Joshi Shashank R, Das Saibal, Xaviar Suja, Samajdar Shambo Samrat, Saha Indranil, Sarkar Sougata, Mukherjee Shatavisa, Tripathi Santanu Kumar, Pal Jyotirmoy, Chatterjee Nandini
Joshi Clinic, Mumbai, India.
Indian Council of Medical Research - Centre for Ageing and Mental Health, Kolkata, India; Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.
Diabetes Metab Syndr. 2023 Jan;17(1):102703. doi: 10.1016/j.dsx.2022.102703. Epub 2023 Jan 2.
This systematic review and meta-analysis was conducted to evaluate the efficacy and safety of lobeglitazone as compared to the standard of care (SOC) in patients with type 2 diabetes mellitus (T2DM).
Databases were searched for relevant randomized controlled trials. The primary outcome was the comparison of the glycated hemoglobin (HbA1C) level after 24 weeks. Pooled mean differences and odds ratios were calculated using random-effects models.
Of 267 studies that were screened, four were included. Treatment with adjunct lobeglitazone showed a reduction in the HbA1C level [mean difference: -0.23% (95% CI: -0.62 to 0.16); p = 0.24; i: 87%; moderate GRADE (Grading of Recommendations Assessment, Development and. Evaluation) of evidence], fasting blood glucose level [mean difference: -7.12 mg/dl (95% CI: -20.09 to 5.85); p = 0.28; i: 87%; moderate GRADE of evidence], and lipid profile as compared to those following treatment with the SOC; however, the changes were not statistically significant. The risk of hypoglycemia was significantly lower [odds ratio: 0.24 (95% CI: 0.08 to 0.70); p < 0.05; i: 0%; moderate GRADE of evidence] without any significant difference in the risk of drug-related adverse events [odds ratio: 1.59 (95% CI: 0.87 to 2.93); p = 0.13; i: 0%; moderate GRADE of evidence] following treatment with lobeglitazone as compared to those following treatment with the SOC.
Treatment with adjunct lobeglitazone showed changes in the blood glycemic status and lipid profile similar to SOC in patients with T2DM, and the results were not statistically significant. Lobeglitazone was well tolerated; its safety profile was comparable to SOC.
进行此项系统评价和荟萃分析，以评估与标准治疗（SOC）相比，洛格列酮治疗2型糖尿病（T2DM）患者的疗效和安全性。
检索数据库以查找相关随机对照试验。主要结局是比较24周后的糖化血红蛋白（HbA1C）水平。使用随机效应模型计算合并平均差和比值比。
在筛选的267项研究中，纳入了4项。与SOC治疗后的患者相比，联合使用洛格列酮治疗使HbA1C水平降低[平均差：-0.23%（95%CI：-0.62至0.16）；p = 0.24；I²：87%；证据质量为中等推荐分级（GRADE）]、空腹血糖水平降低[平均差：-7.12mg/dl（95%CI：-20.09至5.85）；p = 0.28；I²：87%；证据质量为中等GRADE]，且血脂谱有变化；然而，这些变化无统计学意义。低血糖风险显著降低[比值比：0.24（95%CI：0.08至0.70）；p < 0.05；I²：0%；证据质量为中等GRADE]，与SOC治疗后的患者相比，洛格列酮治疗后药物相关不良事件风险无显著差异[比值比：1.59（95%CI：0.87至2.93）；p = 0.13；I²：0%；证据质量为中等GRADE]。
联合使用洛格列酮治疗T2DM患者时，血糖状态和血脂谱变化与SOC相似，结果无统计学意义。洛格列酮耐受性良好；其安全性与SOC相当。
