锯叶棕果实提取物对伴有下尿路症状的BPH一期治疗的有效性和安全性分析

目的探讨锯叶棕果实提取物对伴有下尿路症状（LUTS）的BPH一期治疗（12周）的有效性和安全性。方法采用开放性治疗前后对比方法,选择伴有下尿路症状的BPH门诊患者52例,进行12周开放性研究,患者餐后口服锯叶棕果实提取物软胶囊（商品名：沙芭特160mg每天两次）;分别比较患者治疗前后的主要指标：前列腺症状评分（IPSS）、最大尿流率（Qmax）;次要指标：生活质量评分（QOL）、夜尿次数、前列腺体积、剩余尿量等的变化情况以及不良反应的发生率,并进行统计学分析。结果治疗12周后,患者的IPSS评分、QOL评分、最大尿流率、夜尿次数及剩余尿量较治疗前均有明显改善,前列腺体积则无明显变化且患者均未诉明显不良反应。结论锯叶棕果实提取物可有效地改善BPH患者出现的下尿路症状（LUTS）,且安全性高。     

Improving BPH symptoms and sexual dysfunctions with a saw palmetto preparation? Results from a pilot trial

In elderly men, benign prostatic hyperplasia (BPH) is a major risk factor for sexual dysfunctions (SDys). Additionally, the standard treatments for BPH symptoms, alpha blockers and 5‐alpha‐reductase inhibitors, cause SDys themselves. Preparations from saw palmetto berries are an efficacious and well‐tolerated symptomatic treatment for mild to moderate BPH and have traditionally been used to treat SDys. We conducted an open multicentric clinical pilot trial to investigate whether the saw palmetto berry preparation Prostasan® influenced BPH symptoms and SDys. Eighty‐two patients participated in the 8‐week trial, taking one capsule of 320 mg saw palmetto extract daily. At the end of the treatment, the International Prostate Symptom Score was reduced from 14.4 ± 4.7 to 6.9 ± 5.2 (p < 0.0001); SDys measured with the brief Sexual Function Inventory improved from 22.4 ± 7.2 to 31.4 ± 9.2 (p < 0.0001), and the Urolife BPH QoL‐9 sex total improved from 137.3 ± 47.9 to 195.0 ± 56.3 (p < 0.0001). Investigators' and patients' assessments confirmed the good efficacy, and treatment was very well tolerated and accepted by the patients. Correlation analyses confirmed the relationship between improved BPH symptoms and reduced SDys. This was the first trial with saw palmetto to show improvement in BPH symptoms and SDys as well. [Corrections made here after initial online publication.] Copyright © 2012 John Wiley & Sons, Ltd.     

Phytotherapy of Benign Prostatic Hyperplasia. A Minireview

Benign prostate hyperplasia (BPH) is a common condition affecting older men, with an incidence that is age‐dependent. Histological BPH, which typically develops after the age of 40 years, ranges in prevalence from >50% at 60 years to as high as 90% by 85 years of age. Typical symptoms include increased frequency of urination, nocturia, urgency, hesitancy, and weak urine stream. Conventional medicines used for the treatment of BPH include alpha blockers and 5‐alpha reductase inhibitors. This articles review the mode of action, the efficacy, and the safety, including herb‐drug interactions of the most common botanicals (Serenoa repens, Pygeum africanum, Urtica dioica, and Cucurbita pepo) and nutraceuticals (isoflavones, lycopene, selenium, and β‐Sitosterol) in controlling the lower urinary tract symptoms associated to BPH. Copyright © 2013 John Wiley & Sons, Ltd.     

