By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Clinical Trials as Topic ; Equipment and Supplies/standards* ; Indicators and Reagents/standards* ; Reproducibility of Results ; Research Design/standards*

According to the pathological characteristics of symptomatic chronic thoracic and lumbar osteoporotic vertebral fracture (SCOVF), the different clinical treatment methods are selected, including vertebral augmentation, anterior-posterior fixation and fusion, posterior decompression fixation and fusion, and posterior correction osteotomy. However, there is still a lack of a unified understanding on how to choose appropriate treatment method for SCOVF. In order to reflect the new treatment concept and the evidence-based medicine progress of SCOVF in a timely manner and standardize its treatment, the clinical guideline for surgical treatment of SCOVF is formulated in compliance with the principle of scientificity, practicability and advancement and based on the level of evidence-based medicine.

Objective To detect the oxidative and anti-oxidative imbalance of Hashimoto′s thyroiditis (HT) with specific thyroid function through specific serum.Methods 41 patients with normal thyroid function of Hashimoto′s thyroiditis and 43 healthy controls were enrolled in our hospital from May 2016 to May2017.Through specific serum tests, such as derived active oxygen metabolism (d-ROM) and biological antioxidant potential (BAP), advanced glycation end products (AGE) and advanced oxidized protein products (AOPP) were used to assess oxidative stress.Results The levels of d-ROM and AGEs were significantly increased (P＜0.05) and BAP was significantly lower in both groups compared with HT patients (P＜0.001).In univariate analysis, serum TSH, TgAb and TPOAb were significantly associated with d-ROMs (P＜0.05).HDL-C, serum TSH, TgAb and TPOAb were significantly associated with BAP (P＜0.05).Total cholesterol and LDL-C were significantly associated with AGEs (P＜0.05).Multivariate analysis showed that serum TPOAb was a predictor of d-ROMs (P＜0.001), BAP (P＜0.001), and AGEs (P=0.003).In addition, HDLC was also an independent predictor of BAP levels (P=0.012, R2=2.354, 95％CI:1.191-5.433).While LDL-C was an independent predictor of AGEs (P =0.004, R2=1.102, 95％CI:0.915-1.253).Conclusion HT patients increased oxidant, antioxidants decreased.And AGEs were significantly higher, AGEs levels can be used as a new HT oxidative stress a reliable biomarker.

Objective To investigate the correlation between seminal plasma hepatitis B virus (HBV) DNA copy and semen parameters and sperm DNA fragmentation (SDF).Methods The seminal plasma HBV-DNA was detected by the real-time PCR in 148 infertility males,and those with serum HBV-DNA above (positive) or below (negative) 5.0 × 102U/ml were analyzed respectively by semen parameters,sperm morphology and sperm DNA fragmentation (SDF).Results Of 148 male,60 (40.5％) were seminal plasma HBV-DNA positive,and of 60 positive patients,56 (93.3％) were serum hepatitis B e antigen(HBeAg) positive,which was higher than those of seminal plasma HBV-DNA negative males (31cases,35.2％).Serum HBeAg and HBV-DNA in seminal plasma HBV-DNA positive patients were 845.7(0.2 ～ 1455.0) S/CO and (1.7 ± 1.1) × 108U/ml,which were higher than those of HBV-DNA negative patients [HBeAg:0.1 (0.1 ～ 1374.0) S/CO;HBV-DNA:(2.3 ± 1.1) × 107 U/ml,P ＜ 0.01].Seminal plasma HBV-DNA positive patients exhibited lower semen volume,sperm concentration,the percentage of forward moving sperm and less normal morphology compared to HBV-DNA negative patients [(2.44±1.2)mlvs.(3.07±1.3)ml,(66.8±49.1) ×106/mlvs.(87.1 ±65.4) ×106/ml,(54.3± 16.1)％ vs.(59.1 ±15.3)％,(3.77 ±2.8)％ vs.(6.15 ±4.2)％,P＜0.05].The number of patients with teratozoospermia was significantly higher in seminal plasma HBV-DNA positive patients (56.7％ versus 34.1％,(P ＜ 0.01).The SDF in seminal plasma HBV-DNA positive patients was(18.1 ± 12.3)％,while it was(14.4 ± 8.4)％ in negative patients,and the difference of SDF in these two groups was significantly (t =2.197,P ＜ 0.05).Conclusion Seminal plasma HBV-DNA positive could affect the semen parameters,sperm morphology and SDF.

Objective To compare the value of transrectal ultrasonography(TRUS) and magnetic resonance(MR) in preoperative estimation of circumferential resection margin (CRM) of mid-low rectal cancer.Methods Both TRUS and MR were performed prior to surgery in 111 patients with mid-low rectal cancer.The CRM was evaluated and compared with the postoperative pathologic findings.Results The accuracy of TRUS and MR for CRM was 91.9％(102/111) and 85.6％(95/111),respectively,there was no statistical difference between them (P =0.137).Their specificities were 94.0％ (79/84)and 84.5％ (71/84),there was statistical difference between them(P =0.046).The consistency of the results between TRUS and pathology was better than that between MR and pathology(Kappa1 =0.783,Kappas =0.652).Conclusions TRUS is proved to have an important diagnostic value for CRM of mid-low rectal cancer.

