Objective To study the USA government’s administrative system about medical device standards as well as the standard making. Methods The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. Results The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards. Conclusion The USA’s administrative system about medical device standards as well as many standards can be referenced.
Objective To evaluate the efficacy and safety of L-ornithine-L-aspartate (LOLA) in the treatment of hepatic encephalopathy (HE). Methods Such databases as PubMed, EMbase, Web of Science, CENTRAL, Chinese Journals Full-text Database, CBM and WanFang Data were searched from the date of their establishment to November 30, 2011 to collect the randomized controlled trials (RCTs) on LOLA in treating HE. The quality of included studies was evaluated by two reviewers independently, data were extracted and cross-checked, and then meta-analysis was performed using Review Manager 5.0 software. Results Among the total six included RCTs, 432 patients were diagnosed as type-C HE and 185 were diagnosed as type-A HE. Compared with the placebo group, for the patients with type-C HE, LOLA could significantly reduce the serum ammonia level (WMD=16.60, 95%CI 8.34 to 24.85, Plt;0.000 1) and the time of number connection test-A (NCT-A) (WMD=9.6, 95%CI 5.26 to 13.93, Plt;0.00 01), and it could also effectively improve the clinical remission rate (RR=1.36, 95%CI 1.06 to 1.73, P=0.01). However, no significant differences were found between the two groups for the patients with type-A HE (Pgt;0.05). Conclusion LOLA is effective for the patients with type-C hepatic encephalopathy, and it could be regarded as a choice in clinic. However, more high-quality RCTs are needed to further evaluate the effect of LOLA in treating type-A hepatic encephalopathy.
Objective To investigate the current situation of randomized controlled trials (RCTs) on the treatment of Sjogren’s syndrome with Traditional Chinese Medicine (TCM), and to assess whether there is adequate evidence for clinical practice. Methods Such databases as CNKI, VIP, CBM and PubMed were searched from their establishment date to June 2010 to collect the RCTs on the treatment of Sjogren’s syndrome with TCM according to the predefined inclusion criteria. And the quality was assessed by using the Jadad scale, the revised CONSORT statement and other self-defined indexes.Results Among 19 included RCTs, 1 literature scored four points, 4 scored two points, 13 scored one point, and 1 scored zero point according to Jadad scale; no RCT performed the allocation concealment. According to the CONSORT criteria, 19 RCTs accounting for 100% reported the diagnostic criteria, implement of interventions and result, 11 RCTs applied the 2002 international diagnosis and classification criteria of Sjogren’s syndrome, 17 RCTs carried out positive control including one based on the standard treatment, and two RCTs applied only blank control without placebo control. All RCTs took the comprehensive efficacy assessment as the outcome index, but only 6 RCTs (31.6%) assessed both clinical efficacy and TCM syndrome efficacy. Among 6 RCTs (31.6%) describing the random sequence, no RCT reported the detailed methods. Except 1 RCT (5.3%) carried out the double blinding, all the others were non-blind trials. And only 1 RCT adopted analog. Conclusion Currently, the methodology and reporting quality of studies on the treatment of Sjogren’s syndrome with TCM are not good enough to provide reliable evidence for clinical practice.
【Abstract】 Objective To investigate the possibil ity of BMSCs seeded into collagen Ⅰ -glycosaminoglycan (CG)matrices to form the tissue engineered cartilage through chondrocyte inducing culture. Methods Bone marrow aspirate of dogs was cultured and expanded to the 3rd passage. BMSCs were harvested and seeded into the dehydrothemal treatment (DHT)cross-l inked CG matrices at 1×106 cells per 9 mm diameter sample. The samples were divided into experimental group and control group. In the experimental group, chondrogenic differentiation was achieved by the induction media for 2 weeks. Medium was changed every other day in both experimental group and control group. The formation of cartilage was assessed by HE staining and collagen Ⅱ immunohistochemical staining. Results The examinations under the inverted phase contrast microscopeindicated the 2nd and 3nd passage BMSCs had the similar morphology. HE staining showed the BMSCs in the experimental group appeared polygon or irregular morphology in the CG matrices, while BMSCs in the control group appeared fibroblast-l ike spindle or round morphology in the CG matrices. Extracellular matrix could be found around cells in the experimental group. Two weeks after seeded, the cells grew in the CG matrices, and positive collagen Ⅱ staining appeared around the cells in the experimentalgroup. There was no positive collagen Ⅱ staining appeared in the control group. Conclusion It is demonstrated that BMSCs seeded CG matrices can be induced toward cartilage by induction media.
