1.Construction of a nomogram model for clinical cure of chronic hepatitis B with a low level of hepatitis B surface antigen treated with pegylated interferon α-2b
Yingyuan ZHANG ; Huan MU ; Lixian CHANG ; Danqing XU ; Yuanzhen WANG ; Chunyun LIU ; Weikun LI ; Huangchenghao ZHANG ; Chunyan MOU ; Li LIU
Journal of Clinical Hepatology 2026;42(5):1038-1047
ObjectiveTo investigate the predictive factors for HBsAg clearance in chronic hepatitis B (CHB) patients with a low level of hepatitis B surface antigen (HBsAg) treated with pegylated interferon α-2b (PEG-IFN-α-2b), to establish a combined predictive model and a nomogram based on multiple factors, and to provide a reference for formulating individualized treatment regimens and predicting treatment outcome in clinical practice. MethodsA retrospective analysis was performed for 167 CHB patients with HBsAg <1 500 IU/mL who attended The Third People’s Hospital of Kunming from January 2022 to January 2024 and were treated with PEG-IFN-α-2b. According to whether clinical cure was achieved, the patients were divided into HBsAg clearance group and HBsAg non-clearance group. Related data were collected, including general information and serological/biochemical/virological indicators at different time points during treatment. The independent samples t-test was used for comparison of normally distributed continuous data, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data; the chi-square test was used for comparison of categorical data. The multivariate logistic regression analysis was used to identify independent influencing factors. The receiver operating characteristic (ROC) curve was used to assess the value of indicators used alone or in combination in predicting clinical cure, and calibration curves were plotted to assess the risk prediction model. ResultsThe univariate analysis showed that there were significant differences between the two groups in age (t=-6.839, P<0.05), history of nucleos(t)ide analogue treatment for over 1 year (χ2=59.339, P<0.05), genotype (χ2=4.610, P<0.05), nonalcoholic fatty liver disease (χ2=5.319, P<0.05), hepatitis B virus DNA status before treatment (χ2=60.861, P <0.05), compensated liver cirrhosis (χ2=10.960, P<0.05), HBeAg status before treatment (χ2=19.060, P<0.05), a history of interferon treatment (χ2=8.162, P<0.05), presence of interferon antibodies after treatment (χ2=12.858, P<0.05), HBsAg level before treatment (Z=-7.412, P<0.05), alanine aminotransaminase (ALT) level at baseline (Z=-6.117, P<0.05), ALT level at 12 weeks of treatment (Z=-7.171, P<0.05), platelet count (PLT) at 24 weeks of treatment (Z=-3.622, P<0.05), and thyroid stimulating hormone (TSH) level at 24 weeks of treatment (Z=-2.830, P<0.05). The multivariate logistic regression analysis showed that age (odds ratio [OR]=1.230, P=0.007), history of nucleos(t)ide analogue treatment for over 1 year (OR=0.008, P=0.011), HBeAg status before treatment (OR=0.003, P=0.012), HBsAg level before treatment (OR=1.005, P=0.014), ALT level at baseline (OR=0.949, P=0.014), ALT level at 12 weeks of treatment (OR=0.969, P=0.016), PLT at 24 weeks of treatment (OR=0.969, P=0.022), and TSH level at 24 weeks of treatment (OR=3.608, P=0.045) were independent influencing factors for HBsAg clearance at 48 weeks of treatment in CHB patients with HBsAg <1 500 IU/mL. The Hosmer-Lemeshow goodness-of-fit test yielded χ2=1.398, P=0.994, indicating that the model had good fitting. The Bootstrap method was used to perform internal validation of the nomogram model, and there was a good degree of fitting between the calibration curve and the ideal curve, with a mean absolute error of 0.029. The ROC curve analysis showed that the combination of predictive factors had an area under the ROC curve of 0.982 (95% confidence interval: 0.961 — 0.999), with a sensitivity of 94.10% and a specificity of 93.10%, suggesting that the nomogram model had a good discriminatory ability. For the CHB patients with HBsAg <1 500 IU/mL and different features, further analysis of HBsAg clearance rate at 48 weeks of treatment showed an HBsAg clearance rate of 69.60% for those with HBsAg ≤67.65 IU/mL before treatment, 58.30% for those with a baseline ALT level of ≥62.50 U/L, 68.30% for those with an ALT level of ≥92.50 U/L at 12 weeks of treatment, 42.40% for those with PLT ≥104×109/L at 24 weeks of treatment, and 48.30% for those with a TSH level of ≤1.38 μIU/mL at 24 weeks of treatment, with significant differences between the two groups (all P<0.001). ConclusionAge, history of nucleos(t)ide analogue treatment for over 1 year, HBeAg status before treatment, HBsAg level before treatment, baseline ALT level, ALT level at 12 weeks of treatment, PLT level at 24 weeks, and TSH level at 24 weeks of treatment are independent predictive factors. The combined prediction nomogram model constructed in this study has a relatively high value in predicting clinical cure at 48 weeks of PEG-IFN-α-2b treatment in CHB patients with HBsAg<1 500 IU/mL, thereby providing a reference for selecting suitable treatment population and predicting clinical cure.
