膀胱灌注表阿霉素預防表淺性膀胱癌術后復發的系統評價_《中國循證醫學雜志》

作者：

彭國輝 , 魏強 , 關靜 , 韓平

四川大學華西醫院泌尿外科,成都,610041;

關鍵詞：

表阿霉素膀胱灌注表淺性膀胱癌經尿道膀胱腫瘤電切術系統評價

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目的　評價膀胱灌注表阿霉素預防表淺性膀胱癌術后復發的療效和副作用.
方法　按文內所述納入標準,參考Cochrane協作網工作手冊,計算機檢索Medline(1966～2002.9)、EMbase(1985～2002)、Cochrane Library(2002年第4期)和中國生物醫學文獻光盤數據庫(CBMdisc,1970～2002);手工檢索發表或未發表的文獻,包括 lt;中華泌尿外科雜志 gt;等12種雜志、中華泌尿外科學會組織的學術會議論文集(1990～2002)、美國AUA(1995～2002)、歐洲ECCO會議論文集(1995～2002)和北京大學等3所大學學位論文匯編等.文獻資料用統一的表格由兩名評價者獨立進行提取,采用Jadad質量計分法評價文獻質量,并應用Rev-man 4.2軟件進行數據處理與分析.
結果　共檢索到文獻213篇,經排查后,符合納入標準并進入系統評價的文獻共10篇,其中3篇屬于高質量RCT,其余為低質量RCT.Meta分析結果顯示:表阿霉素膀胱灌注加手術治療與單純手術比較,在1年未復發方面,RR合并=1.51,95%CI(1.32,1.72);在2年未復發方面,RR合并=1.49,95%CI(1.35,1.66);劑量＜50 mg/次的表阿霉素膀胱灌注,在術后復發預防方面,RR合并=1.34,95%CI(1.22,1.48);劑量＞50 mg/次的表阿霉素膀胱灌注,在術后復發預防方面,RR合并=1.63,95%CI(1.48,1.79);單次阿霉素膀胱灌注的術后1年未復發率,RR=1.49,95%CI(1.33,1.66),術后2年未復發率,RR=1.58,95%CI(1.36,1.84);表淺性膀胱癌術后疾病進展率:RR-0.79,95%CI(0.53,1.17);阿霉素膀胱灌注后的總副作用發生率:RR=4.34,95%CI(2.62,7.19).
結論　不同劑量的表阿霉素膀胱灌注均可降低表淺性膀胱癌術后復發率;單次表阿霉素膀胱灌注可以降低表淺性膀胱癌術后復發率,但應謹慎選擇病例;表阿霉素膀胱灌注對表淺性膀胱癌病情進展沒有影響;表阿霉素膀胱灌注可引起一些副作用,但可以耐受,不影響患者正常生活.

引用本文： 彭國輝,魏強,關靜,韓平. 膀胱灌注表阿霉素預防表淺性膀胱癌術后復發的系統評價. 中國循證醫學雜志, 2004, 04(6): 382-388. doi: 復制

