DOI:10.14009/j.issn.1672-2124.2013.08.001 1* 2 3 2 2 1# 1. 100730 2. 050091 3. 201203 R932 B 1672-2124 2013 08-0676 - 06 CBM CNKI Cochrane MEDLINE EMBASE RCT 2003 1 2013 5 RCT 40 2 592 2 314 63 2. 4% 100 4. 3% RR = 0. 562 95% CI = 0. 412 ~ 0. 767 24 RR = 0. 62 95% CI = 0. 46 ~ 0. 82 RR = 0. 70 95% CI = 0. 50 ~ 0. 97 Meta 櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵櫵 2 Monmaturapoj T Montakantikul P Mootsikapunp et al. A 2 prospective randomized double-dummy placebo-controlled trial of oral cefditoren pivoxil 400mg once daily as switch therapy after interavenous ceferiaxom in the treatment of acute pyelonephritis J. Int J Infect Dis 2012 16 12 3 843-849. 3 Ramirez JA Cooper AC Wiemken J et al. Switch therapy in hospitalized patients with community acquired pneumomia tigecycline vs levofloxacin J. BMC Infect Dis 4 2012 19 12 159-164. 4 Ramirez JA. Clinical stability and switch therapy in are we ther yat J. Eur Respir J 2013 41 1 5-6. 2008 12 5 Engel MF Postma DF Hulscher ME et al. Barriers to an early switch from interavenous to oral antibiotics therapy in hospitalized patints with CAP J. Eur Respir J 2013 41 1 123-140. 6. M. 1 Aghazadehi-Habashi A Jamuli F. Pharmacokinetics of 2012 13. 7. meloxicam adiministered as regular and fast dissolving formulations to the rat influence of gastrointestinal dysfunction on the relative bioavailability of two formulations J. Eur J Pham Biopharm 2008 70 3 884-890. hospitalized patient with community acquired pneumonia J. 2011 20 8 751-756. 8 de Waard MC Bierman H Brinckman SL et al. Autometed peritoneal larage an extremely rapid and safe way to induce hypothermia in post-resuscitatuon patients J. Crit Cure 2013 17 1 R31-R35. * E-mail 9. J. wangyanxun2008@ 163. com 2011 23 9 174-176 # E-mail xuzj@ hotmail. com 2013-07-19 676 Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No. 8 2013 13 8
Clinical Drug Safety of Lianhuaqingwen Preparation A Systematic Evaluation WANG Yan-xun 1 ZHANG Ke-yuan 2 HUANG Ji-han 3 HAN Shuo-long 2 ZHAO Jun-hong 2 XU Zuojun 1 # 1. Dept. of Respiratory Diseases Beijing Union Medical College Hospital Chinese Academy of Medical Sciences Beijing 100730 China 2. Hebei Yiling Hospital Affiliated to Hebei Medical University Shijiazhuang 050091 China 3. Clinical Research Center of Shanghai University of Traditional Chinese Medicine Shanghai 201203 China ABSTRACT OBJECTIVE To conduct a systematic evaluation on clinical drug safety of Lianhuaqingwen preparation. METHODS We retrieved Chinese Biomedical Literature Database CBM China Academic Journal Full-text Database CNKI Cochrane Library MEDLINE and Embase to collect clinical literature from January 2003 to May 2013 about randomized controlled trials RCTs on Lianhuaqingwen capsules and Lianhuaqingwen granules. RESULTS We included medical literature of a total of 40 RCTs with 2 592 patients in the test group and 2 314 cases in the control group. 