• 1. 四川大學(xué)華西醫(yī)院內(nèi)分泌科,成都,6100412. 成都市第二人民醫(yī)院內(nèi)科,成都,610017;

目的 　評價(jià)葛根素治療糖尿病周圍神經(jīng)病變的療效和安全性.
方法 　按照國際Cochrane協(xié)作網(wǎng)的系統(tǒng)評價(jià)方法,通過對Cochrane圖書館臨床對照試驗(yàn)庫(2003年第1期)、Medline(1966～2003.2)、EMbase數(shù)據(jù)庫(1984～2001.12.4)、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(1978～2003.2)的機(jī)檢,以及17種中文核心雜志的手檢和參考文獻(xiàn)的查閱,檢索出葛根素治療糖尿病周圍神經(jīng)病變的隨機(jī)或半隨機(jī)對照試驗(yàn)進(jìn)行系統(tǒng)評價(jià).兩位研究者獨(dú)立地評價(jià)試驗(yàn)質(zhì)量和提取資料.
結(jié)果 　10個(gè)試驗(yàn)共包括726例病人符合納入標(biāo)準(zhǔn).大部分試驗(yàn)的方法學(xué)質(zhì)量較差.與常規(guī)治療及B族維生素相比較,葛根素能顯著提(下轉(zhuǎn)第569頁)高治療的總有效率和感覺及運(yùn)動(dòng)神經(jīng)傳導(dǎo)速度.治療期間未發(fā)現(xiàn)嚴(yán)重不良反應(yīng).
結(jié)論 　由于試驗(yàn)方法學(xué)質(zhì)量低下和可能存在發(fā)表偏倚,葛根素治療糖尿病周圍神經(jīng)病變有效的證據(jù)尚不充分,亟待更多大樣本、高質(zhì)量的隨機(jī)對照試驗(yàn)進(jìn)一步予以證實(shí).

引用本文： 田浩明,魏東,賈海燕. 葛根素治療糖尿病周圍神經(jīng)病變的系統(tǒng)評價(jià). 中國循證醫(yī)學(xué)雜志, 2004, 04(8): 556-562. doi: 復(fù)制

版權(quán)信息： ?四川大學(xué)華西醫(yī)院華西期刊社《中國循證醫(yī)學(xué)雜志》版權(quán)所有，未經(jīng)授權(quán)不得轉(zhuǎn)載、改編

