1.Exon Sequencing of HNF1β in Chinese Patients with Early-Onset Diabetes
Siqian GONG ; Hong LIAN ; Yating LI ; Xiaoling CAI ; Wei LIU ; Yingying LUO ; Meng LI ; Si-min ZHANG ; Rui ZHANG ; Lingli ZHOU ; Yu ZHU ; Qian REN ; Xiuying ZHANG ; Jing CHEN ; Jing WU ; Xianghai ZHOU ; Xirui WANG ; Xueyao HAN ; Linong JI
Diabetes & Metabolism Journal 2025;49(2):321-330
Background:
Maturity-onset diabetes of the young (MODY) due to variants of hepatocyte nuclear factor 1-beta (HNF1β) (MODY5) has not been well studied in the Chinese population. This study aimed to estimate its prevalence and evaluate the application of a clinical screening method (Faguer score) in Chinese early-onset diabetes (EOD) patients.
Methods:
Among 679 EOD patients clinically diagnosed with type 2 diabetes mellitus (age at diagnosis ≤40 years), the exons of HNF1β were sequenced. Functional impact of rare variants was evaluated using a dual-luciferase reporter system. Faguer scores ≥8 prompted multiplex ligation-dependent probe amplification (MLPA) for large deletions. Pathogenicity of HNF1β variants was assessed following the American College of Medical Genetics and Genomics (ACMG) guidelines.
Results:
Two rare HNF1β missense mutations (E105K and G454R) were identified by sequencing in five patients, showing functional impact in vitro. Another patient was found to have a whole-gene deletion by MLPA in 22 patients with the Faguer score above 8. Following ACMG guidelines, six patients carrying pathogenic or likely pathogenic variant were diagnosed with MODY5. The estimated prevalence of MODY5 in Chinese EOD patients was approximately 0.9% or higher.
Conclusion
MODY5 is not uncommon in China. The Faguer score is helpful in deciding whether to perform MLPA analysis on patients with negative sequencing results.
2.Effect of National Metabolic Management Center mode in metabolic indexes in different age patients with type 2 diabetic mellitus
Ping WANG ; Lianyong LIU ; Jianhua ZHANG ; Weiping LI ; Yunxia GAN ; Shiya CAI ; Hong WU
Chinese Journal of Postgraduates of Medicine 2025;48(5):428-434
Objective:To explore the impact of National Metabolic Management Center (MMC) mode on the metabolic indexes in different age patients with type 2 diabetic mellitus (T2DM).Methods:A prospective study method was used. A total of 798 T2DM patients underwent the MMC mode management in Shanghai Punan Hospital of Pudong New District from May 2021 to August 2024 were selected. The patients followed the MMC one-stop diagnosis and treatment management service standards to enter the registration, treatment, examination and follow-up processes. The average follow-up time was 12.0 months. The glucose and lipid metabolism indexes, blood pressure and body mass index (BMI) before intervention and after receiving the intervention by MMC were measured. The glucose and lipid metabolism indexes included triacylglycerol, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), fasting blood glucose, 2 h postprandial blood glucose and glycated hemoglobin. The control rates of blood glucose, blood lipid, blood pressure and BMI were calculated after intervention.Results:The triacylglycerol, total cholesterol, LDL-C, fasting blood glucose, 2 h postprandial blood glucose and glycated hemoglobin after intervention in patients with T2DM were significantly lower than those before intervention: (1.75 ± 1.63) mmol/L vs. (2.08 ± 1.74) mmol/L, (4.37 ± 1.11) mmol/L vs. (4.88 ± 1.24) mmol/L, (2.47 ± 0.92) mmol/L vs. (2.92 ± 0.98) mmol/L, (6.54 ± 1.71) mmol/L