楊中華,劉同族,王行環(huán)
(武漢大學(xué)中南醫(yī)院泌尿外科,湖北武漢 430071)
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經(jīng)尿道前列腺銩激光汽化術(shù)與等離子切除術(shù)治療前列腺增生療效的5年隨訪比較
楊中華,劉同族,王行環(huán)
(武漢大學(xué)中南醫(yī)院泌尿外科,湖北武漢430071)
目的比較經(jīng)尿道前列腺銩激光汽化術(shù)前列腺剜除術(shù)(ThuLEP)與經(jīng)尿道前列腺等離子雙極電切術(shù)(PKRP)治療良性前列腺增生癥(BPH)導(dǎo)致下尿路梗阻的中長期有效性、安全性。方法158例保守治療無效的BPH患者隨機(jī)分為兩組,分別接受ThuLEP及PKRP手術(shù)各79例。評估患者術(shù)前及術(shù)后3 ~ 5年國際前列腺癥狀評分評估(IPSS)、生活質(zhì)量評分(QoLS)最大尿流率(Qmax)及殘余尿量 (PVR)等。結(jié)果共80例患者完成了5年隨訪。兩組病例術(shù)前參數(shù)無顯著性差異,術(shù)中無1例發(fā)生電切綜合征,無1例因失血而輸血,術(shù)后均無尿失禁。與PKRP相比,ThuLEP手術(shù)時(shí)間較長[(65.4±22.2)vs. (47.4±15.9) min,P=0.022],術(shù)中出血少血紅蛋白下降[ (1.5±0.2)vs. (3.0±0.3) g/dL,P=0.045]。ThuLEP能減少術(shù)后膀胱沖洗量[(12.4±6.4)vs. (27.2±5.2) L,P=0.022],縮短術(shù)后留置尿管時(shí)間[(2.1±0.8)vs. (3.5±1.2)d,P=0.031]。術(shù)后60個(gè)月的隨訪期間,兩組病例在Qmax、QoLS、IPSS、PVR方面沒有顯著差異(P>0.05)。 結(jié)論ThuLEP和PKRP對于緩解BPH引起的下尿路癥狀同樣安全、有效。在止血、術(shù)后恢復(fù)方面ThuLEP優(yōu)于PKRP,但切割速度不及PKRP。經(jīng)過長達(dá)5年隨訪,兩種術(shù)式在Qmax、QoLS、IPSS、PVR方面無顯著差異。
前列腺增生癥;等離子;銩激光;經(jīng)尿道前列腺電切術(shù)
良性前列腺增生癥(benign prostatic hyperpla-sia,BPH)發(fā)病率隨年齡的增長而增加,嚴(yán)重影響患者日常生活[1]。30多年來經(jīng)尿道前列腺切除術(shù)( transurethral resection of prostate,TURP)一直是手術(shù)治療BPH的金標(biāo)準(zhǔn),近年其并發(fā)癥率顯著降低。REICH等[2]的一項(xiàng)多中心評價(jià)提示TURP圍手術(shù)期死亡率已降至0.1%,然而其并發(fā)癥率仍高達(dá)11.1%。經(jīng)尿道前列腺等離子雙極電切術(shù),如經(jīng)尿道前列腺等離子雙極電切術(shù)( transurethral resection of prostate plasma bipolarelectric cut method,PKRP)和經(jīng)尿道前列腺激光汽化術(shù),如銩激光前列腺汽化術(shù)(transurethral thulium laser vaporization of the prostate surgery,ThuLEP)是TURP的重大改進(jìn)。這些技術(shù)解決了傳統(tǒng)TURP的根本缺陷,避免了電切綜合征的發(fā)生[3]。臨床試驗(yàn)表明PKRP[4-6]及ThuLEP[7-9]在改善排尿方面與單極TURP同樣有效,有望成為BPH手術(shù)治療的新的金標(biāo)準(zhǔn)。本研究旨在通過臨床隨機(jī)對照研究,比較ThuLEP與PKRP治療良性前列腺增生癥導(dǎo)致下尿路梗阻的中長期有效性、安全性。
1.1臨床資料將2009年5月至2010年6月在我中心就診的藥物治療無效的158例BPH患者,隨機(jī)分為ThuLEP治療組和PKRP治療組各79例。該研究獲武漢大學(xué)倫理委員會批準(zhǔn),所有受試者在納入研究前均給予知情同意書。入選標(biāo)準(zhǔn)為年齡小于85歲,最大尿流率(maximum flow rate,Qmax)<15 mL/s,殘余尿(postvoid residual urine volume, PVR)尿量<150 mL,藥物治療失敗,和經(jīng)直腸超聲(transrectal ultrasound, TRUS)前列腺體積<100 mL;排除標(biāo)準(zhǔn):前列腺體積小于30 mL,證實(shí)或懷疑前列腺癌、神經(jīng)源性膀胱、膀胱結(jié)石、憩室、尿道狹窄和最大膀胱容量>500 mL。
