Therapeutics and Clinical Risk Management最新文献

{"title":"Retrospective Study on the Comparative Efficacy of Intra-Articular Injection and Photodynamic Therapy in the Treatment of TMD.","authors":"Xiaotong Wei, Jing Gao, Zhizhengrong Tian, Fengyun Zhao, Hao Wang, Wei Yan","doi":"10.2147/TCRM.S512151","DOIUrl":"10.2147/TCRM.S512151","url":null,"abstract":"<p><strong>Objective: </strong>To compare the effectiveness of intra-articular injection and photodynamic therapy (PDT) in the treatment of temporomandibular joint disorder (TMD).</p><p><strong>Methods: </strong>A retrospective analysis was conducted on the clinical data of 91 TMD patients admitted to our hospital from August 2022 to February 2024. Patients were divided into the control group (n=45, treated with intra-articular injection) and the observation group (n=46, treated with PDT). Clinical outcomes, pain levels [Visual Analog Scale (VAS)], maximum mouth opening, masseter muscle pain threshold, Fricton Temporomandibular Joint Index (including Joints Number (JN), Joint Pain (JP), Muscle Masseter (MM), Disc Displacement Index (DI), Mandibular Position (MP), Pain Index (PI), and Clinical Measurement Index (CMI)], oral health [Oral Health Impact Profile-14 (OHIP-14)], and quality of life [Short Form-36 (SF-36)] were compared between the two groups.</p><p><strong>Results: </strong>The total effective rate in the observation group (91.30%) was significantly higher than the control group (75.56%) (p<0.05). VAS scores showed significant group (F=5.487), time (F=8.356), and interaction effects (F=6.931) (p<0.05). Within-group comparisons showed a significant decrease in VAS scores 1 and 4 weeks after treatment (p<0.05), with the observation group showing lower VAS scores than the control group (p<0.05). After treatment, maximum mouth opening and masseter muscle pain threshold increased in both groups, with the observation group showing greater improvement (p<0.05). Fricton Temporomandibular Joint Index scores decreased significantly in both groups, with the observation group showing a more significant reduction (p<0.05). OHIP-14 scores decreased, and SF-36 scores increased in both groups, with the observation group showing greater improvement (p<0.05).</p><p><strong>Conclusion: </strong>PDT is more effective than intra-articular injection in treating TMD. PDT further relieves pain, increases maximum mouth opening and masseter muscle pain threshold, reduces the Fricton index, and improves oral health and quality of life.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"415-424"},"PeriodicalIF":2.8,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956786/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Novel Three-Step Technique for the Simple, Safe, and Efficient Complete Removal of Idiopathic Epiretinal Membrane.","authors":"Qingquan Wei, Chunyang Cai, Lan Yi, Meiling Li, Wufeng Zhang, Jili Chen, Qinghua Qiu","doi":"10.2147/TCRM.S500766","DOIUrl":"10.2147/TCRM.S500766","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to assess a new three-phase method's efficacy and safety in treating idiopathic macular epiretinal membrane (ERM).</p><p><strong>Methods: </strong>The novel technique involved a precise sequence: flap creation - wide margin- extensive peeling. Following the pars plana vitrectomy (PPV), to locate the epiretinal membrane, we stained the internal limiting membrane (ILM) with indocyanine green (ICG), using the stained ILM beneath as a guide to initiate the ERM flap. To minimize the force required for membrane peeling and traction on the underlying retina, we utilized a curved DSP scraper to form a wide-margin parallel arc along the inner aspect of the vascular arcade from the nasal to temporal side. Subsequently, the wide margin of the ERM was grasped tightly with ILM forceps, and traction was applied towards the central macular area to peel off the entire membrane. Finally, ICG staining was applied to ensure that the ERM was completely removed. The technique requires precise mastery of the three-step surgical skills and proficient use of specialized instruments.</p><p><strong>Results: </strong>In a sample of 55 cases, the surgery achieved significant treatment outcomes. All surgeries were successfully performed with an average duration of 4.23±0.34 minutes for ERM peeling. At the 12-month postoperative follow-up, the mean logarithm of the minimum angle of resolution best-corrected visual acuity (BCVA) significantly improved from 4.74±0.30 to 4.27±0.34. The average central macular thickness (CMT) significantly decreased from 503.64±111.88μm to 353.38±72.64μm. There are no intraoperative or postoperative complications and there was no recurrence.