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A Rare Case of Pulmonary Neuroendocrine Carcinoma in Transfusion-dependent Thalassemia Patient: Clinical Presentation, Management, and Implications. 输血依赖型地中海贫血患者肺神经内分泌癌的罕见病例:临床表现、处理和意义。
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Lia Sasmithae, Amaylia Oehadian, Dimmy Prasetya

Transfusion-dependent thalassemia (TDT) is often accompanied by complications related to iron overload and the development of malignant solid tumors or hematological malignancies. The occurrence of Neuroendocrine carcinoma, specifically in the respiratory tract, is very rare, with a prevalence of approximately 25%. Therefore, this study presented a case of a 42-year-old male with a beta-thalassemia major at 28 years, complaining of shortness of breath. This case was reported due to its rarity in providing information about solid tumors in thalassemia patients. The physical examination revealed several symptoms, including tachycardia, tachypnea, anemia, icteric sclera, elevated jugular venous pressure, coarse wet Ronchi in the medial to basal areas of both lungs, hepatomegaly, and splenomegaly (Schuffner 4). The patient regularly received blood transfusions and iron chelation therapy. A thoracic CT scan showed a lung mass and a biopsy of the mass revealed Pulmonary Neuroendocrine Carcinoma with high-grade proliferation and, large cell type. The patient also passed through cisplatin-etoposide chemotherapy for 6 cycles every 21 days. There is almost no data on pulmonary neuroendocrine carcinoma in thalassemia patients, so it is hoped that this case report can provide information about malignant solid tumors that can occur in thalassemia patients.

输血依赖性地中海贫血(TDT)通常伴有与铁超载有关的并发症,以及恶性实体瘤或血液恶性肿瘤的发展。神经内分泌癌,尤其是呼吸道神经内分泌癌的发病率约为 25%,非常罕见。因此,本研究报告了一例 42 岁男性患者的病例,他患有重型β地中海贫血症 28 年,主诉呼吸急促。报告此病例的原因是其罕见性,可为地中海贫血患者提供有关实体瘤的信息。体格检查发现了一些症状,包括心动过速、呼吸过速、贫血、巩膜褪色、颈静脉压升高、双肺内侧至基底区有粗大的湿性 Ronchi、肝脏肿大和脾脏肿大(Schuffner 4)。患者定期接受输血和螯合铁治疗。胸部 CT 扫描显示有肺部肿块,肿块活检显示为肺神经内分泌癌,呈高分化增殖和大细胞型。患者还接受了顺铂-依托泊苷化疗,6 个周期,每 21 天一次。有关地中海贫血患者肺神经内分泌癌的资料几乎为零,希望本病例报告能为地中海贫血患者提供有关恶性实体瘤的信息。
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引用次数: 0
Updating AFP Level in Chronic Hepatitis B to Evaluate the Risk of Hepatocellular Carcinoma Occurrence. 更新慢性乙型肝炎患者甲胎蛋白水平以评估肝细胞癌发生风险
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Juferdy Kurniawan, Jane Andrea Christiano Djianzonie, Edi Mulyana, Dicky Levenus Tahapary, Andri Sanityoso Sulaiman, Ika Prasetya Wijaya, Sally Aman Nasution, Siti Setiati

Background: Hepatocellular carcinoma (HCC) is a cancer with poor prognosis. Indonesia is a country with high prevalence of chronic hepatitis B infection. The performance of alpha fetoprotein (AFP) as a tumor marker in HCC surveillance is primarily influenced by the etiology of the underlying liver disease. We aimed to determine the best cut-off value of AFP biomarker examination for HCC surveillance in patients with chronic hepatitis B infection.

