【摘要】 目的 系统评价可溶性鸟苷酸环化酶（sGC）刺激剂治疗心力衰竭（HF）的有效性和安全性。方法 系统检索Cochrane图书馆、Web of Science、PubMed、EMbase数据库，检索时限均为建库起至2021年3月31日，检索了sGC刺激剂对比安慰剂治疗HF随机对照试验（RCT）的数据，收集心血管死亡率、全因死亡率、HF住院率、HF住院或心血管死亡率复合事件和安全性的数据进行分析。采用Cochrane偏倚风险评估工具对纳入文献质量进行评价，使用Review Manager 5.4.1软件进行Meta分析。结果 共纳入6项RCT，共计7154例患者（分为试验组和对照组）。Meta分析结果显示：与安慰剂相比，使用sGC刺激剂可显著减少HF的住院率（RR=0.91,95%CI:0.86～0.96,P=0.0005）、HF住院或心血管死亡率复合事件（RR=0.91,95%CI:0.85～0.98,P=0.01），但sGC刺激剂对心血管死亡率（RR=0.96;95%CI:0.81～1.14,P=0.65）及全因死亡率（RR=0.98,95%CI:0.88～1.09,P=0.78）无影响；并且不能改善KCCQ(MD=5.42,95%CI:-0.60～11.44,P=0.08)、6分钟步行距离（MD=2.34,95%CI:-9.73～14.40,P=0.70）、左室收缩末容积（LVESV）(MD=-2.81,95%CI:-6.55～0.92,P=0.14)，但可改善左室舒张末容积（LVEDV）(MD=-3.82,95%CI:-5.87～-1.76,P=0.0003)。安全性方面，与对照组相比，sGC刺激剂对不良反应发生风险（RR=0.99,95%CI:0.97～1.02,P=0.65）及严重不良反应（RR=0.95,95%CI:0.88～1.02,P=0.13）、症状性低血压（RR=1.17,95%CI:0.99～1.39,P=0.07）、晕厥（RR=1.18,95%CI:0.90～1.54,P=0.23）和急性肾损伤（RR=1.06,95%CI:0.84～1.33,P=0.62）等方面无明显影响。结论 现有证据表明，sGC刺激剂可作为HF的辅助治疗，减少HF患者的HF住院率及HF住院及心血管死亡复合风险，改善心室重构，不能改善HF患者症状，但安全性好。受纳入研究质量和数量的限制，上述结论尚待更多高质量研究予以验证。更多还原

【Abstract】 Objective To review systematically the efficacy and safety of soluble guanylyl cyclase(sGC) stimulants in treatment of heart failure(HF). Methods The database of Cochrane Library, Web of Science, PubMed and EMbase were retrieved systematically from database establishment time to Mar. 31, 2021. The data of randomized controlled trials(RCT) about sGC stimulant compared with placebo in HF treatment were retrieved, and the data of cardiovascular mortality, all-cause mortality, HF hospitalization rate, and compound events of HF hospitalization or cardiovascular mortality and safety were collected and analyzed. The quality of included literatures was reviewed by using Cochrane bias risk assessment tool, and a Meta-analysis was conducted by using Review Manager 5.4.1 software.Results There were totally 6 RCT included involved 7154 patients(divided into test group and control group). The results of Meta-analysis showed that compared with placebo, sGC stimulants decreased significantly HF hospitalization rate(RR=0.91, 95%CI: 0.86～0.96, P=0.0005), and compound events of HF hospitalization or cardiovascular mortality(RR=0.91, 95%CI: 0.85～0.98, P=0.01). But sGC stimulants had no affects on cardiovascular mortality(RR=0.96;95%CI: 0.81～1.14, P=0.65) and all-cause mortality(RR=0.98, 95%CI: 0.88～1.09, P=0.78), and did no improve KCCQ(MD=5.42, 95%CI:-0.60～11.44, P=0.08), 6-minute walking distance(MD=2.34, 95%CI:-9.73～14.40, P=0.70),and LVESV(MD=-2.81, 95%CI:-6.55～0.92, P=0.14), but can improve LVEDV(MD=-3.82, 95%CI:-5.87～-1.76,P=0.0003). In terms of safety, sGC stimulants had no significant affects on risk of adverse reactions(RR=0.99,95%CI: 0.97～1.02, P=0.65) and severe adverse reactions(RR=0.95, 95%CI: 0.88～1.02, P=0.13), symptomatic hypotension(RR=1.17, 95%CI: 0.99～1.39, P=0.07), Syncope(RR=1.18, 95%CI: 0.90～1.54, P=0.23) and acute kidney injury(RR=1.06, 95%CI: 0.84～1.33, P=0.62) in test group compared with control group. Conclusion Existing evidences show that sGC stimulants can be used as an adjuvant in HF treatment for reducing HF hospitalization rate and compound risks of HF hospitalization or cardiovascular mortality in HF patients and may improve ventricular remodeling. It cannot relieve symptoms but it is safe in HF patients. Limited by the quality and quantity of included studies, the above conclusion need to be verified by more high-quality studies.更多还原