1.Research progress of traditional Chinese medicine intervention in chemotherapy renal injury
Yeyuan LIU ; Yafeng QI ; Maofu ZHANG ; Xinyu LI ; Yanyun SHEN ; Yu LIU ; Shangzu ZHANG ; Yangyang LI ; Liying ZHANG ; Zhiming ZHANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(4):556-569
Renal injury is one of the common ad-verse reactions in the clinical application of chemo-therapy drugs,which is the main reason why the chemotherapy can not be carried out in the whole cycle.The pathological mechanism of chemothera-py-induced renal injury is very complicated,mainly involving oxidative stress,inflammatory response,apoptosis,mitochondrial dysfunction,and regula-tion of transporters,causing pathological damage to renal tubules or glomeruli.At present,there is no specific pharmacological intervention for the treatment of chemotherapy-induced renal injury.As a treasure of traditional Chinese medicine,tradi-tional Chinese medicine has the advantages of overall regulation,multi-targeting,small adverse re-actions and no obvious drug dependence in the prevention and treatment of chemotherapy-in-duced renal injury.In recent years,there have been more and more studies on the intervention of che-motherapy-induced renal injury by multi-compo-nent and multi-directional intervention of active components,extracts and compounds of tradition-al Chinese medicine,and some progress has been made.A large number of studies have shown that the potential mechanisms of traditional Chinese medicine in preventing and treating renal injury in-duced by chemotherapy include inhibiting oxida-tive stress,reducing inflammatory response and in-hibiting apoptosis.Although there are many stud-ies on the mechanism of action of traditional Chi-nese medicine in the treatment of chemotherapy-induced renal injury,there is still a lack of systemat-ic review.Based on this,this paper summarizes the mechanism of renal injury induced by chemothera-py and the intervention of traditional Chinese medi-cine,so as to provide theoretical support for its clinical treatment and new drug innovation.
2.Construction of a predictive model for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke
Yafeng SHEN ; Deyou XUE ; Haoxiang XU ; Derang JIAO
Chinese Journal of Cerebrovascular Diseases 2025;22(10):690-700
Objective To construct a predictive model for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke and evaluate its predictive efficacy.Methods Patients with acute stroke caused by anterior circulation large vessel occlusion who underwent endovascular treatment with successful vascular recanalization(modified thrombolysis in cerebral infarction[mTICI]grade 2b or 3)admitted to the Department of Neurosurgery of Tianjin Union Medical Center(the First Affiliated Hospital of Nankai University)from January 2022 to January 2025 were retrospectively and consecutively included.Patients were divided into effective recanalization group(modified Rankin scale[mRS]score≤2)and futile recanalization group(mRS score>2)according to the mRS score at 90 days after endovascular treatment.Baseline and clinical data were collected,including sex,age,medical history(stroke history,hypertension,diabetes mellitus,atrial fibrillation),personal history(smoking history,alcohol consumption history),and National Institutes of Health stroke scale(NIHSS)score,blood pressure,blood glucose,total cholesterol,triglycerides,high-density lipoprotein cholesterol,low-density lipoprotein cholesterol,creatinine,neutrophil-to-lymphocyte ratio,fibrinogen,D-dimer,lymphocyte-to-monocyte ratio,white blood cell count,hemoglobin,albumin,C-reactive protein-to-albumin ratio,platelet-to-lymphocyte ratio at admission.Imaging data including culprit vessel(middle cerebral artery,anterior cerebral artery,internal carotid artery),Alberta stroke program early CT score(ASPECTS),infarct