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Commentary on “Protective Effect of Regular Physical Activity Against Diabetes-Related Lower Extremity Amputation”
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-01-22 DOI: 10.1111/1753-0407.70055
Zeinab Mohseni Afshar, Mohammad Barary, Arefeh Babazadeh, Fatemeh Rasulpur, Soheil Ebrahimpour
<p>We read with great interest the article titled “Protective effect of regular physical activity against diabetes-related lower extremity amputation,” published in your esteemed journal [<span>1</span>]. This study's objective—to evaluate the protective effects of appropriate and regular physical activity (PA) on the risk of lower extremity amputation (LEA) in individuals with diabetes—is both timely and relevant. We commend the authors for their valuable contributions to this critical area of research. However, certain study aspects warrant further discussion to enhance their scientific rigor and applicability.</p><p>First, the study did not incorporate specific laboratory parameters that could have strengthened its conclusions. Including biomarkers such as albumin, hemoglobin, thyroid and liver function tests, Vitamin D, Vitamin B12, Vitamin B3, neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR) would provide a more comprehensive understanding of the patients' risk profiles and the potential mechanisms linking PA to reduced LEA risk [<span>2</span>]. For instance, NLR and PLR are well-established predictors of mortality and complications in diabetic foot ulcers and could offer additional prognostic value.</p><p>Second, the study lacked detailed information regarding medications other than antidiabetic agents. Drugs such as antihypertensives and lipid-lowering therapies can significantly impact vascular health and diabetic outcomes. Without this data, it is challenging to isolate PA's protective effects fully.</p><p>Third, while the study considered some comorbidities, a broader exploration of underlying conditions is necessary. Comorbidities such as malignancies, psychological disorders, cerebrovascular diseases, bone deformities, diabetic retinopathy, and autoimmune diseases—in addition to diabetic neuropathy and peripheral artery disease (PAD)—may influence both PA participation and LEA risk [<span>3</span>]. Addressing these factors would provide a clearer understanding of the interactions between diabetes-related complications and PA.</p><p>Moreover, the study would benefit from additional demographic information, including educational level, urban versus rural residency, and history of previous diabetic ulcers. These variables are crucial as they can significantly influence diabetes management and adherence to PA regimens. Furthermore, there was no discussion regarding insulin resistance or the results of venous examinations, both pertinent to evaluating the risk of LEA.</p><p>In conclusion, while this study highlights the protective role of regular PA in preventing LEA among individuals with diabetes, addressing the limitations mentioned above would enhance its robustness and clinical relevance. Such considerations are critical for healthcare providers as they develop tailored strategies to improve patient outcomes. We hope the esteemed authors and editorial board will consider these constructive critiques and p
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引用次数: 0
Advancements and Challenges in Immune Protection Strategies for Islet Transplantation 胰岛移植免疫保护策略的进展与挑战。
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-01-20 DOI: 10.1111/1753-0407.70048
Xue Wang, Ziyuan Zeng, Dayan Li, Kai Wang, Wei Zhang, Yang Yu, Xi Wang

Pancreatic islet transplantation is a crucial treatment for managing type 1 diabetes (T1D) in clinical settings. However, the limited availability of human cadaveric islet donors and the need for ongoing administration of immunosuppressive agents post-transplantation hinder the widespread use of this treatment. Stem cell-derived islet organoids have emerged as an effective alternative to primary human islets. Nevertheless, implementing this cell replacement therapy still requires chronic immune suppression, which may result in life-long side effects. To address these challenges, innovations such as encapsulation devices, universal stem cells, and immunomodulatory strategies are being developed to mitigate immune rejection and prolong the function of the transplant. This review outlines the contemporary challenges in pancreatic β cell therapy, particularly immune rejection, and recent progress in immune-isolation devices, hypoimmunogenic stem cells, and immune regulation of transplants. A comprehensive evaluation of the advantages and limitations of these approaches will contribute to improved future clinical investigations. With these promising advancements, the application of pancreatic β cell therapy holds the potential to effectively treat T1D and benefit a larger population of T1D patients.

胰岛移植是治疗1型糖尿病(T1D)的关键治疗方法。然而,人类尸体胰岛供体的有限可用性和移植后持续使用免疫抑制剂的需要阻碍了这种治疗的广泛使用。干细胞衍生的类胰岛器官已成为替代原代人胰岛的有效方法。然而,实施这种细胞替代疗法仍然需要慢性免疫抑制,这可能导致终生的副作用。为了应对这些挑战,诸如封装装置、通用干细胞和免疫调节策略等创新正在开发中,以减轻免疫排斥反应并延长移植功能。这篇综述概述了当前胰岛β细胞治疗面临的挑战,特别是免疫排斥反应,以及免疫隔离装置、低免疫原性干细胞和移植免疫调节的最新进展。全面评估这些方法的优缺点将有助于改善未来的临床研究。有了这些有希望的进展,胰岛β细胞疗法的应用具有有效治疗T1D的潜力,并使更多的T1D患者受益。
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引用次数: 0
Associations of Tea Consumption With the Risk of All-Cause and Cause-Specific Mortality Among Adults With Type 2 Diabetes: A Prospective Cohort Study in China 中国一项前瞻性队列研究:饮茶与成人2型糖尿病患者全因和特定原因死亡风险的关系
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-01-20 DOI: 10.1111/1753-0407.70040
Lifeng Wang, Xikang Fan, Jian Su, Yu Qin, Zhongming Sun, Yan Lu, Shujun Gu, Chong Shen, Jinyi Zhou, Hao Yu, Ming Wu

Aims

To investigate the associations of tea consumption with all-cause and cause-specific mortality among type 2 diabetes mellitus (T2DM) Chinese patients.

