卡介苗聯合化療藥物交替膀胱灌注預防表淺性膀胱癌TURB-t術后復發的系統評價_《中國循證醫學雜志》

作者：

王宇 ¹ ,  魏強 ² , 曾浩 ² , 羅睿 ¹ , 劉華渝 ¹

1. 四川大學華西臨床醫學院（成都 610041）2. 四川大學華西醫院泌尿外科;

關鍵詞：

表淺性膀胱癌膀胱灌注卡介苗化療藥物系統評價

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目的　系統評價卡介苗聯合化療藥物交替膀胱灌注與單用卡介苗膀胱灌注預防表淺性膀胱癌 TURB-t 術后復發的臨床療效和不良反應。
方法　電子檢索PubMed （1950～2006.12）﹑OVID （1966～ 2006.12）﹑EMbase （1984～ 2006.12）﹑Cochrane 圖書館（2006 年第 4 期 )、中國生物醫學文獻數據庫（1978 ～ 2006）和維普中文科技期刊數據庫（1989 ～ 2006），并手工檢索已發表和未發表文獻，納入卡介苗聯合化療藥物交替膀胱灌注預防表淺性膀胱癌 TURB-t 術后復發的隨機對照試驗，按 Cochrane 系統評價方法對納入研究進行質量評價，并采用RevMan4.2.9 軟件進行 Meta 分析。
結果　共納入 4 個隨機對照試驗，包括 681例表淺性膀胱癌患者。Meta 分析結果顯示，卡介苗聯合化療藥物交替膀胱灌注與單用卡介苗膀胱灌注相比，① 對于 Ta 和 T1 期表淺性膀胱癌，復發率差異有統計學意義［RR合并 0.69，95%CI（0.53，0.90）］；② 對于 Tis期表淺性膀胱癌，復發率差異無統計學意義［RR 1.22， 95%CI（0.97，1.54）］；③ 不良反應發生率差異無統計學意義［RR合并 0.85，95%CI（0.70， 1.03）］。
結論　卡介苗聯合化療藥物交替膀胱灌注與單用卡介苗膀胱灌注相比，對于 Ta 和 T1 期表淺性膀胱癌，前者能有效降低TURB-t 術后腫瘤復發率；對于Tis 期膀胱癌，兩者在 TURB-t術后腫瘤復發率差異無統計學意義；在副作用發生率方面，兩者差異也無統計學意義。但由于本系統評價納入研究數量少，且存在選擇偏倚、實施偏倚以及發表偏倚的中度可能性，很可能影響結果的可靠性，故應謹慎看待以上結論，期待更多高質量的隨機對照試驗提供更可靠的證據。

引用本文： 王宇,魏強,曾浩,羅睿,劉華渝. 卡介苗聯合化療藥物交替膀胱灌注預防表淺性膀胱癌TURB-t術后復發的系統評價. 中國循證醫學雜志, 2007, 07(9): 650-657. doi: 復制

