索格列净治疗2型糖尿病疗效和安全性的meta分析

doi:10.3969/j.issn.1004-583X.2024.07.001

摘要/Abstract

摘要：

目的分析评估索格列净治疗2型糖尿病患者的疗效和安全性。方法检索 PubMed、Embase、Web of Science、Medline、Cochrane Library、美国临床试验注册平台、CNKI、万方、维普、SinoMed等数据库,检索时间为建库起至2023年10月31日,收集有关索格列净与安慰剂(或其他口服降糖药)对照治疗2型糖尿病的随机对照试验(RCT),提取文献有效数据及质量评价后,应用RevMan 5.3软件进行meta分析。结果共纳入14篇RCT,共计16959例患者。Meta分析结果显示:疗效方面,与对照组相比,索格列净能显著降低糖尿病患者糖化血红蛋白[MD=-0.45,95%CI(-0.58,-0.33),P<0.01]、空腹血糖[MD=-0.66,95%CI(-1.01,-0.31),P=0.0002] 和餐后2 h血糖[MD=-1.01,95%CI(-1.58,-0.44),P=0.0005]、提高糖化血红蛋白<7%达标率[RR=1.88,95%CI(1.64,2.15),P<0.01];与对照组相比索格列净可降低收缩压[MD=-2.13,95%CI(-2.81,-1.45),P<0.01]和体质量[MD=-1.40,95%CI(-1.63,-1.17),P<0.01];但在降低舒张压方面差异无统计学意义。安全性方面,索格列净组与对照组低血糖事件发生率相似[RR=1.00,95%CI(0.92,1.09),P=0.97];但索格列净组不良反应发生率更低[RR=0.92,95%CI(0.88,0.96),P<0.01]。按照索格列净使用剂量不同进行亚组分析显示,与对照组相比,索格列净200 mg和400 mg组均可显著降低患者的糖化血红蛋白、空腹血糖水平,提高糖化血红蛋白<7%达标率,降低收缩压、体质量等指标(P<0.05);且均未增加低血糖事件风险(P>0.05)。结论索格列净可显著降低2型糖尿病患者的糖化血红蛋白、空腹血糖、餐后2 h血糖、收缩压和体质量,同时不增加低血糖风险以及不良反应发生率。

关键词: 糖尿病,2型, 索格列净, Meta分析, 疗效, 安全性

Abstract:

Objective To evaluate the efficacy and safety of sotagliflozin in the treatment of type 2 diabetes mellitus (T2DM). Methods Randomized controlled trials (RCTs) involving sotagliflozin versus placebo (or other oral hypoglycemic agents) in the treatment of T2DM pulished before October 31, 2023 were retrieved in PubMed, Embase, Web of science, Medline, Cochrane Library, the North American Clinical Trial Register, CNKI, Wanfang, VIP, SinoMed and other databases. The extracted Valid data were performed for quality evaluation, and a meta-analysis was conducted using RevMan 5.3 software. Results Fourteen RCTs representing 16, 959 patients were included. The results of meta-analysis showed: In terms of efficacy, compared with the control group, sotagliflozin group presented significantly decreased glycated hemoglobin (HbA₁c, MD=-0.45, 95%CI[-0.58, -0.33]; P<0.01) and fasting blood glucose (FBG, MD=-0.66, 95%CI[-1.01, -0.31]; P=0.0002) and 2-h postprandial glucose (2hPG, MD=-1.01, 95%CI[-1.58, -0.44]; P=0.0005), and improved compliance rate of HbA₁c <7% (RR=1.88, 95%CI[1.64, 2.15], P<0.01). Compared with control group, sotagliflozin group had decreased systolic blood pressure (SBP, MD=-2.13, 95%CI[-2.81, -1.45], P<0.01) and body mass (BM, MD=-1.40, 95%CI[-1.63, -1.17], P<0.01), but there was no statistical significance in reducing diastolic blood pressure (DBP). In terms of safety, the incidence of hypoglycemic events was similar between the sotagliflozin group and the control group (RR=1.00, 95%CI[0.92, 1.09], P=0.97). However, the incidence of adverse reactions was significantly lower in sotagliflozin group (RR=0.92, 95%CI [0.88, 0.96], P<0.01). Subgroup analysis according to different doses of sotagliflozin showed that compared with the control group, sotagliflozin 200 mg and 400 mg groups could significantly reduce the HbA₁c and FBG, improve the compliance rate of HbA₁c<7%, and reduce SBP, BM and other indexes (P<0.05), and without increasing the risk of hypoglycemia events (P>0.05). Conclusion Sotagliflozin can significantly reduce HbA₁c, FBG, 2hPG, SBP, and BM in T2DM patients without increasing the risk of hypoglycemia or the incidence of adverse reactions.

