The importance of software version in the medical device software supervision does not cause enough attention at present. First of all, the effect of software version in the medical device software supervision is discussed, and then the necessity of software version in the medical device software supervision is analyzed based on the discussion of the misunderstanding of software version. Finally the concrete suggestions on software version naming rules, software version supervision for the software in medical devices, and software version supervision scheme are proposed.
Equipment and Supplies ; Software

Objective: The FDA regulation requirements for medical device software are relatively mature and systematic, and the research on the FDA regulation thinking of medical device software helps to promote the regulation work of the medical device software in our country. Methods:Based on the comparison of the 1998 edition and 2005 edition FDA software submission guidance, the trend of the FDA regulation requirements for medical device software was analyzed, and then its regulation thinking was discussed according to other current effective software-related guidance. Results:FDA integrally improves the submission requirements for all medical device software, especially for the minor Level of Concern software, and simplifies the requirements for design specification, verification and validation, but strengthens the requirements for traceability analysis and revision history. Conclusion: The regulation work of the medical device software in our country needs to fully consider the particularity of the medical device software, strengthen the audit of software quality management system, implement the software traceability analysis, and determine the regulation requirements for software change.

Objective To explore the correlations between emotions and self-concept in patients with traumatic brain injury. Method The Chinese version of the Positive and Negative Affect Scale and the Tennessee Self-Concept Scale was used to test 178 patients with traumatic brain injury.Results The mean scores on positive and negative emotions were (1.93±0.53) and (2.76±0.61), respectively. The mean score on self-concept was (2.45±0.31). The positive emotions of patients were positively correlated with the level of self-concept and the negative emotions negatively with the level of self-concept (r=0.437and -0.363respectively,bothP<0.01). Conclusions For patients with traumatic brain injury,the negative emotions outnumber the positive emotions and their self-concept was at lower level. Nurses should take measures to improve their positive emotions and reduce their negative emotions in order to improve their self-concept level.

Estimation the postmortem interval(PMI)is an important subject in forensic medicine practice.Recent research has found that the DNA molecular would degrade immediately following death,and the quantity of DNA in nuclear would be decreasing along with the elapse of the time since death.Seven parameter of cell nuclear,including the area and integral optical density,were chosen and the changes of DNA content in the brain cells of 15 rats were determined at every one hour during 48 horus after death by the auto TV imange analyses system.The results showed that the degradation rate of DNA in nuclear has a certainty relationship with early PMI in rats and indicated that the determination of the quantity of DNA in nuclear is the major method to estimate the PMI.

Integrating visualization toolkit and the capability of interaction, bidirectional communication and graphics rendering which provided by HTML5, we explored and experimented on the feasibility of remote medical image reconstruction and interaction in pure Web. We prompted server-centric method which did not need to download the big medical data to local connections and avoided considering network transmission pressure and the three-dimensional (3D) rendering capability of client hardware. The method integrated remote medical image reconstruction and interaction into Web seamlessly, which was applicable to lower-end computers and mobile devices. Finally, we tested this method in the Internet and achieved real-time effects. This Web-based 3D reconstruction and interaction method, which crosses over internet terminals and performance limited devices, may be useful for remote medical assistant.
Diagnostic Imaging ; Image Processing, Computer-Assisted ; Imaging, Three-Dimensional ; Internet ; Software

