头孢替坦二钠治疗急性膀胱炎、肾盂肾炎随机对照临床研究
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摘要
目的:评价头孢替坦二钠治疗急性膀胱炎、急性肾盂肾炎的有效性和安全性。
方法:采用随机、单盲(患者)、阳性药物平行对照试验设计,设试验组和对照组,试验组21例,采用头孢替坦二钠,对照组20例,采用已经上市的头孢美唑钠。用法均为中度感染2g/d,重度感染4g/d,分两次静脉滴注,疗程为7～10天。
结果:有效性结果表明:试验组与对照组在疗程结束时,临床有效率分别为80.00%和84. 21%。以上结果两组比较差异无统计学意义(P=0.732);细菌学评价:试验组与对照组细菌阳性率分别为55.00%和47.37%,细菌清除率分别为81.82%与77.78%。差异均无统计学意义(P>0.05)。安全性结果表明:试验组与对照组共发生4例不良反应,试验组2例,其中皮疹1例,转氨酶ALT升高1例,不良反应发生率为10.0%。对照组2例,其中转氨酶AST升高1例,胃肠道不适1例,不良反应发生率为13.33%。试验组与对照组不良反应发生率比较差异无统计学意义。上述不良反应中,除1例患者因皮疹退出外,其余患者均未影响疗程,且不良反应均为轻度,未给予特殊处理,随访均恢复正常。皮疹患者停药经对症处理恢复正常。
结论:头孢替坦二钠治疗急性膀胱炎、急性肾盂肾炎疗效肯定,不良反应较少,有望成为临床上治疗泌尿系感染的有效药物。
Objective: To evaluate the clinical efficacy and safety of cefotetan disodium in the treatment of acute cystitis and pyelonephritis.
Methods: A randomized, single-blind, controlled clinical trial was performed. The experimental group were treated with cefotetan disodium and the control group were treated with cefmetazole sodium. The dosages were 2g for moderate infection and 4g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days.
Results:At the end of the treatment, clinical efficacy rate of two groups were 80.00% and 84.21%. The values of two groups has no significant differences(P=0.732). Bacteriological evaluation: the positive rates of bacteria in the experimental group and the control group were 55.00% and 47.37% respectively, and bacterial eradication rates were 81.82% and 77.78%.There was no significant difference (P> 0.05).Safety results showed that in the experimental group, there were 2 cases of adverse reactions, 1 case of rash, another case of elevated alanine aminotransferase. The rate of adverse reaction was 10.0%. In the control group, there were 2 cases of adverse events, with 1 case of elevated aspartate aminotransferase, and with 1 case of gastrointestinal discomfort. The rate of adverse reaction rate was 13.33%. The incidence of adverse reactions in the two groups showed no statistical significance. These adverse events were mild and not given special treatment, except for 1 patient withdrawal due to rash; the course of treatment for remaining patients were not affected, and the follow-up were normal. The patient with rash was given symptomatic treatment and became normal after drug withdrawal.
Conclusion: Cefotetan disodium can be an effective treatment for acute cystitis and pyelonephritis. With fewer side effects, cefotetan disodium could be used for clinical use.
方法:采用随机、单盲(患者)、阳性药物平行对照试验设计,设试验组和对照组,试验组21例,采用头孢替坦二钠,对照组20例,采用已经上市的头孢美唑钠。用法均为中度感染2g/d,重度感染4g/d,分两次静脉滴注,疗程为7～10天。
结果:有效性结果表明:试验组与对照组在疗程结束时,临床有效率分别为80.00%和84. 21%。以上结果两组比较差异无统计学意义(P=0.732);细菌学评价:试验组与对照组细菌阳性率分别为55.00%和47.37%,细菌清除率分别为81.82%与77.78%。差异均无统计学意义(P>0.05)。安全性结果表明:试验组与对照组共发生4例不良反应,试验组2例,其中皮疹1例,转氨酶ALT升高1例,不良反应发生率为10.0%。对照组2例,其中转氨酶AST升高1例,胃肠道不适1例,不良反应发生率为13.33%。试验组与对照组不良反应发生率比较差异无统计学意义。上述不良反应中,除1例患者因皮疹退出外,其余患者均未影响疗程,且不良反应均为轻度,未给予特殊处理,随访均恢复正常。皮疹患者停药经对症处理恢复正常。
结论:头孢替坦二钠治疗急性膀胱炎、急性肾盂肾炎疗效肯定,不良反应较少,有望成为临床上治疗泌尿系感染的有效药物。
Objective: To evaluate the clinical efficacy and safety of cefotetan disodium in the treatment of acute cystitis and pyelonephritis.