core volume,hypoperfusion area volume,mismatch volume between infarct core and hypoperfusion area,American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology(ASITN/SIR)collateral circulation grading,trial of Org 10172 in acute stroke treatment(TOAST)classification.Surgery-related data including onset-to-puncture time,successful puncture-to-vascular recanalization time,immediate postoperative mTICI grade,complications within 24 hours postoperatively(fever,hemorrhagic transformation,symptomatic intracranial hemorrhage),immediate postoperative mTICI grade.Factors with P<0.05 and without multicollinearity(variance inflation factor≥5)in univariate analysis were included in multivariate Logistic regression model analysis to analyze independent influencing factors for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.A nomogram prediction model was constructed based on statistically significant factors in multivariate Logistic regression analysis,and Hosmer-Lemeshow test was used to assess the goodness of fit of the model.The receiver operating characteristic(ROC)curve of the nomogram prediction model for predicting futile recanalization after endovascular treatment in patients with anterior circulation large vessel occlusion stroke was drawn,and calibration curve was used to evaluate the calibration of the nomogram prediction model.Results A total of 187 patients who met the criteria of this study were included,comprising 101 males and 86 females,aged 42-85 years,with a mean age of(70±6)years.The mRS scores at 90days after treatment were:0points in 21 cases(11.23%),1 point in 37 cases(19.79%),2 points in 28 cases(14.97%),3 points in 46 cases(24.60%),4 points in 31 cases(16.58%),5 points in 24 cases(12.83%),and 6 points in 0case.There were 86cases in the effective recanalization group and 101 cases in the futile recanalization group.(1)Statistically significant differences between the two groups were observed in age,atrial fibrillation,infarct core volume,admission NIHSS score,neutrophil-to-lymphocyte ratio,lymphocyte-to-monocyte ratio,and C-reactive protein-to-albumin ratio(all P<0.05).(2)Multicollinearity analysis showed that the variance inflation factors of all independent variables with statistically significant differences in univariate analysis were all<5,indicating no multicollinearity.Multivariate Logistic regression analysis showed that age(OR,1.101,95%CI 1.046-1.158,P=0.037),infarct core volume(OR,1.350,95%CI 1.202-1.517,P<0.01),admission NIHSS score(OR,1.501,95%CI 1.213-1.858,P<0.01),lymphocyte-to-monocyte ratio(OR,0.039,95%CI 0.009-0.179,P<0.01),and C-reactive protein-to-albumin ratio(OR,6.015,95%CI 1.625-22.257,P=0.007)were independent influencing factors for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.(3)The receiver operating characteristic curve of the nomogram prediction model for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke was constructed based on statistically significant factors in multivariate analysis showed a specificity of 0.970,sensitivity of 0.895,precision of 0.916,recall of 0.970,and area under the curve of 0.979(95%CI0.962-0.996,P<0.01).The absolute mean error of the calibration curve was 0.008,with predicted values close to actual values.Hosmer-Lemeshow test results showed that the model had good consistency without overfitting(χ2=4.830,P=0.776).Conclusions Age,infarct core volume,admission NIHSS score,lymphocyte-to-monocyte ratio,and C-reactive protein-to-albumin ratio are all independent influencing factors for futile recanalization after endovascular treatment in acute anterior circulation large vessel occlusion stroke.The nomogram prediction model constructed accordingly can predict the risk of futile recanalization after endovascular treatment in patients with anterior circulation large vessel occlusion stroke.
