• Users Online: 1502
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Contacts Reader Login
Export selected to
Endnote
Reference Manager
Procite
Medlars Format
RefWorks Format
BibTex Format
  Access statistics : Table of Contents
   2018| April-June  | Volume 3 | Issue 2  
    Online since July 6, 2018

 
 
  Archives   Previous Issue   Next Issue   Most popular articles   Most cited articles
 
Hide all abstracts  Show selected abstracts  Export selected to
  Viewed PDF Cited
REVIEW
Medication for management of pregnancy-induced hypertension
Yi Lin, Ying Zhang, Yi-Nong Jiang, Wei Song
April-June 2018, 3(2):83-87
DOI:10.4103/2542-3975.235153  
Hypertension refers to increased arterial blood pressure and can be divided into two categories: primary and secondary. Primary hypertension caused by angiogenic degenerative changes is a degenerative disease. With liberalization of China’s reproduction policy and increases in maternal age, the prevalence of pregnancy-induced hypertension (PIH) in China has increased gradually. PIH is not a type of primary hypertension, but there are differences in the treatment of these two types of hypertension. Here, we review the choice and use of drugs for PIH management using drugs for the management of primary hypertension as a reference. First-line drugs such as labetalol, nifedipine, or methyldopa should be taken via the oral route if blood pressure is ≥ 150/90 mmHg. For chronic hypertension, other drugs should be added after the first drug at the highest concentration has been revealed to be ineffective. If the blood pressure of patients with acute hypertension is ≥ 160/110 mmHg, maternal stroke or eclampsia can result. If PIH patients are about to deliver, they can be given labetalol (i.v.), hydralazine (i.v.) or nifedipine (p.o.). Moreover, all anti-hypertensive treatments should be based on considerations of maternal and fetal safety.
  56,087 1,536 2
RESEARCH ARTICLES
Wharton’s jelly derived allogeneic mesenchymal stromal cells for treatment of type 1 diabetes: Study protocol for a double-blinded, randomized, parallel, placebo-controlled trial
Per-Ola Carlsson, Mathias G Svahn
April-June 2018, 3(2):32-37
DOI:10.4103/2542-3975.235141  
Background and objectives: The Wharton’s jelly of the umbilical cord tissue contains a high density of mesenchymal stromal cells (MSCs). Wharton’s jelly derived mesenchymal stromal cells have immunosuppressive potential that can be utilized for treatment of autoimmune diseases such as type 1 diabetes (T1D). The objectives of this study are to assess the safety and efficacy of allogeneic Wharton’s Jelly derived MSCs (WJMSCs) in the treatment of T1D from the viewpoints of changes in beta-cell function, metabolic control, and diabetes treatment satisfaction during one year study period. Design: A two stage design. An open, non-randomized, dose-escalation scheme will be used in the first stage of the study, and a randomized, double-blinded, parallel, placebo-controlled scheme in the second stage of the study. Methods: The study population will consist of adult patients with T1D for < 2 years, 18–40 years of age (inclusive at both ends), only male in the first stage and both sexes in the second stage. In the first stage, a dose-escalation scheme with three doses will be evaluated for safety. The second stage will not be started until all patients in the first stage will have completed the 1-month follow-up visit. The second stage will recruit 15 patients who will be randomized to active treatment or placebo (2:1 ratio). Both patients and investigators will be blinded to the study protocol used in the second stage. Outcome measures: The primary outcome measure of this study will be safety. The secondary outcome measure will be efficacy of treatment, i.e., preservation of endogenous insulin production. This will be evaluated as delta change in C-peptide concentration in response to a mixed meal tolerance test, compared with before treatment. Discussion: By combining the first part (dose-escalation scheme) with the second part (double-blinded, parallel, placebo-controlled scheme), this study will provide both safety and efficacy data for the use of WJMSCs in the treatment of T1D. Obtained findings will guide on how to pursue this concept and indicate what dose of cells will be optimal for future trials. Ethics and dissemination: This study protocol was approved by the Ethics Committee Stockholm (approval number: 2017/1533-31/2) and the Swedish Medicinal Product Agency (EudraCT number: 2017-002766-50), and will be performed in accordance with the Declaration of Helsinki. Dissemination plans include presentations at scientific conferences and scientific publications. Patient recruitment was initiated in January 2018, and the first stage of the trial, the dose escalation, is expected to be completed for 1-month follow-up safety data, in the fourth quarter of 2018. Primary outcome measure will be estimated in 2020. Trial registration: ClinicalTrials.gov identifier: NCT03406585.
