纳米银抗菌剂治疗阴道炎的随机对比性临床研究
摘要
目的：观察纳米银抗菌剂(商品名为阿希米，asimi)治疗各种阴道炎的效果。方法：采用随机对比性临床研究，对400名患有各种类型阴道炎的妇女进行临床观察，将纳米银的治疗效果与目前常用的各类治疗阴道炎的药物的疗效进行比较，比较项目包括：症状、体征、实验室检查、患者对于药物的感受等方面的情况。结果：纳米银对滴虫性阴道炎、念珠菌性阴道炎、细菌性阴道病、其它类型阴道炎的治疗有效率分别为75.47％，93.62％，79.17％，95.35％。纳米银对支原体感染的有效率为68.1％，转阴率为15.38％，对衣原体感染的有效率为88.2％，转阴率73.68％。纳米银治疗后支原体感染定量值降低情况优于常规组。纳米银对滴虫性阴道炎、念珠菌性阴道炎、细菌性阴道病的治疗效果与常规药相比没有显著性差异，对其它类型阴道炎的治疗效果优于常规药物。患者对于纳米银的治疗感受优于常规药物。结论：纳米银抗菌剂治疗阴道炎是一种安全、有效、广谱、不易产生耐药、易于为患者接受的治疗方法，其优势在于在无完善的实验室检查下仍可对患者进行治疗，并可作为支原体、衣原体感染预防和治疗的局部用药。
OBJECTIVE: The aim of the present study was to observe the curative effect of asimi to vaginitis. METHODS: Random-controled clinical study. 400 women with various kinds of vaginitis were bring into the study. Compare the curative effect of asimi with medicine for vaginitis in common use. Observe their effect to symptom, physical examination and laboratory examination, after curative patients were asked to answer their recept to the medicine they were used. RESULTS: The efficient of asimi to trichomonas vaginalis, Candida vaginitis, bacterial vaginosis, other vaginitis were 75. 47%, 93.62%, 79.17%, 95. 35%. The efficient of asimi to chlamydia trachomatis was 68.1%, the turned negative ratio was 73.68%. The efficient of asimi to ureaplsma urealyticum was 88.2%, the turned negative ratio was 15.38%. The curative effect of asimi to chlamydia trachomatis and ureaplsma urealyticum was better than medicine for vaginitis in common use. The treatment results of the two groups of trichomonas vaginalis, Candida vaginitis, bacterial vaginosis had no evidence different, but to other vaginitis group asimi's curative effect was better than medicine in commun use. CNCLUSION: Use asimi to deal with vaginitis was a safety, effective, easy to be accepteded therapy. The virtue of asimi was that it can used directly to those patients whom hadn't had any laboratory examination, and could be used as the curative or defend medicine of ureaplsma urealyticum and chlamydia trachomatis infection .
OBJECTIVE: The aim of the present study was to observe the curative effect of asimi to vaginitis. METHODS: Random-controled clinical study. 400 women with various kinds of vaginitis were bring into the study. Compare the curative effect of asimi with medicine for vaginitis in common use. Observe their effect to symptom, physical examination and laboratory examination, after curative patients were asked to answer their recept to the medicine they were used. RESULTS: The efficient of asimi to trichomonas vaginalis, Candida vaginitis, bacterial vaginosis, other vaginitis were 75. 47%, 93.62%, 79.17%, 95. 35%. The efficient of asimi to chlamydia trachomatis was 68.1%, the turned negative ratio was 73.68%. The efficient of asimi to ureaplsma urealyticum was 88.2%, the turned negative ratio was 15.38%. The curative effect of asimi to chlamydia trachomatis and ureaplsma urealyticum was better than medicine for vaginitis in common use. The treatment results of the two groups of trichomonas vaginalis, Candida vaginitis, bacterial vaginosis had no evidence different, but to other vaginitis group asimi's curative effect was better than medicine in commun use. CNCLUSION: Use asimi to deal with vaginitis was a safety, effective, easy to be accepteded therapy. The virtue of asimi was that it can used directly to those patients whom hadn't had any laboratory examination, and could be used as the curative or defend medicine of ureaplsma urealyticum and chlamydia trachomatis infection .