3.Construction of a predictive model for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke
Yafeng SHEN ; Deyou XUE ; Haoxiang XU ; Derang JIAO
Chinese Journal of Cerebrovascular Diseases 2025;22(10):690-700
Objective To construct a predictive model for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke and evaluate its predictive efficacy.Methods Patients with acute stroke caused by anterior circulation large vessel occlusion who underwent endovascular treatment with successful vascular recanalization(modified thrombolysis in cerebral infarction[mTICI]grade 2b or 3)admitted to the Department of Neurosurgery of Tianjin Union Medical Center(the First Affiliated Hospital of Nankai University)from January 2022 to January 2025 were retrospectively and consecutively included.Patients were divided into effective recanalization group(modified Rankin scale[mRS]score≤2)and futile recanalization group(mRS score>2)according to the mRS score at 90 days after endovascular treatment.Baseline and clinical data were collected,including sex,age,medical history(stroke history,hypertension,diabetes mellitus,atrial fibrillation),personal history(smoking history,alcohol consumption history),and National Institutes of Health stroke scale(NIHSS)score,blood pressure,blood glucose,total cholesterol,triglycerides,high-density lipoprotein cholesterol,low-density lipoprotein cholesterol,creatinine,neutrophil-to-lymphocyte ratio,fibrinogen,D-dimer,lymphocyte-to-monocyte ratio,white blood cell count,hemoglobin,albumin,C-reactive protein-to-albumin ratio,platelet-to-lymphocyte ratio at admission.Imaging data including culprit vessel(middle cerebral artery,anterior cerebral artery,internal carotid artery),Alberta stroke program early CT score(ASPECTS),infarct core volume,hypoperfusion area volume,mismatch volume between infarct core and hypoperfusion area,American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology(ASITN/SIR)collateral circulation grading,trial of Org 10172 in acute stroke treatment(TOAST)classification.Surgery-related data including onset-to-puncture time,successful puncture-to-vascular recanalization time,immediate postoperative mTICI grade,complications within 24 hours postoperatively(fever,hemorrhagic transformation,symptomatic intracranial hemorrhage),immediate postoperative mTICI grade.Factors with P<0.05 and without multicollinearity(variance inflation factor≥5)in univariate analysis were included in multivariate Logistic regression model analysis to analyze independent influencing factors for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.A nomogram prediction model was constructed based on statistically significant factors in multivariate Logistic regression analysis,and Hosmer-Lemeshow test was used to assess the goodness of fit of the model.The receiver operating characteristic(ROC)curve of the nomogram prediction model for predicting futile recanalization after endovascular treatment in patients with anterior circulation large vessel occlusion stroke was drawn,and calibration curve was used to evaluate the calibration of the nomogram prediction model.Results A total of 187 patients who met the criteria of this study were included,comprising 101 males and 86 females,aged 42-85 years,with a mean age of(70±6)years.The mRS scores at 90days after treatment were:0points in 21 cases(11.23%),1 point in 37 cases(19.79%),2 points in 28 cases(14.97%),3 points in 46 cases(24.60%),4 points in 31 cases(16.58%),5 points in 24 cases(12.83%),and 6 points in 0case.There were 86cases in the effective recanalization group and 101 cases in the futile recanalization group.(1)Statistically significant differences between the two groups were observed in age,atrial fibrillation,infarct core volume,admission NIHSS score,neutrophil-to-lymphocyte ratio,lymphocyte-to-monocyte ratio,and C-reactive protein-to-albumin ratio(all P<0.05).(2)Multicollinearity analysis showed that the variance inflation factors of all independent variables with statistically significant differences in univariate analysis were all<5,indicating no multicollinearity.Multivariate Logistic regression analysis showed that age(OR,1.101,95%CI 1.046-1.158,P=0.037),infarct core volume(OR,1.350,95%CI 1.202-1.517,P<0.01),admission NIHSS score(OR,1.501,95%CI 1.213-1.858,P<0.01),lymphocyte-to-monocyte ratio(OR,0.039,95%CI 0.009-0.179,P<0.01),and C-reactive protein-to-albumin ratio(OR,6.015,95%CI 1.625-22.257,P=0.007)were independent influencing factors for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.(3)The receiver operating characteristic curve of the nomogram prediction model for futile recanalization after endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke was constructed based on statistically significant factors in multivariate analysis showed a specificity of 0.970,sensitivity of 0.895,precision of 0.916,recall of 0.970,and area under the curve of 0.979(95%CI0.962-0.996,P<0.01).The absolute mean error of the calibration curve was 0.008,with predicted values close to actual values.Hosmer-Lemeshow test results showed that the model had good consistency without overfitting(χ2=4.830,P=0.776).Conclusions Age,infarct core volume,admission NIHSS score,lymphocyte-to-monocyte ratio,and C-reactive protein-to-albumin ratio are all independent influencing factors for futile recanalization after endovascular treatment in acute anterior circulation large vessel occlusion stroke.The nomogram prediction model constructed accordingly can predict the risk of futile recanalization after endovascular treatment in patients with anterior circulation large vessel occlusion stroke.
