新加良附颗粒治疗Ⅲ/Ⅳ期胃癌合并血液高凝状态临床研究

Clinical research of Xinjia Liangfu Granules in treatment of stage Ⅲ/Ⅳ gastric cancer complicated with hypercoagulable state

目的:通过中央随机、多中心临床试验方法,选取血凝指标、中医证候(症状)、生活质量等观察指标,综合评价新加良附颗粒治疗Ⅲ/Ⅳ期胃癌合并高凝状态临床疗效。方法:按照试验方案规定的诊断、疗效标准与操作规范,通过中央随机系统将符合入选标准的Ⅲ/Ⅳ期胃癌高凝状态患者随机分为试验组与对照组,并进行为期21d的临床治疗。研究者在入组治疗前,治疗第7、21天对受试者进行访视,采集可供有效性和安全性评估的各种试验数据,填写病例观察表(CRF),并将CRF表中各种试验数据录入数据库,最后进行统计学分析。结果:(1)血凝指标变化:治疗后21d,新加良附颗粒对凝血酶时间(PT)、凝血酶原比率(PTR)、凝血酶原百分比活动度(PTA)、凝血酶原国际标准化比值(INR)的改善优于治疗前(P<0.01,P<0.05);(2)中医证候指标:试验组优于对照组(P<0.01);(3)外周血象:对照组治疗7d与治疗前比较,白细胞计数升高(P<0.05);试验组、对照组治疗7d与治疗前比较,中性粒细胞百分比升高,淋巴细胞百分比例、血小板计数降低(P<0.01,P<0.05)。治疗21d两组间比较,血小板分布宽度对照组高于试验组(P<0.05);(4)生活质量评分:试验组改善优于对照组。结论:新加良附颗粒对患者血凝指标、生活质量有一定改善作用,对中医证候(症状)有明显改善效果。

Objective: According to the GCP standards, through the central meta-randomized, multicenter clinical trial method, hemagglutination index, TCM syndrome(symptom), quality of life and other observation indicators were selected, and the clinical efficacy of Xinjia Liangfu Granules in treatment of stage Ⅲ/Ⅳ gastric cancer with hypercoagulable state was evaluated comprehensively. Methods: According to the diagnostic criteria, curative effect standards and operation specification, the patients with high coagulation status of stage Ⅲ/Ⅳ gastric cancer were randomly divided into experimental group and control group. The clinical treatment was carried out for 21 days. Researchers visited the subjects on the 7 th and 21 st day after treatment, collected various data for efficacy and safety evaluation and filled CRF. Various data of CRF were input into the database, and statistical analysis was carried out. Results:(1)Changes of blood coagulation indexes: improvement of Xinjia Liangfu Granules on thrombin time(PT), prothrombin ratio(PTR), prothrombin percentage activity(PTA), prothrombin international normalization ratio(INR), were superior to those before treatment(P<0.01, P<0.05).(2)TCM syndrome indicators: the experimental group were better than those in the control group(P<0.01).(3)Peripheral hemogram: Compared with before treatment, the control group after 7 days' treatment increased white blood cell count(P<0.05), and the percentage of neutrophils in the control and experimental group in 7 day' treatment increased, while the percentage of lymphocyte, platelet count were reduced(P<0.01, P<0.05). After 21 days' treatment, the control group's platelet distribution width was higer than the experimental group(P<0.05).(4)Improvement of life quality: the treatment group was better than that in the control group. Conclusion: Xinjia Liangfu Granules plays a certain improvement role on blood coagulation indexes and life quality, and has obvious improvement on TCM syndrome(symptoms).