Methods: The study collected medical record data of the Hepatobiliary Division of Dr. Cipto Mangunkusumo Hospital from the period of 2017 to 2023. A total of 506 subjects with chronic hepatitis B of all spectrums (hepatitis B without cirrhosis, liver cirrhosis, and early-stage HCC, BCLC 0 and A) were included by total sampling that was performed from 26 July 2023 to 31 August 2023. Determination of the AFP cut-off value was carried out using the receiver operating characteristics (ROC) method.  Results: For HCC surveillance caused by hepatitis B virus, ROC curve analysis resulted in an area under the curve (AUC) of 0.792 (95% CI, 0.719-0.866), and the cut-off value with the highest Youden index was 8.7 ng/ml, with 58% sensitivity, 94% specificity, positive predictive value (PPV)  56.14%, negative predictive value (NPV) 94.43%, positive likelihood ratio (LR+) 10.08, and negative likelihood ratio (LR-) 0.46.

Conclusion: The cut-off value of AFP in HCC surveillance on hepatitis B specific etiology is lower than the cut-off value of AFP in previous HCC surveillance which was not etiologically specific. The cut-off value of 8.7 ng/ml produces the best sensitivity and specificity for the cut-off value for HCC surveillance with hepatitis B etiology.

背景:肝细胞癌(HCC)是一种预后不良的癌症:肝细胞癌(HCC)是一种预后不良的癌症。印度尼西亚是一个慢性乙型肝炎感染率很高的国家。甲胎蛋白(AFP)作为监测 HCC 的肿瘤标志物,其性能主要受基础肝病病因的影响。我们旨在确定甲胎蛋白生物标志物检查的最佳临界值,以监测慢性乙型肝炎感染患者的 HCC:研究收集了 Cipto Mangunkusumo 医生医院肝胆科 2017 年至 2023 年的病历数据。通过从2023年7月26日至2023年8月31日进行的总抽样,共纳入了506名所有谱系的慢性乙型肝炎受试者(无肝硬化乙型肝炎、肝硬化和早期HCC,BCLC 0和A)。采用接收者操作特征(ROC)法确定 AFP 临界值。 结果对于乙肝病毒引起的 HCC 监测,ROC 曲线分析得出的曲线下面积(AUC)为 0.792(95% CI,0.719-0.866),Youden 指数最高的临界值为 8.7纳克/毫升,敏感性为58%,特异性为94%,阳性预测值(PPV)为56.14%,阴性预测值(NPV)为94.43%,阳性似然比(LR+)为10.08,阴性似然比(LR-)为0.46:在对乙型肝炎特异性病因的 HCC 监测中,甲胎蛋白的临界值低于以往不具有病因特异性的 HCC 监测中甲胎蛋白的临界值。8.7 纳克/毫升的临界值对乙肝病因的 HCC 监测具有最佳的灵敏度和特异性。
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引用次数: 0
COVID-19 Infection in Adrenal Tuberculosis Patients with Adrenal Insufficiency Who Complicated with Adrenal Crisis. 肾上腺功能不全并发肾上腺危象的肾上腺结核病人的 COVID-19 感染。
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Matdoan Rifkiah Aisyah, Ira Camelia Fitri, Ardhi Rahman Ahani, Syahidatul Wafa

Adrenal insufficiency can increase the risk of infection. Respiratory infections play a role in the greater number of mortalities in patients with primary adrenal insufficiency. Severe acute illness elevates the risk of adrenal crisis which can give lethal outcome.A 52-year-old woman came to the emergency unit due to worsening gastrointestinal symptoms for the past 3 days. She had chronic epigastric pain, general weakness, weight loss, and skin hyperpigmentation. She was suspected of primary adrenal insufficiency one year ago, but she had poor compliance. In this current admission, she was suspected to have adrenal crisis and was diagnosed with COVID-19. On the 5th day of inpatient care, her condition was worsening, and she was diagnosed with adrenal crisis, septic shock, and severe COVID-19. Her ACTH level was 78.6 pg/mL (normal range 7.4-64.3 pg/mL) and her morning cortisol level was 1.1 ug/dL (normal range 3.7-19.4). Imaging showed unilateral hypertrophy of the adrenal gland, a positive result of IGRA, and fibrotic of the lung that led to tuberculosis of the adrenal as suspected etiology.Making a diagnosis of adrenal insufficiency is challenging because of its non-specific signs and symptoms. The need for education, equipment (adequate steroid supplies), and empowerment (development of specific guidelines for PAI and COVID-19) were taught to help prevent the adrenal crisis. Further examination is needed to obtain the definitive etiology of adrenal insufficiency in this patient.