Objective To explore preliminary clinical results of a new anatomical shape allogeneic bone posterior lumbar fusion cage. Methods Follow-up patients used the allogeneic bone posterior lumbar fusion cage and use imaging methods and clinical score (VAS, ODI) to evaluate the patients′ clinical efficacy. Results 14 patients were followed up for 6 months or more , with an average follow-up time of 9.7 months , mean preoperative VAS 6.8 ± 1.1, ODI 32.7 ± 4.5. The mean preoperative disc height was (9.7 ± 2.0) mm and the average intervertebral height of 3 days post operation was (13.2 ± 1.7) mm. All patients got bony fusion in 6 months post operation, pain and function scores improved significantly compared with the pre-operation: VAS 2.4 ± 0.8 (P =0.000), ODI 9.8 ± 2.5 (P = 0.000), the average intervertebral height was (13.1 ± 1.7) mm (P = 0.000). The average was VAS 2.1 ± 0.1 (P = 0.000), average ODI was 8.9 ± 0.9 (P = 0.000) at last follow up. Average of intervertebral height was (13.0 ± 1.8) mm, no significant difference compared to three days after surgery (P=0.831). No serious complications and deep surgical site infection was observed. All implants were found no fragmentation, shift, cutting boards, and obviously sinking. Conclusion The anatomical shape allogeneic bone posterior lumbar fusion device is suitable for posterior lumbar interbody fusion , advantages of high fusion rate , satisfactory clinical results in the initial clinical trials , but its long-term efficacy requires further observation.

OBJECTIVE: To investigate the effects of Wenyang Huoxue Recipe (WRHXR), a compound traditional Chinese herbal medicine for warming yang and promoting blood flow, on the expression of angiopoietin mRNA in rats with chronic aristolochic acid nephropathy induced by Caulis Aristolochia Manshuriensis (CAM) decoction, and to explore the protection mechanism of WYHXR against kidney damage. METHODS: Twenty-eight male SD rats were randomly divided into normal control group, CAM group and WYHXR-treated group. Rats in the normal control group (n=8) and CAM group (n=10) were intragastrically administered with normal saline 10 ml/(kg.d) or CAM decoction 10 ml/(kg.d) respectively. Rats in the WYHXR-treated group (n=10) were intragastrically administered with WYHXR 30 g/(kg.d) and CAM decoction 10 ml/(kg.d). The expressions of Ang-l and Ang-2 mRNAs were detected by real-time reverse transcription polymerase chain reaction (RT-PCR) after 20-week treatment. RESULTS: Compared with the normal control group, the expression of Ang-l mRNA was significantly decreased, and the expression of Ang-2 mRNA was significantly increased in the CAM group (P<0.01). Compared with the CAM group, the expression of Ang-l mRNA was increased in the WYHXR-treated group (P<0.01). The expression of Ang-2 mRNA had no significant difference between the CAM group and the WYHXR-treated group (P>0.05). Renal pathology showed that renal damage in WYHXR-treated group was significantly reduced as compared with the CAM group. CONCLUSION: WYHXR can up-regulate the expression of Ang-l mRNA, which may be its action mechanism in protecting the kidneys.

Compounds were isolated through various chromatographic techniques and their structures were identified by spectroscopic data analysis and comparison with those reported in the literatures. Thirteen compounds were obtained from the petroleum ether and ethyl acetate extracts. Their structures were identified as 4,4'-dimethoxy-9,9', 10,10'-tetrahydro-(1, 1'-biphenanthrene) -2, 2', 7, 7'-tetrol (1), 4, 4', 7, 7'-tetrahydroxy -2,2'-dimethoxy-1, 1'-biphenanthrene (2), 3, 5-dihydroxy-2, 4-dimethoxyphenanthrene (3), physcion (4), chrysophanol (5), emodin (6), genkwanin (7), quercetin (8), quercetin 3'-O-beta-D-glucopyranoside (9), 3-methoxy-4-hydroxy phenylethanol (10), syringic acid (11), vanillin (12), and p-hydroxybenzaldehyde (13), respectively. Compounds 1-3 and 5-12 are reported from this genus for the first time.
Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Orchidaceae ; chemistry ; Plant Tubers ; chemistry

Churg-Strauss Syndrome ; complications ; Coronary Artery Disease ; complications ; Humans ; Male ; Middle Aged

Adult ; Coombs Test ; Emergency Treatment ; methods ; Erythroblastosis, Fetal ; blood ; immunology ; therapy ; Erythrocyte Transfusion ; Female ; Humans ; Infant, Newborn ; Isoantibodies ; immunology ; Male ; Phototherapy ; Pregnancy ; Rh Isoimmunization ; immunology ; physiopathology ; Rh-Hr Blood-Group System ; immunology ; Rho(D) Immune Globulin ; Treatment Outcome