引文
1. Vukicevic J, Jankicevic J. Therapeutic aspects of trichomoniasis Srp Arh Celok Lek. 2003 Mar-Apr; 131(3-4): 156-161.
2. Schwebke JR. Gynecologic consequences of bacterial vaginosis. Obstet Gynecol Clin North Am. 2003 Dec; 30(4): 685-694.
3. Simms I, Eastick K, Mallinson H. Associations between Mycoplasma genitalium, Chlamydia trachomatis and pelvic inflammatory disease. J Clin Pathol. 2003 Aug; 56(8): 616-618.
4．柯雪琴；范雪瑾．城市已婚女性STD常见菌种感染现状 中国初级卫生保健 2002．05．10；16(5)：26-27
5. Berry JA, Biedlingmaier JF. Whelan PJ. In vitro resistance to bacterial biofilm formation on coated fluoroplastic tympanostomy tubes. Otolaryngol Head Neck Surg. 2000 Sep; 123(3): 246-251.
6. Demling RH, DeSanti L. Effects of silver on wound management. Wounds 2001; 13(1 suppl A): 1-15
7. Mulligan AM, Wilson M, Knowles JC. Effect of increasing silver content in phosphate-based glasses on biofilms of Streptococcus sanguis. J Biomed Mater Res. 2003 Nov 1; 67A(2): 401-412.
8. Nand S, Sengar GK, Jain VK. Dual use of silver for management of chronic bone infections and infected non-unions. J Indian Med Assoc. 1996 Mar;94(3):91-95.
9. Gray JE, Norton PR, Alnouno R. Biological efficacy of electroless-deposited silver on plasma activated polyurethane.Biomaterials.2003
Jul;24(16):2759-2765.
10. Crabtree JH, Burchette RJ, Siddiqi RA The efficacy of silver-ion implanted catheters in reducing peritoneal dialysis-related infections. Petit Dial Int. 2003 Jul-Aug;23(4):368-374.
11. Kawahara K, Tsuruda K, Morishita M Antibacterial effect of silver-zeolite on oral bacteria under anaerobic conditions. Dent Mater. 2000 Nov;16(6):452-455.
12. Bosetti M, Masse A, Tobin E. Silver coated materials for external fixation devices: in vitro biocompatibility and genotoxicity. Biomaterials. 2002 Feb;23(3):887-892.
13. The Silver Institute, Washington DC. Silver, the healthful metal. Dec 31, 1999.
14. Mi FL, Wu YB, Shyu SS, Control of wound infections using a bilayer chitosan wound dressing with sustainable antibiotic delivery. J Biomed Mater Res. 2002 Mar 5;59(3):438-449.
15. Lansdown AB. Silver.I: Its antibacterial properties and mechanism of action. J Wound Care. 2002 Apr; 11(4): 125-130.
16. Tsyba I, Mui BB, Bau R, Noguchi R, Nomiya K. Synthesis and structure of a water-soluble hexanuclear silver(Ⅰ) nicotinate cluster comprised of a "cyclohexane-chair"-type of framework, showing effective antibacterial and antifungal activities: use of "sparse matrix" techniques for growing crystals of water-soluble inorganic complexes. Inorg Chem. 2003 Dec 1;42(24):8028-8032.
17．曹泽毅主编．中华妇产科学 第一版 北京：人民卫生出版社
1991. 1205
18. Edwards L. The diagnosis and treatment of infectious vaginitis. Dermatol Ther. 2004;17(1):102-110.
19. Anderson MR, Klink K, Cohrssen A. Evaluation of vaginal complaints. JAMA.2004 Mar 17;291(11):1368-1379.
20. Alderete JF, Benchimol M, Lehker MW. The complex fibronectin--Trichomonas vaginalis interactions and Trichomonosis. Parasitol Int. 2002 Sep;51(3):285-292.
