1.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
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Alzheimer Disease/drug therapy*
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Male
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Female
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Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
2.Research on the equity of maternal health service utilization in Changning District, Shanghai
Ying HUANG ; Wenli FANG ; Fang BU ; Ye SHEN ; Ning QIAN ; Xuelin BAI ; Shuo YU ; Ji LIANG
Journal of Public Health and Preventive Medicine 2025;36(6):137-141
Objective To understand the equity and influencing factors of maternal health service utilization in Changning District, Shanghai. Methods A convenience sampling method was used to conduct a questionnaire survey among mothers of children aged 1 to 1.5 years old who received health services from the child health care clinics and EPI clinics of 10 community health service centers in Changning District, Shanghai from March to April 2022. Count data was expressed by frequency and percentage. Chi-square analysis, binomial logistic regression analysis, and multivariate logistic regression analysis were used to analyze fairness-related factors. Rate difference, rate ratio and concentration index were used to represent fairness. Results A total of 696 subjects were investigated, with an average age of (33.35±4.76) years. There were statistically significant differences in service utilization among women with different household registrations only in early pregnancy registration (χ2=11.026, P=0.001) and postpartum visits (χ2=4.989, P=0.026). Women with a career showed differently in folic acid supplement (χ2=6.247, P=0.012), early pregnancy registration (χ2=12.989, P=0.002), physical examination in 42 days postpartum (χ2=4.446, P=0.035) and postpartum contraception (χ2=4.061, P=0.044), and the differences were statistically significant. Women with different monthly family income had a statistically significant difference in pre-pregnancy examination (χ2=8.977, P=0.030) and postpartum visit (χ2=16.114, P=0.001). There was a statistically significant difference between women with maternity insurance or not in the early pregnancy registration (χ2=10.576, P=0.001) and physical examination in 42 days postpartum (χ2=8.166, P=0.004). The results of the multivariate analysis showed that occupation (OR=2.616, 95% CI: 1.142-5.990) and maternity insurance (OR=4.490, 95% CI: 1.992~10.120) affected the utilization of service in early pregnancy registration. The monthly household income (OR=0.278, 95% CI: 0.124-0.625) affected the utilization of services in postpartum visit. At the same time, the monthly household income (10,000-19,999: OR=0.286, 95% CI: 0.090-0.907; ≥30,000: OR=0.180, 95% CI: 0.041-0.801) also affected the utilization of service in physical examination in 42 days postpartum. Conclusion The equity of maternal health care service utilization overall is good in central area in Shanghai, but there is still room for improvement. It is necessary to strengthen community mobilization, propagandize maternal health services, and expand the coverage of maternity insurance to improve the equity of maternal health service utilization and provide equal access to maternity health services.
3.Conditional Tnfaip6-Knockout in Inner Ear Hair Cells Does not Alter Auditory Function.
Yue QIU ; Song GAO ; Xiaoqiong DING ; Jie LU ; Xinya JI ; Wenli HAO ; Siqi CHENG ; Haolinag DU ; Yajun GU ; Chenjie YU ; Cheng CHENG ; Xia GAO
Neuroscience Bulletin 2025;41(3):421-433
Noise-induced hearing loss is a worldwide public health issue that is characterized by temporary or permanent changes in hearing sensitivity. This condition is closely linked to inflammatory responses, and interventions targeting the inflammatory gene tumor necrosis factor-alpha (TNFα) are known to mitigate cochlear noise damage. TNFα-induced proteins (TNFAIPs) are a family of translucent acidic proteins, and TNFAIP6 has a notable association with inflammatory responses. To date, there have been few reports on TNFAIP6 levels in the inner ear. To elucidate the precise mechanism, we generated transgenic mouse models with conditional knockout of Tnfaip6 (Tnfaip6 cKO). Evaluation of hair cell morphology and function revealed no significant differences in hair cell numbers or ribbon synapses between Tnfaip6 cKO and wild-type mice. Moreover, there were no notable variations in hair cell numbers or hearing function in noisy environments. Our results indicate that Tnfaip6 does not have a substantial impact on the auditory system.