2.Party building leads the"four-in-one"model to empower the brand construction of medical volunteer services
Yingyuan PAN ; Xiaojia YANG ; Yuan WANG
Modern Hospital 2025;25(6):851-855
This article focuses on the leadership of Party building and the collaborative innovation of volunteer service,based on the advantages of Party building leading medical volunteer service,discusses the dilemma faced by the brand construc-tion of medical volunteer service,and constructs the four-in-one construction path model of"value leadership-organizational em-powerment-brand building-guarantee system"through the case study of the excellent youth volunteer service project in the national health system,and takes the First Affiliated Hospital of Guangdong Pharmaceutical University as an example to illustrate the im-plementation effect of the four-in-one model.The in-depth integration of Party building leadership and volunteer service highlights the governance efficiency of the integration and transformation of the advantages of Party building and the kinetic energy of medical volunteer service,and helps the sustainable and high-quality development of volunteer service.
3.Party building leads the"four-in-one"model to empower the brand construction of medical volunteer services
Yingyuan PAN ; Xiaojia YANG ; Yuan WANG
Modern Hospital 2025;25(6):851-855
This article focuses on the leadership of Party building and the collaborative innovation of volunteer service,based on the advantages of Party building leading medical volunteer service,discusses the dilemma faced by the brand construc-tion of medical volunteer service,and constructs the four-in-one construction path model of"value leadership-organizational em-powerment-brand building-guarantee system"through the case study of the excellent youth volunteer service project in the national health system,and takes the First Affiliated Hospital of Guangdong Pharmaceutical University as an example to illustrate the im-plementation effect of the four-in-one model.The in-depth integration of Party building leadership and volunteer service highlights the governance efficiency of the integration and transformation of the advantages of Party building and the kinetic energy of medical volunteer service,and helps the sustainable and high-quality development of volunteer service.
4.Analysis of influencing factors and construction of predictive model for HBsAg clearance in patients with HBeAg-negative chronic hepatitis B treated with PEG-IFN-α-2b
Yingyuan ZHANG ; Danqing XU ; Huan MU ; Yuanqiang HE ; Yuanzhen WANG ; Chunyun LIU ; Weikun LI ; Chunyan MOU ; Li LIU
Journal of Clinical Hepatology 2025;41(8):1525-1532
Objective To investigate the predictive factors for the occurrence of HBsAg clearance in patients with HBeAg-negative chronic hepatitis B(CHB)receiving peginterferon alfa-2b(PEG-IFN-α-2b)treatment,analyze the effects of various indicators on the HBsAg clearance rate under different characteristics,and construct and evaluate a combined predictive model.Methods We included 125 patients with HBeAg-negative CHB at Kunming Third People's Hospital from May 2021 to May 2023.After treatment with PEG-IFN-α-2b combined with nucleoside analogues for a course of 48 weeks,they were divided into HBsAg clearance group and HBsAg non-clearance group.Their general information and serological,biochemical,and virological indicators at different time points during treatment were recorded.Continuous data in normal distribution were compared using the t test.Continuous data in non-normal distribution were compared using the Mann-Whitney U test,and comparisons across different time points were performed using the multiple paired-sample Friedman test.Categorical data were compared using the χ2 test.A Logistic regression analysis was used to select variables to establish a combined multi-parameter predictive model.Receiver operating characteristic(ROC)curves were generated to evaluate the diagnostic value of individual indicators and the combined predictive model for HBsAg clearance.Results Before treatment,there were