Enterotoxigenic Escherichia coli（ETEC）infection can induce watery diarrhea，leading to dehydration，electrolyte disturbance，and even death in severe cases. Recombinant B subunit/inactivated whole-cell cholera（rBS/WC）vaccine is effective in preventing ETEC infectious diarrhea. On the basis of the latest evidence on etiology and epidemiology of ETEC，as well as the effectiveness，safety，and health economics of rBS/WC vaccine，National Clinical Research Center for Child Health（The Children’s Hospital，Zhejiang University School of Medicine）and Zhejiang Provincial Center for Disease Control and Prevention invited experts to develop expert consensus on rBS/WC vaccine in prevention of ETEC infectious diarrhea. It aims to provide the clinicians and vaccination professionals with guidelines on using rBS/WC vaccine to reduce the incidence of ETEC infectious diarrhea.

OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China.

OBJECTIVE: To report on a case of Smith-Magenis syndrome (SMS) due to a rare small-scale deletion. METHODS: Muscle samples from the the third fetus was collected after the in Medical history and clinical data of the patient were collected. The child and his parents were subjected to chromosome karyotyping analysis, multiplex ligation-dependent probe amplification (MLPA) and copy number variation sequencing (CNV-seq). RESULTS: The child was found to have a normal karyotype. MLPA and CNV-seq detection showed that he has harbored a 1.22 Mb deletion and a 0.3 Mb duplication in the 17p11.2 region. Neither of his parents was found to have similar deletion or duplication. CONCLUSION The child was diagnosed with SMS due to a rare 1.22 Mb deletion in the 17p11.2 region, which is among the smallest deletions associated with this syndrome.
Abnormalities, Multiple/genetics* ; Child ; Chromosome Deletion ; Chromosomes, Human, Pair 17 ; DNA Copy Number Variations ; Humans ; Intellectual Disability/genetics* ; Male ; Smith-Magenis Syndrome/genetics*

Objective To explore the application values of GeneXpert MTB/RIF assay (Xpert assay) for rifampicin resistance and multidrug resistant tuberculosis (MDR-TB).Discordance of Xpert and L-J proportion DST of rifampicin was analyzed.Methods Specimens of 1 300patients from January 2014to June 2016in our hospital were collected for solid culture, Xpert assay and L-J proportion drug susceptibility test (DST).Rifampicin resistance detected by Xpert assay was compared with L-J proportion method as a gold standard.Sequencing of rpoB gene and determination of minimum inhibition concentration were accomplished on the discordant MTB strains between Xpert and L-J proportion DST.Results Compared with the DST, the sensitivity, specificity, positive and negative predictive value of Xpert assay for rifampicin resistance were 99.31％, 97.82％, 92.88％and 99.80％, respectively.Among 1 300culture-positive specimens, mutations were detected from 309specimens by Xpert assay, which included 125initial treatment and 184retreatment patients.Among309specimens with rpoB gene mutations, mutations detected by probes E, D and B were common, and the rates were 65.70％, 14.56％and 10.68％, respectively.Totally 239patients were MDR-TB[77.35％ (239/309) ], of which 94initial treatment patients[75.20％ (94/125) ]and 145retreatment patients[78.80％ (145/184) ]were MDR-TB.Among 22strains which were detected rpoB gene mutations by Xpert, but sensitive by L-J proportion DST, 6strains had no mutation in rpoB gene rifampicin resistance determining region (RRDR);16strains had mutations, which were mainly located in L511Pcodon (8strains) and L533Pcodon (4strains).Among 2strains which had no rpoB gene mutation by Xpert, but were resistant by L-J proportion DST, 1strain had no mutation in rpoB gene RRDR region;1strain had mutation which was located in E546G codon outside RRDR region.Conclusion Xpert assay can be used to rapidly detect rifampicin resistance and to screen MDR-TB.Mutations in codon 511and 533are related to low-level resistance to rifampicin.

Ablation Techniques ; adverse effects ; methods ; Humans ; Lung Neoplasms ; diagnostic imaging ; radiotherapy ; surgery ; Postoperative Complications ; prevention & control ; therapy ; Radio Waves ; therapeutic use ; Radiotherapy, Image-Guided ; adverse effects ; methods ; Treatment Outcome

Objective To examine the change of bilirubin level in neonates and infants after administration of fusidic acid.Methods The data of serum bilirubin,alanine aminotransferasese (ALT),aspartate aminotransferase (AST) and adverse drug reaction were collected retrospectively in neonates and infants and compared statistically before and after administration of fusidic acid.Results Emerging jaundice or exacerbation of the existing jaundice was not found in all the 138 patients after administration of fusidic acid in this analysis.Biochemical markers were measured before and after use of fusidic acid in 64 of the patients.ALT,AST and albumin did not show significant difference before and after use of fusidic acid.However,the ratio between indirect bilirubin and total bilirubin decreased by about 8％ after use of fusidic acid.Conclusions Fusidic acid did not show significant effect on serum bilirubin level in the neonates and infants following fusidic acid treatment.

Aged ; Aged, 80 and over ; Cytarabine ; administration & dosage ; therapeutic use ; Female ; Harringtonines ; administration & dosage ; therapeutic use ; Humans ; Induction Chemotherapy ; methods ; Leukemia, Myeloid, Acute ; drug therapy ; Male ; Middle Aged

The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system still existed some deficiencies which resulting in confusion when filling the forms, especially those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.
China ; Consumer Product Safety ; Equipment and Supplies ; Safety Management

The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system stil existed some deficiencies which resulting in confusion when fil ing the forms, especial y those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.

OBJECTIVE: The study aimed to investigate the efficacy and adverse effects of sublingual immunotherapy (SLIT) of dust mite drops to allergic rhinitis with mite allergy. The compliance and satisfaction of SLIT were also assessed. METHOD: One hundred and three patients of allergic rhinitis sensitive to dust mites were treated with SLIT for 6 months or more. The symptom questionnaire,including items on rhinorrhea, sneezing, nasal obstruction, itchy nose, olfactory disturbance, eye discomfort and sleep disturbance were obtained before and 6 months after SLIT. The patients' satisfaction and adverse effects were also investigated. RESULT: Seventy-five of the 103 patients insist on SLIT for more than 6 months and completed the questionnaire. The duration of receiving SLIT was 9.8 months on average (range from 6 to 13 months). The satisfaction rate was 89.3%. The drop-out rate of SLIT was 31.0%. CONCLUSION The subjective symptoms were improved with SLIT in patients with allergic rhinitis sensitive to dust mites. The drop out rate was high despite of the symptomatic improvement.
Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Female ; Humans ; Male ; Middle Aged ; Patient Compliance ; Patient Satisfaction ; Rhinitis, Allergic ; Rhinitis, Allergic, Perennial ; psychology ; therapy ; Sublingual Immunotherapy ; psychology ; Treatment Outcome ; Young Adult