1.Safety and efficacy of argon-helium cryoablation combined with targeted therapy and anti-programmed death-1 monoclonal antibody in treatment of patients with unresectable hepatocellular carcinoma aged 60 years or older
Shujuan GONG ; Xiujuan CHANG ; Yan LIU ; Dong JI ; Yan CHEN ; Quanwei HE ; Yongping YANG
Journal of Clinical Hepatology 2026;42(3):629-638
ObjectiveTo investigate whether anti-programmed death-1 (PD-1) monoclonal antibody can enhance the efficacy and safety of argon-helium cryoablation combined with targeted therapy in patients with unresectable hepatocellular carcinoma (uHCC) aged 60 years or older. MethodsA retrospective analysis was performed for the clinical data of 124 patients with advanced uHCC aged 60 years or older who were treated at The Fifth Medical Center of Chinese PLA General Hospital from January 2013 to September 2024. After propensity score matching, 57 patients received cryoablation combined with targeted therapy (double combination group), while 57 received cryoablation combined with targeted therapy and anti-PD-1 monoclonal antibody (triple combination group). The indicators for efficacy assessment included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the incidence rate of adverse events. The Mann-Whitney U test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups. The Kaplan-Meier method was used to plot survival curves, and the Log-rank test was used for comparison between groups. A Cox proportional-hazards regression model analysis was used to investigate the influencing factors for survival prognosis. ResultsThe triple combination group had a significantly higher ORR than the double combination group (59.6% vs 29.8%, χ2=9.083, P=0.003), while there was no significant difference in DCR between the two groups (87.7% vs 77.2%, χ2=1.516, P=0.218), and compared with the double combination group, the triple combination group had significantly longer median PFS (9.1 months vs 4.8 months, χ2=7.813, P=0.005) and median OS (26.1 months vs 13.6 months, χ2=14.199, P<0.001). The multivariate Cox proportional-hazards regression model analysis showed that triple combination treatment was an independent influencing factor for PFS (hazard ratio [HR]=0.52, 95% confidence interval [CI]: 0.35 — 0.78, P=0.001) and OS (HR=0.32, 95%CI: 0.20 — 0.51, P<0.001). There was no significant difference in the incidence rate of adverse events between the two groups (P>0.05). ConclusionTriple combination treatment with argon-helium cryoablation, targeted therapy, and anti-PD-1 monoclonal antibody can significantly improve survival benefits in uHCC patients aged 60 years or older, with a controllable safety profile.
2.Potential profiling of family health and its association with quality of life in Chinese patients with chronic diseases
Shujuan CHEN ; Xinyu WANG ; Xiuchun YANG ; Wei ZHOU ; Yihong JIANG ; Jinhong YANG
Chinese Journal of Practical Nursing 2025;41(24):1898-1907
Objective:To explore the potential profile characteristics of family health in patients with chronic diseases, analyze the influencing factors of different family health categories, and further investigate the relationship between family health categories and the quality of life in patients with chronic diseases, providing a scientific basis for targeted intervention strategies.Methods:This study was a cross-sectional survey. The data for the study were obtained from the Chinese Residents' Psychology and Behavior Survey Research Database. A multistage sampling method was employed to select 1 808 patients with chronic diseases as survey respondents from July to September 2021. Data were collected using the General Information Questionnaire, the Family Health Scale, and the European 5-Dimensional 5-Level Health Scale(EQ-5D-5L). Potential profiles of family health in patients with chronic diseases were identified using latent profile analysis. Univariate analysis and multiple Logistic regression were used to examine influencing factors, and generalized linear regression was performed to analyze the impact of different family health categories on quality of life.Results:A total of 1 808 chronic disease patients were enrolled, comprising 986 males and 822 females, with a age of (55.23 ± 7.02) years. The scores of family health, EQ-5D-5L, EuroQol Visual Analogue Scale were 38(34, 43), 0.94(0.84, 1.00), and 78(63, 87) points. The family health of patients with chronic diseases were categorized into three potential profiles: the low family health group (418 cases accounting for 23.1%), the medium family health group (747 cases accounting for 41.3%), and the high family health group (643 cases accounting for 35.6%). Multivariate Logistic regression analysis showed that family type, marital status, nature of household, education level, number of siblings and type of health insurance were significant factors influencing family health categories ( OR values were 0.464-2.503, all P<0.05). The family health was an important factor influencing quality of life ( χ2 values were 4.05-100.68, all P<0.05). Conclusions:There is significant heterogeneity in the family health of patients with chronic diseases, which can be divided into three distinct categories. Patients with higher family health levels have better quality of life. Medical professionals should develop precise intervention programs tailored to the characteristics of each category to improve family health levels and enhance the quality of life of patients with chronic diseases.