significant differences in baseline HBsAg level(Z=-3.997,P<0.05)and treatment history(χ2=8.221,P<0.05)between the two groups.During treatment,gradually decreasing trends were observed in white blood cell count(χ2=104.944),neutrophil count(χ2=132.036),platelet count(χ2=162.881),and thyroid-stimulating hormone level(TSH,χ2=83.304,all P<0.05),while alanine aminotransferase(ALT,χ2=157.618)and alpha fetoprotein(χ2=159.472)showed gradually increasing trends(both P<0.05).At 48 weeks of treatment,treatment history(odds ratio[OR]=0.232,95%confidence interval[CI]:0.071-0.753),baseline HBsAg level(OR=13.423,95%CI:3.276-54.997),the extent of decrease in HBsAg from baseline after 12 weeks of treatment(OR=0.143,95%CI:0.040-0.515),the maximum ALT level during treatment(OR=0.986,95%CI:0.980-0.993),and the minimum TSH level during treatment(OR=3.281,95%CI:1.413-7.619)were independent factors affecting HBsAg clearance(all P<0.05).A combined predictive model for HBsAg clearance was built:Y=-1.603-1.462×treatment history+2.597×baseline HBsAg value-1.944×the extent of HBsAg reduction from baseline after 12 weeks of treatment-0.014×the maximum ALT value during treatment+1.188×the minimum TSH value during treatment.The diagnostic value of the individual indicators for HBsAg clearance from high to low was as following:the maximum ALT value during treatment(AUC=0.824),baseline HBsAg value(AUC=0.727),the minimum TSH value during treatment(AUC=0.707),the extent of HBsAg reduction from baseline after 12 weeks of treatment(AUC=0.641),and treatment history(AUC=0.636).The combined model showed better predictive performance than the individual indicators,with the AUC being 0.921(all P<0.05).Conclusion The combined model,constructed with baseline HBsAg value,the extent of HBsAg reduction from baseline after 12 weeks of treatment,the maximum ALT value during treatment,and the minimum TSH value during treatment,has high predictive value for the occurrence of HBsAg clearance in patients with HBeAg-negative CHB after 48 weeks of treatment with PEG-IFN-α-2b,which can provide a reference for identifying suitable patients for treatment and predicting clinical outcome.
5.Analysis of influencing factors and construction of predictive model for HBsAg clearance in patients with HBeAg-negative chronic hepatitis B treated with PEG-IFN-α-2b
Yingyuan ZHANG ; Danqing XU ; Huan MU ; Yuanqiang HE ; Yuanzhen WANG ; Chunyun LIU ; Weikun LI ; Chunyan MOU ; Li LIU
Journal of Clinical Hepatology 2025;41(8):1525-1532
Objective To investigate the predictive factors for the occurrence of HBsAg clearance in patients with HBeAg-negative chronic hepatitis B(CHB)receiving peginterferon alfa-2b(PEG-IFN-α-2b)treatment,analyze the effects of various indicators on the HBsAg clearance rate under different characteristics,and construct and evaluate a combined predictive model.Methods We included 125 patients with HBeAg-negative CHB at Kunming Third People's Hospital from May 2021 to May 2023.After treatment with PEG-IFN-α-2b combined with nucleoside analogues for a course of 48 weeks,they were divided into HBsAg clearance group and HBsAg non-clearance group.Their general information and serological,biochemical,and virological indicators at different time points during treatment were recorded.Continuous data in normal distribution were compared using the t test.Continuous data in non-normal distribution were compared using the Mann-Whitney U test,and comparisons across different time points were performed using the multiple paired-sample Friedman test.Categorical data were compared using the χ2 test.A Logistic regression analysis was used to select variables to establish a combined multi-parameter predictive model.Receiver operating characteristic(ROC)curves were generated to evaluate the diagnostic value of individual indicators and the combined predictive model for HBsAg clearance.Results Before treatment,there were significant differences in baseline HBsAg level(Z=-3.997,P<0.05)and treatment history(χ2=8.221,P<0.05)between the two groups.During treatment,gradually decreasing trends were