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   2018| January-March  | Volume 3 | Issue 1  
    Online since April 9, 2018

 
 
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REVIEW
Potentially Prescriptions Inappropriate (PPIs) in elderly patients in polytherapy: structured discussion on the effect of medication therapy review using evaluation criteria listed in literature on the administrative health care database
Lorella Magnani
January-March 2018, 3(1):22-26
DOI:10.4103/2542-3975.228988  
In the last few years numerous evidences have shown an increased prevalence of “Potential Inappropriate Prescriptions (PPIs)” in the elderly (>/=65 years) and have estimated that more than 10% of all hospitalizations in this population are hospitalized for problems consequent to drugs given. The predictive factors more strongly related to the inappropriate use of drugs are polytherapy (>/= 5 drugs contemporary), uncritical application of guidelines in many cases inadequate and built with data from young subjects-adults affected by a single pathology, recommend drug regimens that do not consider the changes in the pharmacokinetics and pharmacodynamics parameters, exposing to significant risks. Considering that polytherapy is any case necessary (due to the effect of comorbidity and longer life expectancy), is unavoidable not acknowledge the impossibility, as much for clinicians as for any guideline all interactions: in this perspective the application of evaluation scientifically based criteria and information technology tools could represent a resource for to tend to prescriptive appropriateness, still a challenge for researchers, clinicians, manager, third-payers. The application of explicit criteria (ex. Beers and STOPP & START) to the administrative data base of pharmaceutical prescriptions could represent a screening too, not only to qualitatively and quantitatively asses PPIs, given immediate availability of information, but above all to create practical support for the clinician’s work by crating “adaptive database” for interactive research for specific conditions. However, regardless of more or less functional software applications, more multidimensional and multidisciplinary efforts (ex. geriatric counseling) are needed to take on problems related to polypharmacy in elderly patients: the most appropriate therapeutic regimen should combine guidelines, geriatric assessment, social and economic considerations, the patient’s will and should be periodically reviewed, especially as the presence of multiple comorbidities increases the risk of adverse reactions.
  2,926 289 -
STUDY PROTOCOL
Modified posterior lumbar interbody fusion augmented with bone cement in the treatment of senile degenerative lumbar spondylolisthesis: study protocol for a self-controlled trial
Rong Ren, Qi-Fa Guo, Zhao-Wei Li, Ze-Qing Li, Bao-Ming Tang
January-March 2018, 3(1):8-14
DOI:10.4103/2542-3975.228986  
Background and objectives: Posterior lumbar interbody fusion is the main repair method for senile degenerative lumbar spondylolisthesis. For elderly patients with osteoporosis, single screw rod system fixation regularly results in dislocation. The incidence of implant loosening is high, and therefore, effective internal fixation is not achieved. Thus, this study will use the modified posterior lumbar interbody fusion procedure combined with bone cement augmentation for the treatment of senile degenerative lumbar spondylolisthesis so as to increase the stability of the vertebral body, make the fixator firm, and to maximize the recovery of postoperative motor function. Design: This is a prospective, single-center, self-controlled trial. Methods: 113 patients with senile degenerative lumbar spondylolisthesis, aged 65–70 years, irrespective of sex, will be recruited from the Department of Orthopedics of Affiliated Hospital of Qinghai University of China. The patients will be treated with modified posterior lumbar interbody fusion combined with bone cement augmentation. Follow-up will be performed at 3 and 12 months. Outcome measures: The primary outcome measure is recovery of motor function as indicated by the postoperative Oswestry Disability Index score at 12 months. The secondary outcome measures are the change in the rate of excellent and good Oswestry Disability Index scores (comparing preoperative scores with the 4-month postoperative scores), Visual Analogue Scale scores, intervertebral space height, foraminal height, the preoperative and 4 and 14 months postoperative slip distance and slip angle, incidence of adverse reactions, success rate of vertebral fusion, and incidence of secondary slip 4 and 14 months postoperatively. Discussion: This trial aims to observe the efficacy of modified posterior lumbar interbody fusion combined with bone cement augmentation in the treatment of senile degenerative lumbar spondylolisthesis and to validate whether the procedure is safe and reliable. Ethics and dissemination: This trial has been approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China (approval number: QHY023G). The study protocol will be proformed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. This trial was designed in October 2017. The recruitment of subjects and data collection will begin in June 2018. The recruitment will be finished in December 2018. Outcome measures will be analyzed in January 2020. This trial will be completed in February 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Trial registration: This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800015335). Protocol version (1.0).
  2,293 247 -
Poly(methyl methacrylate) bone cement and injectable artificial bone implantation in the treatment of senile degenerative thoracic osteoporotic vertebral compression fractures: study protocol for a randomized controlled trial
Yuan Zhang, Rong Ren, Ze-Qing Li, Yi-Bo Hu, Ming Li
January-March 2018, 3(1):1-7
DOI:10.4103/2542-3975.228985  
