发散式体外冲击波治疗勃起功能障碍的临床疗效观察

关键词：勃起功能障碍  冲击波  疗效观察  随机对照研究

Keywords:erectile dysfunction  shock wave  efficacy observation  randomized controlled trial

摘要：

      摘要 目的：验证联合运用中低量级能量流动密度（energy flow density，EFD）的发散式体外冲击波疗法（radial extracorporeal shock wave therapy，rESWT）治疗勃起功能障碍（erectile dysfunction，ED）的临床疗效。 方法：36例ED患者随机分为两组，每组18例，一组为rESWT组，另一组为对照组（他达拉非组）。rESWT组接受16次rESWT，每周2次，疗程8周；对照组口服他达拉非片，每日1次，每次5mg，疗程8周。分别于治疗前、治疗1个月、治疗2个月、治疗结束后随访1个月、随访3个月、随访6个月评价患者的5项国际勃起功能指数（5-item international index of erectile function，IIEF-5）、勃起硬度评级（erection hardness score，EHS）。 结果：rESWT组与对照组IIEF-5、EHS各时间点整体比较均存在显著差异（P<0.001）。rESWT组IIEF-5：治疗1个月显著高于治疗前（P<0.001）、低于对照组（P<0.05）；治疗2个月显著高于治疗1个月（P<0.001），与对照组未见差异（P>0.05）；随访1个月、随访3个月较治疗2个月未见差异（P>0.05）；随访3个月高于对照组（P<0.05）；随访6个月高于治疗前（P<0.05）。对照组IIEF-5：治疗1个月较治疗2个月未见差异（P>0.05）且显著高于治疗前（P<0.001）；随访1个月低于治疗2个月（P<0.01）；随访3个月、随访6个月较治疗前未见差异（P>0.05）。rESWT组各时间点的EHS与对照组比较均未见差异（P>0.05），但rESWT组治疗2个月、随访1个月高于治疗前（P<0.05）。 结论：联合运用中低量级EFD的rESWT治疗ED可达到他达拉非的疗效，且在维持疗效及长效性方面优于他达拉非，具有一定的临床应用价值。

Abstract:

      Abstract Objective： To verify the clinical efficacy of using radial extracorporeal shock wave therapy （rESWT） with a combination of low-to-moderate energy flow density （EFD） in the treatment of erectile dysfunction （ED）. Method： Thirty-six patients with ED were randomly divided into two groups， with 18 patients in each group. The rESWT group received 16 sessions of rESWT (twice weekly for 8 weeks), while the control group took oral tadalafil 5 mg once daily for 8 weeks. The 5-item International Index of Erectile Function （IIEF-5） and Erection Hardness Score （EHS） were evaluated before treatment， at 1 month and 2 months during treatment， and at 1 month， 3 months， and 6 months after the completion of treatment. Result： The overall comparison of IIEF-5 and EHS scores between the rESWT group and the control group at various time points showed significant differences （P<0.001）. For the rESWT group， the IIEF-5 score after 1 month of treatment was significantly higher than that before treatment （P<0.001） but lower than that of the control group （P<0.05）. After 2 months， it was significantly higher than at 1 month （P<0.001） with no difference compared to the control group （P>0.05）. There were no significant differences were observed at the 1-month and 3-month follow-ups compared to the 2-month treatment （P>0.05）. At 3 months of follow-up， the score was higher than that of the control group （P<0.05）. At 6 months of follow-up， the score was higher than that before treatment （P<0.05）. For the control group， the IIEF-5 score， there were no differences between 1 and 2 months of treatment （P>0.05）， but both were significantly higher than before treatment（P<0.001）. At 1 month of follow-up， the score was lower than at 2 months of treatment （P<0.01）. There was no difference in EHS between the rESWT group and the control group （P>0.05）， but the rESWT group was treated for 2 months and followed up for 1 month， which was higher than that before treatment （P<0.05）. Conclusion： The combined use of low-to-moderate EFD rESWT can achieve the same efficacy comparable to Tadalafil in ED treatment and demonstrates superior durability of response, indicating its broader clinical application.