vs. (8.12 ± 3.05) mmol/L, (9.04 ± 3.49) mmol/L vs. (12.10 ± 5.28) mmol/L and (6.89 ± 1.23)% vs. (8.85 ± 2.31)%, the HDL-C after intervention was significantly higher than that before intervention: (1.21 ± 0.31) mmol/L vs. (1.13 ± 0.29) mmol/L, and there were statistical differences ( P<0.01). The control rates of blood lipid and blood glucose after intervention in patients with T2DM were significantly higher than those before intervention: 54.6% (436/798) vs. 37.3% (298/798) and 62.0% (495/798) vs. 26.1% (208/798), and there were statistical differences ( P<0.01); there were no statistical differences in the control rates of BMI and blood pressure before intervention and after intervention ( P>0.05). In T2DM patients with age <50 years and from 50 to 59 years, the triacylglycerol, total cholesterol, LDL-C, fasting blood glucose, 2 h postprandial blood glucose and glycated hemoglobin after intervention were significantly lower than those before intervention, the HDL-C after intervention was significantly higher than that before intervention, and there were statistical differences ( P<0.05 or <0.01); the control rates of blood lipid and blood glucose after intervention were significantly higher than those before intervention, the patients with <50 years: 44.5% (114/256) vs. 27.7% (71/256) and 76.6% (196/256) vs. 28.9% (74/256), the patients with 50 to 59 years: 54.8% (86/157) vs. 28.0% (44/157) and 66.9% (105/157) vs. 24.8% (39/157), and there were statistical differences ( P<0.01); there were no statistical differences in the control rates of BMI and blood pressure between before intervention and after intervention ( P>0.05). In T2DM patients with age from 60 to 69 years, the triacylglycerol, total cholesterol, LDL-C, fasting blood glucose, 2 h postprandial blood glucose and glycated hemoglobin after intervention were significantly lower than those before intervention, and there were statistical differences ( P<0.05 or <0.01); there was no statistical differences in HDL-C before intervention and after intervention ( P>0.05); the control rates of blood lipid and blood glucose after intervention were significantly higher than those before intervention: 59.0% (177/300) vs. 47.3% (142/300) and 53.3% (160/300) vs. 25.7% (77/300), and there were statistical differences ( P<0.01); there were no statistical differences in the control rates of BMI and blood pressure before intervention and after intervention ( P>0.05). In T2DM patients with aged ≥70 years, the total cholesterol, LDL-C, 2 h postprandial blood glucose and glycated hemoglobin after intervention were significantly lower than those before intervention, and there were statistical differences ( P<0.05 or <0.01); there were no statistical difference in triacylglycerol, HDL-C and fasting blood glucose between before intervention and after intervention ( P>0.05); the control rate of blood glucose after intervention was significantly higher than that before intervention: 48.2% (41/85) vs. 22.4% (19/85), and there was statistical difference ( P<0.01); there were no statistical differences in the control rates of BMI, blood pressure and blood lipid between before intervention and after intervention ( P>0.05). Conclusions:The intervention based on MMC mode management could effectively improve the glucose and lipid metabolism in patients with T2DM, especially for patients with aged <70 years. However, additional health guidance is needed for patients with aged ≥ 70 years to further enhance their health benefits.
