?AlM:To investigate the sensitive parameters of the anterior chamber changes with Pentacam anterior segment analysis system before and after laser peripheral iridectomy (LPl) in primary angle-closure suspetive (PACS).
? METHODS: Sixty eyes of 33 PACS patients were enrolled in this study. Pentacam examination was performed before and 1d after LPl to measure the central anterior chamber depth ( CACD ) , the peripheral anterior chamber depth ( PACD ) , the anterior chamber volume ( ACV) and the peripheral anterior chamber angle ( ACA) . Statistical analysis used paired t test.
?RESULTS: There was no statistical significance on the changes of ACD. PACD and ACV increased significantly between before and 1d after LPl. ACA was widened from (22. 26o±5. 18o) to (26. 42o±5. 20o), which were increased significantly between before and 1d after LPl.
?CONCLUSlON: LPl can deepen the PACD and increase the ACV in PACS. PACD and ACV are the sensitive parameters of the anterior chamber changes with Pentacam anterior segment analysis system.

Technology readiness level (TRL) refers the general maturity level of a single technology or technical systems (including technology,component or subsystem) during the process of development.Base on the original TRL proposed by NASA,with reference to medical device TRL modified by US Department of Defense and NATO,this study modified TRL definition and description for advanced medical devices with consideration of R&D,review and approval characteristics of advanced medical devices in China.

Background Posterior capsular opacification (PCO)affects the pseudoaccommodation of 1CU accommodative intraocular lens (1CU AIOL).At present,few studies on the effect of PCO and Nd∶ YAG laser capsulotomy on intraocular shifting of 1CU AIOL are published.Objective The present study was to evaluate the effect of PCO and Nd∶YAG laser capsulotomy on the shifting of 1CU AIOL.Methods A respective serial caseobservational study was designed.Written informed consent was obtained from each patient prior to this study.Twentyfour eyes of 20 patients with PCO after phacoemulsification and implantation of 1CU AIOL were included in this study.Ocular examination was performed 3 months after IOL implantation,1 day before Nd:YAG laser capsulotomy and 3 months after Nd∶YAG laser capsulotomy to evaluate the distance corrected near visual acuity(DCNVA).The difference in the anterior chamber depths before and after administering 1％ pilocarpine topical eye drops was measured with the IOLMaster to determine the intraocular shifts of the IOL.The extent of IOL shifting was compared among 3 time points to assess the factors influencing IOL accommodation after 1CU AIOL implantation.Results The shifting amplitude of 1CU AIOL was(0.44±0.21)mm 3 months after implantation of 1CU AIOL,(0.27±0.11)mm 1 day before Nd ∶ YAG laser capsulotomy,and (0.34±0.10) mm 3 months after Nd ∶ YAG laser capsulotomy,showing a significant difference among them(F=7.180,P=0.001).The shifting amplitude of 1CU AIOL significantly declined 1 day before Nd∶YAG laser capsulotomy in comparison with 3 months after implantation of 1 CU AIOL(P =0.006).The shifting amplitude 3 months after Nd∶YAG laser capsulotomy increased slightly in comparison with 1 day before Nd∶YAG laser capsulotomy(P=0.059).DCNVA was(3.1±0.9)J 3 months after implantation of 1CU AIOL,(6.2±0.8) J 1 day before Nd ∶ YAG laser capsulotomy and(3.4±0.7) J 3 months after Nd ∶ YAG laser capsulotomy,with a significant difference among them (F =110.270,P =0.000).DCNVA was lower 1 day before Nd∶ YAG laser capsulotomy than 3 months after implantation of 1CU AIOL(P＜0.05).However,DCNVA was higher 3 months after Nd∶YAG laser capsulotomy than that of 1 day before Nd∶YAG laser capsulotomy (P＜0.05).There was no significant correlations between DCNVA and IOL movement 3 months after IOL implantation,1 day before Nd∶ YAG laser capsulotomy and 3 months after Nd ∶ YAG laser capsulotomy (r1 =-0.150,P1 =0.486,r2 =-0.320,P2 =0.122,r3 =-0.100,P3 =0.633).Conclusions The shifting amplitude of 1CU AIOL markedly declines due to PCO.No clinically significant influence of Nd ∶ YAG laser capsulotomy on the shifting amplitude of 1 CU AIOL is found.DCNVA can improve after Nd∶YAG laser capsulotomy.Multiple inter-related factors concerning pseudophakic accommodation may influence DCNVA.

