Analysis on Work Idea of Medical Device Classification Dynamic Adjustment Mechanism in the United States / 中国医疗器械杂志

OBJECTIVE@#Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.@*METHODS@#Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.@*RESULTS@#The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.@*CONCLUSIONS@#During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.

Mutation analysis of the FGFR3 gene in a patient with Crouzon syndrome complicated by acanthosis nigricans / 中华皮肤科杂志

A 7-year-old female patient presented with frontal bossing and exophthalmos complicated by skin pigmentation all over the body for 7 years.Pigmentation was seen on the flexor aspects of the bilateral elbows 1 week after birth,and skin pigmentation gradually appeared at multiple body sites 1 year later.She had suffered from lacrimal duct obstruction since childhood,and repeated dredging of the duct was ineffective.Parents of the child were healthy and non-consanguineous marriage,and had no family history of the same disease.Physical examination showed square-shaped skull,frontal bossing,maxillary hypoplasia,mandibular prognathism,exophthalmos,ocular hypertelorism,depressed nasal bridge,dental malocclusion,and irregular dentition.Skin examination showed dark brown skin all over the body,coarse skin on the neck,axillary and inguinal regions,papillomatous cutaneous thickening,with velvet-like appearance.The patient was diagnosed with Crouzon syndrome complicated by acanthosis nigricans (CAN).Polymerase chain reaction (PCR)and DNA sequencing were performed to detect mutations in the FGFR3 gene in the patient with CAN,her parents and 100 unrelated healthy controls.A heterozygous missense mutation (C.1172 C ＞ A) was identified in the FGFR3 gene in the proband,but not in her parents or the 100 unrelated healthy controls.The missense mutation in the FGFR3 gene may be a causative mutation leading to the clinical manifestations of the patient.

Construction of a bicistronic expression vector containing human papillomavirus (HPV) type 6b L1 gene and its expression in mammalian cells / 中华皮肤科杂志

Objective To construct a bicistronic expression vector containing HPV type 6b L1 gene, to express the recombinant vector in mammalian cells, and to establish a cell strain stably expressing HPV6b L1 gene. Methods After endonuclease digestion and purification, the gene fragment of HPV6b L1 was cloned into the eukaryotic expression vector pIRES2-enhanced green fluorescent protein (EGFP). The identification of the recombinant was realized via endonuclease digestion and sequence analysis. Then, the recombinant plasmid pIRES2-HPV6bLl-EGFP was transfected into NIH3T3 (a mouse embryonic fibroblast cell line) cells. Subsequently, the expression of EGFP was observed by fluorescent inverted microscopy, and HPV6b L1 mRNA expression by reverse transcription (RT)-PCR. Results The recombinant plasmid pIRES2-HPV6bLl-EGFP was successfully constructed, transfected into N1H3T3 cells, and selected by G418. The expression of EGFP was seen under an inverted fluorescence microscoy. RT-PCR proved the expression of HPV6b LI mRNA in transfected cells. Conclusions The recombinant plasmid pIRES2-HPV6bLl-EGFP was successfully constructed and transfected into NIH3T3 cells. Inverted fluorescent microscopy and RT-PCR confirmed the successful expression of HPV6b L1 in NIH3T3 cells.