关于我国体外诊断试剂监督管理改革的建议

本文综述了美国、欧盟、日本、中国目前对体外诊断产品（试剂）监督管理的现状以及我国存在的问题。并根据我国具体情况提出了对体外诊断试剂监督管理的改革建议。     

Synergistic effect of low dose Cyclosporine A and human interleukin 10 overexpression on acute rejection in rat lung allotransplantation

Objective: Electroporation mediated transfer of plasmid DNA into peripheral muscle results in high transfection efficiency. The aim of this study was to investigate the effect of gene transfer of human IL-10 (hIL-10) into the tibialis anterior muscle (MTA) in combination with low dose Cyclosporine A (CsA) on acute rejection of lung allografts in the rat. Methods: Lung allotransplantation was performed from male BN donor to male Fisher F344 rats. Gene transfer was achieved by intramuscular injection into the MTA of the recipient followed by electroporation (4×20 ms impulses at 200 V/cm) 24 h prior to the transplantation. Group A (n=5) received CsA (2.5 mg/kg bw ip) for 5 days post-transplant and group B (n=5) 2.5 μg of PCIK hIL-10 (plasmid expression vector containing human CMV immediate early gene promoter and enhancer) and a low dose CsA (2.5 mg/kg bw i.p.). Graft function was assessed by blood gas at day 5 after exclusion of the native lung. Animals were sacrificed and blood was drawn to measure serum hIL-10 levels (ELISA) and tissue was sampled for histological grading of rejection. Results: Local expression of hIL-10 was confirmed at the mRNA level by in situ hybridization. All group A control animals showed severe signs of rejection. At day 5 all grafts in group B showed good gas exchange mean PaO2 233±123 mmHg, vs 44±8 mmHg in group A. Histological examination revealed moderate to severe rejection in all animals in group A (IIIB, ISHLT) in contrast to low moderate rejection in group B (II–IIIA). hIL-10 serum levels on day 5 were 14±7 pg/ml in group B vs. 0 in group A. Conclusions: Electroporation mediated hIL-10 overexpression in a peripheral muscle of the recipient in combination with low dose CsA reduces acute rejection in this model of rat lung allotransplantation.     

42例室性心动过速治疗的临床分析

本文介绍了42例室性心动过速的临床资料和特点,讨论了早期后除极与室性心动过速的关系,并探讨各型室速的治疗。     

放线菌素23-21对裸小鼠人鼻咽癌细胞系移植瘤和人胃癌细胞系移植瘤的抑制作用

放线菌素23-21属放线菌素类抗癌抗生素,由浅黄色链霉菌产生,该菌从中国福州土壤样品中分离得到。采用裸小鼠人鼻咽癌细胞系(CNE-2Z)和人胃癌细胞系(MGc-803)两种移植模型观察了放线菌素23-21的作用。放线菌素23—21 50μg/kg,对CNE-27移植瘤和MGc803移植瘤的抑制率分别为58.4%(P<0.05)和68.7%(P<0.05)。肿瘤生长曲线显示,治疗组肿瘤生长缓慢。电镜检查,治疗组瘤细胞可见核仁分离和微球体形成。提示放线菌素23-21可能有抑制核仁rRNA合成的作用。在有效剂量下,未见重要脏器病理改变。     

唾液富组蛋白5抗白念珠菌作用实验性研究

目的探讨不同浓度的富组蛋白5（histidine rich protein5，HRPs5）在体外杀灭白念珠菌孢子、芽管的作用及抑制孢子形成芽管的作用。方法将一定数量的孢子和芽管分别与不同浓度的HRPs5混合培养后，置于400倍的倒置显微下观察菌落数，得出杀孢子率、杀芽管率和抑制孢子不形成芽管率。结果当25μml或更高浓度的HRPs5和白色念珠菌孢子作用后，可使90％以上的孢子丧失活力；100μml的HRPs5和白色念珠菌芽管作用后，可使90％以上的孢子丧失活力；400μg／ml的HRPs5和白色念珠菌孢子作用后，可使100％孢子受到抑制而不形成芽管。而50μg／ml的HRPs5对白色念珠菌孢子形成芽管仅有轻微的抑制作用。结论HRPs5在体外具有较强杀灭白念珠菌孢子、芽管的作用及抑制孢子形成芽管的作用，且随着HRPs5浓度的升高其作用愈强。     

An ecologically based examination of barriers to physical activity in students from grade seven through first-year university

PurposeThe first purpose was to identify barriers to physical activity that students in grade seven through first-year university experienced. A second purpose was to classify barriers using an ecological framework and to examine the pattern of barrier categories (i.e., intrapersonal, interpersonal, institutional, community, public policy, and physical environmental) and specific barrier types as grade increased. The use of an ecological model addressed limitations in prior research revolving around the identification of salient barriers in a manner that makes the design of effective interventions difficult.MethodsParticipants in grades 7–8 (n = 35), 9–10 (n = 67), 11–12 (n = 80), and the freshmen year of university (n = 109) listed barriers to physical activity on an open-ended measure.ResultsFindings revealed a trend for the average number of barriers reported per student to increase as grade in school increased. First-year university students reported significantly more barriers than all other grade groupings. The frequency of barriers reported within the ecological categories was dependent on the specific grade groupings. Further, within each ecological category, distinct barriers were reported across the different grade groupings.ConclusionsFindings highlight the utility of using an ecological model to categorize barriers, rather than simply classifying barriers as internal or external to an individual, as done in prior research. Understanding the pattern of ecologically based barrier categories and specific types of barriers will help to inform the content of future research and interventions designed to alleviate salient barriers to physical activity.     

