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   Table of Contents - Current issue
Coverpage
July-September 2018
Volume 3 | Issue 3
Page Nos. 59-80

Online since Monday, September 10, 2018

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RESEARCH ARTICLES  

Predictive analysis of the severity of hip arthritis using platelet-to-lymphocyte ratio: a cross-sectional study p. 59
Xiu Jiao, Ai-Qing Zhu
DOI:10.4103/2542-4157.240468  
Background and objectives: Inflammatory changes play an important role in the pathogenesis of hip arthritis. However, there are currently no available effective inflammatory markers for the prediction of the severity of hip arthritis. Platelet-to-lymphocyte ratio (PLR) has been shown to be correlated with the severity of rheumatoid arthritis, psoriatic arthritis, and colon cancer. This study hypothesizes that PLR is correlated with the severity of hip arthritis and that it can be used as a marker for evaluating the severity of hip arthritis in a Chinese patient population. Methods: This prospective, single-center, cross-sectional study includes 260 patients with hip arthritis from the wards of Yantai Affiliated Hospital of Binzhou Medical University, China [130 patients with mild and moderate hip arthritis (Kellgren-Lawrence Grading Scale grade 1–2) and 130 patients with severe hip arthritis (Kellgren-Lawrence Grading Scale grade 3–4)]. In addition, 130 healthy controls are also included in this study. This study protocol was approved by Medical Ethics Committee, Yantai Affiliated Hospital of Binzhou Medical University of China in June 2018 (approval No. 20180601001). This study is performed in strict accordance with the Declaration of Helsinki developed by the World Medical Association. Study protocol is 1.0. Written informed consent is obtained from each patient. On the day of admission, patient clinical data are collected, and blood biochemistry tests and hip X-ray examinations are performed. Results: The primary outcome measure is PLR. Secondary outcome measures are platelet count, lymphocyte count, X-ray morphology of the hip, logistic regression analysis results of risk factors for the severity of hip arthritis, area under the ROC curve, cut-off value, sensitivity and specificity of PLR in predicting the severity of hip arthritis. A pilot study involving 182 patients with hip arthritis, consisting of 98 patients with mild and moderate hip arthritis and 84 patients with severe hip arthritis, was performed between January 2014 and June 2017 at Yantai Affiliated Hospital of Binzhou Medical University. PLR was 115.71 ± 29.31 and 146.17 ± 52.00 in 98 patients with mild and moderate hip arthritis and 84 patients with severe hip arthritis, respectively. Logistic regression analysis of this pilot study revealed that diabetes, age, increased body mass index, and increased PLR were associated with aggravation of hip arthritis and were also independent risk factors of this disorder. Conclusion: PLR at a designated cut-off value can be used as a predictor of the severity of hip arthritis. We hope to perform a study involving 390 patients to further shed light on the correlation between PLR and the severity of hip arthritis: whether PLR has the required sensitivity, specificity, and accuracy in predicting the severity of hip arthritis, and what the optimal cut-off value of PLR is in the predicting the severity of hip arthritis based on the ROC curve. Trial registration: This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016820).
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Calcitonin plus calcium for viral cirrhosis with osteoporosis: a randomized, parallel, controlled clinical trial p. 66
Jing-Feng Wang, Tao Liu, Bai-Sui Zhou, Ai-Qun Li
DOI:10.4103/2542-4157.240469  
Background and objectives: In patients with osteoporosis and cirrhosis, the relative deficiency of vitamin D may result in osteomalacia and endocrine disorders. Few studies have investigated drug treatment for chronic liver disease combined with osteoporosis. This study will determine the efficacy and safety of salmon calcitonin combined with calcium in the treatment of viral cirrhosis with osteoporosis. Methods: This prospective, single-center, open-label, randomized, parallel, controlled, 2-year follow-up clinical trial includes 102 outpatients and hospitalized patients with viral cirrhosis plus osteoporosis in Yantai Affiliated Hospital, Binzhou Medical University, China. The 102 patients are equally and randomly divided into two groups. The control group receives oral calcium, while the combination group will receive intramuscular salmon calcitonin plus oral calcium; both groups receives treatment for 24 months. This trial was approved by the Ethics Committee, Yantai Affiliated Hospital, Binzhou Medical University in July 2018 (approval No. 2018071601). The study protocol has been conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent is obtained from all participants. Results: The primary outcome measure is bone mineral density at L2–4 at 24 months after treatment commences. Secondary outcome measures include bone mineral density at L2–4 before treatment, and at 6 and 12 months after treatment commences; bone mineral density of the femoral neck and Ward’s triangle at 6, 12, and 24 months after treatment commences; serum calcium, phosphorus, 1,25(OH)2D3, parathyroid hormone, osteocalcin, interleukin-10, interleukin-6, tumor necrosis factor-alpha, and insulin-like growth factor 1 levels before treatment, and at 6, 12 and 24 months after treatment commences; adverse reaction rate at 6, 12, and 24 months after treatment commences. Our team obtained preliminary results from 2012 to 2016 for 64 patients. The 12-month follow-up results found that compared with the control group (n = 32), the combination group (n = 32) had significantly increased levels of serum calcium, 1,25(OH)2D3, interleukin-10, and insulin-like growth factor 1, and significantly increased bone mineral density at L2–4, femoral neck, and Ward’s triangle, but significantly reduced levels of serum phosphorus, parathyroid hormone, osteocalcin, interleukin-6, and tumor necrosis factor-alpha (all P < 0.05). Conclusion: The results verify that salmon calcitonin combined with calcium is suitable for the treatment of viral cirrhosis with osteoporosis. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800017732) on August 11, 2018. Protocol version (1.0).
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STUDY PROTOCOL Top