Eviprostat suppresses urinary oxidative stress in a rabbit model of partial bladder outlet obstruction and in patients with benign prostatic hyperplasia

Eviprostat is a phytotherapeutic agent that has been used widely for more than 40 years in the treatment of benign prostatic hyperplasia (BPH) in Japan and Germany, and is known to have antioxidant activity. The present study investigated the effect of Eviprostat on the levels of the urinary oxidative stress marker 8‐hydroxy‐2′‐deoxyguanosine (8‐OHdG) in a rabbit model of surgical partial bladder outlet obstruction (PBOO) and in patients with lower urinary tract symptoms (LUTS) associated with BPH. In the rabbit model, 8‐OHdG levels in urine collected after 3 weeks of PBOO were 3.8‐fold higher than in the urine of sham‐operated rabbits. When twice‐daily Eviprostat was administered orally throughout the 3‐week PBOO period, the increase in urinary 8‐OHdG levels was suppressed by 70%. In the clinical study, nine patients who received Eviprostat for 4 weeks showed 2.5‐fold lower urinary 8‐OHdG levels than before treatment. During Eviprostat treatment, the total International Prostate Symptom Score (IPSS) decreased from 16.56 ± 2.74 to 13.67 ± 2.30 and the quality of life score from 4.22 ± 0.40 to 3.22 ± 0.46. The findings provide evidence that the antioxidant activity of Eviprostat is responsible for its beneficial effects in the treatment of BPH. Copyright © 2009 John Wiley & Sons, Ltd.     

Pharmacological characterization and chemical fractionation of a liposterolic extract of saw palmetto (Serenoa repens): Effects on rat prostate contractility

Ethnopharmacological relevance

Saw palmetto (Serenoa repens) was first used medicinally by native American Indians to treat urological disorders. Nowadays, saw palmetto extracts are widely used in Europe and North America to treat the urinary symptoms associated with benign prostatic hyperplasia even though its mechanisms of action are poorly understood. This study aimed to characterize the bioactive constituents of a lipid extract of saw palmetto that are able to affect contractility of the rat prostate gland. The mechanism of action will also be investigated.

Materials and methods

A commercially available lipid extract of saw palmetto was subjected to fractionation using normal phase column chromatography. Composition of fractions was assessed by proton nuclear magnetic resonance spectroscopy (¹H NMR) and mass spectrometry (MS). Contractile activities of these fractions were evaluated pharmacologically using isolated preparations of rat prostate gland and compared to the activity of the crude extract.

Results

Saw palmetto extract inhibited contractions of the rat prostate gland which were consistent with smooth muscle relaxant activity. Only the ethyl acetate fraction resulting from chromatography inhibited contractions of isolated rat prostates similarly to the inhibition produced by the crude lipid extract. Comparison with authentic samples and analysis of NMR data revealed that this bioactivity was due to the fatty acid components present in the ethyl acetate fraction. Bioassay using various pharmacological tools identified multiple contractile mechanisms which were affected by the bioactive constituents.

Conclusion

A fatty acid component of saw palmetto extract causes inhibition of prostatic smooth muscle contractions via a non-specific mechanism.     

Effects of a nanocomposite containing Orbignya speciosa lipophilic extract on Benign Prostatic Hyperplasia

Ethnopharmacological relevance

Lower urinary tract symptoms (LUTS) are a common complaint among aging men and are usually caused by Benign Prostatic Hyperplasia (BPH). A number of medical treatments for LUTS/BPH exist, such as α-blockers, 5α-reductase inhibitors, phytotherapeutical drugs and combination therapies. Babassu is the common name of a Brazilian native palm tree called Orbignya speciosa, whose kernels are commonly used (eaten entirely or as a grounded powder), in parts of Brazil for the treatment of urinary disorders. This study investigates the effects of Orbignya speciosa nanoparticle extract, a newly developed phytotherapic formulation derived from the kernels of babassu, in the treatment of BPH.

Materials and methods

Orbignya speciosa extract was obtained from the kernels, a nanoparticulate system was developed and acute toxicity test was performed. BPH primary stromal cell and tissue cultures were established and treated with 300 μg/mL Orbignya speciosa nanoparticle (NanoOse) extract in order to evaluate its effects on apoptosis induction, cytotoxicity, cell morphology and proliferation.

Results

Our results indicated that NanoOSE shows no toxicity in animals and acts incisively by promoting morphological cell changes, reducing cell proliferation as well as inducing necrosis/apoptosis on BPH cells and tissues.