術(shù)前評估所有患者的國際前列腺癥狀評分(International Prostate Symptom Score, IPSS)、生活質(zhì)量評分(quality of life score, QoLS)、經(jīng)直腸前列腺指診、經(jīng)直腸前列腺彩超、血清前列腺特異性抗原(prostate specific antigen, PSA)、Qmax、PVR (尿量>250 mL)。
1.2設(shè)備和技術(shù)ThuLEP手術(shù)參照王行環(huán)等[10]方法。應(yīng)用意大利Quanta公司生產(chǎn)的Cyber TM150 2 μm連續(xù)波醫(yī)用激光手術(shù)治療系統(tǒng),功率70~150 W。硬膜外麻醉,截石位,術(shù)中以生理鹽水作灌洗液。采用經(jīng)尿道“分割式”前列腺氣化切除術(shù),將光纖探頭通過激光電切鏡操作通道送至前列腺尿道部,首先汽化切除中葉:于5、7點(diǎn)位置,從膀胱頸部至精阜兩側(cè)各切1條深溝,深達(dá)包膜,隨后分塊汽化、切割中葉組織,形成從膀胱頸部至精阜近端的通道;在12點(diǎn)處切一深溝至包膜,長度從膀胱頸部至精阜垂直水平,并將切割后分開的兩側(cè)腺體沿包膜向下剝離;將精阜兩側(cè)的前列腺尖部組織沿包膜用操作鞘剜起后,再從12點(diǎn)處剝離的組織向下正向切割,直至與中葉切割平面匯合。切割順序由膀胱頸部開始,從上至下,從內(nèi)到外,直到剜起的前列腺尖部腺體。同法汽化切割另一側(cè)葉。最后沿前列腺包膜汽化修整創(chuàng)面。術(shù)后組織塊經(jīng)操作鏡鞘沖出。留置F22三腔氣囊導(dǎo)尿管,生理鹽水膀胱沖洗。
PKRP手術(shù)均采用等離子系統(tǒng)進(jìn)行(英國佳樂公司),根據(jù)標(biāo)準(zhǔn)程序手術(shù):術(shù)中以生理鹽水作灌洗液,使用等離子電切環(huán)在電切鏡的配合下,依次切除前列腺中葉、左右側(cè)葉以及尖部,術(shù)中電凝止血,沖洗清除脫落的前列腺組織后置入F22三腔導(dǎo)尿管,術(shù)畢生理鹽水膀胱沖洗。
1.3評估和隨訪記錄圍手術(shù)期相關(guān)參數(shù),包括手術(shù)時(shí)間、血紅蛋白降低、術(shù)后尿管留置時(shí)間、沖洗量、住院時(shí)間、并發(fā)癥等情況。當(dāng)尿液的顏色清晰時(shí),導(dǎo)管被清除。分別在術(shù)后1、2、3、4和5年評價(jià)術(shù)后排尿相關(guān)參數(shù)如IPSS、Qmax、QOLS及PVR等。
2.1兩組患者術(shù)前情況比較兩組患者在年齡、腺瘤體積、PSA水平、IPSS評分、最大尿流率及殘余尿等方面無顯著差異(P>0.05,表1)。
表1 兩組患者術(shù)前臨床資料 ±s)
2.2兩組患者圍手術(shù)期情況比較所有患者均成功完成手術(shù)。無TURS發(fā)生,無1例患者需要輸血。術(shù)后第1周內(nèi), PKRP和ThuLEP術(shù)患者分別有3例和1例出現(xiàn)由前列腺創(chuàng)面血凝塊引起的尿潴留的,均經(jīng)膀胱鏡直視下沖洗成功處理。在隨訪期間兩組均無尿道及膀胱頸狹窄、尿失禁發(fā)生(表2)。
與PKRP相比,ThuLEP手術(shù)時(shí)間較長[(65.4±22.2)vs.(47.4±15.9)min,P=0.022],術(shù)中出血少,血紅蛋白下降[(1.5±0.2)vs.(3.0±0.3)g/dL,P=0.045]。ThuLEP能減少術(shù)后膀胱沖洗量[(12.4±6.4)vs.(27.2±5.2)L,P=0.022],縮短術(shù)后留置尿管時(shí)間[(2.1±0.8vs.(3.5±1.2)d,P=0.031]。
2.3兩組患者隨訪情況比較所有病例均完成了第1年的隨訪;共80例患者完成了5年的隨訪,其中PKRP組41例,ThuLEP組39例。5年隨訪結(jié)果如表3所示,與術(shù)前相比,兩組Qmax、PVR、IPSS及QoLS顯著改善(P<0.05)。在1、3和5年隨訪中,PKRP及ThuLEP組間上述參數(shù)無顯著性差異(P>0.05)。
