Evaluation of adverse reactions induced by adefovir dipivoxil in 85 chronic hepatitis B patients
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摘要:
目的观察阿德福韦酯治疗慢性乙型肝炎的不良反应。方法 2007年12月至2012年2月慢性乙型肝炎患者共120例,排除失代偿性肝病、原发性或继发性泌尿系统疾病。所有病例治疗前无尿常规及肾功能异常。其中单一使用常规剂量阿德福韦酯治疗的初治病例85例(A组),其余35例患者予以拉米夫定或恩替卡韦治疗(B组)。治疗过程中起初12周每4周复查血尿常规及肝肾功能,之后每12周复查血尿常规、肝肾功能、血磷、血清肌酸激酶及淀粉酶等。结果 A组9例(10.59%)出现尿常规异常,包括蛋白尿、镜下血尿等,其中一过性异常5例(5.88%),持续异常4例(4.71%)。B组有1例(2.86%)一过性尿蛋白阳性。两组尿检异常率及持续尿检异常率对比差异均无统计学意义(P>0.05)。A组5例(5.88%)尿素氮(BUN)升高,B组1例(2.86%)BUN升高,均为一过性,两组对比差异无统计学意义(P>0.05)。无血清肌酐(SCr)升高病例,未见其他不良反应。结论常规剂量阿德福韦酯治疗慢性乙型肝炎安全性良好。少数病例出现持续性尿检异常,可考虑换药。
Abstract:Objective To evaluate the adverse reactions induced by adefovir dipivoxil (ADV) treatment in patients with chronic hepatitis B (CHB) .Methods One-hundred-and-twenty patients diagnosed with CHB between December 2007 and February 2012 and treated with a single conventional dosage of ADV [10 mg once daily (OD) ;group A, n=85] or another type of antiviral drug (100 mg OD lamivudine or 0.5 mg OD entecavir;group B, n=35) were analyzed.Pre-treatment routine urinalysis and renal function tests were normal for all patients.After treatment initiation, routine tests of blood, urine, liver function markers, and renal function markers were carried once out every four weeks for 12 weeks.Thereafter, routine tests of blood, urine, liver function markers, renal function markers, serum phosphorus, serum creatine kinase, and serum amylase were carried out once every 12 weeks.Results Nine (10.59%) of the patients in group A showed abnormal urine test results, including positivity for urine protein or microscopic hematuria.Of these nine cases, the abnormal urinalysis parameters were transient for five (5.88%) and sustained for the other four (4.71%) .In contrast, only one patient (2.86%) in group B showed transient abnormal urinalysis.However, the difference between the two groups was not statistically significant (P>0.05) .Five (5.88%) patients in group A and only one (2.86%) patient in group B showed transiently increased blood urea nitrogen (BUN) , but the difference did not reach statistical significance (P>0.05) .No other adverse reactions were observed in either of the groups.Conclusion In general, ADV therapy, at a conventional dose, is a safe treatment modality for chronic hepatitis B patients.Some patients may develop abnormal urine parameters;if this abnormality is sustained, the therapeutic regimen should be modified accordingly.
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Key words:
- hepatitis B /
- chronic /
- liver cirrhosis /
- adefovir dipivoxil /
- lamivudine
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[1] Chinese Society of hepatology and Chinese Society of Infec-tious Disease, Chinese Medical Association.The guideline ofprevention and treatment for chronic hepatitis B[J].J ClinHepatol, 2006, 22 (1) :3-15. (in Chinese) 中华医学会肝病学分会, 中华医学会感染病学分会.慢性乙型肝炎防治指南[J].临床肝胆病杂志, 2006, 22 (1) :3-15. [2] Chinese Society of Hepatiology and Chinese Society of Infec-tious Diseases, Chinese Medical Association.The guidelineof prevention and treatment for chronic hepatitis B (2010version) [J].J Clin Hepatol, 2011, 27 (1) :I-XVI. (in Chi-nese) 中华医学会肝病学分会, 中华医学会感染病学分会.慢性乙型肝炎防治指南 (2010年版) [J].临床肝胆病杂志, 2011, 27 (1) :Ⅰ-ⅩⅥ. [3]Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al.Long-term therapy with adefovir dipivoxil for HBeAg-negativechronic hepatitis B for up to 5 years[J].Gastroenterology, 2006, 131 (6) :1743-1751. [4]Izzedine H, Hulot JS, Launay-Vacher V, et al.Renal safetyof adefovir dipivoxil in patients with chronic hepatitis B:twodouble-blind, randomized, placebo-controlled studies[J].Kidney Int, 2004, 66 (3) :1153-1158. [5]Wang GS, Cai HD.Adefovir dipivoxil and tenofovir-associatedtubulopathy[J].ADRJ, 2010, 12 (1) :31-36. (in Chinese) 王桂爽, 蔡皓东.阿德福韦酯和替诺福韦相关性肾小管病[J].药物不良反应杂志, 2010, 12 (1) :31-36. [6]Zhao P, Zhao MJ, Wu YJ.Comparison of incidence rate of ad-verse effects induced by entecavir and adefovir dipivoxil in thetreatment of patients with chronic hepatitis B[J].Chin J DrugAppl Monit, 2010, 7 (5) :261-262, 278. (in Chinese) 赵攀, 赵沐缙, 吴永杰.恩替卡韦与阿德福韦酯治疗慢性乙肝所致不良反应情况的比较[J].中国药物应用与监测, 2010, 7 (5) :261-262, 278. [7]Marcellin P, Chang T, Lim SG, et al.Long-term efficacyand safety of adefovir dipivoxil for the treatment of hepatitisB e antigen-positive chronic hepatitis B[J].Hepatology, 2008, 48 (3) :750-758. [8]曹聪云.诊断学[M].郑州:郑州大学出版社, 2008:256-257.
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