Conclusions

This study provided the first report of the successful use of NanoOSE on BPH treatment which corroborates with the popular use of the kernels of this plant. The results also suggest the potential of NanoOSE as a candidate new phytotherapeutic agent on the management of BPH.     

良性前列腺增生病因及发病机制的研究现状

良性前列腺增生是泌尿外科的常见病,其临床表现有尿频、尿急、夜尿增多等尿路刺激症状,尿线变细、尿流中断、进行性排尿困难的梗阻症状,其症状严重影响中老年男性的生命质量,给患者本人和家庭带来生活压力及负担。本文结合近10年国内外文献,从BPH病因及发病机制研究方面进行归纳总结,以期为临床BPH防治研究提供参考。     

碎石术辅助自拟排石方对合并膀胱结石的良性前列腺增生患者下尿路症状的改善作用

目的：探讨碎石术辅助自拟排石方对合并膀胱结石的良性前列腺增生(benign prostatic hyperplasia, BPH)患者下尿路症状的改善作用。方法纳入72例BPH合并膀胱结石的患者并按病历尾号随机分为辅助治疗组(35例)和非辅助治疗组(37例)。非辅助治疗组于碎石术后膀胱持续冲洗1周,口服坦索罗辛与非那雄胺片1周;辅助治疗组在碎石术术前2d开始服用自拟排石方,共2周。检测和评价治疗前后最大尿流率(maximum urinary flow rate, Qmax)、残留尿量(residual urine volume, RU)以及国际前列腺症状评分(International Prostate Symptom Score, IPSS)和生活质量(Quality of Life, QOL)。比较2组尿常规恢复正常和尿管留置时间。半年后随访尿瘘、尿失禁和膀胱结石复发。结果治疗后,辅助治疗组IPSS评分[(12.9±4.5)分比(15.7±3.9)分;t＝2.826,P＝0.006]和RU[(47.3±9.2)ml比(58.4±11.3)ml;t＝4.556,P＜0.001]显著低于非辅助治疗组,Qmax显著高于非辅助治疗组[(30.4±4.7)ml/s比(21.4±3.9)ml/s;t＝8.862,P＜0.001]。辅助治疗组尿管留置时间[(5.7±2.1)d比(8.1±2.2)d;t＝4.730,P＜0.001]和尿常规恢复时间[(6.9±2.3)d 比(10.2±3.1)d;t＝5.106,P＜0.001]均较非辅助治疗组显著缩短。随访6个月显示辅助治疗组尿失禁发生率[2.9%(1/35)比18.9%(7/37);χ2＝4.698,P＝0.030]和结石复发率[5.7%(2/35)比24.3%(9/37);χ2＝4.813, P＝0.028]均显著低于非辅助治疗组。辅助治疗组总有效率显著高于非辅助治疗组[62.9%(22/35)比29.7%(11/37);χ2＝6.672,P＝0.011]。结论碎石术辅助自拟排石方治疗可降低合并膀胱结石的BPH患者IPSS评分和RU,提高Qmax,减少尿失禁和膀胱结石复发,改善下尿路症状。     

舒泌通胶囊治疗良性前列腺增生湿热蕴结证的临床观察

目的观察舒泌通胶囊治疗湿热蕴结证良性前列腺增生症的临床疗效。方法将120例良性前列腺增生症患者按2:1随机分为治疗组80例,对照组40例。治疗组应用舒泌通胶囊治疗,每次4粒,日3次;对照组应用癃闭舒胶囊,每次3粒,每日2次。2组均连续用药8周为1疗程。观察治疗前后患者国际前列腺症状评分(I-PSS)、生活质量(QoL)评分、最大尿流率(Q max)、膀胱残余尿量、中医证候积分、前列腺体积,并观察不良反应。结果治疗组总有效率为治疗组总有效率为87.5%(70例),其中显效率为27.5%;对照组总有效为77.5%(31例),其中显效率为15%,2组比较差异有统计学意义(P<0.01)。2组患者治疗后I-PSS、QoL、Q max、膀胱残余尿量、中医证候积分均较治疗前有明显改善(P<0.01),而前列腺体积治疗前后无明显变化。2组患者治疗前后中医证候疗效比较:2组患者治疗后中医证候均较治疗前有明显改善,治疗组总有效率为87.6%,单项证候疗效总有效率为93.8%,对照组总有效率为77.5%,单项证候总有效率为87.5%。经χ2检验进行组间比较,治疗组在改善BPH患者I-PSS、QoL、Q max,中医证候积分方面疗效较佳,在减少膀胱残余尿量和减小前列腺体积方面,2组差异无统计学意义。结论应用具有清热解毒、利尿通淋、软坚散结功效的舒泌通胶囊治疗湿热蕴结证良性前列腺增生症可显著改善BPH引起的下尿路症状,是一个安全有效的制剂,为BPH临床治疗提供了新证据。     

