1.Introduction and Profound Consideration on Intellectual Property Rights Protection Standard Terms Relat-ed to Drugs beyond the Regulations of TRIPS
China Pharmacy 2017;28(4):442-445
OBJECTIVE:To improve response capacity of China to deal with intellectual property rights protection standard terms (Trips-plus terms) beyond the regulations of Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), and to provide reference for improving national intellectual property rights protection policy. METHODS:Trips-plus terms and their common types were introduced to analyze their characteristics and consider about their adverse effects. RESULTS & CONCLU-SIONS:Common TRIPS-plus terms involve data protection,patent interlinkage,patent period extension,limitation of compulsory licensing and parallel importation,etc. These terms pose a significant challenge to developing countries,resulting in delaying entry of generics,increasing drug price,influencing drug accessibility and posing a great threat to public health. China,as the largest de-veloping country mostly relying on generic drugs,should scientifically assess the effects of TRIPS-plus on public health,drug ac-cessibility and pharmaceutical industry in the process of domestic legislation and negotiating a free trade agreement,and make effec-tive use of the TRIPS flexibility to protect the public health.
3.Clinical observation of double-pool shaping trabeculectomy with adjustable sutures in glaucoma
Jing YANG ; Haibo CHEN ; Yiyu SHI
The Journal of Practical Medicine 2015;31(14):2294-2296
Objective To evaluate the recent safety and long-term curative effect of double-pool shaping trabeculectomy with adjustable sutures in glaucoma. Methods A hundred and twenty patients with glaucoma were randomly divided into two groups, in which the control group in 62 patients underwent traditional trabeculectomy and the experimental group in 58 patients underwent double-pool shaping trabeculectomy with adjustable sutures. All patients were followed up for one year. Postoprative intraocular pressure, anterior chamber depth and filtering bleb were observed. Results In the experimental group, after the demolition of adjustable sutures, 3 eyes(5.17%) suffered from I degree shallow anterior chamber. By contrast, 8 eyes suffered from I degree shallow anterior chamber, and 1 eye (total 14.52%) suffered from Ⅱ degree shallow anterior chamber in the control group (P < 0.05). Following up in one year, the functional filtering bleb and intraocular pressure got better in the experimental group than in the control group (P < 0.05). Conclusion Double-pool shaping trabeculectomy with adjustable sutures is a safe and feasible method for glaucoma, in which it can effectively reduce intraocular pressure without complications.
4.Study on the Role of Calcitonin Gene-related peptide and Progesterone in the Pathogenesis of Pregnancy Induced Hypertension
Wenjing SHI ; Jing CHEN ; Shuang LIU
Chinese Journal of Perinatal Medicine 1998;0(01):-
Objective To explore the role of CGRP and progesterone along with it on the etiopathology of PIH. Methods 8 specimens of umbilical vein endothelial cells from women with PIH were cultured. Four groups were divided when cultured cells were confluent: the sera of normal pregnancy women (group 1), the sera of women with PIH (group2), the mixture of the sera of women with PIH and the injection of progesterone (group3), and the same amount of media (group 4). The cultured cell were added respectively into the four different kinds of media. After 24h of incubation, the concentration of endothelin (ET) and CGRP in media were measured by radioimmunoassay. Results 1. Comparing with group1, the concentration of CGRP in group 2 decreased and ET increased significantly. Statistic difference of ET/CGRP was found between the two groups. 2. Comparing with group 1, the concentration of CGRP in group 3 was unchanged and ET increased obviously. No difference of ET/CGRP was shown between them. 3. Comparing with group 3, in group 2, the concentration of CGRP decreased obviously and that of ET unchanged. Significant difference of ET/CGRP was found. Conclusions Progesterone, along with CGRP, might delay the onset and progressing of PIH.
6.Evaluation of ultrasonography in diagnosis of benign PH and malignant thyroid nodules by binary LogisticPHam
Zhicheng CHEN ; Yinyou FANG ; Jing SHI
Chinese Journal of Primary Medicine and Pharmacy 2017;24(16):2464-2468,后插4
Objective To evaluate the clinical value of ultrasonography in diagnosis of benignPHand malignant thyroid nodules by binary Logistic regression model.Methods A retrospective analysis of 240 cases of thyroid nodules confirmed by pathology after operation excision was conducted.173 nodules were benign as control group,67 nodules were malignant as observation group.The ultrasonic features of thyroid nodules were collected.The factor had statistics significance by x2 test between the two groups were analyzed by binary Logistic regression.A logistic regression model was created.The ROC curve was drawn and the area under the curve was calculated.Results There were statistically significant differences among boundary,aspect ratio,shape,internal echo,calcification,acoustic halo,cervical lymphadenectasis between the control group and observation group(x2=45.392,7.590,30.039,24.168,37.406,6.893,16.078,all P<0.01).And after Logistic regression analysis,six variables that entered the regression equation were boundary(P=0.000,OR=8.437),aspect ratio(P=0.000,OR=12.816),microcalcification of the nodules(P=0.000,OR=8.893),shape(P=0.000,OR=8.791),internal echoes(P=0.001,OR=8.313)and cervical lymphadenectasis(P=0.001,OR=6.891).The accuracy of the model was 90.7%(223/246)in predicting malignant nodules in thyroid.The area under the ROC curve was(0.904±0.031).Conclusion The binary Logistic regression can be used to differentiate malignant and benign thyroid nodules,and make a more accurate judgment for the nodules in thyroid.
