1.Determination method of plasma concentrations of 7 anti-tumor drugs and its application
Jinxiu LYU ; Nan YAN ; Wenjun XU ; Jing ZHAO ; Hua ZHU ; Pengzhou HANG
China Pharmacy 2025;36(4):475-481
OBJECTIVE To establish a method for simultaneous determination of 7 anti-tumor drugs (irinotecan, capecitabine, paclitaxel, docetaxel, tamoxifen, letrozole and methotrexate) in human plasma and apply it to the clinic. METHODS After precipitating with a methanol-acetonitrile mixture (1∶ 1, V/V) containing 0.1% formic acid, liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to determine the plasma concentration, using deuterium isotopes of each analyte as internal standards. The chromatography was performed on the Agilent Eclipse Plus C18 column with a gradient elution of water (containing 0.1% formic acid+0.04% 5 mmol/L ammonium formate) as mobile phase A and acetonitrile (containing 0.1% formic acid) as mobile phase B. The flow rate was 0.6 mL/min, and the column temperature was set at 40 ℃ . The sample size was 10 μL, and the analysis lasted for 5.5 min. Electrospray ionization was used in positive and negative ion mode, and multiple reaction monitoring mode was used. The ion pairs used for quantitative analysis were m/z 587.1→167.1 (irinotecan), m/z 360.1→244.1 (capecitabine), m/z 876.4→308.0 (paclitaxel), m/z 830.3→304.2 (docetaxel), m/z 372.1→129.1 (tamoxifen), m/z 284.1→242.1 (letrozole), and m/z 455.0→ 308.0 (methotrexate). A total of 97 patients with malignant tumors in our hospital were selected to measure the plasma concentrations of 7 anti-tumor drugs using the above method. RESULTS The linear ranges of irinotecan, capecitabine, paclitaxel, docetaxel, tamoxifen, letrozole and methotrexate were 2-1 000 ng/mL (r=0.994 3), 20-10 000 ng/mL (r=0.997 5), 2-1 000 ng/mL (r=0.997 9), 1-500 ng/mL (r=0.995 8), 1-500 ng/mL (r=0.995 2), 1-500 ng/mL (r=0.996 4), 10-5 000 (r=0.997 7), respectively. The quantitative lower limits were 2, 20, 2, 1, 1, 1 and 10 ng/mL; RSDs of intra-assay precision were 0.08%-14.86% (n=6). RSDs of inter-batch precision were 1.51%-11.55% (n=3), and the accuracies were 89.17%-114.93% (n=6). The matrix effects ranged from 89.89%-119.74% (n=6). RSDs of the stability tests were 1.98%-14.88% (n=6). The results of E-mail:hangpengzhou@163.com clinical application showed, the average plasma concentrations of irinotecan, capecitabine, paclitaxel and docetaxel were 704.09, 909.40, 36.45, 150.43 ng/mL, respectively. The values of the coefficient of variation were 25.24%, 62.65%, 122.69%, and 92.27%. CONCLUSIONS The established LC-MS/MS method is simple and rapid, and can be used for the simultaneous determination of 7 commonly used anti-tumor drugs in the plasma of patients with malignancy.