Key words: diabetes mellitus, type 2, sotagliflozin, meta-analysis, efficacy, safety

中图分类号:

R587.1

岳江红, 王恒, 蔡钢, 张选明, 彭曦. 索格列净治疗2型糖尿病疗效和安全性的meta分析[J]. 临床荟萃, 2024, 39(7): 581-592.

Yue Jianghong, Wang Heng, Cai Gang, Zhang Xuanming, Peng Xi. Efficacy and safety of sotagliflozin in the treatment of type 2 diabetes mellitus: A meta-analysis[J]. Clinical Focus, 2024, 39(7): 581-592.

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链接本文: https://huicui.hebmu.edu.cn/CN/10.3969/j.issn.1004-583X.2024.07.001

https://huicui.hebmu.edu.cn/CN/Y2024/V39/I7/581

图/表 17

参考文献 37

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第一作者及发表年限	组别	例数	年龄 (岁)	女性比例 (%)	HbA₁c(%)	干预措施	研究周期	结局指标
NCT03315143 Bhatt 2021^[13] SCORED	试验组对照组	5292 5292	69(63~74) 69(63~74)	44.3 45.5	≥7	索格列净400 mg qd 安慰剂	64	⑨
NCT03521934 Bhatt 2021^[14] SOLOIST-WHF	试验组对照组	608 614	69(63~76) 70(64~76)	32.6 34.9	7.1(6.4~8.3) 7.2(6.4~8.2)	索格列净400 mg qd 安慰剂	36	⑨
NCT03242018 Cherney 2021^[15]	试验组	92	66.8±10.0	52.2	8.3±1.0	索格列净200 mg qd
		92	67.3±9.6	46.7	8.3±0.9	索格列净400 mg qd	52	①、②、④、⑤、⑦、⑧、⑨
	对照组	93	68.0±8.3	54.8	8.4±1.1	安慰剂
NCT03242252 Cherney 2023^[16]	试验组	263	69.6±7.5	45.6	8.3±0.9	索格列净200 mg qd
		264	69.5±8.2	42.4	8.3±0.9	索格列净400 mg qd	52	①、②、④、⑤、⑦、⑧、⑨
	对照组	260	69.3±8.1	42.7	8.3±1.0	安慰剂
NCT03462069 Posch 2022^[17]	试验组对照组	20 21	61.0±8.4 64.8±8.53	20.0 81.0	6.5-11	索格列净400 mg qd 恩格列净200 mg qd	8	⑧、⑨
NCT01555008 Zambrowicz 2015^[18]	试验组对照组	16 15	64.8±8.53 68.1±7.33	50.0 40.0	不清楚不清楚	索格列净400 mg qd 安慰剂	1	⑤、⑥、⑧、⑨
NCT01376557 Rosenstock 2014^[19]	试验组	59	56± 9.61	42.4	8.0±0.9	索格列净75 mg qd
		60	55.6±9.25	71.7	8.3±1.0	索格列净200 mg qd
		60	56.1±9.51	51.7	8.1±1.0	索格列净400 mg qd	12	①、②、④、⑤、⑥、⑦、⑨
		60	56.4±8.76	51.7	8.4±0.9	索格列净200 mg bid
	对照组	60	55.1±9.79	56.7	7.9±0.9	安慰剂
NCT02926937^[20]	试验组	107	52.3±11.4	49.5	8.00±0.81	索格列净200 mg qd
		142	54.7±11.2	47.9	8.14±0.92	索格列净400 mg qd	26	①、②、③、④、⑤、⑦、⑧、⑨
	对照组	150	55.3±11.2	48.0	8.11±0.88	安慰剂
NCT02926950^[21]	试验组对照组	259 259	60.0±10.1 59.9±9.4	45.2 43.6	8.20±0.78 8.20±0.78	索格列净400 mg qd 安慰剂	26	①、②、③、④、⑤、⑦、⑧、⑨
NCT03351478 SOTA-EMPA^[22]	试验组	307	58.9±9.7	45.9	8.23±0.84	索格列净400 mg qd
		309	59.7±9.6	51.1	8.21±0.93	恩格列净25 mg qd	26	①、②、③、④、⑤、⑦、⑨
	对照组	154	59.8±9.6	48.7	8.21±0.93	安慰剂
NCT03285594 SOTA-INS^[23]	试验组	141	62.1±10.2	46.1	8.76±0.83	索格列净200 mg qd
		286	62.7±9.1	46.2	8.69±0.80	索格列净400 mg qd	52	①、②、⑤、⑦、⑧、⑨
	对照组	144	62.2±8.9	40.3	8.76±0.79	安慰剂
NCT03066830^[24]	试验组对照组	253 254	63.3±8.8 63.0±9.9	41.1 48.8	8.20±0.83 8.18±0.83	索格列净400 mg qd 安慰剂	26	①、②、④、⑤、⑦、⑧、⑨
NCT03332771 SOTA-GLIM^[25]	试验组	160	58.6±9.9	46.9	8.11±0.86	索格列净200 mg qd
		317	59.7±10.4	49.5	8.09±0.78	索格列净400 mg qd	52	①、④、⑦、⑧、⑨
	对照组	159	58.8±11.2	48.4	8.12±0.73	安慰剂
NCT03386344 SOTA-BONE^[26]	试验组	125	66.1±6.7	44.8	8.32±0.96	索格列净200 mg qd
		125	66.5±6.9	44.0	8.32±0.95	索格列净400 mg qd	26	①、②、④、⑤、⑦、⑧、⑨
	对照组	126	66.3±5.7	44.4	8.38±0.91	安慰剂

