Validating the accuracy of Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure according to the ISO 81060-2:2018+Amd 1:2020 protocol in the general population.

PURPOSE: The performance of the Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018 (E) and amendment (Amd)1:2020 protocol. METHODS: The device was used to assess 98 participants who fulfilled the inclusion criteria, including the range of arm circumference and systolic and diastolic BP, in accordance with the protocol. Data validation and analysis were performed according to the manufacturer's instructions. RESULTS: In the ISO validation procedure (criterion 1), the mean ± SD of the differences between test device readings and reference BP was 0.3 ±â€…6.17/3.6 ±â€…5.26 mmHg (systolic/diastolic). These data fulfilled the ISO requirements of ≤5±≤8 mmHg. The mean differences between the observer measurements and Omron HEM-7372T1-AZAZ (BP5460) readings were 0.3 ±â€…4.82 mmHg for systolic BP and 3.6 ±â€…4.78 mmHg for diastolic BP, fulfilling criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP. Therefore, two ISO criteria were fulfilled. CONCLUSION: The Omron HEM-7372T1-AZAZ BP monitor fulfilled the requirements of the ISO validation standard. This device can be recommended for home BP measurements in the general population.

Validation of Omron HEM-9200T, a home blood pressure monitoring device for the upper arm, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol.

The performance of Omron HEM-9200T for monitoring blood pressure (BP) in the upper arm was validated in accordance with the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 protocol. The device was assessed by using it on 87 participants who fulfilled the inclusion criteria involving the ranges of arm circumference and systolic and diastolic BP provided by the protocol. Validation and data analysis were performed according to the protocol. In the ANSI/AAMI/ISO 81060-2:2013 validation procedure (criterion 1), the mean ± standard deviation of the differences between the test device and reference BP was -0.1 ± 5.06/1.2 ± 5.8 mmHg (systolic/diastolic). The mean differences between the two observers and Omron HEN-9200T were -0.1 ± 3.82 mmHg for systolic BP and 1.2 ± 5.34 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤6.91 for SBP and ≤6.87 for DBP. These two ANSI/AAMI/ISO criteria were fulfilled.The Omron HEM-9200T BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard and can be recommended for BP measurements at home in the general population.

Validation of Omron HEM-7600T, a wearable device for monitoring blood pressure, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol in the general population without arrhythmias.

OBJECTIVE: The present study aimed to evaluate the accuracy of the Omron HEM-7600T automated oscillometric upper-arm blood pressure (BP) monitor according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 protocol. METHODS: We recruited individuals until we obtained 86 eligible participants whose BP levels and ranges of arm circumference met the BP distribution requirements specified by the ANSI/AAMI/ISO. In each individual, we sequentially measured systolic and diastolic blood pressures (DBPs) using a mercury sphygmomanometer (two observers) and the HEM-7600T device (one supervisor) in the left upper arm. Data analysis was performed according to the ANSI/AAMI/ISO guidelines. RESULTS: A total of 101 individuals were recruited, and 86 were finally included in the analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP was -0.6 ± 6.6/1.0 ± 6.5 mmHg (systolic/diastolic). The data were in accordance with criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤ 5 ± ≤ 8 mmHg). In addition, the mean device-observer difference in the 86 participants was -0.6 ± 5.65 mmHg for systolic blood pressure and 1.0 ± 5.96 mmHg for DBP, fulfilling criterion 2 with an SD of ≤6.91 mmHg for systolic blood pressure and ≤6.87 mmHg for DBP. CONCLUSION: The Omron HEM-7600T BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation protocol in adults and can be recommended for home BP measurements.

Validation of the Omron HBP-1320 for professional use according to the ANSI/AAMI/ISO 81060-2: 2013 protocol and the 2010 revision of the European Society of Hypertension International Protocol.

OBJECTIVE: Performance of the Omron HBP-1320, designed for professional use by adding several features to the home blood pressure (BP) measuring device, was validated using two different protocols, specifically the ANSI/AAMI/ISO 81060-2:2013 (ANSI/AAMI/ISO) and the European Society of Hypertension International Protocol, 2010 Revision (ESH IP2), as a separate study. METHODS: Three trained medical technologists validated the performance of this device by comparing data obtained from the device with those obtained using a standard mercury sphygmomanometer throughout the study. RESULTS: Mean differences in mercury readings for systolic BP (SBP) and diastolic BP (DBP) between the devices were 1.6 ± 5.8 and -0.4 ± 5.3 mmHg, respectively, according to the ANSI/AAMI/ISO protocol, and mean device-observer measurement differences were -0.4 ± 4.9 and -0.2 ± 4.2 mmHg, respectively, satisfying Part 1 of ESH IP2. Differences in SBP and DBP both satisfied Part 2 of ESH IP2. The number of absolute differences in the values obtained using the device and those obtained by the observers fulfilled the requirements of the ANSI/AAMI/ISO protocol and ESH IP2. CONCLUSION: Omron HBP-1320 met all requirements of the ANSI/AAMI/ISO protocol and ESH IP2.

