By research on the universal standards classification of medical device, according to their functions and scope of application, they are divided into two levels, universal standard architecture is proposed, to provide opinions and suggestions for standard system construction of medical devices.
Equipment and Supplies ; standards ; Humans

ObjectiveTo study the clinical significance of serum type Ⅳ collagen( Ⅳ - C) levelsfor the diagnosis of hepatic fibrosis. MethodsSerum levels of Ⅳ - C were measured in 209 patientswith viral hepatitis and 53 healthy persons by ELISA. ResultsCompared with the normal group,the serum Ⅳ - C level was significantly increased in patients with chronic moderate hepatitis and wasthe highest in patients with chronic severe hepatitis and hepatic cirrhosis( P < 0.01 ). There was no sig-nificant difference in the serum Ⅳ- C level among acute viral hepatitis, chronic mild hepatitis and con-trols ( P >0.05). There was significant difference in the serum Ⅳ - C level in patients with hepaticcirrhosis by Child- Pugh grading( P < 0.01 ). The serum Ⅳ - C level was positively correlated withthe degree of hepatic fibrosis and the severity of hepatic diseases. ConclusionThe meastrement of serumⅣ- C may be useful for assessment of the degree of hepatic fibrosis and progrosis of chronic hepatitis.

Objective To investigate the methodology and feasibility of an anatomic survey of fetal limbs in the first trimester. Methods In this study, 533 normal fetus and 6 fetal corpse without limb abnormalities form June 2011 to August 2012 underwent an anatomic survey on the limbs in our consultation center. The limbs were scanned using a systematic continuous sequence approach:(1) Displaying upper arm and humerus, forearms and radius/ulna, hands in proximal to distal direction. (2) The thigh and femur, crus and tibia/fibula, feet was attempted from the sagittal section of each structure. (3) If the whole limb couldn′t be visualized in a section then the three segments will be demonstrated respectively. The position and move-ment also should be observed during the scan. Data were collected regarding gestation age, examining time and the structures. Results The limbs except toes of 533 normal fetus were clearly observed, which was completely unaffected by gestational age, with the mean time of scanning is 98.6±37.4 s (rang:36-189 s). The structures (including upper arms and humerus, forearms ,radius and ulna, hands, thigh and femur, crus and tibia, fibula, feet) of fetal limbs were clearly observed on the 6 fetal corpse, but the ossification center of fingers were steadily visualized until 13 weeks and toes after 13 weeks. Conclusions Scanning fetal limbs in the first trimester were feasible by a systematic continuous sequence approach in a short period of time.

[ABSTRACT]OBJECTIVE To obser ve t he pathological changes of nasal mucosa in rats after instillation of 37℃ normal saline. METHODS Forty-eight qualified rats were given instillation of 37℃ nomal saline 30 times, once per minute. Another 2 qualified rats served as control. After instillation, in the 15, 30 minutes and 1st, 3rd, 7th, 14th, 42th, 28th day respectively, the nasal septum mucosa of 6 rats was observed by light and electron microscopy. The corresponding area of the mucosa of control group was also observed by light and electron microscope. RESULTS Under light microscope, the arrangement of cell was disordered in the 1st, 3rd, 7th days. But there is no damage of vascular gland structure. After 14 days, the disorder recovered. With electron microscope, edema of cells, expansion of perinuclear gap, disorder of cilia and microwilli was found in the 30 minutes, 1st, 3rd day. All these began recover in the 7th days, and completely restored in the 28th day. CONCLUSION 37℃ nomal saline drip can damage nasal mucosa, but the damage is light, which is characterized by disorder and shortage of cilia and microvilli, edema of the epithelial cells. And the damage can recover quickly. It began in the 30 minutes after instillation, reached its peak in the 3rd day. And the recovery began in the 7th day, and completed in the 28 day.

BACKGROUND:Positive treatment of perioperative analgesia after total knee arthroplasty can accelerate recovery of joint function, reduce complications after replacement, and improve overal technical evaluation of total knee arthroplasty. ＜br> OBJECTIVE:To summarize commonly used analgesic drugs and analgesia method of total knee arthroplasty. ＜br> METHODS:A computer-based online research of Wanfang database and PubMed database was performed to col ect articles published between 1994 and 2014 with the keywords of“total knee replacement, epidural analgesia, peripheral nerve block, joint local analgesia, patient control ed analgesia, cold treatment”in Chinese and English. ＜br> RESULTS AND CONCLUSION:There were 986 articles after the initial survey. Final y, 55 articles were included according to the inclusion and exclusion criteria. As the technology for total knee arthroplasty, early functional rehabilitation and replacement of pain control has been widely concerned, a large number of literatures about analgesic drugs and analgesic programs emerge. Analgesic drugs include opioids, non-steroidal anti-inflammatory drugs, local anesthetics and N-methyl-aspartate receptor blockers. Analgesic program includes epidural analgesia, peripheral nerve blockage, joint local analgesia, patient-control ed analgesia and cold therapy. These analgesic drugs and methods have their advantages and disadvantages. At present, multimodal analgesia schemes have been recognized, but the optimal pain management scheme remains controversial. Increasing considerations should be paid on the choice of analgesic methods, depending on individual characteristics and existing technology.

