Chinese General Practice ›› 2022, Vol. 25 ›› Issue (08): 995-1006.DOI: 10.12114/j.issn.1007-9572.2021.01.046
Special Issue: 高血压最新文章合辑
• Evidence-based Medicine • Previous Articles Next Articles
Efficacy and Safety of Spironolactone in the Treatment of Resistant Hypertension:a Meta-analysis
Department of Basic Medicine,Guizhou Health Vocational College,Tongren 554300,China
*Corresponding author:ZHANG Ping,Lecturer;E-mail:545077638@qq.com
Received:
2021-07-12
Revised:
2021-11-25
Published:
2022-03-15
Online:
2022-03-02
通讯作者:
张平
基金资助:
CLC Number:
ZHANG Ping, ZOU Jing, GAO Cunzhou, WU Aiping, LI Rongshan.
Efficacy and Safety of Spironolactone in the Treatment of Resistant Hypertension:a Meta-analysis [J]. Chinese General Practice, 2022, 25(08): 995-1006.
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URL: https://www.chinagp.net/EN/10.12114/j.issn.1007-9572.2021.01.046
第一作者 | 发表年份 | 国家 | 病例数(T/C) | 研究类型 | 平均年龄(T/C,岁) | 干预措施 | 结局指标 | 随访时间(周) | |
---|---|---|---|---|---|---|---|---|---|
T | C | ||||||||
ABOLGHASMI [ | 2011 | 伊朗 | 19/22 | RCT | (49±13.2)/(50±10.1) | 基础降压治疗+螺内酯25~50 mg/d | 基础降压治疗+安慰剂 | ①⑦⑧ | 12 |
VA'CLAVÍK [ | 2011 | 捷克 | 55/56 | RCT | (61.4±9.6)/(60.1±9.4) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+安慰剂 | ①②③ ④⑦⑧ | 8 |
郭鑫[ | 2012 | 中国 | 57/58 | RCT | (61.8±11.5)/(59.0±11.6) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗 | ②⑥ | 8 |
马彬[ | 2012 | 中国 | 56/56 | RCT | - | 基础降压治疗+螺内酯20~40 mg/d | 基础降压治疗+卡维地洛12.5~50.0 mg/d | ①⑦⑧ | 8 |
张俊松[ | 2012 | 中国 | 58/66 | RCT | (63.4±14.3)/(63.8±13.9) | 基础降压治疗+螺内酯20~40 mg/d | 基础降压治疗+安慰剂 | ①⑦⑧ | 24 |
OXLUND [ | 2013 | 丹麦 | 61/58 | RCT | (62.9±7.1)/(63.9±6.9) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+安慰剂 | ①②③ ④⑥⑦⑧ | 16 |
NI [ | 2014 | 中国 | 40/36 | RCT | (55.7±12.3)/(54.9±14.2) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+安慰剂 | ①②⑦ | 12 |
VA'CLAVÍK [ | 2014 | 捷克 | 74/76 | RCT | (60.4±9.5)/(59.7±9.9) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+安慰剂 | ①②③ ④⑥⑦⑧ | 8 |
WILLIAMS [ | 2015 | 英国 | 285/274 /282/285 | RCT | 61.4±9.6 | 基础降压治疗+螺内酯25~50 mg/d | 基础降压治疗+安慰剂基础降压治疗+多沙唑嗪4~8 mg/d基础降压治疗+比索洛尔5~10 mg/d | ①⑤ | 12 |
盖延红[ | 2015 | 中国 | 73/71 | RCT | 61.5±9.7 | 基础降压治疗+螺内酯40 mg/d | 基础降压治疗+安慰剂 | ①②③④⑥ | 12 |
DJOUMESSI [ | 2016 | 喀麦隆 | 9/8 | RCT | (64.6±9.6)/(61.0±6.6) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+坎地沙坦8 mg/d,阿替洛尔100 mg/d或甲基多巴750 mg/d | ①⑤ | 4 |
OLIVERAS [ | 2016 | 西班牙 | 13/11 | RCT | (64.9±8.2)/(61.9±6.6) | 基础降压治疗+螺内酯25~50 mg/d | 基础降压治疗+肾脏去交感神经术 | ①②③ ④⑥⑦⑧ | 24 |
ROSA [ | 2016 | 捷克 | 50/51 | RCT | (59±9) /(56±12) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+肾脏去交感神经术 | ①②⑦⑧ | 48 |
YANG [ | 2016 | 中国 | 15/15 | RCT | (44.7±10.8) /(43.4±15.2) | 基础降压治疗+螺内酯20~40 mg/d | 基础降压治疗 | ①②③ ④⑦⑧ | 12 |
曾潇[ | 2016 | 中国 | 78/82 | RCT | (60.7±7.7)/(61.0±8.9) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗+安慰剂 | ①⑥⑦⑧ | 12 |