Animals
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Mice, Knockout
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Hair Cells, Auditory, Inner/pathology*
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Mice
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Mice, Transgenic
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Hearing Loss, Noise-Induced
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Evoked Potentials, Auditory, Brain Stem/physiology*
4.Study on Correlation Between Traditional Chinese Medicine Syndrome Elements and Risk Factors in Patients with Type Ⅱ Cardio-renal Syndrome
Rong YU ; Hanchao HUANG ; Huan DENG ; Wenli DING ; Yanping ZENG
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(7):1568-1573
Objective To investigate the correlation between traditional Chinese medicine(TCM)syndrome elements and risk factors in patients with type Ⅱ cardio-renal syndrome(CRS).Methods A retrospective analysis was conducted on the medical records of 116 patients with type Ⅱ CRS.The distribution of TCM syndrome elements was analyzed,and the correlation between the syndrome elements and risk factors of gender,age,smoking history,alcohol consumption history,coronary heart disease,hypertension,diabetes,and anemia were evaluated.Results(1)The analysis of syndrome elements of 116 patients with type Ⅱ CRS showed that the main disease-location elements were heart(96 cases,82.76%),lung(89 cases,76.72%),kidney(81 cases,69.83%),spleen(71 cases,61.21%),and liver(25 cases,21.56%);the main disease-nature elements were qi deficiency(113 cases,97.41%),blood deficiency(96 cases,82.76%),yang deficiency(95 cases,81.89%),phlegm(94 cases,81.03%),yin deficiency(90 cases,77.59%),dampness(61 cases,52.59%),water retention(55 cases,47.41%),and blood stasis(47 cases,40.52%).(2)The analysis of age groups of 116 patients with type Ⅱ CRS showed that the majority of the patients were middle-aged and elderly individuals over 60 years old,and the age groups covered<60 years old(4 cases,3.45%),61-70 years old(10 cases,8.62%),71-80 years old(28 cases,24.14%),81-90 years old(64 cases,55.17%),and>90 years old(10 cases,8.62%).(3)The analysis of gender of 116 patients with type Ⅱ CRS showed that 46 cases(39.66%)were male,and 70 cases(60.34%)were female,the female outnumbering the male.(4)The exploration of correlation between TCM syndrome elements and risk factors with Logistic regression analysis showed that blood deficiency was positively correlated with alcohol consumption,hypertension,and anemia(P<0.05 or P<0.01),yang deficiency was positively correlated with anemia(P<0.05),yin deficiency was positively correlated with smoking and diabetes(P<0.05),dampness was positively correlated with smoking and anemia(P<0.01),water retention was positively correlated with gender and protein abnormalities(P<0.05 or P<0.01),and blood stasis was positively correlated with hypertension(P<0.05).Conclusion The illness of type Ⅱ CRS is located in the heart,involving the five organs,and is closely related to the lungs and kidneys.The general pathogenesis of type Ⅱ CRS is characterized by being deficiency of qi and yang in the root cause,and having the symptom manifestations of phlegm and blood stasis.In type Ⅱ CRS patients,men are more likely to suffer water retention,smokers are more likely to suffer yin deficiency and dampness,drinkers are more likely to suffer blood deficiency,individuals with hypertension are more likely to suffer blood deficiency and blood stasis,individuals with diabetes are more likely to suffer yin deficiency,individuals with anemia are more likely to suffer blood deficiency,yang deficiency and dampness,and individuals with protein abnormalities are more likely to suffer water retention.
