1.Changes in renal function in chronic hepatitis B patients treated initially with entecavir versus tenofovir alafenamide fumarate and related influencing factors
Shipeng MA ; Yanqing YU ; Xiaoping WU ; Liang WANG ; Liping LIU ; Yuliang ZHANG ; Xin WAN ; Shanfei GE
Journal of Clinical Hepatology 2025;41(1):44-51
ObjectiveTo investigate the influence of entecavir (ETV) versus tenofovir alafenamide fumarate (TAF) on renal function in previously untreated patients with chronic hepatitis B (CHB). MethodsA retrospective analysis was performed for the clinical data of 167 previously untreated CHB patients who received ETV or TAF treatment for at least 48 weeks at the outpatient service of Department of Infectious Diseases in The First Affiliated Hospital of Nanchang University from September 2019 to November 2023, and according to the antiviral drug used, they were divided into ETV group with 117 patients and TAF group with 50 patients. In order to balance baseline clinical data, propensity score matching (PSM) was used for matching and analysis at a ratio of 2∶1, and the two groups were compared in terms of estimated glomerular filtration rate (eGFR) and the incidence rate of abnormal renal function at week 48. According to eGFR at week 48, the patients were divided into normal renal function group and abnormal renal function group. The independent-samples t test or 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 multivariate Logistic regression analysis was used to investigate the influencing factors for abnormal renal function, and the receiver operating characteristic (ROC) curve was used to assess the performance of each indicator in predicting abnormal renal function. The Kaplan-Meier method was used to analyze the cumulative incidence rate of abnormal renal function, and the log-rank test was used for comparison. The analysis of variance with repeated measures was used to compare the dynamic changes of eGFR during antiviral therapy in CHB patients. ResultsAfter PSM matching, there were 100 patients in the ETV group and 50 patients in the TAF group. There were no significant differences in baseline clinical data between the ETV group and the TAF group (all P>0.05), with an eGFR level of 112.29±9.92 mL/min/1.73 m2 in the ETV group and 114.72±12.15 mL/min/1.73 m2 in the TAF group. There was a reduction in eGFR from baseline to week 48 in both groups, and compared with the TAF group at week 48, the ETV group had a significantly lower eGFR (106.42±14.12 mL/min/1.73 m2 vs 112.25±13.44 mL/min/1.73 m2, t=-2.422, P=0.017) and a significantly higher incidence rate of abnormal renal function (17.00% vs 4.00%, χ2=5.092, P=0.024). After the patients were divided into normal renal function group with 131 patients and abnormal renal function group with 19 patients, the univariate analysis showed that there were significant differences between the two groups in age (Z=-2.039, P=0.041), treatment drug (ETV/TAF) (χ2=5.092, P=0.024), and baseline eGFR level (t=4.023, P<0.001), and the multivariate Logistic regression analysis showed that baseline eGFR (odds ratio [OR]=0.896, 95% confidence interval [CI]: 0.841 — 0.955, P<0.001) and treatment drug (OR=5.589, 95%CI: 1.136 — 27.492, P=0.034) were independent influencing factors for abnormal renal function. Baseline eGFR had an area under the ROC curve of 0.781 in predicting abnormal renal function in CHB patients, with a cut-off value of 105.24 mL/min/1.73 m2, a sensitivity of 73.68%, and a specificity of 82.44%. The Kaplan-Meier curve analysis showed that the patients with baseline eGFR≤105.24 mL/min/1.73 m2 had a significantly higher cumulative incidence rate of abnormal renal function than those with baseline eGFR>105.24 mL/min/1.73 m2 (χ2=22.330, P<0.001), and the ETV group had a significantly higher cumulative incidence rate of abnormal renal function than the TAF group (χ2=4.961, P=0.026). With the initiation of antiviral therapy, both the ETV group and the TAF group had a significant reduction in eGFR (F=5.259, P<0.001), but the ETV group only had a significant lower level of eGFR than the TAF group at week 48 (t=-2.422, P=0.017); both the baseline eGFR≤105.24 mL/min/1.73 m2 group and the baseline eGFR>105.24 mL/min/1.73 m2 group had a significant reduction in eGFR (F=5.712, P<0.001), and there was a significant difference in eGFR between the two groups at baseline and weeks 12, 24, 36, and 48 (t=-13.927, -9.780, -8.835, -9.489, and -8.953, all P<0.001). ConclusionFor CHB patients initially treated with ETV or TAF, ETV antiviral therapy has a higher risk of renal injury than TAF therapy at week 48.
