ABSTRACT
BACKGROUND: Previous study suggested that Chinese Herbal Medicine (CHM) Formula Huashibaidu granule might shorten disease course of Corona Virus Disease 2019 (COVID-19) patients. Our research aims to investigate the early treatment effect of Huashibaidu granule in mild COVID-19 patients under well clinical management.METHODS: An unblended cluster-randomized clinical trial was conducted at the Dongxihu FangCang hospital. 2 cabins were randomly allocated to CHM or control group, with 204 randomly sampled mild COVID-19 patients in each cabin. All participants received a 7-day conventional treatment, and CHM group cabin used additional Huashibaidu granule 10g twice daily. Participants were followed up until they met clinical endpoint. The primary outcome was patient become worsening before clinical endpoint occurred. The secondary outcomes was discharge with cure before clinical endpoint occurred and relief of composite symptoms after 7 days treatment.FINDINGS: All 408 participants were followed up to meet clinical endpoint and included in statistical analysis. The baseline characteristics were comparable between 2 groups. The number of worsening patients in the CHM group was 5 (2.5%), and that in the control group was 16 (7.8%). There was a significant difference between groups (P=0.014). 8 foreseeable mild adverse events occurred without statistical difference between groups.INTERPRETATION: 7-day early treatment with Huashibaidu granule reduced worsening conversion of mild COVID-19 patients. Our study supports Huashibaidu Granule as an active option for early treatment of mild COVID-19 in similar medical locations with well management.TRIAL REGISTRATION: The Chinese Clinical Trial Registry: ChiCTR2000029763.FUNDING: This study was supported by “National Key R&D Program of China” (No.2020YFC0841500).DECLARATION OF INTERESTS: The authors guaranteed that there existed no competing interest in this paper.ETHICS APPROVAL STATEMENT: Ethics Review Committee of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Approval of Ethical Review Acceptance Number: S2020-001; Approval Number: P20001/PJ01.
Subject(s)
COVID-19 , Virus Diseases , Neurologic ManifestationsABSTRACT
Objective To sum up the clinical characteristics and chest computed tomography (CT) findings of severe and critical coronavirus disease 2019 (COVID-19) patients, and to explore the factors affecting the outcomes, so as to provide experience for the clinical diagnosis and treatment of severe and critical COVID-19. Methods The data of 25 severe and critical COVID-19 patients, who were treated in our hospital from Jan. 23, 2020 to Mar. 5, 2020, were collected. The clinical characteristics were retrospectively analyzed, and the clinical and laboratory indexes were compared between cured patients and uncured patients. The laboratory indicators of cured patients were further compared between the progressive and recovery stages. The chest CT findings of the patients were observed, and the lesion volume was quantified to assess the evolution of lung lesions using the CT image-based intelligent pneumonia lesion quantitative analysis software. Results There were 19 male and six female COVID-19 patients, and there were three deaths. The median age of 25 patients was 65 (63, 75) years old, and the body mass index (BMI) was 25.60 (23.51, 28.65) kg/m2. Twenty-two patients had a clear epidemiological history. Fever (22 cases) and cough (14 cases) were the most common first symptoms, and 18 patients had underlying diseases. Twelve patients were cured and discharged (median hospital stay was 25.5 d), and 13 patients were not cured, including three deaths and 10 cases with hospital stay>25 d with no remission. Compared with the uncured patients, the cured patients had significantly lower BMI, longer time from onset to progression to severe or critical illness, and higher CD4 +T lymphocyte counts (all P<0.05). Multivariate logistic regression analysis showed that high CD4 +T lymphocyte count was an independent protective factor for the cure and discharge of severe and critical COVID-19 patients (P=0.031). Compared with those in the progressive stage, the lymphocyte count and CD4 +T lymphocyte count of 12 cured patients were significantly higher in the progression stage, and the C-reactive protein (CRP) level, erythrocyte sedimentation rate (ESR) and procalcitonin level were significantly lower (all P<0.01). Twenty-one patients received chest CT examination in the progressive stage;and all of them had multiple ground-glass opacities and consolidation shadows of the multiple-lobe lateral band and the dorsal side of bilateral lungs, 20 cases had pleural thickening, 9 cases had a small amount of bilateral pleural effusion, and 8 cases had mediastinal lymphadenopathy. The 12 cured patients received CT examination during the recovery period, and their lesions were all improved to different extents;some patients had irregular fiber grid shadows and stripe shadows;and the pleural thickening and pleural effusion were reduced to different extents. The quantitative analysis curves showed that lesion volume in the 12 cured patients obviously increased in the progressive stage and reduced in the absorption stage, showing an inverted V shape;and lesion volume in the uncured patients (nine cases received CT examination for two or more times) showed a rapid increase in the progressive stage. Conclusion Most severe and critical COVID-19 patients in Shanghai are older, with higher BMI and underlying diseases. Low BMI, slow disease progression, and high CD4 +T lymphocyte count are beneficial to the improvement of COVID-19. The main findings of chest CT include multiple ground-glass opacities and consolidation shadows, mainly distributing in the lateral band and the dorsal side of lungs and mostly involving the pleura. The laboratory indexes, including the lymphocyte, CRP, CD4 +T lymphocyte, ESR and procalcitonin, and chest CT examination play an important role in the diagnosis, disease monitoring and prognosis assessment of COVID-19