4.Research progress of traditional Chinese medicine intervention in chemotherapy renal injury
Yeyuan LIU ; Yafeng QI ; Maofu ZHANG ; Xinyu LI ; Yanyun SHEN ; Yu LIU ; Shangzu ZHANG ; Yangyang LI ; Liying ZHANG ; Zhiming ZHANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(4):556-569
Renal injury is one of the common ad-verse reactions in the clinical application of chemo-therapy drugs,which is the main reason why the chemotherapy can not be carried out in the whole cycle.The pathological mechanism of chemothera-py-induced renal injury is very complicated,mainly involving oxidative stress,inflammatory response,apoptosis,mitochondrial dysfunction,and regula-tion of transporters,causing pathological damage to renal tubules or glomeruli.At present,there is no specific pharmacological intervention for the treatment of chemotherapy-induced renal injury.As a treasure of traditional Chinese medicine,tradi-tional Chinese medicine has the advantages of overall regulation,multi-targeting,small adverse re-actions and no obvious drug dependence in the prevention and treatment of chemotherapy-in-duced renal injury.In recent years,there have been more and more studies on the intervention of che-motherapy-induced renal injury by multi-compo-nent and multi-directional intervention of active components,extracts and compounds of tradition-al Chinese medicine,and some progress has been made.A large number of studies have shown that the potential mechanisms of traditional Chinese medicine in preventing and treating renal injury in-duced by chemotherapy include inhibiting oxida-tive stress,reducing inflammatory response and in-hibiting apoptosis.Although there are many stud-ies on the mechanism of action of traditional Chi-nese medicine in the treatment of chemotherapy-induced renal injury,there is still a lack of systemat-ic review.Based on this,this paper summarizes the mechanism of renal injury induced by chemothera-py and the intervention of traditional Chinese medi-cine,so as to provide theoretical support for its clinical treatment and new drug innovation.
5.Problems and suggestions in the implementation of drug centralized volume-based procurement policies in the hospitals
Weihua KONG ; Qi QIAO ; Guoqiang LIU ; Nan CHEN ; Chengwu SHEN ; Qi CHEN ; Feng QIU ; Jianhua WANG ; Ling JIANG ; Qinghong LU ; Junyan WU ; Yafeng WANG ; Likai LIN ; Jiajia FENG ; Hong CHENG
Chinese Journal of Hospital Administration 2024;40(7):535-540
Objective:To explore the challenges in the implementation of drug centralized volume-based procurement policies in hospitals and propose corresponding optimization suggestions.Methods:From August to December 2023, a purposive sampling was conducted to select 11 pharmaceutical experts from tertiary hospitals in China for Delphi method. The survey content included " policy recommendations for promoting the acceleration and expansion of national drug centralized procurement and retaining surplus medical insurance funds for centralized procurement" .Results:Survey participants gave feedback on a set of existing problems found in the implementation of drug centralized procurement policies and proposed corresponding optimization methods. Kendall′s W coefficient of the specialist consultation was 0.332( P<0.05), demonstrating good consistency and concentration of the expert opinions. Among the problems, the score of drug supply guarantee was the highest(mean value of importance was 4.45). At the same time, the recommendation of strengthening monitoring and early warning, coordination and dispatch, and effectively ensuring the supply of centralized drug procurement had the highest score and concentration(mean value of importance was 4.91, coefficient of variation was 0.06). Conclusions:Through Delphi method, this study revealed issues and optimization methods in the implementation of drug centralized procurement policies in hospitals. The findings could provide valuable insights for improvements in the pharmaceutical sector and future policy adjustments.
