Objective:To investigate the implementation status of periodic risk evaluation reports(PRER)for medical devices in China,so as to provide references for adapting the development of vigilance system for medical device,and improving the PRER system.Methods:A questionnaire was self-designed,which was online distributed to registrants and filing persons for medical devices,domestic agent for imported medical devices,and the relevant persons of monitoring agencies for adverse events of medical device at all grades through monitoring agencies of each provincial grade in China,so as to understand the evaluation and suggestion of the relevant agencies of medical devices for the PRER work.Combined with review status and special inspection results of all monitoring agencies for PRER,and compared with guidelines of the European Union's Periodic Safety Update Reports(PSURs),the existing issues in the PRER for medical devices in China were analyzed at present.Results:A total of 4,377 valid questionnaires were returned,the respondents by 64.95%acknowledged that PRER can aid stakeholders to identify products'risks.Additionally,the respondents by 41.28%acknowledged that the medical devices of Class I and renewal registrations need be simplify in the PRER,and the respondents by 57.69%considered the frequency of writing and submitting reports should be adjusted.Conclusion:This article combined with the requirements of pilot work of vigilance for medical device,and recommended to strengthen risk analysis in PRER,and streamline reporting formats,and improve the top-level design of safety supervision after medical devices enter the market in China.These measures will promote the supervision and management system of China for medical device to integrate with international standards,and enhance the international competitiveness of the domestically medical device industry.

Objective:To investigate the implementation status of periodic risk evaluation reports(PRER)for medical devices in China,so as to provide references for adapting the development of vigilance system for medical device,and improving the PRER system.Methods:A questionnaire was self-designed,which was online distributed to registrants and filing persons for medical devices,domestic agent for imported medical devices,and the relevant persons of monitoring agencies for adverse events of medical device at all grades through monitoring agencies of each provincial grade in China,so as to understand the evaluation and suggestion of the relevant agencies of medical devices for the PRER work.Combined with review status and special inspection results of all monitoring agencies for PRER,and compared with guidelines of the European Union's Periodic Safety Update Reports(PSURs),the existing issues in the PRER for medical devices in China were analyzed at present.Results:A total of 4,377 valid questionnaires were returned,the respondents by 64.95%acknowledged that PRER can aid stakeholders to identify products'risks.Additionally,the respondents by 41.28%acknowledged that the medical devices of Class I and renewal registrations need be simplify in the PRER,and the respondents by 57.69%considered the frequency of writing and submitting reports should be adjusted.Conclusion:This article combined with the requirements of pilot work of vigilance for medical device,and recommended to strengthen risk analysis in PRER,and streamline reporting formats,and improve the top-level design of safety supervision after medical devices enter the market in China.These measures will promote the supervision and management system of China for medical device to integrate with international standards,and enhance the international competitiveness of the domestically medical device industry.

Professor Lau Wanyee, a member of the Chinese Academy of Sciences and a pro-fessor at the Chinese University of Hong Kong, actively advocates conducting clinical researches through "planting fruit trees" and "growing orchards", aiming to cultivate a team of dual-skilled talents in clinical practice and research, effectively improve the scientific and technological level of clinical medicine in China, make voice heard in the international medical science field, and better serve human health. He organized a clinical research training course in scholars′ forum for Hepatobiliary Young Expert Working Group of Chinese College of Surgeons. Throughout three sessions of the training course, a distinct theme was focused on how to enhance the level of clinical research in China and make voice heard by the international scholars. A group of multi-dimensional experts were gathered, including experts from surgery, methodology, and management, as well as both renowned experts and young talents. A lively teaching model was adopted, combining guided presentations with interactive discussion and debate sessions. A clean and upright academic spirit was strongly advocated, in which international rules were adopted to conduct in-depth analysis and sharp criticism of seven proposed clinical research projects and four published papers with high international influence to find quarrel in a straw. This clinical research training course provides a new model of guidance for young physicians in conducting clinical research. As a result, all attendees felt deeply educated and benefited greatly from the training session. This training activity not only laid a solid foundation for the development of scientization, standardization, and internationali-zation of clinical research in digestive surgery in China, but also demonstrated a correct path for cultivating a group of young and middle-aged clinical medical scientists with scientific spirit.

