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目的评价利多卡因预防超声引导经直肠前列腺穿刺活检术疼痛的有效性和安全性。方法采用随机化分组方法,将180例行经直肠超声引导前列腺穿刺活检术的患者,随机分为试验组(利多卡因组)、生理盐水组(安慰剂生理盐水组)与空白对照组(不使用任何药物),每组60例。试验组患者经直肠在前列腺与精囊连接部两侧各注射2%利多卡因各5ml;生理盐水组注射生理盐水;空白对照组直接行穿刺活检。采用视觉模拟评分尺(VAS)分别在B超探头进入直肠、麻醉术毕、穿刺术毕、穿刺术后20min四个评分点进行疼痛评分,穿刺结束时及术后一周随访评判患者有无并发症及其程度。在临床试验过程中对前列腺穿刺术者、VAS评分操作者、数据评价者与患者实施盲法。结果在四个评分点对三组患者进行疼痛评分,试验组患者疼痛评分分别为(1.085±1.438)、(1.698±1.708)、(2.030±1.877)、(0.972±1.111),生理盐水组分别为(1.062±1.049)、(2.75 3±2.345)、(3.992±2.406)、(1.020±0.731),空白对照组分别为(0.903+0.901)、(0.088±0.240)、(3.495±1.885)、(1.160±1.094)。超声探头进入直肠与穿刺术后20min评分比较差异无统计学意义(P值均0.05);麻醉术毕疼痛评分各组比较差异有统计学意义(P<0.0001),试验组与生理盐水组、空白对照组比较差异有统计学意义(P值均<0.05);穿刺术毕疼痛评分各组比较差异有统计学意义(P<0.0001),试验组与生理盐水组、空白对照组比较差异有统计学意义(P值均<0.01)。3组患者对镇痛效果的满意度分别为91.667%、76.667%与58.333%,各组比较差异有统计学意义(P=0.0001)。所有患者除空白对照组发生1例败血症外,均未见严重血管迷走神经反射、严重感染、严重直肠出血、严重血尿及尿潴留并发症。各组并发症的发生比较差异均无统计学意义(P值均>0.05)。无患者出现局麻药中毒症状、尿潴留等并发症。所有患者均完成一周随访,随访期间无严重并发症发生。结论穿刺术前在前列腺基底部与精囊连接部两侧注射盐酸利多卡因注射液,能显著降低穿刺术中、术后的疼痛程度,具有较好的疗效和安全性。推荐在前列腺穿刺活检术前常规应用。
Objective To evaluate the effectiveness and safety of lidocaine in the prevention of sore-guided transrectal prostate biopsy by ultrasound. Methods A total of 180 patients undergoing transrectal ultrasound guided prostate biopsy were randomly divided into experimental group (lidocaine group), saline group (placebo-treated group) and blank control group Use any medication), 60 in each group. In the test group, 5 ml of 2% lidocaine was injected through the rectum on both sides of the connection between the prostate and the seminal vesicle. The saline group was injected with normal saline. The blank control group was biopsied directly. The visual analogue scale (VAS) was used to evaluate the pain score of the B ultrasound probe in the rectum, anesthesia, biopsy and puncture at 20 minutes after puncture. The patients were followed up at the end of puncture and one week after surgery And its extent. Prostate puncture, VAS score operators, data evaluators and patients were blinded during clinical trials. Results The pain scores of three groups of patients were evaluated at four points. The scores of pain in the test group were (1.085 ± 1.438), (1.698 ± 1.708), (2.030 ± 1.877) and (0.972 ± 1.111), respectively (1.062 ± 1.049), (2.75 3 ± 2.345), (3.992 ± 2.406) and (1.020 ± 0.731) respectively in the blank control group were (0.903 ± 0.901), (0.088 ± 0.240), (3.495 ± 1.885) ± 1.094). There was no significant difference between the two groups (P> 0.05). There was significant difference between the two groups (P <0.0001) in pain scores at the end of anesthesia. There was no significant difference between the experimental group and the saline group There was significant difference between the control group and the control group (all P <0.05). There was significant difference between the two groups (P <0.0001). There was significant difference between the experimental group and the saline group and the blank control group Significance (P <0.01). The satisfaction degree of analgesic effect in the three groups was 91.667%, 76.667% and 58.333%, respectively, with significant difference (P = 0.0001). All patients except one case of sepsis in blank control group, no serious vascular vagal reflex, severe infection, severe rectal bleeding, severe hematuria and urinary retention complications. There was no significant difference in the incidence of complications between the two groups (P> 0.05). No symptoms of local anesthetic poisoning, urinary retention and other complications occurred. All patients completed one week follow-up without serious complications. Conclusion Injection of lidocaine hydrochloride injection on both sides of the base of prostate and seminal vesicle before puncture can significantly reduce the degree of pain during and after puncture, which has good curative effect and safety. Recommended for prostate biopsy prior to routine use.