1.Alanine transferase test results and exploration of threshold adjustment strategies for blood donors in Shenzhen, China
Xin ZHENG ; Yuanye XUE ; Haobiao WANG ; Litiao WU ; Ran LI ; Yingnan DANG ; Tingting CHEN ; Xiaoxuan XU ; Xuezhen ZENG ; Jinfeng ZENG
Chinese Journal of Blood Transfusion 2025;38(4):488-494
[Objective] To conduct a retrospective statistical comparison of alanine aminotransferase (ALT) test values in blood donors prior to blood collection, aiming to analyze the objective characteristics of the population with elevated ALT levels (ALT>50 U/L) and provide reference data for adjusting the screening eligibility threshold for ALT. [Methods] The preliminary ALT screening data of 30 341 blood donor samples collected prior to blood donation from three smart blood donation sites at the Shenzhen Blood Center between 2022 and 2023 were extracted and compared with data from a health examination department of a tertiary hospital in Shenzhen (representing the general population, n=24 906). Both datasets were categorized and statistically described. A retrospective analysis was conducted to examine the associations between ALT test results and factors such as donors' gender, age, ethnicity, donation site, donation season, and frequency of blood donation. [Results] The ALT levels in both blood donors and the general population were non-normally distributed. The 95th percentile of ALT values was calculated as 61.4 U/L (male: 67.8 U/L, female: 39.3 U/L) for blood donors and 58.1 U/L (male: 63.7 U/L, female: 51.2 U/L) for the general population. The non-compliance rates (ALT>50 U/L) were 7.65% (2 321/30 341) in blood donors and 7.08% (1 763/24 906) in the general population. There were significant differences (P<0.05) in the ALT failure rate among blood donors based on gender, age, and donation site, but no significant differences (P>0.05) during the blood donation season. There was no statistically significant difference (P>0.05) in the positive rates of four serological markers (HBsAg, anti HCV, HIV Ag/Ab, anti TP) for blood screening pathogens between ALT unqualified and qualified individuals (2.05% vs 1.5%). If the ALT qualification threshold was raised from 50 U/L to 90 U/L, the non qualification rates of male and female blood donors would decrease from 9.82% (2 074/21 125) to 2.23% (471/21 125) and from 2.70% (249/9 216) to 0.75% (69/9 216), respectively. Among the 154 blood donors who donated blood more than 3 times, 88.31% of the 248 ALT test results were in the range of 50-90 U/L. Among them, 9 cases had ALT>130 U/L, and ALT was converted to qualified in subsequent blood donations. [Conclusion] There are differences in the ALT failure rate among blood donors of different genders and ages, and different blood donation sites and operators can also affect the ALT detection values of blood donors. The vast majority of blood donors with ALT failure are caused by transient and non pathological factors. With the widespread use of blood virus nucleic acid testing, appropriately increasing the ALT qualification threshold for blood donors can expand the qualified population and alleviate the shortage of blood sources, and the risk of blood safety will not increase.
2.Analysis of abnormal ALT in blood donors in five Zang autonomous prefectures of Qinghai Province, China: characteristics and screening strategies
Yingnan DANG ; ; Rong TANG ; Liqin HUANG ; Hailin WU ; Tingting CHEN ; Shengju LI ; Yanli SUN ; Xin ZHENG ; Yanxia LI ; Xianlin YE ; Jinfeng ZENG
Chinese Journal of Blood Transfusion 2025;38(4):502-507
[Objective] To investigate the factors associated with alanine aminotransferase (ALT) abnormalities in multi-ethnic blood donors across five Zang autonomous prefectures in the plateau regions of Qinghai Province, and to provide evidence for ensuring blood safety and formulating screening strategies. [Methods] A retrospective analysis was performed on the ALT abnormal test results of blood donors in the Zang autonomous prefectures of Qinghai from 2022 to 2024. The correlations between ALT levels and factors including gender, age, altitude, and infectious markers were investigated. [Results] The overall ALT unqualified rate among blood donors in this region was 9.01%. Significant differences in ALT levels were observed across genders and age groups (P<0.05). Variations in ALT abnormality rates were also noted among different plateau regions (P<0.05). Overall, ALT values exhibited an increasing trend with rising altitude. The average ALT unqualified rates were 11.19% in Zang donors, 7.96% in Han donors, and 4.79% in donors from other ethnic groups (P<0.05). No statistically significant association was observed between ALT abnormality and the presence of HBV/HCV infectious markers (P>0.05). [Conclusion] In the plateau areas of Qinghai, multi-ethnic blood donors have a relatively high ALT levels and ALT unqualified rates, showing distinct regional characteristics. ALT elevation in voluntary blood donors is related to non-pathological factors such as gender, age, and dietary habits, but not to infectious indicators.
