Kuang Tu-guang, Wang Jun, Zhai Zhen-guo, Guo Xiu-hua, Wang Chen
Beijing Institute of Respiratory Medicine-Beijing Chaoyang Hospital, Capital University of Medical Sciences, Beijing 100020, China.
Zhonghua Yi Xue Za Zhi. 2007 Apr 17;87(15):1021-4.
To evaluate the short-term efficacy and safety of sildenafil in treatment of pulmonary artery hypertension (PAH).
Literatures in regard to sildenafil treatment of PAH were searched in PubMed (from 01/01/1968 to 01/05/2006), Embase (from 1980 to 2006) and China National Knowledge Infrastructure (CNKI) (from 1994 to 2006). Randomized-controlled trials (RCTs) of sildenafil versus placebo in the treatment of PAH were conducted. The quality of the included trials was evaluated by two reviewers independently. Meta-analysis was done by using the Cochrane Collaboration's RevMan 4.2.8.
Ten literatures were retrieved. Four RCTs, including 328 patients, were included and were graded in terms of the quality of randomization, allocation, concealment and blinding. One study was graded as level A and the other three were graded as level B. The meta-analysis showed that compared with placebo treatment, sildenafil therapy can (1) improve the exercise capacity of the PAH patients measured as distance covered in a 6 minute walk test with an increase of 55.76 meters on average in 6 minutes' walk (95% confidence interval, 41.26 to 70.25; P < 0.01), (2) increase the exercise time of the PAH patients by 221.13s on average (95% confidence interval, 146.13 to 296.14; P < 0.01), (3) decrease the pulmonary artery systolic pressure by 11.51 mmHg on average (95% confidence interval, 1.41 to 21.60, P = 0.03), and (4) alleviate the exacerbation of clinical conditions with a total odds ratio (OR) of 0.36 (95% confidence interval, 0.16 to 0.78, P = 0.01); however, it failed to alleviate the headache and hypotension in comparison with the placebo group. No sexual disturbance was seen in the patients treated with sildenafil.
Sildenafil therapy improves the clinical symptoms and exercise capacity, and decreases the pulmonary artery systolic pressure of the PAH patients; and causes no serious side effects.
评估西地那非治疗肺动脉高压（PAH）的短期疗效和安全性。
在PubMed（1968年1月1日至2006年5月1日）、Embase（1980年至2006年）和中国知网（CNKI）（1994年至2006年）中检索关于西地那非治疗PAH的文献。进行西地那非与安慰剂治疗PAH的随机对照试验（RCT）。两名评价者独立评估纳入试验的质量。使用Cochrane协作网的RevMan 4.2.8进行荟萃分析。
检索到10篇文献。纳入4项RCT，共328例患者，并根据随机化、分配、隐藏和盲法的质量进行分级。1项研究评为A级，其他3项评为B级。荟萃分析表明，与安慰剂治疗相比，西地那非治疗可（1）提高PAH患者的运动能力，以6分钟步行试验中的步行距离衡量，平均6分钟步行增加55.76米（95%置信区间，41.26至70.25；P<0.01），（2）使PAH患者的运动时间平均增加221.13秒（95%置信区间，146.13至296.14；P<0.01），（3）使肺动脉收缩压平均降低11.51 mmHg（95%置信区间，1.41至21.60，P = 0.03），以及（4）减轻临床病情加重，总比值比（OR）为0.36（95%置信区间，0.16至0.78，P = 0.01）；然而，与安慰剂组相比，它未能减轻头痛和低血压。接受西地那非治疗的患者未出现性功能障碍。
西地那非治疗可改善PAH患者的临床症状和运动能力，降低肺动脉收缩压；且无严重副作用。
