Meta-analysis of the efficacy and safety of Saccharomyces boulardii versus Bifidobacterium triple live bacteria in the treatment of pediatric diarrhea / 中国药房

OBJECTIVE To compare the efficacy and safety of Saccharomyces boulardii and Bifidobacterium triple live bacteria in the treatment of pediatric diarrhea. METHODS Retrieved from PubMed， Embase， the Cochrane Library， CBM， Wanfang data， CNKI and VIP， randomized controlled trials （RCTs） about S. boulardii （S. boulardii group） versus Bifidobacterium triple liver bacteria （Bifidobacterium group） were collected. After screening the literature， extracting data and evaluating the quality， meta-analysis was performed by using RevMan 5.3 software. RESULTS A total of 9 RCTs were included， involving 898 patients. Results of meta-analysis showed there was no statistical significance in total response rate [OR＝1.69， 95%CI （0.93， 3.09）， P＝0.09]， duration of diarrhea [MD＝－1.39， 95%CI （－3.35， 0.57）， P＝0.16]， the time of abdominal pain disappearance [MD＝0.09， 95%CI（－0.87， 1.05），P＝0.86] or the incidence of adverse reactions [OR＝0.65， 95%CI （0.05， 8.03）， P＝0.74]. The number of stools in S. boulardii group was significantly less than Bifidobacterium group [MD＝－0.91， 95%CI （－1.80， －0.02）， P＝0.04]. The results of subgroup analysis showed that the duration of diarrhea in children with antibiotic-associated diarrhea in S. boulardii group was significantly shorter than Bifidobacterium group （P＜0.05）. CONCLUSIONS The efficacy and safety of S. boulardii are similar to those of Bifidobacterium in the treatment of diarrhea， but S. boulardii is better than Bifidobacterium in terms of stool number， the duration of diarrhea in children with antibiotic-associated diarrhea.

Low BMI is Associated with Poor OI-IUI Outcomes in Patients with Unexplained Primary Infertility / 中山大学学报(医学科学版)

ObjectiveTo evaluate the effect of women's body mass index （BMI） on pregnancy outcomes of ovulation induction intrauterine insemination （OI-IUI） in patients with unexplained primary infertility. MethodsThe study included 764 OI-IUI cycles from January 2016 to December 2022 in reproductive center of Sun Yat-sen Memorial Hospital. According to BMI，patients were divided into three groups：low BMI （BMI<18.5 kg/m2）， normal BMI （18.5 kg/m2 ≤BMI＜23.0 kg/m2）， and high BMI （BMI≥23.0 kg/m2）. Comparison of clinical data and pregnancy outcomes was performed between the groups. Logistic regression was used to analyze the association between BMI and live birth rate. ResultsFrom the low BMI group to the high BMI group， the HCG positive rate （7.08%，9.74%， 13.19%）， clinical pregnancy rate（5.51%， 7.91%， 13.19%）， and live birth rate （4.72%， 6.90%， 12.50%） increased. Among them， the live birth rate of the high BMI group was significantly higher than that of the low BMI group and the normal BMI group， with a statistically significant difference （P=0.034）. While the early miscarriage rate （14.28%， 10.26%， 5.26%） decreased from the low BMI group to the high BMI group. The binary logistic regression analysis revealed that BMI was an independent factor in live birth， and high BMI resulted in a better live birth rate than low BMI （OR=3.15，95%CI=1.191-8.329，P=0.021）. ConclusionLow BMI is associated with poor OI-IUI outcomes in patients with unexplained primary infertility. These patients are encouraged to gain weight in a healthy manner.

A comparison of pre- and post-operative outcomes in living donors undergoing transperitoneal laparoscopic nephrectomy and open nephrectomy: a retrospective single-center study