2.Development and Initial Validation of the Multi-Dimensional Attention Rating Scale in Highly Educated Adults.
Xin-Yang ZHANG ; Karen SPRUYT ; Jia-Yue SI ; Lin-Lin ZHANG ; Ting-Ting WU ; Yan-Nan LIU ; Di-Ga GAN ; Yu-Xin HU ; Si-Yu LIU ; Teng GAO ; Yi ZHONG ; Yao GE ; Zhe LI ; Zi-Yan LIN ; Yan-Ping BAO ; Xue-Qin WANG ; Yu-Feng WANG ; Lin LU
Chinese Medical Sciences Journal 2025;40(2):100-110
OBJECTIVES:
To report the development, validation, and findings of the Multi-dimensional Attention Rating Scale (MARS), a self-report tool crafted to evaluate six-dimension attention levels.
METHODS:
The MARS was developed based on Classical Test Theory (CTT). Totally 202 highly educated healthy adult participants were recruited for reliability and validity tests. Reliability was measured using Cronbach's alpha and test-retest reliability. Structural validity was explored using principal component analysis. Criterion validity was analyzed by correlating MARS scores with the Toronto Hospital Alertness Test (THAT), the Attentional Control Scale (ACS), and the Attention Network Test (ANT).
RESULTS:
The MARS comprises 12 items spanning six distinct dimensions of attention: focused attention, sustained attention, shifting attention, selective attention, divided attention, and response inhibition.As assessed by six experts, the content validation index (CVI) was 0.95, the Cronbach's alpha for the MARS was 0.78, and the test-retest reliability was 0.81. Four factors were identified (cumulative variance contribution rate 68.79%). The total score of MARS was correlated positively with THAT (r = 0.60, P < 0.01) and ACS (r = 0.78, P < 0.01) and negatively with ANT's reaction time for alerting (r = -0.31, P = 0.049).
CONCLUSIONS
The MARS can reliably and validly assess six-dimension attention levels in real-world settings and is expected to be a new tool for assessing multi-dimensional attention impairments in different mental disorders.
Humans
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Adult
;
Male
;
Attention/physiology*
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Female
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Middle Aged
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Reproducibility of Results
;
Young Adult
;
Psychometrics
3.Protocol for development of Guideline for Interventions on Cervical Spine Health.
Jing LI ; Guang-Qi LU ; Ming-Hui ZHUANG ; Xin-Yue SUN ; Ya-Kun LIU ; Ming-Ming MA ; Li-Guo ZHU ; Zhong-Shi LI ; Wei CHEN ; Ji-Ge DONG ; Le-Wei ZHANG ; Jie YU
China Journal of Orthopaedics and Traumatology 2025;38(10):1083-1088
Cervical spine health issues not only seriously affect patients' quality of life but also impose a heavy burden on the social healthcare system. Existing guidelines lack sufficient clinical guidance on lifestyle and work habits, such as exercise, posture, daily routine, and diet, making it difficult to meet practical needs. To address this, relying on the China Association of Chinese Medicine, Wangjing Hospital of China Academy of Chinese Medical Sciences took the lead and joined hands with more than ten institutions to form a multidisciplinary guideline development group. For the first time, the group developed the Guidelines for Cervical Spine Health Intervention based on evidence-based medicine methods, strictly following the standardized procedures outlined in the World Health Organization Handbook for Guideline Development and the Guiding Principles for the Formulation/Revision of Clinical Practice Guidelines in China (2022 Edition). This proposal systematically explains the methods and steps for developing the guideline, aiming to make the guideline development process scientific, standardized, and transparent.
Humans
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Practice Guidelines as Topic/standards*
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Cervical Vertebrae
;
China
4.Research progress in diagnosis and treatment of salivary gland tumors.
