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胃萎Ⅰ号颗粒对脾胃虚弱型萎缩性胃炎的临床疗效评价研究
The Clinical Evaluation of Weiwei I Granule on Spleen Deficiency Chronic Atrophic Gastritis
【作者】 施甜；
【导师】 朱方石；
【作者基本信息】 南京中医药大学 ， 中医学， 2012， 硕士
【摘要】 目的：评价CAG中医优化方案治法之一“健脾益气”的“胃萎I号颗粒”对脾胃虚弱型慢性萎缩性胃炎(chronic atrophic gastritis, CAG)的综合临床疗效,以期为制定规范、实用的中医药CAG治疗方案提供依据。方法：采用多中心、随机、双盲双模拟、平行对照的临床研究设计,对6家研究中心101例脾胃虚弱型CAG患者,按GCP规范进行了临床试验研究,疗程3个月,观察症状学指标、胃镜下黏膜改变及病理组织学的变化,与“维酶素”对照,评价胃萎I号治疗脾胃虚弱型CAG的临床疗效。结果：胃萎I号组治疗前后主症和次症的改善率均>70%,显示了显效,而维酶素组>30%、<70%,则显示了有效。胃萎I号组症状疗效的总有效率为87.10%,维酶素组为56.41%,两组数值有统计学意义(P<0.05)。胃萎I号组治疗前后胃镜下萎缩积分减少率及病理分级积分减少率分别为26.58%、35.48%,而维酶素组则分别为22.64%、21.3１%,经检验两组的胃镜下粘膜征象及病理萎缩分级的改善程度无明显统计学差异(P>0.05)。结论：胃萎I号颗粒能有效的改善脾胃虚弱型CAG临床症状,对胃镜下粘膜征象及病理萎缩状态有一定的治疗作用,显示出较对照药的疗效优势强项,有其应用价值和推广前景。
【Abstract】 Objective:Through evaluating the clinical curative effect of Atrophy I granule on spleen deficiency CAG(chronic atrophic gastritis), may be we can provide theoretical basis for standardized CAG treatment of traditional Chinese medicine.Method:The study chose101patients who were consistent with the clinical diagnosis of spleen insufficiency chronic atrophic gastritis from6research centers to enroll the randomized, parallel, double-blind and double-dummy clinical research, and put the Vitacoenzyme Tablets as control medicine. From the symptom score, symptomatic efficacy, endoscopy findings and pathologic analysis of the results aspects, we can evaluate the clinical efficacy of Atrophy1granule to spleen deficiency CAG.Results:The clinical improvement rate of Atrophy I group was over70,but Vitacoenzyme group’s was less than70and over30.The total cure rate of Atrophy I group was87.1,and Vitacoenzyme group’s was56.41. There were statistical differences between the two groups at clinical effective. The reduce rate of gastroscopic mucosa atrophy score and pathological atrophy level of Atrophy I group were26.58and35.48,and Vitacoenzyme group’s were22.64、21.31.There were no statistical differences between the two groups at atrophy of gastric mucosa.Conclusion:Atrophy1granule can obviously improve the clinical symtoms of spleen deficiency CAG, and also is somewhat effective in treating the atrophy of gastric mucosa. Atrophy1granule has a certain point unique advantage than Vitacoenzyme Tablets on spleen deficiency CAG. As a result, Atrophy I granule has good practical and promotion value.