中华临床医师杂志（电子版）
中華臨床醫師雜誌（電子版）
중화림상의사잡지（전자판）
CHINESE JOURNAL OF CLINICIANS(ELECTRONIC VERSION)
2013年
20期
9099-9102
,共4页
郑艳群%李志勇%张艳清%祝毓琳%朱步东
鄭豔群%李誌勇%張豔清%祝毓琳%硃步東
정염군%리지용%장염청%축육림%주보동
米氮平%恩丹西酮%顺铂%恶心%呕吐%食欲减退
米氮平%恩丹西酮%順鉑%噁心%嘔吐%食欲減退
미담평%은단서동%순박%악심%구토%식욕감퇴
Mirtazapine%Ondansetron%Cisplatin%Nausea%Vomiting%Anorexia
目的：观察米氮平对大剂量顺铂化疗引起的恶心和呕吐的预防效果和安全性。方法采用自身交叉对照方法。63例大剂量顺铂（60 mg/m2或75 mg/m2）联合吉西他滨化疗者在第一周期时随机分配至对照（A）周期或米氮平（B）周期；第2周期用药互相交叉。A和B两周期化疗方案相同。d1～d5代表化疗周期的第1～5天。恶心、呕吐或食欲减退明显减少的患者比例用控制率表示；完全控制（complete response， CR）率代表无恶心、无呕吐或无食欲减退的比例。共观察 d1～d5的恶心、呕吐、食欲减退的控制率。A周期采用恩丹西酮联合地塞米松二药预防恶心和呕吐；B周期在A周期用药基础上联合米氮平。药物用法：（1）恩丹西酮8 mg，iv，每天3次，于d1和d2给药；（2）地塞米松5 mg，iv，每天1次，于d1和d2给药；（3）米氮平15 mg，每天1次，于d1～d5睡前口服；（4）吉西他滨1000 mg/m2或1250 mg/m2，iv，于d1、8给药；（5）顺铂60 mg/m2或75 mg/m2，iv，分2天（于d1、d2）给药。结果米氮平（B）周期与A周期的恶心、急性呕吐、迟发性呕吐、食欲减退控制率分别为71.4%（45/63例）与65.1%（41/63例）（P＜0.01）、79.4%（50/63例）与68.3%（43/63例）（P＜0.01）、88.9%（56/63例）与61.9%（39/63例）（P＜0.01）、50.8%（32/63例）与25.4%（16/63例）（P＜0.05）。B与A周期的恶心、急性呕吐、迟发性呕吐、食欲减退控制率的CR率分别为52.4%（33/63例）与46.0%（29/63例）（P＞0.05）、74.6%（47/63例）与60.3%（38/63例）（P＜0.01）、49.2%（31/63例）与22.2%（19/63例）（P＜0.01）、47.6%（30/63例）与23.8%（15/63例）（P＜0.05）。B与A周期之间迟发性呕吐控制率差值明显高于急性呕吐控制率差值（27.0%vs.11.1%，P＜0.01）。B与A周期中均未见严重副作用。结论米氮平可有效控制大剂量顺铂化疗所致的恶心、呕吐和食欲减退；而迟发性呕吐改善相对更明显。
目的：觀察米氮平對大劑量順鉑化療引起的噁心和嘔吐的預防效果和安全性。方法採用自身交扠對照方法。63例大劑量順鉑（60 mg/m2或75 mg/m2）聯閤吉西他濱化療者在第一週期時隨機分配至對照（A）週期或米氮平（B）週期；第2週期用藥互相交扠。A和B兩週期化療方案相同。d1～d5代錶化療週期的第1～5天。噁心、嘔吐或食欲減退明顯減少的患者比例用控製率錶示；完全控製（complete response， CR）率代錶無噁心、無嘔吐或無食欲減退的比例。共觀察 d1～d5的噁心、嘔吐、食欲減退的控製率。A週期採用恩丹西酮聯閤地塞米鬆二藥預防噁心和嘔吐；B週期在A週期用藥基礎上聯閤米氮平。藥物用法：（1）恩丹西酮8 mg，iv，每天3次，于d1和d2給藥；（2）地塞米鬆5 mg，iv，每天1次，于d1和d2給藥；（3）米氮平15 mg，每天1次，于d1～d5睡前口服；（4）吉西他濱1000 mg/m2或1250 mg/m2，iv，于d1、8給藥；（5）順鉑60 mg/m2或75 mg/m2，iv，分2天（于d1、d2）給藥。結果米氮平（B）週期與A週期的噁心、急性嘔吐、遲髮性嘔吐、食欲減退控製率分彆為71.4%（45/63例）與65.1%（41/63例）（P＜0.01）、79.4%（50/63例）與68.3%（43/63例）（P＜0.01）、88.9%（56/63例）與61.9%（39/63例）（P＜0.01）、50.8%（32/63例）與25.4%（16/63例）（P＜0.05）。B與A週期的噁心、急性嘔吐、遲髮性嘔吐、食欲減退控製率的CR率分彆為52.4%（33/63例）與46.0%（29/63例）（P＞0.05）、74.6%（47/63例）與60.3%（38/63例）（P＜0.01）、49.2%（31/63例）與22.2%（19/63例）（P＜0.01）、47.6%（30/63例）與23.8%（15/63例）（P＜0.05）。B與A週期之間遲髮性嘔吐控製率差值明顯高于急性嘔吐控製率差值（27.0%vs.11.1%，P＜0.01）。B與A週期中均未見嚴重副作用。結論米氮平可有效控製大劑量順鉑化療所緻的噁心、嘔吐和食欲減退；而遲髮性嘔吐改善相對更明顯。
목적：관찰미담평대대제량순박화료인기적악심화구토적예방효과화안전성。방법채용자신교차대조방법。63례대제량순박（60 mg/m2혹75 mg/m2）연합길서타빈화료자재제일주기시수궤분배지대조（A）주기혹미담평（B）주기；제2주기용약호상교차。A화B량주기화료방안상동。d1～d5대표화료주기적제1～5천。악심、구토혹식욕감퇴명현감소적환자비례용공제솔표시；완전공제（complete response， CR）솔대표무악심、무구토혹무식욕감퇴적비례。공관찰 d1～d5적악심、구토、식욕감퇴적공제솔。A주기채용은단서동연합지새미송이약예방악심화구토；B주기재A주기용약기출상연합미담평。약물용법：（1）은단서동8 mg，iv，매천3차，우d1화d2급약；（2）지새미송5 mg，iv，매천1차，우d1화d2급약；（3）미담평15 mg，매천1차，우d1～d5수전구복；（4）길서타빈1000 mg/m2혹1250 mg/m2，iv，우d1、8급약；（5）순박60 mg/m2혹75 mg/m2，iv，분2천（우d1、d2）급약。