Guangyan YU ; Xin PENG ; Min GAO ; Peng YE ; Na GE ; Mengqi JIA ; Bingyu LI ; Zunan TANG ; Leihao HU ; Wenbo ZHANG
Journal of Peking University(Health Sciences) 2025;57(1):1-6
Salivary gland tumor is one of the most common tumors in oral and maxillofacial regions. The diagnosis and treatment of salivary gland tumors had been a clinical characteristic project in Peking University School and Hospital of Stomatology since long time ago. Here we introduced the research progress in diagnosis and treatment of salivary gland tumors during the past 10 years. Among 7 190 cases of salivary gland tumors treated in this institution, 4 654 cases (64.7%) were benign, and 2 536 (35.3%) were malignant, with benign ∶ malignant ratio of 1.84 ∶ 1. Parotid was the most common location, followed by minor salivary gland and submandibular gland, while sublingular gland tumor was seldom seen. The proportion of minor salivary gland tumor was relatively high. Among 1 874 cases with primary malignant tumors, the cases with T3 and stage Ⅲ accounted for only 9.6% and 10.3%, respectively, which indicated that there was shortcoming in the T classification and clinical stage formulated by Union for International Cancer Control (UICC), and further revision was required. The 5, 10, and 15 year survival rates of 1 637 cases with postoperative follow-up were 93.1%, 87.2% and 79.3%, respectively, which were much higher than those we reported 30 years ago. The improvement of treatment results was related to more widely used combined treatment with surgery and postoperative radiotherapy, and the increase in patients with early stage. Adenoid cystic carcinoma was the malignant tumor with high rate of distant metastasis. The 5 and 10 year survival rates of the patients with pulmonary metastasis were 76.2% and 51.8%, respectively, which indicated that the pulmonary metastatic carcinomas developed slowly. Recurrent rate of carcinoma ex pleomorphic adenoma was 46.7% after single treatment of sur-gery, while it decreased to 27.5% after combined theraphy with surgery and radiotherapy, indicating that postoperative radiotheraphy could reduce the recurrent rate effectively. The normal myoepithelial cells had the inhibiting role in the invasion and metastasis of carcinoma ex pleomorphic adenoma. The evaluation of integrity of myoepithelial cells surrounding the tumor mass is helpful to understand the invasiveness of the tumors. The new surgical modalities such as extracapsular resection and partial sialoadenectomy were used in treatment of benign tumors of parotid gland and submandibular gland with advantages of decreased tissue damage and preservation of glandular function. Application of digital surgical techniques such as mixed reality combined with surgical navigation and real-time three-dimensional holograms in the surgical treatment of parotid gland tumors showed the benifits of more safety and precision, and less tissue da-mage.
Humans
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Salivary Gland Neoplasms/pathology*
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Carcinoma, Adenoid Cystic/therapy*
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Adenoma, Pleomorphic/therapy*
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Neoplasm Staging
5.Glucocorticoid Discontinuation in Patients with Rheumatoid Arthritis under Background of Chinese Medicine: Challenges and Potentials Coexist.
Chuan-Hui YAO ; Chi ZHANG ; Meng-Ge SONG ; Cong-Min XIA ; Tian CHANG ; Xie-Li MA ; Wei-Xiang LIU ; Zi-Xia LIU ; Jia-Meng LIU ; Xiao-Po TANG ; Ying LIU ; Jian LIU ; Jiang-Yun PENG ; Dong-Yi HE ; Qing-Chun HUANG ; Ming-Li GAO ; Jian-Ping YU ; Wei LIU ; Jian-Yong ZHANG ; Yue-Lan ZHU ; Xiu-Juan HOU ; Hai-Dong WANG ; Yong-Fei FANG ; Yue WANG ; Yin SU ; Xin-Ping TIAN ; Ai-Ping LYU ; Xun GONG ; Quan JIANG
Chinese journal of integrative medicine 2025;31(7):581-589
OBJECTIVE:
To evaluate the dynamic changes of glucocorticoid (GC) dose and the feasibility of GC discontinuation in rheumatoid arthritis (RA) patients under the background of Chinese medicine (CM).
METHODS:
This multicenter retrospective cohort study included 1,196 RA patients enrolled in the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) from September 1, 2019 to December 4, 2023, who initiated GC therapy. Participants were divided into the Western medicine (WM) and integrative medicine (IM, combination of CM and WM) groups based on medication regimen. Follow-up was performed at least every 3 months to assess dynamic changes in GC dose. Changes in GC dose were analyzed by generalized estimator equation, the probability of GC discontinuation was assessed using Kaplan-Meier curve, and predictors of GC discontinuation were analyzed by Cox regression. Patients with <12 months of follow-up were excluded for the sensitivity analysis.
