中国肿瘤临床
中國腫瘤臨床
중국종류림상
CHINESE JOURNAL OF CLINICAL ONCOLOGY
2014年
20期
1323-1327
,共5页
佟仲生%李淑芬%郑荣生%何志勇%张莉莉%欧阳学农%陈锦飞%于浩%史业辉%汪旭%李晓昕%张宜山
佟仲生%李淑芬%鄭榮生%何誌勇%張莉莉%歐暘學農%陳錦飛%于浩%史業輝%汪旭%李曉昕%張宜山
동중생%리숙분%정영생%하지용%장리리%구양학농%진금비%우호%사업휘%왕욱%리효흔%장의산
帕洛诺司琼%格拉司琼%化疗%呕吐
帕洛諾司瓊%格拉司瓊%化療%嘔吐
파락낙사경%격랍사경%화료%구토
palonosetron%granisetron%chemotherapy%vomiting
目的：观察盐酸帕洛诺司琼注射液预防化疗引起恶心呕吐的有效性和安全性。方法：采用多中心、分层随机、双盲双模拟、自身交叉阳性对照临床试验设计，全部入组125例患者，分为A方案（61例）和B方案（64例）。A方案为每组患者随机采用在第1周期使用盐酸帕洛诺司琼注射液、第2周期使用盐酸格拉司琼注射液，B方案与之相反。试验组为A、B方案中所有使用试验药物的患者，对照组为A、B方案中所有使用对照药物的患者。行2个疗程化疗方案的试验组和对照组的急性和延迟性呕吐的完全控制率以及不良反应比较。结果：中度致吐性化疗组中试验组的预防延迟性呕吐的完全控制率为76.92%（50/65）、对照组为55.38%（36/65），两组差异具有统计学意义（P=0.0110）。第1～5天中度致吐性化疗组中试验组的呕吐次数为（1.32±3.42）次、对照组为（1.94±3.03）次，两组之间比较差异具有统计学意义（P=0.0096）。试验、对照组不良反应发生率均较低，程度也较轻。结论：盐酸帕洛诺司琼预防中、高度致吐性化疗引起的急性及延迟性呕吐疗效确切，特别对预防中度致吐性化疗引起的延迟性呕吐，盐酸帕洛诺司琼优于盐酸格拉司琼，且盐酸帕洛诺司琼不良反应轻微，值得在临床上推广使用。
目的：觀察鹽痠帕洛諾司瓊註射液預防化療引起噁心嘔吐的有效性和安全性。方法：採用多中心、分層隨機、雙盲雙模擬、自身交扠暘性對照臨床試驗設計，全部入組125例患者，分為A方案（61例）和B方案（64例）。A方案為每組患者隨機採用在第1週期使用鹽痠帕洛諾司瓊註射液、第2週期使用鹽痠格拉司瓊註射液，B方案與之相反。試驗組為A、B方案中所有使用試驗藥物的患者，對照組為A、B方案中所有使用對照藥物的患者。行2箇療程化療方案的試驗組和對照組的急性和延遲性嘔吐的完全控製率以及不良反應比較。結果：中度緻吐性化療組中試驗組的預防延遲性嘔吐的完全控製率為76.92%（50/65）、對照組為55.38%（36/65），兩組差異具有統計學意義（P=0.0110）。第1～5天中度緻吐性化療組中試驗組的嘔吐次數為（1.32±3.42）次、對照組為（1.94±3.03）次，兩組之間比較差異具有統計學意義（P=0.0096）。試驗、對照組不良反應髮生率均較低，程度也較輕。結論：鹽痠帕洛諾司瓊預防中、高度緻吐性化療引起的急性及延遲性嘔吐療效確切，特彆對預防中度緻吐性化療引起的延遲性嘔吐，鹽痠帕洛諾司瓊優于鹽痠格拉司瓊，且鹽痠帕洛諾司瓊不良反應輕微，值得在臨床上推廣使用。
목적：관찰염산파락낙사경주사액예방화료인기악심구토적유효성화안전성。방법：채용다중심、분층수궤、쌍맹쌍모의、자신교차양성대조림상시험설계，전부입조125례환자，분위A방안（61례）화B방안（64례）。A방안위매조환자수궤채용재제1주기사용염산파락낙사경주사액、제2주기사용염산격랍사경주사액，B방안여지상반。시험조위A、B방안중소유사용시험약물적환자，대조조위A、B방안중소유사용대조약물적환자。행2개료정화료방안적시험조화대조조적급성화연지성구토적완전공제솔이급불량반응비교。결과：중도치토성화료조중시험조적예방연지성구토적완전공제솔위76.92%（50/65）、대조조위55.38%（36/65），량조차이구유통계학의의（P=0.0110）。제1～5천중도치토성화료조중시험조적구토차수위（1.32±3.42）차、대조조위（1.94±3.03）차，량조지간비교차이구유통계학의의（P=0.0096）。시험、대조조불량반응발생솔균교저，정도야교경。결론：염산파락낙사경예방중、고도치토성화료인기적급성급연지성구토료효학절，특별대예방중도치토성화료인기적연지성구토，염산파락낙사경우우염산격랍사경，차염산파락낙사경불량반응경미，치득재림상상추엄사용。
Objective:To evaluate the efficacy and safety of palonosetron in preventing chemotherapy-induced vomiting. Meth-ods:A multi-center, randomized, double-blind, and self-cross-over positively controlled clinical trial design was used. All patients were randomized into two groups, as follows:Regiment A (61 cases) and Regiment B (64 cases). Regimen A with palonosetron hydrochlo-ride injection (test agent) was used in the treatment cycle A, whereas granisetron hydrochloride injection (control drug) was used in the cycle B. Treatments were randomly administered on the patients of the two groups. Regimen B was on the contrary, the control drug was used in the cycle A, and the test agent was used in the treatment cycle B. All patients treated with the test agent were classified as the test group, whereas those treated with the control drug were classified as the control group. Complete control rate and adverse reac-tion of acute and delayed vomiting in the two groups during the two cycles of chemotherapy regimen were compared. Results: In Group One, the complete control rate of delayed vomiting was significantly higher in the palonosetron administration cycles than in the granisetron cycles (76.92%vs. 55.38%, P=0.0110). In the same group, the frequency of vomiting was significantly less in palonosetron cycles than in the granisetron cycles during day 1 to day 5 (1.32±3.42 vs. 1.94±3.03, P=0.0096). The incidences of adverse effects were low in both groups. No grades 3 and 4 adverse effects were observed. Conclusion: Palonosetron showed efficacy in preventing the acute and delayed chemotherapy-induced vomiting. The drug is superior to granisetron, specifically in delaying vomiting in Group One. Palonosetron hydrochloride showed slight adverse effects. Hence, this drug can be used in clinic.