Preliminary evaluation of vitiligo using in vivo reflectance confocal microscopy

BACKGROUND: Vitiligo is the most common pigmentary disorder with a global incidence from 0.1% to 2% in different geographical areas. Histopathology and histochemistry have shown the reduction of melanocytes in achromic patches, but microscopic changes of lesional and non-lesional skin are still not completely understood. Reflectance confocal microscopy (RCM), based on the different light reflectance index of cutaneous structures, allowed in vivo, en face microscopic evaluation of superficial skin layers with a resolution similar to skin histology. AIM: The purpose of this study was to evaluate RCM features of lesional and non-lesional skin of vitiligo patients. Moreover, re-pigmented areas were taken into consideration in order to evaluate melanocyte response to ultraviolet B (UVB) radiation. SUBJECTS AND METHODS: Sixteen patients of different phototypes affected by active non-segmental vitiligo and 10 controls were enrolled in the study. In vivo skin imaging was done using a commercially available RCM (Lucid, Vivascope 1500. Re-pigmented areas from 6 to 16 patients (after UVB narrow-band therapy) were also examined. RESULTS: Vitiligo lesions showed the disappearance of the bright rings normally seen at the dermo-epidermal junction. Moreover, non-lesional skin of vitiligo patients showed unexpected changes as the presence of half-rings or scalloped border-like features of the bright papillary rings. In re-pigmented areas after UVB narrow band therapy, the presence of activated, dendritic melanocytes was seen. CONCLUSIONS: Considering our results, and following further studies, RCM clinical applications could be used in the therapeutic monitoring and evaluation of the evolution of vitiligo.     

Improved Performance of Hip DXA Using a Novel Region of Interest in the Upper Part of the Femoral Neck: In Vitro Study Using Bone Strength as a Standard of Reference

We tested the hypothesis that bone mineral density (BMD) and bone mineral content (BMC) in proximal human femur specimens in the upper neck region of interest (ROI) and femoral neck axis length (FNAL) provide a significantly better prediction of femoral bone strength than standard ROIs in vitro. BMD and BMC were measured in 110 proximal femur specimens using a standard dual-energy X-ray absorptiometry (DXA) scanner. The analysis included a new ROI in the upper neck as well as the standard ROIs. FNAL was obtained from the scan images. The specimens' failure-load was measured in a mechanical loading device, simulating a fall on the greater trochanter. For the standard ROIs, correlations between failure-load and BMD ranged from R2 = 0.64 (shaft ROI) to R2 = 0.70, p < 0.001 (femoral neck). Prediction of strength by BMD did not significantly differ from those of BMC (R2 ranging from 0.65 to 0.75, p < 0.001). In the upper neck ROI, for both BMD and BMC correlations with failure-load were higher (R2 = 0.76 and 0.81, respectively; p < 0.001). A lower, yet still significant, correlation was found between FNAL and bone strength (R2 = 0.23, p < 0.001). Normalization of failure-load with respect to FNAL did not significantly increase the correlations with densitometric measures. This study provides in vitro evidence indicating that among the ROIs of the proximal femur the newly defined upper neck ROI provides the best prediction of bone strength. Only a weak association was observed between failure load and FNAL.     

Effects of a holistic health program on women''s physical activity and mental and spiritual health

Intervention studies aimed at promoting increased physical activity have been trialled in many different settings including primary care, worksites and the community. Churches are also potential settings for physical activity promotion. However, little is known about the effectiveness of this setting for promoting physical activity, particularly in Australia. The purpose of this study was to evaluate the effectiveness of a mind, body and spiritually based health promotion program in increasing physical activity and promoting mental and spiritual health. Nineteen women completed the 8-week intervention, and 30 women in a non-health related 8-week program at the same church comprised a comparison group. Pre- and post-program surveys assessed outcome measures. Between-group differences over time were examined using one-way MANOVA's. Physical activity was higher in the intervention group than the comparison group. In contrast to the comparison group, both mental health (depression symptoms) and spiritual health improved significantly more among intervention participants. The data highlight the potential for a church-based setting and holistic approach to health promotion as a successful means of increasing physical activity and promoting mental and spiritual health among Australian women.     

Disability,depression and somatization in a low back pain population

Objective: The aim of this study was to determine the prevalence of low back pain (LBP) in a primary care setting population and examine its association with the symptoms of depression and somatization. Methods: This is a cross‐sectional study, utilising a survey carried out in primary health care clinics (PHCs) in Al‐Ain, United Arab Emirates (UAE). A multistage stratified sampling design was used and a representative sample of 1304 UAE nationals aged 18–65 years who attended PHC clinics for any reason were included and 1103 (84.5%) subjects agreed to participate and responded to the questionnaire during a period from June 2001 to January 2002. A specially designed questionnaire with three parts was used for the data collection: socio‐demographic information of the studied subjects, modified version of the Roland‐Morris scale for evaluating back‐related functional disability and SCL‐90 R for depression and somatization subscales was used to assess depressive and somatic symptoms. Results: Of the total number of subjects surveyed (1103), 586 (53.1%) were men and 517 (46.9%) women. The mean age was 34.9 ± 13.4 years for men and 33.5 ± 11.8 years for women. The prevalence of LBP in the studied subjects was 64.7% (95% CI, 60.7–68.5] with 46.7% among men and 53.3% among women. There were a significant differences between the subjects with LBP and without LBP with respect to gender (P < 0.001), body mass index (BMI) (P < 0.001), occupational status (P < 0.001) and living environment (P = 0.016). Functional disability was higher in patients with LBP. Young patients in aged 15–34 years, patients with preparatory/secondary educational level and students showed higher depressive symptoms. A similar pattern was found in patients with somatic symptoms. Factor analysis revealed a strong association between depression and somatization in LBP patients. Conclusions: Functional disability was higher in with LBP. Furthermore, symptoms of depression and somatization are prevalent among LBP patients.