Objective To investigate the clinical effect of different surgical approaches on multi-level cervical spondylosis in elderly patients.Methods A total of 53 aged patients with multi-level cervical spondylosis (≥70 years old) who received operation in our department during May 2007 to May 2014 were retrospectively studied, and divided into anterior cervical surgical group (n=22) and posterior cervical group (n=31), according to the surgical approach.The operation duration, intraoperative blood loss, hospitalization time, postoperative complications, Japanese orthopedics association (JOA) scores, Neck disability index (NDI), postoperative subjective improvement of clinical symptoms and spinal fusion of the two groups were evaluated and compared respectively.Results The mean operative time was longer in the anterior surgical group than in the posterior surgical group [(2.7±0.5)h vs.(1.9±0.3) h, P＜0.05].The average blood loss of the anterior surgical group was less than that of posterior surgical group [(90.0±50.4) ml vs.(160.7±40.5)ml, P＜0.05].The hospitalization time of the anterior surgical group was less than that of posterior surgical group [(10.3±2.5) d vs.(15.7±3.6) d, P＜0.05].Postoperative JOA score of anterior surgical group was higher than that of posterior surgical group 6 months after surgery [(14.7 ±0.8)vs.(13.8±1.2), P＜0.05], while there was no significant difference in JOA score between the two groups up to the last follow-up [(14.8±1.2) vs.(14.7±1.8), P＞0.05].NDI score was lower in anterior surgical group than in posterior surgical group 3, 6, 12 months after operation and at the last follow-up.Among the 41 patients, radiographic outcomes showed that there were 16 cases of anterior surgical group with no bony fusion at the follow-up 3 months after operation, and all the 16 patients achieved bony fusion at the follow-up 1 year after operation, and there were 4 cases with titanium mesh subsidence (＜ 3 mm).Conclusions Both anterior cervical decompression and fusion and posterior cervical single open-door laminoplasty have good efficacy in the treatment of multilevel cervical spondylosis in elderly patients, which have advantages on the limb functional recovery time and cervical function assessment.When anterior cervical surgical contraindications were excluded, the anterior cervical decompression and fusion may be a good choice for the treatment of multilevel cervical spondylosis in aged patients.

Objective To assess sperm chromatin structure assay (SCSA) and sperm chromatin dispersion test (SCD) for DNA fragmentation evaluation in human infertility, and the correlation between these two methods. Methods We used SCSA and SCD assays to detect DNA fragmentation in sperm from 134 infertile men. The correlation of SCSA and SCD assays was analyzed. The sperm DNA fragmentation index (DFI) was divided into 3 groups (≤15%DFI, >15~≤30%DFI and>30%DFI), and the difference between SCSA and SCD assays was assessed. Results The SCSA assay was strongly correlated with the SCD assay for sperm DNA fragmentation (r=0.915, P<0.001). There was no significant difference between>15~ ≤30%DFI and>30%DFI groups. However, SCD showed higher levels of DNA fragmentation than that measured by SCSA for≤15%DFI group (13.50 4.82 vs 9.79 2.60, P<0.001). Conclusion There is a strong positive correlation between SCSA and SCD assays in detection of DNA fragmentation. SCD assay showed higher levels of DNA fragmentation than that measured by SCSA for≤15%DFI group.

Objective To assess the left ventricular systolic function (LVSF) in patients with implanted dual-chamber(DDD) mode cardiac pacemakers using Two-dimensional Echocardiography (2DE),Real-time Tri-plane Echocardiography (RT-3PE)and Full-volume Three Dimensional Echocardiography (FV-3DE).Methods A total of 30 patients with DDD mode cardiac pacemaker were ex-amined by 2DE, RT-3PE and FV-3DE separately.Left ventricle end diastolic volume (LVEDV), left ventricle end systolic volume (LVESV), and ejection fraction (EF) were measured and compared within the three methods above .Results The measurement of EF with patients of post-operation was higher than the patients of pre-operation.The measurements of EF with 2DE were higher than RT-3PE.The measurements of LVEDV , LVESV and SV with 2DE and RT-3PE were lower than FV-3DE, and EF was higher .There were statistically significant differences in above measurements ( P <0.05 ) .But there were no statistically significant differences in measurements of LVEDV and LVESV between 2DE and RT-3DE ( P >0.05).Conclusions Implanting DDD mode cardiac pace-maker can evaluate LVSF of patients obviously .FV-3DE can evaluate LVSF in patients with DDD mode cardiac pacemaker accurately . The LVEDV, LVESV and SV are underestimated by 2DE and RT-3PE, and EF is overestimated by 2DE and RT-3PE.

Objective To measure the related anatomical parameters of lumbosacral nerve root and adjacent structures by magnetic resonance neurography,and to analyze operative safety of transforaminal lumbar interbody fusion in Chinese people.Methods A total of 12 healthy volunteers,including 6 males and 6 females,underwent magnetic resonance neurography of lumbosacral nerve root using a Siemens 3.0T MRI machine.The Osirix software was used to reconstruct the three-dimensional imaging and measure the following anatomic parameters: 1) the distance between the nerve root and the superior pedicle; 2) the distance between the nerve root and the inferior pedicle; 3) the angle between the nerve root and the sagittal plane; 4) the distance between the superior and inferior nerve roots; 5) the distance between the superior and inferior pedicles.Results L1-L5 nerve roots got a good imaging by magnetic resonance neurography in all 12 volunteers.The distance between the nerve root and the superior pedicle and the angle between the nerve root and the sagittal plane gradually became smaller from L1 to L5.But the variation in the distance between the nerve root and the inferior pedicle and the distance between the superior and inferior pedicles was not obvious.The distance between the nerve root and the inferior pedicles,which was closely related to the operating space of TLIF,ranged from (8.99±0.88) mm to (10.72±1.01) mm for males and from (7.76±0.46) mm to (8.54±0.65) mm for females; it was less than 10 mm in each segments in the majority of subjects,and the data of females was significantly smaller than that of males.No significant differences were found in parameters between the left and right sides in the same segment.Conclusion Based on the above anatomical study and measurement analysis,we believe that there is some harassment to the upper nerve root in TLIF for Chinese patients,and for some patients there is a certain injury risk.