1.Effects of sacubitril/valsartan on renal function in patients with primary hypertension
Yajun XIE ; Bei ZHAO ; Xueyao FENG ; Shixing LI ; Xiaoye LI ; Ning SHI
China Pharmacy 2024;35(14):1770-1775
OBJECTIVE To investigate the effects of sacubitril/valsartan on renal function in patients with primary hypertension. METHODS A retrospective study was conducted among patients with primary hypertension who were admitted to PLA Strategic Support Force Characteristic Medical Center from January 2018 to June 2023. Based on their medication, they were divided into two groups: sacubitril/valsartan group and valsartan group. Propensity score matching was used to match baseline data between the two groups. Patients were treated with antihypertensive drugs based on improving their lifestyle. Sacubitril/valsartan group additionally received oral administration of 200 mg Sacubitril/valsartan tablets once daily, while valsartan group additionally received oral administration of 80 mg Valsartan capsules once daily. The increase amplitude of serum creatinine from baseline, the proportion of patients with elevated serum creatinine >30%-50% or >50%, and the proportion of patients with hyperkalemia (serum potassium ≥5.5 mmol/L) were compared between two groups at 2 months and 6 months after treatment. The trends of changes in serum creatinine, serum potassium and estimated glomerular filtration rate (eGFR) were compared between the two groups before treatment (at baseline), 2 months and 6 months after treatment. RESULTS After propensity score matching, there were 62 patients in sacubitril/valsartan group and 61 patients in valsartan group; there were no significant differences in baseline characteristics between the two groups before treatment (P>0.05), indicating comparability. After 6 months of treatment, the increase of serum creatinine in the sacubitril/valsartan group was significantly lower than that in the valsartan group (P=0.003); the proportion of patients with elevated serum creatinine >30%-50% in the sacubitril/valsartan group was significantly lower than that in the valsartan group (P=0.045). None of the patients experienced hyperkalemia events after 2 months and 6 months of treatment. Repeated measures analysis of variance showed significantly statistical differences in serum creatinine and eGFR between the two groups within 6 months of treatment (P<0.001). Patients taking valsartan experienced a continuous increase in serum creatinine levels and a decrease in eGFR, while patients taking sacubitril/valsartan showed a first increase and then a decrease in serum creatinine levels, and a first decrease and then an increase in eGFR with a prolonged duration of medication. CONCLUSIONS Sacubitril/valsartan can delay or even reverse the decline in renal function levels, and limit the deterioration of renal function in patients with primary hypertension, without increasing the risk of hyperkalemia.
2.Overview of management system for conflict of interest of the European Pharmacopoeia Commission and the United States Pharmacopoeia Convention
XU Xinyi ; LIU Jian ; ZHANG Lin ; SHEN Xueyao ; ZHAO Jianfeng ; ZHANG Jun ; FU Jian ; SHU Rong
Drug Standards of China 2024;25(1):0103-0108
This article introduces an overview of management system for conflict of interest of the European Pharmacopoeia Commission (EPC) and the United States Pharmacopoeia Convention (USP). The EPC and USP have standardized the management system for conflict of interest in drug standard work in multiple management documents, such as the Guide for the Work, Code of Practice for the Work, Form for Declaration of Interests and Confidentiality Undertaking of the EPC, bylaws, Rules and Procedures of the Council of Experts, Code of Ethics, Standards of Conduct of the USP, in order to ensure the transparency and fairness of drug standard development, improve the credibility and rigor of drug standards. This article introduces the management system for conflict of interest of the EPC and USP, providing reference for the improvement of relevant management systems of the Chinese Pharmacopoeia Commission.
3.Key Techniques and Methodological Considerations for Formation of Traditional Chinese Medicine Syndrome Classification Standards
Guozhen ZHAO ; Xingyu ZONG ; Xueyao ZHAO ; Huizhen LI ; Feng ZHOU ; Xuanling ZENG ; Jiahao LIN ; Ning LIANG ; Haili ZHANG ; Qianzi CHE ; Bin LIU ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):257-261
The classification of traditional Chinese medicine (TCM) syndromes is one of the core technical elements in the industry standard of Specification of Diagnosis and Therapeutic Effect Evaluation of Diseases and Syndromes in TCM. In the past,when clinical standards for TCM were formulated,the determination of TCM syndrome classification relied heavily on textbooks and expert experience,lacking systematic research. This approach thus failed to reflect the advancement and scientificity of the standards,thereby affecting their implementation and application. This article reviewed the presentation forms and technical methods of TCM syndrome classification,including the two-tier syndrome classification model with primary and secondary symptoms,as well as the application of modern literature research,ancient literature research,Delphi method,in-depth expert interviews,consensus conferences,and real-world research. When syndrome classification standards are developed,it is necessary to build upon modern literature research,adopt a mixed approach combining qualitative research and quantitative analysis results,and reach expert consensus through consensus conferences. Through systematic research,the scientificity,applicability,and coordination of TCM syndrome classification standards can be enhanced,providing guidance for the standardization of TCM.
