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荨麻治疗良性前列腺增生:一项前瞻性、随机、双盲、安慰剂对照、交叉研究。

Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study.

作者信息

Safarinejad Mohammad Reza

机构信息

Department of Urology, Urology Nephrology Research Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

J Herb Pharmacother. 2005;5(4):1-11.

PMID:16635963
Abstract

PURPOSE

To determine the effects of therapy with Urtica dioica for symptomatic relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

MATERIAL AND METHODS

A 6-month, double-blind, placebo-controlled, randomized, partial crossover, comparative trial of Urtica dioica with placebo in 620 patients was conducted. Patients were evaluated using the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), postvoid residual urine volume (PVR), Serum Prostatic- Specific Antigen (PSA), testosterone levels, and prostate size. At the end of 6-month trial, unblinding revealed that patients who initially received the placebo were switched to Urtica dioica. Both groups continued the medication up to 18 months.

RESULTS

558 patients (90%) completed the study (287/305, 91% in the Urtica dioica group, and 271/315, 86% in the placebo group). By intention- to-treat analysis, at the end of 6-month trial, 232 (81%) of 287 patients in the Urtica dioica group reported improved LUTS compared with 43 (16%) of 271 patients in the placebo group (P < 0.001). Both IPSS and Qmax showed greater improvement with drug than with placebo. The IPSS went from 19.8 down to 11.8 with Urtica dioica and from 19.2 to 17.7 with placebo (P = 0.002). Peak flow rates improved by 3.4 mL/s for placebo recipients and by 8.2 mL/s for treated patients (P < 0.05). In Urtica dioica group, PVR decreased from an initial value of 73 to 36 mL (P < 0.05). No appreciable change was seen in the placebo group. Serum PSA and testosterone levels were unchanged in both groups. A modest decrease in prostate size as measured by transrectal ultrasonography (TRUS) was seen in Urtica dioica group (from 40.1 cc initially to 36.3 cc; P < 0.001). There was no change in the prostate volume at the end of study with placebo. At 18-month follow-up, only patients who continued therapy, had a favorable treatment variables value. No side effects were identified in either group.

CONCLUSION

In the present study, Urtica dioica have beneficial effects in the treatment of symptomatic BPH. Further clinical trials should be conducted to confirm these results before concluding that Urtica dioica is effective.

摘要

目的

确定使用异株荨麻治疗良性前列腺增生(BPH)继发的下尿路症状(LUTS)的症状缓解效果。

材料与方法

对620例患者进行了一项为期6个月的双盲、安慰剂对照、随机、部分交叉、异株荨麻与安慰剂对比试验。使用国际前列腺症状评分(IPSS)、最大尿流率(Qmax)、排尿后残余尿量(PVR)、血清前列腺特异性抗原(PSA)、睾酮水平和前列腺大小对患者进行评估。在6个月试验结束时,揭盲显示最初接受安慰剂的患者改用异株荨麻。两组均持续用药长达18个月。

结果

558例患者(90%)完成了研究(异株荨麻组287/305例,91%;安慰剂组271/315例,86%)。按意向性分析,在6个月试验结束时,异株荨麻组287例患者中有232例(81%)报告LUTS改善,而安慰剂组271例患者中有43例(16%)(P<0.001)。IPSS和Qmax均显示药物治疗比安慰剂治疗有更大改善。异株荨麻治疗后IPSS从19.8降至11.8,安慰剂治疗后从19.2降至17.7(P=0.002)。安慰剂组患者的峰值流速提高了3.4 mL/s,治疗组患者提高了8.2 mL/s(P<0.05)。在异株荨麻组中,PVR从初始值73 mL降至36 mL(P<0.05)。安慰剂组未见明显变化。两组血清PSA和睾酮水平均未改变。经直肠超声检查(TRUS)测量,异株荨麻组前列腺大小有适度减小(从最初的40.1 cc降至36.3 cc;P<0.001)。研究结束时,安慰剂组前列腺体积无变化。在18个月的随访中,只有继续治疗的患者具有良好的治疗变量值。两组均未发现副作用。

结论

在本研究中,异株荨麻对有症状的BPH治疗有有益作用。在得出异株荨麻有效结论之前,应进行进一步的临床试验以证实这些结果。

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