Therapeutics and Clinical Risk Management最新文献

{"title":"Efficacy and Risk Assessment of Lateral Position Endotracheal Intubation Combined with Airway Surface Anesthesia in Gastrointestinal Endoscopic Surgery: A Randomized Controlled Non-Inferiority Study.","authors":"Li Tang, Jiehao Huang, Jinxin Guo, Mu Zhang, Wei Chen, Xiaoyong Zhao, Rui Xia, Wei Xu","doi":"10.2147/TCRM.S541144","DOIUrl":"10.2147/TCRM.S541144","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to evaluate and compare the efficacy and safety of endotracheal intubation in the lateral versus supine position, with both approaches combined with airway surface anesthesia, in patients undergoing gastrointestinal endoscopic surgery.</p><p><strong>Patients and methods: </strong>A total of 128 patients undergoing gastrointestinal endoscopic surgery under general anesthesia with intubation were randomized into a lateral (L, n=64) or supine (S, n=64) intubation group, both receiving airway surface anesthesia, between January and March 2025. The primary outcome measure was intubation time, while secondary outcomes included changes in intraoperative vital signs, number of intubation attempts, first-pass success rate, positioning time, healthcare worker satisfaction, and postoperative complications.</p><p><strong>Results: </strong>No significant differences were found between the two groups in terms of age, sex, height, weight, BMI, ASA classification, and airway assessment (<i>P</i> > 0.05). Mean intubation times differed slightly between groups (S group: 37.4±7.6s, 95% CI 35.5-39.3; L group: 40.1±8.5s, 95% CI 38.0-42.2). The non-inferiority margin (δ) for this study was 6s, and the upper limit of the L group's confidence interval (42.2s) was below the threshold of 39.3 + 6s. Thus, lateral position intubation was not inferior to supine intubation in terms of intubation time. There were no significant differences between the groups in the number of intubation attempts or first-pass success rate (<i>P</i> > 0.05). However, during positioning, the S group experienced greater hemodynamic fluctuations and a longer positioning time compared to the L group, and these differences were statistically significant (<i>P</i> < 0.05). Neither group showed any dental injuries or hypoxemia, and there were no significant differences in adverse reactions between the groups (<i>P</i> > 0.05).</p><p><strong>Conclusion: </strong>Compared with conventional supine intubation, lateral position endotracheal intubation with airway surface anesthesia achieves similar efficacy while providing better hemodynamic stability, faster positioning, and higher provider satisfaction.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1473-1483"},"PeriodicalIF":2.8,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12535703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145337594","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":"Reduced Long-Term Survival After Postoperative Complications in Major Gastrointestinal Surgery.","authors":"Daantje N Gratama, Laurence Weinberg, Nattaya Raykateeraroj, Je Min A Suh, Junyan Zhao, Elizabeth P Hu, Vidhura Ratnasekara, Thomas Freeman, David S Liu, Alexandre Joosten, Vijayaragavan Muralidharan, Mehrdad Nikfarjam, Dong-Kyu Lee","doi":"10.2147/TCRM.S543913","DOIUrl":"10.2147/TCRM.S543913","url":null,"abstract":"<p><strong>Purpose: </strong>We primarily evaluated the relationship between postoperative complications and long-term survival in patients undergoing major gastrointestinal surgery. Secondarily, we investigated the relationship between the severity and the number of complications and long-term survival. While postoperative complications are prevalent after major abdominal surgery and associated with increased mortality, the effect of their severity and accumulation remains insufficiently explored.</p><p><strong>Patients and methods: </strong>1989 adult patients undergoing major gastrointestinal surgery between July 2010 and April 2022 were retrospectively studied. Complications were classified using the Clavien-Dindo system. Kaplan-Meier analysis assessed long-term survival, Cox proportional hazards regression with time-dependent coefficients evaluated the impact of complications on mortality.