6.Liver function injury in patients with omicron variant COVID-19 and its influencing factors
Feng DING ; Zelu MENG ; Yina MENG ; Jiangang WANG ; Lingling YING ; Xiaoqing XIE ; Yafeng YU ; Yida YANG ; Huajiang SHEN
Chinese Journal of Clinical Infectious Diseases 2023;16(5):360-366
Objective:To analyze the incidence of liver function injury in patients infected with 2019-nCoV omicron variant and its influencing factors.Methods:The clinical data and laboratory findings of 897 COVID-19 patients infected with omicron variant in Zhejiang province from February 23 to July 14, 2022 were retrospectively analyzed. Patients were divide into liver function injury group ( n=243) and non-liver function injury group ( n=654) based on liver function indicators. The clinical characteristics and laboratory tests were compared between the two groups, and influencing factors of liver function injury were analyzed. SPSS 26.0 statistical software was used for data analysis. Results:The incidence of liver injury in this series was 27.09% (243/897). The median age of patients in liver injury group was older, the body mass index (BMI) was higher( Z=-6.237 and -2.166, both P<0.05), the proportions of patients with hypertension and diabetes, and with severe clinical classification were higher ( χ2=17.087, 27.509 and 12.945, all P<0.01) ; the proportion of vaccinated patients was lower ( χ2=17.766, P<0.01) than those in non-liver injury group. The levels of platelet, hemoglobin, albumin and potassium in liver injury group were lower than those in non-liver injury group ( Z=-4.631, -2.368, -10.593 and -2.141, all P<0.05), while serum ALT, AST, γ-GT, urea nitrogen, glucose and hs-CRP levels were higher than those in the non-liver injury group ( Z=-7.451, -8.663, -4.410, -3.824, -3.278 and -3.884, all P<0.01). Multivariate Logistic regression analysis showed that age ( OR=2.580, 95% CI 1.429-4.657, P=0.002), history of diabetes ( OR=3.650, 95% CI 1.698-7.849, P=0.001), and decreased hemoglobin ( OR=1.993, 95% CI 1.066-3.726, P=0.031) and increased hs-CRP ( OR=1.797, 95% CI 1.283-2.517, P=0.001) were risk factors associated with liver function injury, while vaccination ( OR=0.499, 95% CI 0.312-0.798, P=0.004) was the protective factor for liver function. Conclusion:Liver function injury is frequently observed in COVID-19 patients infected with omicron variant, which is linked to age, underlying disease, and elevated inflammatory markers; while vaccination can lower the risk of liver injury in infected patients.
7.Efficacy and safety of fruquintinib in treatment of elderly patients with advanced metastatic colorectal cancer who failed chemotherapy
Yafeng XU ; Hongshi SHEN ; Yaping WANG ; Qin TAN ; Xufeng CHEN
Cancer Research and Clinic 2022;34(4):291-294
Objective:To investigate the clinical efficacy and safety of fruquintinib in elderly patients with advanced metastatic colorectal cancer who failed chemotherapy.Methods:Ninety-nine elderly patients with advanced metastatic colorectal cancer who failed chemotherapy in No. 904 Hospital of Joint Logistics Support Force from September 2018 to July 2020 were selected. All patients were given furquintinib capsules, 1 time/d, 5 mg/time, and 28 days was 1 cycle. All patients were treated continuously for 2 cycles and the effect was observed. The patient's recent anti-tumor efficacy was counted. The serum levels of carbohydrate antigen 125 (CA125), carcinoembryonic antigen (CEA) and carbohydrate antigen 199 (CA199) in patients before and after treatment were compared. The safety of the medication during the patient's treatment was recorded, and the Kaplan-Meier method was used for survival analysis.Results:A total of 99 elderly patients with advanced metastatic colorectal cancer who failed chemotherapy were treated for 2 cycles, with an objective response rate (ORR) of 22.22% (22/99) and a clinical control rate (CCR) of 75.76% (75/99). The serum levels of CA125, CA199 and CEA after treatment were lower than those before treatment (all P<0.05). The drug adverse reactions in 99 patients during the treatment were mostly grade Ⅰ-Ⅱ, and grade Ⅲ-Ⅳ were rare. The most common gradeⅠ-Ⅱ adverse reactions were hypertension (45.45%, 45/99), hand-foot syndrome (40.40%, 40/99), and elevated aspartate transferase (36.36%, 36/99). Followed up for 12 months, 5 cases were lost to follow-up, the follow-up rate was 94.95%, the median progression-free survival time of the remaining 94 patients was 5.62 months (95% CI 3.57-8.75 months), and the median overall survival time was 8.41 months (95% CI 4.85-11.14 months). Conclusions:Fruquintinib has good efficacy in the treatment of elderly patients with advanced metastatic colorectal cancer who failed chemotherapy. It can reduce the levels of tumor markers, the survival status of patients is good, and the adverse reactions are controllable.