表2圍手術(shù)期臨床資料
指標(biāo)PKRP(n=79)ThuLEP(n=79)t值P值手術(shù)時(shí)間(min)47.4±15.965.4±22.21.3380.022切割速度(g/min)2.1±0.51.4±0.31.3270.021留置尿管時(shí)間(d)3.5±1.22.1±0.83.3670.031膀胱沖洗量(L)27.2±5.212.4±6.44.3190.022Hb降低(g/dL?)0.30±0.030.15±0.022.1530.045住院時(shí)間(d)4.6±1.42.5±1.42.8760.026
*分別在手術(shù)開始時(shí)和手術(shù)結(jié)束后采血檢測血紅蛋白。
表3兩組患者5年隨訪結(jié)果比較
指標(biāo)1年P(guān)KRP(n=65)ThuLEP(n=69)P值3年P(guān)KRP(n=57)ThuLEP(n=61)P值5年P(guān)KRP(n=41)ThuLEP(n=39)P值Qmax(mL/s)23.9±12.323.2±13.50.26322.3±13.222.9±14.30.31518.9±13.719.4±15.30.631PVR(mL)28.3±12.727.4±13.10.13824.7±15.325.1±11.90.23532.6±17.934.9±16.60.553IPSS4.6±1.85.2±1.90.0865.4±2.46.1±2.10.0666.5±2.76.9±3.20.179QoLS1.1±0.71.2±0.90.0861.3±0.81.3±0.60.3751.5±1.11.4±0.80.431
TURP是治療前列腺增生的金標(biāo)準(zhǔn),但也存在諸多不足:術(shù)中使用5%甘露醇或葡糖液等非電解質(zhì)灌洗液,其大量吸收可致體內(nèi)水電解質(zhì)平衡失調(diào),甚至出現(xiàn)TURS;TURP創(chuàng)面凝固層厚度為 0.1~0.3 mm,凝固層薄,止血效果差,失血較多[11]。等離子雙極電切術(shù)及銩激光汽化/切除術(shù)是TURP的技術(shù)改進(jìn),可使用生理鹽水作為灌洗液,且具有較強(qiáng)止血效果,避免了TURS的發(fā)生,降低了大出血的風(fēng)險(xiǎn)。這些改進(jìn)使得在切除較大體積前列腺時(shí)不會因?yàn)閾?dān)心失血和TURS的發(fā)生而導(dǎo)致前列腺切除不完全。
多中心、大樣本薈萃分析表明在短期臨床療效方面,雙極和單極TURP無顯著性差異,但雙極電切術(shù)因無電切綜合征和止血效果好而更具安全性;而激光治療則可以進(jìn)一步減少TURS和大出血的風(fēng)險(xiǎn)。目前已有多種激光設(shè)備應(yīng)用于臨床,其中綠光汽化和鈥激光剜除術(shù)應(yīng)用最為廣泛,可望取代TURP而成為新的金標(biāo)準(zhǔn)[12]。銩激光中心波長1.75~2.22 μm,其能量可導(dǎo)致組織表面瞬間汽化和凝固,深度達(dá)500~2 000 μm,從而達(dá)到安全切割和充分止血目的[13]。
在本研究中,PKRP術(shù)中因出血少而視野清晰,切割創(chuàng)面光滑,切割速度快[ (47.4 ±15.9)vs.(65.4±22.2) min,P<0.05],腺體及周圍包膜結(jié)構(gòu)清晰可辨,因而降低了切穿包膜及術(shù)后疤痕狹窄的風(fēng)險(xiǎn);ThuLEP術(shù)中幾乎無出血,因此縮短術(shù)后膀胱沖洗時(shí)間[(12.4±6.4)vs.(27.2±5.2)L,P<0.05]、縮短留置尿管時(shí)間[(2.1±0.8)vs. (3.5±1.2)d,P<0.05],但創(chuàng)面光滑程度不及PKRP。
在術(shù)后隨訪中,兩組Qmax、PVR、IPSS及QoLS較與術(shù)前相比均獲顯著改善,且無尿失禁及尿道狹窄發(fā)生。在1、3和5年隨訪中,PKRP及ThuLEP組間上述參數(shù)無顯著性差異,表明PKRP及ThuLEP在改善癥狀方面同樣有效。
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(編輯何宏靈)
Comparison of thulium laser enucleation and plasmakinetic resection of the prostate in a randomized prospective trial with 5-year follow-up
