PDF(Pubmed)
Abstract：
UNASSIGNED: Comprehensive evaluation of lisedexamfetamine dimesylate (LDX) alone and in combination with topiramate (TPM) was done for treatment of binge eating disorder (BED) in adults aged 18-55 years.
UNASSIGNED: In the present randomized clinical trial study, 93 patients were selected by convenience sampling method and were allocated to two groups of 48 and 45 using the permuted block randomization method. This study was conducted from January to September 2022 in Shiraz, Iran. Patients received LDX (n = 48) or LDX plus TPM. Average dose of LDX was 37.5 mg/day and 38 mg/day in the first and second group respectively. The second group (n = 45) also received TPM with average dose of 77.7 mg/day.
UNASSIGNED: Twelve weeks treatment caused significant higher mean reduction in level of triglyceride (73.68 vs. 58.97 respectively, p = 0.024), low density lipo-protein (LDL) (9.66 vs. 5.16 respectively, p < 0.001) and body mass index (5.48 vs. 3.41 respectively, p < 0.001) with TPM plus LDX and also greater significant improvement (p < 0.001) in binge eating scale compared to use of LDX alone. Combination therapy with TPM and LDX had better tolerability and lower adverse events such as insomnia (p < 0.001), paresthesia (p = 0.001), confusion (p = 0.035) and ataxia (p = 0.009) compared to monotherapy in BED.
UNASSIGNED: The combinative treatment was more effective than single drug in terms of higher tolerability, safety and causing lesser adverse events for BED patients. However, more studies with larger samples are needed.
UNASSIGNED: In the present randomized clinical trial study, 93 patients were selected by convenience sampling method and were allocated to two groups of 48 and 45 using the permuted block randomization method. This study was conducted from January to September 2022 in Shiraz, Iran. Patients received LDX (n = 48) or LDX plus TPM. Average dose of LDX was 37.5 mg/day and 38 mg/day in the first and second group respectively. The second group (n = 45) also received TPM with average dose of 77.7 mg/day.
UNASSIGNED: Twelve weeks treatment caused significant higher mean reduction in level of triglyceride (73.68 vs. 58.97 respectively, p = 0.024), low density lipo-protein (LDL) (9.66 vs. 5.16 respectively, p < 0.001) and body mass index (5.48 vs. 3.41 respectively, p < 0.001) with TPM plus LDX and also greater significant improvement (p < 0.001) in binge eating scale compared to use of LDX alone. Combination therapy with TPM and LDX had better tolerability and lower adverse events such as insomnia (p < 0.001), paresthesia (p = 0.001), confusion (p = 0.035) and ataxia (p = 0.009) compared to monotherapy in BED.
UNASSIGNED: The combinative treatment was more effective than single drug in terms of higher tolerability, safety and causing lesser adverse events for BED patients. However, more studies with larger samples are needed.
摘要：
■对18-55岁成人的暴食症（BED）进行了单药和与托吡酯（TPM）联合治疗的综合评估。
■在本随机临床试验研究中，采用便利抽样法选择93例患者，采用置换区组随机化法分为48和45例两组。这项研究于2022年1月至9月在设拉子进行，伊朗。患者接受LDX（n=48）或LDX加TPM。在第一组和第二组中,LDX的平均剂量分别为37.5mg/天和38mg/天。第二组(n=45)也接受平均剂量为77.7mg/天的TPM。
■12周的治疗导致甘油三酯水平的平均降低（73.68vs.分别为58.97，p=0.024),低密度脂蛋白（LDL）（9.66vs.5.16分别p<0.001）和体重指数（5.48vs.3.41分别p<0.001），TPM加LDX，与单独使用LDX相比，暴饮暴食规模的显着改善（p<0.001）。TPM和LDX联合治疗具有更好的耐受性和更低的不良事件，如失眠（p<0.001），感觉异常（p=0.001），与单药治疗相比，BED中的混乱（p=0.035）和共济失调（p=0.009）。
■在更高的耐受性方面，联合治疗比单一药物更有效，安全性和对BED患者造成的不良事件较少。然而,需要更大样本的更多研究。
■在本随机临床试验研究中，采用便利抽样法选择93例患者，采用置换区组随机化法分为48和45例两组。这项研究于2022年1月至9月在设拉子进行，伊朗。患者接受LDX（n=48）或LDX加TPM。在第一组和第二组中,LDX的平均剂量分别为37.5mg/天和38mg/天。第二组(n=45)也接受平均剂量为77.7mg/天的TPM。
■12周的治疗导致甘油三酯水平的平均降低（73.68vs.分别为58.97，p=0.024),低密度脂蛋白（LDL）（9.66vs.5.16分别p<0.001）和体重指数（5.48vs.3.41分别p<0.001），TPM加LDX，与单独使用LDX相比，暴饮暴食规模的显着改善（p<0.001）。TPM和LDX联合治疗具有更好的耐受性和更低的不良事件，如失眠（p<0.001），感觉异常（p=0.001），与单药治疗相比，BED中的混乱（p=0.035）和共济失调（p=0.009）。
■在更高的耐受性方面，联合治疗比单一药物更有效，安全性和对BED患者造成的不良事件较少。然而,需要更大样本的更多研究。