RESULTS:
Among 1,196 patients (85.4% female; median age 56.4 years), 880 (73.6%) received IM. Over a median 12-month follow-up, 34.3% (410 cases) discontinued GC, with significantly higher rates in the IM group (40.8% vs. 16.1% in WM; P<0.05). GC dose declined progressively, with IM patients demonstrating faster reductions (median 3.75 mg vs. 5.00 mg in WM at 12 months; P<0.05). Multivariate Cox analysis identified age <60 years [P<0.001, hazard ratios (HR)=2.142, 95% confidence interval (CI): 1.523-3.012], IM therapy (P=0.001, HR=2.175, 95% CI: 1.369-3.456), baseline GC dose ⩽7.5 mg (P=0.003, HR=1.637, 95% CI: 1.177-2.275), and absence of non-steroidal anti-inflammatory drugs use (P=0.001, HR=2.546, 95% CI: 1.432-4.527) as significant predictors of GC discontinuation. Sensitivity analysis (545 cases) confirmed these findings.
CONCLUSIONS
RA patients receiving CM face difficulties in following guideline-recommended GC discontinuation protocols. IM can promote GC discontinuation and is a promising strategy to reduce GC dependency in RA management. (Trial registration: ClinicalTrials.gov, No. NCT05219214).
Adult
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Aged
;
Female
;
Humans
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Male
;
Middle Aged
;
Arthritis, Rheumatoid/drug therapy*
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Glucocorticoids/therapeutic use*
;
Medicine, Chinese Traditional
;
Retrospective Studies
6.Diverse Subtypes of Cardiovascular Disease Risk Evaluated by Novel PREVENT Associated with Different Polycyclic Aromatic Hydrocarbon Metabolites.
Ye XIN ; Yu Cheng SUN ; Lin CHEN ; Feng Tao CUI ; Ying Ge DUAN ; Han Yun WANG ; Li CHEN ; Tian CHEN ; Pi Ye NIU ; Jun Xiang MA
Biomedical and Environmental Sciences 2025;38(10):1217-1229
OBJECTIVE:
To investigate the association of various polycyclic aromatic hydrocarbon (PAH) metabolites with diverse subtypes of cardiovascular disease (CVD) risk.
METHODS:
A novel predicting risk of cardiovascular disease EVENTs PREVENT equation was used to estimate the 10-year diverse subtypes of CVD risk, and their associations with PAH metabolites were analyzed using multiple logistic regression models, the weighted quantile sum (WQS) model, the quantile g-computation (qgcomp) model, and a stratified analysis of subgroups.
RESULTS:
For this study, six thousand seven hundred and forty-five participants were selected, and significant positive associations were observed between PAHs, naphthalene (NAP), and fluorene (FLU), and the risks of total CVD, atherosclerotic cardiovascular disease (ASCVD), and heart failure (HF). NAP and FLU were the primary contributors to the effects of PAH mixtures, and their associations with total CVD, ASCVD, and HF risk were significant in younger participants (30 ≤ age < 50 years); however, the associations of phenanthrene (PHEN) with ASCVD, HF, coronary heart disease (CHD), and stroke were dominant in aging participants (age ≥ 50 years). Notably, pyrene (PYR) was negatively associated with the risk of ASCVD, HF, CHD, and stroke. Similarly, negative associations of PYR with the four CVD subtypes were noticeable in aging participants.
CONCLUSION
Different PAHs metabolites had different impacts on each CVD subtype among different age groups. Notably, the protective effects of PYR on ASCVD, HF, CHD, and stroke were noticeable in aging individuals.