3.Relationship between macrophage activation related factors and clinical symptoms of schizophrenia
Jiao FANG ; Wenjin CHEN ; Wenkai ZHENG ; Mengzhuang GOU ; Yongli LIU ; Song CHEN ; Na LI ; Junchao HUANG ; Yanli LI ; Shujuan PAN ; Yunlong TAN
Chinese Mental Health Journal 2025;39(1):1-7
Objective:To investigate the relationship between macrophage activation related factors and clini-cal symptoms of schizophrenia(SCZ).Methods:Outpatient or inpatient SCZ patients(n=166)and normal con-trols(n=71)meeting the diagnostic criteria of DSM 4th edition were selected as subjects.The psychopathological symptoms were assessed by the Positive and Negative Syndrome Scale(PANSS),and the concentrations of α-Na-Galases,MAF and IL-18 were determined by enzyme-linked immunosorbent assay(ELISA).The correlation be-tween biological indicators and clinical symptoms was analyzed and the mediation effect was tested.Results:The concentrations of α-NaGalases(P<0.001)and MAF(P<0.01)in SCZ group were lower than those in normal control group.In SCZ group,IL-18 was negatively correlated with α-NaGalases concentration(r=-0.24,P<0.01).α-NaGalases was positively correlated with MAF concentration(r=0.67,P<0.001),and the total score of PANSS positive symptom scale was positively correlated with IL-18(r=0.21,P<0.05)and MAF concentration(r=0.22,P<0.01).The mediating effect of α-NaGalases and MAF was statistically significant,and the relative mediating effect accounted for 25.47%.Conclusion:The increase of IL-18 level may indicate the occurrence of positive symptoms of schizophrenia,and α-NaGalases and MAF may negatively regulate the inflammatory damage effect of IL-18 on SCZ,thereby reducing the positive symptoms.
4.Development and preliminary clinical evaluation of an optical digital border molding technique for soft tissue movement boundary in edentulous jaws
Xinkai XU ; Kehui DENG ; Sukun TIAN ; Hu CHEN ; Weiwei LI ; Xing SU ; Xiaobo ZHAO ; Xiaojun CHEN ; Chao MA ; Yongjie JIA ; Shujuan XIAO ; Yuchun SUN
Chinese Journal of Stomatology 2025;60(6):611-617
Objective:To address the critical issue of missing dynamic border molding information in edentulous direct digital impression technology, this study explores innovative digital solutions and conducts preliminary application validation.Methods:Based on the myostatic line theory, a methodology was established: intraoral scanner (IOS) high-frequency video was utilized to dynamically capture functional molding data of soft tissues, integrated with a self-developed mobility gradient recognition algorithm to achieve dynamic threshold segmentation between the muscle dynamic zone and myostatic zone, termed "optical digital molding technology". Ten edentulous patients with well-fitting complete dentures, treated at the Department of Prosthodontics, Peking University School and Hospital of Stomatology from January 2024 to December 2024, were enrolled. The standard deviation between the muscle static line (generated by mobility gradient algorithm with thresholds of 0.3-0.7 mm) and the denture border curve was analyzed to optimize the dynamic threshold, followed by single-case clinical validation.Results:Among the mobility thresholds of 0.3-0.7 mm, the 0.5 mm threshold yielded the smallest standard deviation between the myostatic line and denture border. Clinical validation demonstrated that dentures designed with this threshold exhibited no displacement during dynamic functional tests, with marginal sealing meeting clinical standards.Conclusions:The optical digital border molding technique for edentulous soft tissue boundaries translates the myostatic line theory into quantifiable parameters for the first time. Based on data from 10 cases, a mobility threshold of 0.5 mm is recommended for clinical application.
