• 1. 中國中西醫(yī)結(jié)合雜志社 (北京 100091) 2. 中國中醫(yī)科學院西苑醫(yī)院 (北京 100091);

目的  系統(tǒng)評價血脂康膠囊(簡稱血脂康)治療高脂血癥的有效性和安全性。
方法  電子檢索MEDLINE、EMBASE、Cochrane 圖書館臨床對照試驗注冊庫 、Cochrane 協(xié)作網(wǎng)內(nèi)分泌代謝組資料庫、中國生物醫(yī)學文獻數(shù)據(jù)庫、中國醫(yī)院知識倉庫,手工檢索已發(fā)表與未發(fā)表的相關(guān)文獻(檢索至2005年12月)。納入治療組服用血脂康,對照組服用他汀類等調(diào)脂藥治療高脂血癥的隨機或半隨機對照試驗。采用Cochrane Reviewer’s Handbook4.2.2中的方法進行文獻質(zhì)量評價和資料分析。
結(jié)果  共納入11個研究 ,1 073例原發(fā)性高血脂癥患者。納入研究質(zhì)量均為B或C級。① 血脂康降低TC的作用與他汀類 [WMD 0.06, 95%CI (-0.09, 0.20),RR 1.02, 95%CI (0.93, 1.12)]、貝特類藥物[WMD 0.05, 95%CI (-0.22, 0.31)]及丙丁酚[WMD 0.42, 95%CI (-0.01, 0.85)]相似,并優(yōu)于煙酸肌醇酯[WMD 0.96, 95%CI (0.73, 1.18)]。 ② 血脂康降低TG作用與他汀類藥物[WMD 0.02, 95%CI (-0.10, 0.14), RR 1.17, 95%CI (0.92, 1.49)]、煙酸肌醇酯[WMD 0.28, 95%CI (-0.17, 0.73)]相似、丙丁酚[WMD0.71, 95%CI (0.22, 1.20)],但弱于貝特類[WMD -0.81, 95%CI (-1.40, -0.23)]。③ 血脂康升高HDL-C作用與他汀類藥物相似[WMD -0.03, 95%CI (-0.10, 0.04), RR 1.03, 95%CI (0.80, 1.33)],優(yōu)于煙酸肌醇酯[WMD 0.15, 95%CI (0.01, 0.29)], 與貝特類[WMD 0.03, 95%CI (-0.08, 0.15)]、丙丁酚[WMD 0.04, 95%CI (-0.16, 0.24)]相似。 ④ 血脂康降低LDL-C作用與他汀類藥物比較,差異無統(tǒng)計學意義[WMD -0.23, 95%CI (-0.61, 0.15), RR 1.15, 95%CI (0.75, 1.77)]。血脂康降低LDL-C 作用與貝特類[WMD 0.19, 95%CI (-0.12, 0.50)]、丙丁酚相似[WMD 0.35, 95%CI (-0.03, 0.73)],優(yōu)于煙酸肌醇酯[WMD 0.53, 95%CI (0.16, 0.90)]。 ⑤ 不良反應(yīng):短期服用血脂康的不良反應(yīng)主要為胃腸道反應(yīng),較少有肝功能異常改變和肌痛。
結(jié)論  血脂康能降低高脂血癥患者的TC、TG和LDL-C水平,升高HDL-C水平,其作用與他汀類藥物相似,短期服用血脂康未發(fā)現(xiàn)有明顯的不良反應(yīng)。本系統(tǒng)評價納入研究質(zhì)量和數(shù)量有限,上述結(jié)論尚需更多高質(zhì)量、大樣本、長期隨訪的隨機對照試驗予以驗證。

引用本文: 王衛(wèi)霞,陳可冀. 血脂康膠囊治療高脂血癥有效性和安全性的系統(tǒng)評價. 中國循證醫(yī)學雜志, 2006, 06(5): 352-360. doi: 復(fù)制

1. 血脂異常防治對策專題組. 血脂異常防治建議. 中華心血管病雜志, 1997; 25(3): 169~172.
2. 王俊顯, 陸宗良, 遲家敏,等. 血脂康膠囊治療高脂血癥臨床觀察. 中國實驗方劑學雜志, 1995; 1(1): 37~41.
3. 秦樹存, 張維強, 齊鵬, 等. 隨機雙盲對照試驗觀察血脂康對老年高脂血癥患者的臨床療效. 中華內(nèi)科雜志, 1998; 37(6): 401~402.