肾上腺功能不全会增加感染的风险。呼吸道感染是原发性肾上腺功能不全患者死亡人数较多的原因之一。一名 52 岁的妇女因过去 3 天胃肠道症状恶化而来到急诊室。她患有慢性上腹痛、全身乏力、体重减轻和皮肤色素沉着。一年前,她被怀疑患有原发性肾上腺功能不全,但她的依从性很差。这次入院时,她被怀疑患有肾上腺危象,并被诊断为 COVID-19。住院治疗的第五天,她的病情恶化,被诊断为肾上腺危象、脓毒性休克和严重的 COVID-19。她的促肾上腺皮质激素水平为 78.6 pg/mL(正常范围为 7.4-64.3 pg/mL),晨间皮质醇水平为 1.1 ug/dL(正常范围为 3.7-19.4)。影像学检查显示单侧肾上腺肥大,IGRA呈阳性,肺部纤维化,怀疑病因是肾上腺结核。为帮助预防肾上腺危象,需要进行教育、配备设备(充足的类固醇供应)和增强能力(制定 PAI 和 COVID-19 的具体指南)。要明确该患者肾上腺功能不全的病因,还需要进一步检查。
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引用次数: 0
Exploring the Potential Treatment for Mpox. 探索麻风病的潜在治疗方法。
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Kevin Kevin, Robert Sinto, Leonard Nainggolan, Adeline Pasaribu, Sharifah Shakinah, Khie Chen Lie

Monkeypox (Mpox) is a virus that originally infected only animals. Caused by the monkeypox virus, this infection presents with symptoms similar to smallpox. Although two years have passed since the 2022 outbreak, new cases continue to emerge monthly. Initially, human cases of mpox were confined to outbreaks in central and western Africa. However, the virus has recently spread globally, possibly due to a decline in vaccination rates. In this context, evidence for effective therapies, such as antivirals, is urgently needed. Three antivirals-tecovirimat, brincidofovir, and cidofovir-are known to have activity against the mpox virus. Their use is currently limited to expanded access for treating non-variola orthopoxvirus infections, with ongoing phase 3 trials. This review will discuss the mechanisms of action, clinical use, and efficacy of these antivirals.

猴痘(Mpox)是一种最初只感染动物的病毒。这种由猴痘病毒引起的感染表现出类似天花的症状。尽管自 2022 年爆发以来已经过去了两年,但每月仍有新病例出现。最初,人类感染天花的病例仅限于在非洲中部和西部爆发。然而,可能由于疫苗接种率下降,该病毒最近在全球范围内蔓延。在这种情况下,迫切需要有效疗法的证据,如抗病毒药物。目前已知有三种抗病毒药物--替考韦利马特(tecovirimat)、布林昔多韦(brincidofovir)和西多福韦(cidofovir)对麻风腮病毒有抑制作用。目前,这些药物的使用仅限于治疗非华沙正杆状病毒感染的扩大使用范围,第三阶段试验正在进行中。本综述将讨论这些抗病毒药物的作用机制、临床应用和疗效。
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引用次数: 0
Efficacy of Hyaluronic Acid in Radiation Proctitis: A Case Series. 透明质酸对放射性直肠炎的疗效:病例系列。
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Marcellus Simadibrata, Saskia Aziza Nursyirwan, Rabbinu Rangga Pribadi, Angelica Abigael, Lidya Tanjaya