Methods: A randomized, single-blind, controlled clinical trial was performed. The experimental group were treated with cefotetan disodium and the control group were treated with cefmetazole sodium. The dosages were 2g for moderate infection and 4g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days.
Results:At the end of the treatment, clinical efficacy rate of two groups were 80.00% and 84.21%. The values of two groups has no significant differences(P=0.732). Bacteriological evaluation: the positive rates of bacteria in the experimental group and the control group were 55.00% and 47.37% respectively, and bacterial eradication rates were 81.82% and 77.78%.There was no significant difference (P> 0.05).Safety results showed that in the experimental group, there were 2 cases of adverse reactions, 1 case of rash, another case of elevated alanine aminotransferase. The rate of adverse reaction was 10.0%. In the control group, there were 2 cases of adverse events, with 1 case of elevated aspartate aminotransferase, and with 1 case of gastrointestinal discomfort. The rate of adverse reaction rate was 13.33%. The incidence of adverse reactions in the two groups showed no statistical significance. These adverse events were mild and not given special treatment, except for 1 patient withdrawal due to rash; the course of treatment for remaining patients were not affected, and the follow-up were normal. The patient with rash was given symptomatic treatment and became normal after drug withdrawal.
Conclusion: Cefotetan disodium can be an effective treatment for acute cystitis and pyelonephritis. With fewer side effects, cefotetan disodium could be used for clinical use.
引文
1 . Warren JW, Abrutyne, Hebel JR Johnson JR, Schaeffer AJ, Stamm We: Guidelines for antimicrobial treatment of uncomplicated acute bacterial cystitis and acute pyelonephritis in women. Infectious diseases society of America(IDSA). Clin. Infect. Dis(1999) 29:745-758
2. Foxman B. Epidemiology of urinary tract infectiongs: incidence, morbidity, and economic costs. Am J Med, 2002, 113(Suppl 1A):5S-13S
3. Mazzulli T: Resistance trends in urinary tract pathogens and impact on management. J. Urol.(2002)168:1720-1722
4.Fales AC, Jones RN, Gordon KA et al: Activity and spectrum of 22 antimicrobial agents tested against urinary tract infection pathogens in hospitalized patients in Latin America: report from the second year of the SENTRY antimicrobial surveillance program(1998). J. Antimicrob Chemother. (2000)45:295-303
5. Ruden H, Gastmeier P, Daschner FD, Schumacher M: Nosocomial and community-acquired infections in Germany. Summary of the results of the first national prevalence study(NIDEP). Infection(1997)25:199-202
6.Maki DG, Tambyah PA: Engineering out the risk of infection with urinary catheters. Emerg. Infect. Dis.(2001)7:1-6
7.吴阶平主编.吴阶平泌尿外科学.济南:山东科学技术出版社,2004,25:553-576
8.斯崇文,贾辅忠,李家泰.感染病学.北京:人民卫生出版社,2004.1446-1447
9.那彦群,孙光,等.中国泌尿外科疾病诊断治疗指南.人民卫生出版社,2009,13:219-246
10.药品不良反应报告和监测管理办法.中华人民共和国卫生部.2004