  8,230 648 7
Ranibizumab versus conbercept for wet age-related macular degeneration: Protocol for a prospective cohort study
Jia-Xing Zhang, Dong Li, Qian Hu, Juan Xie, Chun-Hong Yan, Xin Qian, Hua-Ye Zhao
April-June 2018, 3(2):71-76
DOI:10.4103/2542-3975.235152  
Background and objectives: Conbercept is a novel anti-vascular endothelial growth factor (VEGF) agent for the treatment of wet age-related macular degeneration (wAMD). However, no head-to-head study has compared the effectiveness of conbercept with that of ranibizumab. In this study, we will compare the effectiveness, cost-effectiveness and safety profiles of ranibizumab and conbercept in the treatment of wAMD. Design: This is a single-center, prospective, cohort study. Methods: Patients (≥ 50 years old) diagnosed with wAMD will be allocated to the conbercept or ranibizumab group according to their preference. Following a treat-and-extend protocol, patients will receive intravitreal injections of 0.5 mg conbercept or 0.5 mg ranibizumab every month in the first three injections. Outcome measures: The primary outcome is quality of life, measured with the Chinese version of the Low Vision Quality of Life Questionnaire, from baseline to 48 weeks post-treatment. Secondary outcomes include best corrected visual acuity, central retinal thickness, cost of treatment, intraocular pressure, and adverse events. The follow-up phase will last 1 year. Propensity score matching will be used to deal with differences in baseline between the two groups. A cost-effectiveness analysis will be performed. Discussion: The results of this study will provide clinicians with a rational basis for choosing the most effective treatment for wAMD patients. Ethics and dissemination: This study has been approved by the Medical Ethics Committee of Guizhou Provincial People’s Hospital (approval number: 2017113). Patient recruitment was initiated in November 2017. Analysis of primary outcome measures will be completed in October 2020, and the study will be finished in October 2021. Dissemination plans include presentations at scientific conferences and publication in scientific journals. Trial registration: This study was registered in the Chinese Clinical Trial Registry with registration number of ChiCRT-OPC-17013023, protocol version: 2.0.
  6,312 362 -
Deep brain stimulation for the treatment of moderate-to-severe Alzheimer’s disease: Study protocol for a prospective self-controlled trial
Wei Lin, Li-Kun Yang, Jie Zhu, Yu-Hai Wang, Ji-Rong Dong, Tao Chen, Dan Wang, Xiao-Mei Xu, Shi-Bai Sun, Li Zhang
April-June 2018, 3(2):66-70
DOI:10.4103/2542-3975.235150  
Background and objectives: Previous studies have shown that deep brain stimulation can improve clinical symptoms in patients with mild Alzheimer’s disease, but the therapeutic effect in patients with moderate-to-severe Alzheimer’s disease remains unclear. Therefore, we intend to assess the therapeutic effect of deep brain stimulation on moderate-to-severe Alzheimer’s disease through a 24-month follow-up visit. Design: A prospective single-center, self-controlled study. Methods: This trial will be performed at the 101st Hospital of PLA, Wuxi, China. We will include 20 patients with moderate-to-severe Alzheimer’s disease who will be given bilateral deep brain stimulation via an implant located beside the fornical column. Outcome measures: The primary outcome measure is the percent of patients whose scores on the Mini Mental State Examination have improved after 24 months. The secondary outcome measures include the percent of patients whose scores on the Mini Mental State Examination Scale have improved at other visits, their Montreal Cognitive Assessment-Basic score, Rey-Osterrieth Complex Figure Test score, score on the delayed recall of the Rey-Osterrieth Complex Figure Test, trail making test score, Hamilton Rating Scale for Depression score, functional magnetic resonance imaging results, functional PET imaging results at each visit point, and the incidence of adverse events. Discussion: This trial will provide feasible, objective, and quantifiable evidence for deep brain stimulation in the clinical treatment of moderate-to-severe Alzheimer’s disease. Ethics and dissemination: This study protocol was approved by the Institution Review Board of the 101st Hospital of PLA in China (approval No. L2017002) in December 2016. Design of the study was finished in October 2016, and registered in August 2017. Participant recruitment was started at October 2017, and was expected to be finished within 12 months. Data analysis will be completed until October 2020. The results of the study will be disseminated through presentations at peer-reviewed publications. Trial registration: This trial was registered in the Chinese Clinical Trial Registry with registration No. ChiCTR-ONC-17012311 (version 2.0).
