目的：明确消痈溃得康颗粒对胃溃疡活动期患者的临床疗效，“以效证因”反证“毒热”为胃溃疡活动期的病因；阐明“毒热”的辨证求因要点。方法：采用随机、双盲、双模拟、对照、多中心临床试验设计方法，选取胃溃疡活动期符合中医胃毒热证患者300例，随机分为试验组150例，对照组150例；试验药为具有清热解毒、消痈生肌功效的中药新药消痈溃得康颗粒，对照药选用溃疡胶囊。双盲、双模拟方法给药6周，观察主次要症状，并进行量化评分综合疗效判定，进而采用统计分析。结果：试验组临床痊愈率为45.1％（64/142），总有效率为99.3％（141/142）；对照组临床痊愈率为6.9％（10/144），总有效率为91.0％（131/144）。两组比较，试验组临床疗效优于对照组（P＜0.01）。单项症状疗效评价：试验组优于对照组（P＜0.01），治疗后单项症状与基线差值的比较，试验组优于对照组（P＜0.05）。胃脘灼痛症状改善：试验组用药14 d末优于对照组（P＜0.01）。泛酸症状改善：试验组用药14 d末优于对照组（P＜0.01）。急躁易怒症状改善：试验组用药28 d末优于对照组（P＜0.05）。嘈杂症状改善：试验组用药28 d末优于对照组（P＜0.05）。口干症状改善：试验组用药28 d末优于对照组（P＜0.01）。口苦症状改善：试验组用药28 d末优于对照组（P＜0.01）。舌苔改善：试验组用药42 d末优于试验组（P＜0.05）。单项症状分值变化试验组均优于对照组（P＜0.05）。脉象变化：试验组在治疗前、用药14 d末、28 d末和治疗后与对照组均无显著性差异（P＞0.05）。结论：消痈溃得康颗粒治疗胃溃疡活动期胃毒热证可显著改善症状，疗效优于对照组。“以效证因”反证了“毒热”确为胃溃疡活动期的重要病因。胃毒热证的辨证要点为胃脘灼痛，痛势较剧，泛酸嘈杂,口干口苦，舌红，苔黄或腐或腻，治法为清热解毒、消痈生肌。

This study was aimed to clarify the therapeutic effect of Xiao-Yong-Kui-De-Kang Granules (XYKDKG) to gastric ulcer in active stage in order to prove that "toxin-heat" is the etiopathogenisis of the disease. Key points in syndrome differentiation of "toxin-heat" will be explained. A multi-center randomized control, double-blind and double dummy clinical trial was conducted. A total of 300 patients with gastric ulcer in active stage were selected with features of toxin-heat syndrome in traditional Chinese medicine (TCM). All patients were randomly divided into experiment group and control group. In the experiment group, 150 patients were treated with XYKDKG, which is effective in heat-clearing, toxin-relieving, ulcer-reducing, and simulated Kui-Yang capsule (KYC). And in control group, the other 150 patients were treated with KYC and simulated XYKDKG. The double-blind and double dummy clinical trial was continued for 6 weeks. Then, main and secondary symptoms were observed to comprehensively determine the therapeutic effect with quantitative marking criterion. The statistical analysis showed that the clinical recovery rate was 45.1% (64/142) and the total effective rate was 99.3% (141/142) in the experiment group. In the control group, the clinical recovery rate was 6.9% (10/144) and the total effective rate was 91.0% (131/144). The comparison showed that the experimental group achieved better therapeutic effect than the control group (P< 0.01). In the improvement of each symptom, the experiment group is better than control group (P< 0.01). The comparison between post-treatment single symptom and baseline showed that the experiment group was better than the control group (P< 0.05). Furthermore, the experiment group received better effect than control group in relieving stomach burning pain symptom (P< 0.01) in 14 days, acid regurgitation (P< 0.01) in 14 days, impatience (P< 0.05) in 28 days, epigastric upset (P< 0.05) in 28 days, dry mouth (P< 0.01) in 28 days, bitter taste in the mouth (P< 0.01) in 28 days, tongue coating improving (P< 0.05) in 42 days. The score of each symptom pre- and post-treatment is improved in experiment group (P< 0.05). There was no significant statistical difference in pulse presentations pre-treatment, 14-day medication, 28-day medication and post-treatment in both groups (P> 0.05). It was concluded that XYKDKG had an obvious effect in improving symptoms of patients with gastric ulcer in the active stage than control. The therapeutic effect showed that "toxin-heat" is the etiopathogenisis of gastric ulcer in active stage. Key points in syndrome differentiation of toxin-heat syndrome of gastric ulcer are severe stomach burning pain, acid regurgitation, epigastric upset, dry mouth, bitter taste in the mouth, red tongue with yellow or greasy coating. The treatment principle is to clear heat, relieve toxin, and reduce ulcer to generate new tissues.

科学技术部国家重点基础研究发展计划（“973计划”）重大课题（2006CB504809）：基于“以痈论治”胃癌前状态性疾病（活动期）“毒热”病因创新研究，负责人：周学文。