摘要
目的根据现有随机对照临床试验，综合评价波生坦治疗肺动脉高压的疗效与安全性。方法在数据库中检索以肺动脉高压患者为研究对象，并进行了波生坦治疗（治疗组）与安慰剂（安慰剂组）比较的随机对照试验（RCT）研究，对其短、长期疗效和安全性进行Meta分析。结果（1）有2项研究进行了短期疗效与安全性评价。与安慰剂组比较，治疗组患者：①min步行距离平均增加了47．71m（95％ CI 为26．09～69．33，P〈0．0001）；②WHO心功能分级改善率的合并比数比（OR）值为1．84（95％CI为1．06～3．18，P=0．03）；③呼吸困难明显改善，Borg呼吸困难评分平均下降0．71分（95％CI为0．19～1．23，P=0．007）；④病死率差异无统计学意义，其合并OR值为2．45（95％CI为0．28～21．35，P=0．42）；⑤肝损害的发生率差异无统计学意义，其合并OR值为1．78（95％a为0．66～4．81，P=0．26）；⑥临床病情恶化率明显改善，其合并OR值为0．26（95％CI为0．11—0．60，P=0．002）。（2）有2项研究评价了波生坦治疗的长期疗效与安全性：与安慰剂组比较，治疗组患者1年生存率明娃改善，其合并OR值为2．57（95％CI为1．59～4．17，P=0．0001）；肝损害的发生情况：2项研究均报道了治疗组患者转氨酶明显升高的病例，由于缺乏安慰剂组的资料，未对其进行Meta分析。结论波生坦治疗可以提高肺动脉高压患者的运动能力，改善心功能和呼吸困难的症状，提高患者1年生存率。肝损害可能是其主要副作用。
Objective To pool the data of studies about bosentan therapy in pulmonary hypertension （PAH） and evaluate the efficacy and safety of bosentan therapy. Methods A search was performed in PubMed （from 01/01/1968 to01/05/2006）, Embase （from 01/01/1980 to 01/05/2006） and China National Knowledge Infrastructure （CNKI） （from 01/01/1978 to 01/05/2006） to identify relevant articles. Randomized -Controlled Trials （RCT） about the efficacy and safety of bosentan therapy in PAH patients were included to evaluate the short - term and long - term efficacy and safety of bosentan therapy in a method of Meta - analysis. Results （ 1 ） Two RCT studies including 243 PAH patients were chosen to evaluate the short - term efficacy and safety of bosentan therapy. Compared with placebo treatment, bosentan therapy could improve exercise capacity of PAH patients：① Distance covered in a 6 - minute walk test increased 47.71 meters （95% CI：26.09 to 69.33, P 〈0.0001 ） ;② Improved WHO functional class of PAH patients, the total Odds Ratio （OR） of improvement in PAH patients treated with bosentan was 1.84（95% CI：1. 06 to 3.18, P =0.03） ;③Decreased Borg dyspnoea score by 0.71 （95%CI： 0 .19 to 1.23, P =0.007） ;④Decreased the clinical worsening of symptoms, and tile total OR of decrease in PAH patients treated with bosentan was 0.26 （95% CI：0. 11 to 0.60, P = 0. 002 ）, but no differences about mortality and abnormal hepatic function between them were observed, the total OR of mortality in PAH patients treated with bosentan was 2.45 （95% CI：0. 28 to 21.35 ,P =0.42） and the total OR of abnormal hepatic function in PAH patients treated with bosentan was 1.78 （95% CI：0. 66 - 4.81 ,P =0.26）, （2）Two RCT studies including 399 PAH patients were chosen to evaluate the longterm efficacy and safety of bosentan therapy. Compared with placebo treatment, bosentan therapy could improve survival of PAH patients, the total OR of improvement was 2.57 （95% CI.1. 59 to 4.17, P = 0. 00
出处
《中国医师进修杂志（内科版）》
2006年第12期17-20,共4页
Chinese Journal of Postgraduates of Medicine
