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Expert Consensus on the Role of Pharmaco-complementary Medicine for the Management of Diabetic Complications Using Modified Delphi Method 采用改良德尔菲法辅助药物治疗糖尿病并发症的专家共识
Pub Date : 2023-09-02 DOI: 10.15226/2374-6890/10/1/001162
Samir H. Assaad-Khalil, Samir George Samna, Ibrahim Naguib Elebrashy, Mamdouh El-Nahas, M. Hesham El Hefnawy, Lobna Farag Eltoony, Khaled Elsayed Elhadidy, Fawzy AF Elmessallamy, Magdy Helmy Megallaa, Walaa A Khalifa, Tamer M. Elsherbiny, Noha G. Amin, Mohamed Hassan Zeitoun, Michael Safwat
Background: Diabetes mellitus is a chronic metabolic disorder characterized by hyperglycemia resulting from insulin resistance and/or deficiency. It is associated with numerous complications, including microvascular and macrovascular complications. Micronutrient deficiencies are commonly observed in individuals with diabetes due to the metabolic changes that occur in the body and the increased renal excretion. Several studies have shown that diabetes patients are at an increased risk of developing micronutrient deficiencies such as vitamin D, thiamine, vitamin B12, folate, magnesium, and zinc. The consequences of micronutrient deficiencies in diabetic patients can be significant. The aim of this study was to achieve a consensus on the use of complementary pharmacological therapies in the management of diabetic complications, through a modified Delphi methodology. Methods: A three-round modified Delphi Procedure was conducted to define recommendations regarding the role of Pharmaco-Complementary medicine in the management of Diabetic complications using a web-based questionnaire. The questionnaire included a set of 65 questions. The level of Consensus was defined based on the level of agreement among the panelists on specific scientific statements. Strong Consensus was defined as ≥80% agreement, Moderate Consensus with Agreement between 65% and up to 79%, and Low Consensus level with statements below 65% agreement. Results: Eighteen experts in the field of diabetes participated in the development of this consensus. Three rounds of voting were held, followed by data analysis and consensus level calculation. Out of 47 statements, a total of 33 statements achieved moderate – strong consensus (moderate: 65% - 79% agreement, strong: ≥80% agreement). Conclusion: Experts concluded that the use of pharmaco-complementary medications such as CoQ10, Benfotiamine, Magnesium, and EPA can potentially improve glycemic control, insulin sensitivity, and manage diabetic complications. This consensus can serve as a valuable tool for clinicians in managing diabetes, and its complications, and can provide direction for future research. Keywords: Diabetes, Consensus; Pharmaco-complementary, Delphi, Complications
背景:糖尿病是一种以胰岛素抵抗和/或缺乏引起的高血糖为特征的慢性代谢紊乱。它与许多并发症有关,包括微血管和大血管并发症。由于体内代谢变化和肾脏排泄增加,糖尿病患者通常会出现微量营养素缺乏。几项研究表明,糖尿病患者患微量营养素缺乏的风险增加,如维生素D、硫胺素、维生素B12、叶酸、镁和锌。糖尿病患者微量营养素缺乏的后果可能很严重。本研究的目的是通过改进的德尔菲方法,在糖尿病并发症的管理中使用补充药物治疗达成共识。方法:采用基于网络的问卷调查,采用三轮改进的德尔菲程序来确定关于药物补充医学在糖尿病并发症管理中的作用的建议。调查问卷包括65个问题。共识水平是根据小组成员对具体科学陈述的一致程度来定义的。强共识定义为≥80%的共识,中等共识,65%至79%之间的共识,低共识水平,65%以下的共识。结果:18位糖尿病领域的专家参与了这一共识的制定。进行三轮投票,然后进行数据分析和共识水平计算。在47个陈述中,共有33个陈述达到了中度-高度一致(中度:65% - 79%一致,高度:≥80%一致)。结论:专家得出结论,使用辅酶q10、苯丙胺、镁和EPA等药物补充药物可以潜在地改善血糖控制、胰岛素敏感性和管理糖尿病并发症。这一共识可以作为临床医生管理糖尿病及其并发症的宝贵工具,并为未来的研究提供方向。关键词:糖尿病;共识;药物补充,德尔菲,并发症
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引用次数: 0
Universal Screening of Gestational Diabetes Mellitus In Upper Egypt: Prospective Cohort Study of The Prevalence, Risk Factors, and Short-Term Outcomes 上埃及妊娠期糖尿病的普遍筛查:患病率、危险因素和短期结果的前瞻性队列研究
Pub Date : 2023-09-02 DOI: 10.15226/2374-6890/10/1/001161
Lobna F. Eltoony, Walaa A Khalifa, Hani M. Mobarkout, Nagla M. Ahmad, Khaled E Elhadidy, Mohammad A. Mashahet, Ehab Salem, Ahmed M. Abbas, Omar M Shaaban, Hend M. Yousef, Usama A Sharaf El Din
Background: Despite the high prevalence of diabetes mellitus in Egypt, the real prevalence and epidemiology of gestational diabetes mellitus (GDM) in Upper Egypt is still lacking. Objective: This study aims to determine the prevalence and risk factors of GDM among pregnant women in Upper Egypt and to evaluate the foetal and maternal outcomes of this disease. Methods: This prospective cohort study was conducted between July 2014 and July 2018. Universal screening for GDM among all pregnant women attending primary health care clinics was done using Diabetes in Pregnancy Study Group of India (DIPSI) criteria. Those with GDM were followed up until the end of purpureum. Maternal and foetal outcomes were recorded. Results: GDM was diagnosed in 956 out of 7141 pregnant women (13.4%). Previous history of GDM, macrosomic babies, and family history of diabetes were all significantly higher in GDM women (P<0.001 each). However, no definite risk factors were observed in about half of the GDM women. 29% of GDM women responded to medical nutrition therapy (MNT) alone. When the oral glucose tolerance test (OGTT) was repeated Postpartum, diagnosis of DM was established in 14.3% of the cohort, while 25.7% had impaired glucose tolerance. Conclusions: The prevalence of GDM is relatively high in Upper Egypt. Half of GDM cases lack risk factors. Universal screening using OGTT should be routinely performed to all attendant pregnant ladies. Discrete MNT is not an enough management in most of GDM cases. Keywords: GDM; Postpartum OGTT; diabetes; MNT; foetal outcome; maternal outcome.