  5,622 377 7
Fenestration and debridement combined with percutaneous minimally invasive fibula implantation in the treatment of senile degenerative osteonecrosis of the femoral head: A study protocol for a non-randomized, controlled, clinical trial
Di Qin, Xiao-Bo Wu, Hui-Jie Li, Li-Ying He, Tao Wu, Wen-Hui Ma, Li-Xun Li, Yong-Tai Han
April-June 2018, 3(2):38-44
DOI:10.4103/2542-3975.235146  
Background and objectives: Osteonecrosis of the femoral head is one of the common forms of senile degenerative osteoarthropathy. The hip preservation surgery techniques that are currently commonly used include femoral head fenestration, debridement and bone grafting through an anterior approach, and debridement and impaction bone grafting with fibula support through a lateral approach with subtrochanter drilling. These two techniques cause great trauma to the patients, and surgery costs are high. Femoral head collapse occurs easily after surgery. The course inhibition of necrosis of the femoral head and repair effect are not ideal. Thus, we hope to develop a new repair method that can make up for the shortcomings of conventional hip preservation surgery. We will observe the therapeutic effect of fenestration and debridement combined with percutaneous minimally invasive fibula implantation. This low-cost procedure for senile osteonecrosis of the femoral head should have little intraoperative trauma. We will determine if it also prevents postoperative femoral head collapse. Design: This is a prospective, multicenter, non-randomized, controlled, clinical trial. Methods: Seventy patients (117 hips) with senile degenerative osteonecrosis of the femoral head will be recruited from the Hebei Provincial Youfu Hospital and the Third Hospital of Hebei Medical University, Shijiazhuang, China. The patients will be allocated into three groups according to the repair method. (1) Patients in the drilling debridement group will undergo conventional debridement and impaction bone grafting with fibula support through a lateral approach with subtrochanter drilling. (2) Patients in the fenestration debridement group will undergo conventional femoral head fenestration, debridement, and bone grafting through an anterior approach. (3) Patients in the combination repair group will undergo fenestration, debridement, and impaction bone grafting combined with percutaneous minimally invasive fibula implantation. Each group will include 39 hips. Follow-up will be conducted for 12 months. Outcome measures: The primary outcome measure is the incidence of femoral head collapse on the affected side at 12 months after surgery. The secondary outcome measures are intraoperative blood loss, operation time, hospital costs, and Harris hip score for hip function before surgery and 6 and 12 months after surgery and the incidence of adverse reactions at 6 and 12 months after surgery. Discussion: Our results can verify whether the effect of fenestration and debridement combined with percutaneous minimally invasive fibula implantation is better than those of the other two types of conventional hip preservation techniques in the treatment of senile osteonecrosis of the femoral head. In addition, we will validate whether the combined method clearly inhibits postoperative femoral head collapse and improves hip function. Ethics and dissemination: This trial has been approved by the Ethics Committee of Third Hospital of Hebei Medical University of China (approval number: KE2016-011-1). 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 January 2014. Ethics approval was done in December 2014. The recruitment of subjects will begin in June 2018. Samples and data will be collected from June 2018 to June 2019. Outcome measures will be analyzed in August 2019. This trial will be completed in December 2019. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800015124).