ABSTRACT BACKGROUND: Kidney transplantation is often regarded as the preferred therapy for end-stage renal disease. Several surgical procedures have been developed to reduce postoperative donor complications, while maintaining kidney quality. OBJECTIVE: This study aimed to compare the preoperative and postoperative outcomes of living kidney donors who underwent either transperitoneal laparoscopic nephrectomy or open nephrectomy. DESIGN AND SETTING: Retrospective study conducted in Istanbul, Turkey. METHODS: Fifty-five living-related kidney donors underwent nephrectomy and were retrospectively divided into two groups: 21 donors who underwent open nephrectomy (Group 1) and 34 donors who underwent transperitoneal laparoscopic nephrectomy (Group 2). RESULTS: In comparison to the donors who underwent open nephrectomy, those who underwent transperitoneal laparoscopic nephrectomy had significantly shorter postoperative hospital stays (2.3 ± 0.2 versus 3.8 ± 0.8 days, P = 0.003), duration of urinary catheterization (1.2 ± 0.8 days versus 2.0 ± 0.7 days, P = 0.0001), operating times (210 ± 27 minutes versus 185 ± 24 minutes, P = 0.02), and less blood loss (86 ml versus 142 ml, P = 0.048). There was no statistically significant difference between the two groups with regard to the estimated blood transfusion and warm ischemia time. The preoperative week, first postoperative week, and 1-month postoperative serum creatinine levels were comparable between the groups. CONCLUSIONS: Laparoscopic donor nephrectomy can be safely performed at centers with expertise in laparoscopic surgery. Laparoscopic donor nephrectomy has better outcomes than open donor nephrectomy in terms of length of hospital stay, duration of urinary catheterization, operating time, and blood loss.

Evaluación de la calidad de las estadísticas vitales de niños menores de cinco años. Colombia, 2000-2018

Introducción: Las estadísticas vitales son fundamentales para conocer las condiciones de salud de la población y diseñar intervenciones. De su calidad depende la precisión y validez de las métricas derivadas y la relevancia de las decisiones de política pública. Objetivo: Evaluar la calidad de las estadísticas vitales de niños menores de cinco años en Colombia, entre 2000 y 2018. Métodos: Estudio descriptivo y exploratorio. Se analizó la calidad de los registros de nacidos vivos y defunciones publicados por el DANE, utilizando los criterios recomendados por las Naciones Unidas: exactitud (precisión), cobertura (compleción) y oportunidad. Resultados: Se encontraron registros de nacimientos y defunciones con datos perdidos en categorías que indican gradiente social. El 8,2 % de los registros de defunción tenían como causa básica de muerte códigos poco útiles para la toma de decisiones en salud pública. El 97,8 % de los nacidos vivos fueron registrados durante el mismo año de ocurrencia. El subregistro de la mortalidad infantil se estimó en un 28,9 %, con diferencias entre territorios. Conclusiones: La calidad de las estadísticas vitales en niños menores de cinco años de Colombia mejoró en los 19 años evaluados, en particular en exactitud y oportunidad. Sin embargo, persisten problemas en la asignación de la causa básica de muerte y en el subregistro, con diferencias importantes entre territorios. Mejorar la calidad del sistema de estadísticas vitales debe ser un imperativo ético, en especial para comprender las poblaciones de áreas geográficas históricamente invisibilizadas en el país.

Introduction: Vital statistics are essential to identify the health conditions of a population and design interventions. Vital statistics are essential to understand population health and design public health interventions. The accuracy and validity of the derived metrics and the relevance of public policy decisions depend on its quality. Objetive: To evaluate the quality of the vital statistics of children under five years of age in Colombia, between 2000 and 2018. Methods: A descriptive and exploratory study was carried out and the quality of records of live births and deaths published by DANE was analyzed using the criteria suggested by the United Nations: accuracy (precision), opportunity, and coverage (completeness). Results: Of the death records, 8.2% show codes useless for public health purposes as underlying cause of death. Of the live births, 97.8% were registered during the same year of occurrence. We estimated the underregistration of infant mortality at 28.9%, with differences between territories. Conclusions: The quality of vital statistics of children under five years of age has improved in Colombia in the 19 years analyzed, particularly in accuracy and opportunity. However, problems persist in assigning the underlying cause of death and in underregistration, with significant differences between territories. Improving the quality of the vital statistics system must be an ethical imperative, especially to understand the populations of geographic areas historically invisible in the country.

Tendência temporal de nascidos prematuros no estado de Santa Catarina entre 2011 e 2021 / Temporal trend of premature birth in the state of Santa Catarina between 2011 and 2021

