骨瓜提取物致不良反应文献分析

目的分析讨论骨瓜提取物所致不良反应的临床特点及发生规律，为临床合理用药提供参考。方法检索1983年至2012年医药学期刊报道的有关骨瓜提取物致不良反应的文献进行统计分析。结果共检索到骨瓜提取物所致不良反应27例，均为静脉滴注给药，其中男20例，女7例；年龄0～19岁1例（3．7％），20～29岁3例（11．1％），30—39岁8例（29．6％），40—59岁8例（29．6％），≥60岁7例（25．9％）；原患疾病以不同部位不同程度的骨折为主，共23例（85．2％）；多在用药10min内发生，其中1—5min13例（48．1％）。27例药物不良反应中，骨瓜提取物均采取静脉滴注给药，其中21例（77．8％）为50、75、100mg骨瓜提取物＋0．9％氯化钠注射液或5％葡萄糖注射液250—500ml；20例（74．1％）为单独使用骨瓜提取物过程中出现，7例为联合使用药物过程中出现。不良反应累及多个系统和器官，临床表现复杂多样，主要为速发型变态反应，临床表现主要为瘙痒、皮疹、红斑疹、无力、寒战、头痛、发热、多汗、胸闷、心悸、呼吸困难、呼吸急促、抽搐、腹痛、恶心呕吐、皮肤潮红等，严重者可致过敏性休克。结论临床医师、药师应了解骨瓜提取物所致不良反应的规律和特点，加强其应用的监测，以减少不良反应的发生。

Literature analysis of adverse drug reactions induced by Guguatiquwu injection

Objective To study the general pattern and characteristics of adverse drug reactions （ADRs） caused by Guguatiquwu injection. Methods ADRs of Guguatiquwu injection published in Chinese medical periodical from 1983 to 2012 were collected and analyzed statistically. Results All 27 cases of adverse reactions with intravenous administration of Guguatiquwu were retrieved＇. Among them 20 cases were male, 7 cases were female; 1 case （3.7%）was 0-19 old, 3 cases （11.1%）were 20-29 old, 8 cases （29.6%） were 30-39 old, 8 cases （29.6%） were 40-59 years old and 7 cases （25.9%） were ≥60 years old. The major primary disease of 23 cases （85.2%） had different parts and different bone fractures. The onset of ADR was usually within 10 rain after injection. All 27 cases were administrated Guguatiquwu with intravenous drip, and 21 cases （77.8%） had 50,75, 100 mg Guguatiquwu ＋ 0.9% sodium chloride injection or 250-500 ml 5% glucose injection. ADR of 20 cases （74.1% ） were found during the separate use of Guguatiquwu; others were found during the combined use of Guguatiquwu. ADR could affect multiple organs and .systems. Clinical manifestations included mainly pruritus, skin rash, erythematous eruption, adynamia, shiver, headache, febrile, hyperhidrosis, chest distress, palpitation, dyspnea, tachypnea, hyperspasmia, coeliodynia, nausea, vomiting and ernbescence. Severe allergic reactions could result in anaphylactic shock. Conclusion ADRs induced by Guguatiquwu injection can be severe.