Objective: To make a preliminary investigation on the safety and efficacy of focused low-intensity extracorporeal shock wave therapy (LI-ESWT) in the treatment of erectile dysfunction (ED).
Methods: We treated 32 ED patients by focused LI-ESWT with the device of Medispec's ED1000. Before and at 4 and 12 weeks after treatment, we evaluated the erectile function of the patients using the International Index of Erectile Function-erectile function domain (IIEF-EF), Erection Hardness Score (EHS), Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), and Global Assessment Questionnaire questions 1 and 2 (GAQ1 and GAQ2), and recorded the incidence rate of adverse events.
Results: The patients averaged 30.69 years of age. Compared with the baseline, the mean IIEF-EF score of the patients was significantly increased at 4 and 12 weeks after LI-ESWT (14.94 vs 20.97 and 21.47, P <0.01), and so were the EHS (1.75 vs 2.66 and 2.56, P <0.01) and the "Yes" answers to SEP2 (21.88% vs 68.75% and 71.88%), SEP3 (0 vs 43.75% and 56.25%), GAQ1 (NA vs 81.25% and 71.88%) and GAQ2 (NA vs 65.63% and 68.75%). The total effectiveness rates at 4 weeks and 12 weeks were 75% and 71.88% respectively. One of the patients felt penile shaft pain with mild ecchymosis after LI-ESWT but was recovered without special treatment a week later.
Conclusions: LI-ESWT can significantly improve the erectile function of ED patients with no obvious adverse effects within 12 weeks after treatment.
目的: 初步探讨点状体外低能量冲击波（LI-ESWT）治疗勃起功能障碍（ED）患者的安全性和疗效。方法： 选取在我院就诊的采用ED1000治疗的ED患者 32例，分别在治疗前和治疗后4周、12周随访评估患者的勃起功能专项评分(IIEF-EF)、勃起硬度分级(EHS)、性生活日志问题2(SEP2)，性生活日志问题3(SEP3)、总体评估问卷(GAQ)和不良反应发生率。结果： 32例患者平均年龄30.69岁，基线IIEF-EF平均14.94分，治疗后4周、12周随访分别为20.97分和21.47分，与基线水平比较明显改善（P<0.01）。EHS评分基线平均1.75，治疗后4周、12周分别为2.66和2.56，与治疗前比较有明显改善（P<0.01）。治疗前患者SEP2、SEP3回答“能”为21.88%和0，治疗后4周和12周SEP2分别为68.75%和71.88%，SEP3分别为43.75%和56.25%。GAQ问卷回答“有”治疗后4周和12周分别为GAQ1 81.25%和71.88%；GAQ2 65.63%和68.75%；治疗4周和12周总有效率分别为75%和71.88%。1例患者在治疗后出现阴茎体部疼痛，有少量皮下出血瘀斑，未做特殊治疗，1周后痊愈。结论： LI-ESWT治疗后12周内可以明显改善ED患者的勃起功能，且无明显不良反应。.
Keywords: adverse effects; efficacy; erectile dysfunction; low-intensity extracorporeal shock wave therapy.