Gastrointestinal toxicities of radiation might develop after exposure, thus leading to conditions such as abdominal pain, rectal bleeding, diarrhea, anemia, and weight loss. The development of drugs to reduce mucosal damage progression has been a focus on managing radiation proctitis. Radiation proctitis resulting from exposure to pelvic radiotherapies is effectively managed with topical administration on the anal mucosa. The clinical use of hyaluronic acid offers an innovative approach to managing radiation injury. Hyaluronic acid has multiple beneficial properties, such as regulating immune process to reduce inflammation and oxidative stress, supporting natural protective mechanism, promoting mucosa healing, and improving tissue hydration. Therefore, this case series introduces the idea that application of hyaluronic acid could potentially improve patients' clinical conditions.

辐射的胃肠道毒性可能会在照射后出现,从而导致腹痛、直肠出血、腹泻、贫血和体重减轻等症状。开发减少粘膜损伤进展的药物一直是治疗放射性直肠炎的重点。盆腔放疗导致的放射性直肠炎可通过肛门粘膜局部用药得到有效控制。透明质酸的临床应用为治疗放射性损伤提供了一种创新方法。透明质酸具有多种有益特性,如调节免疫过程以减少炎症和氧化应激、支持天然保护机制、促进粘膜愈合和改善组织水合作用。因此,本系列病例介绍了应用透明质酸有可能改善患者临床状况的观点。
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引用次数: 0
Hypertonic Dextrose Prolotherapy Injection in Grade IV Knee Osteoarthritis with Obesity: A Case Report. 高渗葡萄糖局部注射治疗 IV 级膝关节骨关节炎合并肥胖症:病例报告。
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Juwita Raudlatul Salsabil, Rita Vivera Pane, Hasan Hasan, Aufar Zimamuz Zaman Al Hajiri

The main complaint in knee osteoarthritis (KOA) is knee pain and limited range of motion (ROM) which affects the patient's quality of life. Dextrose prolotherapy successfully reduced pain and enhanced functional status and quality of life in chronic knee pain, which is classified as KOA grade II or III by the Kellgren-Lawrence classification. We present a case of grade IV KOA with co-morbid obesity who refused surgical management but got dextrose prolotherapy instead. She received prolotherapy for the right knee 5 times with a gap of 4 weeks between treatments. Western Ontario and McMaster Universities Osteoarthritis (WOMAC score), Numerical Rating Scale (NRS), knee ROM, Barthel index, count test, and Timed Up and Go Test (TUG) were evaluated 1 day after each treatment and compared to each post-injection score. This patient is also comorbid of grade II obesity which is associated with mechanical loads on the knee joint causing inflammation and progression of KOA. After 5 months of prolotherapy treatment, strengthened quadricep muscle exercising and static cycle endurance exercising, she improved her pain, WOMAC score, and cardiorespiratory function. Hypertonic dextrose prolotherapy (HDP) is one of the choices for interventional therapy of its advantages, inexpensive, easily conducted, safe with minimal or even no recorded complications, and long-term efficacy even for grade IV of KOA like this patient.

