替硝唑含片治療牙周炎和冠周炎的療效及安全性的隨機對照臨床試驗_《中國循證醫學雜志》

作者：

史宗道 ¹ , 周學東 ¹ , 王曉毅 ¹ , 丁一 ¹ , 徐屹 ¹ , 肖曉蓉 ¹ , 陳衛 ² , 劉關鍵 ³

1. 四川大學華西口腔醫院,成都,6100412. 深圳中聯制藥有限公司,深圳,5180043. 四川大學華西醫院循證醫學與臨床流行病學中心,成都,610041;

關鍵詞：

含片替硝唑牙周炎冠周炎隨機對照試驗雙盲

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目的　對替硝唑含片治療牙周炎和冠周炎的療效及安全性進行評價.
方法　試驗采用多中心、隨機、雙盲、平行對照臨床試驗設計方案.來自上海、杭州和成都的三個單位分別完成試驗樣本的1/3.試驗藥替硝唑含片(商品名津和(R))由申辦單位深圳市中聯制藥有限公司提供.陽性對照藥為國家食品藥品監督管理局已批準上市的替硝唑含片,均為每次含服5 mg,每日4次,療程6天.療效評定指標包括牙周炎、冠周炎病人的主觀癥狀和客觀體征,牙周炎病人還要評定牙齦指數、出血指數、菌斑指數和牙周袋深度.從牙周炎病人的病變牙菌斑、冠周炎病人的冠周分泌物取樣做需氧和厭氧培養,比較牙周和冠周可疑致病菌培養分離的結果.觀察和記錄不良事件,進行適當處理和隨訪.
結果　共157例符合納入標準,失訪14例(8.9%).遵循設計方案,受試者納入牙周炎109例(試驗組57、對照組52例),冠周炎34例(試驗組、對照組各17例).基線分析顯示兩組具有可比性.治療結束時復查,牙周炎試驗組與對照組牙齦出血85%以上明顯改善,牙齦疼痛、咬合疼痛均有減輕,兩組間差異無統計學意義(P＞0.05);牙周袋深度、出血指數、牙齦指數、菌斑指數均有減少,其差值的兩組間差異無統計學意義(P＞0.05).冠周炎病例60%以上獲得癥狀改善,75%以上冠周膿液消失,60%以上淋巴結腫大消退,張口度均有增加,兩組間差異無統計學意義(P＞0.05).以顯著改善及痊愈計算有效率,兩組均達到88.2%.治療前在牙周、冠周均可查到不同類型的可疑致病菌,而治療后復查發現大部分致病菌株消失或數量減少,兩組間差異無統計學意義(P＞0.05).治療前后在試驗組、對照組均未檢出白色念珠菌.在治療期間共有9例發生不良事件,其中試驗組與對照組分別為5例(6.8%)、4例(5.8%),兩組間比較無顯著差異,均為輕度一過性,不影響繼續用藥.
結論　深圳市中聯制藥有限公司研制的替硝唑含片(商品名津和(R))能有效抑制牙周炎、冠周炎常見病原菌,但不引起菌群失調;可減少牙周、冠周炎的癥的嚴重程度,促進其好轉或康復.不良反應少而輕微.其療效與國家食品藥品監督管理局已批準上市的替硝唑含片相當.

引用本文： 史宗道,周學東,王曉毅,丁一,徐屹,肖曉蓉,陳衛,劉關鍵. 替硝唑含片治療牙周炎和冠周炎的療效及安全性的隨機對照臨床試驗. 中國循證醫學雜志, 2005, 05(11): 811-817. doi: 復制

