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一项随机对照试验比较了单独使用利多卡因前列腺周围神经阻滞与联合使用双氯芬酸钠栓用于经直肠超声(TRUS)引导下前列腺活检的患者。

A randomised controlled trial comparing use of lignocaine periprostatic nerve block alone and combined with diclofenac suppository for patients undergoing transrectal ultrasound (TRUS)-guided prostate biopsy.

机构信息

University of Western Australia, School of Surgery, Perth, Western Australia, Australia; Department of Urology, Fremantle Hospital, Perth, Western Australia, Australia.

出版信息

BJU Int. 2014 Nov;114 Suppl 1:45-9. doi: 10.1111/bju.12610.

Abstract

OBJECTIVE

To examine whether or not the combination of diclofenac suppository with peri-prostatic nerve block (PPNB) was effective in reducing the degree of pain experienced during transrectal ultrasound (TRUS)-guided prostate biopsy in a randomised single-blind placebo-controlled trial.

PATIENTS AND METHODS

In all, 96 patients having a planned TRUS-guided prostate biopsy were randomised into one of the following arms on a 1:1 basis: 10 mL 1% lignocaine PPNB and placebo suppository (control) or 10 mL 1% lignocaine PPNB and 100 mg diclofenac suppository (treatment). Pain scores were recorded using the Numerical Rating Scale for pain (0-10) at the following time-points: (i) introduction of probe, (ii) during biopsy, (iii) 1 h after biopsy, (iv) later that evening (≈6 h after biopsy) and (v) 1 day after biopsy. Patients were asked about their preferred method for pain control if a repeat TRUS-guided prostate biopsy was required: local anaesthetic (LA) again or intravenous sedation.

RESULTS

There were no significant differences in age (P = 0.653) or PSA level (P = 0.584) between either study arm. The differences in pain scores between the control and treatment groups were not significant at Time 1 (probe insertion; P = 0.299), Time 2 (biopsy; P = 0.983), Time 4 (evening after; P = 0.231) and Time 5 (1 day after biopsy; P = 0.384). At Time 3 (1 h after biopsy), the control pain scale scores were statistically significantly higher than the treatment pain scale scores (P = 0.044). There was no difference between treatment (87%) and control (80%) groups as to whether they would prefer to repeat the biopsy under LA (P = 0.373).

CONCLUSION

The use of a diclofenac suppository with PPNB did not show any clinically meaningful effect in decreasing pain or improving tolerability of TRUS-guided prostate biopsy and is not recommended. PPNB TRUS-guided biopsy is extremely well tolerated, with >80% of patients electing for subsequent LA biopsy if required.

摘要

目的

在一项随机、单盲、安慰剂对照试验中,研究双氯芬酸钠栓剂联合前列腺周围神经阻滞(PPNB)是否能降低经直肠超声(TRUS)引导下前列腺活检过程中的疼痛程度。

患者和方法

共有 96 例计划接受 TRUS 引导下前列腺活检的患者,按照 1:1 的比例随机分为以下两组:10mL 1%利多卡因 PPNB 加安慰剂栓剂(对照组)或 10mL 1%利多卡因 PPNB 加 100mg 双氯芬酸钠栓剂(治疗组)。使用数字评分量表(0-10 分)记录以下时间点的疼痛评分:(i)探头插入时,(ii)活检时,(iii)活检后 1 小时,(iv)当晚(活检后约 6 小时)和(v)活检后 1 天。如果需要再次进行 TRUS 引导下前列腺活检,患者被问及他们更愿意选择哪种疼痛控制方法:再次使用局部麻醉剂(LA)还是静脉镇静。

结果

两组患者的年龄(P = 0.653)或 PSA 水平(P = 0.584)均无显著差异。对照组和治疗组在第 1 时间点(探头插入时)、第 2 时间点(活检时)、第 4 时间点(晚上后)和第 5 时间点(活检后 1 天)的疼痛评分差异无统计学意义(P = 0.299、P = 0.983、P = 0.231、P = 0.384)。在第 3 时间点(活检后 1 小时),对照组的疼痛评分明显高于治疗组(P = 0.044)。治疗组(87%)和对照组(80%)患者在是否愿意再次接受 LA 下活检方面没有差异(P = 0.373)。

结论

在 PPNB 中使用双氯芬酸钠栓剂并没有显示出任何在减轻疼痛或提高 TRUS 引导下前列腺活检耐受性方面的临床意义,因此不推荐使用。PPNB TRUS 引导活检具有极好的耐受性,如果需要,超过 80%的患者选择随后进行 LA 活检。

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