膝关节骨性关节炎(KOA)的主要症状是膝关节疼痛和活动范围(ROM)受限,这会影响患者的生活质量。根据 Kellgren-Lawrence 分级法,KOA 分为 II 级或 III 级,葡萄糖增生疗法可成功减轻慢性膝关节疼痛,改善功能状态,提高生活质量。我们介绍了一例 IV 级 KOA 患者,她同时患有肥胖症,但拒绝接受手术治疗,而是接受了葡萄糖增生疗法。她的右膝接受了 5 次增生疗法,每次治疗间隔 4 周。每次治疗后 1 天对西安大略和麦克马斯特大学骨关节炎(WOMAC)评分、数值评定量表(NRS)、膝关节活动度、巴特尔指数、计数测试和定时起立行走测试(TUG)进行评估,并与每次注射后的评分进行比较。该患者还合并有二级肥胖症,这与膝关节的机械负荷有关,会导致炎症和 KOA 的恶化。经过 5 个月的增韧疗法治疗、加强股四头肌锻炼和静态循环耐力锻炼后,她的疼痛、WOMAC 评分和心肺功能都得到了改善。高渗葡萄糖增生疗法(HDP)具有成本低廉、易于操作、安全、并发症少甚至无并发症记录、长期疗效好等优点,是介入治疗的选择之一,即使是像该患者这样的 IV 级 KOA 患者也不例外。
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引用次数: 0
Factors Associated with Psychosomatic Disorders Among Systemic Lupus Erythematosus (SLE) Patients During the Coronavirus Disease 2019 (COVID-19) Pandemic. 2019年冠状病毒疾病(COVID-19)大流行期间系统性红斑狼疮(SLE)患者的心身疾病相关因素。
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Dina Elita, Alvina Widhani, Hamzah Shatri, Ikhwan Rinaldi, Rudy Hidayat, Teguh Harjono Karjadi, Rudi Putranto, Chyntia Olivia Maurine Jasirwan, Siti Setiati

Background:  The COVID-19 pandemic has affected physical and mental health. SLE patients are prone to psychosomatic disorders which can decrease their quality of life. This study aimed to determine the factors associated with psychosomatic disorders among SLE patients during the COVID-19 pandemic. Methods: This was a cross-sectional study of adult female SLE patients from the outpatient clinic of Cipto Mangunkusumo Hospital, Jakarta. Data regarding psychosomatic disorders were collected using SCL-90 questionnaires, and data on demographic factors, perception of COVID-19 conditions, perception of stress, psychosocial stressors, disease activity (MEX-SLEDAI), and treatment were also collected. Bivariate analysis for categorical data was conducted using the Chi-square test. Variables with a p-value <0.25 were further analyzed with logistic regression, and p-values <0.05 were considered significant. Meanwhile, data per domain were analyzed using the Mann-Whitney test with p-values < 0.05 being considered significant. Results: There were 200 female SLE patients recruited. More than half of the subjects (54%) experienced psychosomatic disorders. From multivariate analysis, high educational levels, moderate and high psychosocial stressors, and very severe disease activity levels were found to be significantly associated with the occurrence of psychosomatic disorders in SLE patients during the COVID-19 pandemic.

Conclusion: Education level, psychosocial stressors, and disease activity level were found to be significantly associated with the occurrence of psychosomatic disorders in SLE patients during the COVID-19 pandemic.

背景: COVID-19 大流行影响了患者的身心健康。系统性红斑狼疮患者很容易出现心身障碍,从而降低他们的生活质量。本研究旨在确定 COVID-19 大流行期间系统性红斑狼疮患者的心身疾病相关因素。研究方法这是一项横断面研究,研究对象是雅加达 Cipto Mangunkusumo 医院门诊部的成年女性系统性红斑狼疮患者。使用 SCL-90 问卷收集了有关心身疾病的数据,还收集了有关人口统计学因素、对 COVID-19 病情的感知、对压力的感知、心理社会压力源、疾病活动(MEX-SLEDAI)和治疗的数据。采用卡方检验对分类数据进行二元分析。变量的 p 值 结论研究发现,在 COVID-19 大流行期间,教育水平、社会心理压力和疾病活动水平与系统性红斑狼疮患者心身疾病的发生有显著相关性。
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引用次数: 0
Comparison of CISNE and MASCC Score in Predicting Complications on Post Chemotherapy Febrile Neutropenia. CISNE 和 MASCC 评分在预测化疗后发热性中性粒细胞减少症并发症方面的比较
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Sharifah Shakinah, Erni Juwita Nelwan, Anna Mira Lubis, Robert Sinto, Khie Chen Lie

