评价含西布曲明药物对食源性肥胖患者的减肥效果和安全性

T. Demidova, M. Y. Izmailova, S. E. Ushakova, K. Zaslavskaya, A. Odegova, V. V. Popova, M. E. Nevretdinova, A. Verbovoy, P. A. Bely
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引用次数: 0

摘要

本文介绍西布曲明联合二甲双胍(固定联合)与西布曲明联合微晶纤维素治疗食源性肥胖患者的疗效和安全性的临床研究结果。目的是评价西布曲明+二甲双胍固定剂量联合治疗(Reduxin®Forte)的疗效和安全性,并将其与西布曲明+微晶纤维素联合治疗(Reduxin®)在食性肥胖患者的肥胖治疗过程中进行比较。材料和方法。年龄18 ~ 65岁,伴有食源性肥胖,符合和不符合纳入标准的患者240例,按1:1的比例随机分为两组。第一组(n=120)给予西布曲明+二甲双胍口服1片(850 mg + 10 mg),每天1次;第二组(n=120)给予西布曲明+微晶纤维素(MCC)口服1粒(10 mg + 158.5 mg),每天早晨1次。在第30±1天,在与第一次就诊相比体重没有减轻2 kg的情况下,按照医疗指示增加剂量。治疗期为180 d。随机化列表采用随机数出厂法生成。通过人体测量、临床和实验室参数及SF-36问卷评估疗效和安全性。分析6个月内体重下降5%以上的患者比例、体重、体质指数、腰围、臀围的变化幅度和动态、比例、血脂、血压的变化,以及不良事件的总次数、发生频率和性质。这两种药物在肥胖治疗的所有参数中都显示出疗效。同时,在一项比较分析中,西布曲明+二甲双胍治疗在体重减轻超过5%的患者比例(体重动态)方面具有统计学上显著的优势。在身体质量指数(BMI)的变化幅度方面显示出显著的益处;从统计数据来看,从一种BMI类型切换到另一种BMI类型的患者比例显著增加。到研究结束时,绝大多数患者不再符合“肥胖”的诊断标准。在降低甘油三酯和低密度脂蛋白水平方面,西布曲明+二甲双胍在统计学上也有显著的益处。西布曲明+二甲双胍的安全性参数分析证实了该药的高安全性,对不良事件的存在、严重程度、与治疗的因果关系和结局的比较统计分析未发现组间差异。不良事件是短暂的,不需要停止治疗。研究结果表明,用Reduxin®和Reduxin®Forte治疗可显著降低体重。然而,使用固定组合对血脂和患者生活质量具有更有效的积极作用,这与高安全性相结合,证明了使用Reduxin®Forte治疗肥胖和恢复代谢健康的可能性和方便性,即使在没有额外碳水化合物代谢紊乱的患者中也是如此。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
EVALUATION OF WEIGHT REDUCTION EFFICACY AND SAFETY OF SIBUTRAMIN-CONTAINING DRUGS IN PATIENTS WITH ALIMENTARY OBESITY
The article presents clinical study results of the efficacy and safety of combination therapy with sibutramine and metformin (fixed combination) in comparison with sibutramine therapy with microcrystalline cellulose in patients with alimentary obesity.The aim is to evaluate the efficacy and safety of using the sibutramine+metformin fixed dose combination (Reduxin® Forte) and compare it with the sibutramine + microcrystalline cellulose combination (Reduxin®) in patients with alimentary obesity in the course of the obesity therapy.Materials and methods. Male and female patients (240 people) aged 18 to 65 years inclusive with alimentary obesity, meeting the inclusion criteria and not meeting the non-inclusion criteria, were randomized into 2 groups in a 1:1 ratio. One group (n=120) received sibutramine+ metformin p. o., 1 tablet (850 mg + 10 mg) once per day, the second group (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days. The randomization list was generated by the factory method of random numbers. The efficacy and safety were assessed by anthropometric, clinical and laboratory parameters and the SF-36 questionnaire. The proportion of patients who achieved a decrease in body weight by more than 5% in 6 months, the magnitude and dynamics of changes in body weight and body mass index, waist and hip measurements, their ratios, changes in lipid profile, blood pressure, as well as the total number of adverse events, their frequency and nature of occurrence were analyzed.Results. The both drugs have demonstrated efficacy in all parameters of the obesity therapy. At the same time, in a comparative analysis, a statistically significant advantage of therapy with sibutramine + metformin was demonstrated in relation to the proportion of patients who had achieved more than 5% weight loss (body weight dynamics). Significant benefits were shown in terms of the magnitude of the change in body mass index (BMI); there was a statistically significant increase in the proportion of the patients who had switched from one category of BMI to another. By the end of the study, the vast majority of patients had no longer met the criteria for the diagnosis of “Obesity”. There was also a statistically significant benefit of sibutramine + metformin in terms of lowering triglycerides and low-density lipoprotein levels. The analysis of the safety parameters of sibutramine + metformin confirms a high safety profile of the drug, a comparative statistical analysis of adverse events in terms of their presence, severity, causal relationship with therapy and outcome have not revealed intergroup differences. Adverse events were transient and did not require discontinuation of therapy.Conclusion. The results of the study showed that therapy with Reduxin® and Reduxin® Forte provides a pronounced decrease in body weight. However, the use of a fixed combination has a more effective positive effect on the lipid profile and patients’ quality of life, which, combined with a high safety profile, proves the possibility and expediency of using Reduxin® Forte for the treatment of obesity and restoring metabolic health, even in patients without additional carbohydrate metabolism disorders.
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