21. Swygard H, Sena AC, Hobbs MM. Trichomoniasis: clinical manifestations, diagnosis and management. Sex Transm Infect. 2004 Apr;80(2):91-95.
22. Chen WL, Chen JF, Zhong XR. Ultrastructural and immunohistochemical studies on Trichomonas vaginalis adhering to and phagocytizing genitourinary epithelial cells. Chin Med J (Engl). 2004 Mar; 117(3):376-381.
23. Lubick KJ, Burgess DE. Purification and analysis of a phospholipase A2-like lytic factor of Trichomonas vaginalis. Infect Immun. 2004 Mar;72(3): 1284-90.
24. Dunne RE, Dunn LA, Upcroft P. Drug resistance in the sexually transmitted protozoan Trichomonas vaginalis. Cell Res. 2003 Aug; 13(4):239-249.
25. James R.Johnson, Parissa Delavari, Miguel Azar. Activities of a Nitrofurazone-Containing Urinary Catheter and a Silver Hydrogel Catheter against Multidrug-Resistant Bacteria Characteristic of Catheter-Associated Urinary Tract Infection Antimicrob Agents and Chemother, Dec 1999, 43(12) 2990-2995.
26. Martinez A, Ferrer S, Santos I. Antifungal activities of two new azasordarins,
GW471552 and GW471558, in experimental models of oral and vulvovaginal candidiasis in immunosuppressed rats. Antimicrob Agents Chemother. 2001 Dec;45(12):3304-3309.
27. Wormley FL Jr, Cutright J, Fidel PL Jr. Multiple experimental designs to evaluate the role of T-cell-mediated immunity against experimental vaginal Candida albicans infection. Meal Mycol. 2003 Oct;41(5):401-409.
28. Kelly KA, Gray HL, Walker JC. Chlamydia trachomatis infection does not enhance local cellular immunity against concurrent Candida vaginal infection. Infect Immun. 2001 May;69(5):3451-3454.
29. Marrazzo J. Vulvovaginal candidiasis. BMJ. 2002 Sep 14;325(7364):586.
30. Demirezen S. Bacterial vaginitis: general overview. Mikrobiyol Bul. 2003 Jan;37(1):99-104.
31. Guaschino S. Complications of sexually transmitted diseases: clinical course and treatment Ann Ist Super Sanita. 2000;36(4):431-435.
32. Olmsted SS, Meyn LA, Rohan LC. Glycosidase and proteinase activity of anaerobic gram-negative bacteria isolated from women with bacterial vaginosis. Sex Transm Dis. 2003 Mar;30(3):257-261.
33. Cherpes TL, Meyn LA, Krohn MA. Association between acquisition of herpes simplex virus type 2 in women and bacterial vaginosis. Clin Infect Dis. 2003 Aug 1;37(3):319-325.
34. Harwell JI, Moench T, Mayer KH. A pilot study of treatment of bacterial vaginosis with a buffering vaginal microbicide. J Womens Health (Larchmt). 2003 Apr;12(3):255-259.
35. Judlin P. Genital mycoplasmas Gynecol Obstet Fertil. 2003 Nov;31(11):954-9.
36. van der Schee C, Sluiters HJ, van der Meijden WI. Host and pathogen interaction during vaginal infection by Trichomonas vaginalis and Mycoplasma hominis or Ureaplasma urealyticum. J Microbiol Methods.2001 May;45(1):61-7.
37. Guaschino S. Complications of sexually transmitted diseases: clinical course and treatment Ann Ist Super Sanita.2000;36(4):431-5
38．陆春、朱国兴 子宫颈淋球菌、解脲支原体、人型支原体和沙眼衣原体感染1866例分析 中国实用妇科与产科杂志，2001．12．15，17(12)；729-730
39. Harlan D. Caldwell, Heidi Wood, Debbie Crane. Polymorphisms in Chlamydia trachomatis tryptophan synthase genes differentiate between genital and ocular isolates J Clin Invest. 2003 June 1; 111 (11): 1757-1769
40. Richard P. Morrison. New insights into a persistent problem--chlamydial infections J. Clin. Invest. 2003 111:1647-1649.
