The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.
China ; Consumer Product Safety ; Equipment and Supplies ; Safety Management

Fifty eight patients with amyloidosis diagnosed by biopsy were admitted to Beijing Friendship Hospital from January 1983 to September 2007 and their clinical data were analyzed retrospectively.Twenty of the 58 cases were systemic amyloidosis,and other 38 were local amyloidosis.In 20 cased of systemic amyloidosis,kidney was involved in 75% cases,liver was in 55%,nervous system Was in 55%and heart Was in 50%.The lesion of local amyloidosis was usually limited in one single organ.

Background Conventional corticosteroid therapy after laser epithelial keratomileusis (LASEK) is topical application of 0.1％ fluorometholone eye drops for 4 months,but this therapy increases the ocular hypertension risk and leads to poor compliance in patients.It is necessary to explore a safe and effective brachytherapeutic drug.Objective This study was to compare the clinical outcomes between the brachytherapy of 0.5％ loteprednol etabonate eye drops and the long-term therapy of 0.1％ fluorometholone eye drops after LASEK.Methods Clinical data were retrospectively analyzed from 208 right eyes in 208 mild and moderate myopia patients who received LASEK at Peking University Third Hospital from 2009 to 2013.The eye drops of 0.5％ loteprednol etabonate was used 6 times daily since operation day until postoperative day 5,and 4 times daily for a week,and then tapered for three consecutive weeks in 104 eyes of the loteprednol group after LASEK,and 0.1％ fluorometholone eye drops was applied topically 4 times daily for initial one month and then tapered for three consecutive months in another 104 eyes in the fluorometholone group after LASEK.Corneal epithelial healing time was compared between the two groups by recording the wearing duration of corneal contact lens.Noncontact intraocular pressure (lOP) was detected and corrected 5 days,2 weeks,1 month and 3,6 months after LASEK.Haze was scored based on the criteria of Cheng under the slit lamp microscope and apparently optometry was performed 1 month and 3,6 months after LASEK.Results The number of eyes removed corneal contact lens in 5,6 and 7 days after LASEK was not significantly different between the loteprednol group and the fluorometholone group (x2 =1.180,P =0.554).No considerable differences were seen in the eye numbers with the equivalent spherical lens (absolute value) ≤0.5 D in 1 month,3months and 6 months after LASEK (Z=-1.028,P=0.304;Z=-0.398,P=0.691;Z=-0.445,P=0.656).In the fifth days after surgery,the median corrected IOP was 13.52 mmHg and 13.12 mmHg in the loteprednol group and the fluorometholone group,respectively,showing a significant difference between them (Z =-1.985,P =0.047),but no significant differences were found in IOP in 2 weeks,1 month and 3 months,6 months after surgery between the two groups (all at P＞0.05).IOP elevated (postoperative IOP-preoperative IOP ≥ 5 mmHg) after LASEK in 5 eyes in the loteprednol group and 4 eyes in the fluorometholone group (x2 =0.116,P =0.733).In 1 month after surgery,the number of eyes in different grades of haze was significantly decreased in the loteprednol group compared with the fluorometholone group (x2=13.506,P=0.009),however,there was no significant differences in haze grading in postoperative 3 months and 6 months between the two groups (x2 =2.199,P =0.699;x2 =1.154,P =0.562).Conclusions Brachytherapy of 0.5％ loteprednol etabonate eye drops appears to have a similar effect in antiinflammation and inhibition of haze to the long-term therapy of 0.1％ fluorometholone eye drops after LASEK.Furthermore,topical application of 0.5％ loteprednol etabonate eye drops dose not increase the risk of ocular hypertension.

The article analyzed the system architecture design of the Shanghai municipal hospital clinical information sharing project, aiming to provide reference for system design of a regional medical information sharing system. This project is composed of the following: A universal medical card,hospital's internal information system, an inter-hospital network, a clinical information exchange and sharing platform, a data center, a decision support system and a public service portal. Key issues involved in the system design include the personal identity, the establishment of standards and specifications, the information sharing model, the information storage model, systems related to hospitals and personal privacy protection.