5.Comparison of the efficacy and safety of nanomicroneedle- versus ultrasound-mediated delivery of tranexamic acid for the treatment of melasma: a randomized controlled study
Jiemin ZHONG ; Wei LI ; Shujuan ZHANG ; Yan YANG ; Rujun XUE ; Xinyi LI ; Yanan KE ; Xiaoyin CHEN ; Quan CHEN
Chinese Journal of Dermatology 2025;58(9):829-833
Objective:To compare the clinical efficacy and safety of nanomicroneedle- versus ultrasound-mediated delivery of tranexamic acid for the treatment of melasma.Methods:A prospective, randomized, controlled study was conducted. Patients with melasma were collected from the Department of Dermatology, Guangzhou Dermatology Hospital from March 2023 to May 2024, and divided into a nanomicroneedle group (receiving nanomicroneedle-mediated delivery of tranexamic acid) and an ultrasound group (receiving ultrasound-mediated delivery of tranexamic acid) using the random number table method. Both groups underwent the treatment once a week for a total of 8 sessions. At week 12, outcomes including melasma area and severity index (MASI) scores, treatment response rates, VISIA brown spot scores, pain scores, and adverse reactions were evaluated and compared between the two groups. Statistical analyses were carried out using two-independent-sample t test, Mann-Whitney U test, and chi-square test. Results:A total of 80 patients with melasma were included, with 40 in each group. In the nanomicroneedle group, the patients were aged 40.35 ± 7.39 years (range: 25 - 55 years), with the disease duration being 8.45 ± 4.77 months (range: 1 - 16 months) ; in the ultrasound group, the patients were aged 40.25 ± 7.76 years (range: 25 - 55 years), and their disease duration was 10.45 ± 5.07 months (range: 2 - 17 months) ; there were no significant differences in ages or disease duration between the two groups (both P > 0.05). At week 12, both groups demonstrated reduced MASI scores compared to baseline scores, and the MASI scores were significantly lower in the nanomicroneedle group ( M[ Q1, Q3]: 5.80[4.20, 9.35]) than in the ultrasound group (8.65[5.70, 10.80], Z = 2.50, P = 0.012). The overall response rate was significantly higher in the nanomicroneedle group (97.5%, 39/40) than in the ultrasound group (55.0%, 22/40; χ2 = 19.95, P < 0.001). The lateral facial VISIA brown spot scores were also significantly lower in the nanomicroneedle group (left side: 126.18 ± 36.54 points; right side: 138.50 ± 40.76 points) than in the ultrasound group (left side: 142.37 ± 32.40 points; right side: 157.13 ± 39.59 points; t = -2.10, -2.07, P = 0.039, 0.041, respectively). In the nanomicroneedle group, the pain scores were 4.12 ± 1.47 points, and varying severity of adverse reactions such as erythema, edema and dryness occurred after operation, all of which resolved spontaneously within 48 hours. No marked adverse reactions were observed in the ultrasound group. Conclusion:Nanomicroneedle-mediated delivery of tranexamic acid demonstrated superior clinical efficacy and favorable safety profiles compared to the ultrasound-mediated delivery, providing more options for the treatment of melasma.
