Dahm P, Nitescu P, Appelgren L, Curelaru I
Department of Anesthesiology, Sahlgrenska University Hospital, Göteborg University, Gothenburg, Sweden.
Clin J Pain. 1998 Mar;14(1):4-16. doi: 10.1097/00002508-199803000-00003.
To compare efficacies, failure rates, and technical complication rates of intraspinal treatments in patients with "refractory" nonmalignant pain conditions in relation to the approach (epidural/intrathecal), the drug (opioid/opioid-bupivacaine or bupivacaine), and the type of system used (externalized/internalized). In these comparisons, recent data from a companion paper (Nitescu et al., Clin J Pain 1998;14:17-28) were used as a reference to be compared with data from a literature review of different intraspinal treatment modalities in nonmalignant pain.
Prospective, cohort, nonrandomized, consecutive trial.
Tertiary care center, institutional practice, hospitalized, and ambulatory care.
Five groups according to treatment modality: (a) externalized, long-term intrathecal nylon catheters, connected to external, electronic infusion pumps (companion paper), n = 90; (b) internalized, long-term intrathecal catheters (Silastic) connected to implanted SynchroMed pumps, n = 330 (literature review); (c) externalized, "short-term" epidural catheters for "temporary" infusions, n = 565 (literature review); (d) externalized, long-term epidural catheters, n = 50 (literature review); (e) internalized, long-term epidural catheters, n = 111, connected to implanted systems: Port-A-Cath injection ports, n = 58; Infusaid pumps, n = 46; and SynchroMed pumps, n = 7 (literature review).
In reviewing the literature, we found 21 studies that reported on the intraspinal (epidural or intrathecal) administration of opioids with or without local anesthetics (usually bupivacaine). These studies were analyzed with respect to the rates of the variables satisfactory pain relief (efficacy), failures, and technical complications. A rate is the number of observations of a variable divided by the number of patients or the number of catheters or infusion systems, as logically indicated (e.g., the numbers of complications, such as epidural abscess and meningitis, were related to the number of patients and those of catheter occlusion or leakage to the number of the catheters). The variables were expressed as the means of the rates of a variable from studies belonging to various treatment modalities: approach (epidural vs. intrathecal), duration (short vs. long term), drugs administered intraspinally (opioid vs. opioid and/or local anesthetic), and type of infusion system (externalized vs. internalized). Further, the sums of all observations of one variable in different studies with various treatment modalities were related to the corresponding sums of the patients (alternatively, catheters or implanted devices). The proportions of these sums were tested for significance in relation to treatment modality.
Comparative rates of successful intraspinal treatment and its failures and complications.
(a) The intrathecal approach, compared with the epidural approach, was associated with higher rates of satisfactory pain relief for both externalized (86/90, 95% vs. 17/40, 42.5%, p < .0001) and internalized (295/336, 89% vs. 33/56, 59%, p < .0001) catheters; higher rates of treatment failures with externalized epidural catheters than with internalized intrathecal catheters (24/47, 51%, vs. 36/338, 11%, p < .0001); lower rates of treatment failures with internalized intrathecal catheters than with internalized epidural catheters (36/338, 11% vs. 29/76, 38%, p < .0001); higher rates of system replacement with internalized epidural catheters than with internalized intrathecal catheters (23/32, 72% vs. 6/49, 12%, p < .0001; higher rates of system removal with internalized epidural catheters than with internalized intrathecal catheters (22/49, 45% vs. 5/49, 10%, p < .001); higher rates of catheter-related complications with epidural than with intrathecal catheters (dislodgement 13/126, approximately 10% vs. 6/150, 4%, p < .05; leakage 5/51, approximately 10% vs. 1/116, 0.9%, p < .05; obstruction 2
比较“难治性”非恶性疼痛患者椎管内治疗的疗效、失败率和技术并发症发生率，这些比较涉及治疗途径（硬膜外/鞘内）、药物（阿片类药物/阿片 - 布比卡因或布比卡因）以及所用系统类型（外置/内置）。在这些比较中，将一篇配套论文（Nitescu等人，《临床疼痛杂志》1998年；14：17 - 28）中的近期数据用作参考，与非恶性疼痛不同椎管内治疗方式的文献综述数据进行比较。
前瞻性、队列、非随机、连续试验。
三级医疗中心、机构实践、住院及门诊护理。
根据治疗方式分为五组：（a）外置长期鞘内尼龙导管，连接到外部电子输液泵（配套论文），n = 90；（b）内置长期鞘内导管（硅橡胶材质），连接到植入式SynchroMed泵，n = 330（文献综述）；（c）外置“短期”硬膜外导管用于“临时”输注，n = 565（文献综述）；（d）外置长期硬膜外导管，n = 50（文献综述）；（e）内置长期硬膜外导管，n = 111，连接到植入系统：Port - A - Cath注射端口，n = 58；Infusaid泵，n = 46；SynchroMed泵，n = 7（文献综述）。
在回顾文献时，我们发现21项研究报告了椎管内（硬膜外或鞘内）给予阿片类药物加或不加局部麻醉剂（通常为布比卡因）的情况。对这些研究的变量进行分析，包括满意的疼痛缓解率（疗效）、失败率和技术并发症发生率。比率是一个变量的观察次数除以患者数量、导管数量或输液系统数量，具体依逻辑而定（例如，并发症数量，如硬膜外脓肿和脑膜炎，与患者数量相关；导管堵塞或渗漏数量与导管数量相关）。变量表示为属于各种治疗方式的研究中一个变量比率的均值：治疗途径（硬膜外与鞘内）、持续时间（短期与长期）、椎管内给药药物（阿片类药物与阿片类药物和/或局部麻醉剂）以及输液系统类型（外置与内置）。此外，不同治疗方式的不同研究中一个变量的所有观察值总和与相应的患者总和（或者导管或植入装置总和）相关。对这些总和的比例进行检验，以确定与治疗方式的相关性是否具有显著性。
椎管内治疗成功、失败及并发症的比较率。
（a）与硬膜外途径相比，鞘内途径无论是外置导管（86/90，95%对17/40，42.5%，p <.0001）还是内置导管（295/336，89%对33/56，59%，p <.0001），疼痛缓解满意度更高；外置硬膜外导管的治疗失败率高于内置鞘内导管（24/47，51%对36/338，11%，p <.0001）；内置鞘内导管的治疗失败率低于内置硬膜外导管（36/338，11%对29/76，38%，p <.0001）；内置硬膜外导管的系统更换率高于内置鞘内导管（23/32，72%对6/49，12%，p <.0001；内置硬膜外导管的系统移除率高于内置鞘内导管（22/49，45%对5/49，10%，p <.001）；硬膜外导管相关并发症发生率高于鞘内导管（移位13/126，约10%对6/150，4%，p <.05；渗漏5/51，约10%对1/116，0.9%，p <.05；堵塞2