4.Clinical efficacy of FOLFOX-HAIC combined with lenvatinib and PD-1 inhibitor in the treatment of inter-mediate and advanced Hepatocellular Carcinoma
Junhong XU ; Hongbing YAO ; Xueyao WANG ; Wei GUO ; Caijin LU ; Jiaxing WU ; Jianhui JIANG ; Dongkang ZHAO
The Journal of Practical Medicine 2024;40(6):762-767
Objective To investigate the clinical efficacy and safety of nivolumab(PD-1 inhibitor)in combination with lenvatinib and FOLFOX regimen[5-fluorouracil(5-FU),oxaliplatin(L-OHP),and calcium folinate(LV)]in the treatment of intermediate and advanced hepatocellular carcinoma(HCC)via hepatic arterial infusion chemotherapy(HAIC).Methods A total of 160 patients with intermediate and advanced HCC admitted to the Second Affiliated Hospital of Guilin Medical University from January 2021 to January 2023 were randomly divided into the control group and the observation group,with 80 patients in each group,using a random number table.The control group received once-daily oral lenvatinib and intravenous carrizumab infusions for 12 weeks as part of transcatheter arterial chemoembolization(TACE)therapy.The observation group was administered with FOLFOX regimen via HAIC chemotherapy,plus intravenous infusion of carrizumab for 12 weeks and once-daily oral lenvatinib.All the patients were followed up regularly.The clinical efficacy was evaluated using the mRECIST criteria.The objective response rate(ORR),disease control rate(DCR),overall survival(OS),progression-free survival(PFS),and incidence of adverse reactions were compared between the two groups.Results There were no significant differences in the objective response rate and incidence of adverse reactions between the groups.The disease control rate,overall survival,and progression-free survival in the observation group were significantly higher than those in the control group(P<0.05).Conclusions The FOLFOX-HAIC regimen in combination with nivolumab and lenvatinib is safe and effective for the treatment of intermediate and advanced HCC,without adverse reactions.It can prolong the overall survival and progression-free survival,and improve the patient's quality of life.
5.The incidence and metabolic profiles of adrenal incidentalomas in patients with diabetes
Yingning LIU ; Xiantong ZOU ; Wei ZHAO ; Xun YAO ; Lexuan WANG ; Lingli ZHOU ; Rui ZHANG ; Yingying LUO ; Meng LI ; Xiuying ZHANG ; Yu ZHU ; Xiaoling CAI ; Xianghai ZHOU ; Xueyao HAN ; Linong JI
Chinese Journal of Endocrinology and Metabolism 2024;40(3):192-197
Objective:To determine the incidence of adrenal incidentalomas(AIs) in patients with diabetes mellitus and the metabolism profiles.Methods:A total of 615 hospitalized patients with diabetes mellitus in the Department of Endocrinology and Metabolism of Peking University People′s Hospital from March 2020 to May 2021 were retrospectively included in this study. AIs were screened by unenhanced chest computed tomography(CT) retrospectively and subsequently confirmed by multiplanar reconstruction. Participants′ physical indicators, metabolic profiles, and adrenal function parameters were collected. Unpaired t test, Mann-Whitney U test, and Chi-Square test were adopted to compare the metabolism profiles between diabetes mellitus patients with or without AIs. Regression models were used to estimate the correlations between AIs and the metabolism profiles such as blood glucose, blood lipids, blood pressure, and the adrenal function parameters.Results:Twenty-seven out of 615 participants were detected with AIs(4.4%). Patients with AIs had higher body mass index, waist circumference, and hip circumference than patients without AIs [(29.4±5.1)kg/m 2vs(26.8±3.8)kg/m 2,P=0.018; (102.3±11.7)cm vs(95.8±10.3)cm, P=0.002; (107.3±10.1)cm vs(101.4±7.6)cm, P=0.008]. The levels of serum uric acid and urinary albumin/creatinine ratio were also significantly increased in patients with AIs [(409.6±118.1)μmol/L vs(357.4±100.6)μmol/L, P=0.009; 21.25(7.49, 180.24)mg/g vs 8.60(4.71, 34.56)mg/g, P=0.010]. Besides, individuals with AIs were also associated with a higher risk of co-existing hypertension( P=0.045). Conclusion:The incidence of AIs in patients with diabetes is 4.4%. The presence of AIs in patients with diabetes may associated with increased risk of obesity and hypertension.
