Wegzyn Colleen M, Fredrick Linda M, Stubbs Roxann O, Woodward William C, Norton Michael
1Abbott, Abbott Park, IL, USA.
J Int Assoc Physicians AIDS Care (Chic). 2012 Jul-Aug;11(4):252-9. doi: 10.1177/1545109712442984. Epub 2012 Apr 27.
Antiretroviral therapy is associated with adverse events (AEs). The most frequently reported AE associated with lopinavir/ritonavir (LPV/r) containing regimens is diarrhea. The objective of this meta-analysis is to describe the incidence, prevalence, and duration of diarrhea in individuals taking LPV/r.
This is a meta-analysis of Abbott-conducted clinical trials. Inclusion criteria included prospective randomized clinical trials with the LPV/r tablet formulation and had AE data (moderate/severe diarrhea) available through 48 weeks of treatment.
Three trials (total 1469 participants) met the inclusion criteria. In all, 11.2% of participants reported moderate/severe diarrhea by week 8, with median time to resolution of 7.4 weeks. The overall 48-week incidence of moderate/severe diarrhea was 15.5%. The discontinuation rate due to moderate/severe diarrhea was 1.3%.
Moderate/severe diarrhea occurred in less than 1 in 6 participants taking LPV/r, typically started in the first 8 weeks of treatment and infrequently resulted in premature discontinuation.
抗逆转录病毒疗法与不良事件（AE）相关。与含洛匹那韦/利托那韦（LPV/r）的治疗方案相关的最常报告的不良事件是腹泻。本荟萃分析的目的是描述服用LPV/r的个体中腹泻的发生率、患病率和持续时间。
这是一项对雅培公司开展的临床试验进行的荟萃分析。纳入标准包括采用LPV/r片剂剂型的前瞻性随机临床试验，且有治疗48周期间的不良事件数据（中度/重度腹泻）。
三项试验（共1469名参与者）符合纳入标准。总体而言，11.2%的参与者在第8周报告有中度/重度腹泻，腹泻缓解的中位时间为7.4周。48周时中度/重度腹泻的总体发生率为15.5%。因中度/重度腹泻导致的停药率为1.3%。
服用LPV/r的参与者中，不到六分之一会出现中度/重度腹泻，通常在治疗的前8周开始，很少导致提前停药。