Objetivo: Analisar a tendência temporal de nascimentos prematuros no estado de Santa Catarina entre 2011 e 2021. Métodos: Estudo observacional ecológico de tendência temporal realizado com informações do banco de dados do Sistema de Informação sobre Nascidos Vivos do estado de Santa Catarina (2011-2021), disponibilizado pela Diretoria de Vigilância Epidemiológica. Foram analisados todos os nascidos vivos prematuros segundo o ano de processamento e o local de residência em Santa Catarina (110.422). Foram incluídos os nascidos vivos de gestação com menos de 37 semanas completas. As taxas de nascimentos prematuros foram calculadas proporcionalmente à totalidade de nascimentos e calculadas segundo macrorregião, idade materna, número de consultas do pré-natal, instrução materna e cor de pele. Para o cálculo da tendência temporal, foi utilizada a regressão linear simples, com intervalo de confiança de 95% (p ≤ 0,05). Resultados: A taxa média de nascimentos prematuros no estado de Santa Catarina foi de 10,57%, com tendência estável (p < 0,001). Maiores taxas específicas foram encontradas nas macrorregiões Meio Oeste e Serra e Planalto Norte e Nordeste (11,46%), extremos de idade (10-14 anos e 45-64 anos) e menor escolaridade. Maior número de consultas de pré-natal apresentou taxa de prematuridade menor (7,69%). Tendências crescentes das taxas foram apenas encontradas na macrorregião Grande Oeste, faixa etária materna entre 40-44 anos e entre 4-6 consultas de pré-natal. Conclusão: A tendência da taxa de prematuridade manteve-se estável em Santa Catarina. Baixo número de consultas de pré-natal, extremos de idades e baixa escolaridade mostraram taxas maiores de prematuridade. (AU)

Objective: Analyzing the temporal trend of premature births in the state of Santa Catarina between 2011 and 2021. Methods: Observational ecological temporal trend study carried out with information from the database of the Information System on Live Births in the state of Santa Catarina (2011-2021), made available by the Epidemiological Surveillance Directorate. All premature live births were analyzed according to the year of processing and place of residence in Santa Catarina (110,422). Live births of less than 37 completed weeks were included. The rates of premature births were calculated in proportion to the total number of births and calculated according to macro-region, maternal age, number of prenatal consultations, maternal education and skin color. Simple linear regression was used to calculate the temporal trend, with a confidence interval of 95% (p ≤ 0.05). Results: The average rate of premature births in the state of Santa Catarina was 10.57%, with a stable trend (p < 0.001). Higher specific rates were found in the Midwest and Serra, North Plateau and Northeast macro-regions (11.46%), age extremes (10-14 years and 45-64 years) and lower schooling. A greater number of prenatal consultations had a lower prematurity rate (7.69%). Increasing trends in rates were only found in the Grande Oeste macro-region, maternal age group between 40-44 years and between 4-6 prenatal consultations. Conclusion: The prematurity rate trend remained stable in Santa Catarina. Low number of prenatal consultations, extremes of age and low education showed higher rates of prematurity. (AU)

Vaccination in children with immune-mediated disorders

Abstract Objective: To present an updated review of recommendations for the vaccination of children with immune-mediated diseases, with an emphasis on rheumatic and inflammatory diseases. Source of data: Studies published in the PubMed and Scielo databases between 2002 and 2022, Guidelines of Brazilian Scientific Societies, Manuals and Technical Notes of the Ministry of Health of Brazil, on current immunization schedules for special populations. Data synthesis: Immunosuppressive drugs and biological agents reduce the immunogenicity of vaccines and favor susceptibility to infections. The safety and efficacy of immunogens are important points for vaccination in children with immune-mediated diseases. The safety threshold of a vaccine applied to immunocompromised individuals can be reduced when compared to healthy individuals. Very often, the recommendations for the immunization of children with immunemediated diseases follow the recommendations for immunocompromised patients. Vaccination against COVID-19, on the other hand, should ideally occur when the disease is stabilized and in the absence of a low degree of immunosuppression. The patients should be informed about the possibility that the immunization may fail during treatment with immunosuppressants. Specific vaccination schedules should be considered to ensure better protection. Conclusions: Recent studies have allowed updating the recommendations on the safety and immunogenicity of vaccination in children with immune-mediated diseases, especially for live attenuated vaccines. There is a scarcity of data on the safety and efficacy of COVID-19 vaccines in patients, particularly pediatric patients, with rheumatic diseases. The completion of ongoing studies is expected to help guide recommendations on COVID-19 vaccines in this group of patients.

Anticancer potential of Solanum lycopersicum L. extract in human lung epithelial cancer cells A549

The study aimed to reveal the phytochemical profile, free radical scavenging potential, and anticancer activity of Solanum lycopersicum L. leaf extract (SLLE). According to the study, SLLE contains plant secondary metabolites that are beneficial for health, like phenolics, flavonoids, ascorbic acid, alkaloids, and terpenoids. The SLLE has shown potential free radical scavenging potential in DPPH and ABTS free radical scavenging analysis and its EC50 values (concentration required to inhibit 50% of free radicals) were determined as 481.29 ± 33.82 and 527.56 ± 20.34 µg/mL, respectively. The SLLE has the ability to scavenge free radicals and could be used to treat illnesses brought on by oxidative stress. The anticancer activity of SLLE was assessed by MTT, LDH, micro-morphological, live/dead dual staining, and caspase-3 analysis. In the MTT assay, the IC50 value (concentration required to inhibit 50% of cell viability) of SLLE was determined as 190.41 ± 4.77 µg/mL. Furthermore, SLLE has shown potential anticancer activity by adversely affecting the plasma membrane integrity and escalating the caspase-3 levels. In the biomedical field, SLLE could be highly useful to treat cancer.

