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1 DOI: /j.issn * # R932 B CBM CNKI Cochrane MEDLINE EMBASE RCT RCT % % RR = % CI = ~ RR = % CI = ~ RR = % CI = ~ 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 Ramirez JA Cooper AC Wiemken J et al. Switch therapy in hospitalized patients with community acquired pneumomia tigecycline vs levofloxacin J. BMC Infect Dis Ramirez JA. Clinical stability and switch therapy in are we ther yat J. Eur Respir J 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 M. 1 Aghazadehi-Habashi A Jamuli F. Pharmacokinetics of 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 hospitalized patient with community acquired pneumonia J 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 R31-R35. * 9. J. wangyanxun2008@ 163. com # xuzj@ hotmail. com Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No

2 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 China 2. Hebei Yiling Hospital Affiliated to Hebei Medical University Shijiazhuang China 3. Clinical Research Center of Shanghai University of Traditional Chinese Medicine Shanghai 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 patients in the test group and cases in the control group. 63 cases 2. 4% in the test group versus % showed adverse reactions with regard to the incidence of adverse reactions in the test group and the control group the relative risk RR = % CI = Subgroup analysis of the adverse reactions in 24 RCTs revealed RR = % CI = subgroup analysis of the adverse reactions in digestive system revealed RR = % CI = 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 Meta 1 Meta Meta Meta Stata RCT RR 2 95% CI 3 P P 0. 1I 2 50% I 2 50% Meta CBM Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No

3 RCT RCT χ 2 = ~ 7 d χ 2 = P = I 2 = RR = % CI = ~ RCT % % 3 RR = % CI = ~ P = I 2 = 12. 8% RR = % CI = ~ RCT / Tab 1 Basic characteristics of the included RCTs / /d / / / /105 C / /104 C 3 ~ / / / ~ / / / /74 5 ~ / /16 3 ~ / / /100 3 Duan / / / /100 2 ~ / / / / / ~ / / /29 3 ~ / / / ~ / / / / / / / Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No

4 2 Fig 2 Incidence of adverse reactions in the test and control groups % 4. 3% 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 Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No

5 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 = n = RR /% /% 95% CI ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ RCT 1. Ⅱ J J J J Jadad RCT - J J J Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No

6 J. J J. J H1N1 J J J H1N1 J J H1N1 J J. H1N1 J J J J 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 J H1N1 38 J J EV J. J J J. 28. J H1N1 J J H1N1 136 J. H1N1 J J J J J J Evaluation and analysis of drug-use in hospitals of China 2013 Vol. 13 No