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2.	溫玉明, 李龍江. 口腔頜面部感染[J]. 見: 邱蔚六. 主編. 口腔頜面外科理論與實踐. 北京: 人民衛生出版社; 1998. 348～390.
3.	倪可夫, 來永勝, 陳莉麗, 朱仲珍, 何明灼. 替硝唑治療根尖周炎和成年人牙周炎的臨床觀察[J]. 浙江醫學, 1996; 18(1): 20～21.
4.	易新詮, 史宗道, 張蘊惠, 等. 替硝唑治療牙周炎和冠周的臨床療效觀察和評價[J]. 華西口腔醫學雜志, 1993; 11(4): 260.
5.	史宗道, 易新詮, 溫玉明. 替硝唑對冠周炎、牙周炎的療效及不良反應[J]. 武漢醫藥情報通訊, 1995; 11(4): 159～161.
6.	史宗道, 溫玉明, 易新詮, 章錦才. 國產替硝唑片劑的不良反應[J]. 中國新藥雜志, 1999; 8(2): 114～115.
7.	Zaat JO, Mark TG, Assendelft WJ. A systematic review on the treatment of giardiasis[J]. Trop Med Int Health, 1997; 2(1): 63-82.
8.	Reynolds AV, Hamilton Miller JMT, Bru mfitt W. A comparison of the in vitro activity of metronidazole, tinidazole and nimorazole aginst Gram negative anaerobic bacilli[J]. J Clin Path, 1975; 28(10): 775-778.
9.	Mittendorf R, Williams MA, Aronson MP, Berry RE, Kupelnick B, Chalmers TC. Use of prophylactic tinidazole to avoid the serious infections associated with total abdominal hysterectomy[J]. Aust NZ J Obstet Gynaecol, 1995; 35(3): 314-315.
10.	Ni KF, Lai YS, Chen LL, Zhu ZZ, He MS. Clinical observation on treatment of periapical and adult periodontitis using tinidozole[J]. Zhejiang Medicine, 1996; 18(1): 20-21.
11.	Buranawarodomkul P, Chandeying V, Sutthijumroon S. Seven day metronidazole versus single dose tinidazole as therapy for nonspecific vaginitis[J]. J Med Assoc Thai, 1990; 73(5): 283-287.
12.	Yi XQ, Shi ZD, Zhang YH, et al. Evaluation of tinidozole in treatment of periodontitis and pericoronitis[J]. West China J Stomatol, 1993; 11(4): 260.
13.	Shi ZD, Yi XQ, Wen YM. Treatment effects and adverse reactions of Tinidazole in treating pericoronititis and piriodontitis[J]. Wuhan Medicine Information Communication, 1995; 11(4): 159-161.
14.	Shi ZD, Wen YM, Yi XQ, Zhang JC. Adverse Reactions Spectrum of Tinidozole Tablets[J]. China New Drugs J, 1999; 8(2): 114-115.
15.	Kalowski M, Dybicki J, Kedzia A, Lukianski M. Study of obligate anaerobic bacterial sensitivity to tinidazole and metronidazole (determination of minimal inhibiting concentration-MIC)[J]. Wiad Lek, 1993; 46(56): 211-215.
16.	Packard RS. Tinidazole: a review of clinical experience in anaerobic infection[J]. J Antimicrobial Chemotherapy, 1982; 0(Suppl.A): 65-78.
17.	Jaup BH, Norrby A. Lowdose, short-term triple therapy for cure of helicohacter pylori infection and healing of peptic ulcers[J]. Am J Gastroenteroenterol, 1995; 90(6): 943.
18.	Saberi-Firoozi M, Massarrat S, Zare S, Fattahi M, Javan A, Etaati H, Dehbashi N. Effect of triple therapy or amoxycillin plus omeprazole or amoxycillin plus tinidazole plus omeprazole on duodenal ulcer healing, eradication of helicobacter pylori, and prevention of ulcer relapse over a 1-year follow-up period: a prospective randomized controlled study[J]. Am J Gastroenteroenterol, 1995; 90(9): 1419-1423.
19.	Gerner T, Nygaard K, Kaaresen R, Mjoerual J, Larsen S. Antibiotic prophylaxis in colorectal surgery combined doxycycline-tinidazole vs doxycycline alone[J]. Acta Chir Scand, 1989; 155(2): 121-124.
20.	Dhar KK, Dhall GI, Ayyagari A. Tinidazole prophylaxis in elective abdominal hysterectomy[J]. Int J Gynecol Obstet, 1993; 42(2): 121-125.
21.	Meng HX. Etiology of Periodontitis[J]. In: Cao CF. ed. Periodontology. Beijing:Peoples Health Publishing House; 2001. 29-48.
22.	Wen YM, Li LJ. Infection of the Oral and Maxillary Region[J]. In: Qiu W, ed. Theory and Practice of Oral and Maxillofacial Surgery. Beijing: Peoples Health Publishing House; 1998. 348-390.
23.	Sarkiala-Kessel-EM, Jarvinen-A, Nokelainen-M, Asikainen-S. Concentrations of tinidazole in gingival crevicular fluid and plasma in dogs after multiple dose administration[J]. J Vet Pharmacol Ther. 1996; 19(3): 171-175.
24.	Liew V, Mack G, Tseng P, Cvejic M, Hayden M, Buchanan N. Single-dose concentrations of tinidazole in gingival crevicular fluid, serum, and gingival tissue in adults with periodontitis[J]. J Dent Res, 1991; 70(5): 910-912.
25.	Heikkinen J, Vuopala S. Anaerobic vaginosis: treatment with tinidazole vaginal tablets[J]. Gynecol Obstet Invest, 1989; 28(2): 98-100.