6.Establishment and evaluation of a rat model of perimenopausal dry eye with liver-kidney yin deficiency evidence
Sainan TIAN ; Guicheng LIU ; Yao CHEN ; Pei LIU ; Jun PENG ; Qinghua PENG ; Shujuan HU
Acta Laboratorium Animalis Scientia Sinica 2025;33(9):1270-1279
Objective To establish a rat model of perimenopausal dry eye with liver and kidney yin deficiency from the perspective of"measuring evidence by prescription"in Chinese medicine.Methods Thirty SPF-grade female SD rats were divided randomly into sham-operated,model,and Qiju Dihuang soup groups(n=10).Rats in the latter two groups underwent bilateral ovariectomy and were given 0.1%benzalkonium chloride eye drops combined with provocation for 10 weeks to establish a model of perimenopausal dry eye with liver and kidney yin deficiency.After modeling,rats in the Qiju Dihuang soup group were gavaged with Qiju Dihuang soup at a dose of 8.37 g/(kg·d),rats in the sham-operated and model groups were gavaged with saline at a rate of 1 mL/100(g·d)for 21 d.The general condition,retinal screen test scores,tear secretion,time of tear film rupture,and corneal fluorescein staining were observed and recorded in each group.Serum levels of follicle-stimulating hormone(FSH),estradiol(E2),and progesterone(PROG)were measured by enzyme-linked immunosorbent assay.Pathological damage to the cornea and lacrimal glands were detected by hematoxylin/eosin staining.Expression levels of the inflammatory factors interleukin(IL)-1β and tumor necrosis factor(TNF)-a in the cornea were detected by immunohistochemistry.Results Compared with the sham-operated group,rats in the model group showed behavioral signs of slow action and reaction,irritability,body mass loss,and increased anal temperature(P<0.05),decreased retinal screen test scores(P<0.05),tear secretion(P<0.05),and time of tear film rupture(P<0.05),and pathological damage to the cornea and lacrimal glands.FSH levels increased and E2 and PROG levels decreased(P<0.05)and expression levels of IL-1 and TNF-α increased in the model group compared with the sham group.All the above indexes were significantly improved in the Qiju Dihuang soup group compared with the model group.Conclusions From the perspective of"measuring evidence by formula"in Chinese medicine,we successfully established a rat model of perimenopausal dry eye with liver-kidney yin deficiency syndrome,which provides a theoretical and experimental basis for future systematic and in-depth research on the mechanism of perimenopausal dry eye with formula and evidence.
7.Prevalence and influencing factors of scoliosis among primary and secondary school students in Hunan Province, 2023.
Yang ZHOU ; Miyang LUO ; Jiayou LUO ; Shujuan XIAO ; Yanhua CHEN ; Yaqing TAN ; Fei WANG
Journal of Central South University(Medical Sciences) 2025;50(7):1202-1213
OBJECTIVES:
The detection rate of scoliosis among school-aged children has been rising annually, varying by region, and has become a major public health concern affecting both physical and mental health. Its onset is multifactorial, and early screening combined with targeted interventions can alter disease progression. This study aims to investigate the prevalence and influencing factors of scoliosis among primary and secondary school students in Hunan Province, providing scientific evidence for targeted prevention strategies.
METHODS:
A stratified, randomized cluster sampling method was used to select 281 401 students from 14 prefecture-level cities in Hunan Province for scoliosis screening, physical examination, and questionnaire survey. The chi-square test was used for group comparisons, and trend chi-square test analyzed differences in screening positive rate by age. A multilevel regression model was applied to identify influencing factors, and ArcGIS was used to visualize spatial distribution patterns of scoliosis.
RESULTS:
The overall screening positive rate for scoliosis among Hunan students was 1.61%. Urban areas had a significantly higher rate than rural counties (2.81% vs 0.98%; P<0.01). The rate was equal between boys and girls (1.61% each). Underweight students had a higher rate than those with normal weight, overweight, or obesity (P<0.01). Stratified by age, urban students aged 6-18 years consistently showed higher positive rates than rural peers (P<0.001). No significant gender differences were observed at most ages (all P>0.05), except at age 11, where the females had a higher rate (1.28% vs 1.02%; P=0.048). After age 11, underweight students exhibited significantly higher positive rates than those with normal or higher BMI(all P<0.05). Across all groups, urban/rural, male/female, underweight/normal/overweight/obese, the scoliosis rate increased with age. By region, the screening positive rate ranged from 0.38% to 3.36%, with the top three being Chenzhou (3.36%), Xiangtan (2.78%), and Hengyang (2.71%), while the lowest was Xiangxi Tujia and Miao Autonomous Prefecture (0.38%). Multilevel regression analysis revealed that age (OR=1.160, 95% CI 1.135 to 1.186) and urban residence (OR=2.497, 95% CI 1.946 to 3.205) were positively associated with scoliosis risk (both P<0.01). Conversely, female gender (OR=0.931, 95% CI 0.874 to 0.993), normal nutritional status (OR=0.751, 95% CI 0.671 to 0.840), overweight (OR=0.513, 95% CI 0.447 to 0.590), obesity (OR=0.418, 95% CI 0.358 to 0.489), and engaging in ≥ 60 minutes of moderate-to-vigorous physical activity 2 to 4 days (OR=0.928, 95% CI 0.865 to 0.996) or 5 to 7 days per week (OR=0.912, 95% CI 0.833 to 0.998) were negatively associated with scoliosis risk (all P<0.05).
