灵泽片联合坦索罗辛胶囊治疗良性前列腺增生的早中期疗效分析

Efficacy Analysis of Lingze Tablets Combined with Tamsulosin Hydrochloride Capsules in the Early and Middle Stages of Benign Prostatic Hyperplasia

摘要: 目的：探讨灵泽片联合坦索罗辛缓释胶囊治疗良性前列腺增生(BPH)的临床疗效，为临床优化治疗方案提供依据。方法：选取2022年1月~2025年10月收治的100例良性前列腺增生患者，采用随机数字表法进行随机分组，实施分配隐藏，采用开放标签设计，并基于既往研究数据完成样本量估算，将患者分为A组(中西医联合治疗，50例)与B组(单纯西医治疗，50例)。A组予灵泽片 + 坦索罗辛缓释胶囊，B组仅予坦索罗辛缓释胶囊；治疗3、6个月后，对比两组国际前列腺症状评分(IPSS)、生活质量评分(QOL)、最大尿流率(Qmax)、排尿后残余尿量(PVR)及患者总体改善印象量表(PGI-I)评分。结果：治疗3、6个月后，两组IPSS、QOL、PVR均较基线显著降低，Qmax显著升高(P < 0.001)；A组各指标改善幅度均显著优于B组(P < 0.05)。治疗6个月后，A组IPSS改善 ≥ 5分占86%、Qmax提升 ≥ 40%占82%、主观改善明显占70%，均显著高于B组(P < 0.05)。结论：灵泽片联合坦索罗辛缓释胶囊可更有效地缓解良性前列腺增生患者的下尿路症状，改善尿动力学指标，提升生活质量，疗效优于单用坦索罗辛，安全可靠，值得临床推广。

Abstract: Objective: To investigate the clinical efficacy of Lingze Tablets combined with Tamsulosin Sustained-release Capsules in the treatment of Benign Prostatic Hyperplasia (BPH), and to provide evidence for optimizing clinical treatment strategies. Methods: A total of 100 patients with BPH admitted from January 2022 to October 2025 were enrolled. Random number table method was used for randomization, allocation concealment was implemented, an open-label design was adopted, and sample size estimation was completed based on previous studies before the study started, randomly divided into group A (integrated traditional Chinese and Western medicine, n = 50) and group B (Western medicine alone, n = 50). Group A received Lingze Tablets plus Tamsulosin Sustained-release Capsules, while group B received Tamsulosin alone. After 3 and 6 months of treatment, the International Prostate Symptom Score (IPSS), Quality of Life (QOL) score, maximum urinary flow rate (Qmax), Post-Void Residual urine volume (PVR), and Patient Global Impression of Improvement (PGI-I) score were compared between the two groups. Results: After 3 and 6 months of treatment, IPSS, QOL and PVR in both groups were significantly decreased, and Qmax was significantly increased compared with baseline (P < 0.001). The improvement of all indicators in group A was significantly better than that in group B (P < 0.05). After 6 months of treatment, 86% of patients in group A had IPSS improvement ≥ 5 points, 82% had Qmax increase ≥ 40%, and 70% had significant subjective improvement, all significantly higher than those in group B (P < 0.05). Conclusion: Lingze Tablets combined with Tamsulosin Sustained-release Capsules can more effectively relieve lower urinary tract symptoms, improve urodynamic indexes and quality of life in patients with BPH. The efficacy is superior to Tamsulosin alone, which is safe and reliable and worthy of clinical promotion.