2.Association between temperature and injury death and related excess death burden in Hunan Province
Yiqing XU ; Chunliang ZHOU ; Qianlai SUN ; Donghui JIN ; Jianxiong HU ; Guanhao HE ; Wenjun MA ; Zhihong DENG
Journal of Environmental and Occupational Medicine 2025;42(5):528-535
Background Injury poses a serious threat to human health. As global warming continues to intensify, there is an urgent need to explore the impact of temperature changes on injury deaths. However limited research has focused on this issue. Objective To investigate the relationship between daily mean temperature change (Tm) and injury death, as well as to estimate the associated future death burden in Hunan Province. Methods We employed an individual-level, time-stratified case-crossing design to establish a conditional logistic regression model to analyze the exposure-response relationship between daily mean temperature change and injury death in Hunan Province from 2013 to 2018. Consequently, we conducted subgroup analysis of gender, age group, and injury type. Finally, we estimated the excess burden of injury death attributable to temperature changes under a sustainable development path [low emission scenario (SSP1-2.6)], regional competition path [high emission scenario (SSP3-7.0)], or fossil fuel development path [very high emission scenario (SSP5-8.5)]. Results The study collected
3.A case-crossover study on association between ambient temperature and injury incidence in Shenzhen City
Yan MA ; Qijiong ZHU ; Weicong CAI ; Ping XU ; Zhixue LI ; Jianxiong HU ; Wenjun MA ; Tao LIU ; Ying XU ; Ji PENG
Journal of Environmental and Occupational Medicine 2025;42(5):536-542
Background Under the background of global warming, research on association between ambient temperature and risk of injury is needed. Objective To examine the effect of temperature on injury in Bao'an district, Shenzhen and identify the sensitive population, thereby providing a scientific basis for formulating prevention and control strategies and measures of injury. Methods The injury reports from the Injury Surveillance System and the meteorological data of Bao'an District between 2018 to 2022 were collected. The meteorological data were sourced from the fifth generation of the European Centre for Medium-Range Weather Forecasts (ECMWF) land reanalysis data. Based on time-stratified case-crossover design, conditional logistic regression combined with distributed lag nonlinear model was used to evaluate the exposure-response association between ambient temperature and injury. The stratified analyses were further conducted by gender, age, and causes of injury. Results A total of
4.Clinical Efficacy and Mechanism of Danggui Liuhuang Tang in Reducing Cardiovascular Risk in Patients with Type 2 Diabetes Mellitus with Yin Deficiency and Fire Excess Syndrome
Yuanying XU ; Shanshan YU ; Xinyan JIN ; MAREYANMU·ROSE ; Cheng CHEN ; Wenjun SHA ; Tao LEI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):163-172
ObjectiveThis study aims to observe the clinical effect of Danggui Liuhuang Tang (DGLHT) on patients with type 2 diabetes mellitus (T2DM) complicated by atherosclerotic cardiovascular disease (ASCVD) at high risk, focus on evaluating the influence of DGLHT on cardiovascular risk indicators such as flow-mediated dilation (FMD), atherogenic index of plasma (AIP), and triglyceride-glucose index (TyG), and explore the regulatory effect of DGLHT on the myeloid differentiation factor 88/nuclear factor-kappa B (MyD88/NF-κB) signaling pathway. MethodsThe clinical study was a single-center, double-blind, and randomized controlled trial. A total of 68 patients with T2DM-ASCVD at high risk for cardiovascular events with Yin deficiency and fire excess syndrome were enrolled and randomly assigned to a treatment group and a control group. The treatment group was given atorvastatin calcium tablets and DGLHT, while the control group was given atorvastatin calcium tablets and placebos. The treatment course was 12 weeks, with a final study completion of 30 patients in the treatment group and 29 in the control group. Changes in cardiovascular risk indicators such as FMD, AIP, TyG, and small dense low-density lipoprotein cholesterol (sdLDL-C) index were compared. Human umbilical vein endothelial cells (HUVECs) were used to establish a vascular endothelial injury and inflammation model. The protective effect of DGLHT on endothelial injury was verified by reverse transcription polymerase chain reaction (Real-time PCR) and Western blot . ResultsAfter 12 weeks of treatment, the AIP in the treatment group significantly decreased compared with that before the treatment (P<0.05). Compared with the control group, the treatment group showed significant improvements in FMD and TyG (P<0.05). Additionally, the treatment group demonstrated significant reductions in two-hour postprandial glucose (2 hPG), glycated albumin (GA), triglycerides (TG), apolipoprotein E (Apo E), and sdLDL-C (P<0.05). Analysis of traditional Chinese medicine (TCM) syndrome efficacy indicated that in the treatment group, Yin deficiency and fire excess syndromes, including dry throat and mouth (P<0.05), excessive thirst (P<0.01), tidal fever and night sweats (P<0.05), and dry stools (P<0.05), improved. Compared with the control group, the treatment group showed significant improvements in symptoms of dry throat and mouth (P<0.05) and excessive thirst (P<0.01). TCM syndrome scores significantly decreased (P<0.01), and the overall efficacy rate was 56.67%, significantly higher than the 10.34% observed in the control group (P<0.01). At the cellular level, increasing concentrations of DGLHT led to decreased messenger ribonucleic acid (mRNA) levels of pro-inflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1-beta (IL-1β) in lipopolysaccharide (LPS)-stimulated HUVECs (P<0.01), with significant reductions in the high-concentration group (P<0.01). DGLHT may inhibit the expressions of MyD88 and phosphorylated (p)-NF-κB p65 proteins in a concentration-dependent manner. ConclusionDGLHT shows significant effects in reducing cardiovascular risks and may exert an anti-inflammatory effect by inhibiting the MyD88/NF-κB signaling pathway. This finding provides a new perspective for the prevention and treatment of cardiovascular diseases in high-risk individuals with T2DM-ASCVD.
5.Relationship between haptoglobin gene polymorphism and disease severity and susceptibility in senile vascular dementia patients
Jing CHEN ; Wenjun SHI ; Liyun AN ; Yunzhou ZHENG ; Dongmei XU ; Fukun WANG
International Journal of Laboratory Medicine 2024;45(3):325-329
Objective To explore the relationship between haptoglobin gene polymorphism and disease se-verity and susceptibility in senile vascular dementia patients.Methods A total of 80 patients with senile vas-cular dementia admitted to the hospital from February 2018 to February 2023 were selected as the vascular de-mentia group,and 80 stroke patients with non-vascular dementia admitted to the hospital during the same pe-riod were selected as the control group.The genotype distribution and allele frequency of haptoglobin gene were measured using polymerase chain reaction with sequence-specific primers,and their relationship with the severity and susceptibility of vascular dementia patients was analyzed.Results The proportion of history of hyperlipidemia and diabetes mellitus and the levels of total cholesterol and triglyceride in vascular dementia group were higher than those in control group,the differences were statistically significant(P<0.05).The distribution of genotypes was in Hardy-Weinberg equilibrium(P>0.05).The frequency of haptoglobin 2-2 genotype and haptoglobin 2 allele in vascular dementia group were higher than those in control group,and the differences were statistically significant(P<0.05).There were significant differences in the scores of mini-mental state examination and hachinski ischaemic score among patients with vascular dementia with different haptoglobin genotypes(P<0.05).Multivariate Logistic regression analysis showed that the carrier of hapto-globin 2-2 genotype and the carrier of haptoglobin 2 allele were independent risk factors for vascular dementia(P<0.05).Conclusion Haptoglobin 2-2 genotype and haptoglobin 2 allele distribution frequency are associ-ated with the occurrence of vascular dementia after stroke,and those with high frequency of haptoglobin 2-2 genotype and haptoglobin 2 allele distribution suffer a severe disease,which can provide reference for early i-dentification and assessment of vascular dementia.
