Objective: To observe the clinical effect and safety of the Chinese patent medicine Ningmitai Capsules (NMT) in relieving lower urinary tract symptoms (LUTS) in the patient with benign prostatic hyperplasia (BPH).
Methods: We randomly assigned 40 BPH patients to an experimental and a control group of equal number to receive oral administration of NMT at 4 capsules tid and terazosin hydrochloride tablets at 2 mg qd, respectively, both for 14 days. At 7 and 14 days after medication, we recorded and compared the International Prostate Symptoms Score (IPSS), maximum urinary flow rate (Qmax), quality of life (QoL) scores, results of urinalysis and blood routine examination, and indexes of hepatic and renal function.
Results: Both NMT and terazosin significantly improved the total IPSS score, the IPSS scores in the storage and voiding phases, increased Qmax and urine output, reduced post-void residual urine (PVR), and improved the QoL of the patients. The patients of the NMT group showed a better relief of incomplete bladder emptying, more improved QoL and fewer adverse reactions, while those treated with terazosin achieved a better attenuation of weak urine stream and PVR.
Conclusions: NMT is safe and effective in relieving LUTS in BPH patients. Each of NMT and terazosin has its own advantages in attenuating urinary tract irritation and obstruction, but whether their combination may produce a better effect on LUTS and the specific mechanisms of NMT improving acute symptoms of BPH are yet to be further studied.
目的： 观察中成药宁泌泰胶囊缓解良性前列腺增生（BPH）患者下尿路症状（LUTS）的临床疗效和安全性。方法： 筛选门诊BPH患者40例，随机分为对照组和试验组。对照组口服盐酸特拉唑嗪片每日1次，每次2 mg；试验组口服宁泌泰胶囊，每日3次，每次4粒。两组患者均连续服药14 d，分别于治疗前（门诊当日）、治疗7 d和治疗14 d时观察并记录患者的国际前列腺症状评分（IPSS）、生活质量评分（QoL）和最大尿流率（Qmax），并检测患者的血常规、尿常规和肝肾功能。结果： 宁泌泰胶囊和特拉唑嗪都能改善BPH患者IPSS总分、储尿期和排尿期IPSS，提高Qmax、增加排尿量并减少残余尿，提高患者生活质量。宁泌泰胶囊和特拉唑嗪主要差异在于服用宁泌泰胶囊的患者尿不尽感缓解更明显（IPSS问题1），服用特拉唑嗪的患者尿线变细问题缓解更明显（IPSS问题5）。特拉唑嗪减少残余尿量优于宁泌泰胶囊，而宁泌泰胶囊对QoL的改善作用略优于特拉唑嗪，且总体不良反应发生率较少。结论： 宁泌泰胶囊缓解BPH症状有一定疗效，安全性较好。宁泌泰胶囊和特拉唑嗪对尿路刺激和尿路梗阻症状的缓解各有侧重。.
Keywords: International Prostate Symptoms Score; Ningmitai Capsules; lower urinary tract symptoms; quality of life; terazosin; uroflowmetry; benign prostatic hyperplasia.