背景:尽管糖尿病在埃及的高患病率,妊娠期糖尿病(GDM)在上埃及的真实患病率和流行病学仍然缺乏。目的:本研究旨在确定上埃及孕妇GDM的患病率和危险因素,并评估该疾病的胎儿和母体结局。方法:本前瞻性队列研究于2014年7月至2018年7月进行。采用印度妊娠糖尿病研究组(DIPSI)标准,对所有到初级卫生保健诊所就诊的孕妇进行GDM普遍筛查。GDM患者随访至紫癜期结束。记录产妇和胎儿的结局。结果:7141例孕妇中有956例确诊GDM(13.4%)。GDM女性既往糖尿病史、大婴儿史和糖尿病家族史均显著高于GDM女性(P<均为0.001)。然而,在大约一半的GDM妇女中没有观察到明确的危险因素。29%的GDM女性对药物营养治疗(MNT)有反应。当产后再次进行口服糖耐量试验(OGTT)时,14.3%的队列诊断为糖尿病,25.7%的队列诊断为糖耐量受损。结论:上埃及地区GDM患病率较高。一半的GDM病例缺乏危险因素。所有伴随妊娠的孕妇应常规使用OGTT进行普遍筛查。离散MNT在大多数GDM病例中是不够的。关键词:GDM;产后OGTT;糖尿病;MNT;胎儿的结果;孕产妇的结果。
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引用次数: 0
Epidemiological and Clinical Aspects of Simple Steatosis and Non-Alcoholic Steato- Hepatitis Among Newly Diagnosed Type 2 Diabetes Patients at The Central Hospital in Yaoundé, Cameroon 喀麦隆雅温得中心医院新确诊的 2 型糖尿病患者单纯性脂肪变性和非酒精性脂肪性肝炎的流行病学和临床表现
Pub Date : 2023-07-12 DOI: 10.15226/2374-6890/10/1/001160
Louise A. Mawo, A. Zemsi, M. Etoa, M. Dehayem, O. Njoya, E. Sobngwi, F. Ankouane, Pierre Z. Ongolo, J. Mbanya
Non-alcoholic fatty liver disease (NAFLD) is associated with metabolic comorbidities like type 2 diabetes mellitus (T2DM). The aim of this study was to determine the proportion of simple steatosis and non-alcoholic steatohepatitis, which are components of NAFLD, among newly diagnosed T2DM patients. This cross-sectional study was undertaken at the Central Hospital, Cameroon from March 2020 to September 2020 and it included all recently diagnosed T2DM patients, who had an alcohol consumption <140g (14 drinks/week) for women and <210g (21 drinks/week) for men, and without any signs of liver cirrhosis on abdominal ultrasound. All patients underwent a clinical examination with blood samples taken for lipid profile and transaminases measurements and an abdominal ultrasound assessment using a LOGIQ V5 Expert ultrasound machine. A total of 98 (53 males and 45 females) out of 128 eligible patients consented to participate in the study. The mean age was 50.31±10.51. NAFLD was present in 56.1% (55/98) patients; with mild and homogeneously diffused in 92.7% (51/55) and 94.5% (52/55) respectively. There were no significant differences in lipids profiles and transaminases between those with or without steatosis. Factors associated with fatty liver disease were body mass index ≥ 30 kg / m2 (P = 0.0002), waist circumference ≥ 94 cm for men or ≥ 80cm for women (P = 0.004). In conclusion, NAFLD is a common feature in newly diagnosed T2DM in our setting. There is a need for more attention towards NAFLD by primary care physicians, specialists and health policy makers
非酒精性脂肪肝(NAFLD)与 2 型糖尿病(T2DM)等代谢合并症有关。本研究旨在确定非酒精性脂肪肝的组成部分--单纯脂肪变性和非酒精性脂肪性肝炎在新诊断的 T2DM 患者中所占的比例。这项横断面研究于2020年3月至2020年9月在喀麦隆中央医院进行,研究对象包括所有新近确诊的T2DM患者,女性饮酒量小于140克(14杯/周),男性饮酒量小于210克(21杯/周),腹部超声检查无任何肝硬化迹象。所有患者均接受了临床检查,并采集了血样以测定血脂和转氨酶,还使用 LOGIQ V5 专家型超声波机进行了腹部超声波评估。在 128 名符合条件的患者中,共有 98 人(53 名男性和 45 名女性)同意参与研究。平均年龄为(50.31±10.51)岁。56.1%(55/98)的患者存在非酒精性脂肪肝;轻度和均匀弥漫性非酒精性脂肪肝分别占 92.7%(51/55)和 94.5%(52/55)。有无脂肪肝患者的血脂和转氨酶无明显差异。与脂肪肝相关的因素有体重指数≥ 30 kg / m2(P = 0.0002)、男性腰围≥ 94 cm或女性腰围≥ 80 cm(P = 0.004)。总之,非酒精性脂肪肝是我国新诊断 T2DM 患者的常见特征。初级保健医生、专科医生和卫生政策制定者需要更多地关注非酒精性脂肪肝。
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引用次数: 0
Is Cerebrolysin effective in reducing symptoms of Diabetic Peripheral Neuropathy? 脑溶素能有效减轻糖尿病周围神经病变的症状吗?