5.Development and validation of a clinical prediction model for postoperative pulmonary complications in elderly patients following general anesthesia
Jingjun ZHANG ; Lili JIA ; Mingwei SHENG ; Ying SUN ; Mei DING ; Weihua LIU ; Hongxia LI ; Yiqi WENG ; Wenli YU
Chinese Journal of Emergency Medicine 2025;34(9):1237-1244
Objective:To develop and validate a clinical prediction model for assessing the risk of postoperative pulmonary complications (PPCs) in elderly patients undergoing surgery with general anesthesia.Methods:This prospective observational study enrolled patients aged ≥65 years who underwent general anesthesia with mechanical ventilation duration >3 hours across six tertiary hospitals between December 2022 and August 2023. Based on follow-up outcomes (until discharge or postoperative day 7), patients were categorized into a non-PPCs group and a PPCs group. Detailed records included baseline patient characteristics, preoperative comorbidities, surgical information (type, duration), and bedside lung ultrasound scores (LUS) assessed within 24 hours postoperatively using a standardized 12-zone protocol. Predictor selection was performed using LASSO regression. Significant predictors identified were incorporated into a multivariate logistic regression analysis to build the prediction model, visualized as a nomogram. Internal validation was conducted via bootstrap resampling (1 000 repetitions). Model performance was evaluated using the area under the receiver operating characteristic curve (AUC) for discrimination, calibration curves for calibration accuracy, and decision curve analysis (DCA) for clinical utility.Results:A total of 130 eligible elderly surgical patients were included. PPCs occurred in 17 patients (incidence rate: 13.1%). Multivariate analysis identified LUS ( OR=1.248, 95% CI: 1.099-1.417, P=0.001) and elective surgery type ( OR=0.206, 95% CI: 0.043-0.988, P=0.048) as independent predictors of PPCs. The nomogram model demonstrated an AUC of 0.867 (95% CI: 0.775-0.959) upon initial testing. Internal validation confirmed good discrimination (AUC=0.863, 95% CI: 0.778-0.972). Calibration curves indicated excellent agreement between predicted probabilities and observed outcomes. Decision curve analysis demonstrated significant clinical net benefit across a wide range of threshold probabilities (0.03-0.89). Conclusions:The clinical prediction model, developed using early postoperative LUS scores and surgical type, effectively predicts the risk of postoperative pulmonary complications in elderly patients following surgery under general anesthesia. The model exhibits strong discrimination, calibration, and clinical utility, providing clinicians with a reliable tool for individualized risk assessment to support clinical decision-making and potentially reduce PPC incidence.
6.Effect of subanesthetic dose of esketamine on postoperative hyperalgesia and postpartum depression in patients undergoing caesarean section
Li AO ; Jianhui GAN ; Wenli YU ; Yaowu BAI ; Jinlin SHI
Chongqing Medicine 2024;53(5):690-695
Objective To investigate the effect of subanesthetic dose of esketamine on remifentanil-in-duced hyperalgesia after cesarean section under general anesthesia,and its effect on serum homocysteine(Hcy)level and postpartum depression.Methods A total of fifty patients undergoing cesarean section under general anesthesia were randomly divided into the esketamine group and the control group(25 cases in each group).The two groups were given esketamine 0.2 mg/kg and the same amount of normal saline by slow in-jection 10 min after fetal delivery.Then,the extubation time,visual analogue scale(VAS)score within two hours after operation,and consumption of morphine while in the post-anaesthesia care unit(PACU)were compared between the two groups.The Edinburgh Postnatal Depression Scale(EPDS)scores were compared at one day before surgery,one day,four days,and one month after surgery.Serum Hcy levels were measured at one day before surgery,one day and four days after surgery.Results There was no significant difference in extubation time between the two groups(P>0.05).Compared with the control group,it took a longer time for patients in the esketamine group to have a VAS score≥4 for the first time,but the time from morphine injection to a VAS score<4 was shortened(P<0.05).The amount of morphine used in the esketamine group was lower than that in the control group in PACU(P<0.05).Compared with the control group,the VAS scores of the esketamine group decreased at 15 min,30 min,45 min,one hour,and 90 min after surgery(P<0.05),while there was no statistical significance difference in VAS scores at two hours after surgery(P<0.05).EPDS scores in the esketamine group were lower than those in the control group at one day and four days after surgery(P>0.05),but there was no statistically significant between the two groups at one month after surgery(P>0.05).Serum Hcy level in the esketamine group was lower than that in the control group at one day and four days after surgery(P<0.05).Conclusion The subanesthetic dose of esketamine during caesarean section under general anesthesia can effectively relieve remifentanil-induced postoperative hy-peralgesia and prevent the occurrence of postpartum depression.
