Objective To establish the dissolution curves test method of Ribavirin capsules, and investigate dissolution behavior of domestic Ribavirin capsules.To provide experimental basis for generic drugs quality consistency evaluation.Methods According to the first dissolution method (basket method)stated in appendix Ⅹof Chinese Pharmacopeia(2010 edition),the rotation speed was 50 r/min with dissolution medium volume of 900 mL.The dissolution profiles of Ribavirin capsules in four different mediums( pH 1.2 hydrochloric acid solution,pH 4.5 acetic buffer,pH 6.8 phosphate buffer and water) were determined by HPLC.The determination was performed on C18 column with mobile phase consisted of 4 g/L sodium dihydrogen phosphate solution(pH adjusted to 5.0 ±0.05 using 5% sodium hydroxide solution)-acetonitrile(98:2)at the flow rate of 1.0 mL/min.The detection wavelength was 225 nm,and sample size was 10μL.Results The linear range of ribavirin was 2.5-200μg/mL(r=1).RSD of precision and stability tests were lower than 0.5%.The average recoveries were 101.3%, 100.7%, 100.2%, 100.4% in four mediums.Dissolution behavior of capsules can be more consistent and rapid dissolution in pH4.5 and pH6.8 mediums.But they were quite different in pH1.2 and water mediums, and some of their average dissolution at 15 min could not reach 85%.Conclusion This method is accurate and reliable.There is a difference between domestic Ribavirin capsules dissolution behavior, and the formulation processes have room for improvement.

Objective To analyze peroxide value and anisidine value of ethyl polyenoate soft capsules and imported drugs and evaluate the oxidative stability.Methods The analysis was carried out on a TSK gel ODS-100 V(250 mm ×4.6 mm,5μm)with methanol-water(98:2,V/V)as the mobile phase to determine the structure of the vitamin E as antioxidant.The influence on the antioxidation effect of tocopherol acetate andα-tocopherol as excipient in omega-3 polyunsaturated fatty acid ethyl ester drugs was evaluated.Results The structure of vitamin E as antioxidant in domestic drugs was acetate, while vitamin E as excipient in foreign drugs had the structure of α-tocopherol monomer.As antioxidant, the antioxidation effect of tocopherol acetate was better thanα-tocopherol.The structure of vitamin E had a direct impact on the antioxidation effect of omega-3 polyunsaturated fatty acid ethyl ester drugs.Conclusion The studies provide the basis for evaluate rationality of antioxidant in ethyl polyenoate soft capsules scientifically, which has positive significance for controlling the quality of the drug effectively.

Objective: To explore refractive development of primary school students in Jinshan district of Shanghai during the past five years. Methods: A total of 201 first grade pupils enrolled in 2013 were followed up for 5 years. Annual examination of non-cycloplegic refraction and axial length (AL) was implemented and analyzed. Results: The mean spherical equivalents (SEs) of boys at each grade was (0.22±0.53)(-0.04±0.64)(-0.36±0.92)(-0.74±1.23)(-1.14±1.67)D, respectively; for girls, (0.26±0.88)(-0.03±1.02)(-0.28±1.02)(-0.64±1.32)(-1.13±1.65)D, respectively. The mean ALs of boys at each grade was (22.94±0.60)(23.13±0.68)(23.45±0.69)(23.65±0.81)(24.03±0.93)mm, respectively and was (22.40±0.67)(22.67±0.70)(22.95±0.74)(23.14±0.79)(23.59±0.90)mm for girls at each grade, respectively. There were negative correlations between dioptres and ALs in each grade(r=-0.26, -0.35, -0.41, -0.53, -0.59, P<0.05). Conclusion The dioptre and AL among primary school students in Jinshan district of Shanghai increased gradually and results in developing into myopia. The dioptre negatively associates with AL, which should be both paid attention to among primary school students.

