Petty T L, Rollins D R, Christopher K, Good J T, Oakley R
Webb-Waring Lung Institute, University of Colorado Health Sciences Center, Denver.
Am Rev Respir Dis. 1989 Mar;139(3):694-701. doi: 10.1164/ajrccm/139.3.694.
We studied 68 chronic asthmatic patients, 18 to 76 yr of age, with a percent predicted FEV1 between 33 and 81, comparing cromolyn sodium with placebo. We used a double-blind, comparative group trial design. A 4-wk baseline period was followed by 3 months of active treatment or placebo. Patients recorded symptom severity and frequency of study drug and concomitant medication usage on daily diary cards. At each clinic visit, patients independently assessed the effectiveness of the test medication in controlling their asthma. Physicians also assessed the severity of the patients' symptoms, pulmonary function, and effectiveness of test medication at monthly intervals. Methacholine challenges were done pre- and post-treatment. Use of concomitant therapy was reduced according to a specified schedule. There was significant improvement in the severity of daytime asthma, nighttime asthma, and cough as assessed by the patients in the cromolyn sodium group. Mean use of concomitant medications decreased significantly in cromolyn sodium patients. Despite the reductions in the use of bronchodilators, pulmonary function (FEV1, FVC, FEF25-75) improved significantly in the cromolyn sodium group. Similar improvements did not occur in the control group. The physicians' assessments of symptoms showed significant improvement in favor of the cromolyn sodium group. Both physicians and patients judged cromolyn sodium to be moderately or very effective for 61% of the patients as compared to 27% (by physicians) and 24% (by patients) in the placebo group. There was no significant difference in methacholine response between the two groups, although the mean value for methacholine sensitivity in the cromolyn sodium group was significantly less at the end of the study than at baseline.(ABSTRACT TRUNCATED AT 250 WORDS)
我们研究了68名年龄在18至76岁之间、预测FEV1百分比在33%至81%之间的慢性哮喘患者,将色甘酸钠与安慰剂进行比较。我们采用了双盲、对比组试验设计。为期4周的基线期之后是3个月的积极治疗或安慰剂治疗。患者在每日日记卡上记录症状严重程度以及研究药物和伴随用药的使用频率。每次门诊就诊时,患者独立评估试验药物控制哮喘的有效性。医生也每隔一个月评估患者症状的严重程度、肺功能以及试验药物的有效性。治疗前后均进行了乙酰甲胆碱激发试验。按照特定时间表减少伴随治疗的使用。色甘酸钠组患者评估的白天哮喘、夜间哮喘和咳嗽严重程度有显著改善。色甘酸钠组患者伴随用药的平均使用量显著减少。尽管支气管扩张剂的使用量减少,但色甘酸钠组的肺功能(FEV1、FVC、FEF25 - 75)仍有显著改善。对照组未出现类似改善。医生对症状的评估显示色甘酸钠组有显著改善。与安慰剂组中27%(医生评估)和24%(患者评估)相比,61%的患者和医生均判断色甘酸钠为中度或非常有效。两组之间乙酰甲胆碱反应无显著差异,尽管在研究结束时色甘酸钠组的乙酰甲胆碱敏感性平均值相比基线时显著降低。(摘要截选至250词)