1.Prognostic value of neutrophil-to-lymphocyte ratio and glycemic variability in patients with sepsis
Danyu LI ; Jiali YAO ; Hongjie TONG ; Kun CHEN
China Modern Doctor 2025;63(5):53-56
Objective To investigate the prognostic value of neutrophil-to-lymphocyte ratio(NLR)and glycemic variability(GV)in patients with sepsis.Methods A total of 121 sepsis patients hospitalized in Jinhua Central Hospital from January 2023 to January 2024 were selected and divided into survival group(n=68)and death group(n=53)according to whether they died within 28d of confirmed sepsis.Blood glucose levels on the first 1-3 days after the diagnosis of sepsis were collected,and GV was calculated.The risk factors impacting the prognosis of patients with sepsis were analyzed through binary Logistic regression.Receiver operating characteristic(ROC)curve was used to evaluate the predictive value of relevant indicators.Results Compared with survival group,the levels of neutrophil count,acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ),procalcitonin,NLR and GV levels in death group were significantly increased(P<0.05),while lymphocyte was decreased(P<0.05).Logistic regression analysis indicated that NLR and GV might be independent risk factors affecting the prognosis of sepsis patients(P<0.05).ROC curve showed area under the curve(AUC)of NLR was 0.814 and GV AUC was 0.805.Conclusion NLR and GV could potentially be independent risk factors affecting the prognosis of sepsis patients,and they hold a certain degree of predictive worth for the prognosis of sepsis patients.
2.Role of CDH1 gene DNA methylation in autoimmune thyroiditis in population from different water-iodine regions
Baiming JIN ; Yanbo QI ; Fengge LOU ; Hong CHAO ; Xiaolei YANG ; Hongjie LI ; Zheng ZHOU ; Yao CHEN ; Hongmei SHEN ; Siyuan WAN
Chinese Journal of Endemiology 2025;44(6):431-438
Objective:To study the role of cadherin 1 (CDH1) gene DNA methylation in autoimmune thyroiditis (AIT) in population from different water-iodine regions.Methods:From May to June 2019, the information of AIT cases and healthy individuals in Shandong Province were collected in three types of water-iodine regions: iodine-fortification (IF) region, iodine-adequate (IA) region and iodine-excess (IE) region. A case-control study design was applied to match 176 AIT cases (case group) with age, gender, body mass index, and place of residence in a 1 ∶ 1 ratio to 176 healthy individuals (control group). Fasting urine and whole blood samples were collected to test the contents of urinary iodine, thyroid function indicators [serum free triiodothyronine (FT 3), free thyroxine (FT 4), thyroid stimulating hormone (TSH)], and serum iodine. The DNA methylation levels of the target region of the CDH1 gene and its four CpG sites in whole blood were determined using methylation sequencing technology for target regions (MethylTarget TM). Results:The DNA methylation level of the target region of CDH1 gene in the case group was 0.832 ± 0.044, and that in the control group was 0.828 ± 0.049, there was no statistically significant difference between the two groups ( t = 0.76, P = 0.448). There was no statistically significant difference in DNA methylation levels of the four CpG sites in the target region of CDH1 gene between the case group and the control group ( P > 0.05). There was no statistically significant difference in the DNA methylation level of the CDH1 gene target region between the case group and the control group in IF, IA and IE regions ( P > 0.05). The detection results of DNA methylation levels at CpG sites in the target region of CDH1 gene in different water iodine regions showed that the DNA methylation level at site 83 in case group in IF region was higher than that in the control group ( t = 2.30, P = 0.023). However, there was no statistically significant difference in the DNA methylation levels of the four CpG sites between the case group and the control group in IA and IE regions ( P > 0.05). The DNA methylation level of CDH1 gene target region in AIT patients was not significantly correlated with urinary iodine, serum iodine, and serum FT 3, FT 4, and TSH contents ( P > 0.05), but was significantly negatively correlated with age ( r =-0.19, P = 0.014). Conclusions:The DNA methylation level at CpG site 83 of CDH1 gene in AIT patients in IF region is significantly higher than that in control population, indicating that DNA methylation at this locus may be involved in the occurrence and development of AIT after iodine fortification. The DNA methylation level of CDH1 gene is negatively correlated with age.