第一作者及发表年限	组别	例数	年龄 (岁)	女性比例 (%)	HbA₁c(%)	干预措施	研究周期	结局指标
NCT03315143 Bhatt 2021^[13] SCORED	试验组对照组	5292 5292	69(63~74) 69(63~74)	44.3 45.5	≥7	索格列净400 mg qd 安慰剂	64	⑨
NCT03521934 Bhatt 2021^[14] SOLOIST-WHF	试验组对照组	608 614	69(63~76) 70(64~76)	32.6 34.9	7.1(6.4~8.3) 7.2(6.4~8.2)	索格列净400 mg qd 安慰剂	36	⑨
NCT03242018 Cherney 2021^[15]	试验组	92	66.8±10.0	52.2	8.3±1.0	索格列净200 mg qd
		92	67.3±9.6	46.7	8.3±0.9	索格列净400 mg qd	52	①、②、④、⑤、⑦、⑧、⑨
	对照组	93	68.0±8.3	54.8	8.4±1.1	安慰剂
NCT03242252 Cherney 2023^[16]	试验组	263	69.6±7.5	45.6	8.3±0.9	索格列净200 mg qd
		264	69.5±8.2	42.4	8.3±0.9	索格列净400 mg qd	52	①、②、④、⑤、⑦、⑧、⑨
	对照组	260	69.3±8.1	42.7	8.3±1.0	安慰剂
NCT03462069 Posch 2022^[17]	试验组对照组	20 21	61.0±8.4 64.8±8.53	20.0 81.0	6.5-11	索格列净400 mg qd 恩格列净200 mg qd	8	⑧、⑨
NCT01555008 Zambrowicz 2015^[18]	试验组对照组	16 15	64.8±8.53 68.1±7.33	50.0 40.0	不清楚不清楚	索格列净400 mg qd 安慰剂	1	⑤、⑥、⑧、⑨
NCT01376557 Rosenstock 2014^[19]	试验组	59	56± 9.61	42.4	8.0±0.9	索格列净75 mg qd
		60	55.6±9.25	71.7	8.3±1.0	索格列净200 mg qd
		60	56.1±9.51	51.7	8.1±1.0	索格列净400 mg qd	12	①、②、④、⑤、⑥、⑦、⑨
		60	56.4±8.76	51.7	8.4±0.9	索格列净200 mg bid
	对照组	60	55.1±9.79	56.7	7.9±0.9	安慰剂
NCT02926937^[20]	试验组	107	52.3±11.4	49.5	8.00±0.81	索格列净200 mg qd
		142	54.7±11.2	47.9	8.14±0.92	索格列净400 mg qd	26	①、②、③、④、⑤、⑦、⑧、⑨
	对照组	150	55.3±11.2	48.0	8.11±0.88	安慰剂
NCT02926950^[21]	试验组对照组	259 259	60.0±10.1 59.9±9.4	45.2 43.6	8.20±0.78 8.20±0.78	索格列净400 mg qd 安慰剂	26	①、②、③、④、⑤、⑦、⑧、⑨
NCT03351478 SOTA-EMPA^[22]	试验组	307	58.9±9.7	45.9	8.23±0.84	索格列净400 mg qd
		309	59.7±9.6	51.1	8.21±0.93	恩格列净25 mg qd	26	①、②、③、④、⑤、⑦、⑨
	对照组	154	59.8±9.6	48.7	8.21±0.93	安慰剂
NCT03285594 SOTA-INS^[23]	试验组	141	62.1±10.2	46.1	8.76±0.83	索格列净200 mg qd
		286	62.7±9.1	46.2	8.69±0.80	索格列净400 mg qd	52	①、②、⑤、⑦、⑧、⑨
	对照组	144	62.2±8.9	40.3	8.76±0.79	安慰剂
NCT03066830^[24]	试验组对照组	253 254	63.3±8.8 63.0±9.9	41.1 48.8	8.20±0.83 8.18±0.83	索格列净400 mg qd 安慰剂	26	①、②、④、⑤、⑦、⑧、⑨
NCT03332771 SOTA-GLIM^[25]	试验组	160	58.6±9.9	46.9	8.11±0.86	索格列净200 mg qd
		317	59.7±10.4	49.5	8.09±0.78	索格列净400 mg qd	52	①、④、⑦、⑧、⑨
	对照组	159	58.8±11.2	48.4	8.12±0.73	安慰剂
NCT03386344 SOTA-BONE^[26]	试验组	125	66.1±6.7	44.8	8.32±0.96	索格列净200 mg qd
		125	66.5±6.9	44.0	8.32±0.95	索格列净400 mg qd	26	①、②、④、⑤、⑦、⑧、⑨
	对照组	126	66.3±5.7	44.4	8.38±0.91	安慰剂