Pregnancy Benefit of Acupuncture on in vitro Fertilization: A Systematic Review and Meta-Analysis / 中国结合医学杂志

BACKGROUND@#Currently, more and more infertility couples are opting for combined acupuncture to improve success rate of in vitro fertilization (IVF). However, evidence from acupuncture for improving IVF pregnancy outcomes remains a matter of debate.@*OBJECTIVE@#To quantitatively summarized the evidence of the efficacy of acupuncture among women undergoing IVF by means of systematic review and meta-analysis.@*METHODS@#Four English (PubMed, Web of Science, EMBASE, and Cochrane Register of Controlled Clinical Trials) and Four Chinese databases (Wanfang Databases, Chinese National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, and SinoMed) were searched from database inception until July 2, 2023. Randomized controlled trials (RCTs) that evaluated the acupuncture's effects for women undergoing IVF were included. The subgroup analysis was conducted with respect to the age of participants, different acupuncture types, type of control, acupuncture timing, geographical origin of the study, whether or not repeated IVF failure, and acupuncture sessions. Sensitivity analyses were predefifined to explore the robustness of results. The primary outcomes were clinical pregnancy rate (CPR) and live birth rate (LBR), and the secondary outcomes were ongoing pregnancy rate and miscarriage rate. Random effects model with I2 statistics were used to quantify heterogeneity. Publication bias was estimated by funnel plots and Egger's tests.@*RESULTS@#A total of 58 eligible RCTs representing 10,968 women undergoing IVF for pregnant success were identifified. Pooled CPR and LBR showed a signifificant difference between acupuncture and control groups [69 comparisons, relative risk (RR) 1.19, 95% confifidence intervals (CI) 1.12 to 1.25, I2=0], extremely low evidence; 23 comparisons, RR 1.11, 95%CI 1.02 to 1.21, I2=14.6, low evidence, respectively). Only transcutaneous electrical acupoint stimulation showed a positive effect on both CPR (16 comparisons, RR 1.17, 95%CI 1.06 to 1.29; I2=0, moderate evidence) and LBR (9 comparisons, RR 1.20, 95%CI 1.04 to 1.37; I2=8.5, extremely low evidence). Heterogeneity across studies was found and no studies were graded as high-quality evidence.@*CONCLUSION@#Results showed that the convincing evidence levels on the associations between acupuncture and IVF pregnant outcomes were relatively low, and the varied methodological design and heterogeneity might inflfluence the fifindings. (Registration No. PROSPERO CRD42021232430).

Regulations for the Manufacture and Control of Live Poliovirus Vaccine: International Experience and China's Path / 中国医学科学杂志(英文版)

The eradication of poliomyelitis is a landmark achievement in the history of public health, providing strong protection for children's health. The introduction of the Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine is a prerequisite and safeguard for the large-scale production and use of domestically produced live poliovirus vaccines, serving as an indispensable component of vaccine safety. This article, based on archival documents, letters, collections of essays, and oral interviews, examines the historical experience of the development of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine. It contends that the emphasis on localization and the active engagement in international cooperation are critical factors in the swift introduction of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine.

Application of live biotherapeutic products and perspective in the treatment of inherited metabolic disease / 生物工程学报

Live biotherapeutic products (LBPs) refer to the living bacteria derived from human body intestinal gut or in nature that can be used to treat the human disease. However, the naturally screened living bacteria have some disadvantages, such as deficient therapeutic effect and great divergence, which fall short of the personalized diagnosis and treatment needs. In recent years, with the development of synthetic biology, researchers have designed and constructed several engineered strains that can respond to external complex environmental signals, which speeded up the process of development and application of LBPs. Recombinant LBPs modified by gene editing can have therapeutic effect on specific diseases. Inherited metabolic disease is a type of disease that causes a series of clinical symptoms due to the genetic defect of some enzymes in the body, which may cause abnormal metabolism the corresponding metabolites. Therefore, the use of synthetic biology to design LBPs targeting specific defective enzymes will be promising for the treatment of inherited metabolic defects in the future. This review summarizes the clinic applications of LBPs and its potential for the treatment of inherited metabolic defects.