Through the analysis of the current status and problems of innovative medical devices evaluation, tnis paper discussed the strategies of evaluation, and ultimately raises the frame of evaluation, so as to provide reference for scientific evaluation of medical devices in China.
China ; Equipment and Supplies ; standards ; Evaluation Studies as Topic

No abstract available.
Dinoprost* ; Female ; Laparoscopes* ; Pregnancy ; Pregnancy, Tubal*

To investigate the effect of additional factor XIII on the rate of cross-linked fibrin formation in fibrin glue, we prepared concentrated fibrinogen as a source of fibrin glue using thaw -syphon method from fresh frozen plasma, purified human factor XIII from plasma, and performed biochemical analysis of the fibrin glue formed with or without additional factor XIII. It was concluded that additional factor XIII promoted rapid formation of cross-linked fibrin (gamma-gamma dimer and a-polymer) which would be essential to clinically effective fibrin glue.
Factor XIII* ; Fibrin Tissue Adhesive* ; Fibrin* ; Fibrinogen ; Humans ; Plasma

Objective Establish an objective and fair evaluation index system for the implementation effectiveness of the National Major New Drug Development Program of China.Methods Based on literature review and Delphi method,the framework of the evaluation index system was built and analytic hierarchy process was applied to determine the priority of each indicator of the system.The objectiveness and validness of the results were assured by determining expert activeness coefficient,authority coefficient,indicator rationality,and by applying consistency check.Results A targeted and systematic evaluation index system was constructed for the National Major New Drug Development Program,and through expert consultation and analytic hierarchy process,the factor of product result was considered of the highest weight of 39.03％,followed by technical result,theoretical result and organization and management result.The evaluation index system suggested that product result and technical result are two relatively more significant factors to be considered during evaluation.Conclu sion After consultation on expert opinions,the evaluation index system for the National Major New Drug Development Program was constructed with each factor been assigned with a scientific and rational weight,and this will provide a guideline for the decision making of program administrators and evaluation practice.

Objective To establish rat models of extrahepatic biliary atresia,and to observe the characteristics of 99Tcm-MIBI hepatobiliary scintigraphy and evaluate its association with the expression Pglycoprotein (P-gp) in intestinal tissues.Methods A total of 12 SD rats were randomly divided into the normal control group (3 rats) and the group of common bile duct ligation (CBDL;9 rats).CBDL was used to establish the rat model of extrahepatic biliary atresia.99Tcm-MIBI hepatobiliary scintigraphy was performed at 2,3 and 4 weeks after ligation in the CBDL group and normal control group with continuous dynamic acquisition (3 min/frame) for 30 min and then delaying imaging at 30 min,1,2 and 3 h.After that,all rats were sacrificed,and the blood samples were taken out for the determination of serum ALT,AST,TBIL,DBIL,IBIL,ALP,γ-GT and TBA,and the tissues of duodenum,jejunum,ileum,colon and cecum were taken out for analyzing the expression level of P-gp by immunohistochemistry.Two-sample t test and one-way analysis of variance were used.Results Compared with the normal control group,the serum levels of ALT,AST,TBIL,DBIL,IBIL,ALP,γ-GT and TBA were significantly increasing at 2,3,4 weeks after ligation in CBDL group (t:-3.04 to-44.54,all P＜0.05).99Tcm-MIBI hepatobiliary imaging showed that there was radioactive accumulation in colon or cecum area,excluding the duodenum,jejunum and ileum area,at 3 h after intravenous injection of 99Tcm-MIBI in CBDL group.The results of immunohistochemistry showed that with the obstruction time prolonged,the expression levels of P-gp in duodenum,jejunum and ileum segments were gradually decreased (F=5.17,9.07,23.52;all P＜0.05),while the expression levels in the colon and cecum segments were not changed obviously (F=2.00,3.17;both P＞0.05).Conclusion 99Tcm-MIBI can be excreted through intestinal mucosa,and this process may be associated with P-gp expression.