结局指标	随机效应模型			固定效应模型				去除权重大的研究				去除权重小的研究
结局指标	MD/RR(95%CI)	P值		MD/RR(95%CI)		P值		MD/RR(95%CI)		P值		MD/RR(95%CI)	P值
HbA₁c水平	-0.45[-0.58,-0.33]	<0.01	-0.43[-0.44,-0.42]		<0.01		-0.50[-0.60,-0.41]		<0.01		-0.44[-0.56,-0.31]		<0.01
低血糖事件发生率	1.00[0.92,1.08]	0.94	1.00[0.92,1.09]		0.97		1.00[0.90,1.11]		0.98		1.00[0.92,1.10]		0.93

结局指标	随机效应模型			固定效应模型				去除权重大的研究				去除权重小的研究
结局指标	MD/RR(95%CI)	P值		MD/RR(95%CI)		P值		MD/RR(95%CI)		P值		MD/RR(95%CI)	P值
HbA₁c水平	-0.45[-0.58,-0.33]	<0.01	-0.43[-0.44,-0.42]		<0.01		-0.50[-0.60,-0.41]		<0.01		-0.44[-0.56,-0.31]		<0.01
低血糖事件发生率	1.00[0.92,1.08]	0.94	1.00[0.92,1.09]		0.97		1.00[0.90,1.11]		0.98		1.00[0.92,1.10]		0.93