Objective To explore the related risk factors for neuropathic pain in diabetic rats.Methods Female Wistar rats of clean grade were divided into three groups :Non diabetic standard diet (NdStd) group (n=10) ,diabetic high fat diet and pain (DbHFP) group (n=10) ,and diabetic high fat diet and no pain (DbHFNP) group (n=10).Body weight ,blood glucose ,TG ,TC ,HDL‐C ,LDL‐C and 50%pain threshold were measured regularly to assess the relationship between blood lipids and pain. Results Non‐conditional logistic regression analysis showed that pain threshold was negatively correlated with TG , LDL‐C and blood glucose(P<0.05) ,and positively correlated with HDL‐C (P<0.05). And there was no association between TC and body weight (P> 0.05). Conclusion Pain threshold of diabetic rats was negatively correlated with TG ,LDL‐C and blood glucose ,and positively correlated with HDL‐C.

Objective To access the changes in blood gases and electrolytes during anaphylactic shock induced by Echinococcus granulosus (EG) in sheep.Methods Fifteen healthy sheep of either sex weighing 31.2 ? 3.5 kg were repeatedly infected with EG for six months. The infected sheep were anesthetized with intramuscular thiopental 20mg?kg-1 and ketamine 15 mg?kg-1. The animals were breathing spontaneously and placed on the left side. ECG (lead Ⅱ) was monitored. Swan-Ganz catheter was placed via right internal jugular vein for hemodynamic monitoring. Anaphylactic shock was induced with antigen prepared from fluid in EG capsules. Blood samples were taken from right internal carotid artery before shock (T0) and 3.5 min (T1 ), 8 min (T2), 15 min (T3), 30 min (T4) and 60 min (T5 ) after shock was induced for determination of blood Na+ , K+ , Hct, Hb, pH, PaO2 , PaGO2 and HCO3-. Shock was confirmed by hypotension (MAP decreased by 30%), tachypnea, dyspnea, agitation and pupil dilation. Results Three sheep did not develop shock and two sheep died of severe shock within 10 min after iv antigen challenge. Blood K+ significantly increased at T1 and T2 after antigen challenge and then gradually returned to baseline value at T5 . PaO2 decreased, PaGO2 increased and pH deceased after challenge. Hct and Hb also increased significantly after challenge. Conclusion There are significant changes in blood gas and electrolytes indicated by hyperkalemia, acidosis and hypoxemia during anaphylactic shock induced by EG.

A retrospective analysis of 3 patients with nasal sinus foreign body caused by debris flow admitted to our department. All of the three patients showed foreign odor and mucopurulent discharge in nasal cavity after the debris flow blast injury. CT examination found high density soft tissue shadow or calcification in the nasal sinus. All the diagnoses were nasal sinus foreign body in three patients. The nasal sinus foreign bodies was dislodged through endoscopic sinus surgery. Three patients are all well-healed.
Adult ; Female ; Foreign Bodies ; etiology ; Humans ; Male ; Paranasal Sinuses

time of infusion. Data analysis indicated that A1B3C2 was the best combination of the 3 factors according to the degree of lung injury. Conclusion Adequate amount of HES 200/0.5 infused during compensated stage of hypovolemic shock produces best result.

Objective To establish the normal reference ranges of clinical pathology for Beagle dogs in the Good Laboratory Practice ( GLP ) system.Method Sixteen biochemical indexes , seventeen hematological indexs and three coagulation function indexes of 117 Beagle dogs were detected , and the mean value of each index and the normal reference ranges were calculated and compared .Results Only alkaline phosphatase ( ALP ) from the biochemical items was significantly different between males and females (P<0.01),which was higher among males than among females .Three in-dexes of hematology were significantly different between males and females (P<0.01),with red blood cell(RBC), hemo-globin(HGB)and hematocrit(HCT)lower among males than among females.The coagulation function items were not signif-icantly different between the two sexes .Conclusion Some indexes of clinical pathology were significantly different between males and females , which should be considered during statistic analysis on toxicity .Our study has established the normal reference range of clinical pathology for Beagle dogs in the GLP system , which provides reference for toxicity tests .