</p><p><strong>Results: </strong>Median age was 64 years (IQR 53-74); 41.8% female and 63.0% of patients were diagnosed with malignancy. Elective procedures comprised 73.0% of cases. Complications occurred in 74.6% of patients. Mortality was higher in patients with complications (32.0%, 95% CI 29.7%-34.5%), compared to those without (21.7%, 95% CI 18.3-25.6%; <i>P</i><0.001). Severe complications (Clavien-Dindo Grade ≥III) were associated with a 15.01-fold higher hazard of mortality within 18 months postoperatively (95% CI 6.83-33.0; <i>P</i><0.001).</p><p><strong>Conclusion: </strong>Postoperative complications significantly reduce long-term survival following major gastrointestinal surgery. Both their severity and frequency are critical determinants of poorer outcomes, emphasizing the need for effective prevention strategies.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1459-1472"},"PeriodicalIF":2.8,"publicationDate":"2025-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12523569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145309252","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":"Exploring the Current Tools in Cardiovascular Risk Assessment in the Middle East and the Need for Region-Specific Models - A Scoping Review.","authors":"Gamilah Abdulkarem Al-Ezzi, Adliah Mhd Ali, Mohammed Abdullah Kubas, Adyani Md Redzuan","doi":"10.2147/TCRM.S520628","DOIUrl":"10.2147/TCRM.S520628","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular diseases (CVDs) are a major contributor to premature mortality, disability, and reduced quality of life globally. Assessing CVD risks is central to primary prevention, prompting the development of numerous tools to predict CVD risks for the general population. However, it is unclear which tools are recommended in clinical practice in the Middle East region.</p><p><strong>Aim: </strong>This scoping review aims to identify, review, and summarize the available literature on CVD risk assessment tools recommended for the general population in the Middle East region.</p><p><strong>Methods: </strong>The scoping review synthesized the literature on CVD risk assessment tools recommended for the general population in the Middle East region. It followed PRISMA-ScR guidelines, covering searches in the Web of Science (WOS), Medline, and Scopus databases. English-language articles published between 2015 and 2024 that focused on the primary prevention of CVDs in sixteen Middle Eastern countries were included.</p><p><strong>Results: </strong>Seventeen articles met the inclusion criteria. The studies were distributed over Cyprus (n=1), Iran (n=7), Saudi Arabia (n=4), Qatar (n=1), the United Arab Emirates (n=3), and Egypt (n=1). Various tools are recommended in these countries, including validated Western tools such as ACC/AHA Pooled-Cohort Equations (PCE), Systematic Coronary Risk Evaluation 2 (SCORE 2), World Health Organization charts (WHO/ ISH) for the Eastern Mediterranean region (EMR), Cardiovascular Disease Risk Algorithm (QRISK3), and PREDICT. Some studies in Iran, Saudi Arabia, the United Arab Emirates, and Egypt focused on developing new CVD risk tools tailored for national use.</p><p><strong>Conclusion: </strong>Current studies on CVD risk assessment are limited and have been conducted in six Middle Eastern countries. These studies recommend various tools, including both validated Western models and locally developed frameworks. However, the limitations of existing tools and the gaps in current research underscore the need for further studies to develop or recalibrate models that account for country-specific CVD risk factors across the region.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1443-1458"},"PeriodicalIF":2.8,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12519991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145303347","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":"The Incidence and Risk Factors for Dental Injury in Patients Undergoing General Anesthesia: A Case-Control Study.","authors":"Sarinya Chanthawong, Saranyoo Nonphiaraj, Lady Vongtongchith, Nutrada Tisangka, Junjira Kaewaun, Peerapong Sangsungnern, Thitinuch Ruenhunsa, Laksanawadee Chairatana","doi":"10.2147/TCRM.S552333","DOIUrl":"10.2147/TCRM.S552333","url":null,"abstract":"<p><strong>Purpose: </strong>Dental injury is a known complication of endotracheal intubation during general anesthesia (GA), yet data on its incidence and associated risk factors remain limited. This study aimed to evaluate the incidence, risk factors, and outcomes of dental injury in patients undergoing GA.