锯叶棕果实提取物治疗BPH的疗效及安全性评价
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摘要
目的评价锯叶棕果实提取物治疗良性前列腺增生(BPH)的疗效和安全性。方法采用随机、双盲、安慰剂对照研究的方法选择良性前列腺增生并伴有轻中度下尿路症状患者60例,按1:1的比例随机接受锯叶棕果实提取或安慰剂治疗6个月,比较2组间前列腺症状评分(IPSS)、生活质量评分(QOL)、最大尿流率(Qmax)、残余尿量(PVR)和前列腺体积(PV)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2组患者均未发生明显不良反应。试验组前列腺症状评分(IPSS)、生活质量评分(QOL)、最大尿流率(Qmax)、残余尿量(PVR)的变化与安慰剂组对比均有明显改善(P<0.05);前列腺体积(PV) 2组间比较没有统计学意义。结论与安慰剂相比,锯叶棕果实提取物可以明显改善前列腺增生引起的下尿路症状,且安全性高。
Objective To evaluate the efficacy and safety of Saw Palmetto extract in the treatment of benign prostatic hyperplasia( BPH).Me thods A randomized, double-blind, placebo-controlled study was performed in 60 patients with benign prostatic hyperplasia with mild to moderate lower urinary tract symptoms who were randomized to a 1:1 ratio of saw palmetto extract or placebo for 6 months. The changes of prostate symptom score(IPSS),quality of life score(QOL),maximum urinary flowrate(Qmax),residual urine volume(PVR),and prostate volume(PV),as well as the incidence of adverse reactions were compared between the two groups,and statistically analyzed.Re s ults No significant adverse reactions occurred in both groups. The changes of prostate symptom score(IPSS),Quality of Life score(QOL),maximal urinary flow rate(Qmax) and residual urine volume(PVR) in the experimental group were significantly improved as compared with those of placebo; the prostate volume( PV) had no statistically significant difference between the two groups.Conclus ions Compared with placebo, saw palmetto extract can significantly improve lower urinary tract symptoms caused by benign prostatic hyperplasia with high safety.
Objective To evaluate the efficacy and safety of Saw Palmetto extract in the treatment of benign prostatic hyperplasia( BPH).Me thods A randomized, double-blind, placebo-controlled study was performed in 60 patients with benign prostatic hyperplasia with mild to moderate lower urinary tract symptoms who were randomized to a 1:1 ratio of saw palmetto extract or placebo for 6 months. The changes of prostate symptom score(IPSS),quality of life score(QOL),maximum urinary flowrate(Qmax),residual urine volume(PVR),and prostate volume(PV),as well as the incidence of adverse reactions were compared between the two groups,and statistically analyzed.Re s ults No significant adverse reactions occurred in both groups. The changes of prostate symptom score(IPSS),Quality of Life score(QOL),maximal urinary flow rate(Qmax) and residual urine volume(PVR) in the experimental group were significantly improved as compared with those of placebo; the prostate volume( PV) had no statistically significant difference between the two groups.Conclus ions Compared with placebo, saw palmetto extract can significantly improve lower urinary tract symptoms caused by benign prostatic hyperplasia with high safety.
引文
[1] GACCI M,SEBASTIANELLI A,SPATAFORA P,et al.Best practice in the management of storage symptoms in male lower urinary tract symptoms:a review of the evidence base[J].Ther Adv Urol,2017,10(2):79-92.
[2] HIZL F,UYGUR MC. A prospective study ofthe efficacy of Serenoarepens, Tamsulosin, and Serenoarepens plus Tamsulosin treatment for patients with benign prostate hyperplasia[J]. International Urology&Nephrology,2007,39(3):879.
[3] POYHONEN A,HKKINEN J T,KOSKIM K I J,et al.Empirical evaluation of grouping of lower urinarytract symptoms:principal component analysis of Tampere ageing male urological study data[J]. BJU Int,2013,111(3):467-473.
[4] SMITH D P,WEBER M F,SOGA K,et al.Re lationship between lifestyle and health factors and severe lower urinary tract symptoms(LUTS)in 106,435 middle-aged and older Australian men:population-based study[J].PLo S One,2014,9(10):e109278.
[5] GRATZKE C,BACHMANN A,DESCAZEAUD A,et al.EAU guidelines on the assessment of nonneurogenic male lower urinary tract symptoms including benign prostatic obstruction[J]. Eur Urol,2015,67(6):1099-1109.
[6] GIULIANO F. Impact of medical treatments for benign prostatic hyperplasia on sexual function[J]. Bju International,2006,97(s2):34-38.
[7] NA R,HEFAND B T,CHEN H,et al. A genetic variant near GATA3 implicated in inherited susceptibility and etiology of benign prostatic hyperplasia(BPH)and lower urinary tract symptoms(LUTS)[J]. Prostate,2017,77(11):1213-1220.
[8]居小兵,顾小箭,张征宇,等.锯叶棕果实提取物软胶囊治疗良性前列腺增生的有效性和安全性分析[J].中华男科学杂志,2015,21(12):1098-1101.
[9] DE NUNZIO C,BRASSETTI A,PROIETTI F,et al.Dutasteride add-on therapy reduces detrusor mass in patients with benign prostatic enlargement not satisfied with alpha-adrenergic antagonist monotherapy:a single center prospective study[J]. Neurourol Urodyn,2017,36(8):2096-2100.