11.陈孝平,石应康,邱贵兴,等.外科学.人民卫生出版社,2005,64:831-833
12. Wagenlehner FM, Weidner W, Perletti G, Naber KG. Emerging drugs for bacterial urinary tract infections. 2010 Sep;15(3):375-97
13. Shi S, Liu Y, Li Z, Zheng H, Lv Y, Chen H. Pharmacokinetics and tolerability of intravenous cefotetan disodium for injection in healthy Chinese volunteers: A randomized, open-label, single- and multiple-dose study. Clin Ther. 2010 Sep;32(10):1832-41
14.孙向飞,李娇,苟静,等.常用抗茵药的半衰期、达峰时间及合理使用分析.中国实用医药.2008,3(12):185-186
15. Martin C, Thomachot L, Albanese J. Clinical pharmacokinetics of cefotetan. Clin parmacokinet. 1994 Apr;26(4):248-58. Review
1. Foxman B. Epidemiology of urinary tract infectiongs: incidence, morbidity, and economic costs. Am J Med, 2002, 113(Suppl 1A):5S-13S
2. Hing E., Hall M.J., Xu J.: National health statistics reports. National hospital ambulatory medical care survey: 2006 outpatient department
3.王枢群.医院感染学.重庆:科学技术文献出版设重庆分社.1990:343
4.唐明忠,刘娟,王美荣.尿中大肠埃希氏菌耐药特性的调查.中华医院感染学杂志,1998,8:121
5. Griebling T.L.: Urologic diseases in America project: trends in resource use for urinary tract infections in women. J Urol 173. (4): 1281-1287.2005
6.周鹏,卢根生,张庆华,林吓聪.尿路感染致病菌分布及尿液pH值改变在临床防治中的作用.第三军医大学学报.2010,10:1099-03
7.吴阶平主编.吴阶平泌尿外科学.济南:山东科学技术出版社,2004,25:553-576
8. Schoong S,Whitfield H. Biofilms and their role in infections in urology. BJU Int,2000,86:935-941
9. Kahlmeter G.ECO.SENS.An international survey of antimicrobial susceptibility of pathogens from uncomplicated urinary tract infections: the ECO.SENS project.J Antimicrob Chemother,2003,51:69-76
10.Johns JR,Owens K,Gajewski A,et al. Bacterial characteristics in relation to clinical source of Escherichia coli isolates from women with acute cystilis or pyelonephritis and uninfected women.J Clin Microbiol,2005,43:6064-6072
11.许彩青,杨萍.复杂性尿路感染的致病菌分布及其耐药性分析.新医药,2005,36:91-92
12.黄锦坤,李逊,吴开俊,等.复杂性肾结石感染的菌谱、耐药谱分析.中国医药,2006,1:110-112
13.那彦群,孙光,等.中国泌尿外科疾病诊断治疗指南,2009,13:219-246)
14.刘振声,金大鹏,陈增辉.医院感染管理学[M].北京:军事医学科学出版社,2000:486-493
15.Nicolle LE. Catheter-related urinary tract infection. Drugs Aging,2005,22(8):627-639
16.Warren JW. Catheter-associated urinary tract infections. Int J Antimicrob Agents,2001,17(4):299-303
17.Sedor J, Mulholland SG. Hospital-associated urinary tract infections associated with the indwelling catheter. Urol Clin of North Am,1999,26:821-828
18.Rahav G, Pinco E,Silbgaq F,et al. Molecular epidemiology of catheter-associated bacteriuria in nursing home patients. J Clin Microbiol,1994,32(4):1031-1034
19. Maki DG, Tambyah PA. Engineering out the risk for infection with urinary catheters.Emerg Infect Dis. 2001,7(2):342-7
20. Maki DG, Knasinski V, Tambyah PA. Risk factors for catheter-associated urinary tract infection: a prospective study showing the minimal effects of catheter care violations on the risk of CAUTI[abstract]. Infect Control Hosp Epidemiol 2000;21:165
21. Platt R, Polk BF, Murdock B, Rosner B. Risk factors for nosocomial urinary tract infection. Am J Epidemiol 1986;124:977-85