41．栗玉珍，姚军英，杨发枝．200例阴道炎、宫颈炎患者沙眼衣原体感染状况分析 哈尔滨医科大学学报．2003，37(6)；539-540
42．李楠．妇产科领域中沙眼衣原体感染 现代妇产科进展．1996，5；54-56
43. Berry LJ, Hickey DK, Skelding KA. Transcutaneous immunization with combined cholera toxin and CpG adjuvant protects against Chlamydia muridarum genital tract infection. Infect Immun. 2004 Feb;72(2):1019-28.
44. Joyee AG, Thyagarajan SP, Sowmya B, Venkatesan C, Ganapathy M.Need for specific & routine strategy for the diagnosis of genital chlamydial infection among patients with sexually transmitted diseases in India. Indian J Med Res.
2003 Oct;118:152-7.
45. Betsou F, Borrego MJ, Guillaume N. Cross-reactivity between Chlamydia trachomatis heat shock protein 10 and early pregnancy factor. Clin Diagn Lab Immunol. 2003 May; 10(3):446-50.
46．王荷英、施美琴172株解脲支原体的血清型分型研究 中华皮肤科杂志，1998，31(4)：224-225
47．张传福、姜文华 沙眼衣原体和支原体所引起的非淋菌性尿道炎和宫颈炎的临床资料分析 中国性病艾滋病防治，2000．10．26，6(5)：296-97
48．陆春、朱国兴 解脲支原体对子宫颈致病性的临床分析 临床皮肤科杂志，2002 3，31(3)，149-150
49. van der Schee C, Sluiters HJ, van der Meijden WI, Host and pathogen interaction during vaginal infection by Trichomonas vaginalis and Mycoplasma hominis or Ureaplasma urealyticum. J Microbiol Methods. 2001 May;45(1):61-7.
50. Judlin P. Genital mycoplasmas Gynecol Obstet Fertil. 2003 Nov;31(11):954-9.
2. Schwebke JR. Gynecologic consequences of bacterial vaginosis. Obstet Gynecol Clin North Am. 2003 Dec; 30(4): 685-694.
3. Simms I, Eastick K, Mallinson H. Associations between Mycoplasma genitalium, Chlamydia trachomatis and pelvic inflammatory disease. J Clin Pathol. 2003 Aug; 56(8): 616-618.
4．柯雪琴；范雪瑾．城市已婚女性STD常见菌种感染现状 中国初级卫生保健 2002．05．10；16(5)：26-27
5. Berry JA, Biedlingmaier JF. Whelan PJ. In vitro resistance to bacterial biofilm formation on coated fluoroplastic tympanostomy tubes. Otolaryngol Head Neck Surg. 2000 Sep; 123(3): 246-251.
6. Demling RH, DeSanti L. Effects of silver on wound management. Wounds 2001; 13(1 suppl A): 1-15
7. Mulligan AM, Wilson M, Knowles JC. Effect of increasing silver content in phosphate-based glasses on biofilms of Streptococcus sanguis. J Biomed Mater Res. 2003 Nov 1; 67A(2): 401-412.
8. Nand S, Sengar GK, Jain VK. Dual use of silver for management of chronic bone infections and infected non-unions. J Indian Med Assoc. 1996 Mar;94(3):91-95.
9. Gray JE, Norton PR, Alnouno R. Biological efficacy of electroless-deposited silver on plasma activated polyurethane.Biomaterials.2003
Jul;24(16):2759-2765.
10. Crabtree JH, Burchette RJ, Siddiqi RA The efficacy of silver-ion implanted catheters in reducing peritoneal dialysis-related infections. Petit Dial Int. 2003 Jul-Aug;23(4):368-374.
