芪榔方治疗气阴两虚型功能性便秘的临床研究

Study of clinical effect of Qilang decoction on functional constipation of qi and yin deficiency

关键词:  功能性便秘  芪榔方  气阴两虚型  临床疗效

Key words:  functional constipation  Qilang decoction  qi and yin deficiency  clinical curative effect

摘要:

[目的] 采用随机对照方法，以乳果糖口服溶液为对照，观察芪榔方治疗气阴两虚型功能性便秘的临床疗效与用药安全性。[方法] 将符合气阴两虚型功能性便秘诊断标准的80例受试者按随机数字表法分为治疗组及对照组，治疗组用芪榔方，对照组用乳果糖口服溶液，皆以8周为1个疗程。分别在治疗前、治疗8周进行中医证候、生活质量评分，并在患者治疗前后进行血、尿、便常规、肝肾功能和心电图检查，评价其用药安全性。[结果] 1）治疗组总有效率为97.5%，对照组为82.5%，治疗组总体疗效优于对照组（P<0.05）。2）治疗组能够显著改善气阴两虚型的所有症状（P<0.05），对照组能够显著改善除乏力、心烦失眠以外的症状（P<0.05）；治疗组在改善患者粪便性状、排便无力、纳呆、乏力、心烦失眠等方面，疗效优于对照组（P<0.05）。3）治疗组与对照组均能显著改善气阴两虚型功能性便秘患者生理状态、心理状态、担忧度及满意度4个维度的生活质量（P<0.05），且治疗组各维度疗效均优于对照组（P<0.05）。4）在临床研究过程中各组患者均未出现明显不良反应。[结论] 芪榔方对气阴两虚型功能性便秘疗效确切，临床使用安全，值得推广应用。

Abstract:

[Objective] To observe clinical effect and safety of Qilang decoction on functional constipation of qi and yin deficiency.[Methods] The 80 cases of functional constipation of qi and yin deficiency patients were enrolled in the study and randomly divided into treatment group and control group. The treatment group was treated with Qilang decoction. The control group was provided by lactulose. The treatment time was eight weeks. In the end, the treatment group had 40 patients left while the control group had 40 patients. A comparison between the two groups about traditional Chinese medicine (TCM) symptom integral, PAC-QOL scale of pre-therapy and post-treatment was made to study the clinical validity. And the safety indexes of the two groups (such as the three routine examination, liver and kidney functional examination and electrocardiogram) were detected to study the safety of it.[Results] 1)The clinical total effective rate of the treatment group was 97.5%. The total effective rate of control group was 82.5%. The total effective rate of the treatment group was significantly better than the control group (P<0.05). The difference about heartburn, belching, poor mood, hiccup between two groups was statistically significant (P<0.05). 2) The treatment group could significantly improve all TCM syndrome of qi and yin deficiency (P<0.05) and the control group could also significantly improve all TCM syndrome except fatigue, upset, insomnia (P<0.05). The effects of treatment group in improving stool, defecation, weakness, anorexia, fatigue, insomnia and curative were better than that of the control group (P<0.05). 3)The treatment group could effectively improve the life quality of patients, which could significantly improve physiological state, psychological state, anxiety degree and satisfaction degree four dimensions scores in PAC-QOL (P<0.05). And the treatment group was better than control group (P<0.05). 4)After treatment, the safety index of the two groups was normal.[Conclusion] Qilang decoction is effective and safety in treating functional constipation of qi and yin deficiency. It is worth popularization and application.