6.Clinical value of helium-free magnetocardiography in diagnosis of coronary heart disease
Feng XU ; Chenchen TU ; Shuwen YANG ; Ming DING ; Bin CAI ; Huan ZHANG ; Linqi LIU ; Xueyao YANG ; Shu ZHOU ; Zhao MA ; Xiantao SONG ; Hongjia ZHANG
Chinese Journal of General Practitioners 2023;22(11):1159-1166
Objective:To assess the clinical value of helium-free magnetocardiography(MCG) in the diagnosis of coronary artery disease(CAD).Methods:A total of 213 patients with suspected CAD undergoing MCG in Beijing Anzhen Hospital were enrolled in the study. All patients underwent coronary CT angiography/invasive coronary angiography(CCTA/ICA) within 48 hours after MCG scanning. The parameters of MCG, including magnetic field multipolarization, magnetic field unipolarization, T-wave flattened, change in magnetic field distribution at TT segment, abnormal T-peak amplitude ration of maximum to minimum, significant movement of poles, magnetic field angle deviation and abnormal distribution of positive pole were used for the evaluation of the stenosis of coronary arteries.Results:Among 213 patients, MCG scanning was completed in 193 cases(90.6%), while 20 cases were excluded for various reasons. The CCTA/ICA results were taken as gold standard, the total coincidence rate of MCG with the degree of stenosis was 88.60%(95% CI: 83.25%-92.72%), the sensitivity and specificity of MCG in the diagnosis of CAD was 89.63%(95% CI: 83.21%-94.21%) and 88.23%(95% CI:78.12%-94.78%), respectively; the positive and negative predictive value were 93.80%(95% CI:88.72%-96.68%) and 81.08%(95% CI:72.15%-87.64%), respectively. Conclusion:MCG is highly accurate in the diagnosis of CAD, it may be widely used clinically as an non-invasive method free of radiation or contrast agent.
7.Association between different obesity measurement indexes and serum C-reactive protein in adult women
Xingyue LI ; Huifang YANG ; Jinyu XIAO ; Yu HAO ; Bin XU ; Xueyao WU ; Xunying ZHAO ; Tianpei MA ; Liang LYU ; Wanting FENG ; Jiayuan LI
Chinese Journal of Epidemiology 2023;44(8):1251-1256
Objective:To explore the association of different obesity measurement indexes on serum C-reactive protein (CRP) in Chinese adult women.Methods:The data were obtained from baseline and follow-up surveys of the urban Breast Cancer Screening Program in Shuangliu District, Chengdu. A total of 441 adult women were included in the study. A questionnaire survey, physical examination, and laboratory testing were conducted on the subjects. Multivariate logistic regression model, two-level mixed effects logistic regression model, and restricted cubic spline method were used to investigate the linear and nonlinear correlation between different obesity measurement indexes and serum CRP in adult women.Results:For every 1 unit increase in BMI, waist circumference (WC), and adiposity, the risk of elevated serum CRP or exacerbation of chronic low-grade inflammation in adult women increased by 16.5%, 5.0%, and 11.1% ( P<0.05), respectively. Both BMI and adiposity were nonlinear correlated with serum CRP. Using BMI=24.0 kg/m 2 as the reference point, serum CRP level increased with the increase of BMI when BMI >24.0 kg/m 2. Using adiposity=30% as the reference point, serum CRP level increased with the increase of adiposity when adiposity >30%. Conclusions:Overall, obesity reflected by BMI had the strongest association with serum CRP in adult women, followed by body fat content reflected by adiposity, and central obesity reflected by WC had the weakest association with CRP. Adult women with BMI >24.0 kg/m 2 or adiposity >30% are at high risk for obesity-related inflammatory manifestations.
