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加味下气汤治疗功能性腹胀伴抑郁状态(肝郁脾虚型)的临床研究

发布时间:2019-05-19 11:09
【摘要】:目的:本研究从中医证候、远期疗效、汉密尔顿抑郁量表评分等方面来评价加味下气汤治疗功能性腹胀伴抑郁状态(肝郁脾虚型)的临床疗效以及本方案的安全性,为临床应用和中医药新药开发提供较为科学的理论依据。方法:所有符合纳入标准,经过排除标准筛选的患者作为受试对象,依据估计的样本量,拟设样本例数54例,按20%脱落病例考虑,拟纳入64例患者,以患者就诊顺序编号,采用完全随机数字表法,按1:1匹配比例将所符合标准的64例患者随机分为治疗组32例和对照组32例。治疗组给予加味下气汤治疗,对照组给予枸橼酸莫沙必利片(快力)和米氮平片治疗。两组均以1周为1疗程,共观察3疗程,疗程结束后的3个月分别对两组患者进行回访。观察治疗前后两组患者的中医证候、远期疗效、总有效率以及不良反应事件,同时在回访时要注意观察患者的复发率。结果:(1)经过3个疗程治疗,在改善中医证候积分方面,治疗组优于对照组(P0.05);(2)治疗组在改善便溏方面疗效不佳,对改善胀满、多愁善感、矢气等症状明显优于对照组,差异有统计学意义(P0.05);(3)经3个疗程治疗,总体疗效方面,两组均有改善(P0.05);治疗组与对照组在改善总体疗效方面有差异,差异有统计学意义(P0.05);(4)汉密尔顿抑郁量表疗效比较:治疗后两组HAMD评分均明显降低,治疗组疗效优于对照组(P0.05);(5)远期疗效方面:治疗组复发5例,复发率为17.9%,对照组复发12例,复发率为46.1%,治疗组优于对照组;(6)安全性方面:两组患者治疗前后安全性指标检测均未出现与药物治疗相关的异常改变。结论:加味下气汤治疗功能性腹胀伴抑郁状态(肝郁脾虚型)疗效确切,能显著、全面改善功能性腹胀伴抑郁状态患者的中医证候、总有效率、汉密尔顿抑郁量表评分的情况,且远期疗效良好,改善患者生活质量,缩短治疗时间,并能降低治疗费用,安全性高,是临床上治疗功能性腹胀伴抑郁状态的有效方剂。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of Jiawei Xiqi decoction in the treatment of functional abdominal distension with depression (liver depression and spleen deficiency type) from the aspects of TCM syndrome, long-term curative effect and Hamilton depression scale score. It provides a scientific theoretical basis for clinical application and new drug development of traditional Chinese medicine. Methods: all the patients who met the inclusion criteria and were screened by exclusion criteria were selected as subjects. According to the estimated sample size, the number of samples was 54. According to 20% of the falling off cases, 64 patients were included and numbered according to the order of treatment. According to the 1:1 matching ratio, 64 patients were randomly divided into treatment group (n = 32) and control group (n = 32). The treatment group was treated with Jiawei Xiaqi decoction, while the control group was treated with mosapride citrate tablets and mirtazapine tablets. Both groups were treated with 1 week as a course of treatment, a total of 3 courses of treatment were observed, and the patients in the two groups were visited back 3 months after the end of the course of treatment. The TCM syndrome, long-term curative effect, total effective rate and adverse reaction events of the two groups were observed before and after treatment, and the recurrence rate of the patients should be observed when returning to the visit. Results: (1) after three courses of treatment, the treatment group was superior to the control group in improving the syndrome score of traditional Chinese medicine (P 0.05). (2) the curative effect of the treatment group in improving loose stools was not good, and the symptoms such as swelling, sentimentality and sagittal qi in the treatment group were significantly better than those in the control group (P 0.05). (3) after three courses of treatment, the overall curative effect of the two groups was improved (P 0.05), and there was significant difference between the treatment group and the control group in improving the overall curative effect (P 0.05). (4) comparison of the efficacy of Hamilton depression scale: after treatment, the HAMD scores of the two groups were significantly decreased, and the curative effect of the treatment group was better than that of the control group (P 0.05). (5) long-term curative effect: the recurrence rate of the treatment group was 17.9%, and that of the control group was 46.1%. The recurrence rate of the treatment group was better than that of the control group. (6) Safety: there were no abnormal changes related to drug treatment in both groups before and after treatment. Conclusion: Jiawei Xiaqi decoction is effective in the treatment of functional abdominal distension with depression (liver depression and spleen deficiency type). It can improve the TCM syndrome, total effective rate and Hamilton depression scale score in patients with functional abdominal distension with depression. The long-term curative effect is good, the quality of life is improved, the treatment time is shortened, and the treatment cost is reduced, and the safety is high. It is an effective prescription for the treatment of functional abdominal distension with depression.
【学位授予单位】:河南中医药大学
【学位级别】:硕士
【学位授予年份】:2016
【分类号】:R259

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