Validation of the Omron HBP-9031C professional office blood pressure monitor in the general population according to the ANSI/AAMI/ISO 81060-2:2013 protocol.

The present study aimed to evaluate the accuracy of the Omron HBP-9031C automated oscillometric upper-arm blood pressure (BP) measurement device for professional office BP monitoring, according to the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) in the general population. The device was assessed by using it on 85 participants, who fulfilled our inclusion criteria involving the ranges of arm circumference and systolic and diastolic BP. The validation and data analysis were performed as per the protocol. In the ANSI/AAMI/ISO 81060-2:2013 validation procedure (criterion 1), the mean ± SD of the differences between the test device and reference BP was 1 ± 8/-2 ± 6 mmHg (systolic/diastolic). The mean differences between the two observers and the Omron HBP-9031C were 1 ± 7 mmHg for systolic BP and -2 ± 6 mmHg for diastolic BP, according to criterion 2. The two ANSI/AAMI/ISO criteria were fulfilled. The OMRON HBP-9031C professional BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard and can be recommended for clinical use.

Validation of the Omron HEM-1040 Blood Pressure Monitor According to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 Protocol.

OBJECTIVE: The accuracy of the Omron HEM-1040 automated oscillometric upper-arm blood pressure (BP) monitoring device, designed for home self-measurements in adult populations, was tested according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 protocol. METHODS: The requirements of this protocol were precisely followed with the recruitment of 85 individuals in whom sequential systolic BP (SBP) and diastolic BP (DBP) were measured in the same (left) arm and who fulfilled the inclusion criteria involving the ranges of arm circumference, SBP, and DBP. RESULTS: The mean device-observer difference in the 255 separate pairs of BP data was -2.7 ± 7.14 mmHg for SBP and -3.3 ± 5.70 mmHg for DBP. The data were in accordance with criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤ 5 ± ≤ 8 mmHg). In addition, the mean device-observer difference in the 85 participants was -2.7 ± 5.89 mmHg for SBP and -3.3 ± 4.99 mmHg for DBP, fulfilling criterion 2 with a standard deviation of ≤ 6.39 mmHg for SBP and ≤ 6.09 mmHg for DBP. CONCLUSION: The OMRON HEM-1040 BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard.

Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The performance of Omron HEM-6232T and Omron HEM-6181 for monitoring blood pressure (BP) at the wrist was validated in accordance with the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) and the European Society of Hypertension International Protocol revision 2010 (ESH IP2). METHODS: Three trained medical technologists validated the performance of these devices by comparing data obtained from these devices with those obtained using a standard mercury sphygmomanometer. RESULTS: The mean differences between the devices and mercury readings for SBP and DBP were as follows: HEM-6232T, -0.4±6.7 mmHg and 1.6±5.4 mmHg, respectively; HEM-6181, -0.7±6.2 mmHg and -0.7±5.2 mmHg, respectively, satisfying the ANSI/AAMI/ISO protocol. The mean device-observer measurement difference was -0.9±5.7 mm Hg and 0.2±4.6 mm Hg for SBP and 0.5±4.9 mm Hg and 1.4±3.5 mm Hg for DBP, for HEM-6232T and HEM-6181, respectively, satisfying part 1 of the ESH-IP2. All differences for SBP and DBP in both devices satisfied part 2 of the ESH-IP2. The number of absolute differences in the values obtained using the devices and those measured by the observers fulfilled the requirements of the ANSI/AAMI/ISO and the ESH IP2. CONCLUSION: The Omron HEM-6232T and HEM-6181 devices met all the requirements of the ANSI/AAMI/ISO and the ESH IP2.

The role of CD5 expression in thymic carcinoma: possible mechanism for interaction with CD5+ lymphoid stroma (microenvironment).

