盐酸帕洛诺司琼注射液预防化疗引起恶心呕吐的临床疗效观察

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

doi:10.3969/j.issn.1000-8179.20141171

盐酸帕洛诺司琼注射液预防化疗引起恶心呕吐的临床疗效观察

doi: 10.3969/j.issn.1000-8179.20141171

佟仲生^①, ,,
李淑芬^①,
郑荣生^②,
何志勇^③,
张莉莉^④,
欧阳学农^⑤,
陈锦飞^⑥,
于浩^⑦,
史业辉^①,
汪旭^①,
李晓昕^⑧,
张宜山^⑧

①.
天津医科大学附属肿瘤医院乳腺肿瘤内科，国家肿瘤临床医学研究中心，天津市肿瘤防治重点实验室，乳腺癌防治教育部重点实验室（天津市300060）
②.
蚌埠医学院第一附属医院肿瘤内科
③.
福建省肿瘤医院胸部肿瘤内科
④.
江苏省肿瘤医院肿瘤内科
⑤.
南京军区福州总医院肿瘤科
⑥.
南京市第一医院肿瘤内科
⑦.
南京医科大学公共卫生学院
⑧.
江苏奥赛康药业有限公司

基金项目:

天津市科技计划项目 12ZCDZSY16200

详细信息

作者简介:
佟仲生专业方向为乳腺癌临床及基础研究，肿瘤信号转导通路机制研究。E-mail：tonghang@medmail.com.cn

通讯作者:
佟仲生 tonghang@medmail.com.cn

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出版历程
- 收稿日期: 2014-07-14
- 修回日期: 2014-09-16
- 刊出日期: 2020-12-29

Effect of palonosetron in preventing chemotherapy-induced vomiting

TONG Zhongsheng^{①
, ,},
LI Shufen^①,
ZHENG Rongsheng^②,
HE Zhiyong^③,
ZHANG Lili^④,
OUYANG Xuenong^⑤,
CHEN Jinfei^⑥,
YU Hao^⑦,
SHI Yehui^①,
WANG Xu^①,
LI Xiaoxin^⑧,
ZHANG Yishan^⑧

①.
Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center of Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Key Laboratory of Breast Cancer Prevention and Therapy, Tianjin Medical University, Ministry of Education, Tianjin 300060, China
②.
Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu 23303, China
③.
Department of Thoracic Medical Oncology, Fujian Provincial Cancer Hospital, Fuzhou 350014, China
④.
Department of Medical Oncology, Jiangsu Provincial Cancer Hospital Nanjing 210009, China
⑤.
Department of Oncology, Fuzhou General Hospital of Nanjing Military Command, The People's Liberation Army of China, Fuzhou 350025, China
⑥.
Department of Medical Oncology, The First Hospital of Nanjing, Nanjing 210006, China
⑦.
7 School of Public Health, Nanjing Medical University, Nanjing 211166, China
⑧.
Jiangsu Aosaikang Pharmaceutical Co. Ltd, Nanjing 2111003, China

Funds:

the R & D Program of Key Anticancer Technologies in Tianjin 12ZCDZSY16200

More Information

Corresponding author: TONG Zhongsheng; E-mail:tonghang@medmail.com.cn

摘要

摘要: 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 =0.011 0）。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 =0.009 6）。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。
- 帕洛诺司琼 /
- 格拉司琼 /
- 化疗 /
- 呕吐
Abstract: Objective To evaluate the efficacy and safety of palonosetron in preventing chemotherapy-induced vomiting. Methods 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 hydrochloride 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 reaction 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.
- palonosetron /
- granisetron /
- chemotherapy /
- vomiting

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参考文献(14)

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