Objective To study the changes of receptor activator of nuclear factor-κB ligand (RANKL, an osteoclastogenesis-promoting factor) and osteoprotegerin (OPG, the decoy receptor for RANKL), oxidative stress and bone turnover markers in obstructive sleep apnea-hypopnea syndrome (OSAHS), in order to understand the potential mechanisms underlying bone loss in OSAHS patients. Methods Ninety-eight male patients with OSAHS, confirmed by polysomnography (PSG) study, were enrolled. The patients were divided into mild-moderate groups and severe groups. Forty-two male subjects who were confirmed as not having OSAHS served as the controls. The subjects’ bone mineral density (BMD) and T-score were assessed in lumbar spine and femoral neck using dual-energy X-ray absorptiometry. Blood samples were collected from all subjects for measurement of RANKL, OPG, the bone formation marker bone-specific alkaline phosphatase (BAP), the bone resorption marker tartrate-resistant acid phosphatase-5b (TRAP-5b), total antioxidant capacity (TAOC). Twenty-eight severe OSAHS patients accepted continuous positive airway pressure (CPAP) treatment voluntarily. After 6 months, PSG was conducted, and serum RANKL, OPG, TAOC, TRAP-5b, BAP was measured after six months treatment. Results The BMD, T-score of the femoral neck and the lumbar spine were significantly lower in OSAHS patients as compared to the control group. The level of BAP was significantly decreased in the OSAHS group as compared to the control group, and there was no significant difference in TRAP-5b level between two groups. As compared with the control group, levels of OPG, TAOC and the OPG/RANKL ratio decreased significantly. None of these parameters (BMD, T-score, RANKL, OPG, TRAP-5b, BAP) showed significant difference between patients with mild-moderate and severe OSAHS group. Correlation analysis showed that the apnea hypopnea index and oxygen desaturation index were correlated with TAOC. BAP level was positively correlated with TAOC and lowest pulse oxygen saturation. The serum level of TAOC was lower in the OSAHS group after CPAP therapy, but the levels of RANKL, OPG, TRAP-5b, BAP were not different. As compared with the OSAHS group before CPAP therapy, the BMD of the femoral neck and the lumbar spine were not significant difference. Conclusions In patients with OSAHS, the oxidative stress response is enhanced, and imbalance of OPG/RANKL is shifted, which participates in the occurrence of osteoporosis. The oxidative stress injury of severe OSAHS patients was relieved after non-invasive ventilation treatment, but the effect of oxidative stress response on bone metabolism still needs further evaluation.
ObjectiveTo realize the application status and development trend of oral anticoagulant drugs used in respiratory diseases in 72 hospitals in 6 cities from the year 2013 to 2017.MethodsFrom January 2013 to December 2017, we randomly selected the electronic information from 10 working days per quarter in 6 cities including Beijing, Guangzhou, Shanghai, Chengdu, Shenyang, and Zhengzhou, with 12 hospitals in each city, and summarized the information into the prescription database of the hospital prescription analysis project. Through the hospital information system, we screened out the information of outpatient prescriptions and inpatient medical records which used oral anticoagulants. The prescriptions with respiratory diseases related-diagnosis were selected as the research objects by manual screening. The application of oral anticoagulant drugs used in respiratory diseases was statistically analyzed by drug amount, prescription amount, prescribed daily dose (PDD), and defined daily dose (DDD).ResultsFrom 2013 to 2017, the number of warfarin sodium prescriptions was successively 4 769, 5 747, 7 549, 7 261, and 7 151, which had been always ranked the first in the five years, but decreased year by year since 2015. The proportion of warfarin sodium drug use amount decreased year by year from 32.52% in 2013 to 5.03% in 2017. The proportion of prescription and drug consumption sum of new oral anticoagulants increased year by year in the past five years. The PDD/DDD of warfarin sodium, dabigatran etexilate, rivaroxaban, and apixaban were 0.41, 0.73, 0.68, and 0.33, respectively. There were off lable use of new oral anticoagulants.ConclusionsWarfarin still dominates the proportion of oral anticoagulants prescribed in the 72 hospitals in the 6 cities in the five years. The clinicians have made a comprehensive judgment after fully considering the safety, effectiveness, and economy of drug use when formulating drug treatment programs.
In medical research, pilot and feasibility studies are conducted to reduce the uncertainty of future main trial and enhance its overall quality and probability of successful completion. The objective of a pilot and feasibility study is to answer whether the main trial can be performed, should be performed, and if so, how. Due to the tremendous resources, time, and funding required for a phase Ⅲ clinical trial, conducting a pilot and feasibility study is generally a pivotal step. While pilot and feasibility studies are gaining increasing attention in clinical research, efforts are largely required to promote the dissemination in China. Therefore, in this article, we briefly introduce the concepts of a pilot and feasibility study, its importance to the main trial, and current practice. Examples are also provided to help illustrate the introduction.