8. Analysis of genotypes and hearing phenotypes of mutation infants with deafness
Xianlei WANG ; Xuelei ZHAO ; Lihui HUANG ; Cheng WEN ; Xueyao WANG ; Xiaohua CHENG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2020;34(2):113-118
Objective:
The aim of this study is to explore the genotype and hearing phenotype of deaf infants with mutation of GJB2 gene.
Method:
Subjects were 121 infants with GJB2 gene mutations who were treated in the Children's Hearing Diagnosis Center of Beijing Tongren hospital. All subjects were accepted to undertake the universal newborns hearing screening(UNHS) and series of objective audiometry, including auditory brainstem response, distortion product otoacoustic emission, auditory steady-state response and other audiological tests. All subjects were screened for nine pathogenic variants in four genes or all exons of the GJB2 gene, and then were diagnosed as infants with GJB2 gene mutations. Initially, analyzing their genotypes and hearing phenotypes generally. Then, the subjects were divided into two groups according to the genotypes: T/T group(truncated/truncated mutations, 89 cases) and T/NT group(truncated/non-truncated mutations, 32 cases). Chi-square test was used to analyze the results of UNHS, hearing degree, audiogram patterns and symmetry/asymmetry of binaural hearing phenotype. Eventually, analyzing the results of UNHS.
Result:
The most common truncated mutation was c.235delC(64.88%, 157/242) and the most common non-truncated mutation was c.109G>A(11.16%, 27/242). The homozygous mutation of c.235delC/c.235delC was the dominant in T/T group(38.84%, 47/121), and the compound heterozygous mutation of c.235delC/c.109G>A was the dominant in T/NT group(18.18%, 22/121). 81.82%(99/121) of subjects failed in UNHS, including 74.38%(90/121) with bilateral reference, 7.44%(9/121) with a single pass. The refer rate of UNHS of group T/T and T/NT were 86.52%(77/89) and 68.75%, respectively. There was a statistically significant difference between the two groups(P<0.05). 85.95%(104/121) of subjects were diagnosed as hearing loss and 14.05%(17/121) of subjects were diagnosed as normal hearing. The degree of hearing loss: profound, severe, moderate and mild were 31.40%(38/121), 19.01%(23/121), 24.79%(30/121) and 10.74%(13/121), respectively. There was no subjects with normal hearing in T/T group and individuals with severe and profound hearing loss accounted for the highest proportion(65.17%, 58/89), while in T/NT group, normal hearing accounted for 53.13%(17/32) and mild and moderate hearing loss accounted for the highest proportion(37.5%, 12/32). There was statistically significant difference between the two groups(P<0.05). Of 104 patients(208 ears) with hearing loss, the audiogram patterns: flat, descending, ascending, residual, Valley and other types were 49.03%(102/208), 12.02%(25/208), 8.65%(18/208), 7.69%(16/204), 3.36%(7/204) and 19.23%(40/204), respectively. The two most common types in T/T group were flat(47.19%, 84/178) and other types(20.22%, 36/178), while in T/NT group were flat(60.00%, 18/30) and ascending(20.00%, 6/30). There was statistically significant difference between the two groups(P<0.05). There were 50 cases(48.07%) with symmetrical hearing phenotype and 54 cases(51.93%) with asymmetrical hearing phenotype. Asymmetry was predominant in T/T group(53.93%, 48/89), and symmetry was predominant in T/NT group(60.00%, 9/15). There was no statistically significant difference between the two groups(P>0.05).
Conclusion
In this study, c.235delC/c.235delC homozygous mutation was dominant in T/T group and c.235delC/c.109G>A heterozygous mutation was dominant in T/NT Group. The hearing phenotypes in T/T group were mostly bilateral asymmetric severe hearing loss, and those in T/NT Group were bilateral symmetric mild to moderate hearing loss, special attention should be paid to the audiological characteristics of different genotypes.
9. Application of the superior thyroid artery peak systolic velocity in differentiating Graves′ disease from autoimmune thyroiditis
Chen WANG ; Yu ZHU ; Lingli ZHOU ; Yunyun ZHAO ; Xueyao HAN ; Linong JI
Chinese Journal of Internal Medicine 2020;59(3):207-212
Objective:
To evaluate the clinical value of the superior thyroid artery peak systolic velocity (STA-PSV) for the differential diagnosis of autoimmune thyrotoxicosis.