Humans
;
Cardiovascular Diseases/chemically induced*
;
Middle Aged
;
Polycyclic Aromatic Hydrocarbons/metabolism*
;
Male
;
Female
;
Adult
;
Aged
;
Risk Factors
;
China/epidemiology*
7.Predictive value of disulfidptosis-related genes in the prognosis and drug sensitivity of colorectal cancer
Shuang-Yi SUN ; Xin-Xin HE ; Wen-Tong CHEN ; Bin LYU ; Meng-Xiao GE ; Yu-Meng GUO
Fudan University Journal of Medical Sciences 2024;51(4):473-483
Objective To establish a scoring model for predicting the prognosis and drug sensitivity of colorectal cancer(CRC)based on the expression of disulfidptosis-related genes by bioinformatics analyses combined with the validation with CRC patient-derived organoids(CRC-PDOs).Methods NMF(non-negative Matrix Factorization)algorithm,Cox and LASSO regression analyses were used to identify disulfidptosis-related genes with predictive value for CRC prognosis,and disulfidptosis-related risk scoring formula was constructed.The differential genes and enrichment pathways among different clusters were analyzed by GO(Gene Ontology)and KEGG(Kyoto Encyclopedia of Genes and Genomes).The sensitivity of the high/low-risk clusters of CRC patients to chemotherapy drugs was predicted using the GDSC database and validated using CRC-PDOs.Results The results of NMF algorithm showed that CRC patients could be grouped into two clusters based on the disulfidptosis-related genes.COX regression analysis demonstrated that LRPPRC and SLC7A11 were the only two genes with significance to predict the prognosis of CRC patients(P=0.047,0.033).Low expression of SLC7A11 or high expression of LRPPRC in tumors of CRC patients was significantly correlated with overall survival(OS)(P=0.004,0.003).Based on LASSO regression analysis,the mortality risk scoring formula for disulfidptosis was as follows:Risk score=LRPPRC×(-0.670 5)+SLC7A11×0.311 2,and the GSE161158 dataset could be re-grouped into high-risk and low-risk clusters accordingly.There were 125 differentially expressed genes(DEGs)between the two clusters.According to the GO and KEGG results,the up-regulated genes in high-risk cluster were mainly enriched in immune regulation,such as leukocyte chemotaxis,granulocyte migration and toll-like receptor binding.Low-risk cluster was characterized by pathways associated with sulfide metabolism,such as sulfur compound transmembrane transporter activity.Based on the GDSC database,the expression level of SLC7A11 and LRPPRC could predict chemotherapy drug sensitivity.As a representative,the efficacy of chemotherapy drug(irinotecan)on inhibiting the growth of CRC-PDOs was shown to be linearly correlated with the relative gene expression levels of SLC7A11 and LRPPRC in CRC tissues of patients(P=0.007,0.040).Conclusion According to the results based on the bioinformatics analyses and drug sensitivity testing on CRC-PDOs,disulfidptosis risk score could predict the prognosis and drug sensitivity of CRC patients,with potential clinical application prospect.
8.Body composition and obesity of Ewenki,Daur and Mongolian Buryat
Lu-Ge XI ; Hui-Xin YU ; Yi LIAN ; La-Na YI ; Yuan HAN ; Yong-Lan LI
Acta Anatomica Sinica 2024;55(3):356-362
Objective To analyze the characteristics of adult body composition and obesity status of three ethnic groups:Ewenki,Daur and Mongolian Buryat.Methods The bioelectrical impedance analysis(BIA)was used to measure 18 body composition components in three adults ethnic groups:245(male 124,female 121)Ewenki,207(male 90,female 117)Daur,and 181(male 74,female 107)Mongolian Buryat.The data were processed using Excel 2016 and SPSS 24.0 statistical software.Results The result of correlation analysis showed that visceral fat level was significantly and positively correlated with age(P<0.01).Stature,total body muscle mass,estimated bone mass and trunk muscle mass were all significantly and negatively correlated with age(P<0.01)in males and females of the three ethnic groups.The percent body fat,percent left upper limb fat and percent trunk fat were positively correlated with age in Ewenki males(P<0.05 or P<0.01)and the percent body fat,body mass index(BMI),percent limb fat and percent trunk fat were positively correlated with age in Ewenki females(P<0.05 or P<0.01).Body weight,BMI,percent left upper limb fat,left upper limb muscle mass,bilateral lower limb fat and muscle mass were all negatively correlated with age in Daur males(P<0.05 or P<0.01).Body weight,upper limb muscle mass and left lower limb muscle mass were negatively correlated with age(P<0.05 or P<0.01)in Mongolian Buryat males and percent trunk fat was positively correlated with age(P<0.05)in Mongolian Buryat females.Comparison between ethnic groups showed that most of the body composition index values of the Ewenki and Mongolian Buryat divisions were closest to each other,and the body fat content was higher than that of the Daur.BMI,percent body fat and visceral fat level were all manifested in the Mongolian Buryat Department>Ewenki>Daur.Cluster analysis showed that Ewenki,Daur and Mongolian Buryat were closer to the northern groups and further from the southern groups.Conclusion The Ewenki is most similar to the Mongolian Buryat in body composition characteristics all three ethnic groups has a more serious obesity problem.