Anti‐Proliferation Effects of Garlic (Allium sativum L.) on the Progression of Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is a urologic disease that affects most of men over the age 50. But until now there is no such perfect cure without side effects. Because of diverse adverse effects, it is desirable to develop effective and long term‐safety‐herbal medicines to inhibit the progress of BPH. In spite of garlic's large use and a wide spectrum of studies, including anti‐hyperlipidemic, cardio‐protective, and anti‐inflammatory activities, there was none to prove efficacy for BPH. In this study, we evaluated the efficacy of garlic to prove its suppressing effects on BPH. Garlic administration decreased relative prostate weight ratio, suppressed mRNA expression level of AR, DHT serum levels, and the growth of prostatic tissue in BPH‐induced rats. Moreover, garlic administration decreased the levels of inflammatory proteins, iNOS, and COX‐2 in prostatic tissue. Further investigation showed that garlic induced accumulation of death‐inducing signal complex and activation of AMPK and decreased the levels of anti‐apoptotic proteins, such as Bcl‐2, Bcl‐xL, and survivin. These results suggest that garlic may have suppressing effects on BPH and it has great potential to be developed as treatment for BPH. Copyright © 2016 John Wiley & Sons, Ltd.     

Efficacy and safety of the extract of Serenoa repens in the treatment of benign prostatic hyperplasia: therapeutic equivalence between twice and once daily dosage forms

The efficacy and safety of two dosage forms (160 mg b.i.d. and 320 mg o.d.) of the extract of Serenoa repens were compared during a 1-year treatment in 132 patients suffering from benign prostatic hyperplasia (BPH). Both dosage forms induced a significant improvement in the efficacy variables: international prostate symptom score (60% after 1 year), quality of life score (85% of patients were satisfied after 1 year of treatment), prostatic volume (12% after 1 year), maximum flow rate (22% after 1 year), mean flow rate (17% after 1 year) and residual urinary volume (16% after 1 year). No significant differences were found between the two dosage forms. The percentage of patients or investigators evaluating that the treatment had a medium or bad tolerance was never superior to 4%. Nineteen side effects were observed in 16 patients (12.1%), 8 patients in each group. The majority of these side effects (at least 75%) were related to the natural evolution of the disease itself rather than to the medication. We conclude that the extract of Serenoa repens in its two dosage forms is a safe and effective treatment for the mictional problems associated with BPH. Consequently, it appears to offer a potential pharmacologic alternative capable of improving BPH symptoms in patients with mild-to-moderate disease. © 1997 John Wiley & Sons, Ltd.     

Inhibition of the DHT-induced PSA secretion by Verbascum xanthophoeniceum and Serenoa repens extracts in human LNCaP prostate epithelial cells

Ethnopharmacological relevance

Verbascum xanthophoeniceum is a mullein plant, typical of Balkan region and some parts of Turkey, traditionally used as phytotherapeutic agent due to its anti-inflammatory properties. It is rich in phenylethanoid and iridoid metabolites whose anti-inflammatory properties are under characterization.

Materials and methods

The role of Verbascum xanthophoeniceum crude methanolic extract and its isolated phenylethanoid glycoside verbascoside have been evaluated, in comparison to a saw palmetto extract, on a human in vitro model of androgen-regulated prostate epithelium, the LNCaP cell line. Cytotoxicity and DHT-induced free and total PSA secretion have been thoroughly studied.