Materials and Methods

The present study included 15 718 participants from the Comprehensive Research on the Prevention and Control of Diabetes between 2013 and 2014 in Jiangsu, China. Information on tea consumption (including frequency, amount, and duration) was collected at baseline using interviewer-administered questionnaires. Death data were identified by linkage to the Death Certificate System. Cox proportional hazard regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).

Results

During a median follow-up of 9.77 (9.69, 9.82) years, 3046 deaths were documented, including 922 from cardiovascular disease (CVD) and 736 from cancer. Compared with nonconsumers, regular tea consumption (≥ 3 times/week, 1 cup/day, > 30 years) was associated with reduced all-cause mortality risk in T2DM, with HRs (95% CIs) of 0.82 (0.74, 0.91), 0.80 (0.72, 0.89), and 0.77 (0.68, 0.86). For cardiovascular mortality, the HRs (95% CIs) were 0.79 (0.65, 0.96), 0.72 (0.59, 0.89), and 0.75 (0.60, 0.93). The exposure-response relationship suggested that consuming 4 g/day may offer the most evident health benefits.

Conclusions

Among Chinese T2DM patients, higher tea frequency and amount intake were associated with lower risk of all-cause and CVD mortality. It is suggested that consuming 4 g/day of tea could potentially serve as an intervention target. These findings suggest that tea consumption can be a part of a healthy diet for T2DM patients.

目的:探讨饮茶与中国2型糖尿病(T2DM)患者全因死亡率和病因特异性死亡率的关系。材料与方法:本研究纳入2013 - 2014年中国江苏省糖尿病防治综合研究的15 718名参与者。在基线时,使用访谈者管理的问卷收集饮茶信息(包括频率、数量和持续时间)。死亡数据通过与死亡证明系统的链接进行识别。采用Cox比例风险回归模型估计风险比(hr)和95%置信区间(ci)。结果:在9.77(9.69,9.82)年的中位随访期间,记录了3046例死亡,其中922例死于心血管疾病(CVD), 736例死于癌症。与非饮茶者相比,经常饮茶(≥3次/周,1杯/天,30岁以上)与T2DM患者全因死亡风险降低相关,hr (95% ci)分别为0.82(0.74,0.91)、0.80(0.72,0.89)和0.77(0.68,0.86)。心血管疾病死亡率的hr (95% ci)分别为0.79(0.65,0.96)、0.72(0.59,0.89)和0.75(0.60,0.93)。暴露-反应关系表明,每天摄入4克可能会提供最明显的健康益处。结论:在中国T2DM患者中,较高的饮茶频率和饮茶量与较低的全因死亡率和心血管疾病死亡率相关。建议每天饮用4克茶可能作为一个潜在的干预目标。这些发现表明,饮茶可以成为2型糖尿病患者健康饮食的一部分。
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引用次数: 0
B Lymphocyte—A Prognostic Indicator in Post-Acute Pancreatitis Diabetes Mellitus B淋巴细胞- a在急性胰腺炎后糖尿病中的预后指标。
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-01-12 DOI: 10.1111/1753-0407.70047
Xiaoyan Lin, Xiaoling Li, Junsheng Wang, Huiheng Liu

Objective

To determine the value of lymphocyte subsets and granulocyte/monocyte surface markers in predicting the risk of post-acute pancreatitis diabetes (PPDM-A).

Methods

This study included 308 in patients with acute pancreatitis (AP). The markers of granulocytes and monocytes and lymphocyte subsets were detected by flow cytometry, and the fluorescence intensity, absolute count and percentage were obtained. Based on the occurrence of diabetes after AP, patients were divided into two groups: PPDM-A and PPNG-A (post-acute pancreatitis with normal glucose). Correlations between granulocyte and monocyte surface markers and lymphocyte subsets were analyzed. Binary logistic regression was used to analyze the potential influencing factors of PPDM-A.

Results

Compared with patients with PPNG-A, patients with PPDM-A tend to be younger (p < 0.001) and have a higher proportion of fatty liver, recurrent pancreatitis, and hyperlipidemic pancreatitis. The results of linear regression showed that B% was negatively correlated with MFI of HLA-DR on monocytes (R2 = 0.145, p < 0.001), B% was positively correlated with CD10NEUT% (R2 = 0.291, p < 0.001), and MFI of HLA-DR on monocytes was negatively correlated with CD10NEUT% (R2 = 0.457, p < 0.001). Multivariate logistic regression analysis revealed that age, serous effusion, fatty liver, recurrent pancreatitis, and B% were independent risk factors for the occurrence of PPDM-A.

Conclusion

Our study has first confirmed the correlation between PPDM-A and lymphocyte subsets and CD10NEUT%. Furthermore we indicated that age, fatty liver, serous effusion, recurrent AP, and B% were independent risk factors for PPDM-A. The mechanism of granulocyte and monocyte surface markers and B lymphocytes on PPDM-A is worthy of study. This would help clarify the pathogenesis of PPDM-A at the cellular level and potentially provide new strategies for immunotherapy and even disease prevention. [Correction added on 24 January 2025, after first online publication: the third subtitle in Abstract section has been changed to ‘Results’.]