7.Bio-artificial dura mater in repair of dural defects
Jing CHEN ; Songsheng SHI ; Guoliang ZHANG ; Jianping CHEN
Chinese Journal of Tissue Engineering Research 2013;(51):8914-8919
BACKGROUND:Repairing integrity of the dura mater is very important for the prognosis of patients with convex meningioma.
OBJECTIVE:To investigate the application value of bio-artificial dura mater on giant convex meningioma.
METHODS:The retrospective analysis of 56 cases of dural defects due to tumor erosion in patients with giant convex meningioma was carried out. Meanwhile, the clinical efficacy, complications and fol ow-up results of the repair with artificial dura mater were analyzed.
RESULTS AND CONCLUSION:Except two cases complicated with local effusion, one case with a smal volume of subdural effusion in operative side, one case with tardive epidural hematoma, the remaining patients had no cerebrospinal fluid leakage, intracranial infection, epilepsy, tissue rejection and other adverse reactions. Postoperative CT and MR examinations confirmed the site of implantation of artificial dura without abnormal radiographic changes. Five patients underwent cranioplasty of skul repair in 3 months postoperatively, and the intraoperative findings showed that the artificial dura mater had a good fusion with normal dura mater, with no adhesions and inflammatory reactions. These findings indicate that bio-artificial dura mater can reshape the original anatomical level, protect the cerebral cortex, and reduce the incidence of various complications significantly.
8.Change of coagulation function in patients with high altitude polycythemia
Quangui SHI ; Dongfang FENG ; Fangfang CHEN ; Huaying SHI ; Jing TONG ; Jing XIAO ; Huailin HUANG
International Journal of Laboratory Medicine 2015;(10):1385-1386
Objective To investigate changes of coagulation function in patients with high altitude polycythemia (HAPC) .Meth‐ods Activated partial thromboplastin time (APTT) ,prothrombin time (PT) ,thrombin time (TT) and fibrinogen (Fbg) were de‐tected and compared between 69 patients with HAPC and 60 healthy subjects (controls) .Results Fbg ,APTT and TT levels in pa‐tients with HAPC were higher than controls (P<0 .05) ,while the difference of PT was not significant (P>0 .05) .Dynamic obser‐vation indicated that comprehensive therapy could these recover coagulation function .Conclusion Hemorrhage and coagulation process in patients with HAPC could be very complicated ,including physiological adaptation and the process of physiology evolving into pathology .
9.Visualized study of current status of the research in neonatal non-invasive ventilation
Xiaoyan YANG ; Chao CHEN ; Jing SHI ; Jun TANG ; Dezhi MU
Journal of Clinical Pediatrics 2015;(9):771-775
ObjectivesTo present the current condition of non-invasive ventilation in newborns in the last ifve years in China, to describe the probable research trends of this ifeld, and to provide the possible research directions in future.Methods Using co-word analysis, the keywords “neonate” and “non-invasive ventilation” were searched in the CNKI database. The search results included 457 articles. Then the relation matrix was built by Excel 2010. Finally the visualized network was drawn by Ucinet 6.3.ResultsNasal continuous positive airway pressure (nCPAP) is primarily for the treatment of neonatal respiratory distress syndrome (NRDS) in China. Meanwhile, nasal intermittent positive pressure ventilation (nIPPV) and bilevel positive airway pressure (BiPAP) are gradually applied in clinic. The application scope of non-invasive ventilation is expanding. Besides the neonatologists, nurses are also paying close attention to non-invasive ventilation.ConclusionsThe visualized network, successfully built by Netdraw, relfects the hot topics and current condition in this ifeld.
10.Improvement and optimization of performance verification on enzyme linked immunosorbent assay for determination of hepatitis B markers
Jing SHI ; Ya ZHANG ; Lin ZOU ; Pu CHEN ; Liping ZHANG
International Journal of Laboratory Medicine 2015;(23):3369-3371
Objective To evaluate the performance of enzyme linked immunosorbent assay (ELISA) kit in detection of Hepatitis B virus(HBV) markers by using improved and optimized method ,so as to provide a practical and feasible method and reagents for clinical laboratory .Methods ELISA test was used for the detection of HBV markers .The gradient dilution method was used to e‐valuate the lower limit .The verifiation of cut off value was carried out based on clinical and laboratory standards institute (CLSI) EP12‐A2 document .Samples with cut off values were collected to evaluate the precision ,including repeatability and intermediate precision .The coincidence rates were counted through comparing the results of ELISA with those of external quality assessment and those detected by using Abbott i4000SR chemiluminescence instrument .Results The lower detection limit of HBsAg ,HBsAb , HBeAg ,HBeAb and HBcAb were 0 .2 IU/mL ,20 mIU/mL ,1 NCU/mL ,0 .75 NCU/mL and 0 .05 NCU/mL respectively .The cut‐off value(C50 )± 20% concentration included the concentration range between C5 and C95 .The within‐run coefficient of variation (CV)≤15% ,in sandwich method the between‐run CV≤25% ,in competition method the between‐run CV≤35% .The positive and negative coincidence rates in accuracy and comparing with i 4000SR all were more than 95% and all κ>0 .75 .Conclusion ELISA tests for HBV markers in our laboratory could meet the requirements of the detection performance and clinical needs .