Live biotherapeutic products: the forefront of innovative drug development driven by biotechnology / 生物工程学报

As human microbiome research advances, a large body of evidence shows that microorganisms are closely related to human health. Probiotics were discovered and used as foods or dietary supplements with health benefits in the last century. Microorganisms have shown broader application prospects in human health since the turn of the century, owing to the rapid development of technologies such as microbiome analysis, DNA synthesis and sequencing, and gene editing. In recent years, the concept of "next-generation probiotics" has been proposed as new drugs, and microorganisms are considered as "live biotherapeutic products (LBP)". In a nutshell, LBP is a living bacterial drug that can be used to prevent or treat certain human diseases and indications. Because of its distinct advantages, LBP has risen to the forefront of drug development research and has very broad development prospects. This review introduces the varieties and research advances on LBP from a biotechnology standpoint, followed by summarizing the challenges and opportunities for LBP clinical implementations, with the aim to facilitate LBP development.

Effects of paternal age on pregnancy outcomes in frozen-thaw embryo transfer cycles / 现代泌尿外科杂志

【Objective】 To observe the effects of paternal age on the pregnancy outcomes in frozen embryo transfer (FET) cycles. 【Methods】 The clinical data of two groups after propensity score matching (PSM) were retrospectively analyzed, including 738 cycles in the 0.05). The clinical pregnancy rate (52.2%vs. 67.2%) and live birth rate (41.1% vs. 57.2%) decreased in the 40-60 year group compared with those in the 0.05). 【Conclusion】 Advanced paternal age decreases clinical pregnancy rate and live birth rate.

Effects of live attenuated measles vaccine Hu191 strain on epithelial mesenchymal transition,proliferation and migration of 4T1 breast cancer cells / 中国生物制品学杂志

@#Objective To investigate the effects of live attenuated measles vaccine Hu191 strain(MV-Hu191)on epithelial mesenchymal transition(EMT),proliferation and migration of 4T1 breast cancer cells.MethodsCCK-8 and clone formation assay were used to analyze the effect of MV-Hu191 on the proliferation of 4T1 cells;The effect of MV-Hu191 on 4T1cell migration was analyzed by cell scratch test;The expression of EMT pathway proteins(MMP-2,MMP-9,E-cadherin)in4T1 cells was detected by Western blot;4T1 tumor-bearing mouse model was established in female BALB/c mice. The model mice were divided into control group(PBS),MV-Hu191(1 × 106TCID50)group and paclitaxel group(15 mg/kg),with 10 mice in each group,and injected into tumor at the dosage of 100 μL every 2 d for 5 times. At 28 d after administration,the effects of MV-Hu191 on survival time,tumorigenicity and metastasis in vivo were observed;The pathological characteristics of lung tissue and tumor tissue were observed by HE staining under microscope;The expression of EMT pathway proteins(MMP-2,MMP-9 and E-cadherin)in tumor tissue was detected by immunohistochemical staining.Results The results of in vitro experiment showed that,compared with the control group,MV-Hu191 inhibited the proliferation and migration of 4T1 cells(F = 2. 811 and 13. 535,P = 0. 001 and 0. 002,respectively),down regulated the expression of MMP-2 and MMP-9(F = 45. 433 and 9. 744,P = 0. 011 and 0. 038,respectively),and up regulated the expression of Ecadherin(F = 7. 001,P = 0. 032);The results of in vivo experiment showed that MV-Hu191 significantly prolonged the survival time of tumor-bearing mice,and decreased the tumor quality(F = 8. 301,P = 0. 003)and the number of pulmonary nodules metastasis compared with the control group(F = 33. 792,P = 0. 000);MV-Hu191 treated tumor tissue gap was small,the cells were round,and the alveolar contour was clearly visible;The expression of MMP-2 and MMP-9 in MVHu191 treated tumor tissue decreased significantly(F = 6. 705 and 9. 047,P = 0. 028 and 0. 023,respectively),while the expression of E-cadherin increased significantly(F = 3. 468,P = 0. 039).ConclusionMV-Hu191 signi-ficantly inhibits the proliferation and migration of 4T1 breast cancer cells,antagonizes the tumorigenicity and lung meta-stasis of 4T1 tumorbearing mice,and prolongs the survival time of mice. The possible mechanism of MV-Hu191 against breast cancer is closely related to the regulation of EMT pathway protein expression.

