OBJECTIVE:To study the classification of deviation in drug production. METHODS:From the perspective of dom-inant and hidden deviation,combining with the theory of risk management,risk of deviation was evaluated with different risk man-agement tools to define the severity of the deviation,and it was handled by different methods. RESULTS & CONCLUSIONS:Ac-cording to the identifiability of deviation in actual management,the deviation was divided into dominance and hidden deviation. The dominant deviation can be divided into deep and shallow level. Whether the causes of deviation could be cleared and the conse-quences could be estimates were judged after the shallow level classification,and the deviation was further divided into simple and complex deviation. As for deviation complex,it could be evaluated with the tools of risk management to define the deviation severi-ty. As for hidden deviation,it needed beforehand preventing with the tools of risk management directly to define deviation levels and provide reference for preventive measures. In the process of deviation management,key point is to relay on the scientific meth-od to identify and classify deviation,and divide the influence levels. Combining the theory of risk management to select and use risk tools is the effective way to solve the problem.

Humans ; Infant ; Lymphohistiocytosis, Hemophagocytic ; complications ; genetics ; pathology ; Male ; Thymus Gland ; abnormalities

Objective To develop a nylon membrane chip for rapid and systematic detection of the diabetes-associated 45 mutant loci in mitochondrial DNA(mtDNA).Methods The mutant-and wild-type probes were designed for detection of 45 mutant loci in mtDNA with Primer Premier 5.0 and NCBI BLAST softwares and the 90 probes with 8 poly T were immobilized on the Hybond N~+ nylon membranes which were treated with 5?SSC Buffer by UV-crosslinking;Then asymmetric PCR was employed to obtain the target single strand DNA(ssDNA).The PCR products were labeled with biotin after purification.NBT/BCIP was used as substrate that yields a very intense purple signal followed by AP-avidin,and the signals were observed in 24 samples with known sequences to evaluate the chips,each sample was repeatedly measured three times.Results The specific target fragments of 45 loci can be amplified under the same condition with nine sets of primers.The annealing temperatures of the wild-type [(59.01?1.42)℃] and mutant-type [(59.34?1.29)℃ ] probes are so close(t=1.046,P =0.301)that hybridization can be performed at the same temperature.The spots on the membrane chip are distinct,regular and well-distributed.The results of positive-and negative-control are perfect.The signals of negative probes and the background are similar.The results of chip were nearly concordant with that of DNA sequences(?~2=113.132,Kappa value =0.888,P = 0.000)except for T16189C mutant.Conclusions We have successfully developed a nylon membrane chip for rapid and systematic detection of the diabetes-associated 44 mutant loci in mtDNA.It could be used for screening for diabetic patients and high-risk people.

Objective To investigate the relationship between the genetic predisposition to type 2 diabetes mellitus(T2 DM)and mitochondrial DNA base variants in elderly patients.Methods PCR restriction fragment length polymorphism(PCR-RFLP)analysis was used to screen base variants at position 3243 and 3426 of mitochondrial DNA in 186 elderly cases with T2 DM and 170 healthy controls,and DNA sequence was confirmed.Results No carrier of 3243 A→G variant or 3426 A→G variant was found in both groups,however there was 1 case with 3290 T→C variant in diabetic group.Conclusions No significantly association was found between mitochondrial DNA 3243 or 3426 base variants and the predisposition of type 2 diabetes mellitus in elderly patients.

Objective:To analyze the clinical characteristics of acute drug poisoning, and provide better management for poisoned patients in Emergency Department.Methods:We retrospectively enrolled 197 patients diagnosed as acute drug poisoning in Emergency Department of Beijing Chaoyang Hospital from January 1, 2019 to December 31, 2019. Medical records included age, gender, baseline diseases, medication time, visit time, kinds of drugs, drug concentrations, accompanying symptom, hospitalization duration, treatment, fluid resuscitation and outcomes. The inclusion criteria were as follows: age≥ 14 years old, and met the criteria of acute poisoning. The exclusion criteria were as follows: age<14 years old; incomplete clinical data; pesticide poisoning; toxic gas poisoning; and other non-drug poisoning. All patients were divided into the survival group and death group according to their outcomes at the discharge. Clinical characteristics, laboratory parameters and treatments were compared using the Student’s t test, Mann-Whitney U test, as appropriate. Results:The mean age of all the patients was 38.9±20.4 years. The majority were young patients, accounting for 134 cases (68.0%). The accompanying symptoms included consciousness disturbance (106 cases), dizziness (56 cases), fatigue (38 cases), and nausea and/or vomiting (42 cases). The duration of medication-to-visit time was 0.5-96 h, with an average of 7.17±0.89 h. The types of drugs included 105 (53.2%) sedatives and hypnotics, 73 antipsychotics (37.1%), 17 antibiotics (8.6%), and 20 antipyretic analgesics (10.2%). The Glasgow comascale (GCS) score of patients in the survival group was higher than that of the death group (12.47±3.05 vs 7.60±4.43, P<0.01). In the death group, the alanine aminotransferase, urea nitrogen, creatinine, cardiac troponin I, prothrombin time, activated partial thromboplastin time, plasma fibrinogen and D-dimer were higher than those of the survival group (all P<0.05). One hundred and eighty-seven patients were cured, while 10 patients died. One hundred and fifty-nine patients were treated with gastric lavage, and 23 patients were treated with blood purification. The concentrations of toxic drugs before and after treatment in 134 poisoned patients were compared. The concentration of drugs after treatment was significantly lower than that before treatment. Conclusions:Acute non-pesticide poisoning in Emergency Department is mainly caused by sedatives, hypnotics, antipsychotics, and antipyretics and analgesics. It is important to conduct laboratory examinations for toxic medications to provide better management for poisoned patients. It is necessary to establish a standardized monitoring system and management path for acute drug poisoning.