Objective To study the effect of flushing the pelvis with normal saline at constant pressure on renal function to provide a theoretical basis of pathogenesis of renal injury during endoscopic procedures. Method Fifty rabbits underwent tube ureterocutaneostomy as a method of urinary diversion, the flushing group perfused immediately after ureterocutaneostomy, and the intrapelvic pressure is 60, 80, 100, 120cmH_2O, but the sham-operated group didn′t flush. Urinary protein excretion were examined every day after operation,we also got pathological examination of nephridial tissue continually. The urinary protein include immunoglobulin G, microalbuminuria and ?_2-microglobulin. Result All the flushed rabbits had the change of urinary protein, the difference of urinary protein was of statistical significance between the before and the first day after treatment(P

Objective To investigate the rehabilitation needs of people with disabilities in Wuxi. MethodsRehabilitation demands of 74387 people with disabilities in Wuxi were surveyed.ResultsThere were significant differences in rehabilitation needs of the disabled from age and different types of disabilities.ConclusionDisability community-based rehabilitation system should be improved according to different demands of disability.

Objective:To observe the conditions of isolation,purification and culture of mesenchymal stem cells(MSCs) in vitro derived from human umbilical cord,and to observe the repairing effect on experimental hepatic fibrosis in rats by transplantation with MSCs only or MSCs with IL-10.Methods:The MSCs derived from human umbilical cord were isolated,purified and cultivated in vitro.The model of hepatic fibrosis induced by CCl4 was established.After the model of hepatic fibrosis was succeeded,the rats were divided into three groups:model group,MSCs transplantation group,MSCs transplantation with IL-10 group.MSCs transplantation group was given 1×106 MSCs by the tail vein injection at the first 1 weeks,2 weeks and 3 weeks.MSCs transplantation with IL-10 group not only was given MSCs the same with MSCs transplantation group, but also was injected of IL-10 ( 4 μg/kg ) in abdomen, 4 times a week.After 4 weeks,the rats were executed,rats blood was collected to observe the changes of liver function and the index of liver fibro-sis.The liver HE staining was carried out to observe the changes of liver pathology.Expression of MMP-2 mRNA was detected by RT-PCR method,expression of TGF-βprotein was detected by Western blot method.Results:The rat liver function and the index of liver fibrosis improved obviously with a significant difference between model group , MSCs transplantation group and MSCs transplantation with IL-10 group after transplanting,MSCs with IL-10 was better than MSCs only.Liver tissue of rats with hematoxylin eosin staining suggested,liver fibrosis was obviously improved,and the MSCs transplantation with IL-10 group was best.MMP-2 mRNA expression was significantly higher between normal group and model group,MSCs transplantation group with a significant difference (P<0.05),MMP-2 mRNA expression was higher with a no significant difference between model group and MSCs transplantation with IL-10 group ( P>0.05).TGF-βprotein expression of other groups was higher than normal group with a significant (P<0.05),and MSCs transplantation with IL-10 group was the largest decrease than normal group.Conclusion:MSCs only or MSCs with IL-10 transplantation can improve the biochemical characteristics of rat peripheral blood and liver histological structure,and with IL-10 wan better than MSCs only.MSCs and IL-10 play a role in the treatment of liver fibrosis through lowering the expression of MMP-2 and the expression of TGF-βprotein.

Objective To study the characteristics of peripheral blood lymphocyte subsets in patients with lung cancer,gastric cancer and breast cancer.Methods Five hundred and eight patients with cancer from the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine (256 cases with lung cancer,152 cases with gastric cancer,100 cases with breast cancer),and 50 healthy volunteers were collected.Two ml peripheral blood were obtained from these cases.The distribution of lymphocyte subsets in peripheral blood was measured by flow cytometry in these cases.The data were analyzed using SPSS 16.0 software.Results The number of lymphocytes of cancer patients was decreased,the healthy volunteers was 5125,breast cancer patient was 3642,gastric cancer patient was 3178,lung cancer patient was 2895.The case of outliers of lymphocyte subsets classified based on the three kinds of cancer was 218 (85.2％,lung cancer),133 (87.5％,gastric cancer),88 (88.0％,breast cancer).The case of outliers of T-lymphocyte subsets classified based on the three kinds of cancer was 83 (32.4％,lung cancer),32 (32.0％,breast cancer),44 (28.9％,gastric cancer).The case of outliers of CD4 +/CD8 + classified based on the three kinds of cancer was 185 (72.3％,lung cancer),108 (71.1％,gastric cancer),84 (84.0％,breast cancer).The case of outliers of natural killer-lymphocyte subsets classified based on the three kinds of cancer was 32 (12.5％,lung cancer),22 (14.5％,gastric cancer),16 (16.0％,breast cancer).The case of outliers of B-lymphocyte subsets classified based on the three kinds of cancer was 38 (14.8％,lung cancer),52 (34.2％,gastric cancer),12 (12.0％,breast cancer).Compared to healthy subjects,the CD19+％ of patients with lung cancer was decreased (12.8 ± 5.0 vs.11.5 ± 5.7,t =3.006,P =0.003);the CD4 + ％ of patients with gastric cancer was decreased (39.2 ±7.7 vs.35.3 ± 7.6,t =2.315,P =0.023);the CD19 + ％ of patients with gastric cancer was decreased (12.8 ± 5.0 vs.8.9 ± 4.2,t =3.302,P =0.010);the CD8 + ％ of patients with breast cancer was increased (24.0 ± 8.1 vs.29.1 ± 13.0,t =2.019,P =0.047).Conclusion The number of lymphocytes in cancer patients is decreased,the abnormal rates of lymphocyte subsets in the three kinds of cancer patients are higher than those in healthy volunteers,the lymphocyte subsets of different kinds of cancers perform different characteristics.