卢旭[ | 2017 | 中国 | 41/38 | RCT | (73.45±5.88) /(71.11±7.15) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗+安慰剂 | ①②③ ④⑦⑧ | 48 |
KRIEGER[ | 2018 | 巴西 | 84/78 | RCT | (54±11.1)/(56.3±9.7) | 基础降压治疗+螺内酯12.5~50.0 mg/d | 基础降压治疗+可乐定0.1~0.3 mg/d | ①②③④⑧ | 12 |
ROSSIGNOL[ | 2018 | 多国 | 191/212 | RCT | 74(65,80) /71(63,78) | 基础降压治疗+螺内酯23 mg/d | 基础降压治疗+安慰剂 | ① | 32 |
杨晶敏[ | 2018 | 中国 | 40/40/40 | RCT | (54.7±10.7)/(54.7±8.5) / (57.9±11.3) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗+比索洛尔5 mg基础降压治疗+特拉唑嗪2 mg/d | ②⑦ | 12 |
黄娟[ | 2020 | 中国 | 45/49 | RCT | (60.4±9.5)/(59.7±9.9) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗+倍他乐克50 mg/d | ① ③④ | 8 |
Table 1 Basic characteristics of included studies
第一作者 | 发表年份 | 国家 | 病例数(T/C) | 研究类型 | 平均年龄(T/C,岁) | 干预措施 | 结局指标 | 随访时间(周) | |
---|---|---|---|---|---|---|---|---|---|
T | C | ||||||||
ABOLGHASMI [ | 2011 | 伊朗 | 19/22 | RCT | (49±13.2)/(50±10.1) | 基础降压治疗+螺内酯25~50 mg/d | 基础降压治疗+安慰剂 | ①⑦⑧ | 12 |
VA'CLAVÍK [ | 2011 | 捷克 | 55/56 | RCT | (61.4±9.6)/(60.1±9.4) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+安慰剂 | ①②③ ④⑦⑧ | 8 |
郭鑫[ | 2012 | 中国 | 57/58 | RCT | (61.8±11.5)/(59.0±11.6) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗 | ②⑥ | 8 |
马彬[ | 2012 | 中国 | 56/56 | RCT | - | 基础降压治疗+螺内酯20~40 mg/d | 基础降压治疗+卡维地洛12.5~50.0 mg/d | ①⑦⑧ | 8 |
张俊松[ | 2012 | 中国 | 58/66 | RCT | (63.4±14.3)/(63.8±13.9) | 基础降压治疗+螺内酯20~40 mg/d | 基础降压治疗+安慰剂 | ①⑦⑧ | 24 |
OXLUND [ | 2013 | 丹麦 | 61/58 | RCT | (62.9±7.1)/(63.9±6.9) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+安慰剂 | ①②③ ④⑥⑦⑧ | 16 |
NI [ | 2014 | 中国 | 40/36 | RCT | (55.7±12.3)/(54.9±14.2) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+安慰剂 | ①②⑦ | 12 |
VA'CLAVÍK [ | 2014 | 捷克 | 74/76 | RCT | (60.4±9.5)/(59.7±9.9) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+安慰剂 | ①②③ ④⑥⑦⑧ | 8 |
WILLIAMS [ | 2015 | 英国 | 285/274 /282/285 | RCT | 61.4±9.6 | 基础降压治疗+螺内酯25~50 mg/d | 基础降压治疗+安慰剂基础降压治疗+多沙唑嗪4~8 mg/d基础降压治疗+比索洛尔5~10 mg/d | ①⑤ | 12 |
盖延红[ | 2015 | 中国 | 73/71 | RCT | 61.5±9.7 | 基础降压治疗+螺内酯40 mg/d | 基础降压治疗+安慰剂 | ①②③④⑥ | 12 |
DJOUMESSI [ | 2016 | 喀麦隆 | 9/8 | RCT | (64.6±9.6)/(61.0±6.6) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+坎地沙坦8 mg/d,阿替洛尔100 mg/d或甲基多巴750 mg/d | ①⑤ | 4 |
OLIVERAS [ | 2016 | 西班牙 | 13/11 | RCT | (64.9±8.2)/(61.9±6.6) | 基础降压治疗+螺内酯25~50 mg/d | 基础降压治疗+肾脏去交感神经术 | ①②③ ④⑥⑦⑧ | 24 |
ROSA [ | 2016 | 捷克 | 50/51 | RCT | (59±9) /(56±12) | 基础降压治疗+螺内酯25 mg/d | 基础降压治疗+肾脏去交感神经术 | ①②⑦⑧ | 48 |
YANG [ | 2016 | 中国 | 15/15 | RCT | (44.7±10.8) /(43.4±15.2) | 基础降压治疗+螺内酯20~40 mg/d | 基础降压治疗 | ①②③ ④⑦⑧ | 12 |
曾潇[ | 2016 | 中国 | 78/82 | RCT | (60.7±7.7)/(61.0±8.9) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗+安慰剂 | ①⑥⑦⑧ | 12 |
卢旭[ | 2017 | 中国 | 41/38 | RCT | (73.45±5.88) /(71.11±7.15) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗+安慰剂 | ①②③ ④⑦⑧ | 48 |
