Fu-Zheng-Tong-Luo formula promotes autophagy and alleviates idiopathic pulmonary fibrosis by controlling the Janus kinase 2/signal transducer and activator of transcription 3 pathway.

ETHNOPHARMACOLOGICAL RELEVANCE: Fu-Zheng-Tong-Luo (FZTL) formula is a Chinese herbal prescription which is used to treat idiopathic pulmonary fibrosis (IPF). We previously reported that the FZTL formula could improve IPF injury in rats; however, the mechanism remains unelucidated. AIM OF THE STUDY: To elucidate the effects and mechanisms of the FZTL formula on IPF. MATERIALS AND METHODS: The bleomycin-induced pulmonary fibrosis rat model and transforming growth factor-ß-induced lung fibroblast model were used. Histological changes and fibrosis formation were detected in the rat model after treatment with the FZTL formula. Furthermore, the effects of the FZTL formula on autophagy and lung fibroblast activation were determined. Moreover, the mechanism of FZTL was explored using transcriptomics analysis. RESULTS: We observed that FZTL alleviated IPF injury in rats and inhibited inflammatory responses and fibrosis formation in rats. Moreover, it promoted autophagy and inhibited lung fibroblast activation in vitro. Transcriptomics analysis revealed that FZTL regulates the Janus kinase 2 (JAK)/signal transducer and activator of the transcription 3 (STAT) signaling pathway. The JAK2/STAT3 signaling activator interleukin 6 inhibited the anti-fibroblast activation effect of the FZTL formula. Combined treatment with the JAK2 inhibitor (AZD1480) and autophagy inhibitor (3-methyladenine) did not enhance the antifibrotic effect of FZTL. CONCLUSIONS: The FZTL formula can inhibit IPF injury and lung fibroblast activation. Its effects are mediated via the JAK2/STAT3 signaling pathway. The FZTL formula may be a potential complementary therapy for pulmonary fibrosis.

Efficiency and Safety of Baofei Granules in Chronic Obstructive Pulmonary Disease (Lung and Spleen Qi Deficiency Syndrome): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial.

Background: Baofei Granules (BFGs) have been extensively applied in the clinical treatment of chronic obstructive pulmonary disease (COPD) and significantly have affected COPD patients with lung and spleen qi deficiency syndrome. However, the data from previous small-sample clinical trials are limited. This trial aimed to estimate the efficiency and safety of BFGs in COPD with lung and spleen qi deficiency syndrome. Methods: It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. The 216 stable COPD patients will be divided randomly in a ratio of 1:1. The whole trial period consists of a 4-week introductory period, a 52-week treatment period and a 48-week follow-up. Study visits occur every 4 weeks during the treatment period and every 12 weeks during the follow-up. All the subjects will receive 10g BFGs or placebo three times per day for 56 weeks and be followed up for 48 weeks. The primary efficiency evaluation outcome will be the frequency and duration of AECOPD, and the secondary efficiency evaluation outcome will be pulmonary function tests (PFTs), modified Medical Research Council (mMRC) dyspnoea scale, six-minute walking test (6MWT), COPD assessment test (CAT) score, traditional Chinese medicine (TCM) syndrome score, the frequency of emergency medication, BODE index, and the time to first Clinically important deterioration (CID). The safety evaluation outcomes will be adverse events (AEs), vital signs, physical examination, twelve-lead electrocardiogram (ECG), and laboratory examinations. All the data will be analyzed by SAS9.4. Discussion: This is the first and largest clinical trial that evaluates the efficiency and safety of BFGs for COPD with lung and spleen qi deficiency syndrome. It will provide valuable clinical evidence for recommendations on COPD management by the integrated TCM and western medicine. Trial Registration: CTR20211280. Date: June 09, 2021. http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml?id=383a370ecd9f43d7af6f1c8585779e1a.

[Xingnao Kaiqiao acupuncture on promoting wake-up of vegetative state after brain injury].

