Wen T, Cai Y, Chen X, Xiang L, Wang B, Zhuang Y
Medical Acarology Laboratory, Shanghai Medical University, Shanghai 200032.
Zhongguo Ji Sheng Chong Xue Yu Ji Sheng Chong Bing Za Zhi. 1999;17(5):274-6.
To make a retrieval investigation of safety in using Dermatophagoides farinae extract in diagnosis and immunotherapy with patients of asthma and rhinitis.
A questionnaire evaluation of the safety use of D. farinae extract (SMU-Df) during diagnosis and immunotherapy of patients from 1974 to 1995 was carried out.
A total of 8,46,342 injections were statistically analysed, among whom 142 systemic adverse reactions occurred involving urticaria 0.82@10000, severe attack of asthma 0.77@10000, anaphylactic shock 0.07@10000 (CL = 1.4-12.0/million), and angioedma 0.02@10000. The time of onset of systemic reactions of immediate type was < 30 min in 32 cases-times, and 1 h and 2 h in 6 cases-times; the time to onset of late response type was 3 h-48 h in 23 cases-times with highest incidence of severe asthmatic attacks. The systemic reactions occurred in 18 subjects during skin test, in 96 cases-times during increasing dose phase, and in 14 cases-times during. Among them 6 cases were of anaphylactic shock, and none of it after emergency treatment. The major cause of manifestation of systemic reactions for 41 cases after immunotherapy with SMU-Df extract was due to over dosage errors.
The application of SMU-Df extract in skin test and immunotherapy of asthma and rhinitis sensitive to mite for the past 22 years in this country indicated that the efficacy and safety have been high.
对粉尘螨提取物在哮喘和鼻炎患者诊断及免疫治疗中的使用安全性进行检索调查。
对1974年至1995年期间患者在粉尘螨提取物(SMU-Df)诊断和免疫治疗期间的安全使用情况进行问卷调查评估。
共对846342次注射进行了统计学分析,其中发生142例全身不良反应,包括荨麻疹0.82/10000、哮喘重度发作0.77/10000、过敏性休克0.07/10000(可信区间=1.4-12.0/百万)和血管性水肿0.02/10000。速发型全身反应的发作时间在32例次中<30分钟,在6例次中为1小时和2小时;迟发型反应的发作时间在23例次中为3小时至48小时,其中重度哮喘发作的发生率最高。全身反应发生在18名受试者的皮肤试验期间、96例次的剂量增加阶段和14例次的[此处原文缺失信息]期间。其中6例为过敏性休克,经急救后均无死亡。41例患者使用SMU-Df提取物免疫治疗后出现全身反应表现的主要原因是用药过量错误。
该国过去22年中SMU-Df提取物在对螨敏感的哮喘和鼻炎皮肤试验及免疫治疗中的应用表明其疗效和安全性较高。