KRIEGER[ | 2018 | 巴西 | 84/78 | RCT | (54±11.1)/(56.3±9.7) | 基础降压治疗+螺内酯12.5~50.0 mg/d | 基础降压治疗+可乐定0.1~0.3 mg/d | ①②③④⑧ | 12 |
ROSSIGNOL[ | 2018 | 多国 | 191/212 | RCT | 74(65,80) /71(63,78) | 基础降压治疗+螺内酯23 mg/d | 基础降压治疗+安慰剂 | ① | 32 |
杨晶敏[ | 2018 | 中国 | 40/40/40 | RCT | (54.7±10.7)/(54.7±8.5) / (57.9±11.3) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗+比索洛尔5 mg基础降压治疗+特拉唑嗪2 mg/d | ②⑦ | 12 |
黄娟[ | 2020 | 中国 | 45/49 | RCT | (60.4±9.5)/(59.7±9.9) | 基础降压治疗+螺内酯20 mg/d | 基础降压治疗+倍他乐克50 mg/d | ① ③④ | 8 |
第一作者 | 随机方法 | 盲法 | 分配隐藏 | 结果数据的完整性 | 选择性报告研究结果 | 其他偏倚来源 |
---|---|---|---|---|---|---|
ABOLGHASMI[ | 未报告 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
VA'CLAVÍK[ | 简单无分层随机化 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
郭鑫[ | 随机数字表 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
马彬[ | 未报告 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
张俊松[ | 纳入顺序编号奇偶分配 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
OXLUND[ | 网站生成的随机化方案 | 双盲 | 中心药房分配 | 完整 | 否 | 不清楚 |
NI[ | 未报告 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
VA'CLAVÍK[ | 简单无分层随机化 | 双盲 | 中心药房分配 | 完整 | 否 | 不清楚 |
WILLIAMS[ | 计算机随机数字发生器 | 双盲 | 中心药房分配 | 完整 | 否 | 不清楚 |
盖延红[ | 随机数字表 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
DJOUMESSI[ | 未报告 | 单盲 | 未报告 | 完整 | 否 | 不清楚 |
OLIVERAS[ | 未报告 | 开放标签 | 未报告 | 完整 | 否 | 不清楚 |
ROSA[ | 未报告 | 开放标签 | 未报告 | 完整 | 否 | 不清楚 |
YANG[ | SPSS 19.0软件 | 开放标签 | 未报告 | 完整 | 否 | 不清楚 |
曾潇[ | SPSS软件 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
卢旭[ | 随机数字表 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
KRIEGER[ | 未报告 | 开放标签 | 未报告 | 完整 | 否 | 不清楚 |
ROSSIGNOL[ | 未报告 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
杨晶敏[ | RandA1.0随机化软件 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
黄娟[ | 未报告 | 未报告 | 未报告 | 不完整 | 是,未报告对照组治疗后安全性指标 | 不清楚 |
Table 2 Results of bias risk assessment of included studies
第一作者 | 随机方法 | 盲法 | 分配隐藏 | 结果数据的完整性 | 选择性报告研究结果 | 其他偏倚来源 |
---|---|---|---|---|---|---|
ABOLGHASMI[ | 未报告 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
VA'CLAVÍK[ | 简单无分层随机化 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
郭鑫[ | 随机数字表 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
马彬[ | 未报告 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
张俊松[ | 纳入顺序编号奇偶分配 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
OXLUND[ | 网站生成的随机化方案 | 双盲 | 中心药房分配 | 完整 | 否 | 不清楚 |
NI[ | 未报告 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
VA'CLAVÍK[ | 简单无分层随机化 | 双盲 | 中心药房分配 | 完整 | 否 | 不清楚 |
WILLIAMS[ | 计算机随机数字发生器 | 双盲 | 中心药房分配 | 完整 | 否 | 不清楚 |
盖延红[ | 随机数字表 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
DJOUMESSI[ | 未报告 | 单盲 | 未报告 | 完整 | 否 | 不清楚 |
OLIVERAS[ | 未报告 | 开放标签 | 未报告 | 完整 | 否 | 不清楚 |
ROSA[ | 未报告 | 开放标签 | 未报告 | 完整 | 否 | 不清楚 |
YANG[ | SPSS 19.0软件 | 开放标签 | 未报告 | 完整 | 否 | 不清楚 |
曾潇[ | SPSS软件 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