Objective To investigate the possibility of repairing articular cartilage defects with the mesenchymal stem cells(MSCs) seeded type Ⅰ collagen-glycosaminoglycan(CG) matrices after being cultured with the chondrogenic differentiation medium. Methods The adherent population of MSCs from bone marrow of10 adult dogs were expanded in number to the 3rd passage. MSCs were seeded intothe dehydrothermal treatment (DHT) crosslinked CG matrices; 2×106 cells per 9mm diameter samples were taken. Chondrogenic differentiation was achieved by the induction media for 3 weeks. Cell contractility was evaluated by the measuement of the cell-mediated contraction of the CG matrices with time inculture.The in vitro formation of the cartilage was assessed by an assayemploying immunohistochemical identification of type Ⅱ collagen and by immunohistochemistry to demonstrate smooth muscle actin （SMA）. The cells seededingCGs wereimplanted into cartilage defectsof canine knee joints. Twelve weeks after surgery, the dogs were sacrificed and results were observed. Results There was significant contraction of the MSCsseeded DHT crosslinked CG scaffolds cultured in the cartilage induction medium. After 21 days, the MSCseeded DHT crosslinked matrices were contracted to 64.4%±0.3%; histologically, the pores were found to be compressedandthe contraction coupled with the newly synthesized matrix, transforming the MSCsseeded CG matrix into a solid tissue in most areas. The type Ⅱ collagen staining was positive. The SMA staining was positive when these MSCs were seeded and the contracted CGs were implanted into the cartilage defects of the canine knee joints to repair the cartilage defects. The function of the knee joints recovered and the solid cartilaginous tissue filled the cartilage defects. Conclusion The results demonstrates that MSCs grown in the CG matrices can produce a solid cartilaginous tissuecontaining type Ⅱ collagen after being cultured with the chondrogenic differentiation medium and implanted into cartilage defects. We hypothesize that the following steps can be performed in the chondrogenic process: ①MSCs express SMA, resulting in matrix contraction, thus achieving a required cell density (allowing the cells to operate in a necessary society)； ②Cells interact to form a type Ⅱ collagencontaining extracellular matrix (and cartilaginous tissue)； ③Other factors, suchas an applied mechanical stress, may be required to form a mature cartilage with the normal architecture.
Objective To evaluate the effectiveness of combined posterior decompression with laminoplasty and anterior decompression with fusion for the treatment of cervical spinal canal stenosis with reverse arch. Methods Between May 2009 and February 2012, 13 cases of cervical spinal canal stenosis with reverse arch underwent posterior decompression with laminoplasty surgery in prone position and then anterior decompression with fusion surgery in supine position. There were 7 males and 6 females with an average age of 43.5 years (range, 38-62 years) and an average disease duration of 25 months (range, 18-60 months). All the patients had neck axial symptoms and spinal cord compressed symptoms, and lateral computer radiology (CR) of the neck showed reverse arch of cervical vertebrae. Segments of intervertebral disc protrusion included C3-6 in 4 cases, C4-7 in 4 cases, and C3-7 in 5 cases. After operation, anteroposterior and lateral CR was used to observe the cervical curvature change and fixation loosening, MRI to observe the change of the compression on spinal cord, visual analogue scale (VAS) score to evaluate the improvement of axial symptom, and Japanese Orthopaedic Association (JOA) score to assess the nerve function improvement. Results All incisions healed by first intention. All patients were followed up 9-32 months (mean, 15.4 months). Internal fixator had good position without loosening or breaking and the compression on spinal cord improved significantly after operation. All the patients obtained bony fusion at 6 months after operation. The axial symptoms and the nerve function at last follow-up were improved. VAS score at last follow-up (3.25 ± 1.54) was significantly lower than that at preoperation (6.55 ± 1.52) (P lt; 0.05); JOA score at last follow-up (10.45 ± 4.23) was significantly higher than that at preoperation (7.05 ± 1.32) (P lt; 0.05); and cervical curvature value at last follow-up [(6.53 ± 3.12) mm] was significantly higher than that at preoperation [(3.22 ± 5.15) mm] (P lt; 0.05). Conclusion Combined posterior decompression with laminoplasty and anterior decompression with fusion for the treatment of cervical spinal canal stenosis with reverse arch is a safe and effective surgical method.
Objective To summarize the characteristic imaging signs of ossification of the ligamentum flavum (OLF) associated with dural adhesions by analyzing retrospectively the imaging signs of OLF associated with dural adhesions. Methods A retrospective analysis was made on clinical data of 85 patients undergoing OLF surgery between January 2010 and September 2012. The patients were assigned into the study group and the control group according to the preoperative imaging signs. Of 85 patients, 34 had both “tram track sign” and “jagged line sign” as the study group and 51 had either “tram track sign” or “jagged line sign” and neither of them as the control group. Adherence between dura mater and ligamentum flavum was observed during operation as the “gold standard” for the diagnosis of dural adhesion. The imaging information of CT and MRI in sagittal and axial planes was analyzed. The typical characteristics of dural adhesions were found. Then the sensitivity, specificity, and positive likelihood ratio of the preoperative imaging examinations were calculated to estimate the reference value and diagnostic value (gt; 5 having reference value, and gt; 10 having diagnostic value). Results In the study group, dural adhesion was observed in 26 patients (10 males and 16 females), and the other 8 patients (6 males and 2 females) had no dural adhesion. In the control group, dural adhesion was found in 2 female patients who had “jagged line sign”, and 49 patients had no dural adhesion (14 males and 35 females). In patients having both “tram track sign” and “jagged line sign”, the sensitivity was 92.9%; the specificity was 86.0%; and the positive likelihood ratio was 6.6. In patients having “tram track sign”, the sensitivity was 92.9%; the specificity was 64.9%; and the positive likelihood ratio was 2.6. In patients having “jagged line sign”, the sensitivity was 100%; the specificity was 77.2%; and the positive likelihood ratio was 4.4. Conclusion For patients with OLF having both “tram track sign” and “jagged line sign”, preoperative CT and MRI have a reference value for diagnoses of the OLF associated with dural adhesions.
