Gong Yu-Chen, Chen Xiang, Song Qing-Tian, Gan Yu, Zhang Bo, Li Bing-Sheng, Chen Zhi, He Yao
Department of Urology, Xiangya Hospital, Central South University, Changsha, China.
Transl Androl Urol. 2021 Aug;10(8):3423-3431. doi: 10.21037/tau-21-588.
Benign prostatic hyperplasia (BPH) is a common micturition disorder in middle-aged and elderly males, and it is one of the most common urology-related diseases worldwide. However, standard therapeutic drugs (α1-receptor blockers + 5α reductase inhibitors) do not provide anti-inflammatory or anti-infective effects. The Phellodendron Bawei tablet is a proprietary Chinese medicine with anti-inflammatory and anti-infective effects. Here, we analyzed whether the combination of standard therapeutic drugs and Phellodendron Bawei tablets has more advantages than placebo with standard management in improving the lower urinary tract symptoms (LUTs), sleep quality, sexual function, and medication compliance in patients with BPH.
This study was a prospective, double-blind, single-center, 6-month clinical trial in patients with BPH. Male patients, 45-75 years old, a history of moderate-to-severe BPH/LUTs for more than 6 months, moderate-to-severe LUTs [International Prostate Symptom Score (IPSS) ≥8], maximum urine flow rate (Qmax) of <15 mL/s, and prostate volume (PV) of >30 mL. All patients were randomly divided into two cohorts at baseline. The standard management (SM) group was treated with tamsulosin + finasteride + placebo, while the experimental group was treated with tamsulosin + finasteride + Phellodendron Bawei tablets. The clinical indicators were as follows: Age, body mass index (BMI), blood prostate-specific antigen (PSA), PV, Qmax, IPSS; IPSS voiding subscore (IPSS-V), IPSS storage subscore (IPSS-S), and IPSS quality of life (IPSS-QOL)], five-item version of the International Index of Erectile Function (IEFF-5) score, Athens Insomnia Scale (AIS) score, and the Medication Adherence Questionnaire (MAQ). And adverse drug reactions were observed. Student's -test was used to analyze results.
We randomly divided 120 patients into two groups, with 60 patients in each group, and a total of 105 patients completed the study. IPSS-S (P=0.027) and AIS scores (P<0.001) improved more significantly in the Phellodendron Bawei tablets + SM group, and the MAQ score in this group was lower (P=0.003).
Phellodendron Bawei tablets combined with α1-receptor blockers and 5α-reductase inhibitors can improve lower urinary tract symptoms associated with urine storage, sleep quality, and medication compliance in patients with benign prostatic hyperplasia compared to placebo with standard management.
Chinese Clinical Trial Registry ChiCTR2100046463.
良性前列腺增生（BPH）是中老年男性常见的排尿障碍，是全球最常见的泌尿系统相关疾病之一。然而，标准治疗药物（α1受体阻滞剂+5α还原酶抑制剂）不具有抗炎或抗感染作用。八味黄柏片是一种具有抗炎和抗感染作用的中成药。在此，我们分析了标准治疗药物与八味黄柏片联合使用在改善BPH患者下尿路症状（LUTs）、睡眠质量、性功能和用药依从性方面是否比标准治疗加安慰剂更具优势。
本研究是一项针对BPH患者的前瞻性、双盲、单中心、为期6个月的临床试验。男性患者，年龄45-75岁，中度至重度BPH/LUTs病史超过6个月，中度至重度LUTs[国际前列腺症状评分（IPSS）≥8]，最大尿流率（Qmax）<15 mL/s，前列腺体积（PV）>30 mL。所有患者在基线时随机分为两组。标准治疗（SM）组接受坦索罗辛+非那雄胺+安慰剂治疗，而实验组接受坦索罗辛+非那雄胺+八味黄柏片治疗。临床指标如下：年龄、体重指数（BMI）、血液前列腺特异性抗原（PSA）、PV、Qmax、IPSS；IPSS排尿子评分（IPSS-V）、IPSS储尿子评分（IPSS-S）和IPSS生活质量（IPSS-QOL）]、国际勃起功能指数（IEFF-5）五项版本评分、雅典失眠量表（AIS）评分和用药依从性问卷（MAQ）。并观察药物不良反应。采用Student's -检验分析结果。
我们将120例患者随机分为两组，每组60例，共有105例患者完成研究。八味黄柏片+SM组的IPSS-S（P=0.027）和AIS评分（P<0.001）改善更显著，且该组的MAQ评分更低（P=0.003）。
与标准治疗加安慰剂相比，八味黄柏片联合α1受体阻滞剂和5α还原酶抑制剂可改善良性前列腺增生患者与储尿相关的下尿路症状、睡眠质量和用药依从性。
中国临床试验注册中心ChiCTR2100046463。
