我国肺动脉高压临床防治研究回顾分析

A comment on the clinical studies of prevention and treatment of pulmonary hypertension in China

目的 :按循证医学标准 ,对我国低氧性肺动脉高压临床研究现状予以总结和评价 ,提高临床研究水平。方法 :检索近 10a来 3种中华医学核心杂志上刊登的关于肺动脉高压防治性临床研究文章 ,从实验设计方法、评价指标及统计学处理等多个方面进行逐篇分析。结果 :共检出 2 1篇文章 ,17篇 (81% )针对慢性阻塞性肺疾病导致的低氧性肺动脉高压。 90 .5 %的研究关注的是药物的急性效果 ,通过自身对照设计评价若干实验室指标的变化。仅有 1项研究为随机对照试验。大样本研究只有 1项 ,其余均为小样本研究。纳入对象基线不齐、纳入和排除标准不严格、忽视副作用报告是比较突出的问题。结论 :目前我国肺动脉高压研究具有很大的局限性 ,难以确定某种药物的全面和长期疗效。今后的相关临床研究应在保证短期疗效的前提下尽快过渡到中长期观察 ,评价包括生命重要事件在内的预后指标。同时应积极倡导戒烟和长程氧疗 ,预防肺动脉高压的发生和进展。

Objective:To summarize and evaluate the current situation of clinical studies on hypoxic pulmonary hypertension in China according to evidence based medicine standards.Methods:All articles on prevention and treatment of pulmonary hypertension published in Chinese Journal of Tuberculosis and Respiratory Diseases,Chinese Journal of Internal Medicine and National Medicine Journal of China in the past 10 years were evaluated from the following aspects:the study design,the evaluation indexes and the statistics methods,etc.Results:Of the 21 articles published,17 concerning the hypoxic pulmonary hypertension resulted from chronic obstructive pulmonary disease.Most clinical trials (90.5%)observed the acute effects by self control design. Only 1 was randomized control trial.Most trials were small scale researches except one.There were other quality problems such as base condition imbalance between groups,etc.Conclusion:The clinical trials on pulmonary hypertension performed in the past 10 years in China have obvious limitation. The middle to long term clinical studies are necessary and the prognosis indexes such as life quality or the life important incidence should be evaluated. Smoking cessation and long term oxygen treatment should be promoted in order to prevent the pathogenesis and development of pulmonary hypertension.