[Translation] A multicenter, randomized, double-blind, positive-drug parallel-controlled clinical study on the efficacy and safety of levonidazole disodium phosphate injection in the treatment of pelvic anaerobic infection

以左奥硝唑氯化钠注射液（优诺安）对比，评价注射用磷酸左奥硝唑酯二钠在不同给药方案下治疗盆腔厌氧菌感染的安全性和有效性

[Translation]

To evaluate the safety and efficacy of levonidazole disodium phosphate injection in the treatment of pelvic anaerobic infection at different dosing regimens, compared with levonidazole sodium chloride injection (Unoan).

Start Date07 Feb 2023

Sponsor / Collaborator

Shaanxi Synthetic Pharmaceutical Co., Ltd.

CTR20222765 / CompletedPhase 1

吗啉硝唑氯化钠注射液与盐酸左氧氟沙星氯化钠注射液药物-药物相互作用研究

[Translation] Study on drug-drug interaction between morpholinoazole sodium chloride injection and levofloxacin hydrochloride sodium chloride injection

主要研究目的：评价吗啉硝唑氯化钠注射液与盐酸左氧氟沙星氯化钠注射液联合用药后两者药代动力学的变化情况。次要研究目的：评价使用吗啉硝唑氯化钠注射液与盐酸左氧氟沙星氯化钠注射液后受试者的安全性。

[Translation]

The main purpose of the study is to evaluate the changes in the pharmacokinetics of morpholinidazole sodium chloride injection and levofloxacin hydrochloride sodium chloride injection after combined use. The secondary purpose of the study is to evaluate the safety of subjects after using morpholinidazole sodium chloride injection and levofloxacin hydrochloride sodium chloride injection.

Start Date10 Nov 2022

Sponsor / Collaborator

Jiangsu Hansoh Pharmaceutical Co. Ltd.

CTR20222756 / CompletedPhase 1

吗啉硝唑氯化钠注射液在中度肾功能不全患者与肾功能正常受试者中的药代动力学研究

[Translation] Study on the pharmacokinetics of morpholinotriazole sodium chloride injection in patients with moderate renal insufficiency and subjects with normal renal function

评价中度肾功能不全对吗啉硝唑药代动力学的影响；评价吗啉硝唑氯化钠注射液给药后的安全性。

[Translation]

To evaluate the effect of moderate renal insufficiency on the pharmacokinetics of morpholino; to evaluate the safety of morpholino sodium chloride injection after administration.

Start Date09 Nov 2022

Sponsor / Collaborator

Jiangsu Hansoh Pharmaceutical Co. Ltd.

100 Clinical Results associated with Pelvic peritonitis

100 Translational Medicine associated with Pelvic peritonitis

0 Patents (Medical) associated with Pelvic peritonitis

294

Literatures (Medical) associated with Pelvic peritonitis

01 Nov 2024·Journal of Pediatric Surgery

Reproductive Function and Fertility Preservation in Female Children, Girls, and Adolescents After Appendicular Pelvic Peritonitis: May There Be a Place for Transitional Care?

Letter

Author: Duranteau, Lise ; Pio, Luca ; Scarvaglieri, Silvia ; Zarfati, Angelo ; Guerin, Florent

01 Nov 2024·Injury

Risk factors for fracture-related infections after low-velocity gunshot fractures to the pelvis

Article

Author: Carver, Thomas W. ; Coleman, Madelyn ; Carver, Thomas W ; Bergner, Carisa

BACKGROUNDAlthough treatments have improved dramatically in recent years, mortality following gunshot wounds (GSW) to the pelvis continue to range between 3 and 20 %. This project was designed to determine the incidence and risk factors associated with pelvic fracture-related infection (FRI) following GSWs to the pelvis given the paucity of evidence regarding this complication.METHODSA retrospective review of 13 years (1/2010-12/2022) of patients with GSW to the pelvis was performed. Patients meeting inclusion criteria underwent chart review for the development of pelvic FRI and the following additional data elements were extracted: demographics, presence and type of bowel injury, operations performed, complications, use of postoperative antibiotics (≤24 h vs. >24 h), surgical osseous debridement, presence of retained bullet fragments, and bullet trajectory. Discrete variables were analyzed using Wilcoxon rank-sum test, chi-square, and Fischer's exact test. Pearson correlation coefficients were calculated for continuous variables.RESULTS242 patients were included in the study. Concomitant bowel injury was present in 108 patients (45 %). Eleven patients (4.5 %) developed FRI, all of whom had a concomitant bowel injury (p < 0.001). Neither the presence of retained bullet fragments nor the bullet trajectory (through bowel before the bone) was associated with FRI. Antibiotic duration >24 h was not associated with a lower rate of pelvic FRI.CONCLUSIONDevelopment of FRI after a GSW to the pelvis occurs in 4.5 % of patients and is significantly associated with concomitant bowel injury, specifically colonic injury. These findings can be used to help guide further studies on the role of prophylactic antibiotics or other strategies to prevent pelvic FRI.

06 Sep 2024·Medicine

Safety assessment of basiliximab using real-world adverse event data from the FDA Adverse Event Reporting System Database: A retrospective observational study.

Article

Author: Zhang, Jianqiang ; Ma, Xiaohan ; Chen, Sheng

This study analyzed adverse drug events (ADEs) associated with basiliximab, sourced from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, spanning the first quarter of 2004 to the fourth quarter of 2023. We collected ADE data for basiliximab from 2004 Q1 to 2023 Q4. After standardization, we employed several signal quantification methods for analysis, such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propensity for Neural Networks (BCPNN), and empirical bayes geometric mean (EBGM). In this analysis of 1520 ADEs reports citing basiliximab as the primary suspect, we identified 295 preferred terms across 24 system organ classifications (SOCs). The 3 most prevalent SOCs were investigated (n = 1403, ROR 2.84, PRR 2.54, IC 1.34, EBGM 2.54), infections and infestations (n = 1198, ROR 2.85, PRR 2.59, IC 1.37, EBGM 2.59), and renal and urinary disorders (n = 903, ROR 6.01, PRR 5.48, IC 2.45, EBGM 5.47). Increased blood creatinine and pyrexia were the most frequently reported adverse events (AEs) associated with basiliximab, and cytomegalovirus infection also demonstrated significant signal intensity. Notably, this study revealed some adverse reactions beyond basiliximab drug instructions, such as mitral valve calcification, diastolic dysfunction, pelvic fluid collection, testicular swelling, soft tissue necrosis, and muscle necrosis. Although basiliximab offers therapeutic benefits, it carries the risk of several adverse reactions. Clinicians should monitor patients for signs of increased serum creatinine level, fever, cytomegalovirus infection, anaphylactic shock, mitral valve calcification, diastolic dysfunction, pelvic fluid collection, testicular swelling, soft tissue necrosis, muscle necrosis, and other events during clinical use.

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