二甲双胍与Canthex™治疗黑棘皮病患者的有效性和安全性：一项随机双盲对照试验
Effectiveness and Safety of Metformin versus Canthex™ in Patients with Acanthosis Nigricans: A Randomized, Double-blind Controlled Trial.
作者信息
Sett Arindam, Pradhan Samiksha, Sancheti Karan, Basu Dibyendu, Datta Adrija, Biswas Lekha, Das Sayan, Pal Subhasis Kumar, Gupta Nidhi, Sil Amrita, Das Nilay Kanti
机构信息
Department of Dermatology, Medical College and Hospital, Kolkata, West Bengal, India.
Department of Biochemistry, Medical College and Hospital, Kolkata, West Bengal, India.
出版信息
Indian J Dermatol. 2019 Mar-Apr;64(2):115-121. doi: 10.4103/ijd.IJD_417_17.
BACKGROUND
Acanthosis nigricans has been associated with conditions of insulin resistance such as obesity, polycystic ovary syndrome, and type 2 diabetes. Metformin and alpha-lipoic acid, two types of insulin-sensitizing agents, have been demonstrated to reduce insulin levels and improve insulin sensitivity. Alpha-lipoic acid is available as a fixed-dose combination with biotin, calcium pantothenate, and zinc sulfate as Canthex™.
AIMS
This study aimed to compare the effectiveness, safety, and improvement of the insulin resistance profile of Canthex™ and metformin in acanthosis nigricans.
MATERIALS AND METHODS
In this double-blind, randomized (1:1), active-controlled trial (CTRI/2017/02/007880), participants received either metformin 500 mg BD or Canthex™ BD for 12 weeks. Effectiveness parameters were improvement of severity of neck lesions and neck texture. Serum fasting insulin level, glucose, lipids, body weight, waist circumference, body mass index (BMI), and homeostatic model assessment-insulin resistance (HOMA-IR) were also assessed at baseline and at the end of the study. Adverse effects and changes in routine laboratory parameters were taken as safety parameters.
RESULTS
Thirty-three patients were analyzed by modified-intention-to-treat criteria. Severity of neck lesions and texture were comparable at baseline and it showed significant reduction (<0.001) in both the treatment arms from the first follow-up onward. No intergroup variation was observed in any of the follow-ups. There was reduction in the values of fasting insulin, blood sugar, total cholesterol, and thyroid-stimulating hormone in both the groups. Weight, BMI, and waist circumference and BMI reduced significantly in both the groups. HOMA-IR decreased significantly in metformin group (<0.001).
CONCLUSION
Canthex™ is as effective and safe as metformin in the management of acanthosis nigricans and associated features of insulin resistance.
背景
黑棘皮病与胰岛素抵抗状况有关，如肥胖、多囊卵巢综合征和2型糖尿病。二甲双胍和α-硫辛酸这两种胰岛素增敏剂已被证明可降低胰岛素水平并提高胰岛素敏感性。α-硫辛酸可与生物素、泛酸钙和硫酸锌以固定剂量组合的形式作为Canthex™使用。
目的
本研究旨在比较Canthex™和二甲双胍治疗黑棘皮病的有效性、安全性以及胰岛素抵抗状况的改善情况。
材料与方法
在这项双盲、随机（1:1）、活性对照试验（CTRI/2017/02/007880）中，参与者接受二甲双胍500毫克每日两次或Canthex™每日两次，为期12周。有效性参数为颈部病变严重程度和颈部质地的改善情况。还在基线和研究结束时评估了空腹血清胰岛素水平、血糖、血脂、体重、腰围、体重指数（BMI）和稳态模型评估胰岛素抵抗（HOMA-IR）。不良反应和常规实验室参数的变化作为安全性参数。
结果
33例患者按改良意向性治疗标准进行分析。颈部病变严重程度和质地在基线时相当，从第一次随访开始，两个治疗组均显示出显著降低（<0.001）。在任何一次随访中均未观察到组间差异。两组的空腹胰岛素、血糖、总胆固醇和促甲状腺激素值均有所降低。两组的体重、BMI和腰围以及BMI均显著降低。二甲双胍组的HOMA-IR显著降低（<0.001）。
结论
在治疗黑棘皮病及相关胰岛素抵抗特征方面，Canthex™与二甲双胍一样有效且安全。
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