诺美亭®在中国肥胖症受试者的疗效及安全性分析(5)
血压同样是一种与肥胖症密切相关的疾病[12]。本研究的肥胖症受试者在体重下降后,治疗组和对照组的收缩压和舒张压均比治疗前低,但与之比较,二者均未达到显著性差异(p>0.05)。本结果与Sunge[13]等结果一致,这也说明诺美亭®对受试者的血压没有不良的影响。但是Sunger报告诺美亭®治疗组的脉搏增快,本研究中糖尿病肥胖亚组诺美亭®治疗后的心率变化明显高于对照组(p=0.018),这与已知的诺美亭®引起交感神经张力增高的作用一致。
除了高血压、高脂血症、高血糖以外,胰岛素抵抗是肥胖症各种代谢紊乱的基础,同时也是心血管疾病的主要危险因素之一。空腹高胰岛素血症是胰岛素抵抗的间接指标[14],本研究中共有23名受试者的空腹血胰岛素浓度大于23.0mu/l。经过24周治疗后,可看出治疗组胰岛素水平下降,而对照组则升高,由此可以看出诺美亭®可能有降低肥胖症伴高胰岛素血症受试者空腹血胰岛素水平的趋势,但因为此亚组治疗人数有限,故未得到统计学差异。肥胖伴高尿酸血症受试者仅13例,故未进行统计学分析,这有待于在未来的扩展试验中进一步研究。
, 百拇医药
七 结论
本项临床试验研究证实,诺美亭®用于肥胖症(伴或不伴有高血糖、高血脂、高胰岛素血症)受试者可达到临床上有治疗意义的体重减轻和腰围缩小,同时有助于血糖的改善。诺美亭®的治疗有较好的耐受性和安全性,可用于肥胖症患者及减轻危险因素的减重治疗。
参考文献
1. Ge.L.Body mass Index in Young Chinese adults. Asia Pacific J clin Nutt 1997;6(3): 175-179
2. Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obese Relat Metab Disord. 1992; 16:397-415
, http://www.100md.com
3. Williamson D. International weight loss. Int J Obes Relat Metab Disord. 1997 ;21 (Suppl 1 ):S14-S19
4. Thomas PR, ed. Weighing the options criteria for evaluating weightmanagement programs. Washington DC: National Academy Press;1995
5. National Task Force on the Prevention and Treatment of Obesity. Longterm pharmacotherapy in the management of obesity
6. Weiser M, Frishman WH. The Pharmacologic approach to treatment of obesity. J clin pharmco1 1997;37(6):453-473
, http://www.100md.com
7. Cheatham SC, Viggers JA, Butler SA, Prow MR, Heal Dj. [3H] Nisoxetine- a radioligand for noradrenaline reuptake sites: cor-relation with inhibition of [3H] noradrenaline uptake and effect of DSP-4 lesioning and antide pressant treatment. Neurophar-macology 1996;35:63-70
8. Buckett WR, Luscombe GP, Thomas PC, Diggory GL, Browning JG, Hopcroft RH. The pharmacology of sibutramine hydrochlo-ride (BTS 54 524), a new antidepressant which induces rapidnoradrenergic down- regulation. Prog Neuro-Psychopharmacol Biol Psychiat 1998; 12;575-84
9. Fantino M, Martel P, Souquet A-M, Wieteska L, Brondel L, Courcier S. Decrease of food intake and weight loss induced by sibutramine in the rat. 7th international Symposium on Obesity, Satellite Sym-posium on the Pharmacologic Treatment of Obesity 1994;p41, 百拇医药
除了高血压、高脂血症、高血糖以外,胰岛素抵抗是肥胖症各种代谢紊乱的基础,同时也是心血管疾病的主要危险因素之一。空腹高胰岛素血症是胰岛素抵抗的间接指标[14],本研究中共有23名受试者的空腹血胰岛素浓度大于23.0mu/l。经过24周治疗后,可看出治疗组胰岛素水平下降,而对照组则升高,由此可以看出诺美亭®可能有降低肥胖症伴高胰岛素血症受试者空腹血胰岛素水平的趋势,但因为此亚组治疗人数有限,故未得到统计学差异。肥胖伴高尿酸血症受试者仅13例,故未进行统计学分析,这有待于在未来的扩展试验中进一步研究。
, 百拇医药
七 结论
本项临床试验研究证实,诺美亭®用于肥胖症(伴或不伴有高血糖、高血脂、高胰岛素血症)受试者可达到临床上有治疗意义的体重减轻和腰围缩小,同时有助于血糖的改善。诺美亭®的治疗有较好的耐受性和安全性,可用于肥胖症患者及减轻危险因素的减重治疗。
参考文献
1. Ge.L.Body mass Index in Young Chinese adults. Asia Pacific J clin Nutt 1997;6(3): 175-179
2. Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obese Relat Metab Disord. 1992; 16:397-415
, http://www.100md.com
3. Williamson D. International weight loss. Int J Obes Relat Metab Disord. 1997 ;21 (Suppl 1 ):S14-S19
4. Thomas PR, ed. Weighing the options criteria for evaluating weightmanagement programs. Washington DC: National Academy Press;1995
5. National Task Force on the Prevention and Treatment of Obesity. Longterm pharmacotherapy in the management of obesity
6. Weiser M, Frishman WH. The Pharmacologic approach to treatment of obesity. J clin pharmco1 1997;37(6):453-473
, http://www.100md.com
7. Cheatham SC, Viggers JA, Butler SA, Prow MR, Heal Dj. [3H] Nisoxetine- a radioligand for noradrenaline reuptake sites: cor-relation with inhibition of [3H] noradrenaline uptake and effect of DSP-4 lesioning and antide pressant treatment. Neurophar-macology 1996;35:63-70
8. Buckett WR, Luscombe GP, Thomas PC, Diggory GL, Browning JG, Hopcroft RH. The pharmacology of sibutramine hydrochlo-ride (BTS 54 524), a new antidepressant which induces rapidnoradrenergic down- regulation. Prog Neuro-Psychopharmacol Biol Psychiat 1998; 12;575-84
9. Fantino M, Martel P, Souquet A-M, Wieteska L, Brondel L, Courcier S. Decrease of food intake and weight loss induced by sibutramine in the rat. 7th international Symposium on Obesity, Satellite Sym-posium on the Pharmacologic Treatment of Obesity 1994;p41, 百拇医药