| 摘要: |
| 目的:研究中药夏荔芪胶囊联合盐酸坦索罗辛缓释胶囊治疗前列腺增生症患者的临床疗效观察。方法:选取2021年5月8日—2022年11月30日于我院门诊收治的前列腺增生患者76例，随机分为试验组和对照组:试验组口服夏荔芪胶囊(1.35 g，3次/d)联合坦索罗辛缓释胶囊(0.2 mg，每晚睡前服用)；对照组仅口服坦索罗辛缓释胶囊(0.2 mg，每晚睡前)；两组患者均治疗8周后，比较两组治疗前后国际前列腺症状评分(I-PSS)、中医证候评分、最大尿流率(Qmax)、前列腺体积、残余尿量、NIH-CPSI评分及生活质量评分(QOL)，比较两组用药方案的有效性及安全性。结果:治疗后，两组的I-PSS评分和中医证候评分与治疗前比较均明显降低(P<0.05)，试验组治疗后I-PSS和中医症候评分均小于对照组(P<0.05)，其中试验组中医证候评分降低幅度显著大于对照组(P<0.001)；治疗后试验组与对照组在前列腺体积、残余尿量及QOL均无统计学差异(P>0.05)。试验组治疗后Qmax大于对照组(P=0.007)，且试验组增大幅度显著大于对照组(P<0.001)，试验组治疗后NIH-CPSI小于对照组(P=0.044)，且试验组治疗前后NIH-CPSI差值大于对照组(P=0.008)。试验组总体有效率达94.7%，大于对照组的42.1%，差异有统计学意义(P<0.001)。结论:夏荔芪胶囊联合盐酸坦索罗辛缓释胶囊治疗良性前列腺增生症的有效性显著高于对照组，且在治疗过程中两组患者均未发生不良事件，安全性与±从性好。 |
| 关键词: 夏荔芪胶囊 盐酸坦索罗辛缓释胶囊 前列腺增生 国际前列腺症状评分 中医症候评分 |
| DOI：10.3969/j.issn.1007-6948.2024.05.002 |
| 投稿时间：2024-05-15 |
| 基金项目:天津医科大学第二医院临床试验项目(2021hx007) |
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| Clinical efficacy of Xialiqi capsule combined with tamsulosin sustained-release capsule in the treatment of benign prostate hyperplasia |
| TIAN Ning-ning,LIU BO,ZHANG Qing-jiao |
| Tianjin Fourth Central Hospital,Tianjing(300241),China |
| Abstract: |
| Objective To investigate the efficacy and safety of traditional Chinese medicine Xialiqi capsule combined with Tamsulosin hydrochloride sustained-release capsule in the treatment of patients with prostatic hyperplasia. Methods The study included a total of 76 patients diagnosed with benign prostatic hyperplasia who were admitted to the outpatient department of the Second Hospital of Tianjin Medical University from May 8, 2021, to November 30, 2022. They were randomly assigned into two groups:the experimental group received Xialiqi capsule (1.35 g, three times daily) in combination with tamsulosin sustained-release capsule (0.2 mg, taken before bedtime); the control group received only tamsulosin sustained-release capsule (0.2 mg, taken before bedtime). After an eight-week treatment period following their respective medication regimens, statistical analysis was conducted to compare and analyze the differences in international prostate symptom score (I-PSS), syndrome score of traditional Chinese medicine, maximum urinary flow rate (Qmax), prostate volume, residual urine volume, NIH-CPSI score and quality of life score (QOL) between the two groups before and after treatment. Furthermore, the effectiveness and safety of both medication regimens were evaluated. Results The main outcome measures: After treatment, both the I-PSS score and the syndrome score of traditional Chinese medicine in both groups showed significant decreases compared with those before treatment (P<0.05). The Qmax in the experimental group after treatment was greater than that in the control group (P=0.007), and the increase in the experimental group was significantly greater than that in the control group (P<0.001).The NIH-CPSI after treatment in the experimental group was significantly lower than that in the control group (P=0.044), and the difference in NIH-CPSI before and after treatment in the experimental group was larger than that in the control group (P=0.008). The overall efficacy rate of the experimental group was 94.7%, while that of the control group was 42.1%, with a significant statistical difference (P<0.001). Conclusion The efficacy of Xialiqi capsule combined with tamsulosin hydrochloride sustained-release capsule in the treatment of benign prostatic hyperplasia was significantly higher than that of the control group. No adverse events occurred in the two groups during the treatment, and the safety and compliance were good. |
| Key words: Xialiqi capsule tamsulosin hydrochloride sustained-release capsule benign prostatic hyperplasia international prostate symptom score traditional chinese medicine syndrome score |
