从脾论治治疗功能性腹泻随机、双盲、安慰剂对照临床观察研究

发布时间：2018-05-28 11:56

本文选题：从脾论治 + 功能性腹泻　；参考：《山西中医学院》2016年硕士论文

【摘要】：目的:通过口服中药治疗功能性腹泻(F-D/FDi)前后对照的临床观察试验,客观评价中医药从脾论治功能性腹泻的有效性和安全性。以阐明“脾主运化、统血”等脾脏藏象理论的基本科学内涵,解释功能性胃肠病“从脾论治”临床疗效产生的机制和规律,进一步丰富和发展藏象理论。方法:选择符合纳入标准及排除标准的功能性腹泻(F-D/FDi)患者60例,按照随机、双盲、安慰剂、对照的临床研究设计原则对患者进行临床证候辨证分型,依据分型结果分为脾虚湿阻证和脾阳虚证两组,每组30例。两组患者入组时均进行安全性检查,包括:血、尿、大便常规及潜血(用药前、后各检查一次);肝功能(ALT、AST)肾功能(Cr、BUN)(用药前、后各检查一次);心电图(用药前、后各检查一次)。均统一服用由总课题组配发的中药配方颗粒,每袋12g。对照组使用安慰剂治疗,药品发放严格按照随机化、双盲原则进行。治疗组:脾虚湿阻证组口服中药复方颗粒剂:炙黄芪党参炒白术茯苓煨木香砂仁薏苡仁姜炭车前子炙甘草;用法:1袋/次,3次/日,冲服。连续服用4周。脾阳虚证组口服中药复方颗粒剂为炙黄芪党参炒白术茯苓煨木香砂仁炮附子姜炭肉豆蔻车前子炙甘草;用法:1袋/次,3次/日,冲服。连续服用4周。对照组:口服与中药复方颗粒剂外观、规格完全相同的安慰剂,安慰剂由辅料加原药的1/20制作成。用法、用量及服用时间均与治疗组相同。结果:1、治疗组30例,痊愈0例,显效5例,有效23例,无效2例,总有效率93%;对照组30例,痊愈0例,显效1例,有效10例,无效19例,总有效率36%;提示治疗组临床综合疗效优于对照组,治疗组显效率优于对照组(P0.05),且总体印象治疗组有效率(53%)优于对照组(10%),两者差异有统计学意义(P0.05);2、两组证型治疗组患者治疗后中医症候总积分与治疗前相比均有好转,与对照组比较差异有统计学意义(P0.05),且对于功能性腹泻患者的大便次数和性状均有明显改善,治疗组疗效优于对照组(P0.05);3、两组证型治疗组患者治疗后生存质量状况均优于对照组,差异有统计学意义(P0.05);治疗后两组患者大便潜血情况及肠镜复查结果相比,治疗组疗效优于对照组(P0.05);4、功能性腹泻患者均存在不同程度的焦虑和抑郁症状;5、脾阳虚证治疗组患者治疗后焦虑、抑郁状态优于对照组,差异有统计学意义(P0.05);脾虚湿组证患者治疗后焦虑、抑郁状态与对照组无明显差异(P0.05);6、功能性腹泻20-30岁人群占比较大,男性患者多于女性;7、两组患者在治疗期间均未发生明显的不良反应,其治疗前后实验室检查血常规、尿常规、心电图、肝功及肾功均未发现明显异常,具备安全性。结论:中药“从脾论治”治疗功能性腹泻在改善患者相关临床症状、腹泻次数、大便形状、生存质量状况和焦虑、抑郁状态方面,优于对照组,其总有效率高于对照组。但对脾虚湿阻证患者焦虑、抑郁状态效果不明显。
[Abstract]:Objective: to evaluate the efficacy and safety of traditional Chinese medicine (TCM) in the treatment of functional diarrhea from spleen. In order to elucidate the basic scientific connotation of the theory of "spleen governing transportation, regulating blood" and so on, explain the mechanism and rule of clinical curative effect of functional gastrointestinal disease "treating from spleen", further enrich and develop the theory of Tibetan image. Methods: sixty patients with F D / F Dii, who met the inclusive and exclusion criteria, were selected and classified according to the principles of randomized, double-blind, placebo and control clinical study design. According to the results of classification, 30 cases in each group were divided into two groups: spleen deficiency dampness syndrome and spleen yang deficiency syndrome. The patients in both groups were examined for their safety, including: blood, urine, stool routine and occult blood (before and after treatment) and renal function (before and after treatment), renal function and renal function (before and after treatment) and electrocardiogram (before and after treatment). All of them were given the prescription granules of traditional Chinese medicine, each bag was 12g. The control group was treated with placebo, and the drug distribution was done strictly according to randomization and double blindness. Treatment group: spleen deficiency dampness blocking syndrome group oral Chinese compound granule: fried Astragalus Codonopsis Codonopsis Atractylodes Suckahoe simmer Amomum Seeds Coix seed Ginger charcoal Fructus Glycyrrhiza; use 1 bag 3 times a day take. Take it continuously for 4 weeks. Spleen yang deficiency syndrome group took oral Chinese medicine compound granules as fried Astragalus Codonopsis Codonopsis and Radix Atractylodes Amur to simmer Amomum Kernel Gun Ginger charcoal nutmeg cardamom plantain to burn licorice; use 1 bag / 3 times a day take it. Take it continuously for 4 weeks. Control group: placebo with the same appearance and specification as compound granules was prepared by adding excipient and 20 / 20 of the original medicine. The usage, dosage and duration were the same as those in the treatment group. Results in the treatment group, 30 cases were cured, 5 cases were markedly effective, 23 cases were effective, 2 cases were ineffective, the total effective rate was 93%, while in the control group, 30 cases were cured, 1 case was markedly effective, 10 cases were effective, 19 cases were ineffective. The total effective rate was 36%, which indicated that the clinical comprehensive curative effect of the treatment group was better than that of the control group. The effective rate of the treatment group was better than that of the control group (P0.05A, and the overall impression treatment group's effective rate was 53) better than that of the control group (105L). The difference between the two groups was statistically significant (P 0.05). The total score of TCM symptoms in the treatment group was better than that before treatment. Compared with the control group, the difference was statistically significant (P 0.05), and the defecation frequency and character of the patients with functional diarrhea were improved obviously. The curative effect of the treatment group was better than that of the control group (P 0.05). The quality of life of the patients in the treatment group was better than that in the control group after treatment. The difference was statistically significant (P 0.05), and the results of occult blood in stool and colonoscopy were compared between the two groups after treatment. The curative effect of the treatment group was better than that of the control group (P 0.05), the patients with functional diarrhea had different degree of anxiety and depression symptoms, and the patients in the treatment group of spleen yang deficiency syndrome were better than the control group in terms of anxiety and depression after treatment. There was no significant difference in post-treatment anxiety and depression between the patients with spleen deficiency and dampness group and the control group (P 0.05), and the patients aged 20-30 years old with functional diarrhea accounted for more than those in the control group. There were no obvious adverse reactions in the two groups during the treatment. The blood routine, urine routine, electrocardiogram, liver function and renal function were not abnormal in the laboratory before and after treatment. Conclusion: the treatment of functional diarrhea with "treating from spleen" is superior to the control group in improving the clinical symptoms, diarrhea times, stool shape, quality of life, anxiety and depression, and its total effective rate is higher than that in the control group. However, the effect of anxiety and depression in patients with spleen deficiency and dampness obstruction syndrome is not obvious.
【学位授予单位】：山西中医学院
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R256.34

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