3.Prognostic value of neutrophil-to-lymphocyte ratio and glycemic variability in patients with sepsis
Danyu LI ; Jiali YAO ; Hongjie TONG ; Kun CHEN
China Modern Doctor 2025;63(5):53-56
Objective To investigate the prognostic value of neutrophil-to-lymphocyte ratio(NLR)and glycemic variability(GV)in patients with sepsis.Methods A total of 121 sepsis patients hospitalized in Jinhua Central Hospital from January 2023 to January 2024 were selected and divided into survival group(n=68)and death group(n=53)according to whether they died within 28d of confirmed sepsis.Blood glucose levels on the first 1-3 days after the diagnosis of sepsis were collected,and GV was calculated.The risk factors impacting the prognosis of patients with sepsis were analyzed through binary Logistic regression.Receiver operating characteristic(ROC)curve was used to evaluate the predictive value of relevant indicators.Results Compared with survival group,the levels of neutrophil count,acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ),procalcitonin,NLR and GV levels in death group were significantly increased(P<0.05),while lymphocyte was decreased(P<0.05).Logistic regression analysis indicated that NLR and GV might be independent risk factors affecting the prognosis of sepsis patients(P<0.05).ROC curve showed area under the curve(AUC)of NLR was 0.814 and GV AUC was 0.805.Conclusion NLR and GV could potentially be independent risk factors affecting the prognosis of sepsis patients,and they hold a certain degree of predictive worth for the prognosis of sepsis patients.
4.Role of CDH1 gene DNA methylation in autoimmune thyroiditis in population from different water-iodine regions
Baiming JIN ; Yanbo QI ; Fengge LOU ; Hong CHAO ; Xiaolei YANG ; Hongjie LI ; Zheng ZHOU ; Yao CHEN ; Hongmei SHEN ; Siyuan WAN
Chinese Journal of Endemiology 2025;44(6):431-438
Objective:To study the role of cadherin 1 (CDH1) gene DNA methylation in autoimmune thyroiditis (AIT) in population from different water-iodine regions.Methods:From May to June 2019, the information of AIT cases and healthy individuals in Shandong Province were collected in three types of water-iodine regions: iodine-fortification (IF) region, iodine-adequate (IA) region and iodine-excess (IE) region. A case-control study design was applied to match 176 AIT cases (case group) with age, gender, body mass index, and place of residence in a 1 ∶ 1 ratio to 176 healthy individuals (control group). Fasting urine and whole blood samples were collected to test the contents of urinary iodine, thyroid function indicators [serum free triiodothyronine (FT 3), free thyroxine (FT 4), thyroid stimulating hormone (TSH)], and serum iodine. The DNA methylation levels of the target region of the CDH1 gene and its four CpG sites in whole blood were determined using methylation sequencing technology for target regions (MethylTarget TM). Results:The DNA methylation level of the target region of CDH1 gene in the case group was 0.832 ± 0.044, and that in the control group was 0.828 ± 0.049, there was no statistically significant difference between the two groups ( t = 0.76, P = 0.448). There was no statistically significant difference in DNA methylation levels of the four CpG sites in the target region of CDH1 gene between the case group and the control group ( P > 0.05). There was no statistically significant difference in the DNA methylation level of the CDH1 gene target region between the case group and the control group in IF, IA and IE regions ( P > 0.05). The detection results of DNA methylation levels at CpG sites in the target region of CDH1 gene in different water iodine regions showed that the DNA methylation level at site 83 in case group in IF region was higher than that in the control group ( t = 2.30, P = 0.023). However, there was no statistically significant difference in the DNA methylation levels of the four CpG sites between the case group and the control group in IA and IE regions ( P > 0.05). The DNA methylation level of CDH1 gene target region in AIT patients was not significantly correlated with urinary iodine, serum iodine, and serum FT 3, FT 4, and TSH contents ( P > 0.05), but was significantly negatively correlated with age ( r =-0.19, P = 0.014). Conclusions:The DNA methylation level at CpG site 83 of CDH1 gene in AIT patients in IF region is significantly higher than that in control population, indicating that DNA methylation at this locus may be involved in the occurrence and development of AIT after iodine fortification. The DNA methylation level of CDH1 gene is negatively correlated with age.