卢旭[ | 随机数字表 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
KRIEGER[ | 未报告 | 开放标签 | 未报告 | 完整 | 否 | 不清楚 |
ROSSIGNOL[ | 未报告 | 双盲 | 未报告 | 完整 | 否 | 不清楚 |
杨晶敏[ | RandA1.0随机化软件 | 未报告 | 未报告 | 完整 | 否 | 不清楚 |
黄娟[ | 未报告 | 未报告 | 未报告 | 不完整 | 是,未报告对照组治疗后安全性指标 | 不清楚 |
Figure 2 Forest plot of the effect of reducing clinic systolic blood pressure of spironolactone versus placebo,no-treatment(blank),other antihypertensive drugs and renal sympathetic denervation
Figure 3 Forest plot of the effect of reducing clinic diastolic blood pressure of spironolactone versus placebo,no-treatment(blank),other antihypertensive drugs and renal sympathetic denervation
Figure 6 Forest plot of the effect of reducing 24-hour ambulatory systolic blood pressure of spironolactone versus placebo,no-treatment(blank),other antihypertensive drugs and renal sympathetic denervation
Figure 7 Forest plot of the effect of reducing 24-hour ambulatory diastolic blood pressure of spironolactone versus placebo,no-treatment(blank),other antihypertensive drugs and renal sympathetic denervation
Figure 8 Forest plot of the effect of spironolactone on reducing daytime systolic blood pressure compared with that of placebo,no-treatment(blank),other antihypertensive drugs and renal sympathetic denervation
Figure 9 Forest plot of the effect of spironolactone on reducing daytime diastolic blood pressure compared with that of placebo,no-treatment(blank),other antihypertensive drugs and renal sympathetic denervation
Figure 10 Forest plot of the effect of spironolactone on reducing nighttime systolic blood pressure compared with that of placebo,no-treatment(blank),other antihypertensive drugs and renal sympathetic denervation
Figure 11 Forest plot of the effect of spironolactone on reducing nighttime diastolic blood pressure compared with that of placebo,no-treatment(blank),other antihypertensive drugs and renal sympathetic denervation
Figure 12 Forest plot of the effect of spironolactone on reducing self-measured home systolic blood pressure compared with that of other antihypertensive drugs
Figure 15 Forest plot of the effect of reducing 24-hour pulse pressure of spironolactone versus placebo,no-treatment(blank) and renal sympathetic denervation
Figure 16 Forest plot of the effect of reducing daytime pulse pressure of spironolactone compared with that of placebo and renal sympathetic denervation
Figure 18 Forest plot of the changes in serum potassium levels of spironolactone-treated group compared with those of placebo,blank,other antihypertensive drugs and renal sympathetic denervation groups
Figure 19 Forest plot of the changes in serum creatinine levels of spironolactone-treated group compared with those of placebo,blank,other antihypertensive drugs and renal sympathetic denervation groups
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