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OBJECTIVE：To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union （EU），the United States （U. S. ）and Japan. METHODS：Literature analysis method was used to systematically compare the similarities and differences on definitions ，sources， detection methods and management process of pharmacovigilance signals among EU ，U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS ：Regulatory authorities of the EU ，U. S. and Japan did not have a uniform definition on signals ；EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ，FDA adopted its own definition ，while the Japanese regulatory agency had no clear definition. Currently ，post-marketing surveillance still relied mainly on spontaneous reporting systems ；EU，U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ；EU mainly adopted the proportional reporting ratio method ，U. S. mainly adopts the multiple gamma Poisson Shrinker ，and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ，while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ，draw up guidelines on pharmacovigilance practices ， strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ，for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.
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<p><b>OBJECTIVE</b>To evaluate the associations of oral contraceptives (OC) exposure, angiotensinogen (AGT) gene polymorphism and joint effects on the risk of stroke in Chinese women.</p><p><b>METHODS</b>On the basis of a prospective female cohort of contraceptive use, the first-ever-developed (FED) stroke cases, as well as, two sets of age-(± 3 years) and region-matched controls (including neighborhoods and hospitalized patients) were recruited. Between 1 July 2000 and 30 June 2009, a total of 453 FED stroke cases and 919 controls were recruited. Genotyping for polymorphisms of AGT gene was detected by Taqman method.</p><p><b>RESULTS</b>(1) The risk of stroke gradually increased with the cumulative time of OC use in women (P < 0.0001). Compared with the non-users, the risk of hemorrhagic stroke slightly increased among those with OC use (OR = 1.83, 95%CI: 1.25 - 2.66). (2) Women with AG/GG genotypes of A-6G locus or CA/AA genotypes of C11535A locus indicated that there was a slightly reduced risk of stroke (OR = 0.78, 95%CI: 0.61 - 0.99; OR = 0.73, 95%CI: 0.56 - 0.95). (3) Women with AA genotypes of A-20C locus and AG/GG genotypes of A-6G, when incorporated with CA/AA genotypes of C11535A locus with OC, it could increase the risk of hemorrhagic stroke (OR = 1.99, 95%CI: 1.34 - 2.97; OR = 1.84, 95%CI: 1.15 - 2.94; OR = 1.73, 95%CI: 1.06 - 2.85).</p><p><b>CONCLUSION</b>The AGT gene polymorphisms showed that they did have an impact on the risk of stroke. And the joint effect between women using OC and AGT gene polymorphisms could slightly increase the risk of stroke.</p>
Subject(s)
Aged , Female , Humans , Middle Aged , Angiotensinogen , Genetics , Case-Control Studies , Contraceptives, Oral , Genotype , Risk Factors , Stroke , GeneticsABSTRACT
Objective To evaluate the associations of oral contraceptives (OC) exposure,angiotensin-converting enzyme(ACE) gene polymorphism and their joint actions with the risk of stroke in Chinese women.Methods A case-control study,based on a set cohort,was carried out.Incident cases of stroke identified between July 1 1997 and June 30 2009 were enrolled.One hospital control and healthy community control were matched on region and age ( ± 3 years).A total of 453women with stroke and 919 controls were recruited.I/D genepolymorphism was detected by polymerase chain reaction (PCR) and amplification fragment length polymorphism (AFLP),A-240T polymorphism were detected by TagMan.Results ( 1 ) The risk of stroke gradually increased with the cumulative time of OC being used in women (P＜0.0001).Compared with non-users,the risk of stroke significantly increased among those with cumulative time of using OC longer than 20 years (adjusted OR was 2.07,with 95％ CI as 1.30-3.29).(2) ID/DD genotype of I/D locus indicated significantly an increased risk of hemorrhagic stroke (adjusted OR,2.37; 95％CI,1.46-3.84).(3)Women with ID/DD genotype of I/D locus or with TA/TT genotype of A-240T locus and using OC could significantly increase the risk of hemorrhagic stroke (adjusted OR was 4.59; with 95％ CI as 2.21-9.51 and OR was 2.50; with 95％CI as 1.42-4.38).(4) Data from multivariate analyses showed that both OC and ID/DD genotypes were important risk factors for hemorrhagic stroke.Conclusion ID/DD and TA/TT genotypes of ACE gene,OC and their joint action might increase the risk of stroke,especially on hemorrhagic stroke in Chinese women.
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AIM: To establish the determination of baicalin and wogonin in Chantui Zhike Granules (Periostracum Cicadae, Radix Scutellariae, etc.) by HPLC. METHODS: The determination was carried out by HPLC. The mobile phase was acetonitrile 0.6% phosphoric acid(45∶55) and UV detection wavelength was set at 275nm. The flow rate was 1.0mL?min -1 . The column temperature was at 40 ?C . RESULTS: The contents of baicalin and wogonin in Chantui Zhike Granules could be determined by HPLC. There was a good linearity between the absorption peak area and the concentration in the range of 0.104?g～0.52?g for baicalin and in the range of 0.03?g～0.15?g for wogonin, respectively. The average recoveries were 100.69%( RSD =1.75%) and 98.8%( RSD =1.01%) respectively. CONCLUSION: The method is simple, accurate and can be used to determine the contents of baicalin and wogonin in Chantui Zhike Granules.