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昂丹司琼与格拉司琼预防急性淋巴细胞白血病患儿化疗引起的恶心和呕吐的比较。

Ondansetron versus granisetron in the prevention of chemotherapy induced nausea and vomiting in children with acute lymphoblastic leukemia.

作者信息

Siddique R, Hafiz M G, Rokeya B, Jamal C Y, Islam A

机构信息

Department of Pediatrics Haematology & Oncology, Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka, Bangladesh.

出版信息

Mymensingh Med J. 2011 Oct;20(4):680-8.

Abstract

Effect of ondansetron and granisetron were evaluated in sixty (60) children (age 4-11 years) irrespective of sex, diagnosed case of acute lymphoblastic leukemia (ALL) who received high dose methotrexate and did not receive any antiemetic 24 hours prior to HDMTX. This was a prospective, randomized, double-blind, single center study. Of 60 children, 30 received oral ondansetron (4mg) and rest 30 granisetron (1mg) half an hour before therapy. Drugs were randomly allocated with appropriate code. The patients were followed up from day 1 to day 5 of therapy. Episodes of nausea and vomiting were recorded and scorings was done every 24 hours following chemotherapy. No significant difference was found between two groups according to acute emesis (Day-1) (p=0.053). In day two and day three it was significant (p<0.05). In day four it was significant (p=0.002). Early chemotherapy induced nausea and vomiting (CINV) were controlled 90% in children who received granisetron and 70% in children who received ondansetron. Delayed (Day 2-4) CINV were controlled in 80% of children who received granisetron and 43.4% who received ondansetron (p<0.05). Granisetron group required additional doses only 3.3% cases and ondanseton group 30% cases on the second day (p<0.05). Result was significant between two groups. About 36.7% patients had episodes of nausea on day four of chemotherapy in ondansetron group and it was only 3.3% in granisetron group due to adverse effects of antiemetic drug itself (p=0.001). Maximum episodes of vomiting were found on the second day in ondansetron group 33.3% and in granisetron group 3.3% (p=0.003). Though adverse effects like headache, constipation, abdominal pain and loose motion were common in both group of children but their number was much less in children who received granisetron. On second day of therapy score of nausea and vomiting was maximum in ondansetron and minimum in granisetron treated on day 4 and the result was significant. So, to prevent acute and delayed CINV in children with ALL, oral graniseteron can be considered as more effective and well tolerated with minimum adverse effects compared with ondansetrons.

摘要

对60名(年龄4至11岁)不分性别的急性淋巴细胞白血病(ALL)确诊儿童进行了昂丹司琼和格拉司琼疗效评估,这些儿童接受了高剂量甲氨蝶呤治疗,且在HDMTX前24小时未接受任何止吐药。这是一项前瞻性、随机、双盲、单中心研究。60名儿童中,30名在治疗前半小时口服昂丹司琼(4mg),其余30名口服格拉司琼(1mg)。药物通过适当编码随机分配。对患者从治疗第1天至第5天进行随访。记录恶心和呕吐发作情况,并在化疗后每24小时进行评分。根据急性呕吐情况(第1天),两组之间未发现显著差异(p = 0.053)。在第2天和第3天有显著差异(p<0.05)。在第4天有显著差异(p = 0.002)。接受格拉司琼的儿童中,早期化疗引起的恶心和呕吐(CINV)得到控制的比例为90%,接受昂丹司琼的儿童为70%。接受格拉司琼的儿童中,延迟性(第2 - 4天)CINV得到控制的比例为80%,接受昂丹司琼的儿童为43.4%(p<0.05)。格拉司琼组在第2天仅3.3%的病例需要额外用药,昂丹司琼组为30%(p<0.05)。两组结果有显著差异。由于止吐药本身的不良反应,昂丹司琼组在化疗第4天约36.7%的患者出现恶心发作,而格拉司琼组仅为3.3%(p = 0.001)。昂丹司琼组在第2天呕吐发作最多,为33.3%,格拉司琼组为3.3%(p = 0.003)。虽然两组儿童中头痛、便秘、腹痛和腹泻等不良反应都很常见,但接受格拉司琼的儿童中这些不良反应的数量要少得多。在治疗第2天,昂丹司琼组恶心和呕吐评分最高,格拉司琼组在第4天最低,结果有显著差异。因此,为预防ALL儿童的急性和延迟性CINV,与昂丹司琼相比,口服格拉司琼可被认为更有效、耐受性更好且不良反应最少。

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