Pub Date : 2023-01-24 DOI: 10.15226/2374-6890/10/1/001159
Aim This is an investigator initiated observational comparative medical program, to test the efficacy of Cerebrolysin® intake for 1 month versus 2 months, in patients clinically diagnosed with type 2 diabetes mellitus (T2DM) and suffering from peripheral neuropathy. Methods Patients aged ≥ 18 years old, clinically diagnosed with mild or moderate painful diabetic polyneuropathy, received Cerebrolysin® for 1 or 2 months according to investigators’ decision. Demographic data, detailed medical history, and laboratory results were collected at baseline. All enrolled patients were evaluated for Toronto Clinical Scoring System (TCSS), Visual Analogue Scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS) at baseline and end of the program (1 month/2 month). Results VAS, TCSS, and LANSS were significantly improved for all 136 enrolled patients at the end of their treatment with Cerebrolysin® for 1 or 2 months, regarding gender, duration since diagnosis of T2DM (more than or less than 10 years) and HbA1c ≤ 9% or ˃ 9%, with a very highly statistically significant difference (p-value ˂ 0.001). They were slightly improved more in patients received Cerebrolysin® for 1 month more than for 2 months. There was no statistically significant difference for gender, duration of diagnosis with diabetes mellitus less or more than 10 years, and HbA1c ≤ 9% & ˃ 9% regarding the change of VAS, TCSS, and LANSS as dependent variables, using Linear stepwise regression. While there was noticed improvement in VAS, TCSS, and LANSS with use of Cerebrolysin® for 1 month more than 2 months, Regression Coefficient (B (95% of Confidence interval)) B=0.794 (0.29-1.29), B=1.472 (0.87-2.074), B=2.143 (0.45-3.83) and p-value = 0.002, p-value ˂ 0.001, p-value = 0.13 respectively. There was no adverse event (AE) or serious adverse event (SAE) reported during the program. Conclusion: Cerebrolysin® is considered effective in the management of peripheral neuropathy in patients with T2DM Abbreviations: Adverse Event (AE), Advanced Glycation End products (AGE), Contract Research Organization (CRO), Diabetic Peripheral Neuropathy (DPN), Diacylglycerol (DAG), estimated Glomerular Filtration (eGFR), Fasting Blood Sugar (FBS), Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS), Peripheral Vascular Disease (PVD), Pin- Prick Threshold (PPT), Protein Kinase C (PKC), Statistical Analysis Plan (SAP), Serious Adverse Event (SAE), Standard Deviation (SD), Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM), Toronto Clinical Scoring System (TCSS), Traumatic Brain Injury (TBI), Visual Analogue Scale (VAS).
这是一项由研究者发起的观察性比较医学项目,旨在测试临床诊断为2型糖尿病(T2DM)并患有周围神经病变的患者服用1个月与2个月脑溶素®的疗效。方法年龄≥18岁,临床诊断为轻中度疼痛性糖尿病多发神经病变的患者,根据研究者的决定,给予脑溶素®治疗1或2个月。在基线时收集人口统计数据、详细病史和实验室结果。在基线和项目结束时(1个月/2个月),对所有入组患者进行多伦多临床评分系统(TCSS)、视觉模拟量表(VAS)和利兹神经性症状和体征疼痛量表(LANSS)评估。结果136例入组患者在脑溶血素治疗1或2个月后,不论性别、诊断T2DM持续时间(大于或小于10年)、HbA1c≤9%或≤9%,VAS、TCSS和LANSS均有显著改善,差异具有非常高的统计学意义(p值小于0.001)。接受1个月脑溶血素治疗的患者比接受2个月治疗的患者有轻微的改善。性别、糖尿病诊断时间≤10年、HbA1c≤9%等因素差异无统计学意义;9%以VAS、TCSS和LANSS的变化为因变量,采用线性逐步回归。脑溶血素®治疗1个月较2个月有明显改善,回归系数(B(95%置信区间))B=0.794 (0.29-1.29), B=1.472 (0.87-2.074), B=2.143 (0.45-3.83), p值= 0.002,p值小于0.001,p值= 0.13。在项目期间没有不良事件(AE)或严重不良事件(SAE)的报告。结论:脑溶素®治疗T2DM患者周围神经病变有效。不良事件(AE)、晚期糖基化终产物(AGE)、合同研究组织(CRO)、糖尿病周围神经病变(DPN)、二酰甘油(DAG)、肾小球滤过(eGFR)、空腹血糖(FBS)、利兹神经症状和体征评估疼痛量表(LANSS)、周围血管疾病(PVD)、针刺阈值(PPT)、蛋白激酶C (PKC)、统计分析计划(SAP)、严重不良事件(SAE)、标准差(SD)、1型糖尿病(T1DM), 2型糖尿病(T2DM),多伦多临床评分系统(TCSS),创伤性脑损伤(TBI),视觉模拟量表(VAS)。
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引用次数: 0
Pattern of The Evolution of The Contralateral Adrenal Gland’s Function After Unilateral Adrenalectomy 单侧肾上腺切除术后对侧肾上腺功能的演变模式
Pub Date : 2023-01-12 DOI: 10.15226/2374-6890/10/1/001158
