利胆化痰丸治疗胆囊息肉（胆热痰湿证）的临床研究

发布时间：2018-05-27 06:33

本文选题：利胆化痰丸 + 胆囊息肉　；参考：《河南中医药大学》2016年硕士论文

【摘要】：目的:观察评价利胆化痰丸治疗胆囊息肉(胆热痰湿证)的临床疗效与安全性,为临床广泛推广提供依据。方法:符合纳入标准的患者共60例,均来自2014年10月至2015年12月河南中医药大学第三附属医院肝胆脾胃科门诊及住院部,本研究采用随机对照的方法,将患者按就诊顺序进行编号,使用随机数字表法,将受试者随机分为治疗组和对照组,治疗组30例给予利胆化痰丸治疗,对照组30例给予胆宁片治疗,4周为一疗程,连续服药观察3个疗程,在每疗程结束后,分别观察治疗前后中医证候总积分、影像学疗效及安全性指标检测,并于治疗结束后第12周进行随访,评定其远期疗效。结果:1治疗前,两组患者的性别、年龄及中医证候总积分、单发息肉与多发息肉的数目、单发息肉的直径与多发息肉的最大直径,经统计学分析均无差异,说明两组基线资料具有可比性。2影像学疗效:总体疗效:在治疗4周、8周、12周后,分别对两组组内进行比较,经统计学分析,差异具有统计学意义(P0.05),说明两组息肉直径治疗后均较治疗前有所减小;治疗后两组间比较,经统计学分析,差异有统计学意义(P0.05),说明治疗组对息肉总体的疗效优于对照组。单发息肉疗效:在治疗4周、8周、12周后,分别对两组组内进行比较,经统计学分析,差异具有统计学意义(P0.05),说明两组单发息肉直径治疗后均较治疗前有所减小;治疗后两组间比较,经统计学分析,差异有统计学意义(P0.05),说明治疗组对单发息肉疗效优于对照组。多发息肉疗效:在治疗4周、8周、12周后,分别对两组组内进行比较,经统计学分析,差异具有统计学意义(P0.05),说明两组多发息肉最大直径治疗后均较治疗前有所减小;治疗后两组间比较,经统计学分析,差异有统计学意义(P0.05),说明治疗组对多发息肉疗效优于对照组。3症状的疗效:在治疗4周、8周、12周后,分别对两组组内进行比较,经统计学分析,差异具有统计学意义(P0.05),说明两组中医证候总积分治疗后均较治疗前有所下降;治疗后两组间比较,经统计学分析,差异有统计学意义(P0.05),说明治疗组对中医症状的疗效优于对照组。4复发率比较:在总疗程结束后的随访中发现,治疗组的复发率为8.3%,对照组的复发率为46.7%,经统计学分析,差异有统计学意义(P0.05),说明在控制胆囊息肉复发方面,利胆化痰丸存在显著优势。结论:利胆化痰丸能有效减小胆囊息肉的直径,改善患者的临床症状,控制其复发率,并在一定程度上提高患者的生活质量,并且在临床上服用方便,未见明显不良反应及毒副作用,安全性较高,临床综合疗效优于对照组,利胆化痰丸是治疗胆囊息肉(胆热痰湿证)安全有效的药物。
[Abstract]:Objective: to evaluate the efficacy and safety of Lidanhuatan pills in treating gallbladder polyps (gallbladder heat and phlegm dampness syndrome). Methods: a total of 60 patients from October 2014 to December 2015 in Department of liver, spleen and stomach of the third affiliated Hospital of Henan University of traditional Chinese Medicine were enrolled in the study. The subjects were randomly divided into treatment group and control group. 30 patients in the treatment group were treated with Lidanhuatan pills, and 30 patients in the control group were treated with Danning tablet for 4 weeks as a course of treatment. After each course of treatment, the total score of TCM syndromes, imaging efficacy and safety index were observed before and after treatment, and follow-up was carried out at the 12th week after treatment to evaluate the long-term effect. Results there was no significant difference in sex, age and the total score of TCM syndromes, the number of single polyps and polyps, the diameter of single polyps and the maximum diameters of multiple polyps between the two groups. The results showed that the baseline data of the two groups were comparable. 2. Imaging efficacy: the overall efficacy: after 4 weeks, 8 weeks and 12 weeks of treatment, the two groups were compared and statistically analyzed. The difference was statistically significant (P 0.05), which indicated that the diameter of polyps in the two groups decreased after treatment, and the difference between the two groups after treatment was statistically significant (P 0.05), which indicated that the therapeutic effect of the treatment group on polyp was better than that of the control group. The curative effect of single polyp: after 4 weeks, 8 weeks and 12 weeks of treatment, the two groups were compared, and the difference was statistically significant (P 0.05), which indicated that the diameter of single polyp in the two groups was smaller than that before treatment. After treatment, the difference between the two groups was statistically significant (P 0.05), which indicated that the curative effect of the treatment group on single polyp was better than that of the control group. The curative effect of multiple polyps: after 4 weeks, 8 weeks and 12 weeks of treatment, the two groups were compared. The statistical analysis showed that the difference was statistically significant (P 0.05), which indicated that the maximum diameter of multiple polyps in both groups was smaller than that before treatment. After treatment, the difference between the two groups was statistically significant (P 0.05), which indicated that the therapeutic effect of the treatment group on multiple polyps was better than that of the control group (P < 0.05). After 4 weeks, 8 weeks and 12 weeks of treatment, the two groups were compared respectively. By statistical analysis, the difference was statistically significant (P 0.05), indicating that the total integral of TCM syndromes in the two groups was lower than that before treatment, and the comparison between the two groups after treatment was statistically significant. The difference was statistically significant (P 0.05), which showed that the curative effect of the treatment group on TCM symptoms was better than that of the control group (4%): after the end of the total course of treatment, the recurrence rate of the treatment group was 8.3% and that of the control group was 46.7%, the statistical analysis showed that the curative effect of the treatment group was better than that of the control group. The difference was statistically significant (P 0.05), indicating that Lidan Huatan Pill had a significant advantage in controlling the recurrence of gallbladder polyps. Conclusion: Lidanhuatan pills can effectively reduce the diameter of gallbladder polyps, improve the clinical symptoms, control the recurrence rate, and improve the quality of life of the patients to a certain extent. There were no obvious adverse reactions and side effects, the safety was higher, the clinical comprehensive curative effect was better than the control group, and Lidanhuatan pills was a safe and effective drug for treating gallbladder polyps (gallbladder heat and phlegm dampness syndrome).
【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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