8.Familial aggregation myelodysplastic syndromes/acute myeloid leukemia: report of 3 pedigrees and review of literature
Jing WANG ; Mei CHEN ; Yafeng CAO ; Jun GU ; Hongyu LU ; Hongshi SHEN
Journal of Leukemia & Lymphoma 2022;31(11):659-663
Objective:To investigate the clinical characteristics, gene mutation, treatment and prognosis of familial aggregation myelodysplastic syndromes/acute myeloid leukemia (MDS/AML).Methods:The 3 familial aggregation MDS/AML admitted to Shanghai Yangpu District Hospital from August 2012 to March 2019 were collected. The bone marrow examination, gene mutation detection, therapeutic effect and prognosis of the patients were retrospectively analyzed, and the relevant literature was reviewed.Results:In pedigree 1, the survival time of 2 AML patients was 8 months and 1 month, respectively. In pedigree 2, the transformation time of 2 patients diagnosed MDS to AML/high-risk MDS was 4 and 3 months, the survival time was 5 and 8 months, respectively. TP53 and RUNX1 mutations were detected in the older brother. In pedigree 3, the survival time of the AML patient was 13 months, and the MDS patient was stable.Conclusions:Familial aggregation MDS/AML has rapid progression and short survival time, and its diagnosis needs to be combined with family history, cytogenetics, and molecular biology.
9.Changes in follicular helper T ( Tfh) cells and Tfh-related molecules during HIV-1 infection
Dan LI ; Jianjun LI ; Yafeng LI ; Shuo WANG ; Hua LIANG ; Zhenzhu TANG ; Zhiyong SHEN ; Yueqin DENG ; Yiming SHAO
Chinese Journal of Microbiology and Immunology 2018;38(5):321-326
Objective To analyze the changes in follicular helper T (Tfh) cells during HIV-1 in-fection, to investigate the influences of Tfh cells and Tfh-related molecules on HIV-1 progression and to pro-vide references for further research on using Tfh cells in highly active antiretroviral therapy ( HAART) and vaccines. Methods This study enrolled 33 patients with HIV-1 infection, including 11 long-term nonpro-gressors (LTNP), 10 rapid progressors (RP) and 12 typical progressors (TP), and 11 healthy subjects (normal controls, NC). Peripheral blood mononuclear cells were isolated from each subject. Multicolor flow cytometry was performed to detect CD4+CD45RA-CXCR5+Tfh and CD4+CD45RA-CXCR3-CXCR5+PD-1+Tfh subsets and the levels of inducible costimulatory molecule (ICOS), IFN-γ and IL-21. Moreover, the levels of IL-10 and the percentages of CD19+B cells in plasma samples of each group were also analyzed. Relationships among Tfh, CD4 and B cells were analyzed. Results The percentages of both Tfh subsets were higher in patients with HIV-1 infection than in NC. Compared with NC, LTNP had the highest percent-age of CD4+CD45RA-CXCR3-CXCR5+PD-1+Tfh cells (P<0. 05). Expression of Tfh-related molecules ICOS, IFN-γ and IL-21 were enhanced significantly upon Staphylococcus enterotoxin B ( SEB) stimulation, ICOS+Tfh cells were negatively related with HIV-1 progression, but had a positive correlation with CD19+B cells (r=-0. 49, P<0. 01; r=0. 60, P<0. 05). IL-10 level in plasma increased significantly in patients withHIV-1 infection , especially in TP and RP ( TP vs NC : P<0. 01 ; RP vs NC : P<0. 05 ) . Conclusion HIV-1 patients and NC had significant differences in the expression of Tfh cells and Tfh-related molecules in peripheral blood. ICOS+Tfh cells were closely related to the progression of HIV-1 infection and the function of B cells.