1.	［25］Cumming JA, Kirk D, Newling DW. A multicentre phase Ⅱ study of intravesical EPI rubicin in the treatment of superficial bladder tumor[J]. Eur Urol, 1990;17(31) :20.
2.	［1］Lum BL, Torti. Adjuvant intravesical pharmacology for superficial bladder cancer[J]. Journal of the National Cancer Institute, 1991; 83:682-694.
3.	［2］Jerome P, Ricie MD. Intravesical chemotherapy treatment selection, techniques and results [J ]. Urological Clinics of North America,1992; 19(3): 521-527.
4.	［3］Arnling CL. Diagnosis and management of superficial bladder cancer[J], Curr Probl Cancer, 2001; 25(4): 219-278.
5.	［4］Mulrow CD, Oxman AD. The cochrane Collaboration hand book[ M]. Issue1, 2000, Oxford,Update Sofeware.
6.	［5］Jadad AR, Moore A, Carroll D. Assessing the quality of reports of randomized clinical trials: Is blinding necessary[J].Control Clin Trials, 1996; 17:1-12.
7.	［6］Kjaergard LL, Villumsen J, Gluud C. Quality of randomized clinical trials affects estimates of intervention efficacy[ A]. In:Vll Cochrane Colloquium [C], Rome 1999,p:57.
8.	［7］Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M.Does quality of reports of randomized trials affect estimates of intervention efficacy reported in meta-analyes [ J ]. Lancet. 1998; 352(21 ) :609-613.
9.	［8］Clarke M, Oxman AD. Editors. Cochrane Reviewers Handbook 4.0 [ updated July 1999 ]; Section 6 [ M ]. In: The Cochrane Library[ database on CD/ROM]. The Cochrane Collaboration. Oxford: Update Software, 2000: Issue 1.
10.	［9］Schulz KF, Chalmers I, Hayes R, Altman D. Empirical evidence of bias[J ]. JAMA, 1995; 273 (35) :408-412.
11.	［10］Vander Meijden AP, Kurth KH, Oosterlinck W. Intravesical therapy with adriamycin and 4-EPI rubicin for superficial bladder cancer: the experience of the EOR TC GU Group[J].Cancer Chemother Pharmacol, 1992; 30 (Suppl): S95-98.
12.	［11］Maekawa S, Suzuki H, Ohkubo K. Continuous intravesical instillation of EPI rubicin immediately after transurethral resection of superficial bladder cancer: a prospective controlled study[J]. Hinyokika Kiyo, 2000; 46(5): 301-306.
13.	［12］Aliel DB, el Baz M, Aly AN. Intravesical EPI rubicin versus doxorubicin for superficial bladder tumors (stages pTa and pT1 ): a randomized prospective study[J]. J Urol, 1997; 158(1): 68-74.
14.	［13］Aliel DB, Nabeeh A, el Baz M, et al. Single ～ dose versus multiple instillations of EPI rubicin as prophylaxis for recurrence after transurethral resection of pTa and pT1 transitionalcell bladder tumours: a prospective, randomized controlled study[J]. Br J Urol, 1997; 79(5): 731-735.
15.	［14］Hirao Y, Ozono S, Momose H. Prospective randomized study of prophylaxis of superficial bladder cancer with EPI rubicin: the role of a central pathology laboratory[J]. Cancer Chemother Pharmacol, 1994; 35 Suppl: S36-40.
16.	［15］Melekos MD, Dauaher H, Fokaefs E. Intravesical instillations of4-EPI-doxorubicin (EPI rubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study[J]. J Urol, 1992; 147(2): 371-375.
17.	［16］Melekos MD, Chionis HS, Paranychianakis GS. Intravesical 4-EPI-doxorubicin (EPI rubicin) versus bacillus Calmette-Guerin. A controlled prospective study on the prophylaxis of superficial bladder cancer[J]. Cancer, 1993; 72(5): 1 749-1755.
18.	［17］Okamura K, Murase T, Obata K. A randomized trial of early intravesical instillation ofEPI rubicin in uperficial bladder cancer[J]. Cancer ChemotherPharnacol, 1994; Suppl: S31-35.
19.	［18］Oosterlinck W, Kurth KH, Schroder F. A prospective European Organization for R.esearch and Treatment of Cancer Genitourinary Group randomized trial comparing transurethral resection followed by a single intravesical instillation of EPI rubicin or water in single stage Ta, T1 papillary carcinoma of the bladder[J]. J Urol, 1993; 149(4): 749-752.
20.	［19］Raitanen MP, Lukkarinen O. A controlled study of intravesical EPI rubicin with or without alpha 2b-interferon as prophylaxis for recurrent superficial transitonal cell carcinoma of the bladder. Finnish Multicentre Study Group [J ]. Br J Urol,1995; 76(6): 697-701.
21.	［20］Rajala P, Liukkonen T, Raitanen M. Transurethral resection with perioperative instilation on interferon ～ alpha or EPI rubicin for the prophylaxis of recurrent primary superficial bladder cancer: a prospective randomized multicenter study-Finnbladder III[J]. J Urol, 1999; 161(4): 1133-1136.
22.	［21］The Hokkaido University Bladder Cancer Collaborative Group. Prophylactic chemotherapy with anthracyclines ( adriamycin, EPI rubicin, and pirarubicin) for primary superficial bladder cancer[J]. Cancer Chemother Pharmacol, 1994; 35(Suppl): S41-45.
23.	［22］Cutler SJ, Heney NM, Friedell GH. Longitudinal studyofpatients with bladder cancer: fators associated with disease recurrence and progression [ M ] . AUA Monographs, Bladder Cancer. Press: Williams&Wilkis,vol. 1; chapt. 4, p. 35, 1982.
24.	［23］Heney NM, Ahmed S, Flanagan MJ. Superficial bladder cancer:progression and recurrence[J]. J urol,1983; 130:1 083-1 086.
25.	［24］Prout GR, Bassil B, Griffin P. The treated histories of patients with Ta grade 1 transitional-cell carcinoma of the bladder [J].Arch Surg,1986;121 (72) :1 463.