目的:探讨淋巴细胞亚群和粒细胞/单核细胞表面标志物对急性胰腺炎后糖尿病(PPDM-A)发病风险的预测价值。方法:本研究纳入308例急性胰腺炎(AP)患者。流式细胞术检测粒细胞、单核细胞和淋巴细胞亚群的标志物,获得荧光强度、绝对计数和百分比。根据AP后糖尿病的发生情况,将患者分为PPDM-A组和PPNG-A组(血糖正常的急性胰腺炎后)。分析了粒细胞和单核细胞表面标记物与淋巴细胞亚群之间的相关性。采用二元logistic回归分析PPDM-A的潜在影响因素。方法:与PPNG-A患者相比,PPDM-A患者倾向于年轻化(p 2 = 0.145, p -NEUT%) (R2 = 0.291, p -NEUT% (R2 = 0.457, p)。结论:本研究首次证实PPDM-A与淋巴细胞亚群和CD10-NEUT%之间存在相关性。此外,我们指出年龄、脂肪肝、浆液积液、复发性AP和B%是PPDM-A的独立危险因素。粒细胞、单核细胞表面标志物和B淋巴细胞对PPDM-A的作用机制值得研究。这将有助于在细胞水平上阐明PPDM-A的发病机制,并可能为免疫治疗甚至疾病预防提供新的策略。
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引用次数: 0
Cardiovascular Therapy Benefits of Novel Antidiabetic Drugs in Patients With Type 2 Diabetes Mellitus Complicated With Cardiovascular Disease: A Network Meta-Analysis 新型降糖药对2型糖尿病合并心血管疾病患者的心血管治疗益处:一项网络meta分析
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-01-09 DOI: 10.1111/1753-0407.70044
Saixian Shi, Xiaofeng Li, Ye Chen, Jiahao Li, Yan Dai

Objective

Provide an evidence-based basis for the selection of cardiovascular benefit drugs in Type 2 diabetes mellitus (T2DM) patients with cardiovascular disease (CVD).

Methods

Conduct a comprehensive search of all relevant literature from PubMed, Embase, Web of Science, Cochrane Library, and Clinical Trials.gov from their establishment until December 13, 2023, and select randomized controlled trials (RCTs) that meet the pre-established inclusion and exclusion criteria. Use the Cochrane bias risk assessment tool to evaluate the quality of the included literature. Use R 4.3.2 software to conduct network meta-analysis for drug category comparison.

Results

A total of 24 large-scale randomized controlled trials (RCTs) were included, including 19 intervention measures, and 172 803 patients participated in the study. The results of the network meta-analysis show that: GLP1RA (OR 0.89, 95% CI 0.81–0.97) and SGLT2i (OR 0.91, 95% CI 0.83–0.99) can reduce the occurrence of major adverse cardiovascular events (MACE), GLP1RA (OR 0.88, 95% CI 0.79–0.97) and SGLT2i (OR 0.89, 95% CI 0.81–0.99) reduced the risk of cardiovascular death. SGLT2i (OR 0.68, 95% CI 0.62–0.75) reduced the occurrence of hospitalization for heart failure, GLP1RA (OR 0.88, 95% CI 0.81–0.97) and SGLT2i (OR 0.89, 95% CI 0.80–0.97) reduced the occurrence of all-cause death.

Conclusion

In the comparison of new hypoglycemic drug classes, GLP1RA and SGLT2i reduced MACE, cardiovascular mortality and all-cause mortality in T2DM patients with CVD, with no significant difference in efficacy, and DPP4i was noninferior to placebo. Only GLP1RA reduced the risk of nonfatal stroke, and only SGLT2i reduced the risk of HHF.