7.Effects of γ-Aminobutyric Acid on the Growth and Related Physiological Metabolism of Plantlets of Tetrastigma hemsleyanum Diels et Gilg From Huaiyu Mountain Under Low Temperature Stress
Senrong HONG ; Huanyuan YU ; Ruiling PENG ; Wenli LIU ; Tengxin HU ; Yuting WANG
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(1):132-140
Objective To explore the effect of γ-aminobutyric acid(GABA)on the growth and related physiological metabolism of plantlets of Tetrastigma hemsleyanum Diels et Gilg from Huaiyu Mountain under low temperature stress,which provides a basis for its application of anti-freezing and cold resistance in the wild-imitation cultivation of T.hemsleyanum Diels et Gilg from Huaiyu mountain.Methods Plantlets of T.hemsleyanum Diels et Gilg from Huaiyu Mountain,which were treated with GABA under low temperature stress,were selected as research objects.The growth indicators,physiological indexes,the relative expression levels of chalcone synthase and flavonol synthase genes were measured using plant tissue culture,physiological and biochemical methods and qRT-PCR,respectively.Results Compared with the control group without GABA,the proliferation coefficient,plant height,fresh weight,dry weight,and tissue water content of the two cultivated plantlets of T.hemsleyanum Diels et Gilg from Huaiyu Mountain("Huaiyu 1"and"Huaiyu 2")reach their maximum value when 0.5 g·L-1 GABA was added to the culture medium.Moreover,content of soluble protein(SP),soluble sugar(SS),proline(Pro),reduced glutathione(GSH),ascorbic acid(AsA),indole acetic acid(IAA),zeatin nucleoside(ZR),gibberellin(GA3),jasmonic acid(JA),the activity of superoxide dismutase(SOD),peroxidase(POD),ascorbic acid peroxidase(APX)and glutathione reductase(GR),and the relative expression level(RQ value)of chalcone synthase(CHS)gene were significantly increased.Moreover,relative conductivity,content of abscisic acid(ABA),hydrogen peroxide(H2O2),malondialdehyde(MDA),rate of O2·-production,and relative expression levels(RQ value)of flavonol synthase(FLS)gene were obviously decreased.The growth of plantlets of T.hemsleyanum Diels et Gilg from Huaiyu Mountain,which were treated with GABA under low temperature stress,was positively correlated with the contents of IAA,ZR,GA3,JA,SS,AsA,GSH,and the expression of CHS genes.Conclusion Appropriate concentration of GABA can regulate the contents of endogenous plant hormones and osmoregulation substances,antioxidant substances,and the expression of key genes in secondary metabolites,so as to promote the growth of plantlets of T.hemsleyanum Diels et Gilg from Huaiyu Mountain under low temperature stress.
8.Comparison of interoperability among the standard systems of Chinese,the United States,European,and Japanese Pharmacopoeias and other standard systems
Xinyi XU ; Zhen LIU ; Leran TAO ; Haoyun SONG ; Dan LI ; Wenli YU ; Guannan WANG ; Heng LI ; Yun WANG ; Zhaopeng YANG
China Pharmacist 2024;27(2):233-241
Objective To provide reference for the optimization and improvement of interoperability between the standard system of the Chinese Pharmacopoeia and other standards.Methods The interoperability of various pharmacopoeia standard systems was compared by searching for citations from the Chinese Pharmacopoeia,the United States Pharmacopoeia-National Formulary,the European Pharmacopoeia,the Japanese Pharmacopoeia,and other standards,including references to domestic regulations and guidelines,standards of the International Organization for Standardization,guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use,documents of the World Health Organization,and standards from other countries and international organizations.Results In recent years,pharmacopoeias in the world had continuously increased the citation of non pharmacopoeial standards.The types,quantities,and fields of the United States Pharmacopoeia-National Formulary referencing other standards far exceed those of other pharmacopoeias.The Chinese Pharmacopoeia cites the least number of other standards.Conclusion It is suggested that the Chinese Pharmacopoeia should enhance the interoperability with other standard systems in the standards of various professional fields,enhance the openness,harmonization and advantages,and form a more complete standard system.
