摘要
目的评价癃闭欣通颗粒治疗慢性前列腺炎(湿热瘀滞证)的有效性和安全性。方法将240例患者随机分为低剂量组、高剂量组和安慰剂组,每组各80例。低剂量组给予癃闭欣通颗粒1袋+安慰剂1袋,每袋8g;高剂量组给予癃闭欣通颗粒;安慰剂组给予安慰剂,各组均每次1袋,每日2次。共服药4周。观察各组治疗前后慢性前列腺炎症状评分(NIH-CPSI)、临床疗效、中医症状总积分和不良反应。结果治疗4周后,低剂量组和高剂量组NIH-CPSI评分、中医症状总积分、临床疗效总有效率均优于安慰剂组,差异有统计学意义(P<0.05),治疗后低剂量组与高剂量组组间比较,差异无统计学意义(P>0.05)。结论癃闭欣通颗粒治疗慢性前列腺炎(湿热瘀滞证)患者安全有效,其中高剂量组和低剂量组的治疗效果相当。
Objective To evaluate the efficacy and safety of Longbi Xintong Granule （granule for dysuria） for chronic pros- tatitis patients with damp-heat and blood-stasis syndrome. Methods A multicenter, randomized double blind, placebo paral- leled controlled clinical trial was conducted. Totally 240 chronic prostatitis patients with damp-heat and blood-stasis syndrome were randomized into the small dose trial group, large-dose trail group＇and placebo control group, with 80 in each. The small dose trial group was given one packet of Longbi Xintong Granule （8g per packet） and one packet of placebo per time, twice dai- ly. The large-dose trail group was given two packets of Longbi Xintong Granule （8g per packet） per time, twice daily. The placebo control group was given two packets of placebo per time, twice daily. The treatment lasted for 4 weeks. The National Institutes of Health Chronic Prostatitis Symptom Index （NIH-CPSI）, efficacy of Chinese medical syndrome, total score of Chi- nese medical symptoms and adverse reactions were observed. Results After treatment, the NIH CPSI, total scores of Chinese medical symptoms and total effective rates in two trail groups were superior to those in the placebo group （P〈0.05）, but there was no significant difference between two trail groups （P〉0.05）. The symptoms in two trail groups were significantly relieved as compared with the placebo group （P〈0.05）, but there was no significant difference between two trail groups （P〉0.05）. Conclusion Longbi Xintong Granule is safe and effective for chronic prostatitis with damp-heat and blood-stasis syndrome, with no significant difference between large dose and small dose （P〉0.05）.
出处
《中医杂志》
CSCD
北大核心
2012年第18期1570-1572,1576,共4页
Journal of Traditional Chinese Medicine
关键词
癃闭欣通颗粒
慢性前列腺炎
湿热瘀滞证
剂量
Longbi Xintong Granule （granule for dysuria）
chronic prostatitis
damp-heat and blood-stasis syndrome
dosage
