摘要目的:探讨Rezūm热蒸汽消融系统治疗良性前列腺增生(BPH)的有效性和安全性。方法:回顾性分析2020年12月至2021年1月在海南博鳌一龄生命养护中心收治的22例BPH患者的临床资料。年龄(61.0±5.9)岁。前列腺体积(43.7±8.4)ml。国际前列腺症状评分(IPSS)(19.3±3.7)分，生活质量(QOL)评分(4.2±0.8)分。最大尿流率(Q max)(11.9±3.4)ml/s，残余尿量(PVR)(14.0±19.0)ml。19例有性生活者，术前国际勃起功能指数问卷表-5(IIEF-5)(17.0±5.5)分；男性性健康问卷-射精功能障碍评分(MSHQ-EjD)中射精功能评分(10.0±3.2)分，射精满意度评分(1.5±1.0)分。22例均采用Rezūm热蒸汽消融系统行经尿道前列腺热蒸汽消融术。Rezūm系统由可重复使用的热蒸汽治疗设备和一次性前列腺热蒸汽治疗器械组成。热蒸汽治疗设备利用射频能量将无菌蒸馏水加热，产生103℃高温水蒸汽，在9 s的时间里将每个治疗区域内的组织温度提高约70℃，导致细胞死亡，从而使前列腺组织体积缩小。一次性前列腺热蒸汽治疗器械可置入膀胱镜，头端有可伸缩针尖，针尖伸出长度10.25 mm，针尖上均匀分布12个孔，呈3列，每列4个孔，每列间距为120°，可实现热蒸汽沿圆周均匀扩散。静脉全麻，患者取截石位，采用置入膀胱镜的一次性前列腺热蒸汽治疗器械检查前列腺尿道、膀胱，评估前列腺两侧叶和中叶。治疗器械每个视野下的组织间长度为0.5 cm，计算从膀胱颈部至精阜距离。于左侧叶膀胱颈部3点处外撤2个视野，注射第1针。释放热蒸汽时，针尖与前列腺尿道黏膜垂直，每针穿刺均向前列腺组织注入0.42 ml无菌蒸馏水形成的热蒸汽。热蒸汽喷射持续9 s，等待2~3 s后撤回针尖。每隔2个视野穿刺1针，依次注射至精阜近端尿道。同样方法治疗右侧叶。对于中叶增生明显者，于膀胱颈部外撤2个视野，并斜45°进针，根据中叶增生情况间隔2个视野注射第2针。观察各穿刺点无明显出血，退出器械，留置F16/F18硅胶导尿管。记录手术时间和术后保留尿管时间。比较手术前后患者的前列腺体积、IPSS、Q max、PVR、QOL、IIEF-5、MSHQ-EjD变化情况。以IPSS降低≥5.5分定义为治疗有效。记录术中和术后手术相关的不良事件。 结果:本组22例手术均顺利完成。Rezūm系统操作时间(3.9±1.6)min。术后留置尿管时间(4.8±1.1)d。22例术后随访12~22周，IPSS为(4.4±3.3)分，较术前降低(14.9±4.4)分，差异有统计学意义( P<0.01)；前列腺体积(37.7±8.4)ml，Q max(25.5±9.6)ml/s，PVR(6.2±8.1)ml，QOL(1.6±0.9)分，与术前比较差异均有统计学意义( P<0.05)；19例有性生活患者的IIEF-5(20.4±3.2)分，MSHQ-EjD的射精功能评分(13.1±3.1)分，与术前比较差异有统计学意义( P<0.05)；MSHQ-EjD的射精满意度评分(1.1±0.5)分，与术前比较差异无统计学意义( P>0.05)。22例术后均无BPH的外科再治疗情况。本组22例术中未发生尿道损伤、直肠或膀胱穿孔，术后未发生直肠瘘、膀胱颈口挛缩等严重并发症，无死亡病例。术后发生尿道不适19例次、尿道疼痛8例次、血尿15例次、睡眠质量差2例次，便秘1例次，术后7~10 d恢复；术后4~5周发生勃起功能障碍、逆行射精各1例次，后未再出现；术后21周和25周分别发生前列腺炎、前列腺中叶结节样增生各1例次，未予治疗。 结论:真实世界中采用Rezūm热蒸汽消融系统治疗BPH的短期整体效果满意，该方法具有良好的有效性和安全性。

abstractsObjective:To evaluate the efficacy and safety of Rezūm Water Vapor Thermal Therapy system in the treatment of patients with benign prostatic hyperplasia (BPH).Methods:The clinical data of 22 patients with benign prostatic hyperplasia treated with Rezūm Water Vapor Thermal Therapy system in Boao Yiling Life Care Center in Hainan from December 2020 to January 2021 were retrospectively analyzed, with age of (61.0±5.9) years, prostate volume of (43.7±8.4) ml. international prostate symptom score (IPSS) of (19.3±3.7), quality of life (QOL) score of (4.2±0.8), maximum urinary flow rate (Q max) of (11.9±3.4) ml ml/s, and residual urine volume (PVR) of (14.0±19.0). For 19 patients with sexual life, the International Index of Erectile Function Questionnaire-5 (IIEF-5) were 17.0±5.5, the Men's Sexual Health Questionnaire-Ejaculatory Dysfunction Score (MSHQ-EjD) ejaculatory function score were 10.0±3.2, and the ejaculatory satisfaction score were 1.5±1.0. Twenty-two patients underwent Rezūm Water Vapor Thermal Therapy under intravenous anesthesia (general anesthesia without intubation) in the dorsal lithotomy position. The Rezūm system consisted of reusable thermal steam treatment device and disposable prostate thermal steam treatment instrument. The thermal steam treatment device used radiofrequency energy to heat sterile distilled water, generating high-temperature steam at 103℃. In a 9-second timeframe, the tissue temperature within each treatment area was raised approximately 70℃, causing cell death and resulting in a shrink in prostate tissue volume. The disposable prostate thermal steam treatment instrument could be inserted through a cystoscope and had a retractable needle tip that extends to a length of 10.25 mm. The needle tip had 12 evenly distributed holes arranged in three rows of four holes each, with a spacing of 120° between rows, allowing for even diffusion of thermal steam along the circumference. The patient was placed in a lithotomy position, and the disposable prostate thermal steam