Introduction: The occurrence of an adrenal insufficiency post adrenalectomy usually attests of the success of the operative act. After the adrenalectomy, we could expect a compensatory secretion by the controlateral adrenal gland. However, the integrity of the residual function of the remaining gland depends on the initial secretory character of the mass and on its length. The aim of this study was to evaluate the residual function of the controlateral gland after a unilateral adrenalectomy. Method: This was a 13-month prospective study in Yaoundé Central Hospital. We included in the study, all patients who underwent an adrenalectomy. The adrenal function was assessed in preoperative by the measurement of 8am plasmatic cortisol after a dexamethasone suppression test, while in postoperative periods it was the measure of the baseline plasmatic cortisol at 8am. The latter was possibly completed with a stimulation test with Synacthene 0.25μg. The association between the variables was searched using the Fischer test. A significance threshold of 0.05 was adopted. Results: Seven patients (4 women and 3 men) underwent surgery indicated for an adrenal mass. Median age was 44,7 years [17 – 69 years]. The discovery mode was mainly weight gain (28.6 %) or unexplained weight loss (28.6 %). The median delay to diagnosis was 8months [8 days – 24 months]. In the preoperative period, the median cortisol level after dexamethasone suppression test was 329.9 ng/ml, amongst which 2/7 patients had hypercortisolism. The median values of normetanephrines and metanephrines were 7nmol/L and 71.4 nmol/L, respectively. Pathology described: corticosurrenalomas (2), adrenal adenomas (2), pheochromocytomas (2) and adrenalitis (1). In early postoperative, the median 8 h cortisol was 45.5 ng/ml [34.5-167.1ng/ml]. In late postoperative, the median cortisol value was 95 ng/ml, and strictly normal in 3/6 patients. There was no association between recovery of residual adrenal function and age, tumor size, initial preoperative cortisol value, treatment received preoperatively, and postoperative complications. Conclusion Adrenal insufficiency persists in almost half of the patients in late postoperative. Thus, hydrocortisone supplementation should be maintained as long as possible.
简介:肾上腺切除术后出现肾上腺功能不全通常是手术成功的证明。肾上腺切除术后,控制性肾上腺可产生代偿性分泌。然而,剩余腺体的剩余功能的完整性取决于肿块的初始分泌特征及其长度。本研究的目的是评估单侧肾上腺切除术后控制腺的残余功能。方法:在雅温得中心医院进行为期13个月的前瞻性研究。我们在研究中纳入了所有接受肾上腺切除术的患者。肾上腺功能在术前通过地塞米松抑制试验后8点血浆皮质醇的测量来评估,而在术后期间,在8点测量基线血浆皮质醇。后者可能通过0.25μg的Synacthene刺激试验来完成。使用Fischer检验来搜索变量之间的关联。采用显著性阈值0.05。结果:7例患者(4女3男)因肾上腺肿块接受手术治疗。中位年龄44.7岁[17 ~ 69岁]。发现方式主要为体重增加(28.6%)或不明原因体重减轻(28.6%)。中位诊断延迟为8个月[8天- 24个月]。术前地塞米松抑制试验后皮质醇中位数为329.9 ng/ml,其中2/7患者出现高皮质醇血症。去甲肾上腺素和肾上腺素的中位数分别为7nmol/L和71.4 nmol/L。病理描述:皮质肾腺瘤(2例)、肾上腺腺瘤(2例)、嗜铬细胞瘤(2例)和肾上腺炎(1例)。术后早期,中位8小时皮质醇为45.5 ng/ml [34.5-167.1ng/ml]。术后晚期,皮质醇中位数为95 ng/ml, 3/6患者严格正常。剩余肾上腺功能的恢复与年龄、肿瘤大小、术前初始皮质醇值、术前接受的治疗和术后并发症无相关性。结论近半数患者在术后后期仍存在肾上腺功能不全。因此,应尽可能保持氢化可的松的补充。
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引用次数: 0
Incidence of type 1 diabetes in the children’s hospital dr. Robert reid cabral, 2010-2019. Dominican republic 儿童医院1型糖尿病的发病率Robert reid cabral博士,2010-2019年。多米尼加共和国
Pub Date : 2022-11-19 DOI: 10.15226/2374-6890/9/1/001157
E. Morla, Rosario Almanzar, Carmen A. Rosario, Lunisol Rivera, M. Burgos, M. Ramos, J. Sansary
Background The Children HospitalDr.Robert Reid Cabral, the principal children hospital in the Dominican Republic has no recent data on type 1 diabetes (T1D) incidence in children, therefore a study was undertaken to determine this in people aged <15 years (y). Methods Data were collected on all new T1D diagnoses between 2010-2019 from the The Children Hospital Dr. Robert Reid Cabral that care for children with T1D. Diagnosis was made according to standard American Diabetes Association criteria. No secondary ascertainment source was available. Significances around sex, age and incidence were assessed using the Chi-square (X2) and Pairwise Pearson Correlations tests. Results There were 513 new cases of T1D diagnosed in children aged < 15 y; a mean of 51.3 per year. Mean ± standard deviation age of T1D diagnosis was 8.5 ± 3.8 y, and there was also a not significant female preponderance ( p< 0.35). New cases were consistently highest in the 10-14 y (48.5%), and lowest in the 0-4 y age group (18.6%). Overall, mean crude annual incidence was 1.73 per 100,000 population, with no significant trend of increase or decrease.