Background: Febrile neutropenia (FN) is an oncologic emergency which commonly occurrs in patients who undergo chemotherapy, with a mortality rate of 12.5%. Risk stratification in FN plays an important role in increasing the accuracy of therapy. This study aims to compare the performance between CISNE score and MASCC score in predicting complications on post-chemotherapy FN in solid and hematologic malignancy.  Methods: This is a retrospective cohort study on FN patients undergoing inpatient treatment at Cipto Mangunkusumo Hospital between July 2015 and December 2019. Basic demographic and clinical data were collected from medical records. Subjects were grouped based on the CISNE and MASCC score, and complications during hospitalization were recorded. Predictive performance of each score was analyzed and compared using area of under curve.  Results: CISNE score showed a better performance both in solid malignancy with AUC of CISNE score (0.80 CI 95% 0.73-0.88, p = 0.00) compared to AUC of MASCC score (0.68; 95% CI 0.59 - 0,78, p = 0.00) and in hematologic malignancy with AUC of CISNE score (0.85; 95% CI 0.77 - 0.93, p = 0.00) and AUC MASCC score (0.65 ; 95% CI 0.54 - 0.76, p = 0.007).

Conclusion: CISNE score showed a better performance compared to MASCC score in predicting in-hospital complication in both solid and hematologic malignancy with cut-off point of 2.

背景:发热性中性粒细胞减少症(FN发热性中性粒细胞减少症(FN)是一种肿瘤急症,通常发生在接受化疗的患者身上,死亡率高达 12.5%。对 FN 进行风险分层对提高治疗的准确性起着重要作用。本研究旨在比较 CISNE 评分和 MASCC 评分在预测实体瘤和血液系统恶性肿瘤化疗后 FN 并发症方面的表现。 方法:这是一项回顾性队列研究,研究对象为2015年7月至2019年12月期间在Cipto Mangunkusumo医院接受住院治疗的FN患者。从病历中收集基本人口统计学和临床数据。根据 CISNE 和 MASCC 评分对受试者进行分组,并记录住院期间的并发症。使用曲线下面积对每个评分的预测性能进行分析和比较。 结果显示与 MASCC 评分的 AUC(0.68;95% CI 0.在血液恶性肿瘤中,CISNE评分的AUC(0.85;95% CI 0.77 - 0.93,p = 0.00)与MASCC评分的AUC(0.65;95% CI 0.54 - 0.76,p = 0.007)相比:结论:CISNE评分与MASCC评分相比,在预测实体瘤和血液系统恶性肿瘤的院内并发症方面表现更佳,其临界点为2。
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引用次数: 0
Successfull Treatment of Plantar Fasciitis with Perineural Dextrose Injection. 硬膜外注射葡萄糖成功治疗足底筋膜炎
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Guntur Darmawan, Alif Noeriyanto Rahman, Laniyati Hamijoyo

A 62-year-old active career woman came to the clinic with a chief complaint of left heel pain for 7 months without numbness. She had previously sought consultation at several clinics and was prescribed oral nonsteroidal anti-inflammatory and opioid analgesic drugs with no improvement in symptoms. She was offered plantar corticosteroid injection therapy but refused due to fear of corticosteroid's possible side effects. She had a medical history of dyslipidemia and no other comorbid diseases. She was obese with a body mass index of 27.3 kg/m2. There was tenderness at the plantar medial calcaneal tuberosity, rated as 7/10 on the pain scale. Tinel tests were negative on both feet. Musculoskeletal ultrasound examination demonstrated a 7.7 mm thickness of left plantar fascia. In comparison, her right plantar fascia thickness was 2.8 mm. Three milliliters of dextrose 5% were injected perineural to the tibial nerve, posteriorly to the left medial malleolus. The patient reported a significant reduction of pain to 3. The second session of perineural dextrose injection was performed after one week, resulting in a pain severity reduction to 1. The patient was also advised to consult a dietician for weight loss management and avoid barefoot walking. No study yet compares the efficacy between conventional corticosteroid injection and perineural dextrose injection in treating plantar fasciitis.