5.Clinical efficacy of modified two-stage hepatectomy combined with immunotherapy plus tar-geted therapy in the treatment of borderline resectable liver cancer
Peng YAO ; Jiasui CHAI ; Deng PAN ; Yan CHEN ; Xu WANG ; Hongjie ZHANG ; Xiaozheng LI
Chinese Journal of Digestive Surgery 2024;23(7):984-988
Hepatectomy is the most effective method for the treatment of liver cancer. Asso-ciating liver partition and portal vein ligation for staged hepatectomy (ALPPS) provides resectable opportunities for patients with unresectable or borderline resectable liver cancer. Traditional ALPPS procedures involve a short interval between two stages of the surgery, leading to a higher incidence of perioperative complications and mortality. The authors present a case of two-stage hepatectomy. Initially, laparoscopic ligation of the right hepatic artery and portal vein was performed. To prevent tumor progression after the first stage of surgery, combined immunotherapy and targeted therapy were administered. Three months later, a successful right hemihepatectomy was performed. Postoperative histopathological examination revealed hepatocellular carcinoma with extensive tumor necrosis. A 15-month follow-up showed no tumor recurrence. This indicated that two-stage hepatectomy including simultaneous ligation of the hepatic artery and portal vein, combined with two-stage hepatectomy plus immunotherapy and targeted therapy, showed considerable promise for borderline resectable liver cancer.
6.Clinical application of rapid next-generation sequencing strategy based on targeted amplicon sequencing in the diagnosis of myeloid neoplasms
Jundan XIE ; Yanglin CAO ; Fenghong ZHANG ; Hong YAO ; Airui JIANG ; Hongjie SHEN ; Jiannong CEN ; Depei WU ; Jun HE ; Suning CHEN
Chinese Journal of Laboratory Medicine 2024;47(11):1256-1263
Objective:To explore the clinical application value of rapid next-generation sequencing (NGS) strategy based on targeted amplicon sequencing in the diagnosis of myeloid neoplasms.Methods:In this observational study, both rapid NGS and conventional NGS on the bone marrow or peripheral blood samples of 682 patients were prospectively performed from February 2021 to August 2022 in First Affiliated Hospital of Soochow University. The sequencing results were analyzed using the local Ion Reporter software and our lab′s self-built bioinformatics platform, respectively. The timeliness of the two sequencing platforms was compared, and the Kappa consistency test was used to evaluate the consistency between the two sequencing platforms. Patients aged between 18 and 59 years with newly diagnosed acute myeloid leukemia (AML) underwent screening by rapid NGS combining multiplex RT-PCR and in situ fluorescence hybridization technique within 72 hours, from whom high-risk patients according to European LeukemiaNet (ELN) 2017 were screened for individualized induction therapy.Results:In terms of timeliness, the median time from sample receipt to report issuance were 3 (2, 4) days and 13 (11, 15) days under rapid NGS and conventional NGS testing, respectively, with a statistically significant difference ( Z=?22.636, P<0.001). Among 682 specimens with a total of 1 507 variants, rapid NGS detected a total of 1 499 variants, with a detection rate of 99.5% and 674 cases were accurate, with an accuracy rate of 98.8%; the conventional NGS detected 1 506 variants, with a detection rate of 99.9% and 681 cases were accurate, with an accuracy rate of 99.9%. In 682 specimens, there were 181 negative and 501 positive, in which 8 cases were missed under rapid NGS, and 1 case was missed under conventional NGS. The kappa value was 0.967 by Kappa consistency test, and P<0.001, suggesting good consistency and consistency between the two NGS platforms. From February 2021 to July 2022, 286 patients who were rapidly diagnosed of AML contained 78 patients screened as the ELN 2017 adverse-risk category, including 42 patients enrolled, with age 39 (33, 52) years old. After one cycle of venetoclax combined with decitabine induction therapy, 78.6%(38/42) of the patients achieved composite complete remission. Among the rest 104 additional myeloid neoplasms, rapid NGS detected mutations in 80 patients, with a detection rate of 76.9%, among which 89.0%(215/242) of the variants could serve as the basis for the diagnostic classification, prognostic evaluation, and target therapy of myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and myelodysplastic/myeloproliferative neoplasms (MDS/MPN). Conclusion:The rapid NGS based on targeted amplicon sequencing is in good consistency with conventional NGS, and shorters the diagnostic time, whose sensitivity and detection range meets the need for diagnostic classification, prognostic stratification, and target therapy of myeloid neoplasms.