Methods:
A total of 301 patients with newly diagnosed thyrotoxicosis and without any anti-thyroid drug intervention were collected from the Department of Endocrinology and Metabolism, Peking University People′s Hospital from Jan. 2015 to Oct. 2018. Among them, 241 patients were with Graves′ disease (GD) and 60 patients were with autoimmune thyroiditis (AIT). STA-PSV, thyroid function and thyrotropin receptor antibody (TRAb) were determined. A multiple linear regression was used to identify factors associated with STA-PSV. A receiver operating characteristic (ROC) curve and area under the curve (AUC) were used to evaluate the discriminating ability of STA-PSV to GD.
Results:
STA-PSV leves in GD group were significantly higher than those in AIT group [61.00 (41.00, 86.50) cm/s vs. 34.50 (25.25, 46.00) cm/s,
10.Analysis of genotypes and hearing phenotypes of mutation infants with deafness.
Xianlei WANG ; Xuelei ZHAO ; Lihui HUANG ; Cheng WEN ; Xueyao WANG ; Xiaohua CHENG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2020;34(2):113-118
The aim of this study is to explore the genotype and hearing phenotype of deaf infants with mutation of gene. Subjects were 121 infants with gene mutations who were treated in the Children's Hearing Diagnosis Center of Beijing Tongren hospital. All subjects were accepted to undertake the universal newborns hearing screening(UNHS) and series of objective audiometry, including auditory brainstem response, distortion product otoacoustic emission, auditory steady-state response and other audiological tests. All subjects were screened for nine pathogenic variants in four genes or all exons of the gene, and then were diagnosed as infants with gene mutations. Initially, analyzing their genotypes and hearing phenotypes generally. Then, the subjects were divided into two groups according to the genotypes: T/T group(truncated/truncated mutations, 89 cases) and T/NT group(truncated/non-truncated mutations, 32 cases). Chi-square test was used to analyze the results of UNHS, hearing degree, audiogram patterns and symmetry/asymmetry of binaural hearing phenotype. Eventually, analyzing the results of UNHS. The most common truncated mutation was c.235delC(64.88%, 157/242) and the most common non-truncated mutation was c.109G>A(11.16%, 27/242). The homozygous mutation of c.235delC/c.235delC was the dominant in T/T group(38.84%, 47/121), and the compound heterozygous mutation of c.235delC/c.109G>A was the dominant in T/NT group(18.18%, 22/121). 81.82%(99/121) of subjects failed in UNHS, including 74.38%(90/121) with bilateral reference, 7.44%(9/121) with a single pass. The refer rate of UNHS of group T/T and T/NT were 86.52%(77/89) and 68.75%, respectively. There was a statistically significant difference between the two groups(<0.05). 85.95%(104/121) of subjects were diagnosed as hearing loss and 14.05%(17/121) of subjects were diagnosed as normal hearing. The degree of hearing loss: profound, severe, moderate and mild were 31.40%(38/121), 19.01%(23/121), 24.79%(30/121) and 10.74%(13/121), respectively. There was no subjects with normal hearing in T/T group and individuals with severe and profound hearing loss accounted for the highest proportion(65.17%, 58/89), while in T/NT group, normal hearing accounted for 53.13%(17/32) and mild and moderate hearing loss accounted for the highest proportion(37.5%, 12/32). There was statistically significant difference between the two groups(<0.05). Of 104 patients(208 ears) with hearing loss, the audiogram patterns: flat, descending, ascending, residual, Valley and other types were 49.03%(102/208), 12.02%(25/208), 8.65%(18/208), 7.69%(16/204), 3.36%(7/204) and 19.23%(40/204), respectively. The two most common types in T/T group were flat(47.19%, 84/178) and other types(20.22%, 36/178), while in T/NT group were flat(60.00%, 18/30) and ascending(20.00%, 6/30). There was statistically significant difference between the two groups(<0.05). There were 50 cases(48.07%) with symmetrical hearing phenotype and 54 cases(51.93%) with asymmetrical hearing phenotype. Asymmetry was predominant in T/T group(53.93%, 48/89), and symmetry was predominant in T/NT group(60.00%, 9/15). There was no statistically significant difference between the two groups(>0.05). In this study, c.235delC/c.235delC homozygous mutation was dominant in T/T group and c.235delC/c.109G>A heterozygous mutation was dominant in T/NT Group. The hearing phenotypes in T/T group were mostly bilateral asymmetric severe hearing loss, and those in T/NT Group were bilateral symmetric mild to moderate hearing loss, special attention should be paid to the audiological characteristics of different genotypes.

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