9.Protective role and mechanistic exploration of Irisin in doxorubicin induced-cardiomyopathy
Yu-Ge JIN ; Song-Sen LI ; Hao WANG ; Cai-Ru GUO ; Bing-Bing ZHANG ; Hao-Jie CHEN ; Ya-Xin BAN ; Ru-Bing LIANG
The Chinese Journal of Clinical Pharmacology 2024;40(2):220-224
Objective To study the protective effect of Irisin in doxorubicin(Dox)induced-Cardiomyopathy and its possible mechanism.Methods AC 16 cells were used to construct Dox injury model and divided into control group(AC 16 cells were cultured with complete medium),Irisin group(AC16 cells were treated with 10 ng·L-1 Irisin for 24 h),Dox group(AC 16 cells were treated with 4 μmol·L-1 Dox for 24 h),Dox+Irisin group(AC 16 cells were pretreated with 10 ng·L-1 Irisin for 2 h,and then treated with 4 pmol·L-1 Dox for 24 h).Cell counting kit-8(CCK-8),terminal deoxynucleotidyl transferase-mediated nick end labeling(TUNEL)and lactate dehydrogenase(LDH)were used to detect the proliferation,apoptosis and mortality of AC 16 cells.Western blot was used to detect the expression levels of nuclear factor-κB(NF-κB)signaling pathway and apoptotic factors B-cell lymphoma-2(Bcl-2),Bcl-2-associated X protein(Bax)and caspase-9 protein.Mito-Tracker Red CMXRos probe was used to detect mitochondrial membrane potential.Results In the contrl group,Irisin group,Dox group,Dox+Irisin group,the rate of apoptosis were(0.97±0.09)%,0,(42.80±6.70)%,(11.74±1.79)%;the expression of Bax protein were 0.85±0.01,0.36±0.02,1.15±0.07,0.37±0.11;the expression of caspase-9 protein were 0.52±0.02,0.59±0.03,1.11±0.02,0.67±0.08;the expression of Bcl-2 protein were 1.01±0.04,1.05±0.25,0.43±0.02 and 0.99±0.30;the probability of mitochondrial damage were(0.02±0.01)%,(0.5±0.15)%,(38.6±2.39)%,(1.58±0.54)%.The difference of the above indexes between the contrl group and the Dox group were statistically significant(all P<0.05);the difference between Dox group and Dox+Irisin group were statisically significant(all P<0.05).Conclusion Irisin could reduce the expression level of Bax,caspase-9,p-NF-κB,and p-mTOR caused by Dox,increase the expression level of Bcl-2,ameliorate the myocardial damage caused by Dox,and reduce cardiotoxicity.
10.Bioequivalence study of sidenafil citrate tablets in Chinese healthy subjects
Xiao-Bin LI ; Lu CHEN ; Xiu-Jun WU ; Yu-Xin GE ; Wen-Chao LU ; Ting XIAO ; He XIE ; Hua-Wei WANG ; Wen-Ping WANG
The Chinese Journal of Clinical Pharmacology 2024;40(3):430-434
Objective To evaluate the bioequivalence of oral sidenafil citrate tablets manufactured(100 mg)test preparations and reference preparations in healthy subjects under fasting and fed conditions.Methods Using a single-dose,randomized,open-lable,two-period,two-way crossover design,36 healthy subjects respectively for fasting and fed study were enrolled,and randomized into two groups to receive a single dose of test 100 mg with 7-day washout period.Plasma concentration of sidenafil and N-demethylsildenafil was determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS)method.The pharmacokinetic parameters were calculated by Analyst 1.6.3(AB Scie)using non-compartmental model,and bioequivalence evaluation was performed for the two preparations.Relevant safety evaluations were performed during the trial.Results The main pharmacokinetic parameters of sidenafil after a single oral dose of sidenafil citrate tablets under fasting condition for test and reference were as follows:Cmax were(494.69±230.94)and(558.78±289.83)ng·mL-1,AUC0-t were(1 336.21±509.78)and(1 410.82±625.99)h·ng·mL-1,AUC0-were(1 366.49±512.16)and(1 441.84±628.04)h·ng·mL-1,respectively.The main pharmacokinetic parameters of sidenafil under fed condition for T and R were as follows:Cmax were(381.89±126.53)and(432.47±175.91)ng·mL-1,AUC0-t were(1 366.34±366.99)and(1 412.76±420.37)h·ng·mL-1,AUC0-were(1 403.28±375.32)and(1 454.13±429.87)h·ng·mL-1,respectively.The results demonstrated the bioequivalence of sidenafil citrate tablets between T and R.The incidence of adverse events in fasting and fed tests were 33.33%and 25.00%,respectively.No serious adverse event was reported.Conclusion The test and reference formulation of sidenafil citrate tablets were equivalent and was safe.

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