Zhang Rui-ming, Wang Lei, Chen Guang-yuan, Mao Bing, Chang Jing, Zhang Ying, Li Ting-qian, Gong Mei, Wang Yi-qing, Feng Wu-jin, Li Xue-wu
Department of Integrated Traditional Chinese Medicine and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.
Sichuan Da Xue Xue Bao Yi Xue Ban. 2005 Mar;36(2):233-6.
To assess the efficacy and safety of haiguiyuyang capsule in the treatment of duodenal ulcer (also diagnosed as weiwan pain and hanrecuoza syndrome according to the theory of TCM).
This is a multi-center clinical trial cooperatively conducted from May 2003 to March 2004 in accordance to the principle of informed consent, to the criteria for subject inclusion, exclusion, discontinuation, and to the relevant guidelines for evaluating the therapeutic effects of new TCM drugs. The design of double-blind, double-dummy and randomized controlled trial was adopted. 438 patients were randomized to the Test group (n = 330, treated with haiguiyuyang capsule) and to the Control group (n = 108, treated with ranitidine). The therapeutic course for both groups was 6 weeks.
Regarding the efficacy in treating duodenal ulcer, in the Test group, the Marked Efficacy Rate was 66.37% and the Total Efficacy Rate was 82.13%; in the Control group, the Marked Efficacy Rate was 68.61% and the Total Efficacy Rate was 93.34%; there was no significant difference between the two groups (P>0.05). Regarding the efficacy in treating the syndrome diagnosed by TCM, in the Test group, the Marked Efficacy Rate was 70.31% and the Total Efficacy Rate was 93.34%; in the control group, the rates were 71.29% and 91.66% respectively; there was no significant difference between the two groups (P>0.05). Besides, regarding the abatement of distention and fullness of stomach after treatment, the haiguiyuyang capsule was better than ranitidine (P<0.05). No adverse side-effect was observed.
The efficacy of haiguiyuyang capsule in treating duodenal ulcer is similar to that of ranitidine. No obvious adverse effect of it was observed in this trial.
评价海归养胃胶囊治疗十二指肠溃疡（根据中医理论亦诊断为胃脘痛、寒热错杂证）的有效性和安全性。
本研究为多中心临床试验，于2003年5月至2004年3月按照知情同意原则、受试者纳入、排除、中止标准及中药新药疗效评价相关指导原则协同开展。采用双盲、双模拟、随机对照试验设计。438例患者随机分为试验组（n = 330，给予海归养胃胶囊治疗）和对照组（n = 108，给予雷尼替丁治疗）。两组疗程均为6周。
在治疗十二指肠溃疡疗效方面，试验组显效率为66.37%，总有效率为82.13%；对照组显效率为68.61%，总有效率为93.34%；两组比较差异无统计学意义（P>0.05）。在治疗中医诊断证候疗效方面，试验组显效率为70.31%，总有效率为93.34%；对照组显效率和总有效率分别为71.29%和91.66%；两组比较差异无统计学意义（P>0.05）。此外，在治疗后胃脘胀满缓解方面，海归养胃胶囊优于雷尼替丁（P<0.05）。未观察到不良反应。
海归养胃胶囊治疗十二指肠溃疡的疗效与雷尼替丁相似。本试验未观察到其明显不良反应。
