Luman W, Ghosh S, Palmer K R
Gastrointestinal Unit, Western General Hospital, Edinburgh, United Kingdom.
Gastrointest Endosc. 1999 Mar;49(3 Pt 1):316-21. doi: 10.1016/s0016-5107(99)70007-6.
Endoscopic insertion of biliary prostheses is now an established palliative treatment for frail and elderly patients with distal extrahepatic malignant biliary strictures who are unable to tolerate major surgery. The major limitation to long-term biliary stenting is late stent occlusion caused by bacterial adherence followed by encrustation with amorphous bacterial products. We studied the effect on the duration of stent patency of combination therapy with ciprofloxacin and Rowachol, a choleretic agent, in a group of patients who underwent stent insertion for extrahepatic malignant biliary strictures.
Patients with this diagnosis were randomized to either active treatment with ciprofloxacin (500 mg twice daily) and Rowachol (2 tablets 3 times daily) or no drug treatment (control group). They were followed up prospectively and the end points of the study were stent occlusion and patient survival.
Forty-eight patients who had successful stent placement were recruited; 8 patients were excluded from the final analysis because of death in less than 1 month (5 patients) or stent replacement within a month because of persistent jaundice (3 patients). Twenty patients were randomized to the active and control groups. One patient in the active group withdrew because of nausea. The 2 groups were comparable with regard to age, gender, causes of extrahepatic malignant biliary strictures, and levels of serum alkaline phosphatase and bilirubin. There were significant reductions in mean serum bilirubin and alkaline phosphatase concentrations 1 month after stent placement. At the time of analysis, 12 patients were still alive (7 patients from the control group). Median survival was 23 weeks in both the active treatment group and the control group. There were 9 episodes (45%) of stent occlusions in the active treatment group and 10 episodes (50%) in the control group. The median time to stent occlusion was 23 (range 7 to 68) weeks for the active treatment group and 21 (range 6 to 56) weeks for the control group, p = 0.23. There was no significant difference in the duration of patient survival and of stent patency between the 2 groups. The lack of difference between treated and untreated patients in survival duration and stent patency was also shown if the results were analyzed on an intent-to-treat basis and the 8 patients who were excluded in the final analysis were also analyzed.
Prophylactic therapy with ciprofloxacin and Rowachol does not prolong stent patency or patient survival.
对于无法耐受大手术的肝外远端恶性胆管狭窄的体弱和老年患者，内镜下置入胆管支架现已成为一种既定的姑息治疗方法。长期胆管支架置入的主要限制是细菌黏附随后被无定形细菌产物结痂导致的晚期支架闭塞。我们研究了环丙沙星与利胆剂消胆胺联合治疗对一组因肝外恶性胆管狭窄接受支架置入患者的支架通畅持续时间的影响。
诊断为此病的患者被随机分为接受环丙沙星（每日两次，每次500毫克）和消胆胺（每日3次，每次2片）的积极治疗组或不接受药物治疗的对照组。对他们进行前瞻性随访，研究的终点是支架闭塞和患者生存。
招募了48例成功置入支架的患者；8例患者因在不到1个月内死亡（5例）或因持续性黄疸在1个月内进行支架置换（3例）而被排除在最终分析之外。20例患者被随机分为积极治疗组和对照组。积极治疗组中有1例患者因恶心退出。两组在年龄、性别、肝外恶性胆管狭窄的病因以及血清碱性磷酸酶和胆红素水平方面具有可比性。支架置入后1个月，平均血清胆红素和碱性磷酸酶浓度显著降低。在分析时，12例患者仍存活（对照组7例）。积极治疗组和对照组的中位生存期均为23周。积极治疗组有9次（45%）支架闭塞事件，对照组有10次（50%）。积极治疗组支架闭塞的中位时间为23（7至68）周，对照组为21（6至56）周，p = 0.23。两组患者的生存持续时间和支架通畅持续时间没有显著差异。如果按照意向性分析原则进行结果分析，并对最终分析中排除的8例患者也进行分析，也显示出治疗组和未治疗组在生存持续时间和支架通畅方面没有差异。
环丙沙星和消胆胺的预防性治疗不会延长支架通畅时间或患者生存期。