AIMS: Most thymic carcinomas express the lymphocyte marker CD5 aberrantly. This study was performed to examine the role of the self-reactive CD5 antigen in thymic carcinoma. METHODS AND RESULTS: We examined CD5 expression in thymic carcinoma in relation to the lymphoid stroma. All cases of thymic carcinoma examined expressed CD5. A number of CD5(+) lymphocytes were also present in the stroma of thymic carcinoma. The CD5(+) tumour areas were predominantly in contact with the lymphoid stroma, and the expression level was significantly lower in tumour cells than lymphocytes. Although p53 and Bcl-2 expression levels were significantly higher in thymic carcinoma than normal thymic epithelial cells (TECs), they did not differ between CD5(+) and CD5(-) areas. E-cadherin expression in thymic carcinoma was comparable with that of normal TECs, and it also did not differ between these areas. In contrast, both Ki-67 index and mitotic activity were significantly higher in thymic carcinoma than normal TECs, and they were significantly higher in CD5(+) than CD5(-) areas. CONCLUSIONS: CD5 may be induced by interaction with CD5(+) lymphoid stroma, and may be related to tumour proliferation. CD5 induction may also be a significant and/or specific effect of the tumour microenvironment of the thymus.

[Laboratory Medicine Learned Through Research on the Pathogenesis of Hypertension].

Laboratory tests used in clinical practice to assess hypertension include a differential diagnosis, the assessment of complications, and detection of adverse events with medication, which cover a variety of fields of laboratory medicine. I learned laboratory medicine through basic and clinical studies on the pathogenesis of hypertension, and summarized those findings and my interpretations. Basic research using animal models points to a causal role of the central nervous system in essential hypertension; however, since clinical research is technically difficult to perform, this connection has not been confirmed in humans. Recently, renal nerve ablation in humans proved to continuously decrease the blood pressure in the presence of resistant hypertension. Furthermore, when electrical stimulation was continuously applied to the carotid baroreceptor nerve of human adults, their blood pressure lowered. These findings promoted the concept that the central nervous system may actually be involved in the pathogenesis of essential hypertension, which is closely associated with excess sodium intake. We demonstrated that endogenous digitalis plays a key role in hypertension associated with excess sodium intake via sympathetic activation in rats. An increased sodium concentration inside the brain activates epithelial sodium channels and the renin-angiotensin-aldosterone system in the brain. Aldosterone releases ouabain from neurons in the paraventricular nucleus in the hypothalamus. Angiotensin II and aldosterone of peripheral origin reach the brain to augment sympathetic outflow. Collectively essential hypertension associated with excess sodium intake and obesity, renovascular hypertension, and primary aldosteronism and pseudoaldosteronism are all suggested to have a common cause originating from the central nervous system.

Validation of two automatic devices: Omron HEM-7252G-HP and Omron HEM-7251G for self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The aim of this study was to validate the performance of Omron HEM-7252G-HP and Omron HEM-7251G for monitoring upper arm blood pressure (BP) in accordance with the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010). METHODS: Three trained medical doctors validated the performance of these devices by comparing data obtained from these devices with those obtained using a standard mercury sphygmomanometer. We included 33 participants (19 men and 14 women for the experiment using HEM-7252G-HP; 16 men and 17 women for the experiment using HEM-7251G). The mean age of the participants was 50±12 and 53±10 years in the respective studies. RESULTS: The percentages of test device-observer mercury sphygmomanometer BP differences within 5, 10, and 15 mmHg were 76, 92, and 97% for systolic BP (SBP) and 83, 97, and 99% for diastolic BP (DBP), respectively, in the Omron HEM-7252G-HP and 77, 92, and 99% for SBP and 85, 94, and 98% for DBP, respectively, in the Omron HEM-7251G in the part 1 analysis; both SBP and DBP passed the part 1 and part 2 criteria.The mean differences between the device and mercury readings for SBP and DBP were as follows: HEM-7252G-HP, -1.5±5.1 and -1.2±3.9 mmHg, respectively; HEM-7351G, -0.6±4.7 and -0.2±4.4 mmHg, respectively. CONCLUSION: The Omron HEM-7252G-HP and HEM-7251G passed all the requirements of the ESH-IP 2010 revision.

Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z).