3.Best essential surgical technique training course to improve surgical residents′ laparoscopic peritoneal suturing skills: a cohort study
Zhenghao CAI ; Haiqin SONG ; Jing SUN ; Pei XUE ; Luyang ZHANG ; Chao WU ; Hiju HONG ; Xi CHENG ; Sen ZHANG ; Minhua ZHENG ; Lu ZANG ; Ruijun PAN ; Jianwen LI ; Bo FENG
Journal of Surgery Concepts & Practice 2025;30(2):132-137
Objective To explore the effectiveness of an integrated laparoscopic simulation training course (best essential surgical technique training, BEST) in enhancing laparoscopic peritoneal suturing techniques in surgical residents.Methods As an integrated two-stage program, the BEST course applied basic laparoscopic training system with simple molds in phase Ⅰ training, and then adopted advanced laparoscopic training system, 3D Laparoscope and ex-vivo animal models in phase Ⅱ training. The laparoscopic suturing techniques were practiced in phase Ⅱ training. From August 2021 to July 2024, surgical residents in the second year of the national standardized training program were divided into pilot and control groups based on whether they had undergone the BEST course. Two cases of laparoscopic peritoneal suture were performed by the surgical residents under supervision in the department of gastrointestinal surgery. The operative time, quality of suture, and independent completion rate were compared between the two groups.Results A total of 33 surgical residents (19 in pilot group and 14 in control group) were included in this study, and a total of 66 cases of laparoscopic peritoneal suture were performed (38 in pilot group and 28 in control group). The operative time was significantly shorter in pilot group than that in control group (15.7 min vs. 17.5 min, P=0.025). The quality of suture was significantly better in pilot group compared to control group (P=0.023). In pilot group, all peritoneal sutures were performed by residents independently, whereas in control group, 3 cases (10.7%) were assisted by the supervisor, and the independent completion rate was different significantly (P=0.039).Conclusions The BEST course can help improve surgical residents′ laparoscopic peritoneal suturing techniques and could be promoted in the national standardized training program for surgical residents.
4.Construction of a prediction model for muscular invasion in upper urinary tract urothelial carcinoma based on preoperative MRI features
Haonan CHEN ; Lingkai CAI ; Hongyuan DING ; Hao JI ; Tianxiao HONG ; Hao YU ; Qikai WU ; Chaoran ZHAO ; Xiao YANG ; Qiang CAO ; Xiancheng ZHAO ; Pengchao LI ; Qiang LYU
Chinese Journal of Urology 2025;46(9):661-668
Objective:To construct a nomogram based on preoperative MRI imaging features for the prediction of muscle-invasive upper urinary tract urothelial carcinoma(UTUC)and evaluate its performance.Methods:This retrospective cohort study analyzed the clinical data of 99 UTUC patients treated at the First Affiliated Hospital of Nanjing Medical University from April 2018 to May 2024. Among them,69(69.7%)were male and 30(30.3%)were female,with a median age of 67.0 years. All patients underwent preoperative MRI and radical nephroureterectomy. According to postoperative pathology,tumors staged ≥ T 2 were assigned to the muscle-invasive group,and those staged ≤ T 1 were assigned to the non-muscle-invasive group. Baseline data,pathological information,and imaging characteristics were collected and compared between the two groups. Logistic regression analysis was performed to identify risk factors for muscle-invasive UTUC,and a nomogram was constructed. The diagnostic performance of the model was assessed using receiver operating characteristic(ROC)curves,calibration curves,and decision curve analysis(DCA). Results:Among the 99 patients,70(70.7%)were diagnosed with muscle-invasive UTUC,and 29(29.3%)with non-muscle-invasive UTUC. The muscle-invasive group had significantly larger tumor