ObjectiveTo summarize the treatment and experience of percutaneous transhepatic portal vein recanalization by endovascular approach for treatment of cavernous transformation of the portal vein (CTPV) in a child. MethodThe clinical data of a child with idiopathic CTPV who underwent percutaneous transhepatic portal vein recanalization by endovascular approach were retrospectively analyzed. ResultsWe described a novel percutaneous transhepatic portal vein recanalization approach that had successfully treated a child with idiopathic CTPV following a multidisciplinary team evaluation. The operation time was 1.5 h and blood loss was approximately 1 mL. The child recovered uneventfully at 9-month follow-up, without any clinical evidence of CTPV complications. ConclusionIn light of our successful management, we can envision that the portal vein recanalization is an important therapeutic supplement for treating CTPV and will result in a paradigm change.
Objective To investigate the physicochemical properties, osteogenic properties, and osteogenic ability in rabbit model of femoral condylar defect of acellular dermal matrix (ADM)/dicalcium phosphate (DCP) composite scaffold. Methods ADM/DCP composite scaffolds were prepared by microfibril technique, and the acellular effect of ADM/DCP composite scaffolds was detected by DNA residue, fat content, and α-1, 3-galactosyle (α-Gal) epitopes; the microstructure of scaffolds was characterized by field emission scanning electron microscopy and mercury porosimetry; X-ray diffraction was used to analyze the change of crystal form of scaffold; the solubility of scaffolds was used to detect the pH value and calcium ion content of the solution; the mineralization experiment in vitro was used to observe the surface mineralization. Twelve healthy male New Zealand white rabbits were selected to prepare the femoral condylar defect models, and the left and right defects were implanted with ADM/DCP composite scaffold (experimental group) and skeletal gold® artificial bone repair material (control group), respectively. Gross observation was performed at 6 and 12 weeks after operation; Micro-CT was used to detect and quantitatively analyze the related indicators [bone volume (BV), bone volume/tissue volume (BV/TV), bone surface/bone volume (BS/BV), trabecular thickness (Tb.Th), trabecular number (Tb.N), trabecular separation (Tb.Sp), bone mineral density (BMD)], and HE staining and Masson staining were performed to observe the repair of bone defects and the maturation of bone matrix. Results Gross observation showed that the ADM/DCP composite scaffold was a white spongy solid. Compared with ADM, ADM/DCP composite scaffolds showed a significant decrease in DNA residue, fat content, and α-Gal antigen content (P<0.05). Field emission scanning electron microscopy showed that the ADM/DCP composite scaffold had a porous structure, and DCP particles were attached to the porcine dermal fibers. The porosity of the ADM/DCP composite scaffold was 76.32%±1.63% measured by mercury porosimetry. X-ray diffraction analysis showed that the crystalline phase of DCP in the ADM/DCP composite scaffolds remained intact. Mineralization results in vitro showed that the hydroxyapatite layer of ADM/DCP composite scaffolds was basically mature. The repair experiment of rabbit femoral condyle defect showed that the incision healed completely after operation without callus or osteophyte. Micro-CT showed that bone healing was complete and a large amount of new bone tissue was generated in the defect site of the two groups, and there was no difference in density between the defect site and the surrounding bone tissue, and the osteogenic properties of the two groups were equivalent. There was no significant difference in BV, BV/TV, BS/BV, Tb.Th, Tb.N, and BMD between the two groups (P>0.05), except that the Tb.Sp in the experimental group was significantly higher than that in the control group (P<0.05). At 6 and 12 weeks after operation, HE staining and Masson staining showed that the new bone and autogenous bone fused well in both groups, and the bone tissue tended to be mature. Conclusion The ADM/DCP composite scaffold has good biocompatibility and osteogenic ability similar to the artificial bone material in repairing rabbit femoral condylar defects. It is a new scaffold material with potential in the field of bone repair.
ObjectivesTo evaluate the methodological bias and the reliability of the conclusions of systematic reviews (SRs) on the treatment for acute gout.MethodsPubMed, EMbase, The Cochrane Library, Epistemonikos, CBM, WanFang Data and CNKI databases were electronically searched to collect published systematic reviews and meta-analyses evaluating drug interventions therapy in acute gout from inception to April 8th 2017. Two reviewers independently screened literature, extracted data, assessed the methodological quality of included SRs by the AMSTAR tool, and assessed the quality of the body of evidence for each outcome by the GRADE approach.ResultsA total of seven relevant SRs were included, which contains three main outcome measures. Four SRs contained non-steroidal anti-inflammatory drugs (NSAIDS), three SRs contained colchicine and two SRs contained glucocorticoids. All SRs assessed risk of bias of included original studies. Two used the Jadad scale or modified Jadad scale in this assessment while others used the " assessing risk of bias” tool recommended by Cochrane Collaboration. The assessment results of AMSTAR tool suggested that: three SRs were considered high quality (scores≥9), and the other four were considered moderate quality. GRADE results showed: the quality of the evidence of 11 outcomes was low or very low, and five outcomes was moderate.ConclusionsThe current evidence confirms the effectiveness and safety of several drug interventions in the treatment of acute gout, however, the priority of these drugs is still unclear. We suggest conducting new SRs and updating relevant SRs, to systematically compare different drug interventions therapy in acute gout with the latest evidence. In addition, we still expect to put more efforts in conducting high-quality original studies, in order to fill the gap of relevant fields and improve the level of evidence quality.
