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2017.HSA.doxorubicin.AC.vs.ADTIC
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==='''治疗方案 (Treatment protocol)'''=== 目的是在'''手术干预后 7-10 天内开始化疗'''。第 1 组的狗接受辅助多柔比星 (Doxorubicina, Ebewe Italia s.r.l., Roma, Italy) 和环磷酰胺 [Endoxan®, Baxter s.r.l., Lurago d'Erba, Como, Italy (AC)] 治疗,而第 2 组的狗接受辅助多柔比星和达卡巴嗪 [Deticene®, Aventis Pharma S.p.A, Milano, Italy (ADTIC)]。与 AC 相比,ADTIC 更昂贵,并且由于该研究没有得到资助,因此无法随机分组。由于与传统的 AC 协议相比,ADTIC 在进行本研究时完全处于研究阶段,因此所有选择 ADTIC 的业主都被要求在注册前签署书面知情同意书。 The objective was to initiate chemotherapy within 7–10 days after surgical intervention. Dogs included in group 1 were treated with adjuvant doxorubicin (Doxorubicina, Ebewe Italia s.r.l., Roma, Italy) and cyclophosphamide [Endoxan®, Baxter s.r.l., Lurago d’Erba, Como, Italy (AC)], whereas dogs included in group 2 received adjuvant doxorubicin and dacarbazine [Deticene®, Aventis Pharma S.p.A, Milano, Italy (ADTIC)]. ADTIC was more expensive compared with AC, and as the study was not supported by a grant, groups could not be randomized. Because ADTIC was completely investigational at the time this study was carried out compared with the traditional AC protocol, all owners electing ADTIC were asked to sign a written informed consent prior to enrolment. 在任一治疗组中,阿霉素以 30 mg/m^2 的剂量静脉注射,每 3 周一次,持续四个周期。阿霉素在 20 分钟内以缓慢静脉推注给药。 In either treatment groups, doxorubicin was administered IV at the dose of 30 mg/m^2 every 3 weeks for four cycles. Doxorubicin was administered as a slow IV bolus within 20 min. 在第 1 组中,环磷酰胺以 75 mg/m^2 口服给药,连续 4 天,从每次阿霉素给药当天开始。在第 2 组中,达卡巴嗪以 200 mg/m^2 的剂量静脉注射(每天不超过 250 mg),每天一次,持续 5 天,从每次多柔比星给药之日开始。简言之,将达卡巴嗪与注射用水复溶,以获得10mg/mL的浓度。然后通过先前放置的留置导管静脉输注 1 分钟以上给药复溶药物,以给予多柔比星。然后移除导管,并在接下来的四次给药中反复放置新导管。表1.30列出了两种方案的分数和总和剂量强度(SDI) In group 1, cyclophosphamide was administered orally at 75 mg/m^2 for 4 consecutive days, starting on the day of every doxorubicin administration. In group 2, dacarbazine was administered IV at the dose of 200 mg/m^2 (without exceeding 250 mg total daily) once daily for 5 days, starting on the day of every doxorubicin administration. Briefly, dacarbazine was reconstituted with water for injection to obtain a concentration of 10 mg mL−1. Reconstituted drug was then given by intravenous infusion over 1 min via the indwelling catheter previously placed to administer doxorubicin. The catheter was then removed, and a new catheter was repeatedly placed for the following four administrations. Fractional and summation dose intensities (SDIs) for the two protocols are listed in Table 1.[30] [[文件:2017.HSA.doxorubicin.AC.vs.ADTIC.01.png]] 在任一组中,'''标准止吐治疗包括从化疗第一天开始连续 3 天'''以 2 mg/kg q24h 的剂量口服'''马罗匹坦 (maropitant)'''(赛瑞宁 Cerenia®、Pfizer、Latina、Italy)。'''克拉维酸增强阿莫西林'''(Synulox®,辉瑞,拉丁,意大利)以 12.5-20 mg/kg q12h 的频率预防性口服给药,直到预期的中性粒细胞减少性最低点,此后如图所示。抗生素剂量取决于临床医生的偏好。 In either group, standard antiemetic therapy consisted in maropitant (Cerenia®, Pfizer, Latina, Italy) administered orally at the dose of 2 mg kg−1 q24h for 3 consecutive days starting on the first day of chemotherapy. Clavulanate-potentiated amoxicillin (Synulox®, Pfizer, Latina, Italy) was prophylactically administered orally at 12.5–20 mg kg−1 q12h until the time of the expected neutropenic nadir, and as indicated thereafter. Antibiotic dosage depended on clinician’s preference. 在两个周期的化疗后,进行了重复的临床分期检查,包括胸片和腹部超声检查。如果没有观察到局部复发和/或转移性疾病,则将相同的化疗方案继续两个周期。在疾病进展的情况下,提供了抢救方案。随访重新分期包括在方案结束后 1 个月和之后每 3 个月进行一次胸片和腹部超声检查,以确定对治疗的反应。 A repeated clinical staging work-up consisting of thoracic radiographs and abdominal ultrasoundo was performed after two cycles of chemotherapy. If no local recurrence and/or metastatic disease were observed, the same chemotherapy protocol was continued for two additional cycles. In case of disease progression, a rescue protocol was offered. Follow-up re-staging consisted of thoracic radiographs and abdominal ultrasound performed 1 month after the end of the protocol and every 3 months afterwards to define response to treatment. '''NOTES:''' <source lang=bash> Group 1 & 2: 多柔比星 30 mg/m^2 的剂量静脉注射,每 3 周一次,持续 4 个周期。多柔比星在 20 分钟内以缓慢静脉推注给药。 Group 1: 从每次多柔比星给药当天开始,环磷酰胺以 75 mg/m^2 口服给药,连续 4 天。每个疗程总剂量为 75x4 = 300 mg/m^2 Group 2: 从每次多柔比星给药当天开始,达卡巴嗪以 200 mg/m^2 的剂量静脉注射(每天不超过 250 mg),每天一次,持续 5 天。每个疗程总剂量为 1000 mg/m^2 将达卡巴嗪与注射用水复溶,以获得10mg/mL的浓度。然后通过先前放置的留置导管静脉输注 1 分钟以上给药复溶药物,以给予多柔比星。然后移除导管,并在接下来的四次给药中反复放置新导管。 '''标准止吐治疗''' 从化疗第一天开始连续 3 天以 2 mg/kg q24h 的剂量口服'''马罗匹坦 (maropitant)'''(赛瑞宁 Cerenia®、Pfizer、Latina、Italy)。 '''克拉维酸增强阿莫西林'''(速诺 Synulox®,辉瑞,拉丁,意大利)以 12.5-20 mg/kg q12h 的频率预防性口服给药,直到预期的中性粒细胞减少性最低点。抗生素剂量取决于临床医生的偏好。 </source> <br>
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