observed in white blood cell count(χ2=104.944),neutrophil count(χ2=132.036),platelet count(χ2=162.881),and thyroid-stimulating hormone level(TSH,χ2=83.304,all P<0.05),while alanine aminotransferase(ALT,χ2=157.618)and alpha fetoprotein(χ2=159.472)showed gradually increasing trends(both P<0.05).At 48 weeks of treatment,treatment history(odds ratio[OR]=0.232,95%confidence interval[CI]:0.071-0.753),baseline HBsAg level(OR=13.423,95%CI:3.276-54.997),the extent of decrease in HBsAg from baseline after 12 weeks of treatment(OR=0.143,95%CI:0.040-0.515),the maximum ALT level during treatment(OR=0.986,95%CI:0.980-0.993),and the minimum TSH level during treatment(OR=3.281,95%CI:1.413-7.619)were independent factors affecting HBsAg clearance(all P<0.05).A combined predictive model for HBsAg clearance was built:Y=-1.603-1.462×treatment history+2.597×baseline HBsAg value-1.944×the extent of HBsAg reduction from baseline after 12 weeks of treatment-0.014×the maximum ALT value during treatment+1.188×the minimum TSH value during treatment.The diagnostic value of the individual indicators for HBsAg clearance from high to low was as following:the maximum ALT value during treatment(AUC=0.824),baseline HBsAg value(AUC=0.727),the minimum TSH value during treatment(AUC=0.707),the extent of HBsAg reduction from baseline after 12 weeks of treatment(AUC=0.641),and treatment history(AUC=0.636).The combined model showed better predictive performance than the individual indicators,with the AUC being 0.921(all P<0.05).Conclusion The combined model,constructed with baseline HBsAg value,the extent of HBsAg reduction from baseline after 12 weeks of treatment,the maximum ALT value during treatment,and the minimum TSH value during treatment,has high predictive value for the occurrence of HBsAg clearance in patients with HBeAg-negative CHB after 48 weeks of treatment with PEG-IFN-α-2b,which can provide a reference for identifying suitable patients for treatment and predicting clinical outcome.
6.Efficacy and safety of amoxicillin-clavulanate(10∶1)for injection versus ampicillin-sulbactam in the treatment of community-acquired pneumonia
Xiaohua QIN ; Haihui HUANG ; Xingang HUANG ; Shenghua SUN ; Dongyang HE ; Wenjing WANG ; Yingyuan ZHANG
Chinese Journal of Infection and Chemotherapy 2025;25(4):357-363
Objective To evaluate the efficacy and safety of amoxicillin-clavulanate(10∶1)for injection in the treatment of community-acquired pneumonia(CAP)in adult patients.Methods Eligible patients were randomized to receive amoxicillin-clavulanate(10∶1)2.2 g or ampicillin-sulbactam(2∶1)3.0 g via intravenous infusion q12h or q8h for 7 to 14 days.The primary endpoint was to the clinical efficacy 7-14 days after discontinuation of treatment.The secondary endpoints included microbiological efficacy and safety.Results All enrolled patients(n=324)were included in the full analysis set(FAS),specifically 165 patients receiving amoxicillin sodium-clavulanate potassium(10∶1)and 159 patients receiving ampicillin sodium-sulbactam sodium(2∶1).The clinical cure rate was 78.8%(130/165)for amoxicillin-clavulanate(10∶1)and 77.4%(123/159)for ampicillin-sulbactam 7-14 days after end of treatment(P>0.05).The clinical cure rate was 87.5%(126/144)for amoxicillin-clavulanate(10∶1)and 87.4%(111/127)for ampicillin-sulbactam(2∶1)in per protocol set(P>0.05).Therefore,amoxicillin-clavulanate(10∶1)was non-inferior to ampicillin-sulbactam in the primary endpoint in the treatment of CAP in adult patients.The overall bacterial eradication rate was 94.4%(34/36)for amoxicillin-clavulanate(10∶1)and 89.3%(25/28)for ampicillin-sulbactam(P>0.05).The common study drug-related clinical adverse event were abnormalities of hepatic function in both the amoxicillin-clavulanate(10∶1)group(4.8%,8/165)and ampicillin-sulbactam group(3.1%,5/159)(P>0.05).Conclusions Amoxicillin-clavulanate(10∶1)2.2 g Ⅳ infusion q12h or q8h for 7-14 days was noninferior to ampicillin-sulbactam in terms of clinical and microbiological efficacy in the treatment of CAP in adult patients.The safety of the two dosing regimens was comparable.