OBJECTIVE: To explore the pathological characteristics and significance of RET proto-oncogene screening in multiple endocrine neoplasia type 2A (MEN2A) with cutaneous lichen amyloidosis (CLA). METHODS: Clinical data of 51 members from 7 unrelated pedigrees of MEN2A-CLA were collected. Systemic clinical investigations including biochemical testing, imaging examination, germline RET variant screening and histopathological examination were carried out. RESULTS: RET gene variants were detected in 28 patients with MEN2A (C634G/F/R/S/W and C611Y) including 12 males and 16 females, with the mean age of diagnosis being (41.1 ± 18.3) years old, which were consistent with their clinical manifestations. The incidence of medullary thyroid carcinoma (MTC), pheochromocytoma (PHEO), hyperparathyroidism (HPTH) and CLA among 28 MEN2A patients were 89.3%, 28.6%, 7.1% and 28.6%, respectively. Comparison of the incidence of MTC/PHEO/HPTH and CLA between C611Y and C634G/F/R/S/W, only PHEO and CLA in C611Y were lower than those in C634G/F/R/S/W (P < 0.05; P < 0.05). Among 8 patients with CLA, the male to female ratio was 2 : 6. The clinical features included pruritus in the interscapular region and presence of dry, thickened, scaly, brown pigment, clustered or desquamate-like plaques. The mean onset age of CLA [(18.4 ± 4.6) years] versus the mean age at diagnosis of CLA or MEN2A were significantly different (P < 0.001; P < 0.001). CONCLUSION MEN2A-CLA may be the early clinical manifestation of MEN2A and most frequently occurred along with RET-C634 variant. To facilitate the recognition of MEN2A-CLA, to combine family investigation and screening of RET variant are helpful for early diagnosis and standardized treatment, which can improve the long-term outcome of MEN2A-specific tumors.
Adolescent ; Adrenal Gland Neoplasms ; Adult ; Amyloidosis, Familial ; Carcinoma, Neuroendocrine ; China ; Female ; Humans ; Lichens ; Male ; Middle Aged ; Multiple Endocrine Neoplasia Type 2a/genetics* ; Pheochromocytoma ; Proto-Oncogene Proteins c-ret/genetics* ; Skin Diseases, Genetic ; Thyroid Neoplasms/genetics* ; Young Adult

Objective To investigate the risk factors of hyperbilirubinemia in late preterm infants. Methods The clinical data of 815 late preterm infants (449 males and 366 females) from 25 hospitals in Beijing were collected from October 2015 to April 2016, including 340 cases(41.7％) with hyperbilirubinemia (hyperbilirubinemia group), and 475 cases without hyperbilirubinemia (control group). The clinical data of two groups were compared, and the maternal factors influencing hyperbilirubinemia in late preterm infants were analyzed with logistic regression. Results There were no significant differences in gender ratio (M:F 1.39 vs. 1.12, t=1.811,P=0.172)and birth weight[(2502.6±439.6)g vs. (2470.2±402.9)g,χ2=2.330,P=0.127)]between two groups. The incidence rates of hyperbilirubinemia in infants of 34 wks, 35 wks and 36 wks of gestational age were 22.9％(87/174), 35％(119/300) and 42.1％(143/341) respectively (χ2=1.218,P=0.544). The multivariate logistic regression analysis indicated that the maternal age(OR=1.044,95％ CI:1.010-1.080,P=0.011)was independent risk factor and multiple births(OR=1.365,95％CI:0.989-1.883,P=0.048), premature rupture of membranes(OR=2.350,95％ CI:1.440-3.833,P=0.001), cesarean section(OR=1.540,95％CI:0.588-4.031,P=0.014)were risk factors for hyperbilirubinemia in late preterm infants. Conclusions The incidence of hyperbilirubinemia in late preterm infants is relatively high. Maternal age, multiple births, premature rupture of membranes and cesarean section are risk maternal factors related to hyperbilirubinemia in late preterm infants.

OBJECTIVE To systematically review the efficacy and safety of tranexamic acid （TXA） for hemostasis in cancer patients before and during surgery， and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed， Embase， the Cochrane Library， CNKI， VIP and Wanfang databases， randomized controlled trials （RCTs） about tranexamic acid （trial group） versus 0.9% Sodium chloride injection， Lactated Ringer’s solution， Compound electrolyte solution or placebo （control group） for cancer surgery were electronically searched from the inception to June 9， 2022. After literature screening and data extraction， the quality of included RCTs were evaluated by bias risk assessment tool recommended by Cochrane system evaluator manual 5.1.0. RevMan 5.3 software was used for meta-analysis or descriptive analysis， sensitivity analysis and publication bias analysis. RESULTS A total of 2 032 patients in 22 RCTs were included for meta-analysis. Results of meta-analysis showed that the blood transfusion rate [RR＝0.59， 95%CI （0.50， 0.69）， P＜0.000 01] and the volume of erythrocyte suspension infusion [MD＝－0.53， 95%CI （－0.92， －0.14）， P＝0.007] in trial group were significantly lower than control group； there was no statistical significance in the incidence of thromboembolic events [RR＝0.44， 95%CI （0.16， 1.17）， P＝0.10] or post-operative mortality [RR＝1.27， 95%CI（0.32，5.08）， P＝0.73] between two groups. Results of descriptive analysis showed that the total blood loss and postoperative drainage volume were still controversial between two groups. The results of sensitivity analysis showed that the results were basically stable. The results of publication bias analysis showed that there was little possibility of publication bias in this study. CONCLUSIONS TXA can significantly decrease the blood transfusion， reduce the volume of erythrocyte suspension infusion， whereas does not increase the incidence of thromboembolic events and post-operative mortality in cancer surgery.