Background and objectives: Percutaneous kyphoplasty is an effective treatment method for senile degenerative thoracic osteoporotic vertebral compression fractures. However, its clinical long-term effect is controversial among scholars both inside and outside China. The poly(methyl methacrylate) (PMMA) bone cement commonly used in percutaneous kyphoplasty has good plasticity and formability, but its biocompatibility is not yet clear. Injectable artificial bone is a novel filling material that can induce bone formation, but its long-term efficacy remains to be verified. Therefore, we will compare the efficacy of OSTEOPAL® plus PMMA bone cement and geneX® injectable artificial bone graft in the treatment of senile degenerative thoracic osteoporotic vertebral compression fractures at 24 months postoperatively. Design: This is a prospective, single-center, open-label, randomized controlled trial. Methods: A total of 378 patients with senile degenerative thoracic osteoporotic vertebral compression fractures will be recruited from the Department of Orthopedics, Affiliated Hospital of Qinghai University, China. The patients will be randomized into two groups and undergo percutaneous kyphoplasty. The PMMA group (n = 189) will be treated with OSTEOPAL® plus PMMA bone cement. The artificial bone group (n = 189) will be treated with geneX® injectable artificial bone. Follow-ups will be conducted at 1 week and at 3, 6, 12, and 24 months. Outcome measures: The primary outcome measure will be the vertebral body height restoration rate at 24 months postoperatively to evaluate the repair effect of the damaged thoracic vertebra. The secondary outcome measures will be the vertebral body height restoration rate at 1 week and 3, 6, and 12 months postoperatively; the incidence of bone cement leakage at 1 week and 3, 6, 12, and 24 months postoperatively; the Visual Analog Scale score, Oswestry Disability Index, compression rate of the anterior vertebral height, and thoracic morphology revealed by computed tomography preoperatively and at 1 week and 3, 6, 12, and 24 months postoperatively; and the incidence of adverse reactions at 1 week and 3, 6, 12, and 24 months postoperatively. Discussion: Our results will verify whether OSTEOPAL® plus PMMA bone cement and geneX® injectable artificial bone graft are effective and safe for treating senile degenerative thoracic osteoporotic vertebral compression fractures in the short term and at the 2-year follow-up. Ethics and dissemination: This trial has been approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China in November 2017. The study protocol will be conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. This trial was designed in December 2017. The recruitment of subjects and data collection will begin in July 2018. Outcome measures will be analyzed in September 2020. This trial will be completed in October 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Trial registration: This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800015411). Protocol version (1.0).
  2,223 257 -
Effectiveness and safety of arthroscopic debridement for treatment of degenerative knee osteoarthritis in elderly patients: study protocol for a non-randomized controlled trial
Yong-Chun Lu, Bo Bi, Yong-Sheng Xiang, Xiang-Yang Du
January-March 2018, 3(1):15-21
DOI:10.4103/2542-3975.228987  
Background and objectives: The main treatment goals for degenerative knee osteoarthritis are to relieve pain, restore knee function, improve quality of life, delay knee replacement, and reduce the number of revisions. Knee replacement is currently the most common treatment for degenerative knee osteoarthritis; however, the cost is high, and the procedure is often associated with prosthesis loosening and shedding and many adverse reactions. Therefore, we hypothesize that knee-preserving arthroscopic debridement for treatment of knee degenerative osteoarthritis in elderly patients is lower-cost, effective, safe, and reliable. Design: Prospective, single-center, open-label, non-randomized controlled trial. Methods: In total, 212 elderly patients (knees) with degenerative knee osteoarthritis who receive treatment in the Second Hospital of Chaoyang (Liaoning Province, China) will be included in this study. These patients will be assigned to two groups according to each patient’s condition and wishes (n = 106/group). In the control group, intra-articular injection of sodium hyaluronate will be performed, followed by oral administration of nonsteroidal anti-inflammatory drugs, conventional physiotherapy, and quadriceps functional exercise. In the arthroscopic debridement group, arthroscopic debridement will be performed, followed by oral administration of nonsteroidal anti-inflammatory drugs, conventional physiotherapy, and quadriceps functional exercise. All patients will be followed up at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years. Outcome measures: The primary outcome measure is the percentage of patients with a Hospital for Special Surgery (HSS) knee score of ≥ 85 points at 2 years after surgery, which will be used to evaluate knee function recovery. The secondary outcome measures are the percentage of patients with an HSS knee score of ≥ 85 points before surgery and at 1 week, 1 month, 3 months, 6 months, and 1 year after surgery; the HSS score, visual analog scale score, Western Ontario and McMaster Universities Osteoarthritis Index, knee range of motion, hospitalization costs, and knee X-ray morphology before surgery and 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after surgery; medical costs after 2 years of treatment; and incidence of adverse reactions at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after surgery. Discussion: The findings from this study will reveal whether arthroscopic debridement for the treatment of degenerative knee osteoarthritis in elderly patients has the advantages of fewer adverse reactions and lower treatment costs with effective restoration of knee function. Ethics and dissemination: This study was approved by Medical Ethics Committee of Second Hospital of Chaoyang of China (approval No. 2017-08-01). The study will be performed in accordance with the Declaration of Helsinki. Participants provided signed informed consent regarding the study protocol prior to participation in the study. This study was designed in June 2017. Patient recruitment and data collection will begin in June 2018. Patient recruitment will end in December 2018. Data analysis will be performed in June 2021. The study will be completed in August 2021. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800015208). Protocol version (1.0).
  2,095 198 -
MISCELLANEOUS
Information for authors - Clinical Trials in Degenerative Diseases (CTDD)

January-March 2018, 3(1):27-31
  1,328 131 -