OBJECTIVE:To discuss the operating condition of adverse drug reaction(ADR)report system in China.METHODS:The advantages and disadvantages of the current ADR report system in China were analyzed.RESULTS&CONCLUSION:It is only by establishing standardized measures and effective operating methods on the basis of personnel training,facility construction and daily supervision can ADR report system play its expected role.

OBJECTIVE: To investigate the effect of pharmaceutical care on the treatment outcome of epilepsy and to discuss the necessity for pharmacists' participation in clinical medication and the correlation between the participation of clinical pharmacists and curative effect.METHODS: The epileptic patients treated in our hospital from Jan.2001 to Jan.2007 who accepted serum drug concentration test were included in the study.The treatment outcome data were subjected to statistically analysis.RESULTS & CONCLUSION: The medication guidance provided by pharmacists is highly correlated with the treatment outcome of epilepsy.Reasonable pharmaceutical care provided by pharmacists is much needed in the treatment of epilepsy.

OBJECTIVE:To study the effect of Shenkang injection on the irbesartan pharmacokinetics in rats in vivo. METH-ODS:18 SD rats were randomly divided into control group(normal saline)and Shenkang injection(calculated by crude drug as 4 g/kg),9 in each group,which were intraperitoneally injected twice a day,for 7 d. After 1 h of last administration,25 mg/kg irbe-sartan was intragastrically administrated. 0.3 mL sample blood was taken in fundus venous plexus before administration of irbesartan and after 0.25,0.5,1,2,4,8,12,24,32,48,56,72,96 h of administration. Using biphenyl diester as inner standard,HPLC was adopted to determine the plasma concentration of irbesartan in plasma of rats,and pharmacokinetic parameters were calculated by using non-compartmental model in Phoenix WinNolin? 6.1 pharmacokinetic software. RESULTS:After intragastrically adminis-trated irbesartan in rats in control group and Shenkang injection group,AUC0-96 h were (28.82 ± 10.49),(35.64 ± 9.99) mg·h/L;cmax were(0.64±0.15),(0.76±0.33)mg/L;tmax were(13.07±16.70),(10.23±3.97)h;CLZ/F were(0.85±0.35),(0.63±0.21) L/(h·kg);VZ/F were (38.24 ± 24.87),(30.99 ± 9.75) mL/kg respectively,with no statistical significances (P>0.05). CONCLU-SIONS:Shenkang injection will not affect the in vivo pharmacokinetics process of irbesartan in normal dose on rats.

Objective: To analyze the clinical symptoms and hereditary information of suspicious juvenile neuronal ceroid-lipofuscinosis (JNCL) and determine the genotype in order to explore the diagnosis clues in the patients with ophthalmologic manifestations being initial symptom. Methods: A case-control study was performed in this study.Two families were included in Eye Hospital of Wenzhou Medical in 2013 and 2017, respectively.Medical histories were collected and all participants underwent comprehensive ophthalmologic examinations, and the best corrected visual acuity (BCVA) was obtained.Fundus photography and optical coherence tomography (OCT) were used to image the retinal signs, and visual electrophysiology was recorded to evaluate the visual function.Genomic DNA of 3 patients who initially visited to ophthalmologists and 5 unaffected family members were extracted.Whole exome sequencing (WES), targeted exome sequencing (TES), Sanger sequencing and comprehensive analyses of pathogenicity were performed to determine the genetic cause of the patients.This study was approved by Ethics Committee of Eye Hospital of Wenzhou Medical University (KYK-2017-7), and written informed consent was obtained from each subject prior to any medical examination. Results: All patients presented bull eye sign and disorder of pigment on the fundus photograph, and the retinas were thinning on the OCT image, indicating the diffuse retinal pigment epithelium atrophy of macula and loss of outer layer structure of retina.Three mutations in CLN3 gene were identified by WES, TES, Sanger validation and assessments of pathogenicity, including c. 154T>C(p.Y52H), c.982G>C(p.A328P) and c. 906+ 5G>A, among which p. A328P was a novel mutation.Patients of F1 family harbored the compound heterozygous mutations c. 154T>C (p.Y52H) and c. 982G>C(p.A328P), while proband of F2 family harbored the homozygous splice site mutation c. 906+ 5G>A, which was reported to be a pathogenic mutation of JNCL.Co-segregation and comprehensive pathogenicity analysis revealed that the compound heterozygous mutations in F1 family and the homozygous mutation in a splice site in F2 family were the genetic causes of their phenotypes. Conclusions A novel mutation in CLN3 gene for JNCL is identified, which expands the mutation spectrum of CLN3 gene.Considering the high clinical heterogeneity of inherited retinal diseases, especially syndromic cases, genetic test through next generation plays a vital role in diagnosis, guiding future treatment and prognostic evaluation.

To develop a new recombinant hepatitis E vaccine, we used Hansenula polymorpha expression system to express recombinant hepatitis E virus-like particles (HEV VLPs), to construct a recombinant engineered strain HP/HEV2.3. The fermentation conditions and purification process were studied next. The first working seed lots were fermented in liquid culture, and the fermentation products were collected, then crushed, clarified, purified by ultrafiltration, silica gel adsorbed and desorbed, concentrated by ultrafiltration, purified by liquid chromatography and sterilized by filtration. The purity reached 99% with a yield of 33%. Electron microscopy analysis revealed that both the purified recombinant HEV VLPs from HP/HEV2.3 and natural hepatitis E virus particles appear identical of being 32 nm. The resulting DNA sequence obtained from VLPs is identical to the published HEV sequence. The SDS-PAGE analysis has revealed that the protein molecular weight of the HEV VLPs is 56 kDa, and the expression product HEV VLPs were accumulated up to 26% of total cellular protein. The expression level is 1.0 g/L. Western blotting, enzyme-linked immunosorbent assay (ELISA) results of the protein and ED₅₀ of the vaccine showed that the HEV VLPs have good antigenicity and immunogenicity. In summary, the recombinant HEV VLPs from Hansenula polymorpha can be used in the manufacture of a new genetically engineered vaccine against hepatitis E.