Traditional Chinese Medicine Center for Acquired Immune Deficiency Syndrome Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China.
J Tradit Chin Med. 2022 Jun;42(3):432-438. doi: 10.19852/j.cnki.jtcm.2022.03.010.
To investigate whether Mianyi granules (+mianyi+) are effective and safe in reversing immune nonresponse following antiretroviral therapy (ART) in individuals with human immunodeficiency virus (HIV) infection.
Randomized, double-blind, multi-center, placebo-controlled trial (factorial design) of daily oral Mianyi granules versus placebo for 72 weeks. A total of 361 HIV-positive individuals receiving ART at five Class III Grade I hospitals in China between September 2013 and January 2016 completed the study. The primary endpoints were frequencies of CD3+, CD4+, CD8+, and CD45RA+ cells at seven timepoints over the 72 weeks. Secondary endpoints included viral loads, clinical symptoms, and quality of life at 72 weeks.
A total of 400 participants were enrolled in the study and randomized, of whom 361 completed the study: 189 individuals (140 men and 49 women) in the Mianyi granule group and 172 individuals (135 men and 37 women) in the placebo group. In the intent-to-treat population, CD4+ T cell counts increased from (193 ± 71) cells/mm at baseline to (288 ± 131) cells/mm post-treatment in the Mianyi granule group and from (200 ± 75) cells/mm at baseline to (264 ± 124) cells/mm post-treatment in the placebo group. Patients treated with Mianyi granule had higher increases in CD4+ T cell counts than those treated with placebo ( = 0.045). Reversal of immune nonresponse was defined as a CD4+ T cell increase of more than 100 cells/mm3. After treatment for 72 weeks, Mianyi granule was effective in reversing immune nonresponse in a higher proportion of individuals (20.2%) compared with placebo (9.7%). CD45RA+ cell counts increased from (34 ± 32) cell/mm at baseline to (51 ± 61) cells/mm post-treatment in the Mianyi granule group and from (37 ± 33) cells/mm at baseline to (48 ± 37) cells/mm post-treatment in the placebo group. Mianyi granules were more effective than placebo in increasing CD45RA+ cell counts.
In ART-treated HIV-positive adults with immune nonresponse, treatment with Mianyi granules for 72 weeks was safe and significantly increased CD4+ and CD45RA+ cell counts, thereby promoting immune reconstitution.
研究在接受抗逆转录病毒疗法（ART）治疗的人类免疫缺陷病毒（HIV）感染者中，每日口服绵薏颗粒（+绵薏+）是否能有效逆转免疫无应答。
这是一项随机、双盲、多中心、安慰剂对照试验（析因设计），共纳入 361 例在中国 5 家三级甲等医院接受 ART 治疗的 HIV 阳性个体，于 2013 年 9 月至 2016 年 1 月进行为期 72 周的口服绵薏颗粒或安慰剂治疗。主要终点为 72 周内 7 个时间点 CD3+、CD4+、CD8+和 CD45RA+细胞的频率。次要终点包括 72 周时的病毒载量、临床症状和生活质量。
共有 400 名参与者入组并随机分组，其中 361 名完成了研究：绵薏颗粒组 189 名（140 名男性和 49 名女性），安慰剂组 172 名（135 名男性和 37 名女性）。在意向治疗人群中，绵薏颗粒组 CD4+T 细胞计数从基线时的（193±71）个/μl增加至治疗后的（288±131）个/μl，安慰剂组从基线时的（200±75）个/μl增加至治疗后的（264±124）个/μl。与安慰剂组相比，绵薏颗粒组 CD4+T 细胞计数的增加更高（=0.045）。免疫无应答的逆转定义为 CD4+T 细胞增加超过 100 个/μl。治疗 72 周后，与安慰剂组（9.7%）相比，绵薏颗粒组有更高比例的个体（20.2%）发生免疫无应答逆转。CD45RA+细胞计数从基线时的（34±32）个/μl增加至治疗后的（51±61）个/μl，安慰剂组从基线时的（37±33）个/μl增加至治疗后的（48±37）个/μl。与安慰剂相比，绵薏颗粒更能有效增加 CD45RA+细胞计数。
在接受 ART 治疗的 HIV 阳性免疫无应答成人中，绵薏颗粒治疗 72 周安全且显著增加 CD4+和 CD45RA+细胞计数，从而促进免疫重建。
