Chromatographic fingerprint and quality consistency of colistimethate sodium / 中国药科大学学报

@#The UPLC fingerprint of colistimethate sodium was established for the study of quality consistency.The chromatographic column was Acquity UPLC? Peptide CSH C18 (2.1 mm × 150 mm, 1.7 μm).The mobile phase A was phosphate buffer-acetonitrile (19∶1), and the mobile phase B was phosphate buffer-acetonitrile (1∶1).The mobile phase was in gradient elution at a flow rate of 0.3 mL/min.The column temperature was set at 30 °C and the detection wavelength was 210 nm.The similarity of the fingerprints was analyzed with the Similarity Evaluation System for Chromatographic Fingerprint of Tradition Chinese Medicine (Version 2012) in combination with content determination of multiple index components to evaluate the quality consistency of imported and domestic bulk drugs.The result showed that both the original and generic bulk drugs met the specified limit requirements in the European Pharmacopoeia standards, and that their UPLC fingerprints were highly similar, indicating that the quality of the two substances was consistent.Establishing a fingerprint for similarity evaluation and combining it with the results of indicator component content determination as a comprehensive evaluation method for the study of drug quality consistency of complex components has the characteristics of fast, accurate, and comprehensive, which is helpful for drug quality evaluation and provides ideas for the evaluation of antibiotic quality consistency of complex components.

Neutrophil Gelatinase-associated Lipocalin as a Predictor of Acute Kidney Injury in Patients during Treatment with Colistimethate Sodium / 감염과화학요법

BACKGROUND: The emergence of multidrug-resistant, Gram-negative bacteria has resulted in reconsideration of colistimethate sodium (CMS) as a last resort for treatment of such infections. However, acute kidney injury (AKI) may represent a major limiting adverse effect of use of CMS. Early AKI detection in CMS-treated patients can help prevent progression to acute failure and reduce the need of renal replacement therapy. We hypothesized that plasma neutrophil gelatinase-associated lipocalin (NGAL) may be an early biomarker of AKI in CMS-treated patients. MATERIALS AND METHODS: This prospective cohort study included patients aged ≥20 years who received intravenous CMS between March 2014 and November 2015. AKI was defined according to Kidney Disease: Improving Global Outcomes criteria. The primary endpoint was the difference between the average time to AKI onset based on serum creatinine and empirically derived plasma NGAL levels. RESULTS: Among 109 CMS-treated patients, 23 patients (mean age, 61.3 ± 16.1 years; men, 65.2%) were evaluated. Thirteen (56.5%) patients fulfilled the AKI criteria. The mean time to AKI onset based on serum creatinine after CMS initiation was 78.15 ± 30.49 hours. AKI was detected approximately 22 hours earlier using plasma NGAL than when using serum creatinine as an indicator of AKI (P = 0.035). The baseline plasma NGAL level was 264.0 ± 167.3 ng/mL and 192.7 ± 65.3 ng/mL in patients with and without AKI, respectively (P = 0.218). The area under the curve for plasma NGAL level at 56 hours was 0.796 (95% confidence interval, 0.609–0.983; P = 0.017), with a sensitivity and specificity of 69.2% and 90.0%, respectively (cutoff value, 285 ng/mL). CONCLUSION: NGAL level was found to be a strong predictor of AKI. This study provides additional evidence of the utility of NGAL for AKI in patients with treated CMS. Plasma NGAL represent sensitive and specific predictive early biomarkers for AKI in patient treated CMS.

Neutrophil Gelatinase-associated Lipocalin as a Predictor of Acute Kidney Injury in Patients during Treatment with Colistimethate Sodium / 감염과화학요법

BACKGROUND: The emergence of multidrug-resistant, Gram-negative bacteria has resulted in reconsideration of colistimethate sodium (CMS) as a last resort for treatment of such infections. However, acute kidney injury (AKI) may represent a major limiting adverse effect of use of CMS. Early AKI detection in CMS-treated patients can help prevent progression to acute failure and reduce the need of renal replacement therapy. We hypothesized that plasma neutrophil gelatinase-associated lipocalin (NGAL) may be an early biomarker of AKI in CMS-treated patients. MATERIALS AND METHODS: This prospective cohort study included patients aged ≥20 years who received intravenous CMS between March 2014 and November 2015. AKI was defined according to Kidney Disease: Improving Global Outcomes criteria. The primary endpoint was the difference between the average time to AKI onset based on serum creatinine and empirically derived plasma NGAL levels. RESULTS: Among 109 CMS-treated patients, 23 patients (mean age, 61.3 ± 16.1 years; men, 65.2%) were evaluated. Thirteen (56.5%) patients fulfilled the AKI criteria. The mean time to AKI onset based on serum creatinine after CMS initiation was 78.15 ± 30.49 hours. AKI was detected approximately 22 hours earlier using plasma NGAL than when using serum creatinine as an indicator of AKI (P = 0.035). The baseline plasma NGAL level was 264.0 ± 167.3 ng/mL and 192.7 ± 65.3 ng/mL in patients with and without AKI, respectively (P = 0.218). The area under the curve for plasma NGAL level at 56 hours was 0.796 (95% confidence interval, 0.609–0.983; P = 0.017), with a sensitivity and specificity of 69.2% and 90.0%, respectively (cutoff value, 285 ng/mL). CONCLUSION: NGAL level was found to be a strong predictor of AKI. This study provides additional evidence of the utility of NGAL for AKI in patients with treated CMS. Plasma NGAL represent sensitive and specific predictive early biomarkers for AKI in patient treated CMS.

A Case of Multidrug-resistant Acinetobacter baumannii Ventriculitis Successfully Treated with Intrathecal Colistimethate / 감염과화학요법

Acinetobacter species is a non-fermentative aerobic gram-negative coccobacillus that is an important pathogen found in nosocomial infections. Recently, multi-drug resistant Acinetobacter baumannii (MDR-AB) infections have been increasing and pose a serious problem. Most such infections present as bacteremia, pneumonia, or a wound infection; however, CNS infections are very rare. We herein present a case of ventriculitis caused by MDR-AB in a 37-year old man after a neurosurgical intervention. The patient was successfully treated with intrathecal colistimethate.

A Case of Multidrug-resistant Acinetobacter baumannii Ventriculitis Successfully Treated with Intrathecal Colistimethate / 감염과화학요법

Acinetobacter species is a non-fermentative aerobic gram-negative coccobacillus that is an important pathogen found in nosocomial infections. Recently, multi-drug resistant Acinetobacter baumannii (MDR-AB) infections have been increasing and pose a serious problem. Most such infections present as bacteremia, pneumonia, or a wound infection; however, CNS infections are very rare. We herein present a case of ventriculitis caused by MDR-AB in a 37-year old man after a neurosurgical intervention. The patient was successfully treated with intrathecal colistimethate.