size[4.5(2.8,7.0)cm vs. 3.0(2.3,4.5)cm, P = 0.029],a higher incidence of multifocal tumors[37.1%(26/70)vs. 3.5%(1/29), P < 0.001],patchy tumors[30.0%(21/70)vs. 6.9%(2/29), P = 0.019],spiculated tumor margins[52.9%(37/70)vs. 17.2%(5/29), P = 0.001],tumor compression on renal parenchyma or periureteral/peripelvic fat[68.6%(48/70)vs. 10.3%(3/29), P < 0.001],high-grade pathology[92.9%(65/70)vs. 75.9%(22/29), P = 0.043],lymph node metastasis[28.6%(20/70)vs. 0, P = 0.001],and lymphovascular invasion[42.9%(30/70)vs. 10.3%(3/29), P=0.002]. The apparent diffusion coefficient(ADC)values[0.9(0.8,1.1)× 10 -3 mm2/s vs. 1.1(1.0,1.4)× 10 -3 mm2/s, P < 0.001]and normalized ADC(NADC)values[0.8(0.7,1.0)vs. 0.9(0.8,1.1), P = 0.002]were significantly lower in the muscle-invasive group. Univariate logistic regression identified multifocality,patchy tumor patterns,spiculated tumor margins,tumor compression on renal parenchyma or periureteral/peripelvic fat,and low NADC values as risk factors for muscle-invasive UTUC(all P < 0.05). Multivariate analysis revealed multifocality( OR = 17.903,95% CI 1.650 - 194.253, P = 0.018),tumor compression on renal parenchyma or perirenal / ureteral fat( OR = 14.690,95% CI 3.069 - 70.323, P < 0.001),and low NADC value( OR = 0.016,95% CI 0.001 - 0.471, P = 0.017)as independent risk factors. A nomogram was constructed based on these factors. The area under the ROC curve(AUC)of the model was 0.898(95% CI 0.838 - 0.957),with an optimal cutoff value of 0.639. The model showed an accuracy of 83.8%,sensitivity of 81.4%,and specificity of 89.7%. Calibration curves indicated good calibration,and DCA showed that the model provided substantial clinical net benefit. Conclusions:This study constructed a nomogram based on preoperative MRI features,including tumor multifocality,compression on renal parenchyma or periureteral/peripelvic fat and NADC value,which demonstrates good predictive performances for muscle-invasive UTUC.
5.Expert consensus on visualized tele-round and quality control management based on the improvement of clinical practice ability
Wanhong YIN ; Xiaoting WANG ; Ran ZHOU ; Dawei LIU ; Yan KANG ; Yaoqing TANG ; Xiaochun MA ; Jianguo LI ; Zhenjie HU ; Haitao ZHANG ; Wei HE ; Lixia LIU ; Wenjin CHEN ; Ran ZHU ; Jun WU ; Hongmin ZHANG ; Lina ZHANG ; Wenzhao CHAI ; Shihong ZHU ; Wangbin XU ; Rongqing SUN ; Xiangyou YU ; Tianjiao SONG ; Ying ZHU ; Hong REN ; Ai SHANMU ; Qing ZHANG ; Wei FANG ; Xiuling SHANG ; Liwen LYU ; Shuhan CAI ; Xin DING ; Heng ZHANG ; Guang FENG ; Lipeng ZHANG ; Bo HU ; Dong ZHANG ; Weidong WU ; Feng SHEN ; Xiaojun YANG ; Zhenguo ZENG ; Qibing HUANG ; Xueying ZENG ; Tongjuan ZOU ; Milin PENG ; Yulong YAO ; Mingming CHEN ; Hui LIAN ; Jingmei WANG ; Yong LI ; Feng QU ; Gang YE ; Rongli YANG ; Xiukai CHEN ; Suwei LI ; Juxiang WANG ; Yangong CHAO
Chinese Journal of Internal Medicine 2025;64(2):101-109
Turning to critical illness is a common stage of various diseases and injuries before death. Patients usually have complex health conditions, while the treatment process involves a wide range of content, along with high requirements for doctor′s professionalism and multi-specialty teamwork, as well as a great demand for time-sensitive treatments. However, this is not matched with critical care professionals and the current state of medical care in China. Telemedicine, which shortens the distance of medical professionals and the gap of disease diagnosis and treatments in various regions through electronic information, can effectively solve the current problem. Therefore, there is an urgent need to develop a standardized, high-quality visualization telemedicine round system .Therefore, experts have been organized to search domestic and foreign literature on telemedicine round for critically ill patients and to form this consensus based on clinical experiences so as to further improve the level of critical care treatments in regions.