目的:为2型糖尿病(T2DM)合并心血管疾病(CVD)患者心血管获益药物的选择提供循证依据。方法:全面检索PubMed、Embase、Web of Science、Cochrane Library和Clinical trials .gov网站自成立至2023年12月13日的所有相关文献,并选择符合预先设定的纳入和排除标准的随机对照试验(RCTs)。使用Cochrane偏倚风险评估工具评价纳入文献的质量。使用r4.3.2软件进行网络meta分析,进行药品品类比较。结果:共纳入24项大规模随机对照试验(RCTs),包括19项干预措施,共纳入172 803例患者。网络荟萃分析结果显示:GLP1RA (OR 0.89, 95% CI 0.81-0.97)和SGLT2i (OR 0.91, 95% CI 0.83-0.99)可降低主要心血管不良事件(MACE)的发生,GLP1RA (OR 0.88, 95% CI 0.79-0.97)和SGLT2i (OR 0.89, 95% CI 0.81-0.99)可降低心血管死亡风险。SGLT2i (OR 0.68, 95% CI 0.62-0.75)降低了心力衰竭住院的发生率,GLP1RA (OR 0.88, 95% CI 0.81-0.97)和SGLT2i (OR 0.89, 95% CI 0.80-0.97)降低了全因死亡的发生率。结论:在新降糖药物类别的比较中,GLP1RA和SGLT2i降低T2DM合并CVD患者的MACE、心血管死亡率和全因死亡率,疗效无显著差异,且DPP4i不逊于安慰剂。只有GLP1RA降低了非致死性卒中的风险,只有SGLT2i降低了HHF的风险。
{"title":"Cardiovascular Therapy Benefits of Novel Antidiabetic Drugs in Patients With Type 2 Diabetes Mellitus Complicated With Cardiovascular Disease: A Network Meta-Analysis","authors":"Saixian Shi,&nbsp;Xiaofeng Li,&nbsp;Ye Chen,&nbsp;Jiahao Li,&nbsp;Yan Dai","doi":"10.1111/1753-0407.70044","DOIUrl":"10.1111/1753-0407.70044","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Provide an evidence-based basis for the selection of cardiovascular benefit drugs in Type 2 diabetes mellitus (T2DM) patients with cardiovascular disease (CVD).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Conduct a comprehensive search of all relevant literature from PubMed, Embase, Web of Science, Cochrane Library, and Clinical Trials.gov from their establishment until December 13, 2023, and select randomized controlled trials (RCTs) that meet the pre-established inclusion and exclusion criteria. Use the Cochrane bias risk assessment tool to evaluate the quality of the included literature. Use R 4.3.2 software to conduct network meta-analysis for drug category comparison.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 24 large-scale randomized controlled trials (RCTs) were included, including 19 intervention measures, and 172 803 patients participated in the study. The results of the network meta-analysis show that: GLP1RA (OR 0.89, 95% CI 0.81–0.97) and SGLT2i (OR 0.91, 95% CI 0.83–0.99) can reduce the occurrence of major adverse cardiovascular events (MACE), GLP1RA (OR 0.88, 95% CI 0.79–0.97) and SGLT2i (OR 0.89, 95% CI 0.81–0.99) reduced the risk of cardiovascular death. SGLT2i (OR 0.68, 95% CI 0.62–0.75) reduced the occurrence of hospitalization for heart failure, GLP1RA (OR 0.88, 95% CI 0.81–0.97) and SGLT2i (OR 0.89, 95% CI 0.80–0.97) reduced the occurrence of all-cause death.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>In the comparison of new hypoglycemic drug classes, GLP1RA and SGLT2i reduced MACE, cardiovascular mortality and all-cause mortality in T2DM patients with CVD, with no significant difference in efficacy, and DPP4i was noninferior to placebo. Only GLP1RA reduced the risk of nonfatal stroke, and only SGLT2i reduced the risk of HHF.</p>\u0000 </section>\u0000 </div>","PeriodicalId":189,"journal":{"name":"Journal of Diabetes","volume":"17 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11717902/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142941818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Global and Regional Burden of Type 2 Diabetes Mellitus Attributable to Low Physical Activity From 1990 to 2021 1990年至2021年低身体活动导致的全球和区域2型糖尿病负担
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-01-06 DOI: 10.1111/1753-0407.70043
Lihang Yang, Diya Xie, Fengmin Liu, Jiaying Lin, Xin Lin, Yuquan Chen, Kun Zhang

Aim

Type 2 diabetes mellitus (T2DM) contributes to the heavy burden, but there lacks latest and comprehensive global research on the burden of T2DM attributable to low physical activity (LPA). This study aimed to quantify the global and regional burden of T2DM attributable to LPA from 1990 to 2021.

Methods

We utilized data including disability-adjusted life years (DALYs), mortality, age-standardized disability-adjusted life years (ASDR), and age-standardized mortality rates (ASMR) from the Global Burden of Disease (GBD) 2021. We assessed the burden across different ages, genders, and sociodemographic index (SDI). Joinpoint regression analysis was applied to estimated average annual percent change (AAPC).

Results

Between 1990 and 2021, DALYs and mortality of T2DM attributable to LPA increased rapidly. There was an increase in the ASDR and ASMR, with AAPC of 1.09 (95% CI: 1.03–1.16) and 0.32 (95% CI: 0.2–0.43), which was increased faster in males. Low-middle SDI countries have the highest ASDR and highest ASMR. The global PAF for ASDR and ASMR in 2021 is 7.38% and 9.45%. A U-shaped drift pattern was observed in most SDI quintiles in APC model. Population growth is a major contributor to the burden of T2DM, especially in countries with low SDI. Epidemiological changes also play an important role in DALYs and mortality. A negative correlation existed between SDI and both ASMR and ASDR.

Conclusion

Between 1990 and 2021, there was a marked rise in the global burden of T2DM associated with LPA. The findings lay the groundwork for informed decision-making a public health and healthcare delivery.

