Smith T J, Coyne P J, Staats P S, Deer T, Stearns L J, Rauck R L, Boortz-Marx R L, Buchser E, Català E, Bryce D A, Cousins M, Pool G E
Massey Cancer Center of Virginia Commonwealth University and other institutions, Richmond, VA 23298, USA.
Ann Oncol. 2005 May;16(5):825-33. doi: 10.1093/annonc/mdi156. Epub 2005 Apr 7.
The randomized clinical trial of implantable drug delivery systems (IDDS) plus comprehensive medical management (CMM) versus CMM alone showed better clinical success at 4 weeks for IDDS patients. This 'as treated' analysis assessed if improvements in pain control, drug toxicity and survival were maintained over time.
We compared those who received IDDS with those who did not receive IDDS (non-IDDS). All patients had Visual Analogue Scores (VAS) for pain > or =5/10 on at least 200 mg morphine or equivalent daily.
At 4 weeks, 46 of 52 (88.5%) IDDS patients achieved clinical success compared with 65 of 91 (71.4%; P=0.02) non-IDDS patients, and more often achieved > or =20% reduction in both pain VAS and toxicity [35 of 52 (67.3%) versus 33 of 91 patients (36.3%); P=0.0003]. By 12 weeks, 47 of 57 (82.5%) IDDS patients had clinical success compared with 35 of 45 (77.8%; P=0.55) non-IDDS patients, and more often had a > or =20% reduction in both pain VAS and toxicity [33 of 57 (57.9%) versus 15 of 45 patients (33.3%); P=0.01]. At 12 weeks the IDDS VAS pain scores decreased from 7.81 to 3.89 (47% reduction) compared with 7.21 to 4.53 for non-IDDS patients (42% reduction; P=0.23). The 12 week drug toxicity scores for IDDS patients decreased from 6.68 to 2.30 (66% reduction), and for non-IDDS patients from 6.73 to 4.13 (37% reduction; P=0.01). All individual drug toxicities improved with IDDS at both 4 and 12 weeks. At 6 months, only 32% of the group randomized to CMM and who did not cross over to IDDS were alive, compared with 52%-59% for patients in those groups who received IDDS.
IDDS improved clinical success, reduced pain scores, relieved most toxicity of pain control drugs, and was associated with increased survival for the duration of this 6 month trial.
可植入药物输送系统（IDDS）联合综合药物管理（CMM）与单纯CMM的随机临床试验表明，IDDS患者在4周时临床成功率更高。这项“实际治疗”分析评估了疼痛控制、药物毒性和生存率的改善是否随时间得以维持。
我们将接受IDDS治疗的患者与未接受IDDS治疗的患者（非IDDS组）进行了比较。所有患者的视觉模拟评分（VAS）显示，疼痛程度在≥5/10，且每日至少服用200毫克吗啡或等效药物。
4周时，52例IDDS患者中有46例（88.5%）取得临床成功，相比之下，91例非IDDS患者中有65例（71.4%；P=0.02）取得成功，且IDDS组患者疼痛VAS评分和毒性降低≥20%的情况更为常见[52例中有35例（67.3%），而91例患者中有33例（36.3%）；P=0.0003]。到12周时，57例IDDS患者中有47例（82.5%）取得临床成功，相比之下，45例非IDDS患者中有35例（77.8%；P=0.55）取得成功，且IDDS组患者疼痛VAS评分和毒性降低≥20%的情况更为常见[57例中有33例（57.9%），而45例患者中有15例（33.3%）；P=0.01]。12周时，IDDS组的VAS疼痛评分从7.81降至3.89（降低47%），而非IDDS组患者从7.21降至4.53（降低42%；P=0.23）。IDDS组患者12周时的药物毒性评分从6.68降至2.30（降低66%），而非IDDS组患者从6.73降至4.13（降低37%；P=0.01）。在4周和12周时，IDDS治疗使所有个体药物毒性均得到改善。6个月时，随机分配至CMM组且未交叉接受IDDS治疗的患者中，只有32%存活，而接受IDDS治疗的组中，这一比例为52%-59%。
在这项为期6个月的试验中，IDDS提高了临床成功率，降低了疼痛评分，减轻了大部分疼痛控制药物的毒性，并与生存率提高相关。
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