6.Construction of microfluidic organ-on-a-chip and its application in simulating subchondral bone remodeling
Fuming SHEN ; Lingni LIAO ; Wenjun WANG ; Jilong LI ; Hao ZHANG ; Yan HU ; Ke XU ; Jiacan SU
Chinese Journal of Trauma 2024;40(2):179-189
Objective:To construct a microfluidic organ-on-a-chip and evaluate its capability in simulating subchondral bone remodeling during the progression of osteoarthritis.Methods:The chip′s main body was designed based on the microfluidic technology and cell co-culture technique. MC3T3-E1 cells were cultured adherently within the cell seeding micro-chamber, with the culture medium perfused at a flow rate of 0.5 ml/min at the bottom of the micro-chamber. Evaluation metrics were as follows: (1) Assessment of the microfluidic organ-on-a-chip: The growth culture medium was perfused and simulation experiments were conducted to test the concentration differences and equilibrium times of the fluid inside and at the bottom of the cell seeding micro-chamber at various time points; live-dead staining was performed to observe the biocompatibility of cells cultured continuously for 3 days and 7 days at a set flow rate, which was divided into 3-day and 7-day groups. (2) Osteogenic potential of the microfluidic organ-on-a-chip: The osteogenic induction medium was perfused, and ALP staining and PCR were performed to compare the number of the black alkaline phosphatase (ALP)-positive cells and the expression levels of osteogenesis-related marker genes including osteoblast-specific transcription factor 2 (RUNX2), type I collagen (COL1A1), bone morphogenetic protein-2 (BMP-2), and osteocalcin (OCN) under static, 3-day and 7-day perfusion conditions, which was divided into static non-induced, static-induced and perfusion-induced groups. (3) Characterization of morphology and size, and biocompatibility of extracellular vesicles (EVs) of three osteoblast subtypes: Three different subtypes of osteoblasts were obtained [endothelial-type osteoblasts (EnOB)-EVs, stromal-type osteoblasts (StOB)-EVs and mineralizing-type osteoblasts (MinOB)-EVs]. Their morphology and size were obtained through transmission electron microscopy and particle size analysis. Growth medium containing EVs of three different cell subtypes was perfused, and cell proliferation/apoptosis assay was performed to compare the biocompatibility of the addition of different EVs concentrations (1, 1.25, 2.5, and 5 μg/ml) for 24 hours, which was categorized into the EnOB-EVs group, StOB-EVs group and MinOB-EVs group. (4) Osteogenic effect of EVs from three subtypes of osteoblasts: Osteogenic induction media containing EVs from three different osteoblast subtypes were perfused for 3 days, and ALP staining and PCR were performed to compare the number of black ALP-positive cells and the expression levels of osteogenesis-related marker genes including RUNX2, COL1A1, BMP-2, and OCN, which was divided into non-EVs group, EnOB-EVs group, StOB-EVs group and MinOB-EVs group.Results:(1) Evaluation of the microfluidic organ-on-a-chip: Simulation results showed that the concentration in the top layer of the upper chamber reached more than 95% of that in the lower chamber and that the concentration in the bottom layer was about 96.5% of that in the lower chamber after 12 hours of continuous perfusion, reaching an equilibrium state of the concentration difference between the upper and lower chambers. The results of live-dead staining showed that the chip was biocompatible at a flow rate of 0.5 ml/min, and the cell survival rate at 3 and 7 days of perfusion was (99.48±0.12)% and (97.07±1.05)% ( P<0.01). (2) ALP staining results showed that at 3 days, the perfusion-induced group showed the highest number of black ALP-positive cells, followed by the static-induced group, and the least in the static non-induced group. At 7 days, the static-induced group had the highest number of black ALP-positive cells, followed by the perfusion-induced group, and the least in the static non-induced group. PCR results indicated that at 3 days, the expression levels of RUNX2, COL1A1, BMP-2, and OCN were 1.00±0.03, 1.00±0.12, 1.00±0.01, and 1.00±0.02 respectively in the static non-induced group; 1.80±0.04, 4.05±0.37, 9.80±1.94, and 4.38±0.89 respectively in the static-induced group, and 2.45±0.23, 5.48±0.42, 91.50±4.56, and 10.82±4.96 respectively in the perfusion-induced group ( P<0.01). At 7 days, the expression levels of RUNX2 was 1.00±0.01 in the static non-induced group, 1.46±0.46 in the static-induced group, and 1.11±0.08 in the perfusion-induced group ( P>0.05); the expression levels of COL1A1, BMP-2, and OCN were 1.00±0.03, 