</p><p><strong>Conclusion: </strong>The novel technique is a fast, simple, effective and safe surgical technique for treating idiopathic ERM. It significantly improves visual outcomes and reduces the occurrence of complications and recurrence.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"407-413"},"PeriodicalIF":2.8,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11952143/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum RIPK1, Acute Lung Injury, and Outcomes in Severe Traumatic Brain Injury: A Multicenter Prospective Study.","authors":"Liang Cai, Xianghong Dou, Wensheng Dong, Kangqin Zou, Lixin Zhang, Huayong Hong, Xiaole Zhang, Jin Liu, Da Tian, Xiaoyu Wu, Jianhua Zhang","doi":"10.2147/TCRM.S502775","DOIUrl":"10.2147/TCRM.S502775","url":null,"abstract":"<p><strong>Background: </strong>Receptor-interacting protein kinase-1 (RIPK1), a regulator of necroptosis, is involved in acute brain injury and acute lung injury (ALI). Here, serum RIPK1 levels were measured after severe traumatic brain injury (sTBI), with an endeavor to unveil its prognostic implications and mediation effects of ALI.</p><p><strong>Methods: </strong>In this multicenter prospective study, serum RIPK1 levels were gauged in 100 healthy individuals and 158 sTBI patients in need of decompressive craniectomy for brain herniation. The collected materials encompassed the Glasgow Coma Scale (GCS), pupil enlargement status, basal cisternal shapes, ALI, etc. The extended Glasgow outcome scale (GOSE) was employed for estimating neurological impairments at posttraumatic 180-day mark. Multifactorial analytical methods were applied to assess relevancies.</p><p><strong>Results: </strong>Patients, as opposed to controls, had markedly raised serum RIPK1 levels, with the even substantially higher levels in those with lower GCS scores, bilateral pupil enlargement or obliterated basal cisterns. Using restricted cubic spline, RIPK1 levels were linearly related to occurrent risks of the four outcome variables of interest, that is 180-day death, overall survival, poor prognosis (GOSE scores 1-4) and ALI. RIPK1 levels independently predicted these outcome variables. RIPK1 levels had noninteractional effects with age, sex, hypertension, diabetes, smoking and alcohol habits in terms of its association with these outcome variables. RIPK1 levels exhibited high discriminatory efficiency for these outcome variables under the receiver operating characteristic curve. RIPK1 levels, via partial mediation by ALI, were associated with death and poor prognosis of patients.</p><p><strong>Conclusion: </strong>Elevated serum RIPK1 levels of patients with sTBI may be highly related to trauma severity, and risks of poor outcomes and ALI; and ALI partially explains the links between serum RIPK1 levels, death and poor prognosis, substantializing serum RIPK1 as a serological prognostic predictor of good prospect in sTBI.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"385-405"},"PeriodicalIF":2.8,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11932039/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143701550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hepatic Safety Considerations in the Use of Ulipristal Acetate for Symptomatic Uterine Fibroids.","authors":"Annika Semmler, Maria E de Lange, Joost P H Drenth, Niels S Vermeer, Pierre M Bet, Judith A F Huirne, Wouter J K Hehenkamp","doi":"10.2147/TCRM.S273358","DOIUrl":"10.2147/TCRM.S273358","url":null,"abstract":"<p><strong>Introduction: </strong>Ulipristal acetate (UPA, 5 mg) demonstrated efficacy in symptom reduction for patients with symptomatic fibroids. While registration and post-marketing trials assessing UPA identified few hepatic concerns, post-marketing concerns about potential drug-induced liver injury (DILI) led to significant restrictions, including indication restriction, warning labels and mandatory liver function monitoring. These measures, along with two marketing suspensions, resulted in a decline in UPA use, ultimately leading to the withdrawal of its marketing authorization previously in Canada, Australia, as well as Singapore and in 2024, at the request of the marketing authorization holder for commercial reasons, also for the European Union.</p><p><strong>Methods: </strong>This narrative review critically evaluates the hepatic safety considerations associated with UPA.</p><p><strong>Results: </strong>On reassessment, the risk of severe DILI with UPA is low at 13.5:100.000, with an incidence of 1 in 200,000 for liver transplantation. These numbers are lower than with many other widely prescribed medications, where no regular liver monitoring is recommended. UPA was subjected to strict liver test monitoring although proof of effectiveness of these measures in preventing serious DILI was lacking. While the risk of severe hepatotoxic events is important to consider, a balanced approach to safety measures is needed, particularly in light of the higher risks associated with alternative treatment options such as surgical intervention.