Preparation and application of high titer neutralizing antibody against varicella-herpes zoster virus / 中国生物制品学杂志

@#Objective To prepare high titer specific immune serum of varicella-herpes zoster virus(VZV)for the quality control of live attenuated varicella vaccine and live attenuated herpes zoster vaccine.MethodsMale rabbits were immunized with high purity recombinant gE glycoprotein combined with Freund's adjuvant,aluminum hydroxide adjuvant or MF59 adjuvant,2 rabbits in each group. On the 56th day after immunization,the maximum blood samples(heart or carotid artery)were collected from each rabbit to prepare serum,which was mixed with VZV for neutralization reaction,and then inoculated into a 6-well plate full of monolayer of MRC-5 human diploid cells. After incubation for 7 d,the number of plaques was counted and the neutralizing titer and virus neutralizing ability of immune serumwere determined. The serum with high neutralizing titer and virus neutralizing ability was selected for the identification test of live attenuated varicella vaccine and live attenuated herpes zoster vaccine VZV(Oka strain)working seed lot and the detection of exogenous virus factors.ResultsThe immune sera prepared by immunizing rabbits with various combinations of recombinant gE glycoprotein all showed neutralizing activity,among which the serum prepared by the combination of recombinant gE glycoprotein and Freund's adjuvant had the highest neutralizing titer of 1∶512 and the virus neutralizing ability of 240 000 PFU/mL;The prepared immune serum was usedfor the identification test of VZV(Oka strain)working seed lot and the detection of exogenous virus factors,of which all the results were in line with the requirements. Conclusion The recombinantgE glycoprotein could be used for the preparation of high titer neutralizing antibody against VZV,and the prepared high titer neutralizing antibody is suitable for thequality control of live attenuated varicella vaccine and live attenuated herpes zoster vaccine.

Comparative study of spray characteristics of domestic and foreign nasal spray delivery devices for live attenuated nasal influenza vaccine / 中国生物制品学杂志

@#Objective To compare the spray characteristics of domestic and foreign nasal spray delivery devices for live attenuated influenza vaccine(LAIV). Methods The particle size distribution(DV10,DV50 and DV90),the proportion of droplets smaller than 10 μm and Span of atomized particles of two brands of nasal spray delivery devices at home and abroad were measured by laser diffraction method,the spray pattern[maximum diameter(D_(max)),shortest diameter(D_(min))and ovality(D_(max)/D_(min))]and spray geometry(spray angle and width)were detected by Spray view,and the comparative analysis was performed. Results There was no significant difference in DV10,DV50,DV90 particle size distribution,proportion of droplets smaller than 10 μm and Span of atomized particles between the two kinds of domestic and foreign nasal spray delivery devices[F-values of Levene's test for equality of variances were 0. 622,0. 135,3. 067,0. 212 and 0. 058,P-values were0. 434,0. 714,0. 085,0. 647 and 0. 810,and significance(two-tailed)values of equal variances assumed were 0. 439,0. 228,0. 281,0. 539 and 0. 910,respectively];D_(max),D_(min)and ovality of the spray patterns showed no significant difference[F-values of Levene's test for equality of variances were 2. 102,2. 666 and 0. 514,P-values were 0. 158,0. 114 and0. 479,and significance(two-tailed)values of equal variances assumed were 0. 651,0. 407,and 0. 160,respectively];The geometric mean ratios of spray angle and width were 0. 92 and 0. 91,respectively,which ranged from 0. 90 to 1. 11.Conclusion Both the domestic and foreign nasal spray delivery devices meet the delivery requirement of the nasal spray LAIV,which can be used for the delivery of nasal spray vaccines and drugs.

Reflection on the regulatory path for online sales of Chinese medicinal materials in the context of live streaming / 中国药房

OBJECTIVE To provide feasible regulatory paths for the online sales supervision of Chinese medicinal materials from the perspective of the characteristics of new online sales and the characteristics of Chinese medicinal materials. METHODS Through the investigation of the sales form of Chinese medicinal materials on the e-commerce platform and the search of Chinese medicinal materials online dispute cases， the difficulties and existing problems in the supervision of Chinese medicinal materials under the new online sales model were analyzed， and corresponding countermeasures were proposed. RESULTS & CONCLUSIONS Clarifying the conceptual boundary between Chinese medicinal materials and their decoction pieces， agricultural products and food is the key to standardizing the online sale of Chinese medicinal materials. The regulatory criteria， which determine whether Chinese medicinal materials belong to drug management based on whether they had been included in medicinal channels， didn’t consider the diversity of online sales channels for Chinese medicinal materials， their safety and the disguised sales of Chinese herbal decoction pieces. It is necessary to establish the concept of hierarchical management of Chinese medicinal materials， strictly restrict the behavior of claiming the efficacy of Chinese medicinal materials and selling Chinese herbal decoction pieces in live streaming， improve the defining path of false propaganda of Chinese medicinal materials， implement the responsibilities and obligations of live streaming marketing subjects and platforms， and safeguard the legitimate rights of consumers.

