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拉米夫定 不良反应多数发生在艾滋病人身上 随便停药或危害更大
2010-08-17 10:13 南方都市报
南都讯 记者曾文琼 7月22日,国家食品药品监督管理局发布了《药品不良反应信息通报(第30期)警惕治疗乙型肝炎的核苷类抗病毒药替比夫定和拉米夫定的横纹肌溶解症》。(以下简称《通报》)。《通报》一经发布,立即引起轩然大波。我国估计至少有500万人正在服用核苷类药物,很多患者因害怕不良反应要求医生停药。为此,北京地坛医院主任医师、《药物不良反应杂志》副主编蔡皓东教授提醒广大患者应正确看待药物不良反应,马上停药更危险。
拉米夫定 不良反应多数发生在艾滋病人身上
据蔡皓东教授介绍,拉米夫定是既能治疗艾滋病又能治疗乙肝。但治疗艾滋病每天需服用的剂量是治疗乙肝的3倍。尤其是,拉米夫定治疗艾滋病时绝对不是单药治疗,它需要和齐多夫定等至少三种药物联合应用。药监局所说的不良反应绝大多数发生在治疗艾滋病的过程中,而且肌病及横纹肌溶解症多数与齐多夫定相关。国内外医学文献中,在治疗乙肝过程中只有3例肌病、横纹肌溶解症和3例肾损害的报道,均发生在肝肾移植术后的病人中,这些病人一般还同时服用抗排异药,抗排异药中的他克莫司也有引起横纹肌溶解症的报告。拉米夫定已经应用了10年之久,我国罕有不良反应报道。
替比夫定 确有引起肌病的可能,但及时发现,停药后可恢复
蔡皓东教授指出,替比夫定确实有引起肌病的可能性。在临床研究中,肌病的发生率为0.3%～4%,只要及时发现,停药后均可恢复。替比夫定2007年上市后,我国发生了少数横纹肌溶解症的病例,究其原因,蔡皓东教授认为主要是在一种新药上市后,许多医生在治疗过程中未对患者进行严格的定期监测,另外,一些患者本身就存在潜在的肌病。许多药物也可引起肌病,甚至大量饮酒也可导致横纹肌溶解症。一些医生为了加强抗病毒的效果把替比夫定和干扰素联合起来使用,干扰素不仅可增加替比夫定对肌肉的毒性,还会增加周围神经病的风险。因此,患者在服用替比夫定期间要注意监测肌酸激酶,不要与干扰素联合用药,也不要与可引起肌病的其他药物(如他汀类的降血酯药)联合应用。
国家食品药品监督管理局新闻发言人颜江瑛也表示,这种不良反应在临床上罕见,如能尽早发现进行治疗,预后还是很好的。因此,一旦患者服药后发现弥漫性肌肉疼痛、肌肉触痛、肌无力、关节痛等症状,应立刻到医院就诊。
阿德福韦酯和恩替卡韦 有潜在的不良反应,但极少发生
蔡皓东教授指出,另外两种乙肝的核苷类似物——阿德福韦酯主要的不良反应是潜在的肾损害,目前,全球只有1例肾移植患者在服用后发生了急性肾小管坏死。只要患者注意检查肾功能、血磷就可及时发现问题。而恩替卡韦在说明书中提到,在动物试验中发现了一些动物的肿瘤发生率增加,这使许多患者很紧张。其实,动物试验所用剂量是人类最高推荐剂量(1毫克/日)的几倍甚至几十倍。现在,参加恩替卡韦上市前临床试验的患者已服用七八年,没有发现肿瘤发生增加的情况。
随便停药或换药危害更大
蔡皓东说,四种治疗慢性乙肝的核苷类似物的安全性和有效性都是肯定的,少数不良反应只要定期到医院监测,就能避免造成不良后果。而慢性乙型肝炎的抗病毒治疗已被全球公认是非常必要的。乙肝患者千万不能盲目停药,否则很可能导致肝病加重。此外,也不要随便换药,这可能增加病毒耐药的机会,以后的治疗就会变得很困难。
■名词解释
横纹肌溶解症
横纹肌溶解症俗称肌肉溶解。许多药物可引起横纹肌(骨骼肌)损害,轻者表现为肌肉疼痛和乏力,重者出现横纹肌溶解症、急性肾功能衰竭,甚至危及生命。
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艾滋病成为第一大死因病种[刘君]的对策与思考Lamivudine adverse reactions mainly occur in people with AIDS who stop taking or endangering more
2010-08-17 10:13 Southern Metropolis Daily
Southern News reporter Zeng Joan on July 22, the State Food and Drug Administration issued the "Adverse Drug Reaction Information Bulletin (No. 30) guard against hepatitis B in nucleoside antiviral telbivudine and Lami Fu set rhabdomyolysis. " (Hereinafter referred to as "notification"). "Alert" upon release, immediately caused a great uproar. China is estimated that at least 500 million people are taking nucleoside drugs, many patients fear side effects the doctors discontinued. To this end, Beijing Ditan Hospital, Chief Physician, "Adverse Drug Reactions magazine," deputy editor Professor Cai Haodong to remind the majority of patients should be a correct view of adverse drug reactions, immediately stopping more dangerous.
