ABSTRACT
OBJECTIVES@#To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.@*METHODS@#A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.@*RESULTS@#An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).@*CONCLUSIONS@#Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Administration, Inhalation , China , Coronavirus Infections , Diagnosis , Drug Therapy , Mortality , Dose-Response Relationship, Drug , Drug Administration Schedule , Drugs, Chinese Herbal , Follow-Up Studies , Integrative Medicine , Interferon-alpha , Lopinavir , Pandemics , Pneumonia, Viral , Diagnosis , Drug Therapy , Mortality , Risk Assessment , Severe Acute Respiratory Syndrome , Diagnosis , Drug Therapy , Mortality , Severity of Illness Index , Survival RateABSTRACT
OBJECTIVES@#To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.@*METHODS@#A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.@*RESULTS@#An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).@*CONCLUSIONS@#Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Administration, Inhalation , China , Coronavirus Infections , Diagnosis , Drug Therapy , Mortality , Dose-Response Relationship, Drug , Drug Administration Schedule , Drugs, Chinese Herbal , Follow-Up Studies , Integrative Medicine , Interferon-alpha , Lopinavir , Pandemics , Pneumonia, Viral , Diagnosis , Drug Therapy , Mortality , Risk Assessment , Severe Acute Respiratory Syndrome , Diagnosis , Drug Therapy , Mortality , Severity of Illness Index , Survival RateABSTRACT
<p><b>OBJECTIVE</b>To assess the efficacy and safety of Zhongyan-4 (ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detoxication) in treating HIV/AIDS patients in the early or middle stage.</p><p><b>METHODS</b>Adopted was randomized double-blinded and placebo-parallel-controlled method, with 72 HIV/AIDS patients randomly divided into the ZY-4 group (36 patients) treated with ZY-4 and the control group (36 patients) treated with placebo. The treatment course was six months. The index of CD(4)(+), CD(8)(+) counts, body weight, clinical symptom scoring were estimated at 4 time points (0, 1, 3 and 6 month in the course), and also the viral load before and after treatment. The whole course of observation was completed in 63 patients, 30 in the ZY-4 group and 33 in the control group.</p><p><b>RESULTS</b>CD(4)(+) count in the ZY-4 group got elevated by 7.70 +/- 150.96/mm(3) on average, while that in the control group lowered by 27.33 +/- 85.28/mm(3). Fifteen out of the 30 patients in the ZY-4 group had their CD(4)(+) count increased, which was evidently much higher than that in the control group (8/33, P < 0.05), suggesting that the efficacy of ZY-4 is superior to that of placebo in elevating CD(4)(+) count. Moreover, ZY-4 showed actions in elevating CD(45)RA(+) and CD(8)(+) count, reducing HIV virus load, improving clinical symptom/sign and increasing body weight of patients. No obvious adverse reaction was found in the clinical trial.</p><p><b>CONCLUSION</b>ZY-4 has an immunity-protective and/or rebuilding function in HIV/AIDS patients in the early and middle stage, and also shows effects in lowering viral load, increasing body weight and improving symptoms and signs to a certain degree.</p>
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Acquired Immunodeficiency Syndrome , Drug Therapy , Allergy and Immunology , Virology , Anti-HIV Agents , Therapeutic Uses , Body Weight , CD4 Lymphocyte Count , CD4-CD8 Ratio , Double-Blind Method , Drugs, Chinese Herbal , Therapeutic Uses , HIV Infections , Drug Therapy , Allergy and Immunology , Virology , Leukocyte Common Antigens , Phytotherapy , Viral LoadABSTRACT
<p><b>OBJECTIVE</b>To detect p24 antigen of human immunodeficiency virus (HIV)-1 in the liver biopsy specimens of patients with HIV infection.</p><p><b>METHODS</b>Liver biopsy samples from 14 patients with HIV/AIDS (11 man, 3 women; age range 27-52 years; infection time range 8-13 years) were examined by immunohistochemistry prospectively.</p><p><b>RESULTS</b>Intracellular expression of HIV-1 p24 antigen was detected in Kupffer cells, endothelial cells and hepatocytes. There were more HIV-positive liver cells in the patients with severer liver damage than those with milder liver damage (t=2.5189, P=0.0270).</p><p><b>CONCLUSION</b>These findings indicate that HIV-1 could replicate in the liver of HIV-infected patients and might be related to the liver cells apoptosis.</p>
Subject(s)
Adult , Female , Humans , Male , Middle Aged , HIV Core Protein p24 , HIV Infections , Metabolism , Virology , HIV-1 , Physiology , Hepatocytes , Metabolism , Pathology , Host-Pathogen Interactions , Immunohistochemistry , Liver , Metabolism , Pathology , VirologyABSTRACT
<p><b>OBJECTIVE</b>To investigate the changes of blood corpuscles of patients with severe acute respiratory syndrome (SARS) in Beijing.</p><p><b>METHODS</b>Totally 43 patients (21 male and 22 female, 19-74 years old age range) diagnosed as of probable SARS were included in this study. Their corpuscles in the peripheral blood were tested every two days, and the results were analyzed.</p><p><b>RESULTS</b>Patients with SARS were more likely to develop leukocytopenia, lymphopenia and thrombocytopenia in the early period of disease than those in control group. The situation, especially lymphopenia and thrombocytopenia, could not be reversed in patients who died. Persistent low counts of lymphocytes and platelets at presentation might be associated with adverse outcomes.</p><p><b>CONCLUSION</b>Low counts of leukocytes, lymphocytes and platelets were common among patients in the early stage of SARS. Persistent Lymphopenia and thrombocytopenia may be associated with the prognosis.</p>