22. Johnson JR, Roberts PL, Olsen RJ, Moyer KA, Stamm WE.Prevention of catheter-associated urinary tract infection with a silver oxide-coated urinary catheter: Clinical and microbiologic correlates. J Infect Dis 1990;162:1145-50
23. Riley DK, Classen DC, Stevens LE, Burke JP. A large randomized clinical trial of a silver-impregnated urinary catheter: Lack of efficacy and staphylococcal superinfection. Am J Med 1995;98:349-56
24.American College of Obstetricians and Gynecologists : ACOG Practice Bulletin No. 91: treatment of urinary tract infections in nonpregnant women. Obstet Gynecol 111. (3): 785-794.2008
25. Calogne N. Screening for asymptomatic bacteriuria in adults: U.S. Preventive Services Task Force reaffirmation recommendation statement. Ann Intern Med 149. (1): 43-47.2008
26. Grover M.L., Bracamonte J.D., Kanodia A.K., et al : Assessing adherence to evidence-based guidelines for the diagnosis and management of uncomplicated urinary tract infection. Mayo Clin Proc 82. (2): 181-185.2007
27.陈志英,叶任高.尿路感染的综合研究30年总结(成果综述).中山医科大学学报,1993,14(4):241-248
28. Wagenlehner F.M., Weidner W., Naber K.G. : An update on uncomplicated urinary tract infections in women. Curr Opin Urol 19. (4): 368-374.2009
29.阮艳梅.八正散加减治疗急性膀胱炎100例.时珍国医国药.2004,15,5
30.Rubin RH,Shapiro ED,Andriole VT,Davis RJ,Stamm WE.Evaluation of new anti-infective drugs for the treatment of urinary tract infection. Infectious Diseases Society of America and the Food and Drug Administration. Clin Infect Dis,1992,15(Suppl 1):216-227
31. Williams DH, Schaeffer AJ. Current concepts in urinary tract infections. MinervaUrolNefro, 2004, 56: 15-31
32.Nicolle L,AMMI Canada Guidelines Committee. Complicated urinary tract infection in adults. Can J Infect Dis Med Microbiol,2005,16:349-360
32.陈楠,陈晓农.复杂性尿路感染的诊断与治疗.中华全科医师杂志,2005,4:522-523
33.Neal DE Jr. Complicated urinary tract infections. Urol Clin North Am.2008,35:13-22
34.Ooi ST, Frazee LA, Gardner WG. Management of asymptomatic bacteriuria in patients with diabetes mellitus. Ann Pharmacother,2004,38:490-493
35.Edwards LE, Lock R, Powell C,et al.Post-catheterizaition urethral strictures. A clinical and experimental study. Br J Urol,1983,55(1):53-56
36.王俊霞.导尿相关尿路感染预防研究进展.齐齐哈尔医学院学报.2009,21:2673-2674
37.王慧琴,景继勇,兰美娟.膀胱冲洗护理对导尿管相关性尿路感染影响的Meta分析.中国实用护理杂志,2007,23:34-36
38.导尿管相关尿路感染预防与控制技术指南(试行).卫办医政发〔2010〕187号
39.Harding CK, Nicolle LE, Ronald AR, et al. How long should catheter-acquired urinary tract infection in women be treated? A randomized controlled study. Ann Intern Med, 1991,114(9):713-719
2. Foxman B. Epidemiology of urinary tract infectiongs: incidence, morbidity, and economic costs. Am J Med, 2002, 113(Suppl 1A):5S-13S
3. Mazzulli T: Resistance trends in urinary tract pathogens and impact on management. J. Urol.(2002)168:1720-1722
4.Fales AC, Jones RN, Gordon KA et al: Activity and spectrum of 22 antimicrobial agents tested against urinary tract infection pathogens in hospitalized patients in Latin America: report from the second year of the SENTRY antimicrobial surveillance program(1998). J. Antimicrob Chemother. (2000)45:295-303