9.Protective effect of miR-346 up-regulated by crocin on myocardial ischemia reperfusion injury in rats
Hongxia LI ; Yingying KANG ; Yao LI ; Wenli YU
International Journal of Biomedical Engineering 2024;47(4):335-341
Objective:To explore the protective effect of miR-346 up-regulated by crocin on myocardial ischemia reperfusion injury in rats.Methods:The rat model of myocardial ischemia reperfusion was constructed by open-chest ligation of the left anterior descending coronary artery followed by reperfusion. Fifty male SD rats were randomly divided into the sham operation group, model group, crocin group, miR-346 negative control (miR-NC) group, and miR-346 inhibitor group with 10 rats in each group. Rats in the sham operation group were only received thoracotomy without ligation. Rats in the miR-NC group and miR-346 inhibitor group were injected with miR-NC or miR-346 inhibitor through the tail vein 48 h prior to ligation of the left anterior descending coronary artery ligation. The crocetin reagent for gastric lavage was prepared by dissolving 8 mg of crocetin in 100 ml of physiological saline. Rats in the crocetin group, miR-NC group, and miR-346 inhibitor group were gavaged with crocetin reagent at 80 mg/kg. Rats in the sham operation group and model group were gavaged with saline at 5 ml/kg. The crocetin reagent and saline were gavaged once a day for 15 days. Serum levels of creatine kinase-MB (CK-MB) and lactate dehydrogenase (LDH) were detected by enzyme-linked immunosorbent assay (ELISA). The miR-346 expression level was detected by real-time fluorescence quantitative PCR (qRT-PCR). The pathological changes in cardiac muscle tissues were detected by HE staining. Cardiomyocyte apoptosis rate was detected by TUNEL staining. The expression levels of apoptosis-related proteins were detected by Western Blot.Results:Compared with the sham operation group, the serum levels of CK-MB and LDH, pathological scores, cardiomyocyte apoptosis rate and expression of cleaved cysteinyl aspartate specific proteinase-3 (cleaved Caspase-3) and B-cell lymphoma-2 (Bcl-2)-associated X protein (Bax) were increased in the model group (all P < 0.05), and the miR-346 expression level and Bcl-2 levels in myocardial tissues were decreased (all P < 0.05). Compared with the model group, serum CK-MB and LDH levels, pathological scores, cardiomyocyte apoptosis rate, and cleaved Caspase-3 and Bax expression levels were decreased in the crocin group (all P < 0.05), and miR-346 expression level and Bcl-2 levels in the myocardial tissues were increased (all P < 0.05). Compared with the miR-NC group, the serum levels of CK-MB, LDH, pathological scores, cardiomyocyte apoptosis rate, and cleaved Caspase-3 and Bax expression levels were decreased in the miR-346 inhibitor group (all P < 0.05), and miR-346 expression level and Bcl-2 level were increased in myocardial tissues (all P < 0.05). Conclusions:Crocin can reduce myocardial tissue injury and attenuate cardiomyocyte apoptosis in myocardial ischemia-reperfusion rats by up-regulating miR-346.
10.Effect of s-ketamine on perioperative myocardial injury in patients undergoing liver transplantation
Hongyu HUO ; Lu CHE ; Yuli WU ; Yiqi WENG ; Wenli YU ; Jiangang XU
Chinese Journal of Anesthesiology 2024;44(6):657-661
Objective:To evaluate the effect of s-ketamine on perioperative myocardial injury in patients undergoing liver transplantation.Methods:This was a prospective randomized controlled study. Sixty American Society of Anesthesiologists Physical Status classification Ⅲ or Ⅳ patients, aged 18-64 yr, with New York Heart Association classⅠ-Ⅲ, undergoing elective liver transplantation with general anesthesia in our hospital from May to October 2023, were divided into 2 groups ( n=30 each) using a random number table method: s-ketamine group (group S) and control group (group C). In group S, s-ketamine was intravenously injected at a dose of 0.5 mg/kg after induction of anesthesia, followed by an infusion of 0.5 mg·kg -1·h -1 until the end of surgery. The equal volume of normal saline was given instead in group C. Central venous blood samples were collected after induction of anesthesia (T 0), at 30 min of anhepatic phase (T 1), 30 min of neopepatic phase (T 2), abdominal closure (T 3), 24 h after operation (T 4) and 72 h after operation (T 5) for determination of the concentrations of serum high-sensitivity cardiac troponin I, creatine kinase-MB isoenzyme, N-terminal pro-B-type natriuretic peptide, tumor necrosis factor-α, interleukin-6 (IL-6), IL-10 and high-mobility group protein B1 by enzyme-linked immunosorbent assay. The occurrence of adverse cardiac events during surgery and within 24 h after surgery, postoperative mechanical ventilation time, time of intensive care unit stay, and postoperative length of hospital stay were recorded. Results:Compared with group C, the concentrations of serum high-sensitivity cardiac troponin I, creatine kinase-MB isoenzyme, N-terminal pro-B-type natriuretic peptide, tumor necrosis factor-α and IL-6 at T 2-5 and high-mobility group protein B1 at T 2-4 were significantly decreased, the concentrations of serum IL-10 were increased at T 2-5, the incidence of myocardial ischemia was decreased, the mechanical ventilation time was shortened ( P<0.05), and no significant change was found in the time of intensive care unit stay and postoperative length of hospital stay in S group ( P>0.05). Conclusions:Intraoperative usage of s-ketamine can inhibit the inflammatory responses and reduce perioperative myocardial injury in the patients undergoing liver transplantation.


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