葛根素治療糖尿病周圍神經病變的系統評價_《中國循證醫學雜志》

作者：

田浩明 ¹ , 魏東 ² , 賈海燕 ¹

1. 四川大學華西醫院內分泌科,成都,6100412. 成都市第二人民醫院內科,成都,610017;

關鍵詞：

葛根素糖尿病周圍神經病變系統評價隨機對照試驗半隨機對照試驗 Meta分析

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摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

目的　評價葛根素治療糖尿病周圍神經病變的療效和安全性.
方法　按照國際Cochrane協作網的系統評價方法,通過對Cochrane圖書館臨床對照試驗庫(2003年第1期)、Medline(1966～2003.2)、EMbase數據庫(1984～2001.12.4)、中國生物醫學文獻數據庫(1978～2003.2)的機檢,以及17種中文核心雜志的手檢和參考文獻的查閱,檢索出葛根素治療糖尿病周圍神經病變的隨機或半隨機對照試驗進行系統評價.兩位研究者獨立地評價試驗質量和提取資料.
結果　10個試驗共包括726例病人符合納入標準.大部分試驗的方法學質量較差.與常規治療及B族維生素相比較,葛根素能顯著提(下轉第569頁)高治療的總有效率和感覺及運動神經傳導速度.治療期間未發現嚴重不良反應.
結論　由于試驗方法學質量低下和可能存在發表偏倚,葛根素治療糖尿病周圍神經病變有效的證據尚不充分,亟待更多大樣本、高質量的隨機對照試驗進一步予以證實.