7.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
8.Real world efficacy prediction analysis of infliximab in the treatment of Crohn's disease
Caiyun LYU ; Yongyu CHEN ; Fengfeng YAN ; Sijie PI ; Yao LIU ; Ruidong CHEN ; Wen TANG ; Hongjie ZHANG
Chinese Journal of Inflammatory Bowel Diseases 2024;08(5):378-383
Objective:To identify early predictors of factors influencing the efficacy of infliximab (IFX) treatment in patients with Crohn's disease (CD) .Methods:This study is a nested case-control study, including CD patients treated with IFX at the Second Affiliated Hospital of Soochow University from November 2015 to April 2021 and at the First Affiliated Hospital of Nanjing Medical University from November 2015 to December 2022. All the patients were followed up until June 2023 and categorized into IFX non-response and treatment-effective groups based on changes in clinical symptoms and endoscopic image during the follow-up. Laboratory data of inflammatory markers, post-induction trough IFX concentration and antibody levels in both groups were retrospectively collected and compared. Logistic regression models were employed to identify potential factors associated with the risk of IFX non-responsiveness. Machine learning using random forest analysis was utilized to quantitatively assess the predictive features for IFX treatment efficacy and ROC curves was used to evaluate the model's accuracy.Results:This study included 147 CD patients undergoing IFX treatment, with 58 from the Second Affiliated Hospital of Soochow University and 89 from the First Affiliated Hospital of Nanjing Medical University. Among them, 38 were classified as the IFX non-response group, and 109 as the effective group. Patients in the IFX non-response group had lower trough concentration ( P < 0.001), higher antibody levels ( P < 0.001), and a less pronounced reduction in ESR during the induction therapy ( P < 0.001). Univariate and multi-variate Logistic regression models demonstrated that IFX trough concentration and the ratio of ESR before and after induction therapy was associated with the risk of non-responsiveness. After the induction period, for each unit increase in IFX trough concentration (1 μg/ml), the risk of IFX non-response decreased by 23% ( RR = 0.77, 95% CI = 0.68-0.89), while each doubling of the ESR ratio after induction was associated with a 1.43-fold increase in the risk of non-response ( RR = 2.43, 95% CI = 1.48-4.00). Random forest machine learning analysis revealed that IFX trough concentration below 1.5 μg/ml could predict IFX non-response, with area under the ROC curve was 0.722. Conclusion:Lower post-induction IFX trough concentrations is predictive of IFX non-response, while a lack of significant decrease in ESR during the induction phase is also significantly associated with IFX non-response.