5. Ruden H, Gastmeier P, Daschner FD, Schumacher M: Nosocomial and community-acquired infections in Germany. Summary of the results of the first national prevalence study(NIDEP). Infection(1997)25:199-202
6.Maki DG, Tambyah PA: Engineering out the risk of infection with urinary catheters. Emerg. Infect. Dis.(2001)7:1-6
7.吴阶平主编.吴阶平泌尿外科学.济南:山东科学技术出版社,2004,25:553-576
8.斯崇文,贾辅忠,李家泰.感染病学.北京:人民卫生出版社,2004.1446-1447
9.那彦群,孙光,等.中国泌尿外科疾病诊断治疗指南.人民卫生出版社,2009,13:219-246
10.药品不良反应报告和监测管理办法.中华人民共和国卫生部.2004
11.陈孝平,石应康,邱贵兴,等.外科学.人民卫生出版社,2005,64:831-833
12. Wagenlehner FM, Weidner W, Perletti G, Naber KG. Emerging drugs for bacterial urinary tract infections. 2010 Sep;15(3):375-97
13. Shi S, Liu Y, Li Z, Zheng H, Lv Y, Chen H. Pharmacokinetics and tolerability of intravenous cefotetan disodium for injection in healthy Chinese volunteers: A randomized, open-label, single- and multiple-dose study. Clin Ther. 2010 Sep;32(10):1832-41
14.孙向飞,李娇,苟静,等.常用抗茵药的半衰期、达峰时间及合理使用分析.中国实用医药.2008,3(12):185-186
15. Martin C, Thomachot L, Albanese J. Clinical pharmacokinetics of cefotetan. Clin parmacokinet. 1994 Apr;26(4):248-58. Review
1. Foxman B. Epidemiology of urinary tract infectiongs: incidence, morbidity, and economic costs. Am J Med, 2002, 113(Suppl 1A):5S-13S
2. Hing E., Hall M.J., Xu J.: National health statistics reports. National hospital ambulatory medical care survey: 2006 outpatient department
3.王枢群.医院感染学.重庆:科学技术文献出版设重庆分社.1990:343
4.唐明忠,刘娟,王美荣.尿中大肠埃希氏菌耐药特性的调查.中华医院感染学杂志,1998,8:121
5. Griebling T.L.: Urologic diseases in America project: trends in resource use for urinary tract infections in women. J Urol 173. (4): 1281-1287.2005
6.周鹏,卢根生,张庆华,林吓聪.尿路感染致病菌分布及尿液pH值改变在临床防治中的作用.第三军医大学学报.2010,10:1099-03
7.吴阶平主编.吴阶平泌尿外科学.济南:山东科学技术出版社,2004,25:553-576
8. Schoong S,Whitfield H. Biofilms and their role in infections in urology. BJU Int,2000,86:935-941
9. Kahlmeter G.ECO.SENS.An international survey of antimicrobial susceptibility of pathogens from uncomplicated urinary tract infections: the ECO.SENS project.J Antimicrob Chemother,2003,51:69-76
10.Johns JR,Owens K,Gajewski A,et al. Bacterial characteristics in relation to clinical source of Escherichia coli isolates from women with acute cystilis or pyelonephritis and uninfected women.J Clin Microbiol,2005,43:6064-6072
11.许彩青,杨萍.复杂性尿路感染的致病菌分布及其耐药性分析.新医药,2005,36:91-92
12.黄锦坤,李逊,吴开俊,等.复杂性肾结石感染的菌谱、耐药谱分析.中国医药,2006,1:110-112
13.那彦群,孙光,等.中国泌尿外科疾病诊断治疗指南,2009,13:219-246)
14.刘振声,金大鹏,陈增辉.医院感染管理学[M].北京:军事医学科学出版社,2000:486-493
15.Nicolle LE. Catheter-related urinary tract infection. Drugs Aging,2005,22(8):627-639
16.Warren JW. Catheter-associated urinary tract infections. Int J Antimicrob Agents,2001,17(4):299-303
17.Sedor J, Mulholland SG. Hospital-associated urinary tract infections associated with the indwelling catheter. Urol Clin of North Am,1999,26:821-828
18.Rahav G, Pinco E,Silbgaq F,et al. Molecular epidemiology of catheter-associated bacteriuria in nursing home patients. J Clin Microbiol,1994,32(4):1031-1034