3.Analysis of syncopal DRVR in blood donors: multicenter hemovigilance data (2020—2023)
Junhong YANG ; Qing XU ; Wenqin ZHU ; Fei TANG ; Ruru HE ; Zhenping LU ; Zhujiang YE ; Fade ZHONG ; Gang WU ; Guoqiang FENG ; Xiaojie GUO ; Jia ZENG ; Xia HUANG
Chinese Journal of Blood Transfusion 2025;38(8):1071-1076
Objective: Data on syncopal donation-related vasovagal reaction (DRVR) collected from 74 blood centers between 2020 and 2023 was statistically analyzed to provide a reference for developing preventive strategies against syncopal DRVR. Methods: Data on blood donation adverse reactions and basic information of donors from 2020 to 2023 were collected through the information management system at monitoring sentinel sites. Statistical analysis was performed on the following aspects of syncopal DRVR: characteristics of donors who experienced syncope, reported incidence, triggers, duration, presence and occurrence time of syncope-related trauma, clinical management including outpatient and inpatient treatment, and severity grading. Results: From 2020 to 2023, 45 966 donation-related adverse reactions were recorded. Of these, 1 665 (3.72%) cases were syncopal DRVR. The incidence of syncopal DRVR decreased with age, being the highest in the 18-22 age group. Incidence was significantly higher in female donors than male donors, in first-time donors than repeat donors, and in university and individual donors than group donors (all P<0.05). There was no statistically significant difference among different blood donation locations (P>0.05). The top three triggers were tension, fatigue, and needle phobia or fear of blood. Among syncopal DRVR cases, 60.36% occurred during blood collection, 87.63% lasted for less than 60 seconds, and 5.05% were accompanied by trauma. Notably, 57.14% of these traumas occurred after donor had left the blood collection site. Syncope severity was graded based on required treatment: grade 1 (fully recovered without treatment, 95.50%); grade 2 (recovered after outpatient treatment, 4.02%); and grade 3 (recovered after inpatient treatment, 0.48%). Conclusion: By analyzing the data of syncopal DRVR cases, it is possible to provide a reference for formulating blood donor safety policies.
4.Literature analysis of ADR after the listing of apatinib
Bingjin JIN ; Xuehua WU ; Xin WANG ; Yiwei ZHANG ; Changqing SONG ; Yafeng WANG
China Pharmacy 2024;35(7):837-841
OBJECTIVE To explore the characteristics and regulations of adverse drug reactions (ADR) caused by apatinib, and to provide a reference for the safe use of apatinib in clinic. METHODS Case and group reports on ADR and safety evaluation of apatinib were retrieved from Chinese and English databases such as CNKI, Wanfang medical network, VIP and PubMed since its listing in 2014, literature data were extracted and statistically analyzed after screening. RESULTS Totally 101 cases were included, involving 221 ADR. In the above cases, the male-to-female ratio was 1.24∶1, with the highest proportion of patients aged 51 to 70 years, most of the patients were given a dose of 500 mg or more, and the patients given low dose of apatinib combined with other antitumor drugs were also likely to have ADR. One to two types of adverse reaction were the most common, while the types could reach up to six. Most ADR occurred within 30 days after medication, and the systems/organs involved were mainly the cardiovascular system damage,skin and its accessories damage, gastrointestinal system damage and urinary system damage; the main clinical manifestations were hypertension/aggravation,hand-foot syndrome,abdominal pain diarrhea and albuminuria, etc. Hypertension/aggravation, hand-foot syndrome and myelosuppression were the most common serious ADR. Most ADR could be improved/cured by suspension of administration, dose downregulation and symptomatic treatment. All 4 patients who died had underlying diseases, and their ECOG scores all ≥2 points. Special ADR (such as reversible posterior encephalopathy syndrome, psychiatric disorders, and cognitive impairment) were mostly caused by apatinib itself, or may be caused by apatinib in combination with the primary or underlying disease. CONCLUSIONS Advanced age, large dose, combination medication, underlying diseases and poor physical condition might be the high risks for ADR caused by apatinib. It is recommended to monitor the blood pressure,urine protein and skin of hands and feet of all patients with medication on a daily basis,pay attention to the occurrence of special ADR, and timely detect abnormal states and give effective intervention,so as to avoid the aggravation of ADR and other secondary ADR.
