CAJ | 학술논문

目的探讨帕洛诺司琼预防化疗引起的急性和迟发性恶心、呕吐的疗效和不良反应。方法采用多中心、随机、双肓、自身交叉对照的研究方法。2008年11月至2009年11月计划入组160例，试验药为帕洛诺司琼（A药），对照药为托烷司琼（B药），患者随机数字表法分为AB组和BA组，AB组第1周期应用A药，第2周期应用B药；BA组为相反顺序。对顺铂或蒽环类药物为基础的方案化疗后1～5d的恶心、呕吐程度、止吐疗效以及不良反应进行评价。结果共入组155例，132例可评价疗效，AB组69例，BA组63例。合计中度和重度致吐性化疗A药组急性呕吐的完全控制率为54.55％，B药组为51.52％，两组间比较差异无统计学意义(P＞0.05)；迟发性呕吐的完全控制率A药组为53.03％，B药组为38.64％，A药组完全控制率明显高于B药组(P=0.01)。不良反应分析，A组的发生率分别仅为4.90％，主要为头痛、头晕，且无严重不良事件发生。结论帕洛诺司琼预防中重度致吐性化疗所引起的急性呕吐和迟发性呕吐疗效显著、安全性高。
목적 탐토파락낙사경예방화료인기적급성화지발성악심、구토적료효화불량반응。방법 채용다중심、수궤、쌍황、자신교차대조적연구방법。2008년11월지2009년11월계화입조160례，시험약위파락낙사경（A약），대조약위탁완사경（B약），환자수궤수자표법분위AB조화BA조，AB조제1주기응용A약，제2주기응용B약；BA조위상반순서。대순박혹은배류약물위기출적방안화료후1～5d적악심、구토정도、지토료효이급불량반응진행평개。결과 공입조155례，132례가평개료효，AB조69례，BA조63례。합계중도화중도치토성화료A약조급성구토적완전공제솔위54.55％，B약조위51.52％，량조간비교차이무통계학의의(P＞0.05)；지발성구토적완전공제솔A약조위53.03％，B약조위38.64％，A약조완전공제솔명현고우B약조(P=0.01)。불량반응분석，A조적발생솔분별부위4.90％，주요위두통、두훈，차무엄중불량사건발생。결론 파락낙사경예방중중도치토성화료소인기적급성구토화지발성구토료효현저、안전성고。
ObjectiveTo explore the efficacy and safety of palonosetron in the prevention of acute and delayed chemotherapy-induced nausea and vomiting after moderate to severe emetogenic chemotherapy.MethodsFrom November 2008 to November 2009, a multicenter, randomized, double-blind and selfcrossover phase Ⅱ clinical trial with a total planned enrollment of 160 patients was carried out to compare palonosetron (drug A) with tropisetron (drug B). The subjects were randomized divided into groups AB and BA. The dosing sequence in the group AB was drug A the first cycle and drug B the second cycle while the BA group was administered reversely. The efficacy was evaluated within a period of 5 days after cisplatin or adriamycin-based regimen chemotherapy. Adverse effects were assessed by CTCAE 3.0. ResultsAmong 155 enrolled cases, 132 cases were assessable for efficacy. The complete control rate of acute chemotherapyinduced nausea and vomiting was 54. 55％ vs 51.52％ for drug A vs drug B ( P ＞ 0. 05), but that of delayed reaction was 53.03％ vs 38.64％ respectively. There were significant differences (P =0. 01 ). Meanwhile,the rate of adverse effects was 4. 90％ for investigational agent without severe adverse events.The main adverse reactions were headache and dizziness. ConclusionWith a high safety profile, palonosetron is an effective agent for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.