  5,485 364 -
Percutaneous transforaminal endoscopic discectomy for treatment of degenerative lumbar disc herniation in older adult patients: study protocol for a randomized controlled trial and preliminary results
Li-Chen Xu, Wei-Bing Xu, Dong-Fang Yang, Hai-Bin Zhang
April-June 2018, 3(2):45-51
DOI:10.4103/2542-3975.235147  
Background and objectives: Percutaneous transforaminal endoscopic discectomy (PTED) is a major minimally invasive surgical method for the treatment of degenerative lumbar disc herniation. The choice of posture for patients undergoing PTED is controversial. Surgeons tend to perform PTED with the patient in the prone position rather than in the lateral position. Little is documented on which posture has higher efficacy and safety. This study will be performed to investigate the efficacy and safety of the prone position versus lateral position for older adult patients undergoing PTED for the treatment of degenerative lumbar disc herniation. Design: A prospective, single-center, open-label, randomized controlled trial. Methods: This study will include 168 older adult patients with degenerative lumbar intervertebral disc herniation who receive treatment in the Department of Spine Surgery, Dalian Municipal Central Hospital Affiliated to Dalian Medical University, China. These patients will be randomized to undergo PTED in either the prone or lateral position (n = 84 patients in each surgical position). After surgery, all patients will be followed up for 2, 6, and 12 months. Outcome measures and preliminary results: The primary outcome is the Oswestry Disability Index at 12 months postoperatively. This index is used to evaluate the improvement in low back pain. The secondary outcomes are the Oswestry Disability Index preoperatively (at baseline) and at 2 and 6 months postoperatively; X-ray morphology of the lumbar spine, Visual Analog Scale score, and Japanese Orthopaedic Association score preoperatively and at 2, 6, and 12 months postoperatively; modified MacNab grade at 2, 6, and 12 months postoperatively; partial pressures of oxygen and carbon dioxide preoperatively, intraoperatively, and 1 hour postoperatively; mean arterial pressure, Likert score, and times and doses of vasopressor used intraoperatively; and the incidence of recurrent lumbar intervertebral disc herniation and incidence of adverse reactions 12 months postoperatively. The results of 54 patients included in a pilot study of PTED showed that regardless of use of the prone position (n = 24) or lateral position (n = 28), the Visual Analog Scale score and Oswestry Disability Index at 2 months postoperatively were significantly lower than those before surgery (P < 0.05). Intraoperative arterial blood gas analysis revealed that the partial pressures of oxygen and carbon dioxide were significantly different between patients in the prone and lateral positions (P < 0.05). Discussion: Based on the pilot study, future studies involving larger sample sizes are needed to investigate the short- and medium-term efficacy and safety of the prone versus lateral position for patients undergoing PTED for degenerative lumbar intervertebral disc herniation and to identify a better surgical posture suitable for older adult patients. Ethics and dissemination: This study was approved by Medical Ethics Committee of Dalian Municipal Central Hospital Affiliated to Dalian Medical University, China in May 2018 (approval No. 2018-012-01). This study protocol will be performed in strict accordance with the Declaration of Helsinki. Written informed consent will be obtained from the participants. The study protocol was designed in December 2017. Patient recruitment will begin in August 2018 and end in August 2019. Data analysis will begin in October 2020 and end in November 2020. 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: ChiCTR1800016399). Protocol version: 1.0.
