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中国广西地区 HIV 感染者使用中草药治疗的研究:基于真实世界数据的倾向评分匹配分析。

Chinese herbal medicine for patients living with HIV in Guangxi province, China: A propensity score matching analysis of real-world data.

机构信息

Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.

Beijing Key Laboratory of the Innovative Development of Functional Staple and the Nutritional Intervention for Chronic Disease, China National Research Institute of Food & Fermentation Industries Co,. Ltd, Beijing, China.

出版信息

PLoS One. 2024 Sep 6;19(9):e0304332. doi: 10.1371/journal.pone.0304332. eCollection 2024.

Abstract

BACKGROUND

From 2004 onwards, the Chinese government has freely offered complimentary Chinese herbal medicine (CHM) to Chinese HIV/AIDS patients, alongside the prescribed first line therapy of highly active antiretroviral therapy (HAART). Thus, we aimed to explore the effectiveness and safety of CHM for patients with HIV/AIDS.

METHODS

The data from the Guangxi pilot database and antiviral treatment sites database have been respectively developed into two datasets in this prospective cohort real-world study, the CHM combined HAART group (the integrated group) and the HAART group. A 1:1 propensity score matching (PSM) was performed and the longitudinal data were analyzed using a generalized estimating equation (GEE) model with an autocorrelation matrix and log link function attached to the Gamma distribution.

RESULTS

A final sample of 629 patients, 455 and 174 in the integrated group and HAART group respectively, were obtained from the full dataset. As covariates for PSM, gender, age, baseline CD4+ and CD4+/ CD8+ were assessed based on the results of the logistic regression analyses. Following PSM, 166 pairs from the full dataset were matched successfully, with 98 pairs in the baseline CD4+ > 200 subgroup, and 55 pairs in the baseline CD4+ ≤ 200 subgroup. In the full dataset, HAART group achieved higher CD4+ count (OR = 1.119, 95%CI [1.018, 1.230]) and CD4+/CD8+ ratio (OR = 1.168, 95%CI [1.045, 1.305]) than the integrated group, so did in the CD4+ > 200 subgroup. For the CD4+ ≤ 200 subgroup, the CD4+ (OR = 0.825, 95%CI [0.694, 0.980]) and CD4+/CD8+ (OR = 0.826, 95%CI [0.684, 0.997]) of the integrated group were higher than those of the HAART group. The safety outcomes showed that there were no significant differences in BUN, ALT and AST levels between the groups but Cr showed significantly higher levels in HAART groups of all three datasets.

CONCLUSIONS

Compared to HAART alone, CHMs combined with HAART had better effects in improving the immune function of HIV/AIDS in patients with baseline CD4+ count ≤ 200. The results of the two subgroups are in opposite directions, and chance does not explain the apparent subgroup effect. A study with larger sample size and longer follow-up period is warranted in order to increase study credibility.

摘要

背景

自 2004 年以来,中国政府一直为中国艾滋病毒/艾滋病患者免费提供中草药(CHM),并辅以高效抗逆转录病毒治疗(HAART)的一线治疗。因此,我们旨在探讨 CHM 对艾滋病毒/艾滋病患者的有效性和安全性。

方法

本前瞻性队列真实世界研究分别从广西试点数据库和抗病毒治疗点数据库中开发了两个数据集,即 CHM 联合 HAART 组(联合组)和 HAART 组。采用 1:1 倾向评分匹配(PSM),并使用广义估计方程(GEE)模型对纵向数据进行分析,该模型附有自相关矩阵和对数链接函数,适用于伽马分布。

结果

从完整数据集共获得 629 名患者,分别来自联合组和 HAART 组的 455 名和 174 名患者。基于逻辑回归分析的结果,将性别、年龄、基线 CD4+和 CD4+/CD8+作为 PSM 的协变量进行评估。在 PSM 后,从完整数据集成功匹配了 166 对,其中基线 CD4+>200 亚组有 98 对,基线 CD4+≤200 亚组有 55 对。在完整数据集和基线 CD4+>200 亚组中,HAART 组的 CD4+计数(OR=1.119,95%CI[1.018,1.230])和 CD4+/CD8+比值(OR=1.168,95%CI[1.045,1.305])均高于联合组,而在基线 CD4+≤200 亚组中则无差异。对于基线 CD4+≤200 亚组,联合组的 CD4+(OR=0.825,95%CI[0.694,0.980])和 CD4+/CD8+(OR=0.826,95%CI[0.684,0.997])高于 HAART 组。安全性结果表明,两组的 BUN、ALT 和 AST 水平无显著差异,但 Cr 在所有三个数据集的 HAART 组中均显示出较高水平。

结论

与单独使用 HAART 相比,CHM 联合 HAART 对改善基线 CD4+计数≤200 的艾滋病毒/艾滋病患者的免疫功能有更好的效果。两个亚组的结果方向相反,偶然性并不能解释明显的亚组效应。为了提高研究可信度,需要进行更大样本量和更长随访时间的研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cb17/11379241/111041e5ac6e/pone.0304332.g001.jpg

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