11. Kawahara K, Tsuruda K, Morishita M Antibacterial effect of silver-zeolite on oral bacteria under anaerobic conditions. Dent Mater. 2000 Nov;16(6):452-455.
12. Bosetti M, Masse A, Tobin E. Silver coated materials for external fixation devices: in vitro biocompatibility and genotoxicity. Biomaterials. 2002 Feb;23(3):887-892.
13. The Silver Institute, Washington DC. Silver, the healthful metal. Dec 31, 1999.
14. Mi FL, Wu YB, Shyu SS, Control of wound infections using a bilayer chitosan wound dressing with sustainable antibiotic delivery. J Biomed Mater Res. 2002 Mar 5;59(3):438-449.
15. Lansdown AB. Silver.I: Its antibacterial properties and mechanism of action. J Wound Care. 2002 Apr; 11(4): 125-130.
16. Tsyba I, Mui BB, Bau R, Noguchi R, Nomiya K. Synthesis and structure of a water-soluble hexanuclear silver(Ⅰ) nicotinate cluster comprised of a "cyclohexane-chair"-type of framework, showing effective antibacterial and antifungal activities: use of "sparse matrix" techniques for growing crystals of water-soluble inorganic complexes. Inorg Chem. 2003 Dec 1;42(24):8028-8032.
17．曹泽毅主编．中华妇产科学 第一版 北京：人民卫生出版社
1991. 1205
18. Edwards L. The diagnosis and treatment of infectious vaginitis. Dermatol Ther. 2004;17(1):102-110.
19. Anderson MR, Klink K, Cohrssen A. Evaluation of vaginal complaints. JAMA.2004 Mar 17;291(11):1368-1379.
20. Alderete JF, Benchimol M, Lehker MW. The complex fibronectin--Trichomonas vaginalis interactions and Trichomonosis. Parasitol Int. 2002 Sep;51(3):285-292.
21. Swygard H, Sena AC, Hobbs MM. Trichomoniasis: clinical manifestations, diagnosis and management. Sex Transm Infect. 2004 Apr;80(2):91-95.
22. Chen WL, Chen JF, Zhong XR. Ultrastructural and immunohistochemical studies on Trichomonas vaginalis adhering to and phagocytizing genitourinary epithelial cells. Chin Med J (Engl). 2004 Mar; 117(3):376-381.
23. Lubick KJ, Burgess DE. Purification and analysis of a phospholipase A2-like lytic factor of Trichomonas vaginalis. Infect Immun. 2004 Mar;72(3): 1284-90.
24. Dunne RE, Dunn LA, Upcroft P. Drug resistance in the sexually transmitted protozoan Trichomonas vaginalis. Cell Res. 2003 Aug; 13(4):239-249.
25. James R.Johnson, Parissa Delavari, Miguel Azar. Activities of a Nitrofurazone-Containing Urinary Catheter and a Silver Hydrogel Catheter against Multidrug-Resistant Bacteria Characteristic of Catheter-Associated Urinary Tract Infection Antimicrob Agents and Chemother, Dec 1999, 43(12) 2990-2995.
26. Martinez A, Ferrer S, Santos I. Antifungal activities of two new azasordarins,
GW471552 and GW471558, in experimental models of oral and vulvovaginal candidiasis in immunosuppressed rats. Antimicrob Agents Chemother. 2001 Dec;45(12):3304-3309.
27. Wormley FL Jr, Cutright J, Fidel PL Jr. Multiple experimental designs to evaluate the role of T-cell-mediated immunity against experimental vaginal Candida albicans infection. Meal Mycol. 2003 Oct;41(5):401-409.
28. Kelly KA, Gray HL, Walker JC. Chlamydia trachomatis infection does not enhance local cellular immunity against concurrent Candida vaginal infection. Infect Immun. 2001 May;69(5):3451-3454.