Safety analysis of children of different ages vaccinated with measles, mumps and rubella combined attenuated live vaccine/measles and rubella combined attenuated live vaccine in Jilin Province from 2015 to 2022 / 中国生物制品学杂志

@#Objective To analyze the safety of children of different ages vaccinated with measles,mumps and rubella combined attenuated live vaccine(MMR in brief)/measles and rubella combined attenuated live vaccine(MR in brief)in Jilin Province from 2015 to 2022.Methods The actual vaccination data of MMR and MR from January 1,2015 to December 31,2022 were collected through the Jilin information management system for immunization programming,and all AEFI case information reported after vaccination with MMR and MR in this period was collected through the national adverse event following immunization(AEFI) monitoring and reporting system.The incidence rates of AEFI reports were compared among8-month-old children vaccinated with the first dose of MMR(MMR 8 group) and MR(MR8 group),18-month-old children vaccinated with the first dose of MMR(vaccinated with MR at 8 months old,MMR18-1 group) and the second dose of MMR(vaccinated with the first dose of MMR at 8 months old,MMR18-2 group) to preliminarily evaluate the safety of children vaccinated with MMR and MR at different ages.Results The reported incidence of AEFI in MMR8,MR8,MMR18-1 and MMR18-2 groups were 374.41/100 000,350.81/100 000,101.70/100 000 and 104.91/100 000,respectively,with significant difference among the four groups(χ~2=1 145.47,P=0.00);There was no significant difference between MMR8 and MR8,as well as MMR18-1 and MMR18-2 groups(χ~2=3.780 and 0.194,respectively,each P> 0.05);There were significant differences between MMR8 and MMR18-1,MMR8 and MMR18-2,as well as MR8 and MMR18-1groups(χ~2=920.440,412.110 and 1 021.120,respectively,each P=0.00).Most of the adverse reactions were general reactions,mainly fever,local redness and induration;A few were abnormal reactions,which were mainly allergic reactions(rash,papules,urticaria,etc.).Only one case of coincidence was reported in MMR8 group,and no psychogenic reaction,vaccine quality accident and vaccination accident occurred.All AEFI turned out to be improved or cured.Conclusion The differences of AEFI reported incidence of 8-month-old children vaccinated with MMR and MR were all small,and the difference of AEFI reported incidence of 18-month-old children vaccinated with the second dose of MMR was small regardless of the initial vaccination with MMR or MR.It is safe to use MMR instead of MR for the first vaccination in8-month-old children.

Screening and safety evaluation of heat-resistant protective agents for live classic swine fever vaccine / 中国生物制品学杂志

@#Objective To screen the formulation of heat-resistant protective agent for live classic swine fever(CSF) vaccine in order to prolong the preservation time of vaccine under harsh conditions.Methods The heat-resistant protective agent prepared based on the formula containing gelatin,D-sorbitol,trehalose,D casein hydrolysate of different contents was mixed with the live virus antigen of CSF and then lyophilized.The finished products with qualified appearance were screened for routine detection and aging resistance test,and the over-dose(10 and 30 portions) of the products qualified in the aging resistance test were used to immunize piglets via subauricular neck,5 for each to evaluate the safety of the vaccines.Results Among the 6 batches of lyophilized live CSF vaccine,3 batches(20200301,20200302 and 20200303) met the requirements of the current Chinese Veterinary Pharmacopoeia.The lyophilized loss was within 0.04～0.33 titers,and the moisture contents were all less than 2%;20200301 and 20200302 batches of finished products passed the aging resistance test.No adverse clinical symptoms were observed in all piglets 30 min after vaccination;The body temperatures of piglets vaccinated with 10 and 30 doses of vaccine were normal for 14 d after vaccination.Conclusion The two formulations of heatresistant protective agent selected might be used for freeze-dried preparations of live CSF vaccine with good effect of aging resistance and safety to piglets.

