Hu Shanshan, Su Xiaorong, Fan Guorong
Department of Clinical Pharmacy, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200080, China.
Department of Pharmacy, Xiamen Maternal and Child Health Hospital, Xiamen, 361003, China.
Diabetol Metab Syndr. 2023 Oct 28;15(1):218. doi: 10.1186/s13098-023-01195-7.
To update and assess the efficacy and tolerability of once weekly subcutaneous semaglutide in patients with type 2 diabetes (T2D).
PubMed, Science Direct, Cochrane Library, Clinical trial, Springer, OVID, China National Knowledge Infrastructure (CNKI), WanFang Data and China Science and Technology Journal Database (VIP) were searched from inception to January 18, 2023. Randomized controlled trials (RCTs) comparing subcutaneous semaglutide with placebo or any other antidiabetic agent in adults with T2D were eligible. The risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CIs) were determined to synthesize the results.
A total of 17 trials enrolling 14,940 T2D patients were included. For efficacy, compared with placebo, semaglutide exhibited beneficial effects on glycosylated hemoglobin A1c (HbA1c) control [MD -0.97%, 95% CI (-1.33, -0.62), I = 91%; MD -1.36%, 95% CI (-1.59, -1.13), I = 84%, semaglutide 0.5 and 1.0 mg, respectively], body weight reduction, blood pressure control. At the same time, subcutaneous semaglutide 0.5 and 1 mg reduced HbA by 0.56% (95% CI 0.32 to 0.80) and 0.63% (95% CI 0.35 to 0.91) compared to other glucose-lowering agents. For tolerability, semaglutide did not increase the incidence of adverse events (AEs) and serious adverse events (SAEs), severe or blood glucose (BG) confirmed hypoglycaemia, acute pancreatitis and diabetic retinopathy compared to placebo or active comparators, but did increase the risk of nausea, diarrhea and vomiting.
Semaglutide has a better effect on glycaemic control and weight loss than other therapies. Nevertheless, semaglutide was associated with increased incidence of gastrointestinal-related disorders. Further large, multicenter randomized controlled clinical trials are still needed to obtain more robust evidence to better guide clinical treatment decisions.
更新并评估每周一次皮下注射司美格鲁肽治疗2型糖尿病（T2D）患者的疗效和耐受性。
检索了PubMed、Science Direct、Cochrane图书馆、临床试验、Springer、OVID、中国知网（CNKI）、万方数据和中国科技期刊数据库（维普），检索时间从建库至2023年1月18日。纳入比较皮下注射司美格鲁肽与安慰剂或任何其他抗糖尿病药物治疗成年T2D患者的随机对照试验（RCT）。计算风险比（RR）和平均差（MD）以及95%置信区间（CI）以综合结果。
共纳入17项试验，涉及14940例T2D患者。在疗效方面，与安慰剂相比，司美格鲁肽对糖化血红蛋白A1c（HbA1c）控制[MD -0.97%，95%CI（-1.33，-0.62），I² = 91%；MD -1.36%，95%CI（-1.59，-1.13），I² = 84%，分别为司美格鲁肽0.5和1.0mg]、体重减轻、血压控制均有有益作用。同时，与其他降糖药物相比，皮下注射司美格鲁肽0.5mg和1mg可使HbA降低0.56%（95%CI 0.32至0.80）和0.63%（95%CI 0.35至0.91）。在耐受性方面，与安慰剂或活性对照相比，司美格鲁肽未增加不良事件（AE）和严重不良事件（SAE）、严重或经血糖（BG）确认的低血糖、急性胰腺炎和糖尿病视网膜病变的发生率，但确实增加了恶心、腹泻和呕吐的风险。
司美格鲁肽在血糖控制和体重减轻方面比其他疗法效果更好。然而，司美格鲁肽与胃肠道相关疾病发生率增加有关。仍需要进一步开展大规模、多中心随机对照临床试验以获得更有力的证据，从而更好地指导临床治疗决策。