1.00±0.13, and 1.00±0.09 respectively in the static non-induced group, 9.38±0.25, 14.27±4.35, and 84.01±4.02 respectviely in the static-induced group, and 2.39±0.08, 133.64±8.87, and 86.64±8.36 respectively in the perfusion-induced group ( P<0.01). When comparing the static non-induced, static-induced, and perfusion-induced groups at both 3 and 7 days, the perfusion-induced group demonstrated the strongest osteogenic capability. (3) Characterization of morphology and size and biocompatibility of EVs from three osteoblast subtypes: Under the transmission electron microscope, EVs from EnOB-EVs, StOB-EVs, and MinOB-EVs all exhibited a typical saucer-shaped morphology. The particle sizes of EnOB-EVs, StOB-EVs, and MinOB-EVs were (91.3±14.7)nm, (106.0±16.0)nm, and (68.1±10.7)nm, respectively. Cell proliferation/apoptosis assay results indicated that the optimal administration concentration of EnOB-EVs, StOB-EVs, and MinOB-EVs was all 1.25 μg/mL. (4) Validation of osteogenic effect of the microfluidic organ-on-a-chip on three types of EVs: ALP staining results showed that the non-EVs group had the fewest black ALP-positive cells, followed by the EnOB-EVs group, then the StOB-EVs group, and the MinOB-EVs group had the most. PCR results showed that the expression levels of RUNX2, COL1A1, BMP-2, and OCN were 1.00±0.01, 1.00±0.03, 1.00±0.02, and 1.00±0.02 respectively in the non-EVs group, 1.95±0.11, 6.78±2.04, 7.99±0.57, and 6.93±3.83 repectively in the EnOB-EVs group, 0.79±0.12, 5.68±1.53, 12.59±3.15, and 25.59±0.95 respectively in the StOB-EVs group, and 0.68±0.10, 4.36±0.69, 18.75±3.21, and 34.74±3.98 repectively in the MinOB-EVs group ( P<0.01). Compared with the non-EVs group, EnOB-EVs group, StOB-EVs group, and MinOB-EVs group, the MinOB-EVs group showed the most significant osteogenic effect. Conclusions:The microfluidic organ-on-a-chip constructed using microfluidic technology and cell co-culture techniques is capable of maintaining the normal growth of MC3T3-E1 cells, enhancing their proliferation and osteogenic induction differentiation. EVs released by osteoblasts at different stages possess osteogenic effects and can accelerate the bone sclerosis in the remodeling of subchondral bone during the progression of osteoarthritis.
7.Development of a prognostic model for early diagnosis of HEV infection in patients with chronic liver disease
Yazhou XU ; Wenjun CHEN ; Bo HU
Chinese Journal of Laboratory Medicine 2024;47(3):252-258
Objective:To establish an early clinical prediction model for patients with chronic liver disease who are coinfected with hepatitis E virus (HEV), and quickly evaluate the probability of severe hepatitis in patients.Methods:A retrospective analysis was conducted on 87 patients with chronic liver diseases who were hospitalized at the Third Affiliated Hospital of Sun Yat-sen University from May 2018 to September 2023. Clinical features and laboratory indexes were analyszed and patients were classified to severe (TBIL >171 μmol/L with PTA <40%) and non-severe (TBIL <171 μmol/L with PTA >40%) groups. and Independent factors identified using LASSO regression were incorporated into a novel nomogram to identify patients at high risk of severe hepatitis in the early stages. The performance of the nomogram was evaluated using the area under the curve and the mean absolute error of the calibration curve.Results:Significant difference was observed in the serum total bile acid (TBA) level between the severe group [240.00 (183.30, 268.70) umol/L] and the non-severe group [93.40 (20.10, 271.70) μmol/L, U=269.00, P=0.002]. Additionally, the levels of apolipoprotein A1 (APOA1) [0.32 (0.18, 0.48) g/L] and uric acid (UA) [156.15 (117.00, 202.00) μmol/L] were significantly lower in the severe group compared to the non-severe group (APOA1: [0.77 (0.63, 1.06) g/L, U=71.00, P<0.001]; UA: [334.05 (243.70, 401.00) μmol/L, U=83.00, P<0.001]). The researchers developed a nomogram, which incorporated two independent factors (APOA1 and UA) and an additional variable (TBA), exhibiting a strong predictive ability, with an area under the curve (AUC) of 0.963 (95% confidence interval: 0.927-0.998) and a well-fitted calibration curve. Positive and negative predictive values of 94.0% and 88.2% were calculated, and a nomogram score of 129 or greater was considered indicative of a higher likelihood of developing severe illness. Conclusions:This nomogram offers a rapid and accurate means of evaluating the probability of severe illness in patients with chronic liver disease after overlapping infection with HEV, which can accurately and effectively predict the risk of severe illness in patients.