AIM: To analyze the genotype of the allele distribution of a polymorphic G-954C within the 5 upstream promoter region of the nitric oxide synthetase 2A gene (NOS2A) in samples of diabetic retinopathy in patients with cystoid macular edema in the mainland of China.METHODS: Eighty-nine patients with diabetic retinopathy and cystoid macular edema and 90 healthy controls were enrolled in this study. Nest polymerase chain reaction (PCR)was performed, and restriction endonudease digestion and gene fragments sequence were examined to detect the genotype of NOS24 G-954C.RESULTS: The genotypes of the sample population of 89 cases and 90 healthy controls were all detected as GG.CONCLUSION: The distribution of G-954C of NOS2A polymorphism are at a lower frequency in China, with little relevancy to the frequency of diabetic retinopathy combined with cystoid macular edema.

AlM:To investigate the prevalence of pterygium of the household population aged 40 and above in Hengli Town of Dongguan.
METHODS: Using the method of cluster random sampling, select 3 628 people aged 40 and above in four villages and one community for visual examination, intraocular pressure check, slit lamp examination and questionnaire.
RESULTS: The actual number of subjects was 3 393 people, and examination rate was 93. 52%. We detected 843 patients with pterygium. The prevalence of pterygium was 24. 85%.
CONCLUSlON:There is high prevalence of pterygium in Dongguan area. The prevalence of pterygium is related with age and working environment, but has no relation with gender.

OBJECTIVETo purify salvianolic acids by macroreticular resin,then mensurate the contents of salvianolic acids and analyse the chromatogram with HPLC.

METHODMake salvianolic acids with macroreticular resin; mensurate the content of Salvianolic acids with UV spestrophotometry: the control compound is protocaechuic aldehyde, and the wavelength is 281 nm. Analysis the chromatogram with HPLC, and compare the chromatogram in different technics: zorbax ODS column (4.6 mm x 250 mm, 5 microm), mobilephase: 1% aceticacid-water and methanol in different proportions, the wavelength is 281 nm.

RESULTThe contents of salvianolic acids is 53.8%; HPLC chromatogram indicate that the method is reasonable to make salvianolic acids.

CONCLUSIONDetermination of contents and HPLC chromatogram can control the quality of Salvianolic acids more accurately.

Benzofurans ; analysis ; isolation & purification ; Caffeic Acids ; analysis ; isolation & purification ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; chemistry ; Ion Exchange Resins ; Lactates ; analysis ; isolation & purification ; Salvia miltiorrhiza ; chemistry

OBJECTIVETo assess the diagnostic value of the propranolol-exercise provocative test for growth hormone deficiency (GHD) in children.

METHODSThis study included 120 children who received both the insulin provocative test and the propranolol-exercise provocative test due to short stature between January 2009 and March 2013. Growth hormone (GH) levels in venous blood were measured before and after the provocative test. Peak GH <10 ng/mL was defined as negative stimulation, while peak GH ≥10 ng/mL was defined as positive stimulation. The children whose peak GH levels were <10 ng/ mL after both tests were diagnosed with GHD.

RESULTSTwenty-nine (24.2%) of the 120 children with short stature were diagnosed with GHD. The positive rate in the insulin provocative test was 48.3%, versus 65.8% in the propranolol-exercise provocative test. The overall coincidence rate and positive coincidence rate of the two tests were 62.5% and 79.3%, respectively. The peak GH after the propranolol-exercise provocative test was significantly higher than that after the insulin provocative test (P<0.01). Peak GH occurred mostly at 30-60 minutes after the insulin provocative test, while that occurred mostly at 120 minutes after the propranolol-exercise provocative test. No adverse effects were observed in the propranolol-exercise provocative test.

CONCLUSIONSCoincidence rates in stimulating the secretion of GH are high between the propranolol-exercise provocative test and the insulin provocative test. Compared with the insulin provocative test, the propranolol-exercise provocative test is more likely to stimulate the secretion of GH. GHD can be clinically diagnosed by the insulin provocative test combined with the propranolol-exercise provocative test.

Adolescent ; Child ; Child, Preschool ; Exercise ; Female ; Human Growth Hormone ; blood ; deficiency ; Humans ; Insulin ; Male ; Propranolol