目的:2型糖尿病(T2DM)是加重负担的原因之一,但目前全球缺乏关于低体力活动(LPA)导致的T2DM负担的最新、全面的研究。本研究旨在量化1990年至2021年由LPA引起的全球和区域T2DM负担。方法:我们使用来自2021年全球疾病负担(GBD)的数据,包括残疾调整生命年(DALYs)、死亡率、年龄标准化残疾调整生命年(ASDR)和年龄标准化死亡率(ASMR)。我们评估了不同年龄、性别和社会人口指数(SDI)的负担。采用联合点回归分析估计平均年变化百分数(AAPC)。结果:1990 - 2021年间,LPA导致的T2DM DALYs和死亡率迅速上升。ASDR和ASMR增加,AAPC分别为1.09 (95% CI: 1.03-1.16)和0.32 (95% CI: 0.2-0.43),其中男性增加更快。中低SDI国家的ASDR和ASMR最高。2021年ASDR和ASMR的全球PAF分别为7.38%和9.45%。在APC模型中,大部分SDI五分位数呈u型漂移。人口增长是2型糖尿病负担的主要因素,特别是在低SDI国家。流行病学变化在伤残调整生命年和死亡率中也起着重要作用。SDI与ASMR、ASDR均呈负相关。结论:1990年至2021年间,与LPA相关的T2DM全球负担显著增加。这些发现为公共卫生和医疗保健服务的知情决策奠定了基础。
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引用次数: 0
TangBi Formula for Painful Diabetic Distal Symmetric Polyneuropathy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Parallel-Group Trial 糖痹方治疗疼痛性糖尿病远端对称性多神经病变:一项多中心、随机、双盲、安慰剂对照、平行组试验。
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2025-01-05 DOI: 10.1111/1753-0407.70045
Xuefei Zhao, Xuedong An, Yashan Cui, Liu Dong, Zhaohui Fang, Zhonghua Zheng, Xinhe Zuo, Huailin Gao, Tianshu Gao, Qing Ni, Fengmei Lian, Xiaolin Tong

Objective

To determine whether the use of herbal medicines combined with conventional treatment is more effective than conventional medication alone in improving clinical symptoms in patients with diabetic distal symmetric polyneuropathy (DSPN).

Methods

This multicenter, placebo-controlled, double-blind, randomized controlled clinical trial recruited patients from 6 clinical centers in mainland China. A total of 188 patients were randomly assigned in a 1:1 ratio to the treatment group (Tangbi Formula plus methylcobalamin) and the control group (placebo plus methylcobalamin). Subjects were reassessed after the 24-week intervention. The primary outcomes were differences in changes in clinical signs and symptoms and changes in the Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. Secondary outcomes were changes in nerve conduction velocity (NCV) and single clinical signs and symptoms as measured by the visual-analogue scale (VAS) and Toronto clinical scoring system (TCSS).

Results

Compared with the placebo group, after 24 weeks of treatment, the MDNS score of TangBi Formula group was significantly reduced (p < 0.001). There were no significant changes in NCV results in either group before or after treatment. Compared with baseline, the difference in the change value of VAS score between the two groups after treatment was statistically significant (p = 0.031). A statistically significant difference in the change value of TCSS after treatment compared to baseline was found between the two groups (p = 0.033 at 12 weeks and p = 0.030 at 24 weeks). No severe adverse events due to study participation or study intervention were reported.

Conclusions and Relevance

This trial demonstrated that combining Tangbi Formula with basal therapy can be safer and more effective in improving the symptoms of DSPN patients.

目的:探讨中药联合常规治疗在改善糖尿病远端对称性多神经病变(DSPN)患者临床症状方面是否比单独使用常规药物更有效。方法:该多中心、安慰剂对照、双盲、随机对照临床试验从中国大陆6个临床中心招募患者。188例患者按1:1的比例随机分为治疗组(糖痹方加甲钴胺)和对照组(安慰剂加甲钴胺)。干预24周后对受试者进行重新评估。主要结局是两组患者治疗前后临床体征和症状的变化以及密歇根糖尿病神经病变评分(MDNS)的变化。次要结果是神经传导速度(NCV)的变化,以及用视觉模拟量表(VAS)和多伦多临床评分系统(TCSS)测量的单一临床体征和症状的变化。结果:与安慰剂组比较,治疗24周后,糖痹方组MDNS评分明显降低(p)。结论及相关性:本试验表明,糖痹方联合基础治疗对改善DSPN患者的症状更安全、更有效。
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引用次数: 0
Commentary on the T1D Exchange Quality Improvement Collaborative Learning Session November 2024 abstracts 2024年11月T1D交流质量改进协作学习会议评论摘要。
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-12-25 DOI: 10.1111/1753-0407.70037
Halis K. Akturk, Osagie Ebekozien, Holly Hardison, Nicole Rioles, Stephanie Crossen

