Kongkam Pradermchai, Wagner Dennis L, Sherman Stuart, Fogel Evan L, Whittaker Stephanie C, Watkins James L, McHenry Lee, Lehman Glen A
Indiana University Medical Center, Indianapolis, Indiana 46202, USA.
Am J Gastroenterol. 2009 May;104(5):1249-55. doi: 10.1038/ajg.2009.54. Epub 2009 Apr 14.
The aim of this study was to evaluate the efficacy of intrathecal narcotics pump (ITNP) as an alternative treatment for patients with pain from chronic pancreatitis (CP). ITNP offers the advantages of reversibility, lower total narcotic dose, and the pancreas remaining intact.
Thirteen patients (8 female, 5 male), with mean age 40.6 years (s.d. 9.6 years), who had experienced intractable upper abdominal pain from CP were reviewed. Each patient had multiple other failed treatment modalities, including partial pancreatic resection (n = 6). They were offered ITNP after a successful intraspinal opioid trial. Etiologies of CP included idiopathy (n = 3), cystic fibrosis (n = 2), alcohol (n = 2), and pancreas divisum (n = 6).
The median duration of severe, intractable pain prior to ITNP was 6 years (2-22 years). The median follow-up time after ITNP was 29 months (range, 7-94 months). The ITNP was in situ for a mean duration of 29 months (range, 0.5-94 months). Seven patients had pump exchange or removal for various reasons; improvement of pain at month 53 (n = 1), meningitis (n = 1), meningitis with subsequent replacement (n = 1), pump failure at month 31, 68, 79, and 84 (n = 4). There were no deaths. The mean pain score prior to implantation (score = 8.3, s.d. = 0.9) was significantly higher than 1 year after (score = 2.7, s.d. = 1.9) (P < 0.01) and last follow-up (score = 0.75, s.d. = 2.1) (P < 0.01). The median oral narcotic dose before and 1 year after ITNP were morphine sulfate equivalents 337.5 mg per day (range, 67.5-1,320) and 40 mg per day (range, 0-1,680), respectively (P < 0.01). Two patients were considered failures, as they still require a high dosage of both oral and intrathecal medications to control their pain, despite significant pain-score improvement. One patient who was excluded due to meningitis was also considered a failure. Therefore, the overall success rate of ITNP based on an intention-to-treat analysis was 76.9% (10/13). The major complications of ITNP were central nervous system infection requiring pump removal (n = 1), cerebrospinal fluid leak requiring laminectomy (n = 1), and perispinal abscess with bacterial meningitis requiring pump removal (n = 1).
This study shows the many risks and benefits of ITNP. A longer follow-up is awaited; such pumps appear to be one alternative to aggressive surgical intervention. Failed ITNP trials leave other options open. Therapeutic trials directly comparing pancreatectomy, ITNP, and implanted nerve stimulators are of interest.
本研究旨在评估鞘内麻醉泵（ITNP）作为慢性胰腺炎（CP）疼痛患者替代治疗方法的疗效。ITNP具有可逆性、总麻醉剂量较低以及胰腺保持完整等优点。
回顾了13例（8例女性，5例男性）平均年龄40.6岁（标准差9.6岁）、因CP经历顽固性上腹部疼痛的患者。每位患者都有多种其他治疗方式失败，包括部分胰腺切除术（6例）。在脊髓内阿片类药物试验成功后，为他们提供了ITNP。CP的病因包括特发性（3例）、囊性纤维化（2例）、酒精性（2例）和胰腺分裂症（6例）。
ITNP植入前严重顽固性疼痛的中位持续时间为6年（2 - 22年）。ITNP植入后的中位随访时间为29个月（范围7 - 94个月）。ITNP在位的平均持续时间为29个月（范围0.5 - 94个月）。7例患者因各种原因进行了泵更换或移除；53个月时疼痛改善（1例）、脑膜炎（1例）、脑膜炎后更换（1例）、31、68、79和84个月时泵故障（4例）。无死亡病例。植入前的平均疼痛评分（评分=8.3，标准差=0.9）显著高于1年后（评分=2.7，标准差=1.9）（P<0.01）和最后随访时（评分=0.75，标准差=2.1）（P<0.01）。ITNP植入前和1年后口服麻醉剂的中位剂量分别为硫酸吗啡当量每天337.5毫克（范围67.5 - 1320）和每天40毫克（范围0 - 1680）（P<0.01）。2例患者被认为治疗失败，因为尽管疼痛评分有显著改善，但他们仍需要高剂量的口服和鞘内药物来控制疼痛。1例因脑膜炎被排除的患者也被认为治疗失败。因此，基于意向性分析的ITNP总体成功率为76.9%（10/13）。ITNP的主要并发症包括需要移除泵的中枢神经系统感染（1例）、需要椎板切除术的脑脊液漏（1例）以及伴有细菌性脑膜炎需要移除泵的椎旁脓肿（1例）。
本研究显示了ITNP的诸多风险和益处。有待更长时间的随访；此类泵似乎是积极手术干预的一种替代方法。ITNP试验失败后还有其他选择。直接比较胰腺切除术、ITNP和植入式神经刺激器的治疗试验很有意义。