4. 寇文镕, 石湘蕓, 陸宗良, 等. 血脂康的療效與安全性觀察. 中華內(nèi)科雜志, 1998; 37(6): 406~407.
5. 徐成斌, 康麗萍, 靳三友, 等. 小劑量血脂康長期調(diào)脂作用的臨床觀察. 中華內(nèi)科雜志, 1998; 37(6): 405~406.
6. 曾群英, 麥煒頤, 高修仁, 等. 兩種劑量血脂康膠囊治療高脂血癥的臨床研究. 中國新藥雜志, 2002; 11(3): 229~232.
7. 中華人民共和國衛(wèi)生部. 心血管藥物臨床研究指導(dǎo)原則 (試行). 1988: 86~88.
8. 漆滿英, 章景, 肖建綱. 血脂康治療高膽固醇血癥112例療效觀察. 實用臨床醫(yī)學, 2004; 5(6): 20, 22.
9. 張剛, 沐賢友, 曹雪濱, 等. 血脂康和阿托伐他汀治療混合型高脂血癥的研究. 現(xiàn)代中西醫(yī)結(jié)合雜志, 2005; 14(2): 154~155.
10. 陸國平, 霍淑欽, 沈永初, 等. 血脂康和辛伐汀對高膽固醇血癥調(diào)脂作用的比較. 中華內(nèi)科雜志, 1998; 37(6): 371~373.
11. 金煒, 楊紅, 張承, 等. 血脂康膠囊和美百樂鎮(zhèn)對照治療原發(fā)性高脂血癥. 中國新藥雜志, 1997; 6(4): 265~268.
12. 寇文镕, 陸宗良, 郭靜萱, 等. 血脂康對原發(fā)性高脂血癥的臨床療效. 中華內(nèi)科雜志, 1997; 36(8): 529~531.
13. 徐勝國. 血脂康治療原發(fā)性高膽固醇血癥臨床療效分析. 河南醫(yī)藥信息, 2002; 10(13): 6~7.
14. 劉亮, 李建平, 沈培南. 血脂康治療混合型高脂血癥的臨床觀察. 實用醫(yī)學雜志, 2000; 16(12): 1047~1048.
15. 楊蘇生. 血脂康治療高脂血癥76例. 中成藥, 2002; 24(10): 815~816.
16. 黎國堯, 李建平, 麥煒頤, 等. 微?;侵Z貝特治療混合型高脂血癥. 廣東醫(yī)學, 1999; 20(11): 895~896.
17. 江勁波, 郝小元, 鄧常青, 等. 血脂康對高脂血癥患者血脂譜的作用和對血栓素A2與前列環(huán)素的影響. 中華內(nèi)科雜志, 1999; 38(8): 517~519.
18. 閆鴻第, 郭江紅, 賈淑團. 普魯布考片治療高脂血癥近期療效觀察. 山西臨床醫(yī)藥雜志, 1999; 8(2): 103~104.
19. 趙水平. 主編. 實用循證心臟病治療學. 第1版. 北京: 人民軍醫(yī)出版社; 2005. 428.
20. Sempos CT, Cleeman JI, Carroll MD, et al. Prevalence of high blood cholesterol among US adults. An update based on guidelines from the second report of the National Cholesterol Education Program Adult Treatment Panel. JAMA, 1993; 269(23): 3009-3014.
21. Ford ES, Mokdad AH, Giles WH, et al. Serum total cholesterol concentrations and awareness, treatment, and control of hypercholesterolemia among US adults indings from the National Health and Nutrition Examination Survey, 1999 to 2000. Circulation, 2003; 107: 2185-2189.
22. He J, Gu D, Reynolds K, et al. Serum total and lipoprotein cholesterol levels and awareness, treatment, and control of hypercholesterolemia in China. Circulation, 2004; 110(4): 405-411.
23. Expert Panel on Detection, Evalution, and Treatment of high blood cholesterol in adult. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol In Adults(Adult Treatment Panel Ⅲ). JAMA, 2001; 285 (19): 2486-2497.
24. Focus group of prevention and treatment of dyslipidemia. Suggestion on prevention and treatment of dyslipidemia. Chinese Journal of Cardiology, 1997; 25(3): 169-172.
25. Bucher HC, Griffith LE, Guyatt GH. Systematic review on the risk and benefit of different cholesterol-lowering interventions. Arterioscler Thromb Vasc Biol, 1999; 19(2): 187-195.