YANG Zhong-hua, LIU Tong-zu, WANG Xing-huan
(Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan 430071, China)
ObjectiveTo compare the clinical outcomes between thulium laser transurethral enucleation of the prostate (ThuLEP) and plasmakinetic bipolar resection of the prostate (PKRP) for benign prostatic hyperplasia (BPH) in a prospective randomized trial with 5 years of follow-up. Methods A total of 158 consecutive patients with BPH were randomized to ThuLEP (n=79) and PKRP (n=79) group. All cases were evaluated preoperatively and part of them were evaluated 3~5 years postoperatively with International Prostate Symptom Score (IPSS), quality of life score (QoLS), maximum flow rate (Qmax) and postvoid residual urine volume (PVR). Results A total of 80 patients completed the 5-year follow-up. There were no significant differences in preoperative parameters. Compared with PKRP, ThuLEP required longer operation time [(65.4±22.2)vs.(47.4±15.9)min,P=0.022], less catheterization time [(2.1±0.8)vs.(3.5±1.2)d,P=0.031] and irrigated volume [(12.4±6.4)vs.(27.2±5.2)L,P=0.022], but resulted in less haemoglobin decrease [(1.5±0.2)vs.(3.0±0.3)g/dL,P=0.045]. During the 60-month follow-up, no significant differences in terms of Qmax, IPSS, PVR, and QoLS were observed between the two groups of patients. ConclusionBoth ThuLEP and PKRP can relieve lower urinary tract symptoms effectively and safely. ThuLEP is statistically superior to PKRP in blood loss, catheterization time, irrigated volume and hospital stay, but inferior to PKRP in operation time. There are no significant differences in terms of Qmax, IPSS, PVR, and QoLS between the two approaches.
benign prostatic hyperplasia; plasma; thulium laser; transurethral resection of the prostate
2016-06-09
2016-08-30
王行環(huán),主任醫(yī)師,教授,博士生導(dǎo)師.
E-mail:wangxinghuan@whu.edu.cn.
楊中華(1977-),男(漢族),主治醫(yī)師,博士.研究方向:泌尿男生殖系疾病.E-mail:yangzhonghua@whu.edu.cn.
R699
ADOI:10.3969/j.issn.1009-8291.2016.10.007