10.Comparison of Telbivudine and Entecavir therapy on estimates of glomerular filtration rate in patients with hepatitis B virus-related compensated cirrhosis
Huajiang SHEN ; Feng DING ; Zhiwei WANG ; Fang SUN ; Yafeng YU ; Jiangang WANG ; Jiankang ZHOU ; Wenfang XU ; Shuifa LI
Chinese Journal of Infectious Diseases 2017;35(5):261-267
Objective To compare the impact of Telbivudine (LDT) and Entecavir (ETV) administration on estimates of glomerular filtration rate for anti-viral therapy in patients with hepatitis B virus (HBV)-related compensated cirrhosis by an open, prospective randomized controlled study.Methods Patients with HBV-related compensated cirrhosis at clinic or hospitalized in Shaoxing Municipal Hospital from January 2012 to June 2013 were included.A total of 170 patients were randomly divided into LDT (600 mg/d) or ETV (0.5 mg/d) groups at a ratio of 1∶1 according to the random number table method.All patients were treated for more than 36 months.The LDT group was optimized according to the roadmap.Patients with poor response or resistance in both treatment group were added with Adefovir dipivoxil (ADV) 10 mg/d for optimal treatment.The clinical outcome, creatinine (CR), estimated glomerular filtration rate (eGFR) of patients before and after 36 months of treatment were compared between two groups.All categorical data were analyzed using chi-square test and data accorded with normal distribution were compared by t test.Results After 36 months of treatment, the virological and biochemical responses in LDT group and ETV group were similar.The mean CR levels at month 24 and 36 in LDT group were (74.25±22.98) μmol/L and (70.72±24.75) μmol/L, respectively, which were both lower than baseline level ([83.09±17.68] μmol/L, t=2.811 and 3.145, respectively, both P<0.01).The mean CR levels at month 36 between two groups were statistically different (t=3.431, P=0.001).The mean eGFR levels at month 12, 24 and 36 in LDT group were all significantly lower than that at baseline (t=3.976,8.297 and 10.629, respectively, all P<0.01).The mean eGFR levels at month 24 and 36 between two groups were statistically different (t=9.684 and 15.019, respectively, both P<0.01).A total of 64 patients including 34 in LDT group and 30 in ETV group had mild nephritic injury at baseline.The mean eGFR in patients with mild nephritic injury at baseline in LDT group at month 12, 24 and 36 were significantly different compared to baseline (t=6.098,10.191 and 14.378, respectively, all P<0.01).The mean eGFR level at month 36 in ETV group had statistical difference compared to baseline (t=2.058, P<0.05).The mean eGFR levels at months 12, 24 and 36 were all statistical different between two groups (all P<0.01).The mean eGFR levels at month 24 and 36 in the optimized group were superior to ETV group (P<0.01).Conclusions In patients with HBV-related compensated cirrhosis, LDT and ETV treatment have similar clinical efficacy.LDT is more effective in protecting nephritic function than ETV.

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