1. 孟煥新. 牙周病的病因學[J]. 見: 曹采方. 主編. 牙周病學. 北京: 人民衛生出版社; 2001. 29～48.
2. 溫玉明, 李龍江. 口腔頜面部感染[J]. 見: 邱蔚六. 主編. 口腔頜面外科理論與實踐. 北京: 人民衛生出版社; 1998. 348～390.
3. 倪可夫, 來永勝, 陳莉麗, 朱仲珍, 何明灼. 替硝唑治療根尖周炎和成年人牙周炎的臨床觀察[J]. 浙江醫學, 1996; 18(1): 20～21.
4. 易新詮, 史宗道, 張蘊惠, 等. 替硝唑治療牙周炎和冠周的臨床療效觀察和評價[J]. 華西口腔醫學雜志, 1993; 11(4): 260.
5. 史宗道, 易新詮, 溫玉明. 替硝唑對冠周炎、牙周炎的療效及不良反應[J]. 武漢醫藥情報通訊, 1995; 11(4): 159～161.
6. 史宗道, 溫玉明, 易新詮, 章錦才. 國產替硝唑片劑的不良反應[J]. 中國新藥雜志, 1999; 8(2): 114～115.
7. Zaat JO, Mark TG, Assendelft WJ. A systematic review on the treatment of giardiasis[J]. Trop Med Int Health, 1997; 2(1): 63-82.
8. Reynolds AV, Hamilton Miller JMT, Bru mfitt W. A comparison of the in vitro activity of metronidazole, tinidazole and nimorazole aginst Gram negative anaerobic bacilli[J]. J Clin Path, 1975; 28(10): 775-778.
9. Mittendorf R, Williams MA, Aronson MP, Berry RE, Kupelnick B, Chalmers TC. Use of prophylactic tinidazole to avoid the serious infections associated with total abdominal hysterectomy[J]. Aust NZ J Obstet Gynaecol, 1995; 35(3): 314-315.
10. Ni KF, Lai YS, Chen LL, Zhu ZZ, He MS. Clinical observation on treatment of periapical and adult periodontitis using tinidozole[J]. Zhejiang Medicine, 1996; 18(1): 20-21.
11. Buranawarodomkul P, Chandeying V, Sutthijumroon S. Seven day metronidazole versus single dose tinidazole as therapy for nonspecific vaginitis[J]. J Med Assoc Thai, 1990; 73(5): 283-287.
12. Yi XQ, Shi ZD, Zhang YH, et al. Evaluation of tinidozole in treatment of periodontitis and pericoronitis[J]. West China J Stomatol, 1993; 11(4): 260.
13. Shi ZD, Yi XQ, Wen YM. Treatment effects and adverse reactions of Tinidazole in treating pericoronititis and piriodontitis[J]. Wuhan Medicine Information Communication, 1995; 11(4): 159-161.
14. Shi ZD, Wen YM, Yi XQ, Zhang JC. Adverse Reactions Spectrum of Tinidozole Tablets[J]. China New Drugs J, 1999; 8(2): 114-115.
15. Kalowski M, Dybicki J, Kedzia A, Lukianski M. Study of obligate anaerobic bacterial sensitivity to tinidazole and metronidazole (determination of minimal inhibiting concentration-MIC)[J]. Wiad Lek, 1993; 46(56): 211-215.
16. Packard RS. Tinidazole: a review of clinical experience in anaerobic infection[J]. J Antimicrobial Chemotherapy, 1982; 0(Suppl.A): 65-78.
17. Jaup BH, Norrby A. Lowdose, short-term triple therapy for cure of helicohacter pylori infection and healing of peptic ulcers[J]. Am J Gastroenteroenterol, 1995; 90(6): 943.
18. Saberi-Firoozi M, Massarrat S, Zare S, Fattahi M, Javan A, Etaati H, Dehbashi N. Effect of triple therapy or amoxycillin plus omeprazole or amoxycillin plus tinidazole plus omeprazole on duodenal ulcer healing, eradication of helicobacter pylori, and prevention of ulcer relapse over a 1-year follow-up period: a prospective randomized controlled study[J]. Am J Gastroenteroenterol, 1995; 90(9): 1419-1423.
19. Gerner T, Nygaard K, Kaaresen R, Mjoerual J, Larsen S. Antibiotic prophylaxis in colorectal surgery combined doxycycline-tinidazole vs doxycycline alone[J]. Acta Chir Scand, 1989; 155(2): 121-124.
20. Dhar KK, Dhall GI, Ayyagari A. Tinidazole prophylaxis in elective abdominal hysterectomy[J]. Int J Gynecol Obstet, 1993; 42(2): 121-125.
21. Meng HX. Etiology of Periodontitis[J]. In: Cao CF. ed. Periodontology. Beijing:Peoples Health Publishing House; 2001. 29-48.
22. Wen YM, Li LJ. Infection of the Oral and Maxillary Region[J]. In: Qiu W, ed. Theory and Practice of Oral and Maxillofacial Surgery. Beijing: Peoples Health Publishing House; 1998. 348-390.
23. Sarkiala-Kessel-EM, Jarvinen-A, Nokelainen-M, Asikainen-S. Concentrations of tinidazole in gingival crevicular fluid and plasma in dogs after multiple dose administration[J]. J Vet Pharmacol Ther. 1996; 19(3): 171-175.
24. Liew V, Mack G, Tseng P, Cvejic M, Hayden M, Buchanan N. Single-dose concentrations of tinidazole in gingival crevicular fluid, serum, and gingival tissue in adults with periodontitis[J]. J Dent Res, 1991; 70(5): 910-912.
25. Heikkinen J, Vuopala S. Anaerobic vaginosis: treatment with tinidazole vaginal tablets[J]. Gynecol Obstet Invest, 1989; 28(2): 98-100.

《中國循證醫學雜志》

替硝唑含片治療牙周炎和冠周炎的療效及安全性的隨機對照臨床試驗

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《中國循證醫學雜志》

替硝唑含片治療牙周炎和冠周炎的療效及安全性的隨機對照臨床試驗

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

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Content

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