一位 62 岁的职业女性前来就诊,主诉左足跟痛 7 个月,无麻木感。她曾在多家诊所就诊,医生给她开了口服非甾体类抗炎药和阿片类镇痛药,但症状没有改善。医生为她提供了足底皮质类固醇注射治疗,但她因害怕皮质类固醇可能产生的副作用而拒绝了。她有血脂异常病史,无其他合并症。她身体肥胖,体重指数为 27.3 kg/m2。足底内侧小方结节处有压痛,疼痛评分为 7/10。双脚的Tinel测试均为阴性。肌肉骨骼超声波检查显示,左脚足底筋膜厚度为 7.7 毫米。相比之下,她的右足底筋膜厚度为 2.8 毫米。在左脚内侧踝骨后方的胫神经周围注射了三毫升 5%葡萄糖。一周后进行了第二次硬膜外葡萄糖注射,疼痛严重程度减轻到 1。目前还没有研究对传统皮质类固醇注射和硬膜外葡萄糖注射治疗足底筋膜炎的疗效进行比较。
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引用次数: 0
Effectiveness and Safety of DLBS3233 in Newly Diagnosed Type 2 Diabetes Mellitus: A 12-week Clinical Trial. DLBS3233 对新诊断 2 型糖尿病的有效性和安全性:为期 12 周的临床试验
IF 0.7 Q3 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-07-01
Heri Nugroho, Nurmilawati Nurmilawati, Diana Novitasari, Lidia Rombeallo, Rambu Farah Effendi, Reski Reski, Intan Surayya, Nugroho Agung Daryanto, Solomon Putera, Raymond Rubianto Tjandrawinata

Background: DLBS3233, recognized as an agent enhancing insulin sensitivity, has exhibited promise as a therapeutic option for addressing type 2 diabetes mellitus (T2DM). This study aimed to evaluate the effectiveness and safety of DLBS3233, a natural compound, in individuals newly diagnosed with T2DM.

Methods: A 12-week double-blind, randomized, placebo-controlled clinical trial was conducted with 104 eligible participants. They were assigned to receive DLBS3233 or a placebo along with lifestyle modifications. Various metabolic parameters, including fasting and post-meal plasma glucose levels at two hours, fasting insulin level, HOMA-IR, adiponectin level, lipid profile, superoxide dismutase (SOD) activity, GLUT-4 concentrations, and body weight measurements, were assessed at baseline, Week 6, and Week 12. Safety parameters assessment will include vital signs, liver function, renal function and adverse event.

Results: Participants exhibited similar demographic characteristics in both groups. While no significant changes were noted in fasting plasma glucose and most other parameters, the DLBS3233 group significantly reduced 2-hour postprandial glucose at Week 12 (p = 0.026). There were no substantial differences in A1c levels, fasting insulin, insulin resistance, adiponectin levels, or lipid profiles between the two groups at any point in time. Safety parameters, including blood pressure, liver enzymes, heart rate, gamma GT, and serum creatinine, remained comparable between the groups.

Conclusion: DLBS3233 showed potential for improving postprandial glucose control in newly diagnosed T2DM individuals. Although significant changes were limited, the study suggests that DLBS3233 could enhance glycemic regulation. The safety evaluation indicated no adverse effects on vital parameters. Further research with larger samples and more prolonged duration is warranted to comprehensively explore DLBS3233's potential in T2DM management.