OBJECTIVE To find lead compounds with potent bioactivities from endophytic fungi Trichoderma sp. SHJN1 and Perenniporia sp. SHJG1 from the traditional Chinese medicine Lindera glauca. METHODS The fermentation of Trichoderma sp. SHJN1 and Perenniporia sp. SHJG1 were isolated and purificated by repeated silica gel, ODS, Sephadex LH-20, and semi-preparation HPLC. The structures of compounds were performed by NMR and ESI-MS. The preliminary evaluation of anti-tumor activity of these compounds was performed by human breast cancer cells(MCF-7) and human lung cancer cells(A549). RESULTS A total of 12 compounds were purified from the above two endophytic fungi and identified as alantrypinone(1), oryzalactam(2), phomoindene A(3), cis-gregatin B(4), huaspenone B(5), stigmasta-7,22-dien-3β,5α,6α-triol(6) and ergosterol(7), 1-deoxy-2-demethylviridiol (8), viridiol(9), trichodermamides A(10), chromone(11) and 4-hydroxyphenylacetic acid(12). The evaluation of antitumor activity showed that, compound 3 showed inhibitory activity on MCF-7 cell line with an IC50 value of (62.9±1.02)μmol·L-1[cisplatin(DDP) IC50=(30.1±1.67)μmol·L-1], while compound 8 and 9 showed inhibitory activities on A549 cell line with IC50 values of (34.6±1.57)μmol·L-1 and (44.9±1.74)μmol·L-1, respectively[DDP IC50=(20.6±1.42)μmol·L-1]. CONCLUSION Compounds 3, 8 and 9 show potent anti-tumor effects.

Objective To observe the effects of ziprasidone and risperidone on schizophrenia patients and the change of serum leptin and adiponectin levels .Methods Totally 80 cases of schizophrenia patients were randomly divided into ziprasidone group and risperidone group ,which were treated for 8 weeks .Measure the positive and negative symptoms scale (PANSS) score and body weight of that number ,leptin and adiponectin at baseline ,treatment 4 weeks and 8 weeks respectively for patients ,at the end of the experiment ,the results for statistical analysis .Results Two groups of 4 ,8 weeks after treatment scores compared with baseline scores dropped significantly ,the difference was statistically significant(P<0 .05) .Risperidone group after treatment ,leptin levels significantly increased body mass index ,and adiponectin levels significantly decreased ,compared with the baseline before treatment was statistically significant difference(P<0 .05) .Conclusion Ziprasidone and risperidone in treatment of schizophrenia have similar efficacy .Ziprasidone has no significant effect on body weight ,leptin and adiponectin levels in treatment of schizophrenia patients . However ,risperidone has a significant effect ,long-term use should pay attention to the side effects .

OBJECTIVETo report on clinical, genetic and molecular characterization of two Chinese families with Leber's hereditary optic neuropathy.

METHODSOphthalmological examinations have revealed variable severity and age at onset of visual loss among the probands and other matrilineal relatives of both families. The entire mitochondrial genome of the two probands was amplified with PCR in 24 overlapping fragments using sets of oligonucleotide primers.

RESULTSThe ophthalmological examinations showed that penetrance was 12.5% and 30.0% respectively in the two families. Sequence analysis of the complete mitochondrial genomes in these pedigrees has identified unreported homoplasmic T8821G mutation in the ATPase 6 gene and distinct sets of polymorphisms belonging to haplogroups M10a. The T8821G mutation has occurred at the extremely conserved nucleotide (conventional position 99) of the ATPase6. Thus, this mutation may alter structural formation of ATPase6, thereby leading to failure in the synthesis of ATP involved in visual impairment.

CONCLUSIONAbove observations have suggested that the ATPase6 T8821G mutation may be involved in the pathogenesis of optic neuropathy in these families.

Adolescent ; Asian Continental Ancestry Group ; genetics ; Base Sequence ; China ; DNA, Mitochondrial ; genetics ; Female ; Humans ; Male ; Mitochondrial Proton-Translocating ATPases ; genetics ; Molecular Sequence Data ; Optic Atrophy, Hereditary, Leber ; enzymology ; genetics ; Pedigree ; Point Mutation ; Young Adult