CONCLUSIONS
The prevalence of scoliosis among primary and secondary school students in Hunan Province is relatively high and is significantly associated with age, gender, urban-rural status, nutritional condition, and physical activity frequency. Targeted interventions and enhanced monitoring in high-risk regions and populations are essential to prevent and control scoliosis.
Humans
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Scoliosis/epidemiology*
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Male
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Female
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Adolescent
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China/epidemiology*
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Prevalence
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Child
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Students/statistics & numerical data*
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Rural Population/statistics & numerical data*
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Urban Population/statistics & numerical data*
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Surveys and Questionnaires
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Risk Factors
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Thinness/epidemiology*
8.Analysis of myopia detection rate and influencing factors among primary and secondary school students in Hunan Province in 2022
Shujuan XIAO ; Miyang LUO ; Zhihang HUANG ; Yang ZHOU ; Fei WANG ; Yaqing TAN ; Yanhua CHEN
Chinese Journal of Epidemiology 2025;46(6):1014-1022
Objective:To determine the detection rate of myopia among primary and secondary school students in Hunan Province in 2022 and to analyze the influencing factors at both the school and individual levels, thereby providing a scientific basis for developing myopia prevention and control strategies.Methods:From October to November 2022, a multi-stage stratified cluster random sampling method was employed to select students from Year 4 of primary school to Year 3 of senior high school across 14 prefecture-level (autonomous prefecture) cities in Hunan Province for vision screening and questionnaire surveys. A multilevel regression model was utilized to analyze the influencing factors of myopia at both the school and individual levels.Results:A total of 189 343 primary and secondary school students were included in this study. The overall myopia detection rate was 55.56%, with a significantly higher prevalence observed in female students (60.49%) compared to males (51.03%) and in urban students (59.12%) versus those from rural areas (53.50%). A marked upward trend in myopia prevalence was identified with advancing grade levels (trend test χ2=16 246.13, P<0.001). Multilevel regression analysis revealed that at the individual level, female gender, higher grade level, parental myopia history, daily homework duration ≥2 hours after school, improper reading/writing postures, and taking breaks only after more than 15 minutes of near work were associated with an increased risk of myopia. Conversely, adequate sleep duration, outdoor activity ≥2 hours, and outdoor breaks during recess demonstrated protective effects. At the school level, non-compliant blackboard illumination uniformity emerged as a significant risk factor for myopia development. Conclusions:The detection rate of myopia among primary and secondary school students in Hunan Province remains relatively high and is associated with multiple factors at both the school and individual levels. Targeted interventions should be implemented at different levels to mitigate the risk of myopia.
9.A study on the value of thromboelastography-guided antiplatelet therapy in preventing cerebral ischemic events after stent-assisted coil embolization of intracranial aneurysms
Yingqi WANG ; Xiaoming ZHOU ; Qi WU ; An ZHANG ; Hui DING ; Shujuan CHEN ; Jinlong DENG ; Xin ZHANG
Chinese Journal of Cerebrovascular Diseases 2025;22(6):395-402
Objective To investigate the value of adjusting antiplatelet treatment regimens guided by thromboelastography(TEG)in predicting cerebral ischemic events after stent-assisted embolization of intracranial aneurysms.Methods This study retrospectively and consecutively enrolled patients with intracranial aneurysms who underwent stent-assisted coil embolization admitted to the Department of Neurosurgery of the General Hospital of Eastern Theater Command,from March 2022 to May 2024.Baseline and clinical data of the patients,including gender,age,hypertension,diabetes,dyslipidemia,smoking history,drinking history,and intraoperative use of tirofiban were collected.Antiplatelet therapy(conventional dose aspirin[100 mg once daily]+clopidogrel[75 mg once daily])was initiated immediately after the diagnosis of intracranial aneurysm,and TEG was performed 3 days later.According to the platelet inhibition rate in TEG parameters(platelet inhibition rate