BACKGROUND: Allowing patients to measure their blood pressure (BP) at home will be the standard for evaluating the disease state as the process of clinical diagnosis, and it is recognized as having great clinical utility. To measure BP as accurately as possible, innovative techniques have been incorporated into home BP measurement devices. OBJECTIVE: The present study aimed to evaluate the performance of the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z), which are equipped with functions to detect irregular pulses and arm movement that lead to inaccurate BP readings. METHODS: A team of three trained medical doctors validated the performance of these devices by comparing the data alternatively obtained from both devices with those from a standard mercury sphygmomanometer. RESULTS: The magnitude of the difference in BP readings between the tested device and the standard mercury sphygmomanometer in the Omron BP765 and BP760N was within the range of ±3 mmHg (mean) allowed by the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2009 guidelines. CONCLUSION: The Omron BP765 and BP760N were found useful for the self-measurement of BP at home, and their performance fulfilled the requirement of the ANSI/AAMI/ISO 81060-2:2009 guidelines.

Validation of three automatic devices for the self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7130, HEM-7320F, and HEM-7500F.

OBJECTIVE: The aim of the present study was to validate the Omron HEM-7130, HEM-7320F, and HEM-7500F for monitoring upper arm blood pressure (BP) according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010). METHODS: Three trained medical doctors validated the performance of these devices by comparing the data obtained from the devices with those of a standard mercury sphygmomanometer. We included 33 participants (20 men and 13 women for the HEM-7130 experiment; 18 men and 15 women for the HEM-7320F experiment; and 21 men and 12 women for the HEM-7500F experiment). The mean age of the participants was 49±15, 50±11, and 50±11 years in the respective studies. RESULTS: The mean differences between the device and the mercury readings for systolic and diastolic BP were as follows: HEM-7130, -1.8±5.3 and -0.1±4.0 mmHg, respectively; HEM-7320F, -0.9±4.7 and -1.9±4.4 mmHg, respectively; and HEM-7500F, -1.0±4.6 and -1.1±4.0 mmHg, respectively. These findings indicated that the device was reading lower than the mercury. However, the number of absolute differences between the devices and observers fulfilled the requirement of the ESH-IP revision 2010. CONCLUSION: The Omron HEM-7130, HEM-7320F, and HEM-7500F passed all the requirements of the ESH-IP 2010 revision. Therefore, we recommend these devices for the home measurement of BP in adults.

[A case of micafungin-hyposensitive Candida glabrata due to FKS2 gene mutation].

Candida glabrata was continuously isolated in cultured urine samples from a subject with thrombotic thrombocytopenic purpura. Yeast-like fungal phagocytosis found in gram staining led to agents being tested for antifungal susceptibility, revealing hyposensitivity to micafungin (MCFG) of MIC < 2 mg/mL. MCFG administered for 10 days failed to cure C. glabrata infection. To clarify why hyposensitivity occurred, we analyzed the FKS gene sequence using the PCR, finding a deficit of 3 bases coding phenylalanine at FKS2 gene amino acid 659. MCFG hyposensitivity may thus occur in long-term candin-class anti-fungal agent treatment. Candin-class agents have potent anti-fungal activity with fewer adverse effects and are widely used clinically. Hyposensitivity due to resistant C. glabrata species showed thus be considered in fungal infection treatment.

Clinical potential of oral nicorandil to improve myocardial fatty acid metabolism after percutaneous coronary intervention in hemodialysis patients.

BACKGROUND/AIMS: The assessment of myocardial fatty acid metabolism impairment by single-photon emission computed tomography (SPECT) using (123)I-ß-methyliodophenyl-pentadecanoic acid (BMIPP) might predict the risk of cardiac death in hemodialysis patients. We investigated the potential of oral nicorandil to improve myocardial fatty acid metabolism after percutaneous coronary intervention (PCI) in this population. METHODS: We evaluated 128 hemodialysis patients who had obtained coronary revascularization by PCI (90 men and 38 women, 66 ± 9 years). Participants for the analysis were randomly assigned to either the nicorandil (n = 63) or control group (n = 65). BMIPP SPECT was performed every year after coronary revascularization by PCI. Uptake on SPECT was graded in 17 segments on a 5-point scale (0, normal; 4, absent) and assessed as BMIPP summed scores (SS). RESULTS: The incidence of cardiac death was lower (p = 0.004) in the nicorandil group (7/63, 11.1%) than in the control group (21/65, 32.3%) during a mean follow-up of 2.7 ± 1.4 years. BMIPP SS reduction rates improved in the nicorandil group compared with the control group from 3 years of administration. In Kaplan-Meier analyses, free survival rate of cardiac death was higher in patients with a ≥20% BMIPP SS reduction rate as compared with those with a <20% BMIPP SS reduction rate (p = 0.0001). In multiple logistic analysis, oral administration of nicorandil was associated with ≥20% reduction rates of BMIPP SS (odds ratio 2.823, p = 0.011). CONCLUSION: Long-term oral administration of nicorandil may improve impaired myocardial fatty acid metabolism after coronary revascularization by PCI in hemodialysis patients.