8.Research on quality evaluation and improvement of in vitro diagnostic reagent supply chain based on zero inventory target
Han WU ; Zhiyong XU ; Xiaokun GAO ; Wenjun GE ; Xianli MA ; Wei DING ; Weizheng LI
China Medical Equipment 2024;21(2):127-131,161
Objective:To establish the objective of zero inventory management of in vitro diagnostic reagents,to evaluate the quality of supply chain,and to improve the existing problems in the supply of reagents.Methods:The problems existing in the management of in vitro diagnostic reagents were analyzed from the aspects of inventory,supply efficiency and product quality,and the management system of hospital operation,management quality and patient benefit optimization was established,and the zero-inventory management path and quality evaluation model were constructed.85 models of 21 types of in vitro diagnostic reagents purchased by Jiangsu Subei People's Hospital from January 2020 to March 2023 were selected.According to different supply chain quality management methods,on-demand inventory management mode(referred to as mode 1)and zero inventory management mode(referred to as mode 2)were adopted respectively.The demand procurement,inventory management and clinical use effects of the two management modes were compared.Results:The reagent procurement demand compliance rate,supply capacity high-quality quality rate and clinical use matching rate of mode 2 were(93.35±3.62)%,(94.87±2.63)% and(96.08±2.31)%,respectively,which were higher than those of mode 1,the difference was statistically significant(Z=2.489,2.836,2.838,P<0.05).The number of cases of long-term overstocking of products,substandard environment and untimely information in mode 2 were(2.92±2.54)cases,(2.83±1.59)cases and(5.58±3.12)cases,respectively,which were lower than those in mode 1,the difference was statistically significant(Z=2.959,3.037,3.703,P<0.05).The satisfaction of clinical departments,medical technology departments and procurement center with the supply,distribution and information communication of in vitro diagnostic reagents in mode 2 were 97.8% and 93.3%,97.0% and 87.9%,100% and 84.6%,respectively,which were higher than those in mode 1,the difference was statistically significant(x2clinical departments=5.428,6.133,x2medical technology departments=3.958,3.937,x2procurement center=5.159,4.996,P<0.05).Conclusion:The zero inventory management model can improve the standardization of in vitro diagnostic reagent demand procurement,reduce the incidence of backlog failure in inventory management,and improve the quality of clinical supply services.
