A Randomized,Double-blinded,Drug-controlled and Multicentre Clinical Trial of Chemotherapy Assisted with Jinlong Capsule on Gastric Cancer
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摘要: 目的 评价金龙胶囊对胃癌患者化疗的减毒作用，以及对化疗期间生存质量下降和免疫功能低下等症状的改善作用。方法采用多中心、随机、双盲、阳性对照的研究方法，将141例经病理组织学确诊的胃癌患者随机分为试验组（70例）和阳性对照组（71例），采用FOXFOL4 方案或PF方案化疗2周期。在化疗基础上，接受一疗程6周（42天）金龙胶囊或对照药物治疗，由7个医疗中心共同完成。试验组口服金龙胶囊4粒/次,每日3次；阳性对照组口服贞芪扶正胶囊4粒/次,每日3次。观察两组治疗前后中医症状的变化、卡氏评分变化、免疫功能的变化、体重变化、瘤体变化和化疗完成率，同时评价药物的安全性。结果试验组中医症候总疗效88.34%，生活质量有效率46.67%，体重增加率48.33%，均明显高于阳性对照组（P<0.05），试验组对胃癌单项症状的改善也明显优于阳性对照组；两组的客观疗效分别为16.67%、8.33%，试验组好于对照组，但两组比较差异无统计学意义（P=0.0676）；两组均未观察到严重不良反应。结论金龙胶囊配合化疗治疗胃癌，可以改善患者化疗期间的脘腹胀闷等中医症候，提高患者的生存质量和免疫功能，对化疗的减毒作用明显，安全性良好，值得在临床上推广应用。Abstract: Objective To observe the therapeutic effect and security of chemotherapy assisted with Jinlong Capsule on patients with gastric cancer. Methods As a randomized,double-blinded,drug-controlled and multicentre study,141 gastric cancer patients diagnosed definitely by histopathology were randomly divided into experiment group (n=70) and control group (n=71).The chemotherapy (FOXFOL4 project or PF project for 2 circles) was used to all of the patients,and patients in experiment group or control group took Jinlong Capsule (4 pills once and 3 times per day) or Zhenqifuzheng Capsule (4 pills once and 3 times per day) orally,espectively.The course of treatment lasted 42 days. Results For the experiment group,the total therapeutic effective rate of the traditional Chinese medicine syndrome was 88.34%,the survival quality and body weight were improved respectively with 46.67% and 48.33%,while 59.68%,19.35% and 19.35% in control group,respectively(P<0.05).For some single symptoms of gastric cancer,the patients in experiment group also ameliorated better than that in control group.The objective therapeutic evaluation of tumor was 16.67% in experiment,while 8.33% in control group (P=0.0676).Furthermore,no serious adverse reaction was found in both two groups. Conclusion It is proved that the chemotherapy assisted with Jinlong Capsule has better therapeutic effect on patients with gastric cancer.
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Key words:
- Gastric cancer /
- Jinlong Capsule /
- Chemotherapy
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