ABSTRACT
Objective To estimate the current quality of the reporting of randomized controlled trials (RCTs) related to digestive diseases in China. Methods All the papers related to RCTs published in Chinese Journal of Digestion from 1999 to 2008 were hand-searched by professional staff then evaluated and analyzed them according to the international reference standard. ResultsIn the 3298 issues of the recent ten years, there were 92 research papers of RCTs which was accounting for 2.8%. The sample size ranged from 18 to 5241. Sixty-one (66.0%) trials included the exact standard of internalize and exclusion. Sixteen (17.4%) trails told the specific method of random allocation and 22(23.9%) were double-blinded. Fifty-eight (63.0%) trials compared the baseline condition of each groups. Seventy-three(79.3%) trails showed the specific approach of statistic. In the end, only 7(5.7%) trails were identified as the strictly-designed RCTs. Conclusions The quantity and quality of the clinical RCTs can not satisfy the demand of clinical practice. Strictly-scientific designed, multicentered, large sample prospective clinical RCT should be advocated.
ABSTRACT
Objective To explore the clinical significence of three alternative ways in assessing bronchodilator reversibility in patients with severe chronic obstructive pulmonary disease (COPD).Methods 18 clinically stable patients with severe COPD were collected. Pulmonary ventilation function and capacity of lung were measured after inhaling compound ipratropium bromide solution before and after nebulised saline, and at intervals. Expiratory flow limitation (EFL) was detected by negative expiratory pressure technique concurrently. Results Compared with placebo,bronchodilator caused a significant increase in forced expiratory volume in one second (FEV1)%Pred,forced vital capacity (FVC)%Pred and inspiratory capacity (IC)%Pred and a significant decrease in residual volume (RV)%Pred, functional residual capacity (FRC)% Pred and Borg scale. But there were no changes in total lung capacity (TLC)% Pred, 5-point EFL score and breathing pattern variables. The increase of IC was correlated with the reduction of Borg scale, but such correlation did not exist between the increase of FEV1 and the reduction of Borg scale. When ROC curve was applied to assess the significance of IC, 5-point EFL score and FEV1 in evaluating the effects of broncholilator,the area under curve (AUC) of which was 0. 868,0. 681 and 0. 557 respectively.Conclusions Compared with FEV1, IC has higher sensitivity and reliability to evaluate the clinical response of bronchodilator in patients with severe COPD. The 5-point EFL score is not an appropriate measurement of acute bronchodilator response.