Objectives To evaluate the methodological bias and the reliability of the conclusions of systematic reviews (SRs) on urate-lowering therapy (ULT) for chronic gout. Methods PubMed, EMbase, The Cochrane Library, Epistemonikos, CBM, WanFang Data and CNKI databases were electronically searched to collect published systematic reviews and meta-analyses evaluating urate-lowering drugs in chronic gout from inception to April 8th 2017. Two reviewers independently screened literature, extracted data, assessed the methodological quality of included SRs using the AMSTAR tool, and assessed the quality of the body of evidence for each outcome using the GRADE approach. Results A total of 11 relevant SRs/Mets were included, containing 3 main outcome measures. All these SRs contained allopurinol. Ten SRs contained febuxostat, 3 SRs contained benzbromarone and 1 SR contained probenecid. Ten SRs assessed the risk of bias of included original studies. Eight SRs used the" assessing risk of bias”tool recommended by Cochrane Collaboration for this assessment while 2 used other tools. The assessment results of AMSTAR tool showed: the scores of 4 SRs were ≥9, and the others were ≤8. GRADE results showed: the quality of the evidence of 20 outcomes was low or very low, 10 outcomes was moderate and two outcomes was high. Conclusions Moderate quality evidence shows that febuxostat is beneficial in achieving target serum uric acid levels when comparing to allopurinol, and high quality evidence shows the incidence of gout flares is not significantly different between the two groups. High quality evidence also shows that the safety of febuxostat is better than allopurinol. Evidence of SRs is still insufficient to support the effectiveness and safety of other urate-lowering drugs. It is expected that more scientific and rigorous researches will be performed in the future, for which more high quality evidence will be produced to fill relevant gaps.
ObjectivesTo evaluate the reporting quality of clinical practice guidelines published in Chinese journals in 2017.MethodsCBM, CNKI and WanFang Data databases were searched for articles published in 2017. Two reviewers independently screened literature, extracted data, and evaluated the reporting quality of clinical practice guidelines using the Reporting Items for Practice Guidelines in Healthcare (RIGHT).ResultsOne hundred and seven clinical practice guidelines were included and a total reporting rate of 34.8%±0.1% in RIGHT. Among the seven domains of RIGHT, field on basic information had the highest reporting rate (56.8%) and fields on review and quality assurance had the lowest reporting rate (9.3%).The average reporting rate of RIGHT items of Chinese Science Citation Database (CSCD) articles was lower than non-CSCD [MD=−0.73, 95%CI (−0.78, −0.68)] articles. The average reporting rates of RIGHT items differed between Chinese Medical Association (CMA) journal articles and non-CMA journal articles [MD=2.30, 95%CI (2.26, 2.34)]. The average reporting rates of RIGHT items was lower in guidelines established by associations or institutes [MD=−3.78, 95%CI (−3.83, −3.73)], and was higher reported in Chinese medicine guidelines [MD=21.94, 95%CI (21.91, 21.97)].ConclusionsThe reporting quality of clinical practice guidelines published in journals of mainland China in 2017 is low in general, especially in fields such as review and quality assurance, funding and declaration and management of interests and other information. To improve this phenomena, it is suggested that guideline developers report the guidelines rigorously with international standard.
Objective The purpose of the extension of the RIGHT statement for introductions and interpretations of clinical practice guidelines (RIGHT for INT) was to promote the development of comprehensive and clear article those introduced and interpreted clinical practice guidelines. MethodsThe RIGHT for INT checklist was developed following methods recommended by the EQUATOR Network. The development process included three stages. In the first stage, a multidisciplinary team of experts was recruited by email and WeChat and further divided into three groups (a steering group, a consensus group, and a secretariat group); in the second stage, the initial items were collected by literature review and brainstorming; and in the third stage, the final items were formed through a Delphi survey and expert consultation. ResultsA total of 40 initial items were collected through literature review and brainstorming. A final checklist of 27 items was formed after the Delphi survey and expert consultation. ConclusionThe RIGHT for INT checklist provides guidance for guideline interpreters on how to introduce and interpret clinical practice guidelines in a scientific and comprehensive manner.