To investigate the effects of metallothionein (MT) on isolated rat heart, 16 Wistar rats were randomly divided into 2 groups. In control group (group C), distilled water was injected intraperitoneally and 24 h later isolated hearts were perfused with Langendorff and stored at 4 degrees C for 3 h with histidine-tryptophan-ketoglutarate (HTK) solutions, and then isolated hearts were perfused for 2 h by Langendorff. In experimental group (group E), 3.6% ZnSO(4) was injected intraperitoneally, 24 h later isolated hearts were perfused by Langendorff and stored at 4 degrees C for 3 h with HTK solutions, and then the isolated hearts were perfused for 2 h with Langendorff. MT content, the recovery of hemodynamics, myocardial water content (MWC), lactate dehydrogenase (LDH) and creatine kinase (CK) leakage, adenosine triphosphate (ATP) and malondialdehyde (MDA) content, superoxide dismutase (SOD) activity, myocardial cell Ca(2+) content, Ca(2+)-ATPase activity of mitochondria ([Ca(2+)-ATPase](m)) and its Ca(2+) content ([Ca(2+)](m)), synthesizing ATP activity of mitochondria ([ATP](m)), and the ultrastructure of cells were examined. There were a significant increase in group E in hemodynamic recovery, ATP content, SOD activity, [Ca(2+)-ATPase](m) activity, [ATP](m) activity, and substantial reduction in MWC, LDH and CK leakage, MDA content, myocardial cell Ca(2+) content, [Ca(2+)](m) content, and the ultrastructural injury were obviously milder than that of group C. This study demonstrated that MT has protective effects on isolated rat heart.
Cardiotonic Agents/*pharmacology ; Creatine Kinase/*metabolism ; L-Lactate Dehydrogenase/metabolism ; Metallothionein/biosynthesis ; Metallothionein/*pharmacology ; Myocardium/*metabolism ; Myocardium/ultrastructure ; Random Allocation ; Rats, Wistar ; Superoxide Dismutase/metabolism ; Zinc Sulfate/pharmacology

Objective To explore the role of proton MR spectroscopic imaging(1H-MRSI)and diffusion tensor imaging(DTI)in the diagnosis of adrenoleukodystrophy and to demonstrate the involvement of fibers by using the technique of DTT.Methods 1H-MRSI,DTI and routine imaging examinations were performed in 6 patients with ALD.The values of NAA,Cho,Cr,ADC,and FA were evaluated in different regions of lesion.The involved fibers were demonstrated by using the technique of DTT.Results The ratios of NAA/Cr(0.55±0.19)and NAA/Cho(0.22±0.11)were lower(F=7.693,7.751),and Cho/Cr(2.54±0.37)was higher(F=6.348)in the initial lesions,where higher ADC values(1.49±0.36,F=5.226)and the lowest FA values(0.21±0.08,F=5.139)were also observed(P＜0.05).The decreases of NAA/Cr(1.16±0.03)and NAA/Cho(0.45±0.17)in adjacent regions were more distinct than those of remote regions(t=1.769,1.842,P＜0.05).In the developing regions,the ADC values(0.89±0.03)were lower and the FA values(0.45±0.07)were the highest.There was negative correlation between NAA/Cho and ADC values(r=-0.71,P＜0.05),and there was positive correlation between NAA/Cho and FA values(r=0.31,P＜0.05).Discontinuations and fragments of fibres were observed in corpus callosum and pyramidal tract.Conclusions Combination of 1H-MRSI and DTI can offer a sensitive method for the early diagnosis and monitor the progress of white matter.DTT can be used to directly observe the involvement of fibers.