1. ［25］Cumming JA, Kirk D, Newling DW. A multicentre phase Ⅱ study of intravesical EPI rubicin in the treatment of superficial bladder tumor[J]. Eur Urol, 1990;17(31) :20.
2. ［1］Lum BL, Torti. Adjuvant intravesical pharmacology for superficial bladder cancer[J]. Journal of the National Cancer Institute, 1991; 83:682-694.
3. ［2］Jerome P, Ricie MD. Intravesical chemotherapy treatment selection, techniques and results [J ]. Urological Clinics of North America,1992; 19(3): 521-527.
4. ［3］Arnling CL. Diagnosis and management of superficial bladder cancer[J], Curr Probl Cancer, 2001; 25(4): 219-278.
5. ［4］Mulrow CD, Oxman AD. The cochrane Collaboration hand book[ M]. Issue1, 2000, Oxford,Update Sofeware.
6. ［5］Jadad AR, Moore A, Carroll D. Assessing the quality of reports of randomized clinical trials: Is blinding necessary[J].Control Clin Trials, 1996; 17:1-12.
7. ［6］Kjaergard LL, Villumsen J, Gluud C. Quality of randomized clinical trials affects estimates of intervention efficacy[ A]. In:Vll Cochrane Colloquium [C], Rome 1999,p:57.
8. ［7］Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M.Does quality of reports of randomized trials affect estimates of intervention efficacy reported in meta-analyes [ J ]. Lancet. 1998; 352(21 ) :609-613.
9. ［8］Clarke M, Oxman AD. Editors. Cochrane Reviewers Handbook 4.0 [ updated July 1999 ]; Section 6 [ M ]. In: The Cochrane Library[ database on CD/ROM]. The Cochrane Collaboration. Oxford: Update Software, 2000: Issue 1.
10. ［9］Schulz KF, Chalmers I, Hayes R, Altman D. Empirical evidence of bias[J ]. JAMA, 1995; 273 (35) :408-412.
11. ［10］Vander Meijden AP, Kurth KH, Oosterlinck W. Intravesical therapy with adriamycin and 4-EPI rubicin for superficial bladder cancer: the experience of the EOR TC GU Group[J].Cancer Chemother Pharmacol, 1992; 30 (Suppl): S95-98.
12. ［11］Maekawa S, Suzuki H, Ohkubo K. Continuous intravesical instillation of EPI rubicin immediately after transurethral resection of superficial bladder cancer: a prospective controlled study[J]. Hinyokika Kiyo, 2000; 46(5): 301-306.
13. ［12］Aliel DB, el Baz M, Aly AN. Intravesical EPI rubicin versus doxorubicin for superficial bladder tumors (stages pTa and pT1 ): a randomized prospective study[J]. J Urol, 1997; 158(1): 68-74.
14. ［13］Aliel DB, Nabeeh A, el Baz M, et al. Single ～ dose versus multiple instillations of EPI rubicin as prophylaxis for recurrence after transurethral resection of pTa and pT1 transitionalcell bladder tumours: a prospective, randomized controlled study[J]. Br J Urol, 1997; 79(5): 731-735.
15. ［14］Hirao Y, Ozono S, Momose H. Prospective randomized study of prophylaxis of superficial bladder cancer with EPI rubicin: the role of a central pathology laboratory[J]. Cancer Chemother Pharmacol, 1994; 35 Suppl: S36-40.