  5,146 381 3
Three methods for reducing back pain in older adults with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine: protocol for a non-randomized controlled trial with 2-year follow-up and preliminary results
Kai Wang, Chun-Liang Li, Hai-Yong Zhu, Yu Wang, Zhi-Jin Zhang
April-June 2018, 3(2):59-65
DOI:10.4103/2542-3975.235149  
Background and objectives: Osteoporotic vertebral compression fracture of the thoracolumbar spine manifests clinically as back pain. Percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP) are the preferred treatment methods for this disorder. Our previous studies have shown that both procedures effectively reduce back pain at 6 months post-surgery in older adults with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine. Little is documented about longer-term pain relief after PKP and PVP. The aim of this prospective, single-center, non-randomized, controlled trial is to investigate long-term and medium-term back pain relief after PKP, PVP, and non-surgical treatment of this condition and to analyze risk factors for ongoing back pain. Design: A prospective, single-center, non-randomized, controlled trial. Methods: This study will include 900 patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine scheduled to receive treatment at Qinghai Provincial People’s Hospital. Patients will be assigned to receive PKP, PVP, or nonsurgical treatment (rehabilitation and traditional Chinese medicine; n = 300 per treatment method). Patients will have follow-up evaluation at 1 week and 1, 3, 6, 12, and 24 months. Outcome measures and preliminary results: The primary outcome measure is the prevalence of back pain 24 months post-surgery. Secondary outcome measures are prevalence of back pain at other time points; Visual Analogue Score, Oswestry Disability Index, Japanese Orthopedic Association score, and X-ray morphology before surgery and at all postoperative time points; and incidence of adverse events at each postoperative time point. A pilot study of 621 patients with osteoporotic vertebral compression fracture of the thoracolumbar spine revealed that Visual Analogue Score and Oswestry Disability Index were significantly lower 6 months postoperatively than prior to PKP or PVP, with only 15% of patients having ongoing back pain. Risk factors for back pain were bone cement leakage (direction, volume, and scope) and adverse reactions (P < 0.05). This study’s findings will help clarify the optimal treatment for back pain relief in patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine. Ethics and dissemination: The study protocol was approved by Medical Ethics Committee, Qinghai Provincial People’s Hospital of China in April 2017 (approval No. RM006G). This study will be performed in strict accordance with the Declaration of Helsinki developed by the World Medical Association. Written informed consent will be obtained from each patient. The study protocol was designed in March 2017. Patient recruitment and data collection will begin in September 2018. Patient recruitment will end in September 2019. Data analysis will be performed in October 2021. The whole study will end in November 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: ChiCTR1800016493). Protocol version: 1.0.
  5,145 351 -
Ranibizumab combined with photodynamic therapy for the treatment of advanced-stage exudative age-related macular degeneration: Study protocol for a self-controlled trial and preliminary results
Ping Yu, Qing Wang, Ling-Ling Liu
April-June 2018, 3(2):77-82
DOI:10.4103/2542-3975.235151  
Background and objectives: The lack of visual field in the visual center of older adults with age-related macular degeneration (AMD) has a serious impact on daily activities. AMD is subdivided into atrophic and exudative AMD according to pathology. Patients with advanced stage exudative AMD develop aged-related degeneration in the macular area. Ranibizumab combined with photodynamic therapy is mainly used for the treatment of early exudative AMD; however, treatment outcomes in advanced stage exudative AMD are not well documented. Therefore, we attempt to analyze vision recovery, retinal thickness, and leakage of choroidal neovascular lesions in patients with advanced stage exudative AMD after treatment with ranibizumab plus photodynamic therapy. We also further explore the therapeutic efficacy of the combined therapy. Design: A prospective self-controlled trial. Methods: The trial will be undertaken in the Department of Ophthalmology, Affiliated Hospital of Qinghai University, China. The study population will comprise 113 patients with advanced exudative AMD who are eligible for inclusion. Photodynamic therapy combined with intravitreal injection of ranibizumab will be given as the interventional therapy. Outcome measures and preliminary results: The primary outcome measure of the trial is visual improvement in patients 12 months after treatment. Secondary outcome measures include logarithmic visual acuity chart scores, retinal thickness, and leakage of choroidal neovascular lesions assessed monthly at 1-12 months after treatment. Adverse events are also recorded during follow-up. Pre-test results showed that at 12 months after treatment, visual acuity in 43 affected eyes was increased by ≥ 2 lines, and the average retinal thickness decreased by 111.21 μm compared with before treatment. Leakage of choroidal neovascular lesions in most affected eyes stopped or the lesions were contracted. Discussion: Findings from the trial are expected to provide reliable data on the efficacy of ranibizumab combined with photodynamic therapy in the treatment of advanced exudative AMD. This will provide a basis for the rational use of this combined therapy in the treatment of advanced exudative AMD. Ethics and dissemination: The study was designed in December 2017, and approved by the Ethics Committee of the Affiliated Hospital of Qinghai University (approval No. QHY001Y) in January 2018. The trial was registered with the Chinese Clinical Trial Registry in March 28, 2018. Participant recruitment was initialized in March 2018, and data analysis will be completed in December 2020. The results of this study will be disseminated by publications in peer-reviewed journals. Trial registration: This trial was registered in the Chinese Clinical Trial Registry with registration No. ChiCTR1800015410 (protocol version 1.0).