背景:儿童医院多米尼加共和国主要儿童医院Robert Reid Cabral没有关于儿童1型糖尿病(T1D)发病率的最新数据,因此开展了一项研究,以确定15岁以下人群的1型糖尿病发病率。方法收集儿童医院Robert Reid Cabral博士2010-2019年期间所有新诊断的T1D数据。根据美国糖尿病协会的标准进行诊断。没有第二手确定来源。使用卡方(X2)和成对Pearson相关检验评估性别、年龄和发病率的显著性。结果15岁以下儿童新发T1D 513例;平均每年51.3人。T1D诊断的平均±标准差年龄为8.5±3.8 y,女性也无明显优势(p< 0.35)。新病例在10-14岁年龄组中最高(48.5%),0-4岁年龄组中最低(18.6%)。总体而言,年平均粗发病率为1.73 / 10万人,没有明显的上升或下降趋势。
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引用次数: 0
Oral Benfotiamine 300 mg Versus Intramuscular Thiamine in Diabetic Patients with Peripheral Neuropathy 糖尿病周围神经病变患者口服苯硫胺300mg与肌内硫胺的比较
Pub Date : 2022-09-22 DOI: 10.15226/2374-6890/9/1/001156
M. E. Hefnawy, H. Ramadan, Dina Rabie, A. Effat
Aim: This is a prospective, pilot, open-label, interventional, comparative, randomized study, enrolled 60 patients with type 2 diabetes mellitus (T2DM) to assess the effect of different doses of oral vitamin B containing Benfotiamine 300 mg versus intramuscular B vitamins containing watersoluble Thiamine HCl. Methods Patients ≥ 18 years with T2DM with Peripheral Neuropathy, divided into 3 groups; A & B (Benfotiamine 300 mg) and group C (Thiamine HCl), which were sub-divided to include patients with HbA1c less or more than 8 %. Patients were evaluated at baseline, after 2.5 hours, six days, and two weeks. Results Blood vitamin B1 increased from baseline to after 2.5 hours (T2) by 57%, 79% and 33% in group A, B and C respectively, with statistically significant difference in each group (p value < 0.001). Vitamin B1 continued to increase after six days (T6) in patients of groups A & B by 98% and 165% respectively, while dropped in patients of group C from 33% at T2 to 6% at T6, with p-value ≤ 0.001 between the three groups. Diabetic Neuropathic Symptom Score (DNS) decreased in mean value in all groups after 14 days of treatment by 64.4%, 53.7% and 48.6% in group A, B and C respectively, indicating improvement of peripheral neuropathy. Safety: There was no AE or SAE reported during the study. Conclusion: Oral Benfotiamine 300 mg is safe and more effective than intramuscular Thiamine HCl, in increasing vitamin B1 blood level in patients with diabetic peripheral neuropathy, which in turn relieves peripheral neuropathy. Clinical Trial Registration Number: NA Keywords: Benfotiamine, Bioavailability, Thiamine, Diabetic Peripheral Neuropathy Abbreviations : Adverse Event (AE), Advanced Glycation End products (AGE), Analysis of Variance (ANOVA), Alanine Transaminase (ALT), Body Mass Index (BMI), Case Report Form (CRF), Diabetic Neuropathic Symptom score (DNSS), Diacylglycerol (DAG), Dipeptidyl Peptidase 4 Inhibitor (DPP-4 I), Good Clinical Practice (GCP), Informed Consent Form (ICF), Intent to Treat (ITT), Institutional Review Board (IRB), Ministry of Health (MOH), National Institute of Diabetes and endocrinology (NIDE), Nuclear Factor kappaB (NF-κB), Per Protocol (PP), Protein Kinase C (PKC), Research and health Development (RHD), Serious Adverse Event (SAE), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), Transient Ischemic Stroke (TIA)
目的:这是一项前瞻性、先导性、开放标签、介入性、比较性、随机研究,纳入了60名2型糖尿病(T2DM)患者,以评估不同剂量的含苯硫胺300mg的口服维生素B与含水溶性盐酸硫胺素的肌内维生素B的效果。方法将年龄≥18岁的2型糖尿病合并周围神经病变患者分为3组;A和B组(苯硫胺300mg)和C组(盐酸硫胺),将其细分为HbA1c小于或大于8%的患者。在基线、2.5小时、6天和两周后对患者进行评估。结果A组、B组和C组血液维生素B1从基线到2.5小时后(T2)分别增加57%、79%和33%,各组差异有统计学意义(p值<0.001),三组间p值≤0.001。治疗14天后,A组、B组和C组的糖尿病神经病变症状评分(DNS)平均值分别下降了64.4%、53.7%和48.6%,表明周围神经病变有所改善。安全性:研究期间未报告AE或SAE。结论:口服300 mg苯硫胺比肌内注射盐酸硫胺更安全、更有效地提高糖尿病周围神经病变患者的维生素B1血药水平,从而缓解周围神经病变。临床试验注册号:NA关键词:苯硫胺、生物利用度、硫胺素、糖尿病周围神经病变缩写:不良事件(AE)、晚期糖化终产物(AGE)、方差分析(ANOVA)、丙氨酸转氨酶(ALT)、体重指数(BMI)、病例报告表(CRF)、糖尿病神经病变症状评分(DNSS)、二酰甘油(DAG),二肽基肽酶4抑制剂(DPP-4 I)、良好临床实践(GCP)、知情同意书(ICF)、意向治疗(ITT)、机构审查委员会(IRB)、卫生部、国家糖尿病和内分泌学研究所(NIDE)、核因子κB(NF-κB)、符合方案(PP)、蛋白激酶C(PKC)、研究与健康发展(RHD)、严重不良事件(SAE),血清素和去甲肾上腺素再摄取抑制剂(SNRIs),短暂性脑缺血发作(TIA)
