Radal M, Bera A P, Leisner C, Haillot O, Autret-Leca E
Centre Régional de Pharmacovigilance, CHRU Bretonneau, Hôpital Bretonneau, Tours, France.
Therapie. 1999 Mar-Apr;54(2):233-6.
The aim of this study was to evaluate the frequency and the gravity of Trans Urethral Resection of the Prostate Syndrome or 'TURP Syndrome,' which occurs when irrigating fluids containing 1.5 per cent glycocolle are used. All the adverse effects that occurred with 5 products containing 1.5 per cent glycocolle which were notified to the pharmacovigilance structures in France were reviewed. The adverse effects notified comprised 24 cases of TURP Syndrome and 5 of renal failure. TURP Syndrome consisted of neurological signs (92 per cent); cardiovascular signs (54 per cent); visual disturbance (42 per cent) and digestive signs (25 per cent). Hyponatraemia occurred in all patients (mean 113 +/- 6 mmol.l-1) and 25 per cent of patients died. In 27 per cent of cases TURP Syndrome occurred when glycocolle was in contravention of AMM guidelines. The Drugs Agency has requested that modification be included in the Vidal pharmacopoeia (warnings and adverse reactions) and on glycocolle bags and that surgeons and anaesthetists be informed.
本研究的目的是评估前列腺综合征或“经尿道前列腺切除术（TURP）综合征”的发生频率和严重程度，该综合征在使用含1.5%氨基乙酸的灌洗液时出现。对法国药物警戒机构收到通知的5种含1.5%氨基乙酸产品所引发的所有不良反应进行了审查。所通报的不良反应包括24例TURP综合征和5例肾衰竭。TURP综合征的症状包括神经体征（92%）、心血管体征（54%）、视觉障碍（42%）和消化系统体征（25%）。所有患者均出现低钠血症（平均113±6 mmol·l-1），25%的患者死亡。在27%的病例中，TURP综合征发生在氨基乙酸违反法国药品法典指南的情况下。药品管理局已要求在《维达尔药典》（警告和不良反应）以及氨基乙酸包装袋上进行修改，并告知外科医生和麻醉师。
