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 study effects of autogenous femoral head bone grafting combined with total hip replacement for the treatment of old center dislocation of hip joint, and to evaluate the superiority of acetabular defect reconstruction with autogenous bone.</p><p><b>METHODS</b>From March 2008 to December 2013, 16 patients (16 hips) with old center dislocation of hip joint were treated with autologous bone graft combined with total hip replacement. There were 11 males and 5 females, ranging in age from 41 to 72 years old, with an average of 56.3 years old. The duration of the disease ranged from 3.6 to 37.2 years. Twelve patients had injuries caused by traffic accidents and 4 patients were caused by falling down. The hip joint pain at the first month after operation, Harris score and hip joint movement of all patients were observed by using electronic case follow-up system.</p><p><b>RESULTS</b>All the patients were followed up, and the duration ranged from 11 to 78 months, with an average of 27.3 months. The postoperative hip joint movement of (56.2±23.4)° VAS 86.3±7.2 and Harris score 32.6±12.6 were all better than preoperative (181.8±17.6)°, 11.1±2.6 and 86.3±7.2. The joint pain was reduced and the function limitation was improved after operation, and the prosthesis position was good.</p><p><b>CONCLUSION</b>When the autologous femoral head bone grafting combined with total hip arthroplasty is used to treat old hip central dislocation, the initial and long-term stability of acetabular bone grafting is good, and the technique can avoid allogeneic bone complications, bone source rationally and reduce the economic burden of patients.</p>