</p><p><strong>Conclusion: </strong>While UPA had a unique place in the treatment of uterine fibroids, overly cautious regulatory measures due to exceedingly rare DILI incidences led to the withdrawal of its marketing authorization in most parts of the world. There is a need for an improved understanding of DILI mechanisms and causality assessments to aid in the development of more proportional regulatory responses, balancing patient safety and sustained access to effective innovative treatment.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"367-382"},"PeriodicalIF":2.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11930018/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143693354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutics and Clinical Risk Management - 20^th Anniversary.","authors":"Garry M Walsh, De Yun Wang","doi":"10.2147/TCRM.S523642","DOIUrl":"10.2147/TCRM.S523642","url":null,"abstract":"","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"383-384"},"PeriodicalIF":2.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11930349/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143693355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Perioperative Nursing Care with Incidence of Surgical Site Infections and Short-Term Outcomes in Primary Liver Cancer Patients: A Retrospective Comparison with Standard Care.","authors":"Bin Yang, Xiaoyun Guo, Kewen Qi, Shaolong Sun","doi":"10.2147/TCRM.S512226","DOIUrl":"10.2147/TCRM.S512226","url":null,"abstract":"<p><strong>Background: </strong>Surgical site infections (SSIs) are a significant complication following liver surgery (LS) for primary liver cancer (PLC), contributing to increased morbidity, prolonged hospital stays, and higher healthcare costs. This study aimed to evaluate the association of perioperative nursing care (PNC) with the incidence of SSIs and short-term outcomes, comparing patients receiving structured PNC to those receiving standard care.</p><p><strong>Methods: </strong>A retrospective study was conducted at [specific location] between January 2016 and February 2019. A total of 360 PLC patients undergoing LS were included and divided into an observation group (PNC) and a control group (standard care). Outcome measures included SSI incidence, length of hospital stay, and independent predictors of SSIs. Logistic regression analysis was used to identify significant factors.</p><p><strong>Results: </strong>Among the 360 included PLC patients, 180 received PNC while 180 did not. Patients in the PLC group had a significantly lower incidence of SSIs (28.3% vs 47.2%, P = 0.026) and shorter hospital stays (median: 8.2 vs 13.3 days, P = 0.049) compared to the control group. Multivariate logistic regression identified PNC as a significant protective factor against SSIs (OR = 2.01, 95% CI: 1.08-3.85, P = 0.031). Other significant predictors included education level (college or above: OR = 0.44, 95% CI: 0.24-0.79, P = 0.006) and comorbidities (more than two: OR = 2.21, 95% CI: 1.31-3.76, P = 0.003).</p><p><strong>Conclusion: </strong>PNC emerged as an independent risk factor for SSIs in PLC patients undergoing LS. Thus, the provision of PNC is crucial for reducing the risk of SSIs and improving short-term outcomes in PLC patients undergoing LS.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"355-365"},"PeriodicalIF":2.8,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11928324/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143693352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Ultrasound-Guided Thoracic Paravertebral Block Versus Thoracic Paravertebral Block Combined With Serratus Anterior Plane Block or Erector Spinae Block Following Video-Assisted Thoracoscopic Lobectomy.","authors":"Meng-Meng Zheng, Jue Xie, Wei Tan, Cong-Wang Yuan, Dun-Yi Qi, Jie Sun","doi":"10.2147/TCRM.S507154","DOIUrl":"10.2147/TCRM.S507154","url":null,"abstract":"<p><strong>Purpose: </strong>Compared the efficacy of ultrasound-guided thoracic paravertebral block (TPVB) and thoracic paravertebral combined with serratus anterior plane block (SAPB) or erector spinae block (ESPB) following video-assisted thoracoscopic lobectomy(VATL).