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(yī)科大學(xué)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(jīng)病變31例療效觀察[J].廣東醫(yī)學(xué)院學(xué)報(bào),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(jīng)病變的療效觀察[J].醫(yī)學(xué)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(jié)桂.葛根素注射液治療糖尿病周圍神經(jīng)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(jīng)病變療效觀察[J].牡丹江醫(yī)學(xué)院學(xué)報(bào),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(jīng)病變32例[J].陜西中醫(yī),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(jīng)病變的臨床觀察[J].郴州醫(yī)專學(xué)報(bào),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(jīng)病變療效觀察[J].中國醫(yī)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(jīng)病變例臨床觀察[J].臨床醫(yī)學(xué),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(jīng)病變[J].醫(yī)藥導(dǎo)報(bào),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(jīng)病變療效觀察[J].中國誤診學(xué)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?cái)U(kuò)血管作用及其機(jī)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(jìn)展[J].北京中醫(yī)藥大學(xué)學(xué)報(bào),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(qiáng),劉佩風(fēng).普樂林靜脈滴注致發(fā)熱反應(yīng)六例[J].中國循環(huán)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(yīng)5例[J].藥物流行病學(xué)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(zhuǎn)氨酶增高2例[J].中國醫(yī)院藥學(xué)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(yīng)國內(nèi)文獻(xiàn)的系統(tǒng)性綜述[J].藥物流行病學(xué)雜志,2001;10(4):185～187.
  1. 1. ［1］Qian RL. Chief editor. Diabetes clinical guideline [M].Fist. Beijing: Beijing Medical University Press, 2000:201.
  2. 2. 錢榮立.主編.糖尿病臨床指南[M].第1版.北京:北京醫(yī)科大學(xué)出版社,2000:201.
  3. 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. 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. 5. ［4］Nathan D M. Long-term complications of diabetes mellitus [J]. N Engl J Med, 1993; 328(23): 1 676-1 685.
  6. 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. 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(jīng)病變31例療效觀察[J].廣東醫(yī)學(xué)院學(xué)報(bào),1998;16(1～2):39～40.
  8. 8. ［6］Tang ZM. Treatment of diabetic peripheral neuropathy with Puerarin injection[J]. Anthology of Medicine, 2000; 19(5):651 - 652.
  9. 9. 唐志民.葛根素注射液治療糖尿病周圍神經(jīng)病變的療效觀察[J].醫(yī)學(xué)文選,2000;19(5):651～652.
  10. 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. 11. 林甲宜,戴倫,徐結(jié)桂.葛根素注射液治療糖尿病周圍神經(jīng)病變的療效觀察[J].中國糖尿病雜志,2000;8(5):269～271.
  12. 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. 13. 王艷萍,王桂琴.葛根素治療老年糖尿病周圍神經(jīng)病變療效觀察[J].牡丹江醫(yī)學(xué)院學(xué)報(bào),2001;22(3):38～39.
  14. 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. 15. 諶曦,唐昆.葛根素治療糖尿病周圍神經(jīng)病變32例[J].陜西中醫(yī),2001;22(3):132～133.
  16. 16. ［10］Tan SZ. Effects of Puerarin injection on diabetic peripheral neuropathy[J]. Journal of Chen Zhou Medical College, 2001;3(1): 13.
  17. 17. 譚樹志.葛根素注射液治療糖尿病周圍神經(jīng)病變的臨床觀察[J].郴州醫(yī)專學(xué)報(bào),2001;3(1):13.
  18. 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. 19. 朱惠平,卜如春,熊錦.葛根素治療糖尿病周圍神經(jīng)病變療效觀察[J].中國醫(yī)師雜志,2001;3(4):310～311.
  20. 20. ［12］Lou XJ. Clinical Efficacy of Puerarin on 56 diabetic peripheral neuropathy[J]. Clinical Medicine, 2002; 22 (1): 55.
  21. 21. 樓曉佳.葛根素治療周圍神經(jīng)病變例臨床觀察[J].臨床醫(yī)學(xué),2002;22(1):55.
  22. 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. 23. 陳國鐘,方明,王吉如,陳霞.葛根素治療糖尿病性周圍神經(jīng)病變[J].醫(yī)藥導(dǎo)報(bào),2003;22(3):171～172.
  24. 24. ［14］Xu L. Effects of Puerarin on diabetic peripheral neuropathy [J]. Chinese Journal of Misdiagnostics, 2003; 3(2): 250 -251.
  25. 25. 徐磊.葛根素治療糖尿病周圍神經(jīng)病變療效觀察[J].中國誤診學(xué)雜志,2003;3(2):250～251.
  26. 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. 27. 孫云翔,粟錦遷.葛根素?cái)U(kuò)血管作用及其機(jī)制初探[J].中草藥,2002;33(8):733～734.
  28. 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. 29. 王曉青,傅靜.葛根的藥理作用研究進(jìn)展[J].北京中醫(yī)藥大學(xué)學(xué)報(bào),1994;17(3):39～41.
  30. 30. ［17］D. Ziegler. The design of trials for treatment of diabetic neuropathy[J]. Neuropathy Res Commun, 1997 ; 21 ( 1 ): 83 -91.
  31. 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. 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. 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. 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. 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. 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. 37. ［24］Sun JQ, Liu PF. Pyrexia caused by Puerarin injection-six cases reports [J]. Journal of Chinese Circulation, 1998; 13(2):88.
  38. 38. 孫建強(qiáng),劉佩風(fēng).普樂林靜脈滴注致發(fā)熱反應(yīng)六例[J].中國循環(huán)雜志,1998;13(2):88.
  39. 39. ［25］Li SE, He SP. Hypersensitive effects caused by Puerarin: five cases reports [ J ]. Chinese Journal of Pharmacoepidemiology,1997; 6(4): 251.
  40. 40. 李淑娥,何綏平.普樂林引起過敏反應(yīng)5例[J].藥物流行病學(xué)雜志,1997;6(4):251.
  41. 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. 42. 辛培乾,孫明波.靜脈滴注普樂林注射液致丙氨酸轉(zhuǎn)氨酶增高2例[J].中國醫(yī)院藥學(xué)雜志,1999;19(5):308.
  43. 43. ［27］Lu QZ. Adverse effects of Puerarin: A systemic reviews [J]. Chinese Journal of Pharmacoepidemiology, 2001; 10(4): 185 -187.
  44. 44. 陸奇志.葛根素不良反應(yīng)國內(nèi)文獻(xiàn)的系統(tǒng)性綜述[J].藥物流行病學(xué)雜志,2001;10(4):185～187.