Barabino A, Torrente F, Castellano E, Gandullia P, Calvi A, Cucchiara S, De G L, Fontana M, Lionetti P, De Giacomo C, Gissi A
Pediatric Gastroenterology, G Gaslini Institute, Genoa, Italy.
Aliment Pharmacol Ther. 2002 Aug;16(8):1503-7. doi: 10.1046/j.1365-2036.2002.01308.x.
To asses the efficacy and safety of ciclosporin in a paediatric population with inflammatory bowel disease.
Twenty-three Italian children treated with ciclosporin were studied retrospectively. The indications for treatment were severe unresponsive colitis, chronic active colitis or severe fistulizing Crohn's disease. The treatment duration, follow-up and causes of drug discontinuation were assessed.
Sixteen patients were treated intravenously for a mean time of 10 +/- 7 days (1-24 days) and 19 orally for a mean time of 133 days (17-660 days). The mean follow-up of all patients was 13.2 months. Ciclosporin was totally ineffective, being discontinued for surgery, in nine of 23 patients (39%); it was discontinued for partial response in three patients (13%). During treatment, clinical remission was achieved in eight children (35%) and maintained after drug withdrawal in four (17%). In severe unresponsive colitis, urgent colectomy was avoided in 12 (85%) of 14 patients who tolerated the drug. Side-effects appeared in six of 23 patients (26%), and three (13%) required ciclosporin to be discontinued due to neurotoxicity.
Ciclosporin shows disappointing long-term results in the treatment of refractory inflammatory bowel disease, but can play an important role in preventing urgent surgery in unresponsive severe colitis. Severe side-effects can occur.
评估环孢素在儿童炎症性肠病患者中的疗效和安全性。
对23例接受环孢素治疗的意大利儿童进行回顾性研究。治疗指征为严重难治性结肠炎、慢性活动性结肠炎或严重瘘管性克罗恩病。评估治疗持续时间、随访情况及停药原因。
16例患者接受静脉治疗，平均治疗时间为10±7天（1 - 24天）；19例接受口服治疗，平均治疗时间为133天（17 - 660天）。所有患者的平均随访时间为13.2个月。23例患者中有9例（39%）环孢素完全无效，因手术停药；3例（13%）因部分缓解停药。治疗期间，8例儿童（35%）实现临床缓解，停药后4例（17%）仍维持缓解。在严重难治性结肠炎中，14例耐受该药物的患者中有12例（85%）避免了紧急结肠切除术。23例患者中有6例（26%）出现副作用，3例（13%）因神经毒性需要停用环孢素。
环孢素在治疗难治性炎症性肠病方面显示出令人失望的长期效果，但在预防难治性严重结肠炎的紧急手术中可发挥重要作用。可能会出现严重副作用。