treatment instrument was used to examine the prostate, urethra, and bladder via cystoscopy, assessing the lateral lobes and median lobe of the prostate. The tissue spacing within each field of view of the treatment instrument is 0.5 cm, and the distance from the bladder neck to the verumontanum is calculated. The first needle was injected at 3 o’clock along the left lobe, withdrawing 2 fields of view each time. During the release of thermal steam, the needle tip was positioned perpendicular to the prostate urethral mucosa, and each needle injection delivered 0.42 ml of sterile distilled water-formed thermal steam into the prostate tissue. The thermal steam injection lasted for 9 seconds, followed by a 2-3 seconds waiting period before retracting the needle tip. One needle was injected per 2 fields of view, progressing towards the proximal urethra of the verumontanum. The same method was used to treat the right lobe. For cases with significant median lobe enlargement, two fields of view were retracted at the bladder neck, and the needle was inserted at a 45° angle. The second needle was injected at intervals determined by the extent of median lobe enlargement. Each puncture point was observed for no significant bleeding, and the instrument was then removed, with an F16/F18 silicone catheter left in place. The operative time as well as indwelling catheter time were recorded. The clinical parameters such as IPSS, QOL, prostate volume, Qmax, PVR, QOL, IIEF-5 and MSHQ-EjD at preoperative and 12 to 22 weeks post operation were compared. Adverse events from the Rezūm procedure to 12-22 weeks postoperatively were recorded. Results:All the operations were successfully completed. The operation time of Rezūm system was 3.9±1.6 min, and the indwelling catheter time after operation was 4.8±1.1 days. The IPSS scores of 22 patients at 12-22 weeks after operation were 4.4±3.3, whose reduction was 14.9±4.4 compared with these at baseline( P<0.01). The PV was (37.7±8.4)ml, Qmax was (25.5±9.6)ml/s, PVR was (6.2±8.1)ml, and QOL was 1.6±0.9, all demonstrating statistically significant differences compared to preoperative values ( P<0.05). Among the 19 cases with sexual activity, the IIEF-5 score was 20.4±3.2, and the ejaculatory function score of MSHQ-EjD was 13.1±3.1, both showing statistically significant differences compared to preoperative scores ( P<0.05). The ejaculatory satisfaction score of MSHQ-EjD was 1.1±0.5, and there was no statistically significant difference compared to preoperative scores ( P>0.05). None of the 22 cases required medication or further surgical treatment for BPH after surgery. There were no urethral injuries, rectal or bladder perforations during the surgeries, and no severe complications such as rectal fistula or bladder neck contracture occurred postoperatively. There were no deaths reported. Postoperative discomfort in the urethra occurred in 19 cases, urethral pain in 8 cases, hematuria in 15 cases, poor sleep quality in 2 cases, and constipation in 1 case, all of which resolved within 7 to 10 days after surgery. Erectile dysfunction and retrograde ejaculation occurred in one case each at 4 to 5 weeks postoperatively but did not reoccur thereafter. Prostatitis and nodular hyperplasia of the middle lobe of the prostate occurred in one case each at 21 weeks and 25 weeks postoperatively, respectively, and no treatment was administered. Conclusions:In the real world, the short-term overall effect of Rezūm Water Vapor Thermal Therapy system in the treatment of benign prostatic hyperplasia is satisfactory, which shows good efficacy and safety.