【摘要】：目的:本課題運(yùn)用統(tǒng)計(jì)分析、臨床流行病學(xué)(DME)方法設(shè)計(jì)的隨機(jī)對(duì)照試驗(yàn)等手段觀察參靈啟陽(yáng)顆粒治療陽(yáng)痿的臨床療效,并對(duì)其可能作用機(jī)制進(jìn)行探究,為促進(jìn)臨床推廣和進(jìn)一步深入研究提供科學(xué)依據(jù)。方法:采用隨機(jī)對(duì)照臨床研究,將來(lái)源于廣西中醫(yī)藥大學(xué)第一附屬醫(yī)院男科門診,符合中醫(yī)陽(yáng)痿及西醫(yī)勃起功能障礙診斷標(biāo)準(zhǔn)的患者90例納入觀察對(duì)象,采用計(jì)算機(jī)隨機(jī)數(shù)字生成法隨機(jī)分為實(shí)驗(yàn)組45例、對(duì)照組45例。因資料不全及病例脫落者而剔除4例,實(shí)際有效病例86例,其中實(shí)驗(yàn)組43例、對(duì)照組43例。實(shí)驗(yàn)組給予參靈啟陽(yáng)顆粒1付/日,400ml開水沖泡,均分二份,早、晚餐后溫服。對(duì)照組給予疏肝益陽(yáng)膠囊0.25g*36粒,4粒/次,3次/日,早、中、晚餐后口服。所有入組患者觀察1個(gè)療程(4周),療程結(jié)束后隨訪3個(gè)月。對(duì)兩組的所有患者在就診同時(shí)均給予非藥物干預(yù)措施,包括給患者做適當(dāng)?shù)男睦硎鑼?dǎo),建議患者改變不良生活方式,并指導(dǎo)患者建立健康的生活方式。治療4周后對(duì)比觀察兩組患者的臨床療效、IIEF-5積分、EQS積分、中醫(yī)證候積分、陽(yáng)痿嚴(yán)重程度的變化和安全性指標(biāo),評(píng)價(jià)參靈啟陽(yáng)顆粒治療陽(yáng)痿的療效和安全性。結(jié)果:治療后治療組治愈25例,顯效11例,有效3例,無(wú)效4例,總有效率90.70%;對(duì)照組治愈16例,顯效12例,有效8例,無(wú)效7例,總有效率83.72%,治療組療效優(yōu)于對(duì)照組(p0.05);治療后兩組患者陽(yáng)痿嚴(yán)重程度變化較治療前有顯著性差異(p0.05);治療后,輕度、中度、重度陽(yáng)痿的有效率,治療組分別為92.30%、91.67%、83.33%,對(duì)照組分別為86.67%、85.71%、71.43%,治療組在不同程度陽(yáng)痿的有效率均高于對(duì)照組,但療效無(wú)顯著性差異(p0.05);治療組與對(duì)照組在分布上無(wú)顯著性差異(p0.05);在陽(yáng)痿證型之命門火衰證、驚恐傷腎證、心脾兩虛證和肝氣郁結(jié)證的療效方面,治療組的有效率分別為95.00%、83.33%、88.89%、87.50%,對(duì)照組的有效率分別為88.9%、80.0%、76.92%、85.71%,治療組的有效率均高于對(duì)照組,但療效無(wú)顯著性差異(p0.05);兩組治療后IIEF-5評(píng)分、EQS評(píng)分較治療前明顯提高,治療組療效優(yōu)于對(duì)照組(p0.05);兩組治療后中醫(yī)證候積分較治療前明顯下降,治療組療效優(yōu)于對(duì)照組(p0.05)。治療期間,兩組均未見嚴(yán)重不良反應(yīng),顯示出良好的安全性。治療前后血、尿、糞常規(guī),空腹血糖,血脂,心、肝、腎功能,性激素等安全性指標(biāo)未見明顯異常改變。經(jīng)3個(gè)月的隨機(jī)隨訪,未出現(xiàn)陽(yáng)痿癥狀反復(fù)者。結(jié)論:參靈啟陽(yáng)顆粒治療陽(yáng)痿臨床療效顯著,能明顯提高IIEF-5評(píng)分、EQS評(píng)分,改善勃起功能;能明顯降低中醫(yī)證候積分,改善軀體不適癥狀;療效比較穩(wěn)定,安全性較好,在治療期間無(wú)明顯毒副作用,值得推廣。
[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.
【學(xué)位授予單位】：廣西中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R277.5

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