{"title":"Oral Benfotiamine 300 mg Versus Intramuscular Thiamine in Diabetic Patients with Peripheral Neuropathy","authors":"M. E. Hefnawy, H. Ramadan, Dina Rabie, A. Effat","doi":"10.15226/2374-6890/9/1/001156","DOIUrl":"https://doi.org/10.15226/2374-6890/9/1/001156","url":null,"abstract":"Aim: This is a prospective, pilot, open-label, interventional, comparative, randomized study, enrolled 60 patients with type 2 diabetes mellitus (T2DM) to assess the effect of different doses of oral vitamin B containing Benfotiamine 300 mg versus intramuscular B vitamins containing watersoluble Thiamine HCl. Methods Patients ≥ 18 years with T2DM with Peripheral Neuropathy, divided into 3 groups; A & B (Benfotiamine 300 mg) and group C (Thiamine HCl), which were sub-divided to include patients with HbA1c less or more than 8 %. Patients were evaluated at baseline, after 2.5 hours, six days, and two weeks. Results Blood vitamin B1 increased from baseline to after 2.5 hours (T2) by 57%, 79% and 33% in group A, B and C respectively, with statistically significant difference in each group (p value < 0.001). Vitamin B1 continued to increase after six days (T6) in patients of groups A & B by 98% and 165% respectively, while dropped in patients of group C from 33% at T2 to 6% at T6, with p-value ≤ 0.001 between the three groups. Diabetic Neuropathic Symptom Score (DNS) decreased in mean value in all groups after 14 days of treatment by 64.4%, 53.7% and 48.6% in group A, B and C respectively, indicating improvement of peripheral neuropathy. Safety: There was no AE or SAE reported during the study. Conclusion: Oral Benfotiamine 300 mg is safe and more effective than intramuscular Thiamine HCl, in increasing vitamin B1 blood level in patients with diabetic peripheral neuropathy, which in turn relieves peripheral neuropathy. Clinical Trial Registration Number: NA Keywords: Benfotiamine, Bioavailability, Thiamine, Diabetic Peripheral Neuropathy Abbreviations : Adverse Event (AE), Advanced Glycation End products (AGE), Analysis of Variance (ANOVA), Alanine Transaminase (ALT), Body Mass Index (BMI), Case Report Form (CRF), Diabetic Neuropathic Symptom score (DNSS), Diacylglycerol (DAG), Dipeptidyl Peptidase 4 Inhibitor (DPP-4 I), Good Clinical Practice (GCP), Informed Consent Form (ICF), Intent to Treat (ITT), Institutional Review Board (IRB), Ministry of Health (MOH), National Institute of Diabetes and endocrinology (NIDE), Nuclear Factor kappaB (NF-κB), Per Protocol (PP), Protein Kinase C (PKC), Research and health Development (RHD), Serious Adverse Event (SAE), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), Transient Ischemic Stroke (TIA)","PeriodicalId":73731,"journal":{"name":"Journal of endocrinology and diabetes","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49478493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nutritional Assessment Using the Prognostic Nutritional Index (PNI) and Controlling Nutritional Status (CONUT) Score Predicts Wound Healing In Patients with Diabetic Foot Ulcers 使用预后营养指数(PNI)和控制营养状况(CONUT)评分的营养评估预测糖尿病足溃疡患者的伤口愈合
Pub Date : 2021-05-13 DOI: 10.15226/2374-6890/8/1/001151
Yuri Oda, Kazuki Ikura, T. Babazono
Aims The aim was to examine whether the Prognostic Nutritional Index (PNI) and Controlling Nutritional Status (CONUT) score are predictors of wound healing in patients with diabetic foot ulcers (DFUs). Materials and Methods This was a hospital-based, single-center, observational, longitudinal cohort study of 349 Japanese patients (84 women, 265 men; mean (standard deviation) age 62.8 (12.8) years) with DFUs. The endpoint was complete wound healing. The classical Cox proportional model and competing-risks model were used to calculate the hazard ratios (HRs) and the 95% confidence interval (CI) for reaching the endpoint. Results During a median (range) follow-up of 2.3 (0.03-62.3) months, 220 patients (63.0%) reached the endpoint. In the multivariate Cox proportional hazards model, higher PNI was identified as an independent predictor for the endpoint (HRs 1.22, 95% CI 1.01-1.48, p=0.038). In the multivariate competing-risks model analysis, both higher PNI (HRs 1.26, 95% CI 1.03-1.53, p=0.024) and lower CONUT score (HRs 0.80, 95% CI 0.65-0.99, p=0.045) were identified as independent predictors for the endpoint. Similar results were obtained when the PNI and the CONUT score were treated as categorical variables (≥ median or less). Conclusions Nutritional status, as assessed using the PNI and CONUT score, is a novel clinical predictor for wound healing in patients with DFUs. Keywords: Diabetic foot ulcer; Nutritional assessment; Prognostic nutritional index; Controlling Nutritional Status.
