New Chemical Entities (NCEs) development is a systematic long-term project that involves multiple disciplines. The translation research will help to build an advanced R&D system from the basic laboratory research, preclinical studies and clinical evaluation to clinical application of drug, for the purpose of shortening the R&D cycle and accelerate the launch of new drugs. In new drug R&D and its clinical application, drug disposition (absorption, distribution, metabolism, excretion, ADME) properties are important criteria for assessing drug-likeness of candidates. ADME evaluation of NCEs plays an important role in the translation research throughout innovative drug R&D process. Therefore, ADME evaluation at the early stage of drug design and development will be helpful to improve the success rate and reduce costs, and further access to safe, effective drugs.

Objective:To evaluate the effectiveness and safety of Chinese herbal medicines (CHMs) for incomplete immune reconstruction in patients with HIV/AIDS.Methods:Eight electronic databases were searched for randomized controlled trials (RCTs) on the use of CHM for patients with HIV/AIDS with incomplete immune reconstruction.Outcomes included CD4+ cell count,quality of life,and adverse events/effects.The Cochrane Risk of Bias was employed to evaluate the methodological quality of the included RCTs.Results:We identified 13 eligible RCTs,with an overall high risk of bias,on 10 different CHMs.There was a significant increase in CD4+ cell count after the use of Jianpi Yiqi medicinal paste for 3 months;tripterygium glycosides tablets (TGTs) for 3 months (mean difference[MD]52.63 cells/μL,95％ confidence interval[CI,46.98,58.28]),6,9,and 12 months;Wenshen Jianpi granules for 6 months;Shenling Fuzheng capsules for 6 months (MD 49.53 cells/μL,95％ CI[8.45,90.61]) and 12 months;Aikeqing granules for 9 months (MD 61.51 cells/μL,95％ Cl[16.25,106.77]) and 12 months;Guipi decoction for 12 months;Mianyi No.2 granules (JT) for 12 and 18 months;and Chinese medicine granules for 18 months.The increase in the mean difference ofCD4+ cell count from 6 to 18 months was larger in Chinese medicine granules and Mianyi No.2 granules (JT).Guipi decoction and Jianpi Qushi decoction improved the Karnofsky score.Four RCTs reported the outcome of adverse events/effects,while four cases of minor adverse effects were reported in the TGTs group.Conclusion:Jianpi Yiqi medicinal paste,Wenshen Jianpi granules,Shenling Fuzheng capsules,Aikeqing granules,Guipi decoction,and TGTs may be effective in increasing CD4+ within 12 months,and Mianyi No.2 granules (JT) and Chinese medicine granules may show long-term effects.High-quality large RCTs on the effectiveness and safety of CHMs are still warranted.