0.001). CONCLUSIONS: The postoperative length of hospital stay is longer and the postoperative medical expenditure is higher for patients with a PRI than for those without a PRI.
Subject(s)
Digestive System Surgical Procedures/adverse effects , Health Expenditures , Hospitalization/economics , Infections/economics , Length of Stay/economics , Postoperative Complications/economics , Adult , Aged , Aged, 80 and over , Female , Humans , Incidence , Infections/epidemiology , Infections/etiology , Japan/epidemiology , Male , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiologyABSTRACT
BACKGROUND: The guidelines for the prevention, detection, and management of gastroenterological surgical site infections (SSIs) were published in Japanese by the Japan Society for Surgical Infection in 2018. This is a summary of these guidelines for medical professionals worldwide. METHODS: We conducted a systematic review and comprehensive evaluation of the evidence for diagnosis and treatment of gastroenterological SSIs, based on the concepts of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. The strength of recommendations was graded and voted using the Delphi method and the nominal group technique. Modifications were made to the guidelines in response to feedback from the general public and relevant medical societies. RESULTS: There were 44 questions prepared in seven subject areas, for which 51 recommendations were made. The seven subject areas were: definition and etiology, diagnosis, preoperative management, prophylactic antibiotics, intraoperative management, perioperative management, and wound management. According to the GRADE system, we evaluated the body of evidence for each clinical question. Based on the results of the meta-analysis, recommendations were graded using the Delphi method to generate useful information. The final version of the recommendations was published in 2018, in Japanese. CONCLUSIONS: The Japanese Guidelines for the prevention, detection, and management of gastroenterological SSI were published in 2018 to provide useful information for clinicians and improve the clinical outcome of patients.
Subject(s)
Digestive System Surgical Procedures/adverse effects , Practice Guidelines as Topic , Societies, Medical/organization & administration , Surgical Wound Infection/prevention & control , Surgical Wound Infection/therapy , Antibiotic Prophylaxis , Humans , Japan , Perioperative Care , Surgical Wound Infection/diagnosis , Surgical Wound Infection/etiologyABSTRACT
BACKGROUND: Most surveillance programs for postoperative infection focus on surgical site infections (SSI). However, postoperative remote infections are of emerging clinical importance. Using data from a multicenter survey administered to patients who underwent gastrointestinal surgery, we investigated the incidence of SSI and remote infection after colorectal surgery. METHODS: From September 2015 through March 2016, 1,724 patients underwent colorectal surgery in 28 affiliated centers in Japan. We retrospectively recorded patient age, sex, surgical site, surgical approach, wound classification, performance status at discharge, and postoperative infection status. RESULTS: Postoperative infection was noted in 236 (13.7%) patients; 150 and 86 patients underwent colon and rectal surgeries, respectively (incidence of postoperative infection: 13.7% and 14.8%). The incidence of postoperative infection was significantly lower after laparoscopic surgery than after open surgery, in colon and rectal surgery (p < 0.001). Among patients with postoperative infections, 211 (89.4%) had a single infection and 25 (10.6%) had multiple infections. Among patients with a single postoperative infection, SSI and remote infection occurred in 143 (60.6%) and 68 (28.8%) patients, respectively. The most common multiple postoperative infections were "incisional and organ/space SSIs" and "organ/space SSI and bacteremia of unknown origin" (n = 3 each). CONCLUSIONS: This study revealed the prevalence distributions for postoperative SSI and remote infections. Because of the substantial effect of remote infections on patient quality of life and the associated social burden, prospective periodic surveillance for SSI and remote infection is necessary for careful evaluation and prevention.