Objective To observe the effects of ziprasidone and risperidone on patients with schizophrenia and their influence on bloodglucoseandlipids.Methods 96patientswithschizophrenicenrolledinthestudywererandomlydividedintotwogroups,zi‐prasidone and risperidone group ,and both were treated for 8 weeks .Their blood glucose ,blood lipid of base line and at the end of the 4th ,8th week were determined respectively .Results The positive and negative symptoms scores of the two groups by using Positive and Negative Syndrome Scale(PANSS) before and after treatment were not statistically different(P> 0 .05) .Compared with the baseline scores ,scores at the end of 4th and 8th week in both ziprasidone and risperidone groups significantly decreased(P<0 .05) ,but there was no statistically significant difference between the two groups(P>0 .05) .After 8 weeks′ treatment ,the ef‐fective rate was 91 .7% in ziprasidone groups and 89 .6% in risperidone group .There were no significant differences between the two groups(P>0 .05) .The blood lipids and glucose levels were less increased after ziprasidone treatment ,but was not statistically significant(P>0 .05) .The blood lipids and glucose levels significantly increased after risperidone treatment(P<0 .05) .Conclusion Ziprasidone and risperidone had the same effect on schizophrenia .Ziprasidone had no effect on blood glucose and lipids in schizo‐phrenic patients ,while risperidone could increase blood glucose and lipids level ,we should pay attention to the side effects of long‐term use .

Objective To prepare insulin thiolated hyaluronic acid nanoparticles (Ins-HA-Cys-NPs)and study its physicochemical properties. Methods The Ins-HA-Cys-NPs was prepared by ultrasonic emulsifying method,and the properties of nanoparticles including morphology,mean diameter,Zeta potential,entrapment efficiency and drug loading efficiency were studied,as well as the cryoprotectant selection.Results The prepared nanoparticles was round in appearance and the mean diameter was(178.5 ±0.8)nm,the polydispersity index was (0.214 ±0.013)and the Zeta potential was -(38.47 ±0.46 )mV,while the entrapment efficiency was (48.85 ±0.66 )%,drug loading efficiency was (4.79 ±0.13 )%;10%mannitol as cryoprotectant provided uniform and well dispersed suspension of nanoparticles with blue opalescence after redispersion.Conclusion The thiolated hyaluronic acid nanoparticles may be used as the carrier for oral drug delivery system of insulin,and it provides a basis for studies on rats in vivo.

Objective To compare the efficacy of laparoscopic gallbladder bed dissection(LGBD)between retrograde plus anterograde and anterograde only manners.Methods All of 575 cases of laparoscopic cholecystectomy(LC)were randomly divided into two groups(group A and group B).Patients underwent LGBD with retrograde plus anterograde mannerin group A(297 cases)oronly with anterograde manner in group B(278 cases)respectively.The efficacy and safety were compared between two groups.Results The operative time were(10.0±3.7)min and(13.0±3.9)min in group A and group B respectively (P<0.05).There were 33 cases of bleeding volume more than 5 ml in group A with 85 cages in group B (P<0.05).Three cases of gallbladder rupture were found in group A compared with 10 cases in group B (P<0.05).Postoperative fluid collection in gallbladder bed occurred in 5 cases in group A compared with 19 cases in group B(P<0.05).The conversion rate was 3.70%(11/297)and 3.96%(11/278)in group A and group B respectively(P>0.05).One cage of abdominal fluid collection was observed in group A whichwas relieved after conservative therapy.No other complications occurred.Conclusions LGBD applying retrograde plus anterograde manner may shorten the operative time,decrease the bleeding during operation and minimize the postoperative complications.Surgeons might benefit from its advantage of easier manipulation.

In order to study the functions of the HSPs (Heat shock proteins) of Eimeria tenella, we cloned a novel gene (which designated EtHSP) coding HSP of Eimeria tenella by RT-PCR and RACE (Rapid-amplification of cDNA ends). The full-length cDNA sequence of EtHSP was 1802 bp, containing a 1455 bp ORF (Open reading frame) (GenBank Accession No. FJ911605) encoding a deduced protein of 484 amino acids. Real-time PCR revealed that the mRNA level of EtHSP was much higher in sporozoites of E. tenella than other developmental stages (unsporulated oocysts, sporulated oocysts and merozoites). We constructed the recombinant plasmids pET28a(+)-EtHSP, then transformed it into E. coli BL21(DE3) for expression. SDS-PAGE indicated that the fusion protein was expressed in included bodies, with peak expression 6 h after induction by IPTG Western blotting revealed that the protein was specifically recognized by polyclonal antibodies against E. tenella, showing that the fusion protein was native antigen.
Animals ; Chickens ; Eimeria tenella ; genetics ; metabolism ; Escherichia coli ; genetics ; metabolism ; Heat-Shock Proteins ; genetics ; immunology ; metabolism ; Inclusion Bodies ; metabolism ; Male ; Molecular Sequence Data ; Open Reading Frames ; genetics ; Rabbits ; Recombinant Fusion Proteins ; genetics ; immunology ; metabolism ; Sequence Analysis, Protein