Objective To investigate the effect of quantitative semi-transected blade on the improvement of spinal cord semi-transected and lump defect model. Methods Forty-eight male Sprague Dawley rats (weighing 220-250 g) were divided into the experimental group (n=24) and control group (n=24). The spinal cord semi-transected and lump defect model was made by self-made quantitative semi-transected blade in the experimental group, and by ophthalmic scalpel in the controlgroup. Then, the complications were observed; the electrophysiological results were detected before modeling and at 21 days after modeling; the histological changes at margin of lump defect were observed at 6 hours, 5 days, and 28 days; Basso, Beattie, and Bresnahan (BBB) scores were detected at 1, 3, 5, 7, 14, 21, 28, 35, 42, 56, and 84 days after modeling. Results There was significant difference in the mortality between the experimental group (0) and the control group (26.67%) (P=0.028). Electrophysiological examination: there was no significant difference in latency and ampl itude of motor evoked potentials (MEP) and sensory evoked potentials (SEP) between 2 groups at preoperation (P gt; 0.05); at 21 days after operation, latencies of MEP and SEP increased and the amplitude decreased in the control group, showing significant differences when compared with those in the experimental group and the preoperative values (P lt; 0.05), but no significant difference was seen between preoperation and postoperation in the experimental group (P gt; 0.05). Histological examination: in the control group, small hematoma could be observed at normal side at 6 hours after modeling, increased spaces of spinal tissue and perineural invasion were observed at 5 days, and small cavity formed without normal motoneurons at 28 days in the margin of lump defect. In the experimental group, no small hematoma could be observed at 6 hours after modeling, no inreversible injury of neuron and small cavity were observed at 5 days, and normal motoneurons were observed without small cavity at 28 days in the margin of lump defect.BBB scores: except the scores between experimental group and control group at affected side (P gt; 0.05), there were significant differences between groups, and between normal side and affected side for intragroup (P lt; 0.05). Conclusion Semi-transected and lump defect model could be set up successfully by self-made quantitate semi-transected blade, procedure is repetitive and the model is stable. This model is an ideal model for semi-transected spinal cord injury.
Objective To analysis the safety of high-intensity focused ultrasound (HIFU) in the treatment of uterine fibroids and provide references for clinical practice and prevention of complications of gynecological diseases. Methods Databases including PubMed, The Cochrane Library (Issue 2, 2016), EMbase, CBM, CNKI, and VIP were searched to collect studies concerning the complications of HIFU for uterine fibroids from March 1st 2005 to February 15th 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using R software. Results A total of twenty studies involving 2 405 patients were included. The results of meta-analysis showed that complications rate of gynecological system induced by HIFU was 6.63% (95%CI 3.58% to 12.28%); among them, the incidence of vaginal bleeding was 5.82% (95%CI 3.22% to 10.53%), and the incidence of abdominal pain was 10.02% (95%CI 4.77% to 21.05%). Conclusion The current evidence shows that there is a certain amount of complications of HIFU for uterine fibroids. Due to the limited quantity and quality of included studies, the above results are needed to be validated by more studies.
ObjectiveTo investigate the significance of the expression of vascular endothelial growth factor (VEGF) in portal vein thrombosis after operation in patients with portal hypertension.MethodsThe serum of 146 patients with portal hypertension treated in Dongfeng Hospital Affiliated to Hubei Medicial College from January 2014 to December 2018 and the surgically removed splenic vein and spleen specimens were collected. The serum VEGF level was determined by enzyme-linked immunosorbent assay, and the expressions of VEGF in splenic vein and spleen tissues were detected by immunohistochemistry. According to whether portal vein thrombosis was formed after operation, the patients were divided into thrombosis group and non-thrombosis group, and the differences between the groups were compared.ResultsThe serum VEGF level in the thrombosis group was significantly higher than that in the non-thrombosis group (P<0.05). In splenic vein wall and spleen tissues, VEGF staining indexes in the thrombosis group were significantly higher than those in the non-thrombosis group (P<0.05).ConclusionsPostoperative portal vein thrombosis in patients with portal hypertension may be related to the serum VEGF level. The high expressions of VEGF in splenic vein wall and spleen suggest that VEGF may participate in the formation process of portal vein thrombosis.