Comparing unicompartmental to total knee arthroplasty in medial gonarthritis: study protocol for 2-year follow-up of a randomized controlled trial p. 74
Carl Aulin, Nicolas Martinez-Carranza, Johan Fyhrlund, Hans E Berg, Margareta Hedström
DOI:10.4103/2542-4157.233632  
Background and objectives: Since the 1990s, unicompartmental knee arthroplasty (UKA) are again starting to gain interest worldwide. A mere 3.5% of all knee arthroplasties performed in Sweden 2014 were UKAs, whereas up to 25% had knee osteoarthritis isolated to the medial side. Reasons for this discrepancy might be that UKAs are considered more technically demanding, thus requiring more surgical training, and that long-term survival of these implants has been inferior compared to total knee arthroplasty (TKA). This has been addressed by improving surgical instruments and discontinuation of underperforming implants, and by improving surgical technique including mini-invasive incision and patient selection. In support of using the less surgically invasive UKA, a few cohort studies show less pain, fewer hospital days, and faster rehabilitation. However, to the best of our knowledge, there is a lack of high quality randomized clinical trials (RCTs) showing unequivocal clinical superiority of UKA compared to TKA. The aim of the present study is to compare changes in muscle mass, strength, performance based measures (PBMs), and patient reported outcome measures (PROMs) in patients randomized to UKA or TKA. Design: A 2-year follow-up RCT. Methods: The study will include 80 patients with medial knee osteoarthritis, aged 50 years or more, who will be scheduled for a knee replacement and equally randomized to either TKA or UKA. Outcome measures: The primary outcome is muscle mass change at 6 weeks, 6, 12 and 24 months post-operatively measured by computed tomography. Secondary outcomes are PBMs, PROMs, muscle strength, and 3D motion analysis at the same occasions. Discussion: Although patients subjected to total hip arthroplasty are typically satisfied with their surgical results, patients with TKA are less so. It is of importance to improve surgical procedure, and less invasive surgery of the knee might be a solution. Ethics and dissemination: The study has been approved by the Regional Ethics Committee in Stockholm (DNR: 2014/1895-31/3) and will be conducted in accordance with the ethical principles of the Declaration of Helsinki. All patients will sign a consent form after being given oral and written information of the study. Patient recruitment began in November 2015 and will end in December 2019. Data collection will complete in June 2021. We plan to present results in open access scientific publications and at scientific conferences and meetings. Trial registration: The study protocol was registered with ClinicalTrials.gov (identifier: NCT 02563756) on September 18, 2015. Protocol version: 1.0.
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