6.Effects of smoking on regulatory T cells, TGF-β 1, and IL-10 in peripheral blood of elderly patients with non-small cell lung cancer
Yuanling LIU ; Congrui FENG ; Yuluo CHEN ; Sizhi WU ; Yanjun ZENG ; Huake SUN ; Danyan CAI ; Hong WANG ; Gang XU ; Yu LU ; Wei MA
Chinese Journal of Health Management 2025;19(6):429-433
Objective:To explore the effects of smoking on peripheral regulatory T cells (Tregs), transforming growth factor beta1 (TGF-β 1) and interleukin-10 (IL-10) in elderly patients with non-small cell lung cancer (NSCLC). Methods:This was a cross-sectional study. A total of 43 elderly patients (≥60 years old) who were hospitalized in the Department of Geriatrics Medicine, Guangzhou First People′s Hospital from January 2018 to December 2024 and were newly diagnosed with NSCLC were recruited. According to smoking history, patients were divided into non-smoking group (15 cases), low smoking group (13 cases, smoking index<400) and high smoking group (15 cases, smoking index≥400). Venous blood samples were collected from participants, plasma and cells were separated. Flow cytometry was used to measure the proportions of Tregs and the expression of forkhead box P3 (Foxp3) in peripheral blood. Plasma levels of TGF-β 1 and IL-10 were measured by enzyme-linked immunosorbent assay. The effects of smoking on peripheral Tregs, TGF-β 1, and IL-10 in elderly patients with NSCLC were analyzed. Data were analyzed by one-way ANOVA, rank-sum test, and Fisher′s exact test. Results:The proportions of Tregs in non-smoking group, low smoking group and high smoking group were 2.50% (2.32%, 2.81%), 2.83% (2.48%, 3.72%), and 3.01% (2.37%, 3.73%), respectively, and there were no statistically significant differences among the three groups ( H=3.845, P>0.05). The proportions of Foxp3 +Tregs were (3.72±0.84)%, (4.64±1.10)%, and (4.68±1.27%), respectively. The mean fluorescence intensities (MFI) of Foxp3 were 123.0 (108.0, 128.0), 131.0 (123.5, 350.0), and 222.0 (141.0, 311.0), respectively. Both the proportions of Foxp3 +Tregs and the MFI of Foxp3 were higher in low smoking group and high smoking group than those in non-smoking group (all P<0.05). However, there were no significant differences between low smoking group and high smoking group (all P>0.05). The concentrations of IL-10 were 2.27 (1.42, 3.95), 3.42 (2.30, 5.08), and 3.26 (2.35, 6.28) ng/L, respectively. There were no statistically significant differences among the three groups ( H=2.930, P>0.05). The concentrations of TGF-β 1 were (10.72±9.37), (13.46±10.39), and (25.28±16.67) ng/ml, respectively. The concentration of TGF-β 1 in high smoking group was higher than that in non-smoking group and low smoking group (all P<0.05). However, there was no statistically significant difference between low smoking group and non-smoking group ( P>0.05). Conclusions:Smoking intensity may be correlated with the immunosuppressive function of Tregs in elderly patients with NSCLC. Higher smoking levels are associated with increased Foxp3 expression in Tregs and elevated plasma levels of TGF-β 1, potentially enhancing the immunosuppressive function of Tregs.
7.Exon Sequencing of HNF1β in Chinese Patients with Early-Onset Diabetes
Siqian GONG ; Hong LIAN ; Yating LI ; Xiaoling CAI ; Wei LIU ; Yingying LUO ; Meng LI ; Si-min ZHANG ; Rui ZHANG ; Lingli ZHOU ; Yu ZHU ; Qian REN ; Xiuying ZHANG ; Jing CHEN ; Jing WU ; Xianghai ZHOU ; Xirui WANG ; Xueyao HAN ; Linong JI
Diabetes & Metabolism Journal 2025;49(2):321-330
Background:
Maturity-onset diabetes of the young (MODY) due to variants of hepatocyte nuclear factor 1-beta (HNF1β) (MODY5) has not been well studied in the Chinese population. This study aimed to estimate its prevalence and evaluate the application of a clinical screening method (Faguer score) in Chinese early-onset diabetes (EOD) patients.