1.	Lum BL, Torti FM. Adjuvant intravesical pharmacology for superficial bladder cancer. J Natl Cancer Inst, 1991, 83(10): 682-694.
2.	Tolley DA, Hargreave TB, Smith PH, et al. Effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: interim report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). Br Med J, 1988, 296(6639): 1759-1761.
3.	Melekos MD, Dauaher H, Fokaefs E, et al. Intravesical instillations of 4-epi-doxorubicin (epirubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study. J Urol, 1992, 147(2): 371-375.
4.	Oosterl inck W, Kurth KH, Schroder F, et al. A prospective European Organization for Research and Treatment of Cancer Genitourinary Group. Randomized trial comparing transurethral resection followed by a single intravesical instillation of epirubicin or water in single stage Ta, T1 papillary carcinoma of the bladder. J Urol, 1993, 149(4): 749-752.
5.	Martinez-Pineiro JA, Leon J, Martinez-Pineiro LJr. Bacillus Calmette-Guerin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol, 1990, 143(3): 502-506.
6.	Carl L, Bo Johan N, Peter E, et al. A randomized prospective study comparing long-term intravesical instillations of mitomycin C and bacillus Calmette-Guerin in patients with superficial bladder carcinoma. J Urol, 1996, 156(2): 368-376.
7.	Adrian PM, van der Meijden, Brausi M, et al. Intravesical instillation of epirubicin, bacillus Calmette-Guerin and bacillus Calmette-Guerin plus isoniazid for intermediate and high risk Ta, T1 papillary carcinoma of the bladder: a European Organization for Researchand Treatment of Cancer Genitourinary Group Randomized Phase III Trial. J Urol, 2001, 166: 476-481.
8.	Lamm DL, van der Meijden PM, Morales A, et al. Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol, 1992, 147(3): 596-600.
9.	Koya MP, Simon MA, Soloway MS. Complications of intravesical therapy for urothelial cancer of the bladder. J Urol, 2006, 175(6): 2004-2010.
10.	Higgins J, Green S, editors. Cochrane Handbook for SystematicReviews of Interventions 4.2.6[updated month year]. In: The Cochrane Library, Issue 4, 2006. Chichester: Wiley. Updated quarterly.
11.	Montie JE. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. J Urol, 2006, 176(2): 507-508.
12.	Di Stasi SM, Giannantoni A, Giuriol i A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. Urologic Oncology, 2006, 24(3): 271-272.
13.	Kamat AM, Col in PN. A combination of intravesical and BCG electromotive mitomycin for high-risk superficial bladder cancer. Nat Clin Pract Urol, 2006, 3(9): 472-473.
14.	Rintala E, Jauhiainen K, Rajala P, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for carcinoma in situ of the bladder. The Finnbladder Group. J Urol, 1995, 154(6): 2050-2053.
15.	Jauhiainen K, Rintala E. Superficial urinary bladder cancer. Results from the Finnbladder studies and a review on instillation treatments. Ann Chir Gynaecol Suppl, 1993, 206: 31-38.
16.	Jauhiainen KE, Alfthan OS. Instillation therapy in superficial urinary bladder cancer. Finnbladder Group. Scand J Urol Nephrol Suppl, 1991, 138: 179-185.
17.	Al i-El-Dein B, Sarhan O, Hinev A, et al Superficial bladder tumors: analysis of prognostic factors and construction of a predictive index. BJU International, 2003, 92: 393-399.
18.	Witjes JA, Caris CTM, Mungan NA, et al. Results of a randomized phase III trial of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin versus mitomycin C alone in patients with superficial bladder cancer. J Urol, 1998, 160(5): 1668-1671.
19.	Rintala E, Jauhiainen K, Rajala P, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for caicinoma in situ of the bladder. J Urol, 1995, 154(6): 2050-2053.
20.	Rintala E, Jauhiainen K, Kaasinen E, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation prophylaxis for recurrent papillary (stages Ta to T1) superficial bladder cancer. J Urol, 1996, 156(1): 56-59.
21.	Al i-El-Dein B, Nabeeh A, Ismail EH, et al. Sequential bacillus Calmette-Guerin and epirubicin versus bacillus Calmette-Guerin alone for superficial bladder tumors: a randomized prospective study. J Urol, 1999, 162(2): 339-342.
22.	Bilen CY, Ozen H, Aki FT, et al. Clinical experience with BCG alone versus BCG plus epirubicin. Int J Urol, 2000, 7(6): 206-209.
23.	Kaasinen E, Wijkstrom H, Malmstrom PU, et al. Alternating mitomycin C and BCG instillations versus BCG alone in treatment of carcinoma in situ of the urinary bladder: a nordic study. Eur Urol, 2003, 43(6): 637-645.
24.	Di Stasi SM, Giannantoni A, Giuriol i A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. The lancet oncology, 2006, 7(1): 43-51.
25.	Bohle A, Brandau S. Immune mechanisms in bacillus Calmette-Guerin immunotherapy fou superficial bladder cancer. J Urol, 2003, 170: 964-969.
26.	Wolf H, Melsen F, Pedersen SE, et al. Natural history of carcinoma in situ of the urinary bladder. Scand J Urol Nephrol, 1994, 157(suppl): 147.
27.	Sarosdy MF. Management of high grade superficial bladder cancer: role of BCG. AUA Update Series, 1998, 17(12): 90.
28.	Utz DC, Hanash K A, Farrow GM. The pl ight of the patient with carcinoma of the bladder. Trans Am Assoc Genitourin Surg, 1969, 61: 90-100.

