MOE Key Laboratory of Bioinformatics and Bioinformatics Division, Tsinghua National Laboratory for Information Science and Technology/Department of Automation, Tsinghua University, Beijing 100084, PR China.
Complement Ther Med. 2010 Feb;18(1):21-7. doi: 10.1016/j.ctim.2009.10.002. Epub 2009 Dec 2.
A randomised controlled trial was performed to compare the symptomatic effects on patients with benign prostatic hyperplasia (BPH) treated by two therapeutic approaches - the Western medicine (WM) and traditional Chinese medicine (TCM).
Four primary outcome measures, namely the quality of life (QOL), maximum urine flow ratio (UFR), International Prostate Symptom Score (IPSS) and prostate volumes, as well as four urethra-related and 35 non-urethra-related symptoms, were investigated to evaluate the effects on 31 BPH patients subjected to WM (Terazosin Hydrochloride Hytrin, THH) and 30 cases to TCM (herbal Saxifrage tablet, HST). The effects of both treatments are compared by the two-sample Kolmogorov-Smirnov test. The contributions of symptoms for four assessments are analysed by the logistic regression model and the Chow test.
The effect of TCM is weaker than that of WM in the assessment of the IPSS score (p<0.05), and both treatments are similar in the prostate volumes, the maximum UFR and the QOL assessments (p>0.05), as well as in the effective number of urethra-related or non-urethra-related symptoms before and after treatment (p>0.05). By comparing the linear regression models, different urethra-related and non-urethra-related symptom patterns associated with TCM and WM therapies are detected for four assessments, especially for the prostate volume assessment (p<0.01).
TCM (HST) is a potentially effective treatment in improving the QOL, prostate volumes and maximum UFR for patients with BPH, though it is less effective in ameliorating the IPSS score when compared with WM (THH). The non-urethra-related symptoms experienced by BPH patients might be one of the parameters to further achieve the tailored diagnosis and treatment for BPH.
本研究采用随机对照试验,比较两种治疗方法(西药和中药)对良性前列腺增生(BPH)患者的症状改善效果。
本研究共纳入 31 例西药(盐酸特拉唑嗪哈乐)治疗的 BPH 患者和 30 例中药(复方菝葜颗粒)治疗的 BPH 患者,通过生活质量(QOL)、最大尿流率(UFR)、国际前列腺症状评分(IPSS)和前列腺体积等 4 项主要疗效指标,以及尿道相关症状和 35 项非尿道相关症状,评估两种治疗方法的疗效。采用双样本 Kolmogorov-Smirnov 检验比较两种治疗方法的疗效。采用 logistic 回归模型和 Chow 检验分析 4 项评估的症状贡献。
中药组在 IPSS 评分方面的疗效弱于西药组(p<0.05),而在前列腺体积、最大 UFR 和 QOL 评估方面,两组的疗效相当(p>0.05),且治疗前后尿道相关和非尿道相关症状的有效数量也相当(p>0.05)。通过比较线性回归模型,发现对于 4 项评估,中药和西药治疗的不同尿道相关和非尿道相关症状模式存在差异,尤其是在前列腺体积评估方面(p<0.01)。
与西药(哈乐)相比,中药(复方菝葜颗粒)可能是一种有效的治疗方法,可以改善 BPH 患者的 QOL、前列腺体积和最大 UFR,但在改善 IPSS 评分方面效果较弱。BPH 患者的非尿道相关症状可能是进一步实现 BPH 个体化诊断和治疗的参数之一。