5.Ershiwuwei Guijiu Pill Activates PI3K/Akt/mTOR-mediated Autophagy to Alleviate Osteoporosis in Ovariectomized Rats
Yunan JIANG ; Lixue ZHANG ; Fanglin DUAN ; Yao YU ; Fenghui LI ; Lina MA ; Peifeng WU ; Changxing LI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):43-51
ObjectiveTo investigate the mechanism of Ershiwuwei Guijiu pill in preventing and treating postmenopausal osteoporosis (PMOP) by activating the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway and inhibiting excessive autophagy. MethodFemale SD rats were ovariectomized and randomly divided into the sham operation group (Sham), the operation group (OVX), the Ershiwuwei Guijiu pill (GJ) group, and the raloxifene hydrochloride (RLX) group, with 10 rats in each group. Enzyme-linked immunosorbent assay (ELISA) and colorimetric methods were used to detect the levels of estrogen, bone metabolism markers in serum, and total superoxide dismutase (T-SOD), malondialdehyde (MDA), and glutathione peroxidase (GSH-Px) in tibial tissue. Flow cytometry was used to detect reactive oxygen species (ROS) levels in bone marrow mesenchymal stem cells. Masson staining was used to observe pathological changes in the proximal tibia, and micro-computed tomography (Micro-CT) was used to observe changes in tibial microstructural parameters. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot were used to detect the expression of autophagy-related proteins Beclin1, microtubule-associated protein 1A/1B-light chain 3 (LC3), autophagy-related 5 (Atg5), as well as PI3K, Akt, and mTOR in tibial tissue. ResultCompared with the Sham group, the OVX group showed a significant decrease in serum levels of estradiol (E2) and calcium ion (Ca2+), and T-SOD, GSH-Px, PI3K, Akt, and mTOR mRNA levels in bone tissue (P<0.05, P<0.01), significantly reduced bone mineral density (BMD), bone surface/bone volume (BS/BV), trabecular thickness (Tb.Th), trabecular number (Tb.N), and trabecular connectivity (Con) in the tibia (P<0.05, P<0.01), thinner epiphyseal growth plate, and the bone marrow cavity filled with fat vacuoles. Moreover, the levels of phosphorus (P), MDA, ROS, and mRNA and protein expression of Beclin1, LC3, and Atg5, as well as trabecular separation (Tb.Sp) were significantly elevated (P<0.05, P<0.01). Compared with the OVX group, the GJ and RLX groups showed significant increases in serum E2 and Ca2+, and bone tissue levels of SOD, GSH-Px, and the mRNA levels of PI3K, Akt, and mTOR (P<0.05, P<0.01), significantly increased BMD, BS/BV, Tb.Th, Tb.N, and Con in the tibia, thickened epiphyseal growth plate, and significantly reduced fat vacuoles in the bone marrow cavity (P<0.05, P<0.01). Additionally, the levels of P, MDA, ROS, Beclin1, LC3, Atg5 mRNA and proteins, and Tb.Sp were significantly decreased (P<0.05, P<0.01). The ratios of p-PI3K/PI3K, p-Akt/Akt, and p-mTOR/mTOR, which were significantly reduced in the OVX group (P<0.01), were significantly increased in the GJ and RLX groups (P<0.01). ConclusionThe Ershiwuwei Guijiu pill reduces oxidative stress and inhibits autophagy, thereby preventing and treating postmenopausal osteoporosis. Its mechanism may be related to the activation of the PI3K/Akt/mTOR signaling pathway, which inhibits autophagy.
