View clinical trials related to Toxicity, Drug.
Filter by:With the aging of the population, osteoarthritis of knees and hips become major orthopedic problems worldwide. Osteoarthritis of the knees and hips is associated with a significant pain problem and functional disability. Total joints replacement is the ultimate surgical procedure to deal with such problems. Multimodal analgesia, including periarticular local infiltration of analgesia (LIA), regional nerve block using adductor canal block (ACB), opioid and non-opioid have been shown to be effective in managing postoperative pain. Regional nerve block using femoral nerve block or adductor canal block (ACB) is also a well-established analgesic technique after total knee replacement. Standard bupivacaine (SB), levobupivacaine, ropivacaine were used in ACB in these studies. Whether combining ACB with periarticular LIA has the additional benefit of prolonging analgesia or with synergistic effect remains controversial, because the number of RCTs conducted is not enough. Liposomal bupivacaine (LB) may further prolong the analgesic effect of ACB, as the therapeutic levels of bupivacaine are below the toxic range and sustained for 72 hours after injection. The purpose of this study is to evaluate the safety and systemic levels of serum bupivacaine following adductor canal block using LB 66.5mg in patients undergoing TKA with LIA over a 72-hour period. This also serves as a pilot study to determine the dose and timing of blood taking for serum bupivacaine level of a previously IRB approved study - "Comparing the efficacy of combining periarticular local infiltration of analgesia and adductor canal block using liposomal bupivacaine and standard bupivacaine- A prospective randomized controlled trial".
Today, using a multi-modal approach consisting of preoperative (neoadjuvant) systemic polychemotherapy followed by local surgical therapy and then postoperative (adjuvant) chemotherapy, long-term, disease-free survival can be achieved in 60- 70% of osteosarcoma patients. However treatment options for osteosarcomas, especially in the setting of metastatic or unresectable disease, are very scarce. Apatinib has been proved to be an effective agent to prolong progression-free survival in advanced osteosarcoma. But after 4-6 months' treatment, secondary resistance always occurred with musculoskeletal lesions' progression or new metastasis. Nowadays giving therapeutic doses of IE concurrently with anti-angiogenesis tyrosine kinase inhibitors is a conceptually attractive strategy for treating patients with refractory osteosarcoma according to prospective trial of lenvatinib +IE reported by Gaspar et al at 2019 ESMO and 2020 ESMO. Thus This study was designed to review our experience in real world for off-label use and characterize the toxicity profile of concurrent apatinib+IE and IE alone in patients with relapsed or refractory osteosarcoma.
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced chondrosarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of two Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated chondrosarcoma.
Maculopathy induced by retinal toxicity of synthetic antimalarials is to be screened at the sub-clinical stage. Indeed, when the first visual symptoms appear, macular damage is already irreversible and the clinical picture may even continue to deteriorate for several years after the end of synthetic antimalarial use. In opposition, the early termination of hydroxychloroquine in patients showing recent alterations on the multifocal electroretinogram (nfERG) allowed he reversibility of toxic damage over a six month period. It is therefore critical to detect early retinal anatomic changes during retinotoxicity screening before the occurrence of irreversible anatomical and functional consequences. The usual patient monitoring consists of an annual eye examination, detecting subjective functional abnormalities (visual acuity, color vision, central visual field testing) or macular lesions (eye fundus). These abnormalities show a constituted infringement and do not contribute to the early diagnosis of synthetic antimalarial maculopathy. The mfERG is an objective examination, able to detect retinal damage whilst still reversible. It is recommended during the annual monitoring and is, today, the gold standard for the screening and diagnosis of synthetic antimalarial maculopathy. However, its realization is time consuming, requires a good patient cooperation and is difficult to access due to the few ophthalmology centers offering it. In practice, it is rarely done as a systematic annual screening for patients on long-term synthetic antimalarial treatment. It is often limited to second-line studies (for patients already showing functional or anatomical abnormalities) whereas its interest lies in the detection of early lesions. The Optical Coherence Tomography Spectral Domain (OCT-SD) is a non-invasive eye examination, commonly used since nearly 10 years. A special image analysis provides a panoramic viewing of the state of the photoreceptor layer, and a non-invasive detection of any anatomical changes, even subtle, within this layer. The concordance between the "en face" OCT and the mfERG in the screening of synthetic antimalarial maculopathy is considered in this study.