Padwal R, Li S K, Lau D C W
Division of Internal Medicine, University of Alberta Hospital, 2E3. Walter C Mackenzie Health Sciences Centre, Edmonton, AB, Canada.
Int J Obes Relat Metab Disord. 2003 Dec;27(12):1437-46. doi: 10.1038/sj.ijo.0802475.
Safe and effective strategies to curb rising obesity prevalence rates are urgently needed and medications may play a more prominent role in future therapeutic regimens.
To review systematically the long-term efficacy and safety of approved antiobesity medications.
MEDLINE, EMBASE, the Cochrane Controlled Trials Register, Current Science Meta-register of Controlled Trials, and reference lists of original studies and reviews were searched. Drug manufacturers and two obesity experts were contacted. No language restrictions were imposed.
Double-blind, randomized controlled studies of approved antiobesity medications with follow-up periods of 1 y or greater were eligible for inclusion.
Two reviewers independently assessed all potentially relevant studies for inclusion and methodological quality using standardized abstraction forms.
A total of 11orlistat (n=6021) and three sibutramine (n=929) studies met inclusion criteria. Attrition rates averaged 33% in orlistat studies and 48% in sibutramine studies. A random effects model was used for meta-analysis. Compared to placebo, orlistat-treated patients displayed a 2.7 kg (95% CI: 2.3-3.1 kg) or 2.9% (95% CI: 2.3-3.4%) greater reduction in weight and patients on sibutramine displayed a 4.3 kg (95% CI: 3.6-4.9 kg) or 4.6% (95% CI: 3.8-5.4%) greater weight reduction after 1 y of follow-up. The number of patients achieving 10% or greater weight loss was 12% (95% CI: 8-16%) higher with orlistat and 15% (95% CI: 4-27%) higher with sibutramine compared to placebo. Orlistat caused gastrointestinal side effects and sibutramine increased blood pressure and pulse rate.
There is a relative paucity of long-term studies of antiobesity agents. In weight loss trials of 1-y duration, orlistat and sibutramine appear modestly effective in promoting weight loss. Longer, more methodologically rigorous studies that are powered to examine end points such as mortality and cardiovascular morbidity are required.
迫切需要安全有效的策略来遏制不断上升的肥胖患病率，药物可能在未来的治疗方案中发挥更突出的作用。
系统回顾已批准的抗肥胖药物的长期疗效和安全性。
检索了MEDLINE、EMBASE、Cochrane对照试验注册库、当前科学对照试验元注册库以及原始研究和综述的参考文献列表。联系了药品制造商和两名肥胖专家。未设语言限制。
符合纳入标准的为对已批准的抗肥胖药物进行的随访期为1年或更长时间的双盲、随机对照研究。
两名评价者使用标准化的提取表格独立评估所有可能相关的研究，以确定其是否纳入及方法学质量。
共有11项奥利司他研究（n = 6021）和3项西布曲明研究（n = 929）符合纳入标准。奥利司他研究的失访率平均为33%，西布曲明研究为48%。采用随机效应模型进行荟萃分析。与安慰剂相比，接受奥利司他治疗的患者体重减轻更多，1年后体重减轻2.7 kg（95%CI：2.3 - 3.1 kg）或2.9%（95%CI：2.3 - 3.4%）；接受西布曲明治疗的患者体重减轻4.3 kg（95%CI：3.6 - 4.9 kg）或4.6%（95%CI：3.8 - 5.4%）。与安慰剂相比，体重减轻达到或超过10%的患者人数，使用奥利司他的高出12%（95%CI：8 - 16%），使用西布曲明的高出15%（95%CI：4 - 27%）。奥利司他会引起胃肠道副作用，西布曲明会升高血压和脉搏率。
抗肥胖药物的长期研究相对较少。在为期1年的减肥试验中，奥利司他和西布曲明在促进体重减轻方面似乎有一定效果。需要进行更长期、方法学上更严谨且有足够效力来检验死亡率和心血管发病率等终点的研究。