Subject(s)
Colon/surgery , Communicable Diseases/epidemiology , Digestive System Surgical Procedures/adverse effects , Postoperative Complications/epidemiology , Rectum/surgery , Surgical Wound Infection/epidemiology , Adult , Aged , Aged, 80 and over , Data Analysis , Databases, Factual , Female , Humans , Incidence , Japan/epidemiology , Male , Middle Aged , Postoperative Complications/prevention & control , Retrospective Studies , Surgical Wound Infection/prevention & control , Time Factors , Young AdultABSTRACT
BACKGROUND: Postoperative infections can be classified as surgical site infections and remote infections. Postoperative respiratory tract infections (PRTI) are a type of remote infection and may be associated with prolonged hospitalization and increased medical expenses. This study compared postoperative duration of hospitalization and medical expenses between patients with and without PRTI after gastrointestinal surgery. METHODS: We retrospectively analyzed data from a multicenter study of centers affiliated with the Japan Society for Surgical Infection and used 1-to-1 matching analysis to evaluate 86 patients who underwent gastrointestinal surgery during the period from March 1, 2014 through February 29, 2016. RESULTS: Duration of postoperative hospitalization was significantly longer for patients with PRTI (38.6 days) than for those without PRTI (16.1 days), and postoperative medical expenses were significantly higher for patients with PRTI (1388.2 USD) than for those without PRTI (629.4 USD). CONCLUSIONS: Duration of hospitalization is longer and medical expenses are higher for patients that develop surgical site infections. This study found that this was also the case for patients with PRTI after gastrointestinal surgery. However, further studies are needed in order to confirm these results.
Subject(s)
Digestive System Surgical Procedures/adverse effects , Health Care Costs , Hospitalization/economics , Length of Stay/economics , Postoperative Complications/economics , Postoperative Complications/etiology , Respiratory Tract Infections/economics , Respiratory Tract Infections/etiology , Data Analysis , Female , Humans , Japan , Male , Multicenter Studies as Topic , Retrospective Studies , Surgical Wound Infection/economics , Surgical Wound Infection/etiologyABSTRACT
INTRODUCTION: The aim of this study was to compare surgical outcomes and hospitalization costs between immediate surgery and non-operative management followed by interval appendectomy in adults presenting with appendicitis with abscess. METHODS: From 2003 to 2015, 3316 patients presented with appendicitis, including 101 who presented with appendicular abscess. Between 2003 and 2006, 33 patients with appendicular abscess were managed with emergency operations (emergency group). Non-operative management followed by interval appendectomy was implemented in 2007 and offered to 68 patients during the study period. Of these patients, 64 patients underwent the procedure (interval group), and 4 patients refused. RESULTS: Non-operative management was successful in 76.6% of cases (49/64 patients) in the interval group. Operative time and length of hospital stay were similar between the emergency and interval groups. In the interval group, blood loss, the need for extended resection, and overall postoperative morbidity were significantly lower than in the emergency group (P < 0.01, respectively). Medical costs for surgery in the interval group were lower than in the emergency group ($4512 vs $6888, P = 0.002), but this group's total medical costs were higher ($9591 vs $6888, P < 0.01). CONCLUSION: The interval strategy is associated with a reduced need for extended resection, lower postoperative morbidity, and a shorter length of hospital stay. However, total medical costs for the interval strategy are higher than those for emergency operations in cases of appendicular abscess in adults.
Subject(s)
Abscess/therapy , Appendectomy , Appendicitis/therapy , Health Care Costs , Time-to-Treatment/economics , Abscess/etiology , Adolescent , Adult , Aged , Appendicitis/complications , Cohort Studies , Female , Hospitalization/economics , Humans , Japan , Male , Middle Aged , Operative Time , Retrospective Studies , Treatment Outcome , Young AdultABSTRACT
PURPOSE: We herein report the findings of the Japan Postoperative Infectious Complication Survey in 2015 (JPICS'15), which evaluated the rate of post-operative infections and colonization due to antimicrobial-resistant (AMR) bacteria after digestive tract surgery. METHODS: This survey by the Japan Society of Surgical Infection included patients undergoing digestive tract surgery at 28 centers between September 2015 and March 2016. Data included patient background characteristics, type of surgery, contamination status, and type of post-operative infections, including surgical site infections (SSIs), remote infections (RIs), and colonization. RESULTS: During the study period, 7,565 surgeries (of 896 types) were performed; among them, 905 cases demonstrated bacteria after digestive tract surgery. The survey revealed that post-operative infections or colonization by AMR bacteria occurred in 0.9% of the patient cohort, constituting 7.5% of post-operative infections, including 5.6% of SSIs and 1.8% of RIs. Extended-spectrum ß-lactamase-producing Enterobacteriaceae and methicillin-resistant Staphylococcus aureus were the predominant AMR bacteria isolated from patients after digestive tract surgery. Patients infected with AMR bacteria had a poor prognosis. CONCLUSION: Our results reveal that 7.5% of the post-operative infections were due to AMR bacteria, indicating the need for antibacterial coverage against AMR bacteria in patients with critical post-operative infections.