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引用次数: 0
Simplicity: The Ultimate Sophistication in Managing Type 2 Diabetes With Severe Hyperglycemia 简单:管理伴有严重高血糖的2型糖尿病的终极复杂性。
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-12-20 DOI: 10.1111/1753-0407.70042
Liehua Liu, Yanbing Li
<p>Diabetes mellitus, affecting 537 million people globally [<span>1</span>], is a chronic metabolic disorder with well-documented “legacy effects” of early hyperglycemia on complications that persist for decades [<span>2</span>]. The importance of early intensive glycemic control is evidenced by long-term follow-up data from the United Kingdom Prospective Diabetes Study, demonstrating that it lowers the risks of mortality and both microvascular and macrovascular complications, yielding life-long benefits [<span>3</span>].</p><p>Nevertheless, glycemic control in type 2 diabetes (T2DM) remains inadequate globally, particularly in China, where only fewer than 50% of patients achieve HbA1c < 7% [<span>4</span>]. Moreover, severe hyperglycemia at diagnosis is prevalent. A retrospective study in China showed that 44.5% of newly diagnosed patients present with HbA1c > 9% [<span>5</span>]. This fact poses a substantial challenge for achieving early and sustained glycemic control.</p><p>The traditional stepwise escalation approach, which gradually intensifies treatment in response to worsening hyperglycemia, often fails to achieve optimal glycemic control and prevent progressive β-cell dysfunction. Timely initiation of combination therapy is recommended for marked hyperglycemia. Current guidelines from the American Diabetes Association recommend combination therapy when HbA1c exceeds treatment targets by 1.5% (≥ 8.5%) and insulin for HbA1c > 10%, expecting simplifying treatment after correction of glucotoxicity [<span>6</span>]. However, because high-quality evidence is lacking, no standardized guidance could be provided. Indeed, more potent combination regimens may result in superior glycemic control. As shown in the EDICT study, a triple therapy regimen consisting of metformin, pioglitazone, and exenatide achieved HbA1c < 6.5% in 78% of participants over 3 years [<span>7</span>]. However, real-world challenges, including adherence, tolerability, and cost, limit broader implementation of combination therapy, particularly that with injectable agents [<span>8</span>].</p><p>Simplified treatment regimens have consistently been an urgent need for healthcare providers and patients. Nevertheless, as Leonardo da Vinci famously said, “Simplicity is the ultimate sophistication.” Achieving both optimal glycemic control and treatment simplification requires a shift in strategy to pay more attention to the reversibility of β-cell dysfunction in early T2DM. This requires addressing the major mechanisms of disease progression. In patients with significant hyperglycemia, glucotoxicity plays a central role in β-cell dysfunction, reducing β-cell secretory capacity through mechanisms such as triggering β-cell dedifferentiation and endoplasmic reticulum stress [<span>9, 10</span>]. Our previous studies have shown that short-term intensive insulin therapy (SIIT) effectively alleviates glucotoxicity, significantly improving β-cell function and insulin sensitivit