</p><p><strong>Patients and methods: </strong>This retrospective case-control study was conducted between January 2021 and June 2024. A total of 42,826 patients underwent GA during the study period; 72 cases of dental injury were identified from the departmental database. Controls were time-matched patients who underwent surgery in the same anatomical region, using a case-to-control ratio of 1:4. Univariable and multivariable logistic regression analyses were performed to identify independent risk factors for dental injury.</p><p><strong>Results: </strong>The incidence of dental injury was 0.17%. Univariate analysis identified the following factors as associated with dental injury: age ≥ 60 years, pre-existing dental pathology, Mallampati classification ≥ 3, anticipated difficult intubation, and difficult airway. In the multivariable logistic regression analysis, pre-existing dental pathology (adjusted OR 3.87, 95% CI: 1.92-7.81, p < 0.001), anticipated difficult intubation (adjusted OR 4.99, 95% CI: 1.84-13.50, p = 0.002), and difficult intubation (laryngoscopic view grade ≥ 3) (adjusted OR 10.56, 95% CI: 4.24-26.29, p < 0.001) remained significant independent predictors of dental injury during GA. The most common complication was bleeding.</p><p><strong>Conclusion: </strong>Dental injury during GA is uncommon, with an incidence of 0.17%. Pre-existing dental pathology, anticipated difficult intubation, and poor laryngoscopic view (grade ≥ 3) were identified as independent risk factors. Awareness and thorough preoperative assessment of these factors may help reduce the risk of dental injury and related complications.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1431-1441"},"PeriodicalIF":2.8,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12517181/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145293865","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":"The Effect of Dexmedetomidine Nasal Spray on Extubation-Related Stress Response and Delayed Extubation After Laparoscopic Surgery: A Randomized Controlled Trial.","authors":"Yurong Liu, Xiaohan Wang, Jingjing Dang, Qi Wang, Qi Xia, Zhiping Wang","doi":"10.2147/TCRM.S548792","DOIUrl":"10.2147/TCRM.S548792","url":null,"abstract":"<p><strong>Purpose: </strong>Smooth removal of the tracheal tube post-laparoscopic surgery is crucial. Dexmedetomidine suppresses airway reflexes and mitigates stress responses. This study sought to assess the effect of dexmedetomidine nasal spray on extubation-related stress response and delayed extubation after laparoscopic surgery.</p><p><strong>Patients and methods: </strong>This study involved 124 patients scheduled for laparoscopic surgery, who were randomly allocated to one of two groups: the dexmedetomidine nasal spray group (Group D, n=62) and the control group (Group C, n=62). 30 min before the end of the surgery, Group D was administered 100 μg of the dexmedetomidine nasal spray, while Group C was given an equivalent volume of normal saline nasal spray. Extubation events and extubation time were documented. Hemodynamic data, Ramsay sedation scale (RSS), NRS scores, postoperative nausea and vomiting (PONV), and total recovery time were evaluated during medication administration and the subsequent postoperative recovery period.</p><p><strong>Results: </strong>The rate of smooth tracheal extubation was significantly higher in Group D than in Group C (93.5% vs 64.5%, <i>p</i> < 0.001). Extubation time was markedly reduced in Group D compared to Group C (<i>p</i> = 0.045). Hemodynamic characteristics were comparable across the two groups, but MAP was higher in Group C at 1 and 10 min after extubation (<i>p</i> < 0.05), and HR was higher at 1 and 3 min after extubation (<i>p</i> < 0.05). More favorable sedation was achieved in Group D at 30 min postoperatively (<i>p</i> = 0.025). No significant changes were observed in postoperative PO₂ and PCO₂, NRS pain score, and the incidence of PONV between the groups.</p><p><strong>Conclusion: </strong>Dexmedetomidine nasal spray safely and effectively ameliorated extubation-related stress response following laparoscopic surgery, resulting in smoother extubation. Furthermore, it facilitated the maintenance of hemodynamic stability, shortened extubation time, and provided better postoperative sedation.