9.Real world efficacy prediction analysis of infliximab in the treatment of Crohn's disease
Caiyun LYU ; Yongyu CHEN ; Fengfeng YAN ; Sijie PI ; Yao LIU ; Ruidong CHEN ; Wen TANG ; Hongjie ZHANG
Chinese Journal of Inflammatory Bowel Diseases 2024;08(5):378-383
Objective:To identify early predictors of factors influencing the efficacy of infliximab (IFX) treatment in patients with Crohn's disease (CD) .Methods:This study is a nested case-control study, including CD patients treated with IFX at the Second Affiliated Hospital of Soochow University from November 2015 to April 2021 and at the First Affiliated Hospital of Nanjing Medical University from November 2015 to December 2022. All the patients were followed up until June 2023 and categorized into IFX non-response and treatment-effective groups based on changes in clinical symptoms and endoscopic image during the follow-up. Laboratory data of inflammatory markers, post-induction trough IFX concentration and antibody levels in both groups were retrospectively collected and compared. Logistic regression models were employed to identify potential factors associated with the risk of IFX non-responsiveness. Machine learning using random forest analysis was utilized to quantitatively assess the predictive features for IFX treatment efficacy and ROC curves was used to evaluate the model's accuracy.Results:This study included 147 CD patients undergoing IFX treatment, with 58 from the Second Affiliated Hospital of Soochow University and 89 from the First Affiliated Hospital of Nanjing Medical University. Among them, 38 were classified as the IFX non-response group, and 109 as the effective group. Patients in the IFX non-response group had lower trough concentration ( P < 0.001), higher antibody levels ( P < 0.001), and a less pronounced reduction in ESR during the induction therapy ( P < 0.001). Univariate and multi-variate Logistic regression models demonstrated that IFX trough concentration and the ratio of ESR before and after induction therapy was associated with the risk of non-responsiveness. After the induction period, for each unit increase in IFX trough concentration (1 μg/ml), the risk of IFX non-response decreased by 23% ( RR = 0.77, 95% CI = 0.68-0.89), while each doubling of the ESR ratio after induction was associated with a 1.43-fold increase in the risk of non-response ( RR = 2.43, 95% CI = 1.48-4.00). Random forest machine learning analysis revealed that IFX trough concentration below 1.5 μg/ml could predict IFX non-response, with area under the ROC curve was 0.722. Conclusion:Lower post-induction IFX trough concentrations is predictive of IFX non-response, while a lack of significant decrease in ESR during the induction phase is also significantly associated with IFX non-response.
10.Clinical study of Ganoderma lucidum hypoglycemic formula in improving insulin resistance in patients with type 2 diabetes mellitus with liver and kidney yin deficiency
Haishan ZHOU ; Xiaoli HE ; Yanming HE ; Shasha YUAN ; Weiguo YAO ; Hongjie YANG
Chinese Journal of Primary Medicine and Pharmacy 2023;30(7):967-972
Objective:To investigate the clinical efficacy and mechanism of Ganoderma lucidum hypoglycemic formula in the treatment of insulin resistance in patients with type 2 diabetes mellitus (T2DM) with liver and kidney yin deficiency. Methods:A total of 86 patients with T2DM with liver and kidney yin deficiency who were diagnosed and treated at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine from January 2021 to February 2022 were included in this study. These patients were divided into a control group and a treatment group, with 43 patients in each group using a 1:1 ratio using the sealed envelope method. Both groups were treated with standardized Western medicine. The treatment group was also treated with the Ganoderma lucidum hypoglycemic formula. All patients were followed up for 12 weeks. The clinical symptoms, curative effect, glucose and lipid metabolism, inflammatory factors, oxidative stress change, and safety were compared between the two groups. Results:The total response rate in the treatment group was 88.4% (38/43), which was significantly higher than 53.5% (23/43) in the control group ( χ2 = 12.69, P < 0.001). After treatment, the traditional Chinese medicine syndrome score, fasting blood glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin, insulin resistance index, total cholesterol, triglyceride, tumor necrosis factor α, and interleukin-6 decreased in each group. The amplitudes of decrease of the above indexes were greater in the treatment group compared with the control group (all P < 0.05). C-peptide in the fasting state, C-peptide at 2 hours after a diet, and superoxide dismutase increased in each group. The amplitudes of increase of the three indexes were greater in the treatment group compared with the control group (all P < 0.05). Conclusion:Ganoderma lucidum hypoglycemic formula can greatly improve insulin resistance and glucose and lipid metabolism in T2DM patients with liver and kidney yin deficiency. The underlying mechanism may be to further reduce the inflammatory response and anti-oxidative stress by down-regulating tumor necrosis factor α and interleukin-6 levels and up-regulating superoxide dismutase level, thereby effectively alleviating insulin resistance in T2DM.

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