29. Marrazzo J. Vulvovaginal candidiasis. BMJ. 2002 Sep 14;325(7364):586.
30. Demirezen S. Bacterial vaginitis: general overview. Mikrobiyol Bul. 2003 Jan;37(1):99-104.
31. Guaschino S. Complications of sexually transmitted diseases: clinical course and treatment Ann Ist Super Sanita. 2000;36(4):431-435.
32. Olmsted SS, Meyn LA, Rohan LC. Glycosidase and proteinase activity of anaerobic gram-negative bacteria isolated from women with bacterial vaginosis. Sex Transm Dis. 2003 Mar;30(3):257-261.
33. Cherpes TL, Meyn LA, Krohn MA. Association between acquisition of herpes simplex virus type 2 in women and bacterial vaginosis. Clin Infect Dis. 2003 Aug 1;37(3):319-325.
34. Harwell JI, Moench T, Mayer KH. A pilot study of treatment of bacterial vaginosis with a buffering vaginal microbicide. J Womens Health (Larchmt). 2003 Apr;12(3):255-259.
35. Judlin P. Genital mycoplasmas Gynecol Obstet Fertil. 2003 Nov;31(11):954-9.
36. van der Schee C, Sluiters HJ, van der Meijden WI. Host and pathogen interaction during vaginal infection by Trichomonas vaginalis and Mycoplasma hominis or Ureaplasma urealyticum. J Microbiol Methods.2001 May;45(1):61-7.
37. Guaschino S. Complications of sexually transmitted diseases: clinical course and treatment Ann Ist Super Sanita.2000;36(4):431-5
38．陆春、朱国兴 子宫颈淋球菌、解脲支原体、人型支原体和沙眼衣原体感染1866例分析 中国实用妇科与产科杂志，2001．12．15，17(12)；729-730
39. Harlan D. Caldwell, Heidi Wood, Debbie Crane. Polymorphisms in Chlamydia trachomatis tryptophan synthase genes differentiate between genital and ocular isolates J Clin Invest. 2003 June 1; 111 (11): 1757-1769
40. Richard P. Morrison. New insights into a persistent problem--chlamydial infections J. Clin. Invest. 2003 111:1647-1649.
41．栗玉珍，姚军英，杨发枝．200例阴道炎、宫颈炎患者沙眼衣原体感染状况分析 哈尔滨医科大学学报．2003，37(6)；539-540
42．李楠．妇产科领域中沙眼衣原体感染 现代妇产科进展．1996，5；54-56
43. Berry LJ, Hickey DK, Skelding KA. Transcutaneous immunization with combined cholera toxin and CpG adjuvant protects against Chlamydia muridarum genital tract infection. Infect Immun. 2004 Feb;72(2):1019-28.
44. Joyee AG, Thyagarajan SP, Sowmya B, Venkatesan C, Ganapathy M.Need for specific & routine strategy for the diagnosis of genital chlamydial infection among patients with sexually transmitted diseases in India. Indian J Med Res.
2003 Oct;118:152-7.
45. Betsou F, Borrego MJ, Guillaume N. Cross-reactivity between Chlamydia trachomatis heat shock protein 10 and early pregnancy factor. Clin Diagn Lab Immunol. 2003 May; 10(3):446-50.
46．王荷英、施美琴172株解脲支原体的血清型分型研究 中华皮肤科杂志，1998，31(4)：224-225
47．张传福、姜文华 沙眼衣原体和支原体所引起的非淋菌性尿道炎和宫颈炎的临床资料分析 中国性病艾滋病防治，2000．10．26，6(5)：296-97
48．陆春、朱国兴 解脲支原体对子宫颈致病性的临床分析 临床皮肤科杂志，2002 3，31(3)，149-150
49. van der Schee C, Sluiters HJ, van der Meijden WI, Host and pathogen interaction during vaginal infection by Trichomonas vaginalis and Mycoplasma hominis or Ureaplasma urealyticum. J Microbiol Methods. 2001 May;45(1):61-7.
50. Judlin P. Genital mycoplasmas Gynecol Obstet Fertil. 2003 Nov;31(11):954-9.