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本帖最后由 interdetect 于 2011-4-13 22:16 编辑
Musculoskeletal(对肌肉骨骼肌的影响始终是一个问题啊)Increased CK(肌酸激酶升高) occurred more frequently during telbivudine treatment during clinical trials. By 104 weeks of treatment, 79% of telbivudine-treated patients and 47% of lamivudine-treated patients reported Grade 1 to 4 CK elevations. Thirteen percent and 4% of telbivudine- and lamivudine-treated patients reported Grade 3 or 4 CK elevations, respectively. Most patients with CK elevations did not exhibit symptoms, but the average recovery time was longer in telbivudine-treated patients versus lamivudine-treated patients. Of the telbivudine-treated patients with Grade 1 to 4 CK elevations, 10% experienced a musculoskeletal side effect compared to 5% of lamivudine-treated patients.
Myopathy(肌病) has been reported with telbivudine use several weeks to months following treatment initiation.
Musculoskeletal side effects have included increased CK (11%), arthralgia (4%), back pain (4%), myalgia (3%), myopathy, myositis, and muscular weakness. CK greater than 7 times upper limit of normal (ULN) has been reported in 13% of patients. Fibromyalgia, muscle strain, chest wall pain, noncardiac chest pain, chest discomfort, flank pain, muscle cramp, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal discomfort, musculoskeletal stiffness, myofascial pain syndrome, neck pain, pain in extremity, and tenderness have been reported. Rhabdomyolysis has been reported during postmarketing experience.
GastrointestinalGastrointestinal side effects have included diarrhea (6%), upper abdominal pain (6%), nausea (5%), abdominal pain (3%), abdominal distension (3%), and dyspepsia (3%). Lipase greater than 2.5 times ULN (2%) and amylase greater than 3 times ULN (less than 1%) have been reported. Gastritis, sore throat, dry mouth, decreased appetite, abdominal discomfort, lower abdominal pain, and gastrointestinal pain have been reported.
Nervous systemNervous system side effects have included headache (10%), dizziness (4%), insomnia (3%), and peripheral neuropathy. Migraine, sinus headache, and tension headache have been reported. Paresthesia and hypoesthesia have been reported during postmarketing experience.
HepaticHepatic side effects have included increased ALT (3%), hepatitis B exacerbation (2%), and lactic acidosis and severe hepatomegaly with steatosis. ALT greater than 10 times ULN and 2 times baseline (5%), ALT greater than 3 times baseline (7%), AST (SGOT) greater than 3 times baseline (6%), and total bilirubin greater than 5 times ULN (less than 1%) have been reported. Hypercholesterolemia has been reported. Posttreatment exacerbations of hepatitis have occurred after discontinuation of telbivudine.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of telbivudine and other nucleoside analogs alone or in combination with other antiretroviral agents.
The incidence of ALT flares (ALT greater than 10 times ULN and greater than 2 times baseline) was similar (3%) in the two treatment arms in the first 6 months. After week 24, ALT flares were reduced to 2% in telbivudine-treated patients versus 5% in lamivudine-treated patients.
MetabolicMetabolic side effects have included lactic acidosis during postmarketing experience.
HematologicHematologic side effects have included neutropenia (absolute neutrophil count less than or equal to 749/mm3; 2%) and thrombocytopenia (platelets less than or equal to 49,999/mm3; less than 1%).
OtherOther side effects have included fatigue (13%) and pyrexia (4%). Malaise, vertigo, influenza and influenza-like symptoms, and postprocedural pain have been reported.
RespiratoryRespiratory side effects have included cough (6%) and pharyngolaryngeal pain (5%). Upper respiratory tract infection and nasopharyngitis have been reported.
DermatologicDermatologic side effects have included rash (4%), pruritus (2%), and acne.
RenalAt least one patient reporting polyuria was receiving a diuretic for ascites.
Renal side effects have included polyuria.
GenitourinaryGenitourinary side effects have included hematuria and irregular menstruation
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