Subject(s)
Bacterial Infections/epidemiology , Bacterial Infections/microbiology , Digestive System Surgical Procedures/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/microbiology , Surgical Wound Infection/epidemiology , Surgical Wound Infection/microbiology , Adult , Aged , Anti-Bacterial Agents/administration & dosage , Antibiotic Prophylaxis , Cohort Studies , Drug Resistance, Bacterial , Enterobacteriaceae/isolation & purification , Female , Humans , Japan/epidemiology , Male , Methicillin-Resistant Staphylococcus aureus/isolation & purification , Middle Aged , Postoperative Complications/prevention & control , Prognosis , Time FactorsABSTRACT
PURPOSE: To investigate changes in the incidence of postoperative infections in the surgical department of a teaching hospital. METHODS: During the 30-year period from September 1987 to August 2017, 11,568 gastroenterological surgical procedures were performed in our surgical department. This 30-year period was divided into seven periods (A-G), ranging from 2 to 7 years each and based on the infection control methods used in each period. We then compared the rates of incisional surgical site infection (SSI) and organ/space SSI; remote infection (RI) including respiratory tract infection (RTI), intravascular catheter-related infection, and urinary tract infection (UTI); and antibiotic-associated colitis caused by methicillin-resistant Staphylococcus aureus (MRSA) enteritis or Clostridioides (Clostridium) difficile-associated disease (CDAD) among the seven periods. RESULTS: In periods B (September 1990-August 1997) and E (November 2004-July 2007), when a unique antibiotic therapy devised in our department was in use, MRSA was isolated from only 0.3% and 0.4% of surgical patients, respectively, and these rates were significantly lower than those in the other periods (p < 0.05). The rate of CDAD increased during period F (August 2007-July 2014), but in period G (August 2014-August 2017), restrictions were placed on the use of antibiotics with a strong anti-anaerobic action and, in this period, the rate of CDAD was only 0.04%, which was significantly lower than that in period F (p < 0.05). CONCLUSIONS: Limiting the use of antibiotics that tend to disrupt the intestinal flora may reduce the rates of MRSA infection and CDAD after gastroenterological surgery.
Subject(s)
Clostridioides difficile , Clostridium Infections/prevention & control , Digestive System Surgical Procedures , Methicillin-Resistant Staphylococcus aureus , Postoperative Complications/prevention & control , Staphylococcal Infections/prevention & control , Clostridium Infections/microbiology , Humans , Staphylococcal Infections/microbiology , Time FactorsABSTRACT
AIM: To survey postoperative infections (PI) after digestive surgery. METHODS: This survey, conducted by the Japan Society of Surgical Infection, included patients undergoing digestive surgery at 28 centers between September 2015 and March 2016. Data collected included patient background characteristics, type of surgery, contamination status, and type of PI, including surgical site infection (SSI), remote infection (RI), and antimicrobial-resistant (AMR) bacterial infections and colonization. RESULTS: Postoperative infections occurred in 10.7% of 6582 patients who underwent digestive surgery (6.8% for endoscopic surgery and 18.7% for open surgery). SSI and RI, including respiratory tract infection, urinary tract infection, antibiotic-associated diarrhea, drain infection, and catheter-related bloodstream infection, occurred in 8.9% and 3.7% of patients, respectively. Among all PI, 13.2% were overlapping infections. The most common overlapping infections were incisional and organ/space SSI, which occurred in 4.2% of patients. AMR bacterial infections occurred in 1.2% of patients after digestive surgery and comprised 11.5% of all PI. Rate of AMR bacterial colonization after digestive surgery was only 0.3%. CONCLUSION: Periodic surveillance of PI, including AMR bacteria, is necessary for a detailed evaluation of nosocomial infections.
