The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.
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J Neurosurg
January 2025
4Department of Neurosurgery, Korea University Anam Hospital, Seoul, Republic of Korea.
Objective: Focused ultrasound (FUS)-mediated blood-brain barrier (BBB) opening is safe and potentially beneficial in patients with Alzheimer's disease (AD) for the removal of amyloid-beta (Aβ) plaques. However, the optimal BBB opening intervals and number of treatment sessions for clinical improvement remain undefined. Therefore, the aim of this study was to evaluate the safety and benefits of repeated and more extensive BBB opening alone.
View Article and Find Full Text PDFPatients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) have poor outcomes. Gemcitabine + oxaliplatin (GemOx) with rituximab, a standard salvage therapy, yields complete response (CR) rates of approximately 30% and median overall survival (OS) of 10-13 months. Patients with refractory disease fare worse, with a CR rate of 7% for subsequent therapies and median OS of 6 months.
View Article and Find Full Text PDFAm Surg
January 2025
Department of Medicine, Ziauddin Medical College, Karachi, Pakistan.
Aims: The purpose of this systematic review was to assess the safety and effectiveness of beta antagonists for improving clinical care in burn patients, compared to placebo.
Methods: Articles from randomized-controlled trials were identified by a literature search on PubMed and Cochrane. We included relevant trials involving patients with burn.
Medicine (Baltimore)
January 2025
Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Background: This study evaluates the efficacy and safety of sitagliptin versus gliclazide, combined with metformin, in treatment-naive patients with type 2 diabetes mellitus (T2DM) and glucotoxicity.
Methods: In this single-center, randomized, controlled noninferiority trial, 129 treatment-naive patients with T2DM with glucotoxicity (fasting plasma glucose [FPG] ≥ 200 mg/dL and glycated hemoglobin ≥ 9.0%) were randomized to receive sitagliptin plus metformin (n = 66) or gliclazide plus metformin (n = 63) for 12 weeks.
J Bronchology Interv Pulmonol
January 2025
Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard Medical School.
Background: Open window thoracostomy (OTW) is the standard of care for debilitated patients with chronic pleural infection and nonexpandable lungs (NEL) who are not candidates for major surgical intervention. Tunneled pleural catheters (TPC) offer tremendous treatment potential in this setting based on their efficacy in malignant pleural effusion and NEL. We aim to assess the efficacy, safety, and health care utilization of TPC in this setting.
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