[A Case of Heparin-Induced Thrombocytopenia with Discrepancy in the Results of Anti-Platelet Factor 4/Heparin Antibodies between Latex-Particle-Enhanced Immunoturbidimetric Assay and Enzyme Immunoassay].

A female patient in her seventies with diabetes mellitus, hyper-lipidemia and mitral regurgitation was admitted because of the acute heart failure. She was treated with diuretics and vasodilators, however these were not effective. Therefore the CHDF using heparin was required for the patients. After the introduction of CHDF, the platelet count subsequently decreased to less than 7.0 x 10(4)/µl. After stopping CHDF, the platelet count recovered. In the second CHDF treatment, the platelet count decreased again. HIT was suspected because of both the usage of heparin and five points of 4T's score in the patient. Heparin was discontinued immediately and then her platelet count improved. The HIT antibody by latex-particle-enhanced immunoturbidimetric assay was performed simultaneously, however it was not detected. After re-using heparin by heparin lock, platelet count had been decreasing. Furthermore the thrombus was observed in the infusion tube. We considered that a clinical course did not accord with the result of HIT antibody. We measured HIT antibody by another method, an enzyme immunoassay (EIA), and the positive antibody was observed. We encountered a rare case with discrepancy in the results of HIT antibody between two methods. When HIT is suspected by the results from the clinical course and 4T's score, even though the negative HIT antibody, heparin should be discontinued and the different assay for HIT antibody such as an EIA in this case should be performed.

[The basic research on the high-sensitive troponin I assay, and the application to evaluation of chronic heart failure].

The mortality among patients with heart diseases increases steadily in an aging society like Japan. Among those, the patients with chronic heart failure (CHF) are thought to be increasing rapidly although the official report is missing. It is well-known that BNP or NT-proBNP is useful for a clinical diagnosis of CHF, but a role of the cardiac troponin (cTn) attracts attention as a novel biomarker of their prognosis. However, because the level of cTn in patients with CHF is far lower than that in cases of acute coronary syndrome (ACS), development of the high-sensitive method with precision is desired. In the present study, a new sensitive assay system with an analyzer, ARCHITECT STAT (cTnI hs-ARCH) was basically studied and found more sensitive than other conventional 2 sensitive methods. The performance of cTnI hs-ARCH was evaluated in patients with CHF by comparing it to findings with other 2 methods. When CHF patients are allocated into categories of NYHA classification according to their subjective symptoms, cTnI hs-ARCH was superior to other methods in discriminating subgroups. In addition, multivariable analysis disclosed that cTnI hs-ARCH is influenced by the level of renal function at the minimum among the 3 methods. Therefore, cTnI hs-ARCH may be a useful method for evaluation of prognosis in patients with CHF who often have impaired renal function.

Validation of Omron RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010.

BACKGROUND: Allowing patients to measure their blood pressure at home is recognized as being of clinical value. However, it is not known how often these measurements are taken correctly. Blood pressure monitors for home use fall into two types based on the position of the cuff, ie, at the upper arm or the wrist. The latter is particularly convenient, as measurements can be taken fully clothed. This study aimed to evaluate the performance of the wrist-type blood pressure monitors Omron RS8 (HEM-6310F-E), Omron RS6 (HEM-6221-E), and Omron RS3 (HEM-6130-E). METHODS: A team of three trained doctors validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. All the devices met the validation requirements of the European Society of Hypertension International Protocol revision 2010. RESULTS: The difference in blood pressure readings between the tested device and the standard mercury sphygmomanometer was within 3 mmHg, which is acceptable according to the European Society of Hypertension guidelines. CONCLUSION: All the home devices tested were found to be suitable for measuring blood pressure at home because their performance fulfilled the requirement of the guidelines.

Efficacy of single-dose intravenous immunoglobulin administration for severe sepsis and septic shock.

