Makino Sohei, Adachi Mitsuru, Ohta Ken, Kihara Norio, Nakajima Sigenori, Nishima Sankei, Fukuda Takeshi, Miyamoto Terumasa
Internal Medicine, Jobu Hospital for Respiratory Disease, Maebashi, Gunma, Japan.
Allergol Int. 2006 Dec;55(4):395-402. doi: 10.2332/allergolint.55.395.
Theophylline is a useful drug for the treatment of asthma. The Asthma Prevention and Management Guidelines (JGL) recommend use of sustained-release theophylline products as controllers and of injectable aminophylline products as relievers. The Global Initiative for Asthma: Global Strategy for Asthma Management and Prevention, the NHLB/WHP Workshop Report 1995 (GINA, 1995) and guidelines in Western countries recommend sustained-release theophylline, but not as positively as in the JGL. The aim of this survey was to determine the occurrence of serious adverse reactions.
The survey was conducted in 66 institutions staffed by physicians certified by the Japanese Society of Allergology (JSA). The target diseases were asthma and COPD including chronic bronchitis and pulmonary emphysema, which are indications for use of sustained-release theophylline products in Japan.
3,921 patients were included in the safety evaluation. No serious adverse reactions were observed among the patients in this survey, although 54 patients (1.38%) exhibited non-serious adverse reactions. The incidence of adverse reactions was found to be high in patients who had begun use of sustained-release theophylline products at the time of registration in this survey, and in patients who were concomitantly taking macrolide antibiotics.
The present survey demonstrates that sustained-release theophylline is safe, as long as used appropriately, although adverse reactions tend to develop early after initiation of administration.
茶碱是治疗哮喘的一种有效药物。《哮喘预防与管理指南》（JGL）推荐使用缓释茶碱产品作为控制药物，注射用氨茶碱产品作为缓解药物。《全球哮喘防治创议：哮喘管理和预防全球策略》、1995年美国国立心肺血液研究所/世界卫生组织研讨会报告（GINA，1995）以及西方国家的指南推荐使用缓释茶碱，但不像JGL那样积极。本次调查的目的是确定严重不良反应的发生率。
该调查在66家由日本变态反应学会（JSA）认证的医生所在机构进行。目标疾病为哮喘和慢性阻塞性肺疾病（COPD），包括慢性支气管炎和肺气肿，这些在日本是使用缓释茶碱产品的适应证。
3921例患者纳入安全性评估。本次调查中患者未观察到严重不良反应，尽管有54例患者（1.38%）出现非严重不良反应。在本次调查登记时开始使用缓释茶碱产品的患者以及同时服用大环内酯类抗生素的患者中，不良反应发生率较高。
本次调查表明，只要合理使用，缓释茶碱是安全的，尽管不良反应往往在给药开始后早期出现。