16. ［15］Melekos MD, Dauaher H, Fokaefs E. Intravesical instillations of4-EPI-doxorubicin (EPI rubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study[J]. J Urol, 1992; 147(2): 371-375.
17. ［16］Melekos MD, Chionis HS, Paranychianakis GS. Intravesical 4-EPI-doxorubicin (EPI rubicin) versus bacillus Calmette-Guerin. A controlled prospective study on the prophylaxis of superficial bladder cancer[J]. Cancer, 1993; 72(5): 1 749-1755.
18. ［17］Okamura K, Murase T, Obata K. A randomized trial of early intravesical instillation ofEPI rubicin in uperficial bladder cancer[J]. Cancer ChemotherPharnacol, 1994; Suppl: S31-35.
19. ［18］Oosterlinck W, Kurth KH, Schroder F. A prospective European Organization for R.esearch and Treatment of Cancer Genitourinary Group randomized trial comparing transurethral resection followed by a single intravesical instillation of EPI rubicin or water in single stage Ta, T1 papillary carcinoma of the bladder[J]. J Urol, 1993; 149(4): 749-752.
20. ［19］Raitanen MP, Lukkarinen O. A controlled study of intravesical EPI rubicin with or without alpha 2b-interferon as prophylaxis for recurrent superficial transitonal cell carcinoma of the bladder. Finnish Multicentre Study Group [J ]. Br J Urol,1995; 76(6): 697-701.
21. ［20］Rajala P, Liukkonen T, Raitanen M. Transurethral resection with perioperative instilation on interferon ～ alpha or EPI rubicin for the prophylaxis of recurrent primary superficial bladder cancer: a prospective randomized multicenter study-Finnbladder III[J]. J Urol, 1999; 161(4): 1133-1136.
22. ［21］The Hokkaido University Bladder Cancer Collaborative Group. Prophylactic chemotherapy with anthracyclines ( adriamycin, EPI rubicin, and pirarubicin) for primary superficial bladder cancer[J]. Cancer Chemother Pharmacol, 1994; 35(Suppl): S41-45.
23. ［22］Cutler SJ, Heney NM, Friedell GH. Longitudinal studyofpatients with bladder cancer: fators associated with disease recurrence and progression [ M ] . AUA Monographs, Bladder Cancer. Press: Williams&Wilkis,vol. 1; chapt. 4, p. 35, 1982.
24. ［23］Heney NM, Ahmed S, Flanagan MJ. Superficial bladder cancer:progression and recurrence[J]. J urol,1983; 130:1 083-1 086.
25. ［24］Prout GR, Bassil B, Griffin P. The treated histories of patients with Ta grade 1 transitional-cell carcinoma of the bladder [J].Arch Surg,1986;121 (72) :1 463.

《中國循證醫學雜志》

膀胱灌注表阿霉素預防表淺性膀胱癌術后復發的系統評價

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《中國循證醫學雜志》

膀胱灌注表阿霉素預防表淺性膀胱癌術后復發的系統評價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

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