目的探讨预后营养指数(PNI)和控制营养状态(CONUT)评分是否能预测糖尿病足溃疡(DFUs)患者的伤口愈合。材料和方法这是一项基于医院、单中心、观察性、纵向队列研究,纳入了349名日本患者(84名女性,265名男性;平均(标准差)年龄为62.8(12.8)岁。终点是伤口完全愈合。采用经典Cox比例模型和竞争风险模型计算达到终点的风险比(hr)和95%置信区间(CI)。结果在中位(范围)随访2.3(0.03-62.3)个月期间,220例(63.0%)患者达到终点。在多变量Cox比例风险模型中,较高的PNI被确定为终点的独立预测因子(hr 1.22, 95% CI 1.01-1.48, p=0.038)。在多变量竞争风险模型分析中,较高的PNI (HRs 1.26, 95% CI 1.03-1.53, p=0.024)和较低的CONUT评分(HRs 0.80, 95% CI 0.65-0.99, p=0.045)被确定为终点的独立预测因子。当PNI和CONUT评分作为分类变量(≥中位数或更小)时,得到了类似的结果。结论:通过PNI和CONUT评分评估的营养状况是预测DFUs患者伤口愈合的一个新的临床预测指标。关键词:糖尿病足溃疡;营养评估;预后营养指数;控制营养状况。
{"title":"Nutritional Assessment Using the Prognostic Nutritional Index (PNI) and Controlling Nutritional Status (CONUT) Score Predicts Wound Healing In Patients with Diabetic Foot Ulcers","authors":"Yuri Oda, Kazuki Ikura, T. Babazono","doi":"10.15226/2374-6890/8/1/001151","DOIUrl":"https://doi.org/10.15226/2374-6890/8/1/001151","url":null,"abstract":"Aims The aim was to examine whether the Prognostic Nutritional Index (PNI) and Controlling Nutritional Status (CONUT) score are predictors of wound healing in patients with diabetic foot ulcers (DFUs). Materials and Methods This was a hospital-based, single-center, observational, longitudinal cohort study of 349 Japanese patients (84 women, 265 men; mean (standard deviation) age 62.8 (12.8) years) with DFUs. The endpoint was complete wound healing. The classical Cox proportional model and competing-risks model were used to calculate the hazard ratios (HRs) and the 95% confidence interval (CI) for reaching the endpoint. Results During a median (range) follow-up of 2.3 (0.03-62.3) months, 220 patients (63.0%) reached the endpoint. In the multivariate Cox proportional hazards model, higher PNI was identified as an independent predictor for the endpoint (HRs 1.22, 95% CI 1.01-1.48, p=0.038). In the multivariate competing-risks model analysis, both higher PNI (HRs 1.26, 95% CI 1.03-1.53, p=0.024) and lower CONUT score (HRs 0.80, 95% CI 0.65-0.99, p=0.045) were identified as independent predictors for the endpoint. Similar results were obtained when the PNI and the CONUT score were treated as categorical variables (≥ median or less). Conclusions Nutritional status, as assessed using the PNI and CONUT score, is a novel clinical predictor for wound healing in patients with DFUs. Keywords: Diabetic foot ulcer; Nutritional assessment; Prognostic nutritional index; Controlling Nutritional Status.","PeriodicalId":73731,"journal":{"name":"Journal of endocrinology and diabetes","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44402744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Utility of Flash Glucose Monitoring for Patients with Type 1 Diabetes Mellitus during Fasting in Ramadan 快速血糖监测在1型糖尿病患者斋月禁食期间的应用
Pub Date : 2021-04-28 DOI: 10.15226/2374-6890/8/1/001150
Dr. Raisa Minhas, Dr. Jenan Obaid, Dr. Atif Munir Nizami, Dr. Naji Alamuddin, D. Alromaihi
Aims The study aimed to assess the effectiveness of the Flash Glucose Monitor (FGM) in empowering patients with Type 1 Diabetes Mellitus (T1DM) to fast safely during the month of Ramadan. Methods In this prospective interventional study, eligible adult patients with T1DM were monitored with FGM and completed a survey after Ramadan. Time in range, glucose variability, changes in HbA1c, and renal function was evaluated. IRB approval and informed consent were acquired prior to the study. For data analysis (SPSS) Version 25 was used. Results The study included 8 adults (5 females, 3 males). The use of FGM enabled 25% of patients who were not able to fast in the previous year to fast in the current year.The median frequency of hypoglycemic episodes increased during Ramadan from 8 to 24 (p-value 0.049), however. Glucose variability during Ramadan was reduced by 4.05 ± 7.00 % but was not significant (p-value 0.17). The time in range before Ramadan was 51.00% ±10.75, during Ramadan was 53.42% ±14.83,and post-Ramadan was 55.85%± 10. HbA1cand creatinine did not change before and after Ramadan, (p-values of 0.465 and 0.315 respectively) indicating that glycemic control and renal function were maintained. Conclusion Active glucose monitoring using FGM coupled withstructured pre-Ramadan counseling and patient education aids in empowering patient to fast safely and maintain glycemic control during month of Ramadan and avoid complications including DKA and severe hypoglycemia. Keywords: Diabetes Mellitus; Flash glucose monitoring; Fasting, Ramadan; Time in Range.
