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单次多针注射酒精硬化治疗单纯性肾囊肿的疗效和安全性:一项多中心、前瞻性、随机、对照临床试验。

Efficacy and safety of alcohol sclerotherapy involving single-session multiple injections to treat simple renal cysts: a multicenter, prospective, randomized, controlled trial.

机构信息

Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.

出版信息

Chin Med J (Engl). 2013 Mar;126(5):803-7.

PMID:23489780
Abstract

BACKGROUND

Alcohol has been used for treating simple renal cysts since 1981. Since then, various observational studies have examined the technique, but they differ significantly in the details of the procedures and efficacy measures used. This has made it difficult to assess the safety and efficacy of this technique. We carried out a randomized controlled trial to evaluate the efficacy and safety of ultrasound-guided alcohol sclerotherapy involving single-session multiple injections to treat simple renal cysts.

METHODS

A total of 144 patients with simple renal cysts were randomly allocated to either the treatment group (ultrasound-guided percutaneous drainage and alcohol sclerotherapy with single-session multiple injections) or control group (ultrasound-guided simple percutaneous drainage). Follow-up CT scans of ablated cysts were collected 3 and 6 months after the procedure. The outcome was considered successful if cyst volume between baseline and 6 months decreased by at least 87.5%.

RESULTS

Intention-to-treat analysis revealed an average volume reduction of 94.2% in the treatment group and 50.8% in the control group (P < 0.0001). The percentage of patients achieving successful outcomes was 88.9% (95%CI 77.0% - 100.0%) in the treatment group and 22.2% (95%CI 6.54% - 37.9%) in the control group (P < 0.0001). The corresponding results in the per-protocol analysis were an average volume reduction of 96.4% in the treatment group and 50.8% in the control group (P < 0.0001). The percentage of patients achieving a successful outcome was 94.3% (95%CI 85.6% - 100.0%) in the treatment group and 22.2% (95%CI 6.54% - 37.9%) in the control group (P < 0.0001).

CONCLUSION

Alcohol sclerotherapy involving single-session multiple injections is safe and efficacious in the treatment of renal cysts.

摘要

背景

自 1981 年以来,酒精已被用于治疗单纯性肾囊肿。此后,各种观察性研究都对该技术进行了检查,但在使用的程序和疗效测量细节上有很大差异。这使得评估该技术的安全性和有效性变得困难。我们进行了一项随机对照试验,以评估单次多针超声引导下酒精硬化治疗单纯性肾囊肿的疗效和安全性。

方法

共有 144 例单纯性肾囊肿患者被随机分配到治疗组(超声引导下经皮引流和单次多针酒精硬化治疗)或对照组(超声引导下单纯经皮引流)。在术后 3 个月和 6 个月收集消融囊肿的 CT 随访。如果囊肿体积在基线至 6 个月之间减少至少 87.5%,则认为结果是成功的。

结果

意向治疗分析显示,治疗组平均体积减少 94.2%,对照组减少 50.8%(P<0.0001)。治疗组成功的患者比例为 88.9%(95%CI 77.0% - 100.0%),对照组为 22.2%(95%CI 6.54% - 37.9%)(P<0.0001)。在方案分析中,治疗组平均体积减少 96.4%,对照组减少 50.8%(P<0.0001)。治疗组成功的患者比例为 94.3%(95%CI 85.6% - 100.0%),对照组为 22.2%(95%CI 6.54% - 37.9%)(P<0.0001)。

结论

单次多针超声引导下酒精硬化治疗肾囊肿安全有效。

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