糖尿病影响着全球 5.37 亿人[1],是一种慢性代谢性疾病,早期高血糖对并发症的 "遗留效应 "已得到充分证明,并将持续数十年[2]。英国前瞻性糖尿病研究(United Kingdom Prospective Diabetes Study)的长期随访数据证明了早期强化血糖控制的重要性,它降低了死亡风险以及微血管和大血管并发症的风险,使患者终生受益[3]。然而,全球范围内 2 型糖尿病(T2DM)的血糖控制仍然不足,尤其是在中国,只有不到 50% 的患者 HbA1c 达到 7% [4]。此外,确诊时的严重高血糖也很普遍。中国的一项回顾性研究显示,44.5% 的新诊断患者 HbA1c 为 9%[5]。传统的循序渐进的治疗方法,即根据高血糖的恶化情况逐步加强治疗,往往不能达到最佳的血糖控制和防止进行性β细胞功能障碍。对于明显的高血糖,建议及时启动联合疗法。美国糖尿病协会的现行指南建议,当 HbA1c 超过治疗目标 1.5%(≥ 8.5%)时应进行联合治疗,HbA1c &gt; 10% 时应使用胰岛素,期望在纠正葡萄糖毒性后简化治疗[6]。然而,由于缺乏高质量的证据,因此无法提供标准化的指导。事实上,更有效的联合治疗方案可能会带来更好的血糖控制效果。如 EDICT 研究所示,由二甲双胍、吡格列酮和艾塞那肽组成的三联疗法可使 78% 的参与者在 3 年内达到 HbA1c &lt; 6.5% [7]。然而,现实世界中的挑战,包括依从性、耐受性和成本,限制了联合疗法的广泛实施,尤其是使用注射剂的联合疗法[8]。然而,正如达芬奇的一句名言:"简单是最终的复杂"。要实现最佳血糖控制和简化治疗,就必须转变策略,更多地关注早期 T2DM β 细胞功能障碍的可逆性。这就需要解决疾病进展的主要机制。在有明显高血糖的患者中,葡萄糖毒性在β细胞功能障碍中起着核心作用,通过引发β细胞去分化和内质网应激等机制降低β细胞的分泌能力[9, 10]。我们之前的研究表明,短期胰岛素强化治疗(SIIT)可有效缓解葡萄糖毒性,显著改善β细胞功能和胰岛素敏感性。此外,50%以上的患者通过这种方法获得了持续一年以上的糖尿病缓解[11-14]。然而,长期保持 SIIT 的疗效仍是一项挑战。难以坚持生活方式干预以及老龄化等不可改变因素的影响等因素导致了这一复杂性。SIIT 治疗后的缓解率会随着时间的推移而下降,从治疗后立即缓解的 70% 降至第一年年底的约 50% 和第二年年底的约 40%[14]。这些观察结果提供了两个重要启示:首先,通过 SIIT 逆转高血糖和 β 细胞功能障碍可为长期血糖控制奠定坚实的基础。其次,在强化治疗后实施持续的降糖策略对于预防反复高血糖和长期保护β细胞功能至关重要。基于这些认识,我们开发了一种 "强化-简化 "策略。基于这些认识,我们开发了一种 "强化-简化 "策略。这种方法首先使用 SIIT 最大程度地消除葡萄糖毒性,然后使用简化的口服降糖药来维持血糖控制。为了评估这一策略的疗效,我们在中国 15 家医院开展了一项开放标签、多中心、随机对照试验[15]。主要终点是在 48 周随访期结束时达到 HbA1c &lt; 7% 的参与者比例。基线 HbA1c 为 11.0% ± 1.9%,平均空腹血浆葡萄糖 (FPG) 为 11.4 mmol/L,餐后 2 小时血糖 (PPG) 为 20.5 mmol/L。值得注意的是,76% 的参与者出现了严重的高血糖症状,如多尿、多饮和体重减轻。在 "强化 "阶段,SIIT 有效地将平均 FPG 降至 5.9 mmol/L,PPG 降至 13.8 mmol/L。在随后的 "简化 "阶段,LIN + MET 组 HbA1c &lt; 7% 的比例最高(80%),明显高于对照组(60%,P = 0.003)。
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引用次数: 0
Glucagon-Like Peptide-1 Receptor Agonists and Anesthesia—Are We Clearer on the Correct Approach? 胰高血糖素样肽-1受体激动剂和麻醉-我们是否更清楚正确的方法?
IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-12-19 DOI: 10.1111/1753-0407.70041
Zachary Bloomgarden
<p>A bit over a year ago, we argued in these pages against a consensus statement recommendation from the American Society of Anesthesiologists that patients taking glucagon-like peptide-1 receptor agonists (GLP-1RA) should not take these agents for 1 week before elective procedures [<span>1</span>]. We pointed out the number of medications potentially interfering with gastric motility, including opiate analgesics, anticholinergics, antidepressants, calcium channel blockers, and gastric acid suppressants, with the lack of specific requirements that such treatments be held in preparation for anesthesia and sedation [<span>1</span>]. Some institutions now require that GLP-1RA be withheld for several weeks before procedures, and indeed evidence based on drug levels suggests that “complete dissipation of the effect” would require 4–5 half-lives, although this would likely be “potentially harmful” by virtue of requiring complete reorganization of diabetes treatment for many patients [<span>2</span>].</p><p>The imposition of these guidelines on people with diabetes has burdened them with the dilemma of not using important glucose-lowering and appetite-suppressing treatments with evidence of cardiovascular, renal, hepatic, and pulmonary benefits. Has there been interim progress?</p><p>In a study of 133 patients with type 2 diabetes undergoing 192 upper endoscopies, gastric contents were present in 19% of those taking versus 5% of those not taking a GLP-1RA [<span>3</span>]. Another study of 124 patients with type 2 diabetes undergoing endoscopy found residual gastric contents in 56% versus 19% of those taking versus not taking a GLP-1RA [<span>4</span>]. A study comparing 24 824 GLP-1RA users with 18 541 sodium-glucose cotransporter-2 inhibitor users undergoing upper endoscopy, however, found similar pulmonary aspiration risks of 4.2 versus 4.3 per 1000, respectively, although endoscopy discontinuation rates were 9.8 versus 4.9 per 1000, respectively, the significantly greater risk with GLP-1RA seen only among those with BMI ≥ 30 kg/m<sup>2</sup>, which the authors speculated might be related to retained gastric contents [<span>5</span>]. A