6.Incidence and prognosis of olfactory and gustatory dysfunctions related to infection of SARS-CoV-2 Omicron strain: a national multi-center survey of 35 566 population.
Meng Fan LIU ; Rui Xia MA ; Xian Bao CAO ; Hua ZHANG ; Shui Hong ZHOU ; Wei Hong JIANG ; Yan JIANG ; Jing Wu SUN ; Qin Tai YANG ; Xue Zhong LI ; Ya Nan SUN ; Li SHI ; Min WANG ; Xi Cheng SONG ; Fu Quan CHEN ; Xiao Shu ZHANG ; Hong Quan WEI ; Shao Qing YU ; Dong Dong ZHU ; Luo BA ; Zhi Wei CAO ; Xu Ping XIAO ; Xin WEI ; Zhi Hong LIN ; Feng Hong CHEN ; Chun Guang SHAN ; Guang Ke WANG ; Jing YE ; Shen Hong QU ; Chang Qing ZHAO ; Zhen Lin WANG ; Hua Bin LI ; Feng LIU ; Xiao Bo CUI ; Sheng Nan YE ; Zheng LIU ; Yu XU ; Xiao CAI ; Wei HANG ; Ru Xin ZHANG ; Yu Lin ZHAO ; Guo Dong YU ; Guang Gang SHI ; Mei Ping LU ; Yang SHEN ; Yu Tong ZHAO ; Jia Hong PEI ; Shao Bing XIE ; Long Gang YU ; Ye Hai LIU ; Shao wei GU ; Yu Cheng YANG ; Lei CHENG ; Jian Feng LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(6):579-588
Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
Female
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Humans
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Adolescent
;
SARS-CoV-2
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Smell
;
COVID-19/complications*
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Cross-Sectional Studies
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COVID-19 Vaccines
;
Incidence
;
Olfaction Disorders/etiology*
;
Taste Disorders/etiology*
;
Prognosis
7.A study of factors influencing the willingness of primary healthcare workers in Qinghai Province to engage in non-discriminatory behaviors towards HBV-infected patients
Juan WU ; Kezhong A ; Zengping HAO ; Ruiyao DING ; Zizhe GUO
Shanghai Journal of Preventive Medicine 2023;35(12):1206-1211
ObjectiveTo understand the current status of primary healthcare workers’ knowledge of hepatitis B and their willingness to engage in non-discriminatory behaviors, to explore the factors influencing their willingness, and to provide a basis for health education on hepatitis B for primary healthcare workers in Qinghai Province. MethodsA questionnaire survey was conducted among primary healthcare institutions in eight cities (prefectures) of Qinghai Province using a combination of random sampling and convenience sampling. The questionnaire included demographic information, knowledge related to hepatitis B, and willingness to engage in non-discriminatory behaviors. ResultsA total of 393 subjects were included in the survey. The accurate awareness rate of hepatitis B transmission route among primary healthcare workers in Qinghai Province was 36.89%. Of the respondents, 46.31% were unwilling to live with family members infected with HBV or carriers, and 50.13% were unwilling to dine with friends infected with HBV or carriers. The willingness of primary healthcare workers to engage in non-discriminatory behaviors related to hepatitis B varied by different places of residence, gender, marital status and per capita household income (P<0.05). Regarding different dimensions of HBV-related knowledge, there were significant differences in age, education level, and per capita household income for transmission route (P<0.05). Vaccination showed significant differences based on marital status and per capita family income (P<0.05). There were significant differences in treatment and outcome among different gender, education level, and per capita family income. Anti-discrimination policies varied significantly by place of residence, age, ethnicity, and per capita income. Multivariate logistic regression analysis showed that primary healthcare workers’ knowledge of hepatitis B transmission route was a significant factor influencing their willingness to engage in non-discriminatory behaviors (OR=0.49, 95%CI:0.29‒0.84). ConclusionIt is essential to continuously strengthen hepatitis B health education for primary healthcare workers in western China to reduce the willingness to engage in non-discriminatory behaviors towards hepatitis B and protect the rights of HBV-infected individuals.