7.Efficacy and safety of coblopasvir hydrochloride combined with sofosbuvir in treatment of patients with genotype 3 hepatitis C virus infection
Yingyuan ZHANG ; Huan MU ; Danqing XU ; Chunyan MOU ; Yuanzhen WANG ; Chunyun LIU ; Weikun LI ; Li LIU
Journal of Clinical Hepatology 2025;41(6):1075-1082
ObjectiveTo investigate the efficacy and safety of the direct-acting antiviral agents coblopasvir hydrochloride/sofosbuvir (CLP/SOF) regimen used alone or in combination with ribavirin (RBV) in the treatment of patients with genotype 3 hepatitis C virus (HCV) infection in terms of virologic response rate, liver function recovery, improvement in liver stiffness measurement (LSM), and adverse drug reactions, and to provide a reference for clinical medication. MethodsA total of 98 patients with genotype 3 HCV infection who attended The Third People’s Hospital of Kunming from January 2022 to December 2023 were enrolled, and according to the treatment method, the patients were divided into CLP/SOF+RBV treatment group with 55 patients and CLP/SOF treatment group with 43 patients. The patients were observed in terms of rapid virologic response at week 4 (RVR4), sustained virologic response (SVR), previous treatment experience, underlying diseases, laboratory and imaging indicators, and adverse reactions during treatment. The course of treatment was 12 weeks, and the patients were followed up for 12 weeks after drug withdrawal. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the Friedman test was used for comparison within each group at different time points, and the Bonferroni method was used for further comparison and correction of P value; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups. The univariate and multivariate Logistic regression analyses were used to investigate the influencing factors for SVR12. ResultsBefore treatment, there were significant differences between the CLP/SOF+RBV treatment group and the CLP/SOF treatment group in terms of LSM, total bilirubin (TBil), gamma-glutamyl transpeptidase (GGT), HCV genotype, and the presence or absence of liver cirrhosis and compensation (all P<0.05). The 98 patients with genotype 3 HCV infection had an RVR4 rate of 81.6% and an SVR12 rate of 93.9%. The patients with genotype 3a HCV infection had an RVR4 rate of 84.44% and an SVR12 rate of 97.78%, while the patients with genotype 3b HCV infection had an RVR4 rate of 79.25% and an SVR12 rate of 90.57%. There were significant differences in RVR4 and SVR12 rates between the patients without hepatocellular carcinoma and those with hepatocellular carcinoma, there was a significant difference in RVR4 rate between the patients without HIV infection and those with HIV infection, and there was a significant difference in SVR12 rate between the previously untreated patients and the treatment-experienced patients (all P<0.05). The univariate Logistic regression analysis showed that treatment history, hypertension, hepatocellular carcinoma, ascites, albumin (Alb), and platelet count were influencing factors for SVR12 (all P<0.05), and the multivariate Logistic regression analysis showed that hepatocellular carcinoma (odds ratio=0.034, 95% confidence interval: 0.002 — 0.666, P=0.026) was an independent influencing factor for SVR12. After treatment with CLP/SOF combined with RBV or CLP/SOF alone, the patients with genotype 3 HCV infection showed gradual reductions in the liver function parameters of TBil, GGT, and alanine aminotransferase (all P<0.05) and a gradual increase in the level of Alb (P<0.05). As for renal function, there were no significant changes in blood urea nitrogen and creatinine after treatment (P>0.05). For the patients with or without liver cirrhosis, there was a significant reduction in LSM from baseline after treatment for 12 weeks (P<0.05). Among the 98 patients with genotype 3 HCV infection, 9 tested positive for HCV-RNA at 12 weeks after treatment, 2 showed no response during treatment, 4 showed virologic breakthrough, and 3 experienced recurrence. The overall incidence rate of adverse events during treatment was 17.35% for all patients. ConclusionCLP/SOF alone or in combination with RBV has a relatively high SVR rate in the treatment of genotype 3 HCV infection, with good tolerability and safety in patients during treatment, and therefore, it holds promise for clinical application.