背景:DLBS3233被认为是一种提高胰岛素敏感性的药物,有望成为治疗2型糖尿病(T2DM)的一种选择。本研究旨在评估天然化合物 DLBS3233 对新诊断出的 T2DM 患者的有效性和安全性:方法:对 104 名符合条件的参与者进行了为期 12 周的双盲、随机、安慰剂对照临床试验。他们被分配接受 DLBS3233 或安慰剂以及生活方式的调整。在基线、第6周和第12周评估各种代谢参数,包括空腹和餐后两小时血浆葡萄糖水平、空腹胰岛素水平、HOMA-IR、脂肪连素水平、血脂概况、超氧化物歧化酶(SOD)活性、GLUT-4浓度和体重测量值。安全参数评估包括生命体征、肝功能、肾功能和不良事件:结果:两组参与者的人口统计学特征相似。虽然空腹血浆葡萄糖和大多数其他参数没有明显变化,但 DLBS3233 组在第 12 周显著降低了餐后 2 小时血糖(p = 0.026)。在任何时间点,两组之间的 A1c 水平、空腹胰岛素、胰岛素抵抗、脂肪连接蛋白水平或血脂概况均无实质性差异。安全性参数,包括血压、肝酶、心率、伽马GT和血清肌酐,在两组之间仍具有可比性:DLBS3233显示出改善新诊断T2DM患者餐后血糖控制的潜力。结论:DLBS3233 显示出改善新诊断 T2DM 患者餐后血糖控制的潜力,虽然明显变化有限,但研究表明 DLBS3233 可增强血糖调节。安全性评估表明,该药物对生命参数没有不良影响。为了全面探索 DLBS3233 在 T2DM 管理中的潜力,有必要对更大的样本和更长的持续时间进行进一步研究。
{"title":"Effectiveness and Safety of DLBS3233 in Newly Diagnosed Type 2 Diabetes Mellitus: A 12-week Clinical Trial.","authors":"Heri Nugroho, Nurmilawati Nurmilawati, Diana Novitasari, Lidia Rombeallo, Rambu Farah Effendi, Reski Reski, Intan Surayya, Nugroho Agung Daryanto, Solomon Putera, Raymond Rubianto Tjandrawinata","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>DLBS3233, recognized as an agent enhancing insulin sensitivity, has exhibited promise as a therapeutic option for addressing type 2 diabetes mellitus (T2DM). This study aimed to evaluate the effectiveness and safety of DLBS3233, a natural compound, in individuals newly diagnosed with T2DM.</p><p><strong>Methods: </strong>A 12-week double-blind, randomized, placebo-controlled clinical trial was conducted with 104 eligible participants. They were assigned to receive DLBS3233 or a placebo along with lifestyle modifications. Various metabolic parameters, including fasting and post-meal plasma glucose levels at two hours, fasting insulin level, HOMA-IR, adiponectin level, lipid profile, superoxide dismutase (SOD) activity, GLUT-4 concentrations, and body weight measurements, were assessed at baseline, Week 6, and Week 12. Safety parameters assessment will include vital signs, liver function, renal function and adverse event.</p><p><strong>Results: </strong>Participants exhibited similar demographic characteristics in both groups. While no significant changes were noted in fasting plasma glucose and most other parameters, the DLBS3233 group significantly reduced 2-hour postprandial glucose at Week 12 (p = 0.026). There were no substantial differences in A1c levels, fasting insulin, insulin resistance, adiponectin levels, or lipid profiles between the two groups at any point in time. Safety parameters, including blood pressure, liver enzymes, heart rate, gamma GT, and serum creatinine, remained comparable between the groups.</p><p><strong>Conclusion: </strong>DLBS3233 showed potential for improving postprandial glucose control in newly diagnosed T2DM individuals. Although significant changes were limited, the study suggests that DLBS3233 could enhance glycemic regulation. The safety evaluation indicated no adverse effects on vital parameters. Further research with larger samples and more prolonged duration is warranted to comprehensively explore DLBS3233's potential in T2DM management.</p>","PeriodicalId":6889,"journal":{"name":"Acta medica Indonesiana","volume":"56 3","pages":"291-301"},"PeriodicalIF":0.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142492660","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}
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Acta medica Indonesiana
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