63 cases 2. 4% in the test group versus 100 4. 3% showed adverse reactions with regard to the incidence of adverse reactions in the test group and the control group the relative risk RR = 0. 562 95% CI = 0. 412-0. 767. Subgroup analysis of the adverse reactions in 24 RCTs revealed RR = 0. 62 95% CI = 0. 46-0. 82 subgroup analysis of the adverse reactions in digestive system revealed RR = 0. 70 95% CI = 0. 50-0. 97 suggestive of lower incidence of adverse reactions in Lianhuaqingwen preparation-treated group than in control group. CONCLUSION Gastrointestinal reaction is the common clinical adverse reactions of Lianhuaqingwen preparation and the incidence of adverse reactions was significantly lower in Lianhuaqingwen preparation-treated group than in control group in the treatment of different diseases. KEY WORDS Lianhuaqionngwen preparation Randomized controlled trials Systematic review Meta-analysis CNKI Lianhuaqingwen capsul Lianhuaqingwen granules Cochrane 13 MEDLINE EMBASE 2003 1 2013 5 Meta 1 Meta 1. 4 2 Meta Meta 3 1. 5 1 1. 1 1. 6 Stata 11. 0 1 RCT RR 2 95% CI 3 P 0. 1 4 P 0. 1I 2 50% I 2 50% 1. 2 1 2 Meta 3 4 1. 3 2 2. 1 CBM 104 1 44 2013 13 8 Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No. 8 677
61 2 4 5 12 2. 3. 2 40 RCT RCT 40 1-40 40 16 24 4 906 2 592 24 χ 2 = 2 314 1 2. 2 19 3 8 6 1 2. 3. 3 40 2 1 1 1 1 26 24 24 14 3 ~ 7 d χ 2 = 22. 85 P = 0. 470 I 2 = 0 34 6 RR = 0. 70 95% CI = 0. 50 ~ 0. 97 1 4 2. 3 2. 3. 1 40 RCT 63 2. 4% 2 100 4. 3% 3 RR = 0. 562 95% CI = 0. 412 ~ 0. 767 1 26. 38 P = 0. 283 I 2 = 12. 8% RR = 0. 62 95% CI = 0. 46 ~ 0. 82 RCT 16 2. 3. 4 / Tab 1 Basic characteristics of the included RCTs / /d 1 2005 197 /67 3 2 2005 116 /119 3 3 2006 29 /28 + 7 4 2006 122 /105 C 3 5 2007 30 /30 + 3 6 2008 102 /104 C 3 ~ 5 7 2008 80 /80 7 8 2008 100 /100 3 9 2008 25 /25 + 3 ~ 5 10 2009 25 /25 5 11 2010 90 /60 3 12 2010 64 /60 5 13 2010 60 /74 5 ~ 7 14 2010 116 /29 5 15 2010 30 /16 3 ~ 5 16 2010 136 /136 + + 3 17 2010 30 /30 + 7 18 2011 100 /100 3 Duan 19 2011 122 /122 5 20 2011 50 /50 3 21 2011 38 /38 + 5 22 2011 100 /100 2 ~ 4 23 2011 40 /40 3 24 2011 35 /35 3 25 2011 50 /50 3 26 2011 46 /41 + + 3 27 2011 62 /62 + 3 ~ 7 28 2012 50 /50 5 29 2012 26 /24 + 3 30 2012 29 /29 3 ~ 5 31 2012 40 /40 3 32 2012 24 /24 + 7 33 2012 56 /56 + 3 ~ 5 34 2013 24 /22 + + 6 35 2009 38 /35 + 5 36 2010 68 /68 7 37 2010 68 /68 6 38 2011 38 /36 3 39 2013 76 /76 + 3 40 2013 60 /60 3 678 Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No. 8 2013 13 8