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To improve the image quality of photon-counting energy-dispersive X-ray computed tomography (CT) and to reduce the incident dose for the object, we have developed a low-dose low-scattering CT scanner with high-spatial and -energy resolutions using a cooled cadmium telluride (CdTe) detector. X-ray photons are absorbed by the CdTe crystal, and the event pulses from the shaping amplifier are input to a high-speed triple-energy (TE) counter. In the TE-CT, four 3.0-mm-thick lead (Pb) pinholes are used. The line-beam diameter is roughly reduced using the first 2.0-mm-diam pinhole. Using the second 0.5-mm-diam pinhole, the line-beam diameter is reduced again, and the 0.5-mm-diam line beam is exposed to the object. The scattering photon count was reduced using the third 0.5-mm-diam pinhole, and the only penetrating photons are absorbed by the cooled CdTe crystal through the fourth 0.3-mm-diam pinhole for improving the spatial resolution. K-edge tomograms using iodine (I) and gadolinium (Gd) media were obtained simultaneously at two energy ranges of 33-50 and 50-100â¯keV, respectively. Utilizing I-K-edge CT, coronary arteries filled with I medium were visible. Next, blood vessels filled with Gd medium were observed at high contrasts using Gd-K-edge CT. The maximum count rate was 30 kilocounts per second (kcps) at a tube current of 0.33â¯mA, and the minimum count rate after penetrating objects was approximately 2 kcps. The maximum incident dose for the object was approximately 0.3 mGy, and the exposure time for TE-CT was 19.6â¯min at a total rotation angle of 360°. The energy resolution of the detector was 1.1% at 59.5â¯keV, and the spatial resolutions had values of 0.3â¯×â¯0.3 mm2.
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INTRODUCTION: Here we report a prospective study on whether a temporary suprapubic catheter (SPC) can be safely inserted as a substitute for transurethral balloon catheterization during laparoscopy-assisted colectomy. METHODS: Our subjects included 52 cases who gave informed consent to have an SPC inserted. These subjects were selected from cases who underwent laparoscopy-assisted surgery for primary colorectal cancer from October 2014 to August 2015. RESULTS: An SPC was inserted into 45 of the original 52 cases. The median surgical duration was 220 min (range, 11-438 min), and the SPC insertion was performed at a median of 133 min (range, 9-384 min) after the start of surgery. Insertion required a median duration of 116 s. In one case (2.2%), the bladder was perforated by the paracentesis needle, and in two cases (4.4%), hematuria was observed at the time of insertion; however, surgery was completed without any incident in these three cases. Six of the remaining 42 cases (13.3%) demonstrated neither micturition desire nor independent urination on the day the catheter was clamped. In these cases, the clamp was released two to four times, and draining of an average of 586-mL urine, micturition desire, and independent urination were confirmed 2-4 days later. CONCLUSION: Transurethral balloon catheterization is a simple procedure that is commonly used on surgical patients, but it can cause pain, discomfort, and infection. In contrast, SPC insertion is a procedure that avoids crossing the urethra and its associated disadvantages. Here we were able to demonstrate that the procedure can be safely used in laparoscopic surgery patients.
Subject(s)
Colectomy , Colorectal Neoplasms/surgery , Intraoperative Care/methods , Laparoscopy , Urinary Catheterization/methods , Adult , Aged , Aged, 80 and over , Feasibility Studies , Female , Humans , Male , Middle Aged , Operative Time , Prospective Studies , Time FactorsABSTRACT
Esophageal carcinosarcoma is a rare malignant tumor. A 76-year-old man consulted near hospital about dysphagia. A gastrointestinal fiberscopy showed a stricture of the thoracic esophagus at approximately 34 cm from the incisor, and the macroscopic type of the tumor was 0-Ip. Biopsy results indicated carcinosarcoma. The patient underwent esophagectomy and regional lymphadenectomy with gastric tube reconstruction by laparoscopy-assisted surgery and thoracotomy. Pathological examination of the surgical specimen revealed that the majority of the tumor was composed of spindle-shaped atypical cells, but because a very small transitional area between squamous cell carcinoma and sarcoma was noted, a diagnosis of carcinosarcoma was made. The depth of invasion was small, and no region lymph node metastasis was detected. We classified the tumor as pT1b(SM)N0M0, pStage I. Immunohistochemically, the spindle-shaped sarcomatous cells displayed a posi- tive reaction to vimentin and cytokeratin AE1/AE3. Ki -67(MIB-1)labeling index was high. The patient was discharged after an uneventful postoperative course and remains well as an outpatient at his 6-month follow-up. We report this case with a review of the literature.