目的本研究旨在评估快速血糖监测仪(FGM)在1型糖尿病(T1DM)患者斋月期间安全禁食方面的有效性。方法在本前瞻性介入研究中,对符合条件的成年T1DM患者进行女性生殖器切割监测,并在斋月后完成调查。评估范围内的时间、葡萄糖变异性、HbA1c变化和肾功能。研究前获得了IRB批准和知情同意书。数据分析(SPSS)采用25版。结果本研究包括8名成年人(5名女性,3名男性)。女性生殖器切割的使用使25%在前一年无法禁食的患者在本年禁食。然而,斋月期间低血糖发作的中位频率从8次增加到24次(p值0.049)。斋月期间的血糖变异性降低了4.05±7.00%,但并不显著(p值0.17)。斋月前的时间范围为51.00%±10.75,斋月期间为53.42%±14.83,斋月后为55.85%±10。HbA1c和肌酐在斋月前后没有变化(p值分别为0.465和0.315),表明血糖控制和肾功能得到了维持。结论应用女性生殖器切割进行主动血糖监测,结合斋月前的结构化咨询和患者教育,有助于患者在斋月期间安全禁食并保持血糖控制,避免DKA和严重低血糖等并发症。关键词:糖尿病;闪光葡萄糖监测;斋戒、斋月;范围内的时间。
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引用次数: 0
Esophageal Tear with Pneumomediastinum Secondary to Esophageal Candidiasis in a Patient with Autoimmune Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) 一例自身免疫性多endocrinopathy Candidiasis Ectodermal Dystrophy(APCED)患者继发于食管念珠菌感染的食管撕裂伴纵隔气肿
Pub Date : 2021-02-26 DOI: 10.15226/2374-6890/8/1/001149
Timothy Johnson DO, Chheki Sherpa MD, G.Ohel Md
Autoimmune Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) is a rare condition that diffusely affects many organ systems. Chronic mucocutaneous candidiasis is one of the features of APECED, which needs to be treated and monitored to prevent severe complications. This case demonstrates esophageal structuring and resultant esophageal perforation, in the setting of chronic mucocutaneous candidiasis. Learning Points • Chronic mucocutaneous candidiasis (CMC) can be present without overt esophageal thrush • CMC can result in esophageal lesions causing significant morbidity. • APECED patients with dysphagia should be assessed for chronic candida esophagitis and treated accordingly. • Patients with recurrent candida esophagitis should be considered for intermittent topical and systemic antifungal prophylactic therapy. • Esophageal perforation due to candidiasis is most often seen in the setting of immunocompromised states. Background Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED) is a rare autosomal recessive disease caused by mutations of the AIRE (autoimmune regulator) genes [1, 2, 6, 7]. It is characterized by the clinical trial of chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, and adrenal insufficiency [7]. APECED has been reported worldwide, but is more prevalent in some historically- isolated homogeneous populations in Finland (1/25000), Sardinia, and Iranian Jews (1/9000) [7]. APECED is also seen at a lower incidence in Norway, Sweden, Slovenia, Great Britain, Italy, Ireland, and North America [7]. Most patients have CMC from early childhood [2, 3]. Rarely, untreated esophageal candidiasis may lead to complications such as esophageal stricture, rupture and or fistula formation [4, 5].
自身免疫性多内皮细胞病念珠菌性外胚层营养不良(APCED)是一种罕见的疾病,广泛影响许多器官系统。慢性粘膜皮肤念珠菌感染是APECED的特征之一,需要对其进行治疗和监测,以预防严重并发症。该病例显示食道结构和由此导致的食道穿孔,在慢性粘膜皮肤念珠菌感染的情况下。学习要点•慢性粘膜皮肤念珠菌病(CMC)可在没有明显食道鹅口疮的情况下出现•CMC可导致食道病变,导致显著的发病率。•应评估患有吞咽困难的APCED患者是否患有慢性念珠菌性食管炎,并进行相应治疗。•复发性念珠菌性食管炎患者应考虑间歇性局部和全身抗真菌预防性治疗。•由念珠菌感染引起的食道穿孔最常见于免疫功能低下的情况。背景自身免疫性多发性endoclindopathy candiosis extordermal dystrophy(APCED)是一种罕见的常染色体隐性疾病,由自身免疫调节因子AIRE基因突变引起[1,2,6,7]。其特征是慢性粘膜皮肤念珠菌感染(CMC)、甲状旁腺功能减退和肾上腺功能不全的临床试验[7]。APCED在世界各地都有报道,但在芬兰(1/25000)、撒丁岛和伊朗犹太人(1/9000)的一些历史上孤立的同质人群中更为普遍[7]。在挪威、瑞典、斯洛文尼亚、英国、意大利、爱尔兰和北美,APCED的发病率也较低[7]。大多数患者从小就患有CMC[2,3]。罕见的是,未经治疗的食道念珠菌感染可能导致并发症,如食道狭窄、破裂和/或瘘管形成[4,5]。
{"title":"Esophageal Tear with Pneumomediastinum Secondary to Esophageal Candidiasis in a Patient with Autoimmune Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED)","authors":"Timothy Johnson DO, Chheki Sherpa MD, G.Ohel Md","doi":"10.15226/2374-6890/8/1/001149","DOIUrl":"https://doi.org/10.15226/2374-6890/8/1/001149","url":null,"abstract":"Autoimmune Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) is a rare condition that diffusely affects many organ systems. Chronic mucocutaneous candidiasis is one of the features of APECED, which needs to be treated and monitored to prevent severe complications. This case demonstrates esophageal structuring and resultant esophageal perforation, in the setting of chronic mucocutaneous candidiasis. Learning Points • Chronic mucocutaneous candidiasis (CMC) can be present without overt esophageal thrush • CMC can result in esophageal lesions causing significant morbidity. • APECED patients with dysphagia should be assessed for chronic candida esophagitis and treated accordingly. • Patients with recurrent candida esophagitis should be considered for intermittent topical and systemic antifungal prophylactic therapy. • Esophageal perforation due to candidiasis is most often seen in the setting of immunocompromised states. Background Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED) is a rare autosomal recessive disease caused by mutations of the AIRE (autoimmune regulator) genes [1, 2, 6, 7]. It is characterized by the clinical trial of chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, and adrenal insufficiency [7]. APECED has been reported worldwide, but is more prevalent in some historically- isolated homogeneous populations in Finland (1/25000), Sardinia, and Iranian Jews (1/9000) [7]. APECED is also seen at a lower incidence in Norway, Sweden, Slovenia, Great Britain, Italy, Ireland, and North America [7]. Most patients have CMC from early childhood [2, 3]. Rarely, untreated esophageal candidiasis may lead to complications such as esophageal stricture, rupture and or fistula formation [4, 5].","PeriodicalId":73731,"journal":{"name":"Journal of endocrinology and diabetes","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49659894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Journal of endocrinology and diabetes
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