8.Influencing factors for recompensation in patients with decompensated hepatitis C cirrhosis
Danqing XU ; Huan MU ; Yingyuan ZHANG ; Lixian CHANG ; Yuanzhen WANG ; Weikun LI ; Zhijian DONG ; Lihua ZHANG ; Yijing CHENG ; Li LIU
Journal of Clinical Hepatology 2025;41(2):269-276
ObjectiveTo investigate the influencing factors for recompensation in patients with decompensated hepatitis C cirrhosis, and to establish a predictive model. MethodsA total of 217 patients who were diagnosed with decompensated hepatitis C cirrhosis and were admitted to The Third People’s Hospital of Kunming l from January, 2019 to December, 2022 were enrolled, among whom 63 patients who were readmitted within at least 1 year and had no portal hypertension-related complications were enrolled as recompensation group, and 154 patients without recompensation were enrolled as control group. Related clinical data were collected, and univariate and multivariate analyses were performed for the factors that may affect the occurrence of recompensation. The independent-samples t test was used for comparison of normally distributed measurement data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed measurement data between two groups; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups. A binary Logistic regression analysis was used to investigate the influencing factors for recompensation in patients with decompensated hepatitis C cirrhosis, and the receiver operating characteristic (ROC) curve was used to assess the predictive performance of the model. ResultsAmong the 217 patients with decompensated hepatitis C cirrhosis, 63 (29.03%) had recompensation. There were significant differences between the recompensation group and the control group in HIV history (χ2=4.566, P=0.034), history of partial splenic embolism (χ2=6.687, P=0.014), Child-Pugh classification (χ2=11.978, P=0.003), grade of ascites (χ2=14.229, P<0.001), albumin (t=4.063, P<0.001), prealbumin (Z=-3.077, P=0.002), high-density lipoprotein (t=2.854, P=0.011), high-sensitivity C-reactive protein (Z=-2.447, P=0.014), prothrombin time (Z=-2.441, P=0.015), carcinoembryonic antigen (Z=-2.113, P=0.035), alpha-fetoprotein (AFP) (Z=-2.063, P=0.039), CA125 (Z=-2.270, P=0.023), TT3 (Z=-3.304, P<0.001), TT4 (Z=-2.221, P=0.026), CD45+ (Z=-2.278, P=0.023), interleukin-5 (Z=-2.845, P=0.004), tumor necrosis factor-α (Z=-2.176, P=0.030), and portal vein width (Z=-5.283, P=0.005). The multivariate analysis showed that history of partial splenic embolism (odds ratio [OR]=3.064, P=0.049), HIV history (OR=0.195, P=0.027), a small amount of ascites (OR=3.390, P=0.017), AFP (OR=1.003, P=0.004), and portal vein width (OR=0.600, P<0.001) were independent influencing factors for the occurrence of recompensation in patients with decompensated hepatitis C cirrhosis. The ROC curve analysis showed that HIV history, grade of ascites, history of partial splenic embolism, AFP, portal vein width, and the combined predictive model of these indices had an area under the ROC curve of 0.556, 0.641, 0.560, 0.589, 0.745, and 0.817, respectively. ConclusionFor patients with decompensated hepatitis C cirrhosis, those with a history of partial splenic embolism, a small amount of ascites, and an increase in AFP level are more likely to experience recompensation, while those with a history of HIV and an increase in portal vein width are less likely to experience recompensation.