1. Lum BL, Torti FM. Adjuvant intravesical pharmacology for superficial bladder cancer. J Natl Cancer Inst, 1991, 83(10): 682-694.
2. Tolley DA, Hargreave TB, Smith PH, et al. Effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: interim report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). Br Med J, 1988, 296(6639): 1759-1761.
3. Melekos MD, Dauaher H, Fokaefs E, et al. Intravesical instillations of 4-epi-doxorubicin (epirubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study. J Urol, 1992, 147(2): 371-375.
4. Oosterl inck W, Kurth KH, Schroder F, et al. A prospective European Organization for Research and Treatment of Cancer Genitourinary Group. Randomized trial comparing transurethral resection followed by a single intravesical instillation of epirubicin or water in single stage Ta, T1 papillary carcinoma of the bladder. J Urol, 1993, 149(4): 749-752.
5. Martinez-Pineiro JA, Leon J, Martinez-Pineiro LJr. Bacillus Calmette-Guerin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol, 1990, 143(3): 502-506.
6. Carl L, Bo Johan N, Peter E, et al. A randomized prospective study comparing long-term intravesical instillations of mitomycin C and bacillus Calmette-Guerin in patients with superficial bladder carcinoma. J Urol, 1996, 156(2): 368-376.
7. Adrian PM, van der Meijden, Brausi M, et al. Intravesical instillation of epirubicin, bacillus Calmette-Guerin and bacillus Calmette-Guerin plus isoniazid for intermediate and high risk Ta, T1 papillary carcinoma of the bladder: a European Organization for Researchand Treatment of Cancer Genitourinary Group Randomized Phase III Trial. J Urol, 2001, 166: 476-481.
8. Lamm DL, van der Meijden PM, Morales A, et al. Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol, 1992, 147(3): 596-600.
9. Koya MP, Simon MA, Soloway MS. Complications of intravesical therapy for urothelial cancer of the bladder. J Urol, 2006, 175(6): 2004-2010.
10. Higgins J, Green S, editors. Cochrane Handbook for SystematicReviews of Interventions 4.2.6[updated month year]. In: The Cochrane Library, Issue 4, 2006. Chichester: Wiley. Updated quarterly.
11. Montie JE. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. J Urol, 2006, 176(2): 507-508.
12. Di Stasi SM, Giannantoni A, Giuriol i A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. Urologic Oncology, 2006, 24(3): 271-272.
13. Kamat AM, Col in PN. A combination of intravesical and BCG electromotive mitomycin for high-risk superficial bladder cancer. Nat Clin Pract Urol, 2006, 3(9): 472-473.
14. Rintala E, Jauhiainen K, Rajala P, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for carcinoma in situ of the bladder. The Finnbladder Group. J Urol, 1995, 154(6): 2050-2053.
15. Jauhiainen K, Rintala E. Superficial urinary bladder cancer. Results from the Finnbladder studies and a review on instillation treatments. Ann Chir Gynaecol Suppl, 1993, 206: 31-38.
16. Jauhiainen KE, Alfthan OS. Instillation therapy in superficial urinary bladder cancer. Finnbladder Group. Scand J Urol Nephrol Suppl, 1991, 138: 179-185.
17. Al i-El-Dein B, Sarhan O, Hinev A, et al Superficial bladder tumors: analysis of prognostic factors and construction of a predictive index. BJU International, 2003, 92: 393-399.
18. Witjes JA, Caris CTM, Mungan NA, et al. Results of a randomized phase III trial of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin versus mitomycin C alone in patients with superficial bladder cancer. J Urol, 1998, 160(5): 1668-1671.
19. Rintala E, Jauhiainen K, Rajala P, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for caicinoma in situ of the bladder. J Urol, 1995, 154(6): 2050-2053.
20. Rintala E, Jauhiainen K, Kaasinen E, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation prophylaxis for recurrent papillary (stages Ta to T1) superficial bladder cancer. J Urol, 1996, 156(1): 56-59.
21. Al i-El-Dein B, Nabeeh A, Ismail EH, et al. Sequential bacillus Calmette-Guerin and epirubicin versus bacillus Calmette-Guerin alone for superficial bladder tumors: a randomized prospective study. J Urol, 1999, 162(2): 339-342.
22. Bilen CY, Ozen H, Aki FT, et al. Clinical experience with BCG alone versus BCG plus epirubicin. Int J Urol, 2000, 7(6): 206-209.
23. Kaasinen E, Wijkstrom H, Malmstrom PU, et al. Alternating mitomycin C and BCG instillations versus BCG alone in treatment of carcinoma in situ of the urinary bladder: a nordic study. Eur Urol, 2003, 43(6): 637-645.
24. Di Stasi SM, Giannantoni A, Giuriol i A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. The lancet oncology, 2006, 7(1): 43-51.
25. Bohle A, Brandau S. Immune mechanisms in bacillus Calmette-Guerin immunotherapy fou superficial bladder cancer. J Urol, 2003, 170: 964-969.
26. Wolf H, Melsen F, Pedersen SE, et al. Natural history of carcinoma in situ of the urinary bladder. Scand J Urol Nephrol, 1994, 157(suppl): 147.
27. Sarosdy MF. Management of high grade superficial bladder cancer: role of BCG. AUA Update Series, 1998, 17(12): 90.
28. Utz DC, Hanash K A, Farrow GM. The pl ight of the patient with carcinoma of the bladder. Trans Am Assoc Genitourin Surg, 1969, 61: 90-100.

《中國循證醫學雜志》

卡介苗聯合化療藥物交替膀胱灌注預防表淺性膀胱癌TURB-t術后復發的系統評價

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《中國循證醫學雜志》

卡介苗聯合化療藥物交替膀胱灌注預防表淺性膀胱癌TURB-t術后復發的系統評價

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