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目的:观察复方蓝棕果片联合坦索罗辛治疗良性前列腺增生伴尿路梗阻的疗效和安全性。方法:86例良性前列腺增生伴尿路梗阻患者随机分为对照组(43例)和观察组(43例)。对照组患者给予盐酸坦索罗辛口崩缓释片0.2 mg,口服,每晚1次。观察组患者在对照组治疗的基础上给予复方蓝棕果片500 mg,餐前口服,每日3次。两组均以4周为1个疗程,共治疗3个疗程。治疗期间两组患者均以清淡食物为主,禁食辛辣刺激食物。观察两组患者的临床疗效,治疗前后中医症状评分、白细胞介素(IL)-8、IL-10、肿瘤坏死因子(TNF)-α、最大尿流率(Qmax)、剩余尿量(PVR)、国际前列腺症状(IPSS)评分及不良反应发生情况。结果:观察组患者总有效率显著高于对照组,差异有统计学意义(P<0.05)。治疗前,两组患者中医症状评分、Qmax、PVR、IPSS评分、IL-8、IL-10、TNF-α比较,差异均无统计学意义(P>0.05)。治疗后,两组患者中医症状评分、IPSS评分、IL-8、IL-10、TNF-α、PVR均显著低于同组治疗前,且观察组低于对照组,Qmax显著高于同组治疗前,且观察组高于对照组,差异均有统计学意义(P<0.05)。两组患者治疗期间均未见严重不良反应发生。结论:复方蓝棕果片联合坦索罗辛治疗良性前列腺增生伴尿路梗阻的疗效优于单用坦索罗辛,可减轻炎症反应,减少尿液残留,且安全性较好。
OBJECTIVE: To observe the efficacy and safety of Compound sabal berry tablet combined with tamsulosin in the treatment of benign prostatic hyperplasia complicated with urinary obstruction. METHODS: 86 patients with benign prostatic hyperplasia complicated with urinary obstruction were randomly divided into control group (43 cases) and observation group (43 cases).Control group orally received 0.2 mg Tamsulosin hydrochloride orally disintegrating sustained-release tablet, once every evening. Observation group additionally received 500 mg Compound sabal berry tablet before a meal, 3 times a day. 4-week was regarded as 1 treatment course, and it lasted 3 courses. During the treatment, all patients in the two groups ate light food, avoiding spicy and bland food. The clinical efficacy, TCM symptom scores, interleukin-8 (IL-8), interleukin-10 (IL-10), tumor necrosis factor α (TNF-α), maximum flow rate (Qmax), post-void residual (PVR), the International Prostate Symptom Score (IPSS) scores before and after treatment and the incidence of adverse reactions in the 2 groups were observed. RESULTS: The total effective rate in observation group was significantly higher than control group, the difference was statistically significant (P<0.05). Before treatment, there were no significant differences in the TCM symptom scores, Qmax, PVR, IPSS scores, IL-8, IL-10 and TNF-α between 2 groups (P>0.05). After treatment, TCM symptom scores, IPSS scores, IL-8, IL-10, TNF-α and PVR in 2 groups were significantly lower than before, and observation group was lower than control group, Qmax was significantly higher than before, and observation group was higher than control group, the differences were statistically significant (P<0.05). And there were no severe adverse reactions during treatment. CONCLUSIONS: The efficacy of Compound sabal berry tablet combined with tamsulosin is superior to tamsulosin alone in the treatment of benign prostatic hyperplasia complicated with urinary obstruction, it can reduce the inflammatory reactions and residual urine, with good safety.
良性前列腺增生尿路梗阻复方蓝棕果片坦索罗辛疗效安全性
Benign prostatic hyperplasiaUrinary obstructionCompound sabal berry tabletTamsulosinEfficacySafety
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