Objective:The contaminated microorganisms in the whole production process of Yujin,mulberry leaf and cicada were investigated,and a database was established to explore the microbial key control points and control measures in the production process of traditional Chinese medicine(TCM)formula granules,in order to provide demonstration research for enterprises,provide basis for formulating standards and improving production processes,and fill the blank of the whole.Methods:The raw materials,intermediate products and final products of three kinds of TCM formula particles were analyzed according to the Chinese Pharmacopoeia 2020,and the supporting mi-croorganisms were identified by mass spectrometry technology.The degree of exogenous polluting microorganisms from raw materials to finished products of TCM formula particles and the types of microorganisms easily contamina-ted were analyzed and studied.Results:The raw materials(TCM decoction pieces)of the three TCM formulations granules had serious microbial pollution,and the thermostable bacillus of the raw materials could still be detected in the intermediate products and final products even after the process treatment,and the total number of aerobic bacte-ria in some batches exceeded the limit.Enterococcus faecium from human and animal intestines was also detected in intermediate products and finished products.Conclusion:①Strengthening the control of microbial contamination of TCM decoction pieces is conducive to reducing the microbial load of final products;②There are risks of spore microorganism contamination in the production technology of 3 kinds of formula granuleshas,and the production process parameters should be optimized to reduce the microbial load;③Pharmaceutical companies need to strength-en the whole process of product control to reduce the risk of microbial contamination.

Objective To analyze the short-term complications and long-term outcomes of spleenpreserving distal pancreatectomy (SPDP) in pediatric pancreatic tumors.Methods A retrospective analysis was conducted on 43 patients with tumors of the body and tail of the pancreas in Beijing Children's Hospital from Jan 2007 to Jan 2018.Results There were 17 boys (39.53％) and26girls (60.47％),with a median age of 123 (80,141) months.The median maximum diameter of primary tumor was 7.60 cm.Diagnoses included solid pseudopapillary tumor (n =28),pancreatoblastoma (n =10),neuroendocrine tumor (n =4),and pancreatic cyst (n =1).Two cases (4.65％) received tumor enucleation,4 cases (9.30％) did distal pancreatectomy plus splenectomy,and 37 cases (86.05％) did SPDP.16 cases (37.21％) had short-term complications,including pancreatic fistula (n =13),delayed gastric emptying (n =3),abdominal infection (n =7) and postoperative bleeding (n =2).After a median follow-up of 46 (23,71) months,38 cases (88.37％) were disease-free;two cases (4.65％) with tumor recurrence;one case of pancreatoblastoma died of tumor recurrence.Two cases lost to follow-up.Three patients had long-term complications,including chronic fatty diarrhea (n =2) and hypoglycemia (n =1).Three patients underwent second operation for recurrent tumor (one pancreatoblastoma and two solid pseudopapillary tumor).Conclusions SPDP is safe and effective in the treatment of tumors of the body and tail of the pancreas in children.

Objective To analyze the clinical characteristics and gene mutations of 56 patients with congenital hyperinsulinism(CHI)and to provide a theoretical basis for clinical diagnosis and treatment of CHI.Methods Fifty-six children who were diagnosed as CHI between February 2002 and January 2016 in Beijing Children's Hospital Affiliated to Capital Medical University were selected as research subjects.A retrospective study was done about the clinical data and the treatment procedures of the 56 patients,such as perinatal conditions,clinical manifestations,laboratory data,treatments,prognosis and so on.Polymerase chain reaction(PCR)-DNA technology or next-generation sequencing technology was used to analyze the CHI relevant genes of the 56 patients.Results Thirty of the 56 patients carried CHI gene mutation.(1)Twenty-three of 56 patients(41.0％)carried ABCC8/KCNJ11 gene mutations:4 of 23 patients carried complex heterozygous mutation,1 of 23 patients carried both ABCC8 and KCNJ11 gene mutation,1 of 23 patients carried maternally inherited ABCC8 gene mutation,12 of 23 patients carried paternally inherited ABCC8 gene mutation,1 of 23 patients carried paternally inherited KCNJ11 gene mutation,3 of 23 patients carried de novo ABCC8 gene mutation,1 of 23 patients had unknown genetic way,19 of 23 patients were treated with Diazoxide,2 of 19 patients were responsive to Diazoxide,7 of 19 patients were unresponsive to Diazoxide and 10 of 19 patients were uncertain to Diazoxide.(2)Five of 56 patients(8.9％)carried GLUD1 gene mutation,4 of 5 patients were treated with Diazoxide and they were all responsive to Diazoxide.(3)One of 56 patients(1.7％)carried de novo GCK gene mutation,responsive to Diazoxide treatment.(4)One of 56 patients(1.7％)carried maternally inherited SLC16A1 gene mutation,responsive to Diazo-xide treatment.Conclusions The ABCC8 gene and GLUD1 gene mutation are the main causative genes of CHI.The GCK gene and SLC16A1 gene mutation are in the minority.Most ABCC8 gene and KCNJ11 gene mutation are unresponsive to Diazoxide treatment.

Objective To analyze the relationship between the clinical features of hepatoblastoma and serum alpha-fetoprotein level.Methods We did a retrospective study in 74 cases into the relationship of clinical stages,treatment,prognosis,and AFP value in hepatoblastoma.Results In Stage Ⅰ and Ⅱ patients,the average AFP was (36 333 ± 13 782) ng/ml and in Stage Ⅲ and Ⅳ,the average AFP was (78 346 ± 27 956) ng/ml,P ＜ 0.05.68 patients received preoperative chemotherapy with alpha-fetoprotein determinations before and after chemotherapy respectively.In 44 cases AFP decreased ＞ 50％ after chemotherapy,and in 20 cases AFP declined ＞90％,while in 13 cases AFP increased after chemotherapy.15 cases had serum AFP measured on the first postoperative day,among them 10 cases had a ＞ 50％ AFP decline,3 cases had a ＜ 50％ AFP decline,while in 2 cases AFP value increased.52 cases were postoperatively followed-up,with overall 3 year-survival rate of 86.5％ ; 7 cases recurred,4 died.The average preop AFP level in 7 recurred cases was (27 060 ± 3 569) ng/ml,while the average preop AFP level in those of 3-year recurrence-free was (29 865 ± 5 867) ng/ml,P ＞ 0.05.Only 57％ tumor recurred cases had back to normal AFP level within one month postop,while 89％ long term survivals reported normal range of AFP during that period,P ＜ 0.05.Conclusions Serum AFP level in patients with hepatoblastoma is related to the course of disease.It can be used to estimate the effect of clinical chemotherapy.The speed of alpha-fetoprotein decline postop can be used as an indicator of prognosis.The postoperative normal AFP level within 4 weeks predicts a favorable prognosis.

Objective To study the effect of traditional Chinese medicine on survival time in children solid tumors with chemotherapy. Methods 76 children with solid tumors, which were collected from January 2005 to March 2006, were randomly divided into treatment group (35 cases), control group (41 cases). The treatment group was treated with chemotherapy + self-dispensing Fuzheng Jianpi Chinese medicine. The control group was treated with chemotherapy alone. Results The survival rate of the treatment group was higher than that of the control group, the difference was statistically significant (P = 0.0024). The average survival time after chemotherapy in the treatment group was (31± 2) months (95 % CI 27-34 months), the control group was (21±2) months (95 % CI 16-25 months), which was shorter than the treatment group.Conclusion Chinese medicine and chemotherapy can prolong the survival time of children with solid tumors.