BACKGROUND: Although some studies conducted outside of Japan have addressed the effectiveness of intravenous immunoglobulins (IVIG) in treating infections, the dosing regimens and amounts used in Japan are very different from those reported. Here, we investigate the effectiveness of single-dose administration of IVIG in sepsis patients in Japan. METHODS: We analyzed 79 patients admitted to the intensive care unit (ICU) of a tertiary care institution due to severe sepsis or septic shock. Patients were randomly divided into a group that was administered standard divided doses of IVIG (5 g/day for 3 days, designated the S group) or a group that was administered a standard single dose of IVIG (15 g/day for 1 day, H group); freeze-dried sulfonated human IVIG was used. The longitudinal assessment of procalcitonin (PCT) levels, C-reactive protein (CRP) levels, white blood cell count, blood lactate levels, IL-6 levels, Sequential Organ Failure Assessment (SOFA) score, and Systemic Inflammatory Response Syndrome (SIRS) was conducted. We also assessed mechanical ventilation duration (days), ICU stay (days), 28-day survival rate, and 90-day survival rate. RESULTS: The study showed no significant differences in PCT levels, CRP levels, 28-day survival rate, and 90-day survival rate between the two groups. However, patients in the H group showed improvements in the various SIRS diagnostic criteria, IL-6 levels, and blood lactate levels in the early stages after IVIG administration. In light of the non-recommendation of IVIG therapy in the Surviving Sepsis Campaign Guidelines 2012, our findings of significant early post-administration improvements are noteworthy. IVIG's anti-inflammatory effects may account for the early reduction in IL-6 levels after treatment, and the accompanying improvements in microcirculation may improve blood lactate levels and reduce SOFA scores. However, the low dosages of IVIG in Japan may limit the anti-cytokine effects of this treatment. Further studies are needed to determine appropriate treatment regimens of single-dose IVIG. CONCLUSIONS: In this study, we investigated the effectiveness of single-dose IVIG treatment in patients with severe sepsis or septic shock. Although there were no significant effects on patient prognoses, patients who were administered single-dose IVIG showed significantly improved IL-6 levels, blood lactate levels, and disease severity scores.

[Performance and clinical utility of a high-sensitivity troponin T assay].

In the present study, we evaluated the performance and clinical utility of a high-sensitivity troponin T (hs-cTnT) assay. The within- and between-assay variations (coefficients of variation: CV) in the low and high concentrations of troponin T in serum samples were 0.84% to 3.34%, respectively. Analysis of interferents showed that only hemoglobin negatively influenced the assay results. Blank assay was < 0.001 ng/mL, and a limit of quantification (10% CV) was found at 0.005 ng/mL. The correlation coefficient (r) between hs-cTnT and the conventional assay was 0.997 (p < 0.000). The high-sensitivity assay system could detect cTnT in 88% of samples in which the conventional assay could not detect any immunoreactivity. The 99th percentile in healthy subjects, determined using 559 samples from medical checkups, was 0.011 ng/mL. There was a gender difference (hs-cTnT levels were higher in men than in women), and hs-cTnT levels increased with age. Because hs-cTnT level exceeded 0.011 ng/mL approximately 2 hours after the onset of chest pain in patients with acute myocardial infarction, hs-cTnT can serve as a biomarker for early detection of myocardial infarction. There was a positive correlation (r = 0.491, p < 0.001) between hs-cTnT and NT-proBNP, and hs-cTnT levels increased with the progression of the disease state, as assessed using New York Heart Association (NYHA) classification. These findings indicate that the hs-cTnT assay is sensitive enough to diagnose early-stage acute myocardial infarction and congestive heart failure.

Epidemiology of Escherichia coli, Klebsiella species, and Proteus mirabilis strains producing extended-spectrum ß-lactamases from clinical samples in the Kinki Region of Japan.

In the present study, nonduplicate, clinical isolates of extended-spectrum ß-lactamase (ESBL)-producing Escherichia coli, Klebsiella spp, and Proteus mirabilis were collected during a 10-year period from 2000 to 2009 at several hospitals in the Kinki region, Japan. The detection rate of E coli markedly increased from 0.24% to 7.25%. The detection rate of Klebsiella pneumoniae increased from 0% to 2.44% and that of P mirabilis from 6.97% to 12.85%. The most frequently detected genotypes were the CTX-M9 group for E coli, the CTX-M2 group for K pneumoniae, and the CTX-M2 group for P mirabilis. E coli clone O25:H4-ST131 producing CTX-M-15, which is spreading worldwide, was first detected in 2007. The most common replicon type of E coli was the IncF type, particularly FIB, detected in 466 strains (69.7%). Of the K pneumoniae strains, 47 (55.3%) were of the IncN type; 77 P mirabilis strains (96.3%) were of the IncT type. In the future, the surveillance of various resistant bacteria, mainly ESBL-producing Enterobacteriaceae, should be expanded to prevent their spread.