9.Research Progress in the Molecular Mechanism of the Relationship Between Hypertension and Hyperlipidemia Under the Influence of Obesity
Tongli XU ; Qinhong LIU ; Yinchu WANG ; Yulin CUI ; Wenjun LI ; Song QIN
Chinese Journal of Modern Applied Pharmacy 2024;41(4):545-555
In the past few decades, the global obesity population has been increasing, and still has an upward trend. With obesity, the risk of cardiovascular and cerebrovascular diseases has increased. It’s found that an increase in body mass index is associated with the occurrence of some cardiovascular and cerebrovascular diseases Hypertension and hyperlipidemia, as common chronic cardiovascular diseases, are particularly affected by obesity, which has attracted extensive attention in recent years. Moreover, the occurrence of hypertension and hyperlipidemia under the influence of obesity is significantly related, and their synergy can also cause a variety of cardiovascular and cerebrovascular diseases. However, there is still less work to study these three factors at the same time. Therefore, on the basis of summarizing the molecular mechanisms of obesity affecting hypertension and hyperlipidemia, this paper summarizes the relevant molecular mechanisms of hypertension and hyperlipidemia under the influence of obesity, and points out the co-acting molecules, providing a reference for future research on cardiovascular and cerebrovascular diseases.
10.The Effects of Huqi Zhengxiao Formula (槲芪癥消方) on the Survival Rate and Quality of Life of Patients of Stage Ⅲ Hepatitis B-Associated Primary Liver Cancer with Syndrome of Healthy Qi Deficiency, Toxic Stasis Accumulation After Transcatheter Arterial Chemoembolisation Treatment
Wenjun XU ; Jingying LI ; Xiaojun WANG ; Chun ZHANG
Journal of Traditional Chinese Medicine 2024;65(4):382-387
ObjectiveTo observe the effects of Huqi Zhengxiao Formula (槲芪癥消方) on the survival rate and quality of life of patients with stage Ⅲ hepatitis B-associated primary liver cancer (PLC) with syndrome of healthy qi deficiency and toxic stasis accumulation after transcatheter arterial chemoembolisation (TACE) treatment. MethodsOne hundred and twenty-six patients with stage Ⅲ hepatitis B-associated PLC who were identified as syndrome of healthy qi deficiency and toxic stasis accumulation after TACE treatment were selected, and were randomly assigned to 63 cases each of the treatment group and the control group in a ratio of 1∶1 by using the random number table method; the control group was given symptomatic supportive treatments with western internal medicine, and the treatment group was given the addition of Huqi Zhengxiao Formula on the basis of the control group. All patients were treated for a period of 48 weeks, and were followed up at weeks 4, 8, 12, 24, 36, and 48 of the treatment process. The primary effectiveness index was the 1-year survival rate, and the secondary effectiveness index was the Karnofsky score and the traditional Chinese medicine (TCM) syndrome score. Survival analysis was performed using the Kaplan-meier method, and Log-rank test was used to compare the differences between the survival curves of each group. ResultsSix withdrawals in the treatment group and seven withdrawals in the control group, and finally 57 patients in the test group and 56 patients in the control group were included in the statistical analysis. The 1-year survival rate of patients in the treatment group was 56.1% (32/57), which was higher than that of 33.9% (19/56) in the control group (P = 0.033). The mean survival time was (275.30±15.50) days in the treatment group, higher than (227.16±17.11) days in the control group (P = 0.039). Thirty-two patients in the treatment group and 19 patients in the control group completed the Karnofsky score and TCM symptom score at each time point. At weeks 4, 8, 12 and 36, the difference in the Karnofsky score between the two groups was not statistically significant (P>0.05); at weeks 24 and 48, the Karnofsky score in the treatment group was higher than that in the control group at the same time point (P<0.05); analysis of variance of repeated measurements found that the downward trend of the Karnofsky score in the treatment group was slower than that in the control group (F = 4.47, P = 0.037). The difference between the TCM symptom scores of the two groups at each follow-up observation point was not statistically significant (P>0.05); there was a tendency for the TCM symptom scores of the two groups to increase, but the ANOVA of repeated measurements found that the difference between the two groups was not statistically significant either (F = 0.31, P = 0.58). Concusion The oral administration of Huqi Zhengxiao Formula can improve the survival rate, prolong the survival time, and improve the quality of life of patients with stage Ⅲ hepatitis B-associated PLC with syndrome of healthy qi deficiency and toxic stasis accumulations after TACE treatment.


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