26. Castelli WP. Cholesterol and lipids in the risk of coronary artery disease the Framingham Heart Study. Can J Cardiol, 1988; 4 (Suppl A): 5A-10A.
27. Wang JX, Lu Z, Chi JM, et al. Clinical trial of Xuezhikang capsule for treating hyperlipidemia. Chinese Journal of Experimental Medical Formulae, 1995; 1(1): 37-41.
28. Qin SC, Zhang WQ, Qi P, et al. Effect of Xuezhikang on elderly patients with hyperlipidemia: a randomized, double-blinded, controlled trial. Chinese Journal of Internal Medicine, 1998; 37(6): 401-402.
29. Kou WR, Shi XY, Lu ZL, et al. Observaiton on the efficacy and safety of Xuezhikang. Chinese Journal of Internal Medicine, 1998; 37(6): 406-407.
30. Xu CB, Kang LP, Jin SY, et al. Clinical observation on long-term lipid regulation of low dose of Xuezhikang. Chinese Journal of Internal Medicine, 1998; 37(6): 405-406.
31. Zeng QY, Mai WY, Gao XR, et al. Clinical study on treating dyslipidemia with two doses of Xuezhikang. Chinese Journal of New Drugs, 2002; 11(3): 229-232.
32. Ministry of Health, P. R. China. Guiding principle of clinical research on cardiovascular drugs (Trial). 1988: 86-88.
33. Qi MY, Zhang J, Xiao JG. Efficacy observation of Xuezhikang in treating 112 patients with hypercholesteremia. Practical Clinical Medicine, 2004; 5(6): 20, 22.
34. Zhang G, Mu XY, Cao XB, et al. Study of Xuezhikang and atorvastatin on mix type hyperlipidemia. Modern Journal of Integrated Traditional Chineseand Western Medicine, 2005; 14(2): 154-155.
35. Lu GP, Huo SQ, Shen YC, et al. Comparison of the effects of Xuezhikang with simvastatin on lipid profile modification in patients with hypercholesterolemia. Chinese Journal of Internal Medicine, 1998; 37(6): 371-373.
36. Jin W, Yang H, Zhang C, et al. A comparative study of xuezhikang and mevalotin treatment of essential hyperlipidemia. Chinese New Drug Journal, 1997; 6(4): 265-268.
37. Kou WR, Lu ZL, Guo JX, et al. Effect of xuezhikang on the treatment of primary hyperlilpidemia. Chinese Journal of Internal Medicine, 1997; 36(8): 529-531.
38. Xu SG. Efficacy analysis of Xuezhikang in treatment of hypercholesteremia. Henan Medical Information, 2002; 10(13): 6-7.
39. . Liu L, Li JP, Shen PN. Clinical observation of Xuezhikang in treating combined hyperlipidemia familial. The Journal of Practical Medicine, 2000; 16(12): 1047-1048.
40. Yang SS. Observation of Xuezhikang in treating 76 patients with hyperlipidemia. Chinese Traditional Patent Medicine, 2002; 24(10): 815-816.
41. Li GY, Li JP, Mai WY, et al. Effect of Lipantil in treatment of combined hyperlipidemia familial. Guangdong Medical Journal, 1999; 20(11): 895-896.
42. Jiang JB, He XY, Deng CQ, et al. The effects of Xuezhikang on serum lipid profile, thromboxane A2 and prostacyclin in patients with hyperlipidemia. Chinese J of Internal Medicine, 1999; 38(8): 517-519.
43. Yan HD, Guo JH, Jia ST. Observation on short-term efficacy of Xuezhikang in treating hyperlipidemia. Shanxi Clinical Medicine Journal, 1999; 8(2): 103-104.
44. Zhao SP. Chief editor. Practical Evidence-based Therapy on Cardiology. 1st ed. Beijing: People’s Military Medical Press; 2005. 428.
  1. 1. 血脂異常防治對策專題組. 血脂異常防治建議. 中華心血管病雜志, 1997; 25(3): 169~172.
  2. 2. 王俊顯, 陸宗良, 遲家敏,等. 血脂康膠囊治療高脂血癥臨床觀察. 中國實驗方劑學雜志, 1995; 1(1): 37~41.
  3. 3. 秦樹存, 張維強, 齊鵬, 等. 隨機雙盲對照試驗觀察血脂康對老年高脂血癥患者的臨床療效. 中華內(nèi)科雜志, 1998; 37(6): 401~402.