引用本文： 田浩明,魏東,賈海燕. 葛根素治療糖尿病周圍神經病變的系統評價. 中國循證醫學雜志, 2004, 04(8): 556-562. doi: 復制

1.	［1］Qian RL. Chief editor. Diabetes clinical guideline [M].Fist. Beijing: Beijing Medical University Press, 2000:201.
2.	錢榮立.主編.糖尿病臨床指南[M].第1版.北京:北京醫科大學出版社,2000:201.
3.	［2］Partanen J, Niskanen L, Lehtinen J, Mervaala E, Siitonen O, Uusitupa M. Natural history of peripheral neuropathy in patients with non-insulin-dependent diabetes mellitus[J]. N Engl J Med, 1995; 333(2) : 89-94.
4.	［3］Diabetes Control and Complication Trial Research Group.The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in InsulinDependent Diabetes Mellitus [ J ]. N Engl J Med , 1993; 329(14): 977 -986.
5.	［4］Nathan D M. Long-term complications of diabetes mellitus [J]. N Engl J Med, 1993; 328(23): 1 676-1 685.
6.	［5］Xie YC, Sun JD, Chen WP, Wu G. Effects of Puerarin injection on diabetic peripheral neuropathy: Analysis of 31 cases [J]. Journal of Guangdong Medical College, 1998; 16 ( 1 -2): 39 -40.
7.	謝英才,孫晶丹,陳文璞,武革.普樂林注射液治療糖尿病性周圍神經病變31例療效觀察[J].廣東醫學院學報,1998;16(1～2):39～40.
8.	［6］Tang ZM. Treatment of diabetic peripheral neuropathy with Puerarin injection[J]. Anthology of Medicine, 2000; 19(5):651 - 652.
9.	唐志民.葛根素注射液治療糖尿病周圍神經病變的療效觀察[J].醫學文選,2000;19(5):651～652.
10.	［7］Lin JY, Dai L, Xu JG. Effects of Puerarin on diabetic peripheral neuropathy [ J ]. Chinese Journal of Diabetes, 2000; 8(5): 269 -271.
11.	林甲宜,戴倫,徐結桂.葛根素注射液治療糖尿病周圍神經病變的療效觀察[J].中國糖尿病雜志,2000;8(5):269～271.
12.	［8］Wang YP, Wang GQ. Clinical Efficacy of Puerarin on older diabetic patients with peripheral neuropathy[J]. Journal of Mudanjing Medical College, 2001; 22(3): 38-39.
13.	王艷萍,王桂琴.葛根素治療老年糖尿病周圍神經病變療效觀察[J].牡丹江醫學院學報,2001;22(3):38～39.
14.	［9］Chen X, Tang K. Effects of Puerarin on 32 diabetic peripheral neuropathy[J]. ShanXi Journal of Traditional Chinese Medi cine, 2001; 22(3): 132-133.
15.	諶曦,唐昆.葛根素治療糖尿病周圍神經病變32例[J].陜西中醫,2001;22(3):132～133.
16.	［10］Tan SZ. Effects of Puerarin injection on diabetic peripheral neuropathy[J]. Journal of Chen Zhou Medical College, 2001;3(1): 13.
17.	譚樹志.葛根素注射液治療糖尿病周圍神經病變的臨床觀察[J].郴州醫專學報,2001;3(1):13.
18.	［11］Zhu HP. , Pu RC, Xiong J. Effects of Puerarin on diabetic peripheral neuropathy [J]. Journal of Chinese Physician,2001; 3(4):310-311.
19.	朱惠平,卜如春,熊錦.葛根素治療糖尿病周圍神經病變療效觀察[J].中國醫師雜志,2001;3(4):310～311.
20.	［12］Lou XJ. Clinical Efficacy of Puerarin on 56 diabetic peripheral neuropathy[J]. Clinical Medicine, 2002; 22 (1): 55.
21.	樓曉佳.葛根素治療周圍神經病變例臨床觀察[J].臨床醫學,2002;22(1):55.
22.	［13］Chen GZ, Fang M, Wang JR, Chen X. Effects of Puerarin on diabetic peripheral neuropathy [J]. Herald of Medicine,2003; 22(3): 171 -172.
23.	陳國鐘,方明,王吉如,陳霞.葛根素治療糖尿病性周圍神經病變[J].醫藥導報,2003;22(3):171～172.
24.	［14］Xu L. Effects of Puerarin on diabetic peripheral neuropathy [J]. Chinese Journal of Misdiagnostics, 2003; 3(2): 250 -251.
25.	徐磊.葛根素治療糖尿病周圍神經病變療效觀察[J].中國誤診學雜志,2003;3(2):250～251.
26.	［15］Sun YX, Su JQ. Mechanism of Puerarin on dilatation of blood vessels[J]. Chinese Traditional and Herbal Drugs, 2002; 33(8): 733 - 734.
27.	孫云翔,粟錦遷.葛根素擴血管作用及其機制初探[J].中草藥,2002;33(8):733～734.
28.	［16］Wang XQ, Fu J. Research proceedings on pharmacological effects of Puerarin[J]. Journal of Beijing University of Traditional Chinese Medicine, 1994; 17(3): 39 -41.
29.	王曉青,傅靜.葛根的藥理作用研究進展[J].北京中醫藥大學學報,1994;17(3):39～41.
30.	［17］D. Ziegler. The design of trials for treatment of diabetic neuropathy[J]. Neuropathy Res Commun, 1997 ; 21 ( 1 ): 83 -91.
31.	［18］Pfeifer MA, Schumer MP. Clinical trials of diabetic neuropathy: past, present and future[J]. Diabetes, 1995; 44(12) :1 355-1 361.
32.	［19］Dyck PJ, O’ Brien PC. Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic neuropathy[J]. Diabetes Care, 1989;12(9): 649 -652.
33.	［20］Dyck PJ, Davies JL, Litchy WJ, O’ Brien PC. Longtiudinal assessment of diabetic polyneuropathy using a composite score in the Rochester Diabetic Neuropathy Study cohort[J]. Neurology, 1997; 49(1): 229-239.
34.	［21］Ziegler D, Hanefeld M, Ruhnau KJ, Hasche H, Lobisch M, Schutte K, Kerum G, Malessa R. Treatment of symptomatic diabetic polyneuropathy with the antioxidant α-lipoic acid[J].Diabetes Care, 1999; 22(8): 1 296-1 301.
35.	［22］Hotta N, Toyta T, Matsuoka K, Shingeta Y, Kikkawa R,Kaneko T, Takahashi A, Sugimura K, Koike Y, Ishii J,Sakamoto N. Clinical efficacy of fidarestat, a novel aldose reductase inhibitor, for diabetic peripheral neuropathy[J]. Diabetes Care, 2001; 24(10): 1 776-1 782.
36.	［23］Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR,Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH.Quantitative sensory testing. Report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology [J]. Neurology, 2003; 60(6): 898 -904.
37.	［24］Sun JQ, Liu PF. Pyrexia caused by Puerarin injection-six cases reports [J]. Journal of Chinese Circulation, 1998; 13(2):88.
38.	孫建強,劉佩風.普樂林靜脈滴注致發熱反應六例[J].中國循環雜志,1998;13(2):88.
39.	［25］Li SE, He SP. Hypersensitive effects caused by Puerarin: five cases reports [ J ]. Chinese Journal of Pharmacoepidemiology,1997; 6(4): 251.
40.	李淑娥,何綏平.普樂林引起過敏反應5例[J].藥物流行病學雜志,1997;6(4):251.
41.	［26］Xin PQ, Sun MB. Elevated alanine aminotransferase caused by Puerarin injection- two cases reports [J]. Chinese Journal of Hospital Pharmacy, 1999; 19(5):308.
42.	辛培乾,孫明波.靜脈滴注普樂林注射液致丙氨酸轉氨酶增高2例[J].中國醫院藥學雜志,1999;19(5):308.
43.	［27］Lu QZ. Adverse effects of Puerarin: A systemic reviews [J]. Chinese Journal of Pharmacoepidemiology, 2001; 10(4): 185 -187.
44.	陸奇志.葛根素不良反應國內文獻的系統性綜述[J].藥物流行病學雜志,2001;10(4):185～187.

