参灵启阳颗粒治疗阳痿的临床研究

发布时间：2018-07-16 12:25

【摘要】：目的:本课题运用统计分析、临床流行病学(DME)方法设计的随机对照试验等手段观察参灵启阳颗粒治疗阳痿的临床疗效,并对其可能作用机制进行探究,为促进临床推广和进一步深入研究提供科学依据。方法:采用随机对照临床研究,将来源于广西中医药大学第一附属医院男科门诊,符合中医阳痿及西医勃起功能障碍诊断标准的患者90例纳入观察对象,采用计算机随机数字生成法随机分为实验组45例、对照组45例。因资料不全及病例脱落者而剔除4例,实际有效病例86例,其中实验组43例、对照组43例。实验组给予参灵启阳颗粒1付/日,400ml开水冲泡,均分二份,早、晚餐后温服。对照组给予疏肝益阳胶囊0.25g*36粒,4粒/次,3次/日,早、中、晚餐后口服。所有入组患者观察1个疗程(4周),疗程结束后随访3个月。对两组的所有患者在就诊同时均给予非药物干预措施,包括给患者做适当的心理疏导,建议患者改变不良生活方式,并指导患者建立健康的生活方式。治疗4周后对比观察两组患者的临床疗效、IIEF-5积分、EQS积分、中医证候积分、阳痿严重程度的变化和安全性指标,评价参灵启阳颗粒治疗阳痿的疗效和安全性。结果:治疗后治疗组治愈25例,显效11例,有效3例,无效4例,总有效率90.70%;对照组治愈16例,显效12例,有效8例,无效7例,总有效率83.72%,治疗组疗效优于对照组(p0.05);治疗后两组患者阳痿严重程度变化较治疗前有显著性差异(p0.05);治疗后,轻度、中度、重度阳痿的有效率,治疗组分别为92.30%、91.67%、83.33%,对照组分别为86.67%、85.71%、71.43%,治疗组在不同程度阳痿的有效率均高于对照组,但疗效无显著性差异(p0.05);治疗组与对照组在分布上无显著性差异(p0.05);在阳痿证型之命门火衰证、惊恐伤肾证、心脾两虚证和肝气郁结证的疗效方面,治疗组的有效率分别为95.00%、83.33%、88.89%、87.50%,对照组的有效率分别为88.9%、80.0%、76.92%、85.71%,治疗组的有效率均高于对照组,但疗效无显著性差异(p0.05);两组治疗后IIEF-5评分、EQS评分较治疗前明显提高,治疗组疗效优于对照组(p0.05);两组治疗后中医证候积分较治疗前明显下降,治疗组疗效优于对照组(p0.05)。治疗期间,两组均未见严重不良反应,显示出良好的安全性。治疗前后血、尿、粪常规,空腹血糖,血脂,心、肝、肾功能,性激素等安全性指标未见明显异常改变。经3个月的随机随访,未出现阳痿症状反复者。结论:参灵启阳颗粒治疗阳痿临床疗效显著,能明显提高IIEF-5评分、EQS评分,改善勃起功能;能明显降低中医证候积分,改善躯体不适症状;疗效比较稳定,安全性较好,在治疗期间无明显毒副作用,值得推广。
[Abstract]:Objective: to observe the clinical efficacy of Shenling Qiyang granule in the treatment of impotence by means of statistical analysis and randomized controlled trial designed by clinical epidemiology (DME), and to explore its possible mechanism. It provides scientific basis for promoting clinical popularization and further research. Methods: a randomized controlled clinical study was conducted on 90 patients who met the diagnostic criteria of impotence and erectile dysfunction in the first affiliated Hospital of Guangxi University of traditional Chinese Medicine. The computer random number generation method was used to divide the experimental group (45 cases) and the control group (45 cases) randomly. There were 4 cases excluded because of incomplete data and exfoliation, 86 cases were effective, 43 cases were in the experimental group and 43 cases in the control group. The experimental group was given Shenling Qiyang granule 1 Fu / d 400 ml boiling water, equally divided into 2 parts, early morning, warm after dinner. The control group was given Shugan Yiyang capsule 0.25g*36 4 capsules / 3 times a day, morning, middle, after dinner oral. One course of treatment (4 weeks) was observed and followed up for 3 months. All patients in both groups were given non-drug intervention at the same time, including appropriate psychological counseling, suggested that patients change their unhealthy lifestyle, and guide patients to establish a healthy lifestyle. After 4 weeks of treatment, the clinical effects of the two groups were compared and observed. The clinical efficacy of the two groups was compared with that of the IIEF-5 integral EQS, the TCM syndrome score, the severity of impotence and the safety index, and the efficacy and safety of Shenling Qiyang granule in the treatment of impotence were evaluated. Results: in the treatment group, 25 cases were cured, 11 cases were effective, 3 cases were effective, 4 cases were ineffective, and the total effective rate was 90.70%, while in the control group, 16 cases were cured, 12 cases were effective, 8 cases were effective, 7 cases were ineffective. The total effective rate was 83.72, the curative effect of the treatment group was better than that of the control group (p0.05), the change of the severity of impotence in the two groups was significantly different from that before treatment (p0.05), the effective rate of slight, moderate and severe impotence after treatment was higher than that of the control group (p0.05). The effective rate of impotence in the treatment group was higher than that in the control group, but there was no significant difference (p0.05); there was no significant difference in distribution between the treatment group and the control group (p0.05); in the type of impotence, there was no significant difference between the treatment group and the control group (p0.05); in the type of impotence, the effective rate of impotence was higher than that in the control group, but there was no significant difference between the treatment group and the control group (p0.05), and there was no significant difference in the distribution between the treatment group and the control group (p0.05). The effective rates of the treatment group were 95.00 and 83.33 respectively, and the effective rates of the control group were 88.89 and 87.50, respectively, and the effective rates of the control group were 88.98.80.010 and 76.92% respectively. The effective rate of the treatment group was higher than that of the control group, and the effective rate of the treatment group was higher than that of the control group, and the effective rate of the treatment group was higher than that of the control group. After treatment, the IIEF-5 score and EQS score of the treatment group were significantly higher than that of the control group (p0.05), the TCM syndrome score of the two groups was significantly lower than that of the control group (p0.05), the therapeutic effect of the treatment group was better than that of the control group (p0.05). During the treatment, no serious adverse reactions were observed in both groups, showing good safety. Blood, urine, fecal routine, fasting blood glucose, blood lipid, heart, liver, kidney function, sex hormone and other safety indexes showed no obvious abnormal changes before and after treatment. After 3 months of random follow-up, there was no recurrent symptoms of impotence. Conclusion: Shenling Qiyang granule has a significant clinical effect on impotence, can obviously improve the score of IIEF-5 and improve erectile function, can obviously reduce the score of TCM syndrome and improve the symptoms of body discomfort, the curative effect is relatively stable and the safety is good. There are no obvious side effects during the treatment, so it is worth popularizing.
【学位授予单位】：广西中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R277.5

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