  4. 4. 寇文镕, 石湘蕓, 陸宗良, 等. 血脂康的療效與安全性觀察. 中華內(nèi)科雜志, 1998; 37(6): 406~407.
  5. 5. 徐成斌, 康麗萍, 靳三友, 等. 小劑量血脂康長期調(diào)脂作用的臨床觀察. 中華內(nèi)科雜志, 1998; 37(6): 405~406.
  6. 6. 曾群英, 麥煒頤, 高修仁, 等. 兩種劑量血脂康膠囊治療高脂血癥的臨床研究. 中國新藥雜志, 2002; 11(3): 229~232.
  7. 7. 中華人民共和國衛(wèi)生部. 心血管藥物臨床研究指導(dǎo)原則 (試行). 1988: 86~88.
  8. 8. 漆滿英, 章景, 肖建綱. 血脂康治療高膽固醇血癥112例療效觀察. 實用臨床醫(yī)學, 2004; 5(6): 20, 22.
  9. 9. 張剛, 沐賢友, 曹雪濱, 等. 血脂康和阿托伐他汀治療混合型高脂血癥的研究. 現(xiàn)代中西醫(yī)結(jié)合雜志, 2005; 14(2): 154~155.
  10. 10. 陸國平, 霍淑欽, 沈永初, 等. 血脂康和辛伐汀對高膽固醇血癥調(diào)脂作用的比較. 中華內(nèi)科雜志, 1998; 37(6): 371~373.
  11. 11. 金煒, 楊紅, 張承, 等. 血脂康膠囊和美百樂鎮(zhèn)對照治療原發(fā)性高脂血癥. 中國新藥雜志, 1997; 6(4): 265~268.
  12. 12. 寇文镕, 陸宗良, 郭靜萱, 等. 血脂康對原發(fā)性高脂血癥的臨床療效. 中華內(nèi)科雜志, 1997; 36(8): 529~531.
  13. 13. 徐勝國. 血脂康治療原發(fā)性高膽固醇血癥臨床療效分析. 河南醫(yī)藥信息, 2002; 10(13): 6~7.
  14. 14. 劉亮, 李建平, 沈培南. 血脂康治療混合型高脂血癥的臨床觀察. 實用醫(yī)學雜志, 2000; 16(12): 1047~1048.
  15. 15. 楊蘇生. 血脂康治療高脂血癥76例. 中成藥, 2002; 24(10): 815~816.
  16. 16. 黎國堯, 李建平, 麥煒頤, 等. 微?;侵Z貝特治療混合型高脂血癥. 廣東醫(yī)學, 1999; 20(11): 895~896.
  17. 17. 江勁波, 郝小元, 鄧常青, 等. 血脂康對高脂血癥患者血脂譜的作用和對血栓素A2與前列環(huán)素的影響. 中華內(nèi)科雜志, 1999; 38(8): 517~519.
  18. 18. 閆鴻第, 郭江紅, 賈淑團. 普魯布考片治療高脂血癥近期療效觀察. 山西臨床醫(yī)藥雜志, 1999; 8(2): 103~104.
  19. 19. 趙水平. 主編. 實用循證心臟病治療學. 第1版. 北京: 人民軍醫(yī)出版社; 2005. 428.
  20. 20. Sempos CT, Cleeman JI, Carroll MD, et al. Prevalence of high blood cholesterol among US adults. An update based on guidelines from the second report of the National Cholesterol Education Program Adult Treatment Panel. JAMA, 1993; 269(23): 3009-3014.
  21. 21. Ford ES, Mokdad AH, Giles WH, et al. Serum total cholesterol concentrations and awareness, treatment, and control of hypercholesterolemia among US adults indings from the National Health and Nutrition Examination Survey, 1999 to 2000. Circulation, 2003; 107: 2185-2189.
  22. 22. He J, Gu D, Reynolds K, et al. Serum total and lipoprotein cholesterol levels and awareness, treatment, and control of hypercholesterolemia in China. Circulation, 2004; 110(4): 405-411.
  23. 23. Expert Panel on Detection, Evalution, and Treatment of high blood cholesterol in adult. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol In Adults(Adult Treatment Panel Ⅲ). JAMA, 2001; 285 (19): 2486-2497.