Methods:
Among 679 EOD patients clinically diagnosed with type 2 diabetes mellitus (age at diagnosis ≤40 years), the exons of HNF1β were sequenced. Functional impact of rare variants was evaluated using a dual-luciferase reporter system. Faguer scores ≥8 prompted multiplex ligation-dependent probe amplification (MLPA) for large deletions. Pathogenicity of HNF1β variants was assessed following the American College of Medical Genetics and Genomics (ACMG) guidelines.
Results:
Two rare HNF1β missense mutations (E105K and G454R) were identified by sequencing in five patients, showing functional impact in vitro. Another patient was found to have a whole-gene deletion by MLPA in 22 patients with the Faguer score above 8. Following ACMG guidelines, six patients carrying pathogenic or likely pathogenic variant were diagnosed with MODY5. The estimated prevalence of MODY5 in Chinese EOD patients was approximately 0.9% or higher.
Conclusion
MODY5 is not uncommon in China. The Faguer score is helpful in deciding whether to perform MLPA analysis on patients with negative sequencing results.
8.Exon Sequencing of HNF1β in Chinese Patients with Early-Onset Diabetes
Siqian GONG ; Hong LIAN ; Yating LI ; Xiaoling CAI ; Wei LIU ; Yingying LUO ; Meng LI ; Si-min ZHANG ; Rui ZHANG ; Lingli ZHOU ; Yu ZHU ; Qian REN ; Xiuying ZHANG ; Jing CHEN ; Jing WU ; Xianghai ZHOU ; Xirui WANG ; Xueyao HAN ; Linong JI
Diabetes & Metabolism Journal 2025;49(2):321-330
Background:
Maturity-onset diabetes of the young (MODY) due to variants of hepatocyte nuclear factor 1-beta (HNF1β) (MODY5) has not been well studied in the Chinese population. This study aimed to estimate its prevalence and evaluate the application of a clinical screening method (Faguer score) in Chinese early-onset diabetes (EOD) patients.
Methods:
Among 679 EOD patients clinically diagnosed with type 2 diabetes mellitus (age at diagnosis ≤40 years), the exons of HNF1β were sequenced. Functional impact of rare variants was evaluated using a dual-luciferase reporter system. Faguer scores ≥8 prompted multiplex ligation-dependent probe amplification (MLPA) for large deletions. Pathogenicity of HNF1β variants was assessed following the American College of Medical Genetics and Genomics (ACMG) guidelines.
Results:
Two rare HNF1β missense mutations (E105K and G454R) were identified by sequencing in five patients, showing functional impact in vitro. Another patient was found to have a whole-gene deletion by MLPA in 22 patients with the Faguer score above 8. Following ACMG guidelines, six patients carrying pathogenic or likely pathogenic variant were diagnosed with MODY5. The estimated prevalence of MODY5 in Chinese EOD patients was approximately 0.9% or higher.
Conclusion
MODY5 is not uncommon in China. The Faguer score is helpful in deciding whether to perform MLPA analysis on patients with negative sequencing results.
9.Exon Sequencing of HNF1β in Chinese Patients with Early-Onset Diabetes
Siqian GONG ; Hong LIAN ; Yating LI ; Xiaoling CAI ; Wei LIU ; Yingying LUO ; Meng LI ; Si-min ZHANG ; Rui ZHANG ; Lingli ZHOU ; Yu ZHU ; Qian REN ; Xiuying ZHANG ; Jing CHEN ; Jing WU ; Xianghai ZHOU ; Xirui WANG ; Xueyao HAN ; Linong JI
Diabetes & Metabolism Journal 2025;49(2):321-330
Background:
Maturity-onset diabetes of the young (MODY) due to variants of hepatocyte nuclear factor 1-beta (HNF1β) (MODY5) has not been well studied in the Chinese population. This study aimed to estimate its prevalence and evaluate the application of a clinical screening method (Faguer score) in Chinese early-onset diabetes (EOD) patients.