1. ［1］Qian RL. Chief editor. Diabetes clinical guideline [M].Fist. Beijing: Beijing Medical University Press, 2000:201.
2. 錢榮立.主編.糖尿病臨床指南[M].第1版.北京:北京醫科大學出版社,2000:201.
3. ［2］Partanen J, Niskanen L, Lehtinen J, Mervaala E, Siitonen O, Uusitupa M. Natural history of peripheral neuropathy in patients with non-insulin-dependent diabetes mellitus[J]. N Engl J Med, 1995; 333(2) : 89-94.
4. ［3］Diabetes Control and Complication Trial Research Group.The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in InsulinDependent Diabetes Mellitus [ J ]. N Engl J Med , 1993; 329(14): 977 -986.
5. ［4］Nathan D M. Long-term complications of diabetes mellitus [J]. N Engl J Med, 1993; 328(23): 1 676-1 685.
6. ［5］Xie YC, Sun JD, Chen WP, Wu G. Effects of Puerarin injection on diabetic peripheral neuropathy: Analysis of 31 cases [J]. Journal of Guangdong Medical College, 1998; 16 ( 1 -2): 39 -40.
7. 謝英才,孫晶丹,陳文璞,武革.普樂林注射液治療糖尿病性周圍神經病變31例療效觀察[J].廣東醫學院學報,1998;16(1～2):39～40.
8. ［6］Tang ZM. Treatment of diabetic peripheral neuropathy with Puerarin injection[J]. Anthology of Medicine, 2000; 19(5):651 - 652.
9. 唐志民.葛根素注射液治療糖尿病周圍神經病變的療效觀察[J].醫學文選,2000;19(5):651～652.
10. ［7］Lin JY, Dai L, Xu JG. Effects of Puerarin on diabetic peripheral neuropathy [ J ]. Chinese Journal of Diabetes, 2000; 8(5): 269 -271.
11. 林甲宜,戴倫,徐結桂.葛根素注射液治療糖尿病周圍神經病變的療效觀察[J].中國糖尿病雜志,2000;8(5):269～271.
12. ［8］Wang YP, Wang GQ. Clinical Efficacy of Puerarin on older diabetic patients with peripheral neuropathy[J]. Journal of Mudanjing Medical College, 2001; 22(3): 38-39.
13. 王艷萍,王桂琴.葛根素治療老年糖尿病周圍神經病變療效觀察[J].牡丹江醫學院學報,2001;22(3):38～39.
14. ［9］Chen X, Tang K. Effects of Puerarin on 32 diabetic peripheral neuropathy[J]. ShanXi Journal of Traditional Chinese Medi cine, 2001; 22(3): 132-133.
15. 諶曦,唐昆.葛根素治療糖尿病周圍神經病變32例[J].陜西中醫,2001;22(3):132～133.
16. ［10］Tan SZ. Effects of Puerarin injection on diabetic peripheral neuropathy[J]. Journal of Chen Zhou Medical College, 2001;3(1): 13.
17. 譚樹志.葛根素注射液治療糖尿病周圍神經病變的臨床觀察[J].郴州醫專學報,2001;3(1):13.
18. ［11］Zhu HP. , Pu RC, Xiong J. Effects of Puerarin on diabetic peripheral neuropathy [J]. Journal of Chinese Physician,2001; 3(4):310-311.
19. 朱惠平,卜如春,熊錦.葛根素治療糖尿病周圍神經病變療效觀察[J].中國醫師雜志,2001;3(4):310～311.
20. ［12］Lou XJ. Clinical Efficacy of Puerarin on 56 diabetic peripheral neuropathy[J]. Clinical Medicine, 2002; 22 (1): 55.
21. 樓曉佳.葛根素治療周圍神經病變例臨床觀察[J].臨床醫學,2002;22(1):55.
22. ［13］Chen GZ, Fang M, Wang JR, Chen X. Effects of Puerarin on diabetic peripheral neuropathy [J]. Herald of Medicine,2003; 22(3): 171 -172.
23. 陳國鐘,方明,王吉如,陳霞.葛根素治療糖尿病性周圍神經病變[J].醫藥導報,2003;22(3):171～172.
24. ［14］Xu L. Effects of Puerarin on diabetic peripheral neuropathy [J]. Chinese Journal of Misdiagnostics, 2003; 3(2): 250 -251.
25. 徐磊.葛根素治療糖尿病周圍神經病變療效觀察[J].中國誤診學雜志,2003;3(2):250～251.