  24. 24. Focus group of prevention and treatment of dyslipidemia. Suggestion on prevention and treatment of dyslipidemia. Chinese Journal of Cardiology, 1997; 25(3): 169-172.
  25. 25. Bucher HC, Griffith LE, Guyatt GH. Systematic review on the risk and benefit of different cholesterol-lowering interventions. Arterioscler Thromb Vasc Biol, 1999; 19(2): 187-195.
  26. 26. Castelli WP. Cholesterol and lipids in the risk of coronary artery disease the Framingham Heart Study. Can J Cardiol, 1988; 4 (Suppl A): 5A-10A.
  27. 27. Wang JX, Lu Z, Chi JM, et al. Clinical trial of Xuezhikang capsule for treating hyperlipidemia. Chinese Journal of Experimental Medical Formulae, 1995; 1(1): 37-41.
  28. 28. Qin SC, Zhang WQ, Qi P, et al. Effect of Xuezhikang on elderly patients with hyperlipidemia: a randomized, double-blinded, controlled trial. Chinese Journal of Internal Medicine, 1998; 37(6): 401-402.
  29. 29. Kou WR, Shi XY, Lu ZL, et al. Observaiton on the efficacy and safety of Xuezhikang. Chinese Journal of Internal Medicine, 1998; 37(6): 406-407.
  30. 30. Xu CB, Kang LP, Jin SY, et al. Clinical observation on long-term lipid regulation of low dose of Xuezhikang. Chinese Journal of Internal Medicine, 1998; 37(6): 405-406.
  31. 31. Zeng QY, Mai WY, Gao XR, et al. Clinical study on treating dyslipidemia with two doses of Xuezhikang. Chinese Journal of New Drugs, 2002; 11(3): 229-232.
  32. 32. Ministry of Health, P. R. China. Guiding principle of clinical research on cardiovascular drugs (Trial). 1988: 86-88.
  33. 33. Qi MY, Zhang J, Xiao JG. Efficacy observation of Xuezhikang in treating 112 patients with hypercholesteremia. Practical Clinical Medicine, 2004; 5(6): 20, 22.
  34. 34. Zhang G, Mu XY, Cao XB, et al. Study of Xuezhikang and atorvastatin on mix type hyperlipidemia. Modern Journal of Integrated Traditional Chineseand Western Medicine, 2005; 14(2): 154-155.
  35. 35. Lu GP, Huo SQ, Shen YC, et al. Comparison of the effects of Xuezhikang with simvastatin on lipid profile modification in patients with hypercholesterolemia. Chinese Journal of Internal Medicine, 1998; 37(6): 371-373.
  36. 36. Jin W, Yang H, Zhang C, et al. A comparative study of xuezhikang and mevalotin treatment of essential hyperlipidemia. Chinese New Drug Journal, 1997; 6(4): 265-268.
  37. 37. Kou WR, Lu ZL, Guo JX, et al. Effect of xuezhikang on the treatment of primary hyperlilpidemia. Chinese Journal of Internal Medicine, 1997; 36(8): 529-531.
  38. 38. Xu SG. Efficacy analysis of Xuezhikang in treatment of hypercholesteremia. Henan Medical Information, 2002; 10(13): 6-7.
  39. 39. . Liu L, Li JP, Shen PN. Clinical observation of Xuezhikang in treating combined hyperlipidemia familial. The Journal of Practical Medicine, 2000; 16(12): 1047-1048.
  40. 40. Yang SS. Observation of Xuezhikang in treating 76 patients with hyperlipidemia. Chinese Traditional Patent Medicine, 2002; 24(10): 815-816.
  41. 41. Li GY, Li JP, Mai WY, et al. Effect of Lipantil in treatment of combined hyperlipidemia familial. Guangdong Medical Journal, 1999; 20(11): 895-896.
  42. 42. Jiang JB, He XY, Deng CQ, et al. The effects of Xuezhikang on serum lipid profile, thromboxane A2 and prostacyclin in patients with hyperlipidemia. Chinese J of Internal Medicine, 1999; 38(8): 517-519.
  43. 43. Yan HD, Guo JH, Jia ST. Observation on short-term efficacy of Xuezhikang in treating hyperlipidemia. Shanxi Clinical Medicine Journal, 1999; 8(2): 103-104.
  44. 44. Zhao SP. Chief editor. Practical Evidence-based Therapy on Cardiology. 1st ed. Beijing: People’s Military Medical Press; 2005. 428.