결과미담평（B）주기여A주기적악심、급성구토、지발성구토、식욕감퇴공제솔분별위71.4%（45/63례）여65.1%（41/63례）（P＜0.01）、79.4%（50/63례）여68.3%（43/63례）（P＜0.01）、88.9%（56/63례）여61.9%（39/63례）（P＜0.01）、50.8%（32/63례）여25.4%（16/63례）（P＜0.05）。B여A주기적악심、급성구토、지발성구토、식욕감퇴공제솔적CR솔분별위52.4%（33/63례）여46.0%（29/63례）（P＞0.05）、74.6%（47/63례）여60.3%（38/63례）（P＜0.01）、49.2%（31/63례）여22.2%（19/63례）（P＜0.01）、47.6%（30/63례）여23.8%（15/63례）（P＜0.05）。B여A주기지간지발성구토공제솔차치명현고우급성구토공제솔차치（27.0%vs.11.1%，P＜0.01）。B여A주기중균미견엄중부작용。결론미담평가유효공제대제량순박화료소치적악심、구토화식욕감퇴；이지발성구토개선상대경명현。
Objective To observe the effects and safety of Mirtazapine in prevention of nausea and emesis caused by high-dose cisplatin-based chemotherapy. Methods This was a self-controlled crossover clinical trial. Sixty-three patients, treated by high-dose cisplatin(60 mg/m2 or 75 mg/m2) plus gemcitabine, were randomly assigned to either control (A) cycle or Mirtazapine (B) cycle with first course, with crossover to the opposite treatment with the second course. The identical chemotherapy regimen was used on cycle A and cycle B. The d1-d5 served as first day through fifth day of chemotherapy cycle. The significant protection from nausea, emesis and anorexia was denoted as control rates, the complete protection rate denoted by CR rates. The control rates of nausea, emesis and anorexia on d1-d5 were observed. Patients received ondansetron with dexamethasone on cycle A to prevent nausea, emesis and anorexia. The mirtazapine in combination with ondansetron and dexamethasone was used on cycle B. Drug methods was used as following:Ondansetron 8 mg (intravenous, iv), once daily on days 1 and 2 of chemotherapy, cisplatin 60 mg/m2 or 75 mg/m2, iv, used in two-day schedules, mirtazapine 15 mg orally once daily on days 1 through 5 of chemotherapy, dexamethasone 5 mg iv, once per day on days 1 and 2, and gemcitabine 1000 mg/m2 or 1250 mg/m2, iv, once daily on days 1 and days 8. Results The control rate of nausea, acute emesis, delayed emesis and anorexia on cycle B or A was 71.4%(45/63) or 65.1%(41 /63)(P<0.01), 79.4%(50/63) or 68.3%(43/63)(P<0.01), 88.9%(56/63) or 61.9%(39/63)(P<0.01), and 50.8%(32/63)(41/63) or 25.4%(16/63)(P<0.05) of patients, respectively. The CR rate of nausea, acute emesis, delayed emesis and anorexia on cycle B or A was achieved in 52.4%(33/63) or 46.0%(29/63)(P>0.05), 74.6%(47/63) or 60.3%(38/63)(P<0.01), 49.2%(31/63) or 22.2%(19/63)(P<0.01), and 47.6%(30/63) or 23.8%(15/63)(P<0.05) of patients, respectively. More protection from delayed emesis was observed than from acute emesis (27.0% vs. 11.1%, P<0.01). No serious adverse events were observed on cycle B or A. Conclusion Mirtazapine is effective in treatment of nausea, emesis and anorexia caused by high dose cisplatin-based chemotherapy. Also, the improvement of delayed emesis is more obviously.