[10] GACCI M,ANDERSSON KE,CHAPPLE C,etal.Latest evidence on the use of phosphodiesterase type 5 inhibitors for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia[J]. Eur Urol,2016,70(1):124-133.
[11] DIMITROPOULOS K,GRAVAS S. Solifenacin/tamsulosin fixed-dose combination therapy to treat lower urinary tract symptoms in patients with benign prostatic hyperplasia[J].Drug Des Devel Ther,2015,9(5):1707-1716.
[12] BORST S E,YARROW J F,CONOVER C F,et al.Musculoskeletal and prostate effects of combined testosterone and finasteride administration in older hypogonadal men:a randomized,controlled trial[J]. Am J Physiol Endocrinol Metab,2014,306(4):433-442.
[13] PALIN M F,FAGUY M,LEHOUX J G,et al. Inhibitory effects of Serenoarepens on the kinetic of pig prostatic microsomal 5α-reductase activity[J]. Endocrine,1998,9(1):65-69.
[14]SINESCU I,GEAVLETE P,MULTESCU R,et al. LongTerm Efficacy of Serenoarepens Treatment in Patients with Mild and Moderate Symptomatic Benign Prostatic Hyperplasia[J]. Urologia Internationalis,2011,86(3):284-289.
[15] ABE M,ITO Y,SUZUKI A,et al. Isolation and pharmacological characterization of fatty acids from saw palmetto extract[J]. Analytical Sciences the International Journal of the Japan Society for Analytical Chemistry,2009,25(4):553.
[16]SUZUKI M,OKI T,SUGIYAMA T,et al. Muscarinic and alpha 1-adrenergic receptor binding characteristics of saw palmetto extract in rat lower urinary tract[J]. Urology,2007,69(6):1216-1220.
[2] HIZL F,UYGUR MC. A prospective study ofthe efficacy of Serenoarepens, Tamsulosin, and Serenoarepens plus Tamsulosin treatment for patients with benign prostate hyperplasia[J]. International Urology&Nephrology,2007,39(3):879.
[3] POYHONEN A,HKKINEN J T,KOSKIM K I J,et al.Empirical evaluation of grouping of lower urinarytract symptoms:principal component analysis of Tampere ageing male urological study data[J]. BJU Int,2013,111(3):467-473.
[4] SMITH D P,WEBER M F,SOGA K,et al.Re lationship between lifestyle and health factors and severe lower urinary tract symptoms(LUTS)in 106,435 middle-aged and older Australian men:population-based study[J].PLo S One,2014,9(10):e109278.
[5] GRATZKE C,BACHMANN A,DESCAZEAUD A,et al.EAU guidelines on the assessment of nonneurogenic male lower urinary tract symptoms including benign prostatic obstruction[J]. Eur Urol,2015,67(6):1099-1109.
[6] GIULIANO F. Impact of medical treatments for benign prostatic hyperplasia on sexual function[J]. Bju International,2006,97(s2):34-38.
[7] NA R,HEFAND B T,CHEN H,et al. A genetic variant near GATA3 implicated in inherited susceptibility and etiology of benign prostatic hyperplasia(BPH)and lower urinary tract symptoms(LUTS)[J]. Prostate,2017,77(11):1213-1220.
[8]居小兵,顾小箭,张征宇,等.锯叶棕果实提取物软胶囊治疗良性前列腺增生的有效性和安全性分析[J].中华男科学杂志,2015,21(12):1098-1101.
[9] DE NUNZIO C,BRASSETTI A,PROIETTI F,et al.Dutasteride add-on therapy reduces detrusor mass in patients with benign prostatic enlargement not satisfied with alpha-adrenergic antagonist monotherapy:a single center prospective study[J]. Neurourol Urodyn,2017,36(8):2096-2100.
[10] GACCI M,ANDERSSON KE,CHAPPLE C,etal.Latest evidence on the use of phosphodiesterase type 5 inhibitors for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia[J]. Eur Urol,2016,70(1):124-133.
[11] DIMITROPOULOS K,GRAVAS S. Solifenacin/tamsulosin fixed-dose combination therapy to treat lower urinary tract symptoms in patients with benign prostatic hyperplasia[J].Drug Des Devel Ther,2015,9(5):1707-1716.
[12] BORST S E,YARROW J F,CONOVER C F,et al.Musculoskeletal and prostate effects of combined testosterone and finasteride administration in older hypogonadal men:a randomized,controlled trial[J]. Am J Physiol Endocrinol Metab,2014,306(4):433-442.
[13] PALIN M F,FAGUY M,LEHOUX J G,et al. Inhibitory effects of Serenoarepens on the kinetic of pig prostatic microsomal 5α-reductase activity[J]. Endocrine,1998,9(1):65-69.
[14]SINESCU I,GEAVLETE P,MULTESCU R,et al. LongTerm Efficacy of Serenoarepens Treatment in Patients with Mild and Moderate Symptomatic Benign Prostatic Hyperplasia[J]. Urologia Internationalis,2011,86(3):284-289.
[15] ABE M,ITO Y,SUZUKI A,et al. Isolation and pharmacological characterization of fatty acids from saw palmetto extract[J]. Analytical Sciences the International Journal of the Japan Society for Analytical Chemistry,2009,25(4):553.
[16]SUZUKI M,OKI T,SUGIYAMA T,et al. Muscarinic and alpha 1-adrenergic receptor binding characteristics of saw palmetto extract in rat lower urinary tract[J]. Urology,2007,69(6):1216-1220.