Results

We have found that similar to saw palmetto, Verbascum xanthophoeniceum extract and its isolated phenylethanoid glycoside verbascoside have no cytotoxicity in human LNCaP prostate epithelial cells, whereas an inhibitory effect on the DHT-induced free and total PSA secretion, a recognized anti-androgen like activity, has been shown in case of both Verbascum xanthophoeniceum extract and pure verbascoside. Furthermore, in the absence of the endogenous androgen DHT, an androgen-like activity in Verbascum xanthophoeniceum is detectable as it is for saw palmetto, suggesting that a mixed androgen-antiandrogen activity is present.

Conclusions

For the first time, Serenoa repens and Verbascum xanthophoeniceum extracts have shown an absence of cytotoxicity and an inhibitory effect on DHT-induced PSA secretion in an in vitro model of human prostate epithelium, whereas the phenylethanoid glycoside verbascoside appeared to explain only part of the Verbascum xanthophoeniceum inhibitory activity on PSA secretion.     

补肾导浊颗粒治疗良性前列腺增生

目的探讨补肾导浊颗粒在良性前列腺增生治疗中的作用。方法选择经临床确诊的良性前列腺增生(BPH)患者80例,随机分成对照组(35例)和治疗组(45例)。对照组患者服用甲磺酸多沙唑嗪(可多华)4 mg,每晚1次;治疗组服用补肾导浊颗粒(每次200 mL,2次/d)。2组分别在治疗前和治疗4周后行国际前列腺症状评分(IPSS)、生活质量评分(QOL),并计算疾病疗效及总有效率,同时对出现的不良反应事件进行记录。结果 80例患者均完成了4周的治疗,均未见明显不良反应。对照组治疗前的IPSS和QOL评分分别由(17.8±2.7)分、(4.8±1.1)分下降到治疗后的(16.1±2.4)分、(3.1±1.0)分(P<0.05)。治疗组的IPSS和QOL评分分别由(18.0±2.8)分、(4.9±1.2)分下降到治疗后的(14.1±2.3)分、(2.3±0.7)分(P<0.05),并且效果优于对照组(P<0.05)。对照组显效9例,有效13例,无效13例,总有效率为62.9%。治疗组显效18例,有效20例,无效7例,总有效率为84.4%,其疾病疗效及总有效率均优于对照组(P<0.05)。结论补肾导浊颗粒能迅速改善BPH患者的IPSS和QOL评分,疗效优于多沙唑嗪。补肾导浊颗粒在改善BPH患者的下尿路症状及全身症状上都发挥着重要作用。     

孟河医派思想指导下治疗湿热下注型尿路感染的临床疗效观察

[目的] 观察中药清热利湿之剂治疗湿热下注型尿路感染的疗效。[方法] 将72例尿路感染患者随机分为治疗组和对照组,治疗组予以中药清热利湿之剂口服,对照组予以中成药银花泌炎灵片口服,观察主要症状消除时间、尿常规、血沉及免疫球蛋白等相关化验指标,并比较两组临床疗效。[结果] 总有效率治疗组为94.44%,对照组为72.22%,两组比较,差异具有统计学意义（P<0.05）;两组主要症状的消除时间比较,治疗组均短于对照组,差异具有统计学意义（P<0.05）;尿常规、血沉、免疫功能改善情况治疗组均优于对照组,差异具有统计学意义（P <0.05）。[结论] 清热利湿之剂治疗湿热下注型尿路感染能显著提高临床疗效,改善患者免疫功能。     

通淋散治疗尿路感染临床分析

目的：分析通淋散治疗湿热下注型急性尿路感染临床疗效。方法：据患者是否使用通淋散分为两组,A组为通淋散联合抗生素治疗,B 组为单用抗生素治疗,分析用药前后两组症状、体征及化验结果的变化。结果：A 组显效率为89.2%,B组显效率为69.7%,两组比较有显著差异（P〈0.05）。结论：通淋散治疗湿热下注型急性尿路感染疗效尤佳。     