Objective To evaluate the effects of different sedation depths of propofol on brain injury in patients undergoing cardiac valve replacement with cardiopulmonary bypass (CPB).Methods Forty-five ASA physical status Ⅲ or Ⅳ patients of both sexes,aged 26-64 yr,weighing 50-85 kg,scheduled for elective cardiac valve replacement with CPB,were divided into 3 groups according to intraoperative sedation depths (n =15each):30 ≤ bispectral index (BIS) value ＜ 40 (group A) ; 40 ≤ BIS value ≤ 50 (group B) ; 50 ＜ BIS value ≤ 60(group C).Anesthesia was induced with iv injection of lidocaine,midazolam,sulfentanil,etomidate and vecuronium.The patients were tracheally intubated and mechanically ventilated.PET CO2 was maintained at 35-45 mm Hg.Anesthesia was maintained with iv infusion of propofol at a rate of 7,5 and 3 mg· kg-1 · h-1 in A,B and C groups,respectively,intermittent iv boluses of sulfentanil and pipecuronium,and intermittent inhalation of sevoflurane.The infusion rate of propofol was adjusted to maintain the corresponding anesthesic depth in each group.Before CPB (T1),at 30 min of CPB (T2),immediately after termination of CPB (T3) and at 1 h after the end of CPB (T4),blood samples were obtained from the jugular bulb vein and radial artery for determination of plasma S-100β protein concentration and for blood gas analysis,and the arterial to venous blood oxygen content difference (Dj-aO2),cerebral O2 extraction rate (CERO2) and jugular bulb venous to arterial blood lactic acid content difference (Dj-aL) were calculated.Results Compared with group C,the plasma S-100β protein concentrations were significantly decreased,SjvO2 was increased,and Dj-aO2 and CERO2 were decreased at T3-4,and Da-jL was decreased at T3 in groups A and B (P ＜ 0.05).Compared with group B,the plasma S-100β protein concentrations were significantly decreased at T3-4,SjvO2 was increased at T2,Da-jO2 and CERO2 were decreased at T2,and DajL was decreased at T3 in group A (P ＜ 0.05).Conclusion Moderately deepened anesthetic depth of propofol (30≤ BIS value ＜ 40) is helpful in attenuating the brain injury in patients undergoing cardiac valve replacement with CPB.

Objective By analyzing the epidemiological characteristics of brucellosis in Shanxi Province,to provide a scientific basis in formulation of strategies for effective prevention and control of the disease.Method Surveillance data of human brucellosis from China Information System for Disease Control and Prevention between 2004 and 2013 were statistically analyzed by descriptive epidemiological method.The regional,time,age and sex,occupational distribution of brucellosis were analyzed.The prevalence trend of brucellosis in Shanxi Province was summarized.Results From 2004 to 2013,the total incidence presented a rising tendency and the highest reported incidence was 19.10/10 million in 2013.A total of 43 061 cases of brucellosis occurred in Shanxi Province.The average incidence of brucellosis was 12.52/10 million.Regional distribution range was relatively focused on the north areas of Shanxi Province,the number of reported cases of Datong City was the largest (12 157 cases),being 28.23％.The incidence of Shuozhou City was the highest (42.97/10 million).The epidemic was spreading through all county areas.The disease was found each month throughout the year,the obvious incidence peak seasons were between March and June.The disease was most commonly found in 15-64 age groups(87.19％,37 545/43 061).Occupation distribution of patients was mainly farmers (83.34％,35 887/43 061).Conclusions The situation of brucellosis epidemic in Shanxi Province is relatively serious;the reported incidence of brucellosis in Shanxi Province is in a rapid upward trend year by year,even highly active in some particular areas.Different regions should establish regional mechanisms for joint prevention and control and implement different prevention and control measures to comprehensively and sequentially control brucellosis.