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1419-1429"},"PeriodicalIF":2.8,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12515004/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145281146","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":"Analysis of Modification Zones in Mandibular Complete Denture Models Designed with the Bio-Functional Prosthetic System.","authors":"Lei Yan, Yang Liu, Yu-Yu Yan, Wei Li, Hong-Wei Li, Yun-Long Wang, Zhen-Fang Zhang, Xiao-Ling Li","doi":"10.2147/TCRM.S540674","DOIUrl":"10.2147/TCRM.S540674","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to analyze the regions and extent of modifications made to the final mandibular complete denture model designed using the bio-functional prosthetic system (BPS), compared to the initial model, utilizing digital scanning technology.</p><p><strong>Methods: </strong>Twenty individuals with edentulism requiring mandibular restoration using BPS were included in the study. Digital scans of the initial and final gypsum models of the edentulous mandible were obtained. The models were aligned, registered, and analyzed for modification zones using Geomagic Warp software.</p><p><strong>Results: </strong>Statistically significant differences were observed in three specific regions: the posterior fossa of the mylohyoid, the submandibular gland region, and the labial vestibule (<i>p</i> < 0.05). In contrast, differences in the posterior molar pad area were minimal (<i>p</i> > 0.05). Overall, the final model exhibited significant deviations from the initial model (<i>p</i> < 0.05), with the greatest variation observed in the posterior fossa of the mylohyoid and the least variation in the posterior molar pad area.</p><p><strong>Conclusion: </strong>The final mandibular complete denture model, constructed using BPS, demonstrates improved accuracy in representing mucosal movement, shape, and positioning under occlusal pressure compared to the initial model. The posterior fossa of the mylohyoid, submandibular gland region, and labial vestibule exhibited enhanced delineation of mucosal movement boundaries, contributing to a more precise functional representation.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1409-1418"},"PeriodicalIF":2.8,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12495919/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145233415","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":"Incidence of Complications in High-Risk Patients Undergoing Combined Esophagogastroduodenoscopy and Colonoscopy with Total Intravenous Anesthesia: A Prospective Cohort Study.","authors":"Wilaiporn Supan, Araya Ongiem, Papiroon Noitasaeng, Pathomporn Bunnag, Uayporn Kaosombatwattana, Orawan Supapueng, Phongthara Vichitvejpaisal","doi":"10.2147/TCRM.S541750","DOIUrl":"10.2147/TCRM.S541750","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the incidence, characteristics, and risk factors of complications related to anesthesia complication in ASA Class III patients undergoing combined esophagogastroduodenoscopy (EGD) and colonoscopy under total intravenous anesthesia (TIVA).</p><p><strong>Materials and methods: </strong>This prospective cohort study was conducted from April 1, 2024, to February 11, 2025. Data collected included baseline characteristics (age, sex, comorbidities, functional capacity, nutritional status, smoking, fasting and medications) and intraoperative/postoperative parameters (anesthetic technique, sedative dosing, IV fluids, complications, and 24-hour status). Descriptive statistics, univariate analysis, and binary logistic regression were applied.</p><p><strong>Results: </strong>Of 403 ASA Class III patients enrolled, 393 were analyzed after excluding 10 for inadequate bowel prep or early termination due to malignancy. A total of 207 patients (52.7%) experienced at least one complication. Common complications included transient hypotension (40.2%), desaturation (15.8%), and airway obstruction (15.5%). Less frequent events were bradycardia (4.1%), hypoxia (1.8%), hypertension (1.8%), tachycardia (0.3%) and respiratory depression (0.5%). Five independent risk factors were significantly associated with complications: preexisting cardiovascular disease - odds ratio (OR=1.678), respiratory disease (OR=1.877), functional capacity < 4 metabolic equivalents (METs), (OR=1.851), nutritional screening score ≥1 (OR =1.518), and single - dose bowel prep regimen (OR=1.614). Complications were more common in women, patients aged 65 years or older, and inpatients, although the difference in hospitalization and outpatient was not statistically significant. Patients with complications received lower total doses of propofol and fentanyl per weight per hour. Dexmedetomidine use was significantly associated with complications among inpatients (p = 0.015). The duration of the procedure was longer in patients with complications (p = 0.002).