</p><p><strong>Patients and methods: </strong>This retrospective study analyzed the medical records of 295 patients who underwent VATL surgery between August 2021 and January 2023. Patients were divided into three groups: TPVB (92 patients), TPVB combined with SAPB (106 patients), and TPVB combined with ESPB (97 patients). The primary outcomes were postoperative pain levels, measured using an 11-point visual analogue scale (VAS) both at rest and during coughing at 2, 6, 12, 24, and 48 hours postoperatively, as well as cumulative oxycodone consumption within 24 and 48 hours postoperatively.</p><p><strong>Results: </strong>Postoperative cumulative oxycodone consumption within 24 and 48 hours was significantly lower in the TPVB+SAPB and TPVB+ESPB groups compared to the TPVB group (<i>P</i> < 0.001), with no significant difference between the TPVB+SAPB and TPVB+ESPB groups. The TPVB group exhibited higher VAS pain scores both at rest and during coughing at 2 and 6 hours postoperatively compared to the other two groups (<i>P</i> < 0.005). Within 24 hours postoperatively, the Area Under Curve (AUC) for VAS scores at rest was significantly lower in the TPVB+SAPB group than in the other two groups (<i>P</i> < 0.05), while the AUC for coughing pain was significantly lower in the TPVB+ESPB group compared to the TPVB group (<i>P</i> = 0.049). Nausea or vomiting occurred more frequently in the TPVB group compared to the other groups (<i>P</i> = 0.016).</p><p><strong>Conclusion: </strong>TPVB combined with SAPB or ESPB provides superior analgesic effects compared to TPVB alone after video-assisted thoracoscopic lobectomy, with both techniques showing comparable analgesic efficacy. However, TPVB+SAPB may offer slightly better analgesia at rest, while TPVB+ESPB may have a potential advantage in reducing postoperative nausea and vomiting.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"343-353"},"PeriodicalIF":2.8,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11922505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Synergistic Effect of the CHA₂DS₂-VASc Score and Left Atrial Epicardial Adipose Tissue Volume on Predicting Atrial Fibrillation Recurrence After Ablation.","authors":"Chuanyi Sang, Renjie Gu, Tian Xia, Yameng Shao, Ye Zhu, Fukun Chen, Lei Sun, Xiang Gu, Chaoqun Zhang","doi":"10.2147/TCRM.S504531","DOIUrl":"10.2147/TCRM.S504531","url":null,"abstract":"<p><strong>Objective: </strong>The CHA₂DS₂-VASc score and left atrial epicardial adipose tissue (LA-EAT) volume have been identified as potential risk factors for atrial fibrillation (AF) recurrence after ablation. However, there is currently a lack of research specifically examining the interaction between these two AF risk factors. This study aims to evaluate the predictive potential of combining CHA₂DS₂-VASc score and LA-EAT volume in predicting recurrence in patients with AF who undergo ablation.</p><p><strong>Methods: </strong>The study encompassed a cohort of 507 patients who underwent ablation for AF finally. Follow-up assessments were conducted 1, 3, 6, and 12 months after ablation, including clinical evaluation, a 12-lead ECG, and 24-hour Holter monitoring. Recurrence was characterized by symptomatic or asymptomatic AF episodes or atrial tachycardia lasting more than 30 seconds, as evidenced by any ECG following the 3-month BP. Patients were stratified into groups based on the defined cut-off values of CHA₂DS₂-VASc score and LA-EAT volume. Cox regression analysis was employed to estimate the risk factor of AF recurrence after ablation. The interaction between CHA₂DS₂-VASc score and LA-EAT volume was assessed using the relative excess risk due to interaction (RERI), attributable proportion (AP), and synergy index (SI).</p><p><strong>Results: </strong>140 patients experienced AF recurrence after ablation during the follow-up period. Multivariable Cox regression analysis demonstrated that CHA₂DS₂-VASc score and LA-EAT volume were independent risk factors for AF recurrence. Patients with higher CHA₂DS₂-VASc score and LA-EAT volume exhibited a higher risk of recurrence than those with lower score and volume. Furthermore, a significant synergistic interaction existed between CHA₂DS₂-VASc score and LA-EAT volume. The LA-EAT volume and clinical model combination improved the predictive value reclassification, and discriminant abilities improved significantly.</p><p><strong>Conclusion: </strong>There is a significant additive interaction between CHA₂DS₂-VASc score and LA-EAT volume, with the coexistence of both factors significantly increasing the risk of AF recurrence after ablation.