Ensminger W, Niederhuber J, Dakhil S, Thrall J, Wheeler R
Cancer Treat Rep. 1981 May-Jun;65(5-6):393-400.
A totally implanted drug delivery system for hepatic arterial chemotherapy was evaluated in 13 patients with metastatic (11 colon and one carcinoid) or primary (one hepatoma) cancer of the liver. During laparotomy, a Silastic catheter was positioned in the hepatic artery for infusion to the entire liver arterial vasculature as ascertained by low-flow radionuclide angiography with 99Tc-macroaggregated albumin. The catheter was connected to a subcutaneously implanted model 400 Infusaid pump (Metal Bellows Corp, Sharon, MA). Each pump had a 50-ml volume and a set rate (3--6 ml/day) and required refill every 8--16 days. A side port bypassed the pumping mechanism and allowed direct catheter injection for nuclide angiography, for bolus drug administration, or for clearing of a blocked catheter. Pump refills and side port injections were performed by percutaneous injection. The 13 patients in this ongoing study received a median of 6 months (range, 4.5--17) of continuous hepatic arterial infusion. The pump performed reliably with stable (+/- 10%) flow rates and only one malfunction in 2800 cumulative days of use. Flow distribution determined by low-flow radionuclide angiography did not change in 12 patients. Patient acceptance was excellent, with the ability to participate fully in normal daily activities. Eleven patients showed partial hepatic tumor regressions documented by physical examination and nuclide liver scans. All patients were treated with 5-fluorodeoxyuridine. Two patients failed 5-fluorodeoxyuridine therapy and subsequently responded briefly to dichloromethotrexate. This implanted system should facilitate future investigation of regional chemotherapy using these and other agents.
对13例肝转移癌（11例结肠癌和1例类癌）或原发性肝癌（1例肝癌）患者评估了一种完全植入式肝动脉化疗给药系统。在剖腹手术期间，将硅橡胶导管置于肝动脉内，通过用99Tc - 大颗粒聚合白蛋白进行低流量放射性核素血管造影确定其可向整个肝动脉血管系统输注。导管连接到皮下植入的400型Infusaid泵（金属波纹管公司，马萨诸塞州沙龙）。每个泵的容积为50毫升，设定速率为3 - 6毫升/天，每8 - 16天需要重新填充一次。一个侧端口绕过泵机制，允许直接进行导管注射以进行核素血管造影、推注给药或清除堵塞的导管。通过经皮注射进行泵的重新填充和侧端口注射。在这项正在进行的研究中的13例患者接受肝动脉持续输注的中位数为6个月（范围为4.5 - 17个月）。该泵性能可靠，流速稳定（±10%），在累计使用2800天中仅出现一次故障。12例患者经低流量放射性核素血管造影测定的血流分布未发生变化。患者接受度良好，能够充分参与正常日常活动。11例患者经体格检查和核素肝脏扫描记录显示肝肿瘤部分消退。所有患者均接受5 - 氟脱氧尿苷治疗。2例患者5 - 氟脱氧尿苷治疗失败，随后对二氯甲氨蝶呤有短暂反应。这种植入系统应有助于未来使用这些及其他药物进行区域化疗的研究。