  5,006 338 -
Rapamycin-eluting stents for unprotected left main coronary artery stenosis in older adult patients with coronary atherosclerosis: study protocol for a prospective, non-randomized, controlled trial and preliminary results
Wei Chen, Zhi-Cheng Fang, Xiang Zheng, Bo-Yi Liu, Ji-Xian Zhao, Ying-Ying Liao
April-June 2018, 3(2):52-58
DOI:10.4103/2542-3975.235148  
Background and objectives: Coronary artery bypass grafting (CABG) is the gold standard therapy for unprotected left main coronary artery (ULMCA) stenosis in coronary atherosclerosis. However, ULMCA stenosis has recently been successfully treated with drug-eluting stents. The present study aims to compare the safety and efficacy of CABG versus rapamycin-eluting stents for ULMCA stenosis in older adult patients with degenerative coronary atherosclerosis. Methods: The proposed prospective, non-randomized, controlled trial will include 224 older adult patients with degenerative coronary atherosclerosis with ULMCA stenosis being treated at Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) and Renmin Hospital Affiliated to Hubei University of Medicine, China. Patients will be divided into two groups in accordance with each patient’s treatment choice and indications (n = 112/group): the stent group will receive rapamycin-eluting stents, while the CABG group will undergo CABG. All patients will be followed up at 9, 12, 24, and 36 months postoperatively. Outcome measures and preliminary results: The primary outcome measure will be the rate of repeat revascularizations in the target lesion at 36 months postoperatively. The secondary outcome measures will be the rates of repeat revascularizations in the target lesion at 9, 12, and 24 months postoperatively, the rate of restenosis, mortality, causes of death, and survival at 9, 12, 24, and 36 months postoperatively, and the angiographic appearance of the diseased vessels preoperatively and at 9, 12, 24, and 36 months postoperatively. The safety indicator will be the incidence of major adverse cardiac and cerebrovascular events at 9, 12, 24, and 36 months postoperatively. Pilot study results showed that the stent group (n = 48) had a significantly reduced waiting time for surgery, hospitalization time, and rate of complete revascularizations in the target lesion compared with the CABG group (n = 38) (P < 0.05). At 6 months postoperatively, there were no significant differences between the two groups in mortality, and incidences of myocardial infarction, repeat revascularizations in the target lesion, and cardiovascular events. Discussion: The results of this study will indicate the medium- and long-term efficacy and safety of rapamycin-eluting stents versus CABG in older adult patients with ULMCA stenosis. Ethics and dissemination: This study was approved by Medical Ethics Committee, Taihe Hospital (approval No. TH0058X), and Shiyan Renmin Hospital (approval No. RM011X), China in July 2017. This study protocol will be performed in strict accordance with the Declaration of Helsinki. Written informed consent will be obtained from each patient. The study protocol was designed in January 2018. Patient recruitment will begin in August 2018 and end in August 2019. Data analysis will begin in October 2022. The study will end in December 2022. 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: ChiCTR1800016413). Protocol version: 1.0.
  4,758 322 -