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"331-341"},"PeriodicalIF":2.8,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11913026/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143650916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Obstetric Air Cushion for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section: A Randomized Controlled Clinical Trial.","authors":"Yang Dong, Wei-Wei Cao, Hao Weng, Rong Liu, Ding-Ding Huang","doi":"10.2147/TCRM.S499475","DOIUrl":"10.2147/TCRM.S499475","url":null,"abstract":"<p><strong>Purpose: </strong>Intravenous administration of large doses of vasopressors to treat hypotension due to spinal anesthesia can adversely affect the fetus and the mother. We assessed the effect of a novel obstetric air cushion pretreatment on the incidence of hypotension after spinal anesthesia.</p><p><strong>Patients and methods: </strong>Eighty parturients were randomly assigned to the air cushion or blank control group (Group A or B, respectively). The air cushion was placed in the lumbar area between the lower border of the costal arch and the iliac crest. The primary endpoint was the incidence of hypotension, while the secondary endpoints included norepinephrine dosage, success rate of maternal hypotension management, and adverse reactions like bradycardia.</p><p><strong>Results: </strong>Hypotension occurred in 50% of the participants in Group A and 75% of those in Group B(<i>P</i>=0.035). Group A (median 4μg, range 0-8μg) required a lower norepinephrine dose than Group B (median 4μg, range 0-12μg; <i>P</i>=0.015). The success rate of hypotension management was significantly higher for Group A at 97.4% than for Group B at 83.3% (<i>P</i>=0.035). Bradycardia was less frequent for Group A than for Group B (10.5% vs 30.6%, <i>P</i>=0.032). Group A also showed a higher umbilical artery blood pH than Group B(<i>P</i>=0.026).</p><p><strong>Conclusion: </strong>The novel air cushion pretreatment reduces the incidence of hypotension after spinal anesthesia in pregnant women, reduces the dose of single intravenous norepinephrine, improves the success rate of hypotension management, and increases the pH of fetal umbilical artery blood.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"321-330"},"PeriodicalIF":2.8,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11911231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143650915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Manifestations and Risk Factors of Liver Injury Induced by PD-1 Inhibitors in Patients with Malignancies: A Case-Control Study.","authors":"Pengfei Zhao, Lihong Yu, Wenming Ma, Ting Zhao","doi":"10.2147/TCRM.S510973","DOIUrl":"https://doi.org/10.2147/TCRM.S510973","url":null,"abstract":"<p><strong>Background: </strong>Hepatic injury induced by immune checkpoint inhibitors (ICPIs) is an inevitable challenge in the era of innovative anti-tumor therapies. However, studies on immune-related liver injury are relatively insufficient, and the associated risk factors are still lacking. The purpose of this study was to explore the incidence and clinical manifestations of immunotherapy-related liver injury.</p><p><strong>Methods: </strong>A retrospective case-control study was conducted involving patients treated with PD-1 inhibitors at Weifang People's Hospital, a tertiary general hospital in China, from January 1, 2021 and July 31, 2024. Univariate and multivariate logistic regression analyses were employed to identify the potential risk factors. Then, the predictive value of these risk factors was evaluated using receiver operating characteristic (ROC) curve analysis.</p><p><strong>Results: </strong>In total, 300 patients were included. Among these patients, 52 patients experienced liver injury. The mean time from the initiation of immunotherapy to the onset of liver injury was 28.4 days, with a range from 2 to 219 days. 71.15% of patients developed liver injury within the first 30 days. 82.69% presented with mild cases (grade 1), 13.46% with moderate cases (grade 2), and 3.84% with severe cases (grades 3-4). The overall incidence of PD-1 inhibitors-related liver injury was 0.34%. Specifically, nivolumab exhibited the highest incidence at 2.86%, followed by sintilimab at 0.41%. Both toripalimab and camrelizumab exhibited an incidence of 0.34%, while tislelizumab had the lowest at 0.28%. Multivariate logistic regression analysis showed that GGT and AST were independent risk factors for liver injury. ROC curve analysis revealed that patients with baseline ALT≥19.5 U/L, AST≥19.5 U/L, and GGT≥28.5 U/L were at increased risk of developing liver injury.</p><p><strong>Conclusion: </strong>In clinical therapy, close monitoring of liver function is recommended, especially for patients with baseline ALT≥19.5 U/L, AST≥19.5 U/L, and GGT≥28.5 U/L during immunotherapy with PD-1 inhibitors.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"309-320"},"PeriodicalIF":2.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11910050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143650904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}