Subject(s)
Carcinosarcoma/surgery , Esophageal Neoplasms/surgery , Esophageal Stenosis/etiology , Aged , Carcinoma, Squamous Cell/complications , Carcinoma, Squamous Cell/surgery , Carcinosarcoma/complications , Deglutition Disorders/etiology , Esophageal Neoplasms/complications , Esophageal Neoplasms/pathology , Esophageal Stenosis/surgery , Esophagectomy , Humans , Male , Treatment OutcomeABSTRACT
Orbital metastasis of gastric cancer occurs very rarely.A 76-year-old woman, who consulted another doctor with the chief complaints of palpitation, shortness of breath, and anorexia 1 month previously, was referred to our clinic for workup and treatment.Workup revealed type III advanced gastric cancer at the lesser curvature of the gastric antrum.Biopsy revealed a diagnosis of poorly differentiated adenocarcinoma.As computed tomography suggested periaortic lymph node metastasis, a diagnosis of T4a(SE)N3aM1(LYM), cStage IV was made.Two weeks later, ptosis was observed in the right eye, and positron emission tomography-computed tomography(PET-CT)revealed metastasis to the right superior rectus muscle.No intracranial tumor progression was observed.The Cyberknife system(20 Gy/1 Fr)was used for treating the orbital tumor. Increased LYM was observed even after 2 courses of S-1 plus oxaliplatin(SOX)therapy.Therefore, weekly combination therapy of paclitaxel and ramucirumab(wPTX plus Rmab)was administered as second-line therapy.No new distal metastasis has been detected in the 10 months since the orbital metastasis development, and the patient is still alive.
Subject(s)
Adenocarcinoma/secondary , Adenocarcinoma/therapy , Blepharoptosis/etiology , Orbital Neoplasms/secondary , Orbital Neoplasms/therapy , Stomach Neoplasms/pathology , Stomach Neoplasms/therapy , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemoradiotherapy , Female , HumansABSTRACT
We assessed the efficacy and safety of fidaxomicin, a narrow-spectrum macrocyclic antibiotic, for treating inpatients with Clostridioides (Clostridium) difficile infection (CDI) in Japan. The objective was to demonstrate the non-inferior efficacy of fidaxomicin versus vancomycin. This Phase III, vancomycin-controlled, double-blind, parallel-group study enrolled adults with CDI. Patients were randomly assigned to receive fidaxomicin (200 mg twice daily, orally) or vancomycin (125 mg four-times daily, orally) for 10 days. The primary endpoint was global cure rate of CDI (proportion of patients cured at end of treatment with no recurrence during 28-day follow-up). Non-inferiority margin of 10% was pre-specified. Two-hundred and twelve patients were randomized and received treatment at 82 hospitals. Global cure rate was 67.3% (70/104) with fidaxomicin and 65.7% (71/108) with vancomycin: difference 1.2% [95% confidence interval (CI) -11.3-13.7]. Non-inferiority was not demonstrated. Post-hoc analysis in full analysis set patients who received at least 3 days' treatment revealed a higher global cure rate for fidaxomicin [70/97 (72.2%)] than vancomycin [71/106 (67.0%)]: difference 4.6% (95% CI -7.9-17.1). Recurrence rate in the full analysis set for recurrence was lower in fidaxomicin- [17/87 (19.5%)] than vancomycin-treated [24/95 (25.3%)] patients. Adverse event incidences and profiles were similar for both treatments. Though non-inferiority was not demonstrated for fidaxomicin versus vancomycin, global cure rate was numerically higher and recurrence rate lower for fidaxomicin than vancomycin. Fidaxomicin could be an option for the treatment of CDI in an era of reduced antibiotic susceptibility, and to reduce the incidence of recurrence in Japanese patients. CLINICALTRIALS. GOV IDENTIFIER: NCT02179658.