9.Risk factors for concurrent hepatic hydrothorax before intervention in primary liver cancer and construction of a nomogram prediction model
Yuanzhen WANG ; Renhai TIAN ; Yingyuan ZHANG ; Danqing XU ; Lixian CHANG ; Chunyun LIU ; Li LIU
Journal of Clinical Hepatology 2025;41(1):75-83
ObjectiveTo investigate the influencing factors for hepatic hydrothorax (HH) before intervention for primary hepatic carcinoma (PHC), and to construct and assess the nomogram risk prediction model. MethodsA retrospective analysis was performed for the clinical data of 353 hospitalized patients who attended the Third People’s Hospital of Kunming for the first time from October 2012 to October 2021 and there diagnosed with PHC, and according to the presence or absence of HH, they were divided into HH group with 153 patients and non-HH group with 200 patients. General data and the data of initial clinical testing after admission were collected from all PHC patients. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups. After the multicollinearity test was performed for the variables with statistical significance determined by the univariate analysis, the multivariate Logistic regression analysis was used to identify independent influencing factors. The “rms” software package was used to construct a nomogram risk prediction model, and the Hosmer-Lemeshow test and the receiver operating characteristic (ROC) curve were used to assess the risk prediction model; the “Calibration Curves” software package was used to plot the calibration curve, and the “rmda” software package was used to plot the clinical decision curve and the clinical impact curve. ResultsAmong the 353 patients with PHC, there were 153 patients with HH, with a prevalence rate of 43.34%. Child-Pugh class B (odds ratio [OR]=2.652, 95% confidence interval [CI]: 1.050 — 6.698, P=0.039), Child-Pugh class C (OR=7.963, 95%CI: 1.046 — 60.632, P=0.045), total protein (OR=0.947, 95%CI: 0.914 — 0.981, P=0.003), high-sensitivity C-reactive protein (OR=1.007, 95%CI: 1.001 — 1.014, P=0.025), and interleukin-2 (OR=0.801, 95%CI: 0.653 — 0.981, P=0.032) were independent influencing factors for HH before PHC intervention, and a nomogram risk prediction model was established based on these factors. The Hosmer-Lemeshow test showed that the model had a good degree of fitting (χ2=5.006, P=0.757), with an area under the ROC curve of 0.752 (95%CI: 0.701 — 0.803), a sensitivity of 78.40%, and a specificity of 63.50%. The calibration curve showed that the model had good consistency in predicting HH before PHC intervention, and the clinical decision curve and the clinical impact curve showed that the model had good clinical practicability within a certain threshold range. ConclusionChild-Pugh class, total protein, interleukin-2, and high-sensitivity C-reactive protein are independent influencing factors for developing HH before PHC intervention, and the nomogram model established based on these factors can effectively predict the risk of developing HH.
10.Efficacy and safety of amoxicillin-clavulanate(10∶1)for injection versus ampicillin-sulbactam in the treatment of community-acquired pneumonia
Xiaohua QIN ; Haihui HUANG ; Xingang HUANG ; Shenghua SUN ; Dongyang HE ; Wenjing WANG ; Yingyuan ZHANG
Chinese Journal of Infection and Chemotherapy 2025;25(4):357-363
Objective To evaluate the efficacy and safety of amoxicillin-clavulanate(10∶1)for injection in the treatment of community-acquired pneumonia(CAP)in adult patients.Methods Eligible patients were randomized to receive amoxicillin-clavulanate(10∶1)2.2 g or ampicillin-sulbactam(2∶1)3.0 g via intravenous infusion q12h or q8h for 7 to 14 days.The primary endpoint was to the clinical efficacy 7-14 days after discontinuation of treatment.The secondary endpoints included microbiological efficacy and safety.Results All enrolled patients(n=324)were included in the full analysis set(FAS),specifically 165 patients receiving amoxicillin sodium-clavulanate potassium(10∶1)and 159 patients receiving ampicillin sodium-sulbactam sodium(2∶1).The clinical cure rate was 78.8%(130/165)for amoxicillin-clavulanate(10∶1)and 77.4%(123/159)for ampicillin-sulbactam 7-14 days after end of treatment(P>0.05).The clinical cure rate was 87.5%(126/144)for amoxicillin-clavulanate(10∶1)and 87.4%(111/127)for ampicillin-sulbactam(2∶1)in per protocol set(P>0.05).Therefore,amoxicillin-clavulanate(10∶1)was non-inferior to ampicillin-sulbactam in the primary endpoint in the treatment of CAP in adult patients.The overall bacterial eradication rate was 94.4%(34/36)for amoxicillin-clavulanate(10∶1)and 89.3%(25/28)for ampicillin-sulbactam(P>0.05).The common study drug-related clinical adverse event were abnormalities of hepatic function in both the amoxicillin-clavulanate(10∶1)group(4.8%,8/165)and ampicillin-sulbactam group(3.1%,5/159)(P>0.05).Conclusions Amoxicillin-clavulanate(10∶1)2.2 g Ⅳ infusion q12h or q8h for 7-14 days was noninferior to ampicillin-sulbactam in terms of clinical and microbiological efficacy in the treatment of CAP in adult patients.The safety of the two dosing regimens was comparable.

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