study of 274 211 outpatient upper endoscopy procedures among individuals aged 18–64 with type 2 diabetes from 2005 to 2021 compared claims for aspiration and associated pulmonary adverse events in the 14 days following upper endoscopy, highlighting the infrequency of such events, with aspiration, aspiration pneumonia, and respiratory failure occurring with frequencies of 6.8, 7.6, and 25.6 cases per 10 000 endoscopies, respectively; there was no significant difference in event rates between users of GLP1-RA and those of dipeptidyl peptidase 4 inhibitors (DPP4i), and significantly lower rates of pneumonia, respiratory failure, and hospitalization and ER visits among those using GLP-1RA compared with individuals using chronic opioids, albeit without significant changes in documented aspiration or aspiration pneumonia [<
一年多以前,我们在本刊中反对美国麻醉医师协会的共识声明建议,即服用胰高血糖素样肽-1受体激动剂(GLP-1RA)的患者在选择手术前一周内不应服用这些药物。我们指出了一些可能干扰胃运动的药物,包括阿片类镇痛药、抗胆碱能药、抗抑郁药、钙通道阻滞剂和胃酸抑制剂,但缺乏在麻醉和镇静bb0前进行此类治疗的具体要求。一些机构现在要求GLP-1RA在治疗前要保留几周,事实上,基于药物水平的证据表明,“完全消除效果”需要4-5个半衰期,尽管这可能是“潜在有害的”,因为这需要对许多患者的糖尿病治疗进行完全重组。将这些指南强加于糖尿病患者,使他们陷入两难境地,无法使用具有心血管、肾脏、肝脏和肺部益处的重要降糖和抑制食欲治疗。有没有临时进展?在一项对133名2型糖尿病患者进行了192次上腔内镜检查的研究中,19%的患者服用GLP-1RA[3],而5%的患者未服用GLP-1RA[3]。另一项对124名2型糖尿病患者进行内窥镜检查的研究发现,服用GLP-1RA[4]和未服用GLP-1RA[4]的患者中,胃内容物残留的比例分别为56%和19%。然而,一项比较24824名GLP-1RA使用者和18541名钠-葡萄糖共转运蛋白2抑制剂使用者的研究发现,肺误吸风险相似,分别为4.2 / 1000和4.3 / 1000,尽管内窥镜停止率分别为9.8 / 1000和4.9 / 1000,GLP-1RA的风险明显更高,仅在BMI≥30 kg/m2的人群中可见,作者推测这可能与胃内容物残留[5]有关。一项研究对2005年至2021年期间18-64岁2型糖尿病患者的274211例门诊上颌内窥镜检查进行了比较,比较了上颌内窥镜检查后14天内误吸和相关肺部不良事件的索赔,强调了此类事件的发生率,误吸、吸入性肺炎和呼吸衰竭的发生率分别为6.8例、7.6例和25.6例/ 10000例内窥镜检查;GLP-1RA使用者与二肽基肽酶4抑制剂(DPP4i)使用者之间的事件发生率无显著差异,与使用慢性阿片类药物的个体相比,GLP-1RA使用者的肺炎、呼吸衰竭、住院和急诊室就诊率显著降低,尽管记录的误吸或吸入性肺炎bbb没有显著变化。然而,另一项研究发现,GLP-1RA使用者与非使用者相比,内窥镜检查后吸入性肺炎的风险增加了1.33倍,使用倾向评分匹配来调整基线差异;在GLP-1RA使用者中,总共有15114例内窥镜检查中发生126例事件,每1000例内窥镜检查中发生8.3例事件。一项对2015年至2021年接受急诊手术的2型糖尿病患者术后呼吸衰竭或吸入性肺炎发生率的研究发现,在3502名使用GLP-1RA[8]的患者和20117名未使用GLP-1RA[8]的患者中,调整后的事件发生率相同,为2.7%。在一项对接受手术的成人糖尿病患者的研究中,2256名患者接受了GLP-1RA, 1405名患者接受了口服降糖药,术后临床证据显示胃排空速度减慢的比例为21.5%,吸入性肺炎的发生率分别为0.4%和0.6%,倾向评分匹配表明,未使用GLP-1RA的患者使用抗吐剂的比例降低了19%,但术后7天肠梗阻的发生率无显著差异。术后吸入性肺炎[9]无显著性差异。在一项对14例接受手术的2型糖尿病患者的荟萃分析中,GLP-1RA的使用与未使用分别与9%和3%的手术前和手术前后胃肠道症状相关,术后恶心或呕吐无显著增加,胃内容物潴留分别为8%和3%;接受GLP-1RA治疗的患者血糖控制得到改善,术后胰岛素给药需求降低61%。一项涉及GLP-1RA治疗和不良胃肠道/胆道事件的研究的小型综述/文献检索证实,在上胃镜检查时,GLP-1RA与胃内容物潴留有关,这表明这与胃排空延迟有关,但需要注意的是,首先,长期存在的伴有并发症的2型糖尿病与胃排空延迟导致胃内容物潴留密切相关,其次,这与吸入性[11]很少相关。 因此,有(或没有)GLP-1RA治疗的糖尿病患者术中肺误吸的病例报告可能仅仅是由于与长期糖尿病bbb相关的胃运动异常所致。这些考虑表明,术前使用GLP-1RA几乎没有危害,并导致美国FDA于2024年11月1日建议改变围手术期使用GLP-1RA的建议[13,14],说明使用semaglutide(与利拉鲁肽和替西帕肽的建议相同)。“有罕见的上市后报告称,接受GLP-1受体激动剂的患者在接受择期手术或需要全身麻醉或深度镇静的手术时,尽管有报告称遵守术前禁食建议,但仍有胃内容物残留。现有数据不足以为减轻全身麻醉或深度镇静期间肺误吸风险的建议提供依据……包括修改术前禁食建议或暂时停用OZEMPIC是否可以减少胃内容物潴留的发生率。美国胃肠病学协会、美国代谢与减肥外科学会、美国麻醉师学会、国际肥胖患者围手术期护理学会和美国胃肠内镜外科学会的指南对围手术期使用GLP-1RA给出了三条建议[16,17]。首先,根据“提示胃排空延迟的胃肠道症状”来确定胃排空延迟的风险;最近增加剂量,增加剂量,每周给药。”不幸的是,很少或根本没有临床试验或观察证据表明这些看似合理的风险因素实际上与结果有关。“使用GLP-1RA以外的医疗条件,也可能延迟胃排空”是额外的风险建议。第二项建议是,“如果不担心胃排空延迟,术前继续GLP-1RA治疗。”然而,糖尿病是一种医学疾病,因此该建议继续建议“在常规推荐的禁食方案下,手术前至少24小时只吃流质饮食,或者……如果GLP-1RAs需要停止使用药物桥接”。接下来是第三条建议,“如果不担心胃排空延迟,则继续进行手术……(否则)考虑即时胃超声和/或……快速顺序诱导全身麻醉。”作者强调,这“应该被视为指导,而不是基于证据的指导”,给我们留下了问题,但没有真正的答案。我们该怎么做呢?《医学快报》上的一篇分析将新建议解释为“建议大多数患者在围手术期可以继续服用这些药物”。这可能是最好的办法。内镜研究确实表明,接受GLP-1RA的2型糖尿病患者在内镜检查期间胃内容物潴留的可能性更高,但三个大型临床数据集分析中有两个显示吸入性肺炎没有增加[5,6],第三个研究中,事件风险增加33%,接受GLP-1RA的患者发生率为0.83%,未接受这些药物的患者发生率为0.63%。两项对2型糖尿病手术患者的研究均未发现误吸或其他并发症的增加[8,9]。荟萃分析支持这些结论。鉴于GLP-1RA治疗糖尿病患者(以及肥胖、心力衰竭或肾脏疾病患者)的诸多益处,根据新的FDA和社会指南,一个合理的方法可能是继续使用这些药物,并在有胃轻瘫症状的患者术前使用液体饮食方法,同时调整空腹糖尿病治疗,以进一步减少任何误吸的机会。作者声明无利益冲突。
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Journal of Diabetes
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