中国医药指南
中國醫藥指南
중국의약지남
CHINA MEDICINE GUIDE
2015年
9期
31-33
,共3页
帕洛诺司琼%托烷司琼%顺铂%化疗%不良反应
帕洛諾司瓊%託烷司瓊%順鉑%化療%不良反應
파락낙사경%탁완사경%순박%화료%불량반응
Palonosetron%Tropisetron%Cisplatin%Chemotherapy%Adverse reactions
目的：观察和比较5-HT3受体拮抗剂帕洛诺司琼与托烷司琼联合地塞米松预防含多天顺铂方案化疗引起恶心、呕吐的疗效及安全性。方法将连续使用2周期含多天顺铂方案化疗的住院恶性肿瘤患者，按随机、交叉自身对照的方法分为AB、BA组。AB组病例第1周期的第1、3天化疗前静脉滴注帕洛诺司琼0.25mg，并于每天化疗前静脉滴注地塞米松10mg。BA组病例第1周期的第1~3天化疗前均分别静脉滴注托烷司琼5mg和地塞米松10mg。第2周期的止吐方案为两组病例第1周期的止吐方案交叉使用。观察化疗开始后7d内患者恶心、呕吐的控制情况及不良反应发生率。结果共入组49例病例，47例可评价疗效：AB组23例，BA组24例；两组患者在年龄、性别、有无化疗史及病种等方面无显著性差异（P>0.05）。帕洛诺司琼组在延迟期和全期的化疗相关性恶心呕吐（CINV）的完全控制率显著高于托烷司琼组，分别为57.4%（27/47）和34.0%（16/47），P=0.023；55.3%（26/47）和29.8%（14/47），P=0.012。但在急性CINV方面，两组患者的完全控制率无显著性差异，分别为63.8%（30/47）和53.2%（22/47），P>0.05。两种止吐药物的不良反应多表现为便秘、头痛、疲劳、呃逆等，发生率较低，程度较轻，差异无统计学意义（P>0.05）。结论帕洛诺司琼对含多天顺铂方案化疗引起的迟发性CINV的完全控制率优于托烷司琼。多剂量帕洛诺司琼联合全程使用地塞米松的不良反应轻微。
目的：觀察和比較5-HT3受體拮抗劑帕洛諾司瓊與託烷司瓊聯閤地塞米鬆預防含多天順鉑方案化療引起噁心、嘔吐的療效及安全性。方法將連續使用2週期含多天順鉑方案化療的住院噁性腫瘤患者，按隨機、交扠自身對照的方法分為AB、BA組。AB組病例第1週期的第1、3天化療前靜脈滴註帕洛諾司瓊0.25mg，併于每天化療前靜脈滴註地塞米鬆10mg。BA組病例第1週期的第1~3天化療前均分彆靜脈滴註託烷司瓊5mg和地塞米鬆10mg。第2週期的止吐方案為兩組病例第1週期的止吐方案交扠使用。觀察化療開始後7d內患者噁心、嘔吐的控製情況及不良反應髮生率。結果共入組49例病例，47例可評價療效：AB組23例，BA組24例；兩組患者在年齡、性彆、有無化療史及病種等方麵無顯著性差異（P>0.05）。帕洛諾司瓊組在延遲期和全期的化療相關性噁心嘔吐（CINV）的完全控製率顯著高于託烷司瓊組，分彆為57.4%（27/47）和34.0%（16/47），P=0.023；55.3%（26/47）和29.8%（14/47），P=0.012。但在急性CINV方麵，兩組患者的完全控製率無顯著性差異，分彆為63.8%（30/47）和53.2%（22/47），P>0.05。兩種止吐藥物的不良反應多錶現為便祕、頭痛、疲勞、呃逆等，髮生率較低，程度較輕，差異無統計學意義（P>0.05）。結論帕洛諾司瓊對含多天順鉑方案化療引起的遲髮性CINV的完全控製率優于託烷司瓊。多劑量帕洛諾司瓊聯閤全程使用地塞米鬆的不良反應輕微。
목적：관찰화비교5-HT3수체길항제파락낙사경여탁완사경연합지새미송예방함다천순박방안화료인기악심、구토적료효급안전성。방법장련속사용2주기함다천순박방안화료적주원악성종류환자，안수궤、교차자신대조적방법분위AB、BA조。AB조병례제1주기적제1、3천화료전정맥적주파락낙사경0.25mg，병우매천화료전정맥적주지새미송10mg。BA조병례제1주기적제1~3천화료전균분별정맥적주탁완사경5mg화지새미송10mg。제2주기적지토방안위량조병례제1주기적지토방안교차사용。관찰화료개시후7d내환자악심、구토적공제정황급불량반응발생솔。결과공입조49례병례，47례가평개료효：AB조23례，BA조24례；량조환자재년령、성별、유무화료사급병충등방면무현저성차이（P>0.05）。파락낙사경조재연지기화전기적화료상관성악심구토（CINV）적완전공제솔현저고우탁완사경조，분별위57.4%（27/47）화34.0%（16/47），P=0.023；55.3%（26/47）화29.8%（14/47），P=0.012。단재급성CINV방면，량조환자적완전공제솔무현저성차이，분별위63.8%（30/47）화53.2%（22/47），P>0.05。량충지토약물적불량반응다표현위편비、두통、피로、애역등，발생솔교저，정도교경，차이무통계학의의（P>0.05）。결론파락낙사경대함다천순박방안화료인기적지발성CINV적완전공제솔우우탁완사경。다제량파락낙사경연합전정사용지새미송적불량반응경미。
Objective?In order to assess the safety and antiemetic efifcacy of multiple-day dosing of palonosetron plus dexamethasone, we conducted this study?that?compared?palonosetron?to?tropisetron?combined?with?dexamethasone?in?malignant?patients?receiving?multiple-day?cisplatin-based?chemotherapy.?Methods?Patients receiving two consecutive identical courses of a 3-day cisplatin-based chemotherapy were randomly assigned to group AB and group BA. Palonosetron?was?administered?on?day?1?and?3,?combined?with?dexametha-sone?every?day?during?the?entire?period?of?chemotherapy?for?the?initial?course?of?group AB. And tropisetron plus dexamethasone was administered daily for group BA during the entire period of chemotherapy. Patients were crossover to the opposite?treatment?with?the?second?course.?Results?In?all,?49?patients?were?screened?for?the?study?and?47?were?evaluable.?21?patients?were?randomly?assigned?to group AB and 24 to group BA. During the delayed phase (d 4-7), nausea and vomiting were absent in 57.4% of patients of the palonosetron group and 34.0%?of?the?control?group?(P=0.023).?During?the?overall?period?of?observation?(d?1-7),?the?number?was?55.3%?and?29.8%,?P=0.012.?During?the?acute?phase(d?1-3),?the?absent?of?nausea?and?vomiting?was?numerically?superior?with?palonosetron?(63.8%?and?53.2%),?but?there?was?no?statistical?difference?between?the?groups,?P=0.097.?There?was?no?statistical?difference?of?toxicity?with?palonosetron?compared?with?tropisetron,?P>0.05.?Conclusion?There was a signiifcant improvement?in?totally?control?of?delayed?CINV?with?multiple-day?dosing?of?palonosetron?plus?dexamethasone?for?patients?receiving?multiple-day?cisplatin-based?chemotherapy,?and?it?was?safe?and?well?tolerated.