Objectives:To study the molecular characteristics, virulence gene and resistance profiles of Staphylococcus aureus ( S. aureus, SA) isolates from bloodstream infections (BSI), so as to further understand the molecular characteristics of S. aureus in pediatric patients. Methods:A total of 53 S. aureus strains in bloodstream infections from Shanghai Children′s Hospital between 2016 and 2021 were collected. Antimicrobial susceptibility test were adopted by instrumental and disk diffusion method. Thirty-two kinds of virulence genes were detected by PCR and underwent multi-locus sequence typing (MLST), Staphylococcus protein A (spa) typing and staphylococcal chromosome cassette (staphylococcal cassette chromosome mec, SCCmec) typing characterizing methicillin-resistant Staphylococcus aureus (MRSA). Statistical analysis was performed using χ 2 test or Fisher exact test. Results:MRSA isolates accounted for 50.94% of the total(27/53), with ST398-t034-SCCmecV (6/53, 11.32%) and ST59-t437-SCCmecIV (4/53, 7.55%) as the most common MRSA clones. Methicillin-sensitive Staphylococcus aureus (MSSA) isolates occupied 49.06% (26/53), among which typing ST22-t309 (3/53, 5.66%) and ST7-t091/t1685 (2/53, 3.77% each) were prevalent. Of the 53 strains, all carried ≥6 virulence genes, 33 strains (62.26%) carried ≥10 virulence genes, including 18 strains of MSSA (69.23%) and 15 strains of MRSA (55.56%). The carriage rate of pvl gene in MSSA was higher than that of MRSA isolates (12/26, 33.33% vs. 6/27, 22.22%), and sasX was only detected in MRSA isolates (4/53, 7.55%). The resistant rates of BSI-SA isolates to penicillin, erythromycin and clindamycin were 98.11%, 49.06% and 41.51%, respectively. MRSA were more resistant to clinical antimicrobial agents than MSSA. Conclusions:MRSA strains cover a high proportion in S. aureus bloodstream infection of children, with ST398-t034 and ST59-t437 being the most common clones. The virulence gene carrying rate for BSI-SA was high with a greater pvl gene carrying rate in MSSA isolates while sasX was only detected in MRSA isolates. More clinical attention should be paid to the high resistance status and virulence genes characteristics of BSI-SA.

Objective: To analyze the clinical characteristics of cases of novel coronavirus pneumonia and a preliminary study to explore the relationship between different clinical classification and liver damage. Methods: Consecutively confirmed novel coronavirus infection cases admitted to seven designated hospitals during January 23, 2020 to February 8, 2020 were included. Clinical classification (mild, moderate, severe, and critical) was carried out according to the diagnosis and treatment program of novel coronavirus pneumonia (Trial Fifth Edition) issued by the National Health Commission. The research data were analyzed using SPSS19.0 statistical software. Quantitative data were expressed as median (interquartile range), and qualitative data were expressed as frequency and rate. Results: 32 confirmed cases that met the inclusion criteria were included. 28 cases were of mild or moderate type (87.50%), and four cases (12.50%) of severe or critical type. Four cases (12.5%) were combined with one underlying disease (bronchial asthma, coronary heart disease, malignant tumor, chronic kidney disease), and one case (3.13%) was simultaneously combined with high blood pressure and malignant tumor. The results of laboratory examination showed that the alanine aminotransferase (ALT), aspartate aminotransferase (AST), albumin (ALB), and total bilirubin (TBil) for entire cohort were 26.98 (16.88 ~ 46.09) U/L and 24.75 (18.71 ~ 31.79) U/L, 39.00 (36.20 ~ 44.20) g/L and 16.40 (11.34- ~ 21.15) mmol/L, respectively. ALT, AST, ALB and TBil of the mild or moderate subgroups were 22.75 (16.31- ~ 37.25) U/L, 23.63 (18.71 ~ 26.50) U/L, 39.70 (36.50 ~ 46.10) g/L, and 15.95 (11.34 ~ 20.83) mmol/L, respectively. ALT, AST, ALB and TBil of the severe or critical subgroups were 60.25 (40.88 ~ 68.90) U/L, 37.00 (20.88 ~ 64.45) U/L, 35.75 (28.68 ~ 42.00) g/L, and 20.50 (11.28 ~ 25.00) mmol/L, respectively. Conclusion The results of this multicenter retrospective study suggests that novel coronavirus pneumonia combined with liver damage is more likely to be caused by adverse drug reactions and systemic inflammation in severe patients receiving medical treatment. Therefore, liver function monitoring and evaluation should be strengthened during the treatment of such patients.