induced by arachidonic acid[AA]pathway[AA inhibition rate]or adenosine diphosphate[ADP]pathway[ADP inhibition rate],AA inhibition rate ≥ 50%indicated aspirin effectiveness,AA inhibition rate<50%indicated aspirin resistance;ADP inhibition rate ≥ 30%indicated clopidogrel effectiveness,ADP inhibition rate<30%indicated clopidogrel resistance),the patients were divided into the control group(TEG test results met the criteria,i.e.,AA inhibition rate ≥ 50%and ADP inhibition rate ≥ 30%),the conventional dual antiplatelet therapy group(TEG test results did not meet the criteria but were not adjusted for antiplatelet therapy,i.e.,AA inhibition rate<50%and/or ADP inhibition rate<30%,but with complex aneurysm morphology[such as irregular shape,daughter sac formation]or high bleeding risk,continuing conventional dual antiplatelet therapy),and the intensified group(TEG test results did not meet the criteria and the antiplatelet therapy regimen was adjusted,i.e.,AA inhibition rate<50%and/or ADP inhibition rate<30%,adjusting the antiplatelet therapy regimen).All patients underwent stent-assisted coil embolization after TEG testing.From 0 to 3 months after the operation,all three groups maintained the above antiplatelet therapy.At 3 months after the operation,routine head MRI,CT and other examinations were performed.If no cerebral ischemic events occurred and the imaging results were satisfactory(good stent position,no aneurysm occlusion residual or slight residual at the neck[neck width of the aneurysm 2mm]),the treatment could be adjusted to single antiplatelet therapy(aspirin 100 mg once daily).If a patient experienced a cerebral ischemic event during the follow-up period,regardless of the stage after the operation,dual antiplatelet therapy(aspirin[100mg once daily]+clopidogrel[75 mg once daily])was immediately restarted or maintained and continued for at least 6 months.The primary endpoint was intraoperative and 6-months postoperative cerebral ischemic events(including DSA-confirmed intraoperative acute thrombosis and infarction foci confirmed by head CT or MRI).Baseline and clinical data of the three groups were compared.All patients were divided into groups with ischemic stroke event and without according to the primary endpoint,univariate Logistic regression analysis was then performed on both groups.Variables with P<0.1 in the univariate Logistic regression analysis were included in the multivariate Logistic regression analysis to explore the influencing factors of cerebral ischemic events after stent-assisted coil embolization for intracranial aneurysms.Results A total of 499 patients were included,including 178 males and 321 females,with a median age of 59(53,68)years.Among them,there were 341 patients in the control group,42 in the conventional dual antiplatelet therapy group,and 116 in the intensified group.There were 47 cases of cerebral ischemic events and 452 cases without cerebral ischemic events.There was a statistically significant difference in the intraoperative use rate of tirofiban across the control group,the conventional dual antiplatelet therapy group,and the intensified group(20.2%[69/341]vs.26.2%[11/42]vs.42.2%[49/116],P<0.01);no statistically significant differences were observed among the three groups in terms of age,gender composition,the proportion of patients with hypertension,diabetes,dyslipidemia,smoking history,drinking history,and the incidence of cerebral ischemic events(all P>0.05).The results of multivariate Logistic regression analysis showed that hypertension(OR,2.924,95%CI 1.416-6.037,P=0.004)and intraoperative use of tirofiban(OR,3.638,95%CI 1.892-6.996,P<0.01)were independent risk factors for intraoperative and 6-months postoperative cerebral ischemic events after stent-assisted coil embolization in patients with intracranial aneurysms.In comparison with the control group,the intensified group has reduced the risk of cerebral ischemic events(OR,0.238,95%CI 0.088-0.646,P=0.005),while there was no statistically significant difference between the conventional dual antiplatelet therapy group and the control group(OR,0.521,95%CI 0.149-1.826,P=0.308).Conclusions This study demonstrates that adjusting the antiplatelet therapy regimens in patients with intracranial aneurysms who did not meet the platelet inhibition rate based on TEG results can significantly reduce the risk of intraoperative and 6-months postoperative cerebral ischemic events.These finding may require validation through further,large-scaled,prospective studies.
10.Interpretation of"Guideline 9213 for validation,verification,and transfer of microbiological analytical methods"in Chinese Pharmacopoeia 2025 Edition
Yan YANG ; Hong SHAO ; Shujuan WANG ; Rong FU ; Qian YANG ; Junhao CHEN ; Zhen SHEN ; Chunyan AN ; Yiling FAN ; Meicheng YANG ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):462-467
The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.

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