8.A descriptive analysis on hypertension in adult twins in China.
Yu Tong WANG ; Wei Hua CAO ; Jun LYU ; Can Qing YU ; Sheng Feng WANG ; Tao HUANG ; Dian Jian Yi SUN ; Chun Xiao LIAO ; Yuan Jie PANG ; Zeng Chang PANG ; Min YU ; Hua WANG ; Xian Ping WU ; Zhong DONG ; Fan WU ; Guo Hong JIANG ; Xiao Jie WANG ; Yu LIU ; Jian DENG ; Lin LU ; Wen Jing GAO ; Li Ming LI
Chinese Journal of Epidemiology 2023;44(4):536-543
Objective: To describe the distribution characteristics of hypertension among adult twins in the Chinese National Twin Registry (CNTR) and to provide clues for exploring the role of genetic and environmental factors on hypertension. Methods: A total of 69 220 (34 610 pairs) of twins aged 18 and above with hypertension information were selected from CNTR registered from 2010 to 2018. Random effect models were used to describe the population and regional distribution of hypertension in twins. To estimate the heritability, the concordance rates of hypertension were calculated and compared between monozygotic twins (MZ) and dizygotic twins (DZ). Results: The age of all participants was (34.1±12.4) years. The overall self-reported prevalence of hypertension was 3.8%(2 610/69 220). Twin pairs who were older, living in urban areas, married, overweight or obese, current smokers or ex-smokers, and current drinkers or abstainers had a higher self-reported prevalence of hypertension (P<0.05). Analysis within the same-sex twin pairs found that the concordance rate of hypertension was 43.2% in MZ and 27.0% in DZ, and the difference was statistically significant (P<0.001). The heritability of hypertension was 22.1% (95%CI: 16.3%- 28.0%). Stratified by gender, age, and region, the concordance rate of hypertension in MZ was still higher than that in DZ. The heritability of hypertension was higher in female participants. Conclusions: There were differences in the distribution of hypertension among twins with different demographic and regional characteristics. It is indicated that genetic factors play a crucial role in hypertension in different genders, ages, and regions, while the magnitude of genetic effects may vary.
Adult
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Female
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Humans
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Male
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Alcohol Drinking
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Diseases in Twins/genetics*
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Hypertension/genetics*
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Twins, Dizygotic/genetics*
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Twins, Monozygotic/genetics*
9.A descriptive analysis of hyperlipidemia in adult twins in China.
Ke MIAO ; Wei Hua CAO ; Jun LYU ; Can Qing YU ; Sheng Feng WANG ; Tao HUANG ; Dian Jian Yi SUN ; Chun Xiao LIAO ; Yuan Jie PANG ; Zeng Chang PANG ; Min YU ; Hua WANG ; Xian Ping WU ; Zhong DONG ; Fan WU ; Guo Hong JIANG ; Xiao Jie WANG ; Yu LIU ; Jian DENG ; Lin LU ; Wen Jing GAO ; Li Ming LI
Chinese Journal of Epidemiology 2023;44(4):544-551
Objective: To describe the distribution characteristics of hyperlipidemia in adult twins in the Chinese National Twin Registry (CNTR) and explore the effect of genetic and environmental factors on hyperlipidemia. Methods: Twins recruited from the CNTR in 11 project areas across China were included in the study. A total of 69 130 (34 565 pairs) of adult twins with complete information on hyperlipidemia were selected for analysis. The random effect model was used to characterize the population and regional distribution of hyperlipidemia among twins. The concordance rates of hyperlipidemia were calculated in monozygotic twins (MZ) and dizygotic twins (DZ), respectively, to estimate the heritability. Results: The age of all participants was (34.2±12.4) years. This study's prevalence of hyperlipidemia was 1.3% (895/69 130). Twin pairs who were men, older, living in urban areas, married,had junior college degree or above, overweight, obese, insufficient physical activity, current smokers, ex-smokers, current drinkers, and ex-drinkers had a higher prevalence of hyperlipidemia (P<0.05). In within-pair analysis, the concordance rate of hyperlipidemia was 29.1% (118/405) in MZ and 18.1% (57/315) in DZ, and the difference was statistically significant (P<0.05). Stratified by gender, age, and region, the concordance rate of hyperlipidemia in MZ was still higher than that in DZ. Further, in within-same-sex twin pair analyses, the heritability of hyperlipidemia was 13.04% (95%CI: 2.61%-23.47%) in the northern group and 18.59% (95%CI: 4.43%-32.74%) in the female group, respectively. Conclusions: Adult twins were included in this study and were found to have a lower prevalence of hyperlipidemia than in the general population study, with population and regional differences. Genetic factors influence hyperlipidemia, but the genetic effect may vary with gender and area.