Lamivudine adverse reactions mainly occur in AIDS patients who
According to Professor Cai Haodong introduction, lamivudine is not only AIDS treatment but also treatment of HBV. But the treatment of AIDS every day need to take a dose of the treatment of hepatitis B 3 times. In particular, lamivudine treatment of AIDS is absolutely not a single drug treatment, it needs to, and zidovudine and so at least three drugs in combination. FDA said adverse reaction the vast majority in the treatment of AIDS in the process, and myopathy and rhabdomyolysis majority and zidovudine-related. Domestic and foreign medical literature, in the treatment of hepatitis B during the only three cases of myopathy, rhabdomyolysis, and 3 cases of renal damage were reported, all occurred in the liver and kidney transplantation patients, these patients also generally also take anti-rejection drugs , anti-rejection drugs in the tacrolimus have caused rhabdomyolysis were reported. Lamivudine has been used for 10 years, China's rare adverse events reported.
Telbivudine does cause myopathy may be, but to discover, after stopping resume
Professor Cai Haodong that telbivudine does have caused myopathy possibilities. In clinical studies, the myopathy rate was 0.3% to 4%, as long as the timely detection, after treatment can be resumed. Telbivudine in 2007 after the listing, China has a small number of rhabdomyolysis cases, reason, Professor Cai Haodong think the key is in a new drug, the many doctors in the course of treatment without the patient strict regular monitoring, In addition, some patients themselves to potentially myopathy. Many medications can cause myopathy, even heavy drinking can also lead to rhabdomyolysis. Some doctors to enhance anti-viral effect of the telbivudine and interferon combined use of interferon can not only increase telbivudine of muscle toxicity, but also increase peripheral neuropathy risks. Therefore, patients taking telbivudine period should pay attention to monitoring of creatine kinase, not with interferon combination therapy, and do not and can cause myopathy and other drugs (such as statins to lower blood lipids drugs) in combination.
State Food and Drug Administration spokeswoman Yan Jiangying also said that adverse events are clinically rare, such as the early detection of treatment, the prognosis is good. Therefore, once the patient medication revealed diffuse muscle pain, muscle tenderness, muscle weakness, joint pain and other symptoms, should be immediately to the hospital.
Adefovir dipivoxil and entecavir have potential side effects, but rarely occurs
Professor Cai Haodong pointed out that two other hepatitis B nucleoside analogues - adefovir dipivoxil major adverse events is a potential kidney damage, now, the world's only one case of renal transplant patients taking occurs after acute tubular necrosis. As long as patients pay attention to check kidney function, serum phosphate can discover the problem. And entecavir in the manual mentioned in the animal experiments have shown that some animals tumor incidence increased, which makes many patients nervous. In fact, animal studies used a dose of the human maximum recommended dose (1 mg / day) several times or even dozens of times. Now, to participate in entecavir pre-market clinical trials of patients have taken in 2078 and found no tumor increases.
Stop taking or change dressings more dangerous
Caihao Dong said that the four treatment of chronic hepatitis B nucleoside analogues safety and efficacy are positive, a small number of adverse reactions as long as regularly to the hospital for monitoring, can avoid adverse consequences. And chronic hepatitis B antiviral therapy has been recognized worldwide as is necessary. Hepatitis B patients must not blind withdrawal, or is likely to lead to liver disease increased. In addition, Do not change dressings, which may increase the virus resistant to the opportunity, after the treatment would be very difficult.
■ Glossary
Rhabdomyolysis
Called rhabdomyolysis muscle dissolved. Many drugs can cause rhabdomyolysis (skeletal muscle) damage, light are manifested as muscle pain and fatigue, severe cases occur rhabdomyolysis, acute renal failure, even life-threatening.
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