Surveillance of adverse events following immunization with combined attenuated live measles, mumps and rubella vaccines in Huzhou City from 2015 to 2021 / 预防医学

Objective@#To monitor the adverse events following immunization (AEFI) with combined attenuated live measles, mumps and rubella vaccines (MMR) in Huzhou City from 2015 to 2021, so as to provide insights into the implementation of the MMR immunization strategy.@*Methods@#All AEFI caused by MMR immunization in Huzhou City from 2015 to 2021 were captured from the AEFI Monitoring Information Management System of the Immunization Planning System of Chinese Disease Control and Prevention Information System, and the incidence, clinical features and epidemiological features of AEFI were analyzed descriptively.@*Results@#The reported incidence of AEFI caused by MMR immunization appeared a tendency towards a rise in Huzhou City from 2015 to 2021 (χ2trend=124.126, P<0.001). Totally 324 386 doses of MMR vaccines were immunized, and 317 cases with AEFI were reported, with an reported incidence rate of 9.77/104 doses. Following two-dose immunization, the reported incidence of AEFI caused by two-dose MMR immunization was significantly lower than by one-dose immunization (6.01/104 doses vs. 25.43/104 doses; χ2=113.692, P<0.001). The incidence rates of general reactions, abnormal reactions and coincidental events were 6.20/104 doses, 3.42/104 dose and 0.15/104 doses, respectively. Fever and allergic rash were predominant clinical manifestations of AEFI, and no vaccine quality accident, inoculation accident or psychogenic reaction were reported. There were 246 (77.60%) cases with AEFI within 24 hours following vaccination, and among children with AEFI, there were 173 boys (54.57%), and 200 children (63.09%) age ages of less than one year (63.09%). AEFI was reported in each quarter, and 99 cases (31.23%) were reported in the fourth quarter. The largest number of children with AEFI was reported in Wuxing District (78 cases, 24.61%).@*Conclusions@#The safety of MMR vaccination is high in Huzhou City. General reaction is the predominant AEFI, which mainly occurs within 24 hours following vaccination. Two-dose MMR vaccination does not increase the risk of AEFI.

Effects of methyl methanesulfonate and UV sensitive gene clone 81 on hepatocellular carcinoma cells / 中华肝胆外科杂志

Objective:To detect the expression of methyl methanesulfonate and UV sensitive gene clone 81 (Mus81) in hepatocellular carcinoma(HCC) and to observe the effects of Mus81 on the migration, invasion and metastatic ability of human HCC cells.Methods:Thirty-two tissue specimens were selected from HCC tissues and corresponding paraneoplastic tissues of patients with HCC who underwent surgical resection in Guangzhou Red Cross Hospital Affiliated to Jinan University from January 2020 to June 2021. The expression levels of Mus81 in 32 HCC specimens, 374 HCC samples from the cancer genome atlas database, human normal liver cell line HL-7702 and human HCC cell lines JHH-7, Huh-7 and Hep3B were analyzed. Mus81 knockdown in JHH-7, Huh-7 and overexpressed in Hep3B HCC cell lines were constructed, and the effects of Mus81 on HCC cells were observed by scratch assay, Transwell migration and invasion assay and tail vein injection transfer assay in nude mice.Results:The expression of Mus81 was higher in HCC tissues or cell lines than which in paraneoplastic tissues or normal hepatocyte lines (all P<0.05). The migration rate, metastatic and invasive cell numbers of Mus81-knockdown Huh-7 HCC cells were 22.24%±2.16%, 49.04±5.62, 3.81±1.08, the negative control group were 26.89%±1.15%, 86.81±4.79, 19.78±3.30, and the differences between the two groups were statistically significant ( t=4.24, 26.59, 23.92, all P<0.01). The migration rate, metastatic and invasive cell numbers of Mus81-overexpressed Hep3B HCC cells were 80.57%±5.12%, 18.74±8.07, 33.81±8.44, which were significantly higher than those of the empty vector group 64.17%±7.20%, 10.96±5.32, 3.04±1.13, and the differences were statistically significant ( t=4.15, 4.18, 18.78, all P<0.01). Tail vein transfer experiments in nude mice showed that the total fluorescence expression, weight of metastatic tumors, and the metastatic rates in kidney, vertebral column, neck, axilla and subcutis in nude mice injected with Mus81-knockdown JHH-7 cells were significantly lower than those in the control group (all P<0.05). Conclusion:Mus81 gene expression is upregulated in HCC and promotes the migration, invasion and metastatic ability of HCC cells, suggesting that Mus81 may be a potential therapeutic target for HCC.