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目的评价西地那非治疗肺动脉高压的疗效与安全性。方法在数据库 PubMed(1968年1月至2006年5月),Embase(1980年至2006年),中国期刊网(1994年1月至2006年5月)中,以(pulmonary hypertension)或(pulmonary artery hypertension)和 Sildenafil 为英文检索词,并以human,randomized-controlled trial,English 加以限制,以“西地那非,肺动脉高压”为中文检索词,检索以肺动脉高压(PAH)为研究对象、西地那非治疗与安慰剂比较的随机对照试验(RCT)研究,并应用RevMan4.2.8软件对其临床疗效与安全性进行 Meta 分析。结果共检索到10篇文献,共有4项RCT 研究进行了疗效与安全性评价,328例 PAH 患者入选。根据随机方法、分配隐藏与盲法对纳入研究质晕进行评价,结果1项研究为 A 级,其余均为 B 级。与安慰剂组比较,西地那非治疗组患者:(1)6 min 步行距离平均增加55.76 m(95%CI 为41.26～70.25,P<0.01);(2)运动时间平均增加221.13 8(95%CI 为146.13～296.14,P<0.01);(3)肺动脉收缩压平均下降11.51 mm Hg(95% CI 为1.41～21.60,P=0.03);(4)临床病情恶化率明显改善,其合并比值比(OR)为0.36(95% CI为0.16～0.78,P=0.01);(5)头痛和低血压的发生率与安慰剂组比较差异无统计学意义;(6)两地那非的应用对患者的性欲改变无明显影响。结论西地那非治疗在短期内比较安全,并可以提高肺动脉高压患者的运动耐力,增加运动时间,降低肺动脉压,缓解临床病情恶化。
Objective To evaluate the efficacy and safety of sildenafil in the treatment of pulmonary hypertension. Methods In the databases PubMed (January 1968 to May 2006), Embase (1980 to 2006), China Journal Network (January 1994 to May 2006) hypertension and Sildenafil were searched in English, and restricted by human, randomized-controlled trial and English. The search terms of “sildenafil, pulmonary hypertension” were used as the Chinese search terms, and pulmonary hypertension (PAH) Sildenafil was compared with placebo in a randomized controlled trial (RCT) study and Meta-analysis of clinical efficacy and safety using RevMan 4.2.8 software. Results A total of 10 articles were retrieved. A total of 4 RCTs were evaluated for efficacy and safety, and 328 patients with PAH were enrolled. According to the random method, the distribution of hidden and blind method for the inclusion of research quality halo evaluation, results of a study for the A level, the rest are B level. Patients in the sildenafil group experienced an average increase of 55.76 m (95% CI, 41.26 to 70.25, P <0.01) over 6 minutes of walking compared with placebo; (2) an average increase of exercise time of 221.13 8 % CI was 146.13 ~ 296.14, P <0.01); (3) Pulmonary systolic pressure decreased by 11.51 mmHg on average (95% CI 1.41 ~ 21.60, P = 0.03); (4) The clinical progression rate was significantly improved, OR was 0.36 (95% CI 0.16-0.78, P = 0.01); (5) The incidence of headache and hypotension was not significantly different from placebo group; (6) No significant effect on the patient’s sexual desire changes. Conclusion Sildenafil treatment is safe in the short term and can improve exercise endurance, increase exercise time, decrease pulmonary arterial pressure and alleviate clinical deterioration in patients with pulmonary hypertension.