Department of Gastroenterology, Petz Aladár County and Teaching Hospital, 9024 Győr, Hungary.
World J Gastroenterol. 2013 Feb 14;19(6):889-96. doi: 10.3748/wjg.v19.i6.889.
To investigate the effect of mesalazine granules on small intestinal injury induced by naproxen using capsule endoscopy (CE).
This was a single center, non-randomized, open-label, uncontrolled pilot study, using the PillCam SB CE system with RAPID 5 software. The Lewis Index Score (LIS) for small bowel injury was investigated to evaluate the severity of mucosal injury. Arthropathy patients with at least one month history of daily naproxen use of 1000 mg and proton pump inhibitor co-therapy were screened. Patients with a minimum LIS of 135 were eligible to enter the 4-wk treatment phase of the study. During this treatment period, 3 × 1000 mg/d mesalazine granules were added to ongoing therapies of 1000 mg/d naproxen and 20 mg/d omeprazole. At the end of the 4-wk combined treatment period, a second small bowel CE was performed to re-evaluate the enteropathy according to the LIS results. The primary objective of this study was to assess the mucosal changes after 4 wk of mesalazine treatment.
A total of 18 patients (16 females), ranging in age from 46 to 78 years (mean age 60.3 years) were screened, all had been taking 1000 mg/d naproxen for at least one month. Eight patients were excluded from the mesalazine therapeutic phase of the study for the following reasons: the screening CE showed normal small bowel mucosa or only insignificant damages (LIS < 135) in five patients, the screening esophagogastroduodenoscopy revealed gastric ulcer in one patient, capsule technical failure and incomplete CE due to poor small bowel cleanliness in two patients. Ten patients (9 female, mean age 56.2 years) whose initial LIS reached mild and moderate-to-severe enteropathy grades (between 135 and 790 and ≥ 790) entered the 4-wk therapeutic phase and a repeat CE was performed. When comparing the change in LIS from baseline to end of treatment in all patients, a marked decrease was seen (mean LIS: 1236.4 ± 821.9 vs 925.2 ± 543.4, P = 0.271). Moreover, a significant difference between pre- and post-treatment mean total LIS was detected in 7 patients who had moderate-to-severe enteropathy gradings at the inclusion CE (mean LIS: 1615 ± 672 vs 1064 ± 424, P = 0.033).
According to the small bowel CE evaluation mesalazine granules significantly attenuated mucosal injuries in patients with moderate-to-severe enteropathies induced by naproxen.
使用胶囊内镜（CE）研究美沙拉嗪颗粒对萘普生引起的小肠损伤的影响。
这是一项单中心、非随机、开放标签、非对照的初步研究，使用配备 RAPID 5 软件的 PillCam SB CE 系统。使用小肠损伤的 Lewis 指数评分（LIS）评估黏膜损伤的严重程度。筛选至少有一个月每天使用 1000mg 萘普生和质子泵抑制剂联合治疗史的关节炎患者。最小 LIS 为 135 的患者有资格进入研究的 4 周治疗阶段。在治疗期间，将 3×1000mg/d 的美沙拉嗪颗粒添加到正在进行的 1000mg/d 萘普生和 20mg/d 奥美拉唑治疗中。在 4 周联合治疗结束时，根据 LIS 结果再次进行第二次小肠 CE 以重新评估肠病。本研究的主要目的是评估 4 周美沙拉嗪治疗后的黏膜变化。
共筛选了 18 名（16 名女性）年龄在 46 至 78 岁之间（平均年龄 60.3 岁）的患者，他们均至少服用 1000mg/d 的萘普生一个月。8 名患者因以下原因被排除在美沙拉嗪治疗阶段之外：5 名患者的筛查 CE 显示小肠黏膜正常或仅存在轻微损伤（LIS<135），1 名患者的筛查食管胃十二指肠镜检查显示胃溃疡，2 名患者因胶囊技术失败和小肠清洁度差导致不完全 CE。10 名患者（9 名女性，平均年龄 56.2 岁）的初始 LIS 达到轻度和中度至重度肠病分级（135 至 790 和≥790），进入 4 周治疗阶段并进行重复 CE。当比较所有患者从基线到治疗结束时 LIS 的变化时，发现明显下降（平均 LIS：1236.4±821.9 与 925.2±543.4，P=0.271）。此外，在纳入 CE 时患有中重度肠病分级的 7 名患者中，治疗前后的平均总 LIS 差异有统计学意义（LIS：1615±672 与 1064±424，P=0.033）。
根据小肠 CE 评估，美沙拉嗪颗粒可显著减轻萘普生引起的中重度肠病患者的黏膜损伤。