溴莫普林治疗感染性疾病的临床研究

 目的 评价溴莫普林(BMP)的有效性和安全性。方法 采用随机对照试验,选用复方磺胺甲基异左（口）右（恶）唑(SMZ/TMP,SMZco)为对照药,共治疗细菌性感染40例。其中BMP和SMZco分别为20例,包括呼吸道、泌尿道感染。结果 BMP治愈率40%,有效率75%,细菌清除率90%;SMZco相应为55%,85%,90%。统计学处理两组无明显差异。BMP不良反应发生率为10%。结论 BMP在药效和不良反应方面与SMZco相似,是一种长效、安全的新型抗菌药。     

自拟五草巴苓汤治疗慢性泌尿系感染34例

[目的]观察自拟五草巴苓汤治疗泌尿系感染临床疗效。[方法]治疗组34例,治宜温补肾气,清热利湿,方用自拟五草巴苓汤。[结果]治疗组痊愈25例,好转7例,无效2例,总有效率96%。[结论]自拟五草巴苓汤可改变泌尿系的感染因素,增强抗药作用,缓解临床症状,促进健康。     

Blockade of Androgen Markers Using a Novel Betasitosterol,Thioctic Acid and Carnitine‐containing Compound in Prostate and Hair Follicle Cell‐based Assays

Androgenetic alopecia (AGA) affects approximately 70% of men and 40% of women in an age‐dependent manner and is partially mediated by androgen hormones. Benign prostatic hyperplasia (BPH) similarly affects 50% of the male population, rising by 10% each decade. Finasteride inhibits 5‐alpha reductase (5AR) and is used to treat both disorders, despite offering limited clinical benefits accompanied by significant adverse side effects. Building on our previous work demonstrating the efficacy of naturally derived 5AR inhibitors (such as stigmasterol and beta sitosterol), we hypothesize that targeting 5AR as well as inflammatory pathways may yield improved efficacy in AGA and BPH. Here we address these dual pathomechanisms by examining the potency of a novel composition using in vitro assays of representative cell lines for AGA (hair follicle dermal papilla cells) and BPH (LNCaP prostate cells), respectively. Exposure of cells to the novel test composition down‐regulated mRNA expression profiles characteristic of both disease processes, which outperformed finasteride. Changes in mRNA expression were corroborated at the protein level as assessed by western blotting. These studies provide proof of concept that novel, naturally derived compositions simultaneously targeting 5AR and inflammatory mediators may represent a rational approach to treating AGA and BPH. Copyright © 2016 John Wiley & Sons, Ltd.     

糖淋清治疗糖尿病泌尿系感染的临床研究

目的:观察糖淋清胶囊治疗糖尿病泌尿系感染的疗效。方法:对确诊为糖尿病泌尿系感染且中医辨证为湿热下注证者,采用随机方法分为两组,治疗组(103例)给予糖淋清胶囊,对照组(52例)给予阳性对照药三金胶囊,观察两组治疗前后症状积分、血糖、血脂、尿常规和尿细菌学检查的变化。结果:治疗组总有效率91.26％,对照组总有效率84.62％,治疗组优于对照组(P<0.05);治疗组在改善临床症状、降低血糖血脂方面,均优于对照组(P<0.05)。结论:糖淋清胶囊能降低糖尿病泌尿系感染患者的血糖,改善尿检异常,具有明显的尿菌阴转作用,并能迅速消除临床症状,对糖尿病泌尿系感染有显著疗效。     

淋痛灵治疗糖尿病合并泌尿系感染52例临床观察

观察中药汤剂治疗糖尿病合并泌尿系感染的效果。方法：淋痛灵方剂由丹参、当归、丹皮、益母草、小蓟、半枝莲、石苇等药物组成。以淋痛灵与达美康加三金片对照,疗程1月。结果：对于改善泌尿系感染症状,降低血糖,治疗组优于对照组,有效率90.38%,对照组70%。结论：淋痛灵治疗糖尿病合并泌尿系感染有效,值得推广。