Zhou Huaying, Zheng Yuhuang, He Yan, Gong Guozhong, Chen Zi, Liu Meng, Yin Wei, Liu Chun
AIDS Research Laboratory, Second Xiangya Hospital, Changsha 410011, China.
Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2009 Aug;34(8):731-7.
To evaluate the long-term efficacy and safety of nevirapine (NVP)-based regimens for HIV-infected Chinese patients in routine clinical practice.
From October 2002 to May 2004, 57 HIV-1-infected patients commenced highly active antiretroviral therapy (HAART), and were followed to December 2008. They originally received 2 nucleoside reverse transcriptase inhibitors (NRTIs) and nevirapine. HIV RNA levels, T lymphocyte subsets and safety were assessed. Blood routine test and main laboratory parameter changes were traced. If apparent side effects or virological failure appeared we would, if necessary, terminate the therapy or change the regimen.
Of the 57 subjects, 34 were followed-up for more than 4 years. After 5-6 years, 63.3% of the subjects (19/30) had HIV RNA levels<50 copies/microL, and the median increase in CD4(+) cell count from the baseline was 329 cells/microL. The mean decrease in CD8(+) cell count was 128 cells/microL. At the same time, the CD4(+) CD45RA+CD62L cell count and CD4(+)CD45RO(+) cell gradually increased, and the counts of CD8(+)CD38(+) cell declined gradually. These changes are apparent 2 years after HAART. The increase rate slowed down after 2 years. But they did not recover completely as well as healthy people at year 6. About 56% (32/57) of HIV-infected patients developed various drug-related side effects. The most common was gastrointestinal side effect, followed nervous disorder, baldness, and rashes, mostly happened in 6 months. Gamma-GT increased occurred in 29.8% of patients (17/57), and serum cholesterol and triglyceride elevated in 26.3% of the patients (15/57). Six patients developed lipodystrophy, mainly in female patients, and 25 patients showed abnormal blood picture and liver function, renal function changes and amylase elevation. Grade 3-4 adverse events occurred in 3 cases (2 peripheral neuropathy, and 1 suspected lactic acidosis). One subject experienced grade 3 rashes.
Antiretroviral therapy with NVP-based regimens is safe and effective by suppressing HIV viremia and producing continued CD4 cell increases in subjects with HIV or AIDS for 6 years.
评估在常规临床实践中，以奈韦拉平（NVP）为基础的治疗方案对中国HIV感染患者的长期疗效和安全性。
2002年10月至2004年5月，57例HIV-1感染患者开始接受高效抗逆转录病毒治疗（HAART），并随访至2008年12月。他们最初接受2种核苷类逆转录酶抑制剂（NRTIs）和奈韦拉平治疗。评估HIV RNA水平、T淋巴细胞亚群及安全性。追踪血常规检查及主要实验室参数变化。若出现明显副作用或病毒学失败，必要时将终止治疗或更换治疗方案。
57例受试者中，34例随访超过4年。5至6年后，63.3%的受试者（19/30）HIV RNA水平<50拷贝/微升，CD4(+)细胞计数较基线的中位数增加329个细胞/微升。CD8(+)细胞计数平均下降128个细胞/微升。同时，CD4(+)CD45RA+CD62L细胞计数及CD4(+)CD45RO(+)细胞逐渐增加，CD8(+)CD38(+)细胞计数逐渐下降。这些变化在HAART治疗2年后明显。2年后增加速率减缓。但在第6年时未完全恢复至健康人水平。约56%（32/57）的HIV感染患者出现各种药物相关副作用。最常见的是胃肠道副作用，其次是神经紊乱、脱发和皮疹，大多发生在6个月内。29.8%的患者（17/57）γ-谷氨酰转移酶升高，26.3%的患者（15/57）血清胆固醇和甘油三酯升高。6例患者出现脂肪代谢障碍，主要为女性患者，25例患者出现血常规及肝功能、肾功能异常和淀粉酶升高。3例患者发生3 - 4级不良事件（2例周围神经病变，1例疑似乳酸酸中毒）。1例受试者出现3级皮疹。
以NVP为基础的抗逆转录病毒治疗方案安全有效，可抑制HIV病毒血症，并使HIV或艾滋病患者的CD4细胞持续增加6年。