19. Maki DG, Tambyah PA. Engineering out the risk for infection with urinary catheters.Emerg Infect Dis. 2001,7(2):342-7
20. Maki DG, Knasinski V, Tambyah PA. Risk factors for catheter-associated urinary tract infection: a prospective study showing the minimal effects of catheter care violations on the risk of CAUTI[abstract]. Infect Control Hosp Epidemiol 2000;21:165
21. Platt R, Polk BF, Murdock B, Rosner B. Risk factors for nosocomial urinary tract infection. Am J Epidemiol 1986;124:977-85
22. Johnson JR, Roberts PL, Olsen RJ, Moyer KA, Stamm WE.Prevention of catheter-associated urinary tract infection with a silver oxide-coated urinary catheter: Clinical and microbiologic correlates. J Infect Dis 1990;162:1145-50
23. Riley DK, Classen DC, Stevens LE, Burke JP. A large randomized clinical trial of a silver-impregnated urinary catheter: Lack of efficacy and staphylococcal superinfection. Am J Med 1995;98:349-56
24.American College of Obstetricians and Gynecologists : ACOG Practice Bulletin No. 91: treatment of urinary tract infections in nonpregnant women. Obstet Gynecol 111. (3): 785-794.2008
25. Calogne N. Screening for asymptomatic bacteriuria in adults: U.S. Preventive Services Task Force reaffirmation recommendation statement. Ann Intern Med 149. (1): 43-47.2008
26. Grover M.L., Bracamonte J.D., Kanodia A.K., et al : Assessing adherence to evidence-based guidelines for the diagnosis and management of uncomplicated urinary tract infection. Mayo Clin Proc 82. (2): 181-185.2007
27.陈志英,叶任高.尿路感染的综合研究30年总结(成果综述).中山医科大学学报,1993,14(4):241-248
28. Wagenlehner F.M., Weidner W., Naber K.G. : An update on uncomplicated urinary tract infections in women. Curr Opin Urol 19. (4): 368-374.2009
29.阮艳梅.八正散加减治疗急性膀胱炎100例.时珍国医国药.2004,15,5
30.Rubin RH,Shapiro ED,Andriole VT,Davis RJ,Stamm WE.Evaluation of new anti-infective drugs for the treatment of urinary tract infection. Infectious Diseases Society of America and the Food and Drug Administration. Clin Infect Dis,1992,15(Suppl 1):216-227
31. Williams DH, Schaeffer AJ. Current concepts in urinary tract infections. MinervaUrolNefro, 2004, 56: 15-31
32.Nicolle L,AMMI Canada Guidelines Committee. Complicated urinary tract infection in adults. Can J Infect Dis Med Microbiol,2005,16:349-360
32.陈楠,陈晓农.复杂性尿路感染的诊断与治疗.中华全科医师杂志,2005,4:522-523
33.Neal DE Jr. Complicated urinary tract infections. Urol Clin North Am.2008,35:13-22
34.Ooi ST, Frazee LA, Gardner WG. Management of asymptomatic bacteriuria in patients with diabetes mellitus. Ann Pharmacother,2004,38:490-493
35.Edwards LE, Lock R, Powell C,et al.Post-catheterizaition urethral strictures. A clinical and experimental study. Br J Urol,1983,55(1):53-56
36.王俊霞.导尿相关尿路感染预防研究进展.齐齐哈尔医学院学报.2009,21:2673-2674
37.王慧琴,景继勇,兰美娟.膀胱冲洗护理对导尿管相关性尿路感染影响的Meta分析.中国实用护理杂志,2007,23:34-36
38.导尿管相关尿路感染预防与控制技术指南(试行).卫办医政发〔2010〕187号
39.Harding CK, Nicolle LE, Ronald AR, et al. How long should catheter-acquired urinary tract infection in women be treated? A randomized controlled study. Ann Intern Med, 1991,114(9):713-719