Adult
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Female
;
Humans
;
Male
;
Middle Aged
;
Young Adult
;
China/epidemiology*
;
Diseases in Twins/genetics*
;
Hyperlipidemias/genetics*
;
Metabolic Diseases
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Twins, Dizygotic
;
Twins, Monozygotic/genetics*
10.Intracranial activity of first-line immune checkpoint inhibitors combined with chemotherapy in advanced non-small cell lung cancer.
Zhe HUANG ; Fang WU ; Qinqin XU ; Lianxi SONG ; Xiangyu ZHANG ; Zhan WANG ; Li DENG ; Yongchang ZHANG ; Liang ZENG ; Nong YANG
Chinese Medical Journal 2023;136(12):1422-1429
BACKGROUND:
Immune checkpoint inhibitors (ICIs) are increasingly used as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) harboring no actionable mutations; however, data on their efficacy among patients presenting with intracranial lesions are limited. This study aimed to explore the efficacy and safety of ICIs combined with chemotherapy in advanced NSCLC patients with measurable brain metastasis at initial diagnosis.
METHODS:
Our study retrospectively analyzed clinical data of a total of 211 patients diagnosed with driver gene mutation-negative advanced NSCLC with measurable, asymptomatic brain metastasis at baseline from Hunan Cancer Hospital between January 1, 2019 and September 30, 2021. The patients were stratified into two groups according to the first-line treatment regimen received: ICI combined with chemotherapy ( n = 102) or chemotherapy ( n = 109). Systemic and intracranial objective response rates (ORRs) and progression-free survival (PFS) were analyzed. Adverse events were also compared between the groups.
RESULTS:
Compared with the chemotherapy-based regimen, the ICI-containing regimen was associated with a significantly higher intracranial (44.1% [45/102] vs . 28.4% [31/109], χ2 = 5.620, P = 0.013) and systemic (49.0% [50/102] vs . 33.9% [37/109], χ2 = 4.942, P = 0.019) ORRs and longer intracranial (11.0 months vs . 7.0 months, P <0.001) and systemic (9.0 months vs . 5.0 months, P <0.001) PFS. Multivariable analysis consistently revealed an independent association between receiving ICI plus platinum-based chemotherapy as a first-line regimen and prolonged intracranial PFS (hazard ratio [HR] = 0.52, 95% confidence interval [CI]: 0.37-0.73, P <0.001) and systemic PFS (HR = 0.48, 95% CI: 0.35-0.66, P <0.001). No unexpected serious adverse effects were observed.
CONCLUSION:
Our study provides real-world clinical evidence that ICI combined with chemotherapy is a promising first-line treatment option for driver gene mutation-negative advanced NSCLC patients who present with brain metastasis at initial diagnosis.
CLINICAL TRIAL REGISTRATION
https://www.clinicaltrials.gov/ , OMESIA, NCT05129202.
Humans
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Carcinoma, Non-Small-Cell Lung/genetics*
;
Lung Neoplasms/genetics*
;
Immune Checkpoint Inhibitors/therapeutic use*
;
Retrospective Studies
;
Brain Neoplasms/genetics*

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