Department of Pharmacology, University of Florence, Tuscan Regional Centre of Pharmacovigilance, Florence, Italy.
Drug Saf. 2010 Sep 1;33(9):789-99. doi: 10.2165/11536810-000000000-00000.
Fluoroquinolones are widely used both in primary care and in hospital settings. Since the last comparison performed in Italy on the safety profiles of different fluoroquinolones, a new molecule, prulifloxacin, has been introduced into the market and several warnings concerning this class of drugs have been released. The aim of this study was to reassess the safety profiles of fluoroquinolones using the database of the Italian Interregional Group of Pharmacovigilance (IGP) and the administrative data of fluoroquinolone prescriptions.
All adverse drug reactions (ADRs) reported in four Italian regions (Lombardy, Veneto, Emilia Romagna and Tuscany) were retrieved from the IGP database. Consumption data (defined daily dose [DDD]/1000 inhabitants/day) were used as denominators. Both single reports and all ADRs (classified by System Organ Classes and MedDRA Preferred Term [PT]) due to fluoroquinolones were considered as numerators of each analysis, comparing two periods (2005 vs 2006). All fluoroquinolones with at least ten reports per year were included in the analysis.
On the basis of 272 reports (532 single ADRs or PTs), patients did not show any statistically significant differences between 2005 and 2006 in terms of sex, age and number of concurrent medications. After adjustment for drug consumption, moxifloxacin showed the highest reporting rate (84.6 reports/DDD/1000 inhabitants/day; 15.4 serious reports/DDD/1000 inhabitants/day) followed by prulifloxacin (72.2; 22.2 serious) and levofloxacin (55.3; 30.6 serious) in 2005. An increment of ADR/report rates was observed over the 2 years for all fluoroquinolones except prulifloxacin, which had the lowest ADR reporting rate in 2006 (25.0; 12.5 serious). In 2006, the rate of serious ADRs associated with prulifloxacin was lower than with ciprofloxacin, while in 2005 serious events were almost equal for both compounds (55.6 vs 47.6 serious ADRs/DDD/1000 inhabitants/day). Ciprofloxacin showed the highest proportion of cutaneous PTs (e.g. rash, exanthema). Tendinopathies were mainly due to levofloxacin.
These data suggest that different fluoroquinolones are characterized by different rates and types of ADRs. Among them, prulifloxacin was associated with more ADRs than other fluoroquinolones in 2005 but with fewer ADRs in 2006, when its consumption increased. Although these findings may represent an encouraging perspective towards a more appropriate use of fluoroquinolones because of their individual safety profiles, further pharmacoepidemiological studies must be performed to substantiate these results.
氟喹诺酮类药物在初级保健和医院环境中都被广泛使用。自意大利上一次对不同氟喹诺酮类药物的安全性进行比较以来，一种新的药物普鲁氟沙星已被引入市场，并且针对该类药物发布了几项警告。本研究旨在使用意大利区域间药物警戒组（IGP）数据库和氟喹诺酮类药物处方的行政数据重新评估氟喹诺酮类药物的安全性概况。
从 IGP 数据库中检索了在意大利四个地区（伦巴第、威尼托、艾米利亚-罗马涅和托斯卡纳）报告的所有药物不良反应（ADR）。使用消费数据（定义日剂量[DDD]/1000 居民/天）作为分母。将单一报告和所有因氟喹诺酮类药物引起的 ADR（按系统器官类别和 MedDRA 首选术语[PT]分类）均视为每个分析的分子，比较两个时期（2005 年与 2006 年）。将每年至少有 10 份报告的所有氟喹诺酮类药物均纳入分析。
基于 272 份报告（532 份单一 ADR 或 PT），2005 年和 2006 年患者在性别、年龄和同时使用的药物数量方面无统计学显著差异。在调整药物消费后，莫西沙星显示出最高的报告率（84.6 份报告/DDD/1000 居民/天；15.4 份严重报告/DDD/1000 居民/天），其次是普鲁氟沙星（72.2；22.2 份严重）和左氧氟沙星（55.3；30.6 份严重）在 2005 年。除普鲁氟沙星外，所有氟喹诺酮类药物在 2 年内的 ADR/报告率均有所增加，而普鲁氟沙星在 2006 年的 ADR 报告率最低（25.0；12.5 份严重 ADR/DDD/1000 居民/天）。2006 年，与普鲁氟沙星相关的严重 ADR 率低于环丙沙星，而 2005 年，两种化合物的严重事件几乎相等（55.6 比 47.6 份严重 ADR/DDD/1000 居民/天）。环丙沙星显示出最高比例的皮肤 PT（例如皮疹、疹）。肌腱病主要与左氧氟沙星有关。
这些数据表明，不同的氟喹诺酮类药物具有不同的 ADR 发生率和类型。其中，普鲁氟沙星在 2005 年的 ADR 发生率高于其他氟喹诺酮类药物，但在 2006 年其消费增加时 ADR 发生率较低。尽管这些发现可能代表着朝着更适当使用氟喹诺酮类药物的方向迈出了令人鼓舞的一步，因为它们具有各自的安全性概况，但必须进行进一步的药物流行病学研究来证实这些结果。