Subject(s)
Aminoglycosides/adverse effects , Aminoglycosides/therapeutic use , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/therapeutic use , Clostridium Infections/drug therapy , Adult , Aged , Aged, 80 and over , Clostridioides difficile/drug effects , Double-Blind Method , Female , Fidaxomicin , Hospitalization , Humans , Japan , Male , Middle Aged , Recurrence , Secondary Prevention , Treatment Outcome , Vancomycin/adverse effects , Vancomycin/therapeutic use , Young AdultABSTRACT
The principle of empirical therapy for patients with intra-abdominal infections (IAI) should include antibiotics with activity against Enterobacteriaceae and Bacteroides fragilis group species. Coverage of Pseudomonas aeruginosa, Enterobacter cloacae, and Enterococcus faecalis is also recommended for hospital-associated IAI. A nationwide survey was conducted to investigate the antimicrobial susceptibility of pathogens isolated from postoperative IAI. All 504 isolates were collected at 26 institutions and referred to a central laboratory for susceptibility testing. Lower susceptibility rates to ciprofloxacin and cefepime were demonstrated in Escherichia coli. Among E. coli, 24.1% of strains produced extended-spectrum ß-lactamase (ESBL). Carbapenems, piperacillin/tazobactam, cephamycins/oxacephem, aminoglycosides, and tigecycline had high activity against E. coli, including ESBL-producing isolates. Among E. cloacae, low susceptibility rates to ceftazidime were demonstrated, whereas cefepime retained its activity. P. aeruginosa revealed high susceptibility rates to all antimicrobials tested except for imipenem. Among B. fragilis group species, low levels of susceptibility were observed for cefoxitin, moxifloxacin, and clindamycin, and high susceptibility rates were observed for piperacillin/tazobactam, meropenem, and metronidazole. Ampicillin, piperacillin, and glycopeptides had good activity against E. faecalis. Imipenem had the highest activity against E. faecalis among carbapenems. In conclusion, we suggested the empirical use of antimicrobials with the specific intent of covering the main organisms isolated from postoperative IAI. Piperacillin/tazobactam, meropenem, or doripenem, are appropriate in critically ill patients. Combination therapy of cefepime (aztreonam in patients with ß-lactam allergy) plus metronidazole plus glycopeptides, imipenem/cilastatin or cephamycins/oxacephem plus ciprofloxacin plus metronidazole are potential therapeutic options.
Subject(s)
Anti-Bacterial Agents/pharmacology , Biliary Tract Diseases/microbiology , Enterobacteriaceae/drug effects , Enterococcus faecalis/drug effects , Peritonitis/microbiology , Postoperative Complications/microbiology , Pseudomonas aeruginosa/drug effects , Academic Medical Centers , Biliary Tract Diseases/drug therapy , Drug Resistance, Multiple, Bacterial , Drug Therapy, Combination , Enterobacteriaceae/enzymology , Enterobacteriaceae/isolation & purification , Enterococcus faecalis/enzymology , Enterococcus faecalis/isolation & purification , Humans , Japan , Microbial Sensitivity Tests , Peritonitis/drug therapy , Postoperative Complications/drug therapy , Pseudomonas aeruginosa/enzymology , Pseudomonas aeruginosa/isolation & purification , beta-Lactamases/metabolismABSTRACT
The recurrence of gastric cancer is rarely associated with cardiac tamponade induced by carcinomatous pericarditis. We encountered a patient in whom cancer recurred as carcinomatous pericarditis 9 years after surgery for advanced gastric cancer. Furthermore, pericardial effusion caused marked subcutaneous edema in her trunk and lower limbs after percutaneous pericardial drainage was applied to treat cardiac tamponade. A 49-year-old woman presented with lower limb edema and exertional dyspnea 9 years after distal gastrectomy for advanced gastric cancer. Chest computed tomography and ultrasonography showed bilateral pleural effusion and pericardial effusion. Pericardial drainage and thoracocentesis were performed, and her symptoms of respiratory distress remitted. Class V adenocarcinoma was detected on cytology from both effusions, and was diagnosed as the recurrence of gastric cancer. After systemic chemotherapy, she was admitted for the aggravation of dyspnea because of recurrent retention of pericardial effusion. Pericardiocentesis was repeated. The pericardial effusion became subcutaneously retained in the trunk below the puncture site over the lower limbs via the drainage route. Edema in the trunk below the abdomen and lower limbs gradually aggravated over time. The skin extended and became sclerotic because of severe edema, liquid leaked from abdominal skin injuries, and the condition became similar to skin lymphorrhea in lymphedema. Neoplastic cardiac tamponade due to gastric cancer has an extremely low incidence and a poor prognosis. We encountered a patient in whom pericardial effusion caused subcutaneous edema in the trunk and lower limbs after percutaneous pericardial drainage was applied to treat carcinomatous pericarditis associated with gastric cancer.