Wang Chang-Hui, Zhang Qian, Li Ming, Fu Pei-Fang, Yan Zheng-Mao, Peng Ai-Mei, Zhang Guo-Liang
Department of Respiratory Medicine, Tenth People's Hospital of Tongji University, Shanghai 200072, China.
Zhonghua Yi Xue Za Zhi. 2010 Mar 2;90(8):540-6.
To evaluate the efficacy and safety of oral theophylline versus placebo in patients with stable chronic obstructive pulmonary disease (COPD).
The databases Medline, Embase, Web of Science, Cochrane Central Register of Controlled Trials and Chinese Biomedical Database were retrieved by using the key words "Uniphyl or Theophylline or Theo-Dur or theo or Theotrim or Elixophyllin or Elixophyllin or Phyllocontin or aminophylline or Methylxanthine or nuelin or doxofylline" and "obstructive or bronchitis or pulmonary emphysema or bronchial hyperreactivity or COPD or COLD or emphysema" so as to search the materials about the randomized controlled clinical trials comparing the effectiveness of stable COPD treated by oral theophylline and placebo. A meta-analysis was conducted. For continuous variables, the results of individual studies were pooled using fixed-effect weighted mean difference (WMD) with a corresponding 95% confidence interval (CI). Where the results were expressed as dichotomous variables, the relative risk (RR) with 95%CI was calculated.
Thirty-four documents about randomized controlled clinical trials, including a total of 2087 patients, from the retrieved 2010 documents accorded to the demand of enrollment. The results of meta-analysis showed that theophylline significantly improved the forced expiratory volume in 1 s, forced vital capacity and peak expiratory flow rate (WMD 0.09 L, 95%CI 0.09 - 0.09; WMD 0.14 L, 95%CI 0.13 - 0.14; WMD 17.0 L/min and 95%CI 6.9 - 27.2 respectively). Arterial oxygen tension and arterial carbon dioxide tension at rest both improved with treatment (WMD 2.89 mm Hg, 95%CI 1.11 - 4.66; WMD -2.05 mm Hg and 95%CI -3.59 to -1.42 respectively). Six-minute walk distance significantly improved (WMD 38.89 meters, 95%CI 21.55 - 56.22) in treatment group. The RR of acute exacerbations was smaller between both groups (RR 0.74, 95%CI 0.59 - 0.93). The RR of total adverse events was similar (RR 1.05, 95%CI 0.95 - 1.16) while RR of drug-related adverse events was greater (RR 2.54, 95%CI 1.37 - 4.70). And there was significant statistical difference.
Compared with the placebo, theophylline can improve lung function, arterial blood gas tensions and walking distance while the incidence of drug-related adverse events is higher.
评估口服茶碱与安慰剂对稳定期慢性阻塞性肺疾病(COPD)患者的疗效及安全性。
通过使用关键词“优喘平或茶碱或茶喘平或茶硷或茶丙羟酸或埃索美拉唑或埃索美拉唑或菲洛康或氨茶碱或甲基黄嘌呤或奴林或多索茶碱”和“阻塞性或支气管炎或肺气肿或支气管高反应性或COPD或慢性阻塞性肺病或肺气肿”检索Medline、Embase、科学引文索引、Cochrane对照试验中心注册库和中国生物医学数据库,以查找比较口服茶碱和安慰剂治疗稳定期COPD有效性的随机对照临床试验资料。进行荟萃分析。对于连续变量,采用固定效应加权均数差(WMD)及相应的95%置信区间(CI)汇总各研究结果。若结果以二分变量表示,则计算相对危险度(RR)及95%CI。
从检索到的2010篇文献中筛选出34篇关于随机对照临床试验的文献,共2087例患者符合纳入要求。荟萃分析结果显示,茶碱显著改善了第1秒用力呼气量、用力肺活量和呼气峰值流速(WMD分别为0.09L,95%CI为0.09 - 0.09;WMD为0.14L,95%CI为0.13 - 0.14;WMD为17.0L/min,95%CI为6.9 - 27.2)。静息时动脉血氧分压和动脉血二氧化碳分压均随治疗而改善(WMD分别为2.89mmHg,95%CI为1.11 - 4.66;WMD为 -2.05mmHg,95%CI为 -3.59至 -1.42)。治疗组6分钟步行距离显著改善(WMD为38.89米,95%CI为21.55 - 56.22)。两组急性加重的RR较小(RR为0.74,95%CI为0.59 - 0.93)。总不良事件的RR相似(RR为1.05,95%CI为0.95 - 1.16),而药物相关不良事件的RR更大(RR为2.54,95%CI为1.37 - 4.70)。且存在显著统计学差异。
与安慰剂相比,茶碱可改善肺功能、动脉血气张力和步行距离,但药物相关不良事件的发生率较高。