肠胃舒胶囊治疗恶性肿瘤胃肠功能紊乱临床方案设计特色

Clinical Trial Scheme of Changweishu Capsule in Treating Gastrointestinal Disorders of Malignant Tumor

目的:评价中药新药“肠胃舒胶囊”治疗肿瘤患者由脾胃湿热证引发胃肠功能紊乱临床疗效与安全性。方法:采用实用性中央随机分配、多中心临床研究方法,遵照“同病异治、异病同治”的中医治则理论,选择恶性肿瘤化疗与靶向药物治疗导致胃肠功能紊乱,中医辨证为“脾胃湿热或肠道湿热证”患者为目标人群,以“食少纳呆,脘腹疼痛、恶心呃逆、口干口苦、大便不调”五组临床症状以及血管活性肠肽(VIP)、胆囊收缩素(CCK)、胃蛋白酶原为观察指标。结果:预期结果是观察“肠胃舒胶囊治疗肿瘤患者脾胃湿热证引发胃肠功能紊乱的有效性与安全性,并通过现代指标观察,探索肠胃舒胶囊改善恶性肿瘤患者胃肠功能部分效应机制。结论:肠胃舒胶囊治疗肿瘤患者由脾胃湿热证引发胃肠功能紊乱临床疗效方案设计除具备标准临床方案设计特点外,在审视药物功能主治、异病同治原理设计以及主观与客观指标结合三方面具有明显的设计特色。

Objective:To evaluate the clinical efficacy and safety of Changweishu Capsule in treating gastrointestinal disorders caused by damp-heat of Spleen and Stomach in patients with malignant tumor.Methods:A practical central randomized,multi-center clinical research approach was applied according to the TCM theory of treating different diseases with same method and treating the same disease with different methods.The patients included into the study were those received therapy for malignant tumor and for gastrointestinal disorders,who were diagnosed as the syndrome of damp-heat of Spleen and Stomach,or the syndrome of dampness in intestines.The observation indexes include clinical symptoms,such as poor appetite,abdominal pain,nausea and hiccups,dry mouth,bitter feeling in mouth and stool irregularities these five groups of clinical symptoms,and vasoactive intestinal peptide,cholecystokinin and pepsinogen.Results:The expected result is to observe the efficacy and safety of Changweishu Capsule in treating gastrointestinal dysfunction caused by damp-heat of Spleen and Stomach in patients with malignant tumor,thus to explore its action mechanism.Conclusion:This clinical trial scheme possesses the features of standard clinical design,it also has obvious features in terms of indication of the medication,the design of treatment for different diseases,as well as the combination of subjective and objective indicators.