2 Fig 2 Incidence of adverse reactions in the test and control groups 40 4 906 2 592 2 314 2. 4% 4. 3% 2 1 24 Fig 1 Literature screening process and outcome on RCTs of Lianhuaqingwen preparation 1 Fig 3 3 Meta Forest plot of meta-analysis of adverse reactions in the test group vs. control group 2013 13 8 Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No. 8 679
Fig 4 4 Meta Forest plot of meta-analysis of adverse reactions of digestive system in the test group vs. control group 2 Tab 2 Classified analysis of adverse reactions n = 2 592 n = 2 314 RR /% /% 95% CI 53 2. 0 73 3. 3 0. 65 0. 46 ~ 0. 92 7 0. 3 20 1. 0 0. 31 0. 13 ~ 0. 74 0 0 9 0. 3 0. 05 0 ~ 0. 81 0 0 1 0 0. 30 0. 01 ~ 7. 30 0 0 1 0 0. 30 0. 01 ~ 7. 30 16 0. 6 14 0. 6 1. 02 0. 50 ~ 2. 09 3 0. 1 7 0. 4 0. 38 0. 10 ~ 1. 48 4 0. 2 2 0. 1 1. 79 0. 33 ~ 9. 74 23 0. 9 19 0. 8 1. 08 0. 59 ~ 1. 98 6 0. 2 10 0. 4 0. 54 0. 19 ~ 1. 47 0 0 1 0 0. 30 0. 01 ~ 7. 30 6 0. 2 9 0. 4 0. 60 0. 21 ~ 1. 67 0 0 5 0. 2 0. 08 0 ~ 1. 47 0 0 5 0. 2 0. 08 0 ~ 1. 47 0 0 3 0. 1 0. 13 0. 01 ~ 2. 47 0 0 3 0. 1 0. 13 0. 01 ~ 2. 47 3 0. 1 7 0. 3 0. 38 0. 10 ~ 1. 48 3 0. 1 2 0. 1 1. 34 0. 22 ~ 8. 01 0 0 5 0. 2 0. 08 0 ~ 1. 47 RCT 1. Ⅱ J. 2005 16 4 290-293. 2. 280 J. 2005 4 5 276-278. 3. J. 2006 21 11 70-71. 4. J. 2006 17 Jadad 6 78-79. 40 7 5 5. 6 3 15 2 12 1 RCT - J. 2007 16 26 3812. 2 6. 102 J. 2008 27 11 1337-3 1340. 7. J. 2008 19 27 2146-2148. 680 Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No. 8 2013 13 8
8. 25. J. J. 2011 9 19 306-307. 2008 13 9 1118-1119. 9. J. J. 2008 7 1 24-26. 10. 2011 11 28 6840. H1N1 J. 2009 30 23 91-92. 11. 29. J. 2010 31 9 1327-1328 J. 2012 12. 14 12 143-144. 9 1 14-16. 13. H1N1 J. 2010 31 10 1351-1353. 14. J. 2012 5 H1N1 J. 2010 7 22 102-103. 30 6-8. 15. J. H1N1 J. 2010 25 12 2012 10 10 1198-1199. 2010 29 33 38. 17. 30 34. J. 2010 5 3 158-159. J. 2013 2 75. 18. 100 35. J. 2011 46 5 333. 19 Duan ZP Jia ZH Zhang J et al. Natural herbal medicine Lianhuaqingwen capsule anti-influenza A H1N1 trial a randomized double blind positive controlled clinical trial J. Chin Med J Engl 2011 124 18 2925-2933. 20. 524-525. J. 2011 23 10 162-163. 21. 32 16 76-78. H1N1 38 J. 2011 33 5 753-754. 22. 2013 34 1 79-80. J. 2011 19 5 832-833. 40. EV71 23. J. J. 2013 23 2011 18 18 137-138. 2 152. 24. 35 J. 2011 18 6 517-518. 26. 2011 18 1 69-70. 27. J. 28. J. 2012 5 25 78. H1N1 J. 2010 30. J. 2012 31 16 108. 31. 32. 2318-2319. 33. 16. H1N1 136 J. H1N1 J. 2012 21 3 345-346. J. 2009 2 9 49. 36. J. 2010 31 22 183-184. 37. J. 2010 9 7 38. J. 2011 39. J. 2013-06-21 2013 13 8 Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No. 8 681