</p><p><strong>Conclusion: </strong>Anesthesia-related complications were frequent among ASA Class III patients who underwent combined EGD and colonoscopy under TIVA, particularly cardiovascular and respiratory events. Identification of five preprocedural risk factors supports the need for improved risk stratification and individualized sedation planning to optimize safety in this high-risk group.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1395-1408"},"PeriodicalIF":2.8,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12485486/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145213724","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":"Transplant Without Borders: Clinical Outcomes and Challenges in Transborder Living Donor Pediatric Liver Transplantation in Jordan.","authors":"Fareed Khdair Ahmad, Dima Abu Nasrieh, Mohammad Moazi Rwalah, Abdullah Ghanma, Yaser Rayyan, Yara Hamad, Tahani Ahmad, Saeed Mohammad","doi":"10.2147/TCRM.S530639","DOIUrl":"10.2147/TCRM.S530639","url":null,"abstract":"<p><strong>Purpose: </strong>To describe the clinical outcomes, complications, and logistical challenges of pediatric living donor liver transplantation (LT) in Jordanian children referred abroad, in the absence of a national transplant program.</p><p><strong>Patients and methods: </strong>This retrospective study reviewed all pediatric cases referred to the Jordanian Center for Organ Transplantation (JCOT) for LT between 2019 and 2023. Data were collected from JCOT records and follow-up interviews with caregivers. Variables included patient demographics, indications for transplantation, donor-recipient relationships, post-operative complications, survival outcomes, and financial aspects.</p><p><strong>Results: </strong>A total of 31 children were referred for LT, of whom 20 (64.5%) successfully underwent living donor liver transplantation abroad-primarily in Turkey-while 11 (35.5%) remained on the waiting list. Biliary atresia (25%) was the most common indication, followed by Alagille syndrome and progressive familial intrahepatic cholestasis (each 20%). Primary hyperoxaluria, Crigler-Najjar syndrome, and maple syrup urine disease were also observed. Parents were the most frequent donors (70%). The most common complications were bile duct leakage (35%), portal vein thrombosis (20%), and infections (15%). The 5-year post-transplant survival rate was 90%. Among the waiting list group, four children (36.4%) died before receiving a transplant. No children underwent transplantation for pediatric acute liver failure during the study period. The average cost per transplant covered by the Ministry of Health was $61,071, excluding out-of-pocket expenses borne by families.</p><p><strong>Conclusion: </strong>This study highlights the feasibility and challenges of transborder pediatric liver transplantation in Jordan. While clinical outcomes for transplanted children were favorable, significant barriers remain, including delayed referrals, financial strain, and mortality among waitlisted patients. These findings underscore the urgent need to establish a national pediatric liver transplant program to improve timely access and long-term care for children with end-stage liver disease in Jordan.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1383-1393"},"PeriodicalIF":2.8,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12466558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145186745","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 Outcomes of Ilizarov Bone Transport for Distal Tibial Defects in Refractory Osteomyelitis: A Retrospective Study.","authors":"Abudusalamu Alimujiang, Qiyu Jia, Jian Guo, Jun Zhang, Xi Wang, Meng Zhao, Meidege Ouzhabayier, Yingbo Wang, Chuang Ma","doi":"10.2147/TCRM.S525768","DOIUrl":"10.2147/TCRM.S525768","url":null,"abstract":"<p><strong>Background: </strong>Distal tibial defects following refractory osteomyelitis pose a significant orthopedic challenge, necessitating effective reconstruction. The Ilizarov bone transport technique is a potential treatment option, but its clinical outcomes specifically for distal tibial infectious defects need further evaluation.