Methods:
Among 679 EOD patients clinically diagnosed with type 2 diabetes mellitus (age at diagnosis ≤40 years), the exons of HNF1β were sequenced. Functional impact of rare variants was evaluated using a dual-luciferase reporter system. Faguer scores ≥8 prompted multiplex ligation-dependent probe amplification (MLPA) for large deletions. Pathogenicity of HNF1β variants was assessed following the American College of Medical Genetics and Genomics (ACMG) guidelines.
Results:
Two rare HNF1β missense mutations (E105K and G454R) were identified by sequencing in five patients, showing functional impact in vitro. Another patient was found to have a whole-gene deletion by MLPA in 22 patients with the Faguer score above 8. Following ACMG guidelines, six patients carrying pathogenic or likely pathogenic variant were diagnosed with MODY5. The estimated prevalence of MODY5 in Chinese EOD patients was approximately 0.9% or higher.
Conclusion
MODY5 is not uncommon in China. The Faguer score is helpful in deciding whether to perform MLPA analysis on patients with negative sequencing results.
10.Effect and Safety of Fuzheng Huazhuo Decoction against Prolonged SARS-CoV-2 Clearance: A Retrospective Cohort Study.
Wen ZHANG ; Hong-Ze WU ; Xiang-Ru XU ; Yu-Ting PU ; Cai-Yu CHEN ; Rou DENG ; Min CAO ; Ding SUN ; Hui YI ; Shuang ZHOU ; Bang-Jiang FANG
Chinese journal of integrative medicine 2025;31(5):387-393
OBJECTIVE:
To evaluate the effect and safety of Chinese medicine (CM) Fuzheng Huazhuo Decoction (FHD) in treating patients with coronavirus disease 2019 (COVID-19) who persistently tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
METHODS:
This retrospective cohort study was conducted at Shanghai New International Expo Center shelter hospital in China between April 1 and May 30, 2022. Patients diagnosed as COVID-19 with persistently positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test results for ⩾8 days after diagnosis were enrolled. Patients in the control group received conventional Western medicine (WM) treatment, while those in the FHD group received conventional WM plus FHD for at least 3 days. The primary outcome was viral clearance time. Secondary outcomes included negative conversion rate within 14 days, length of hospital stay, cycle threshold (Ct) values of the open reading frame 1ab (ORF1ab) and nucleocapsid protein (N) genes, and incidence of new-onset symptoms during hospitalization. Adverse events (AEs) that occurred during the study period were recorded.
RESULTS:
A total of 1,765 eligible patients were enrolled in this study (546 in the FHD group and 1,219 in the control group). Compared with the control group, patients receiving FHD treatment showed shorter viral clearance time for nucleic acids [hazard ratio (HR): 1.500, 95% confidence interval (CI): 1.353-1.664, P<0.001] and hospital stays (HR: 1.371, 95% CI: 1.238-1.519, P<0.001), and a higher negative conversion rate within 14 days (96.2% vs. 82.6%, P<0.001). The incidence of new-onset symptoms was 59.5% in the FHD group, similar to 57.8% in the control group (P>0.05). The Ct values of ORF1ab and N genes increased more rapidly over time in the FHD group than those in the control group post-randomization (ORF1ab gene: β =0.436±0.053, P<0.001; N gene: β =0.415 ±0.053, P<0.001). The incidence of AEs in the FHD group was lower than that in the control group (24.2% vs. 35.4%, P<0.001). No serious AEs were observed.
CONCLUSION
FHD was effective and safe for patients with persistently positive SARS-CoV-2 PCR tests. (Registration No. ChiCTR2200063956).
Humans
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Drugs, Chinese Herbal/adverse effects*
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Retrospective Studies
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Male
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Female
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Middle Aged
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COVID-19 Drug Treatment
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SARS-CoV-2/drug effects*
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COVID-19/virology*
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Adult
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Aged
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Treatment Outcome

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