论文标题:中药新药治疗经前期综合征（肝气郁结、脾运失调证）临床研究
Symptom Features and Pathogenisis of Decompensated Liver Cirrhosis with Ascites and Intestinal Endotoximia and Treatment by TCM
论文作者 谢琪
论文导师 贺兴东,论文学位 硕士,论文专业 中药学
论文单位 北京中医药大学,点击次数 119,论文页数 99页File Size5088k
2004-05-01论文网 http://www.lw23.com/lunwen_86110762/ 经前期综合征,临床研究,中药新药
decompensated liver cirrhosis, intestinal endotoxin mia, Chinese Medicine
本文首先阐述了中医学对经前期综合征(又称经前期紧张综合征)的病因病机和辨证论治的相关认识，重点对近十年中医药治疗经前期综合征的研究进展进行了归纳总结，并从现代医学角度介绍了经前期综合征的发病机理、临床表现以及治疗方法的研究进展。通过分析对照经前期综合征的主要临床表现，拟订其主要证候属于肝疏泄失常、脾运化不利所致，故将该病定位于肝、脾，定型为肝气郁结、脾运失调，以养肝解郁，理气止痛为治疗大法，从根本上治疗经前期综合征。 在此基础上，通过临床试验探讨了中药新药治疗经前期综合征的疗效。试验设计采用随机，双盲、平行对照、多中心临床研究方法，以逍遥冲剂为对照药，评价中药新药治疗经前期综合征(肝气郁结、脾运失调证)的有效性和安全性。经全国5家医院药品临床试验基地对400例受试者临床试验结果表明，中药新药治疗经前期综合征(肝气郁结、脾运失调证)总有效率优于对照组逍遥冲剂，对经前期综合征的主要症状：经前情绪低落、郁闷不乐、经前乳房胀痛的改善率亦优于对照组，有显著性差异；治疗组和对照组不良事件的发生率均较低，无显著性差异。提示中药新药是治疗经前期综合征(肝气郁结、脾运失调证)安全、有效的药物。 该课题科研设计合理，先后3次召开集中研讨会，由研制单位与各中心科研人员、科研管理人员共同参加，对研究方案的设计与结果进行讨论。目前，研究已全部结束，资料已完成总结报告与分报告，并完成新药申报材料，呈报国家食品药品监督管理局。研究过程规范，严格按照方案执行，由研究者委派监查员进行监查。为进一步规范操作规程，建立完善了相关的管理制度，制定了监查手册、数据管理手册。 在研究过程中，在保障受试者的权益，规范化操作的同时，为了加快临床研究的进度，同时又能减轻研究者的压力，采取了广告、组织宣传会，向社会广泛征募和组织受试者的有效措施，对于促进受试者与研究人员的沟通，保证了受试者的依从性，从而保障研究工作的顺利进行起到了积极的促进作用，丰富了临床研究的形式，对于保障临床研究的质量也是一种有益而行之有效的尝试。
1 ObjectivesTo observe the symptoms and signs of patients with decompensated liver cirrhosis combined with intestinal endotoximia. To study the curative effects of compound formula qing-du-tang .To search for a effective way to treat intestinal endotoximia for the patients with decompensated liver cirrhosis combined with ascites.2 Methods2.1 CasesAll the cases are hospitalized patients in Ditan Hospital, from January, 2002 to January ,2003;aged from 18 to 65. All the patients meet the the diagnosis of decompensated liver cirrhosis, combined with ascites and intestinal endotoximia.2.2 Therapetic regimen60 cases were divided into 2 groups according to the admission time, one for therapy group, another for contrast group. The basic treatment is similar to the two groups: thymic peptide injection 100mg/d; Xiang-Dan Injection 40ml/d. Dihydrochlorothiazide 25-50 mg/d ; Aldactone 20-100mg/d. Antibiotics was given according to the case condition. Qing-Du-Tang decoct was used in the therapy group for 10 days, 100ml, twice a day. Lactulose was used in the contrast group for 10 days, 10-20ml, twice a day.2.3 Observations2.3.1 Observed the symptoms and signs of patients. Score the main symptoms and signs . 2.3. 2 Compared the changes of total scores for the main symptoms between the therapy group and the contrast group. Compare the changes of the liver function , renal function, and endotoxin quantitation of the two groups.3 ResultsFever, severe abdominal distention, abdominal pain, nausea, vomit, dark red tongue, thick and greasy tongue fur, dry stool were observed in the patients with intestinal endotoximia . It showed the features of wet heat , qi-stagnancy and blood stasis. Qind-Du-Tang was better than Lactulose on improving symptoms, eliminating endotoxin and lowering blood ammonia.4 ConclusionThe patients with liver cirrhosis combined with ascites and intestinal endo -toximia showed asthenia in origin and sthenia in superficial it. Asthenia inorigin was marked by hepatic and renal yin deficiency, asdthenic splenonephro-yang; sthenia in superficial it included wet heat, toxin, stagnant blood. Disfunction of liver, spleen , kidney and wet heat , toxin , stagnant blood coalescing together were its main pathogenisis mechanism . Qing-Du-Tang had the effects of clearing heat, depriving the evil wetness, promoting blood flow, detoxicating, opening bowels, nourishing yin and cooling blood. It showed better effects on clearing endotoxin in this study. No side effects were observed.
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