</p><p><strong>Methods: </strong>In this retrospective observational single-arm study, we analyzed the clinical data of 22 patients who had undergone multiple debridements for refractory distal tibial osteomyelitis (DTO) and had associated bone defects, and were subsequently treated with the Ilizarov bone transport technique. Following debridement surgery, bone transport treatment was administered. Regular X-ray examinations, rehabilitation guidance, and follow-up were conducted to assess infection control, bone healing, limb function recovery, and complications. Therapeutic effects were evaluated using the Association for the Study and Application of Methods of Ilizarov (ASAMI), Visual Analog Scale (VAS) score, Activities of Daily Living (ADL) score, and American Orthopaedic Foot & Ankle Society (AOFAS) score improvement.</p><p><strong>Results: </strong>The mean follow-up was 29.32±20.92 months, with an average of 3.77±1.83 debridements. All bone defects healed, though 5 patients later required ankle arthrodesis. Complications included pin tract infection (n=10), axial deviation (n=3), ankle joint stiffness (n=2), non-union at the docking site (n=2), and delayed consolidation (n=2). At the last follow-up, ASAMI bone results: 15 excellent, 5 good, 2 poor (90.9% superiority rate). ASAMI functional results: 6 excellent, 14 good, 1 fair, 1 poor (90.9% superiority rate). VAS decreased from 4.86±0.83 to 0.5±0.66 (p<0.001). ADL improved from 80 (78.75-85) to 92.5 (90-95) (p<0.001). AOFAS score increased from 32 (25-38.25) to 82 (77-87.5) (p<0.001), with an 86.4% overall superiority rate.</p><p><strong>Conclusion: </strong>Bone transport post - debridement is a valuable salvage for reconstructing distal tibial defects post-refractory osteomyelitis, with high safety, healing rate, and good efficacy. However, further comparative studies are warranted to confirm its advantages over other treatments.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1369-1382"},"PeriodicalIF":2.8,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450385/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145125830","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":"Combined Ruyi Zhenbao Pills-Baimai Ointment Therapy on Acute Ischemic Stroke: A Multi-Arm, Randomized, Double-Blind, Placebo Controlled Clinical Study.","authors":"Ziying Jiang, Xinzuo Qin, Xiao Wu, Zijian Wang, Xinyu Wang, Lingqian He, Mingji Cuomu, Zhinan Mei, Hongping Hou, Haiqing Song, Juexian Song","doi":"10.2147/TCRM.S536519","DOIUrl":"10.2147/TCRM.S536519","url":null,"abstract":"<p><strong>Background: </strong>Ruyi Zhenbao Pills (RZPs) and Baimai Ointment (BMO), prescribed Tibetan formulations, have been confirmed as having a neuroprotective role in animal and cell models of stroke. However, the effects of RZPs and BMO in individuals with acute ischemic stroke (AIS) remain unclear. This is the first multicenter, large-sample, controlled trial to evaluate the therapeutic potential of traditional Tibetan medicine-specifically the RZP and BMO-in the treatment of AIS, thereby extending ethno-pharmacological evidence into modern stroke care.</p><p><strong>Methods: </strong>A multi-arm, randomized, double-blind, placebo controlled clinical trial was conducted at 21 hospitals in China between December 2020 and September 2022. The inclusion criteria are as follows: individuals diagnosed as AIS, 18 to 75 years of age and within 14 days of AIS onset. Subjects were randomly assigned in a 1:1:1:1 ratio to RZPs+BMO, RZPs, BMO, or placebo. The primary outcome was change of Fugl-Meyer assessment (FMA) score from baseline to day 90.</p><p><strong>Results: </strong>Four hundred and twenty-three participants were recruited and randomly allocated to the RZPs+BMO group (n=108), RZPs group (n=108), BMO group (n=99), or placebo group (n=108). The change from baseline to D90 in FMA score was 31.22 (SD 16.64) with RZPs+BMO, 29.25 (15.92) with RZPs, 29.88 (15.42) with BMO, and 19.20 (14.38) with placebo (RZPs+BMO group versus placebo group, <i>P</i>< 0.001).</p><p><strong>Conclusion: </strong>Among Chinese patients suffering from AIS, combined RZPs and BMO therapy improved significantly the primary outcome of 90-day motor functions compared with placebo with acceptable safety, indicating that RZPs and BMO might be an effective therapeutic strategy in patients with AIS.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1359-1368"},"PeriodicalIF":2.8,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145125850","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}