26. ［15］Sun YX, Su JQ. Mechanism of Puerarin on dilatation of blood vessels[J]. Chinese Traditional and Herbal Drugs, 2002; 33(8): 733 - 734.
27. 孫云翔,粟錦遷.葛根素擴血管作用及其機制初探[J].中草藥,2002;33(8):733～734.
28. ［16］Wang XQ, Fu J. Research proceedings on pharmacological effects of Puerarin[J]. Journal of Beijing University of Traditional Chinese Medicine, 1994; 17(3): 39 -41.
29. 王曉青,傅靜.葛根的藥理作用研究進展[J].北京中醫藥大學學報,1994;17(3):39～41.
30. ［17］D. Ziegler. The design of trials for treatment of diabetic neuropathy[J]. Neuropathy Res Commun, 1997 ; 21 ( 1 ): 83 -91.
31. ［18］Pfeifer MA, Schumer MP. Clinical trials of diabetic neuropathy: past, present and future[J]. Diabetes, 1995; 44(12) :1 355-1 361.
32. ［19］Dyck PJ, O’ Brien PC. Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic neuropathy[J]. Diabetes Care, 1989;12(9): 649 -652.
33. ［20］Dyck PJ, Davies JL, Litchy WJ, O’ Brien PC. Longtiudinal assessment of diabetic polyneuropathy using a composite score in the Rochester Diabetic Neuropathy Study cohort[J]. Neurology, 1997; 49(1): 229-239.
34. ［21］Ziegler D, Hanefeld M, Ruhnau KJ, Hasche H, Lobisch M, Schutte K, Kerum G, Malessa R. Treatment of symptomatic diabetic polyneuropathy with the antioxidant α-lipoic acid[J].Diabetes Care, 1999; 22(8): 1 296-1 301.
35. ［22］Hotta N, Toyta T, Matsuoka K, Shingeta Y, Kikkawa R,Kaneko T, Takahashi A, Sugimura K, Koike Y, Ishii J,Sakamoto N. Clinical efficacy of fidarestat, a novel aldose reductase inhibitor, for diabetic peripheral neuropathy[J]. Diabetes Care, 2001; 24(10): 1 776-1 782.
36. ［23］Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR,Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH.Quantitative sensory testing. Report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology [J]. Neurology, 2003; 60(6): 898 -904.
37. ［24］Sun JQ, Liu PF. Pyrexia caused by Puerarin injection-six cases reports [J]. Journal of Chinese Circulation, 1998; 13(2):88.
38. 孫建強,劉佩風.普樂林靜脈滴注致發熱反應六例[J].中國循環雜志,1998;13(2):88.
39. ［25］Li SE, He SP. Hypersensitive effects caused by Puerarin: five cases reports [ J ]. Chinese Journal of Pharmacoepidemiology,1997; 6(4): 251.
40. 李淑娥,何綏平.普樂林引起過敏反應5例[J].藥物流行病學雜志,1997;6(4):251.
41. ［26］Xin PQ, Sun MB. Elevated alanine aminotransferase caused by Puerarin injection- two cases reports [J]. Chinese Journal of Hospital Pharmacy, 1999; 19(5):308.
42. 辛培乾,孫明波.靜脈滴注普樂林注射液致丙氨酸轉氨酶增高2例[J].中國醫院藥學雜志,1999;19(5):308.
43. ［27］Lu QZ. Adverse effects of Puerarin: A systemic reviews [J]. Chinese Journal of Pharmacoepidemiology, 2001; 10(4): 185 -187.
44. 陸奇志.葛根素不良反應國內文獻的系統性綜述[J].藥物流行病學雜志,2001;10(4):185～187.

《中國循證醫學雜志》

葛根素治療糖尿病周圍神經病變的系統評價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

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Content

《中國循證醫學雜志》

葛根素治療糖尿病周圍神經病變的系統評價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

Format

Content

摘要全文圖表視頻參考文獻施引文獻補充材料