OBJECTIVE: To observe the clinical effect of Xingnao Kaiqiao acupuncture on promoting wake-up of vegetative state after brain injury on the basis of comprehensive rehabilitation training. METHODS: A total of 100 patients with vegetative state after brain injury were randomly divided into an observation group (50 cases, 2 cases dropped off) and a control group (50 cases). Both groups were treated with routine clinical treatment. The patients in the control group were treated with rehabilitation and hyperbaric oxygen; on the basis of the control group treatment, the patients in the observation group were treated with Xingnao Kaiqiao acupuncture at Neiguan (PC 6), Shuigou (GV 26), Sanyinjiao (SP 6), Chize (LU 5), Weizhong (BL 40), Hegu (LI 4) and Taichong (LR 3). The acupuncture was given once a day, 5 days per week, for continuous 30 days. The Glasgow coma scale (GCS) and coma recovery scale-revised (CRS-R) scores were observed before treatment and 10, 20 and 30 days into treatment. The wake-up rate of the two groups was compared after treatment. RESULTS: On 10, 20 and 30 days into treatment, the GCS and CRS-R scores in the two groups were higher than those before treatment (P<0.01), and the scores in the observation group were higher than those in the control group (P<0.01). After treatment, the wake-up rate was 16.7% (8/48) in the observation group, which was higher than 12.0% (6/50) in the control group (P<0.01). CONCLUSION: On the basis of comprehensive rehabilitation and wake-up promotion therapy, the Xingnao Kaiqiao acupuncture could promote the recovery of consciousness level in patients with vegetative state after brain injury.

Early therapeutic interventions of traditional Chinese medicine in COVID-19 patients: A retrospective cohort study.

OBJECTIVE: To observe the early interventions of traditional Chinese Medicine (TCM) on the conversion time of nucleic acid in patients with coronavirus disease 2019 (COVID-19), and find possible underlying mechanisms of action. METHODS: A retrospective cohort study was conducted on 300 confirmed COVID-19 patients who were treated with TCM, at a designated hospital in China. The patients were categorized into three groups: TCM1, TCM2 and TCM3, who respectively received TCM interventions within 7, 8-14, and greater than 15 days of hospitalization. Different indicators such as the conversion time of pharyngeal swab nucleic acid, the conversion time of fecal nucleic acid, length of hospital stay, and inflammatory markers (leukocyte count, and lymphocyte count and percentage) were analyzed to observe the impact of early TCM interventions on these groups. RESULTS: The median conversion times of pharyngeal swab nucleic acid in the three groups were 5.5, 7 and 16 d (P < 0.001), with TCM1 and TCM2 being statistically different from TCM3 (P < 0.01). TCM1 (P < 0.05) and TCM3 (P < 0.01) were statistically different from TCM2. The median conversion times of fecal nucleic acid in the three groups were 7, 9 and 17 d (P < 0.001). Conversion times of fecal nucleic acid in TCM1 were statistically different from TCM3 and TCM2 (P < 0.01). The median lengths of hospital stay in the three groups were 13, 16 and 21 d (P < 0.001). TCM1 and TCM2 were statistically different from TCM3 (P < 0.01); TCM1 and TCM3 were statistically different from TCM2 (P < 0.01). Both leucocyte and lymphocyte counts increased gradually with an increase in the length of hospital stay in TCM1 group patients, with a statistically significant difference observed at each time point in the group (P < 0.001). Statistically significant differences in lymphocyte count and percentage in TCM2 (P < 0.001), and in leucocyte count (P = 0.043) and lymphocyte count (P = 0.038) in TCM3 were observed. The comparison among the three groups showed a statistically significant difference in lymphocyte percentage on the third day of admission (P = 0.044). CONCLUSION: In this study, it was observed that in COVID-19 patients treated with a combination of Chinese and Western medicines, TCM intervention earlier in the hospital stay correlated with faster conversion time of pharyngeal swab and fecal nucleic acid, as well as shorter length of hospital stay, thus helping promote faster recovery of the patient. The underlying mechanism of action may be related to improving inflammation in patients with COVID-19.

Effects of Tanreqing Capsule on the negative conversion time of nucleic acid in patients with COVID-19: A retrospective cohort study.

OBJECTIVE: Traditional Chinese medicine plays a significant role in the treatment of the pandemic of coronavirus disease 2019 (COVID-19). Tanreqing Capsule (TRQC) was used in the treatment of COVID-19 patients in the Shanghai Public Health Clinical Center. This study aimed to investigate the clinical efficacy of TRQC in the treatment of COVID-19. METHODS: A retrospective cohort study was conducted on 82 patients who had laboratory-confirmed mild and moderate COVID-19; patients were treated with TRQC in one designated hospital. The treatment and control groups consisted of 25 and 57 cases, respectively. The treatment group was given TRQC orally three times a day, three pills each time, in addition to conventional Western medicine treatments which were also administered to the control group. The clinical efficacy indicators, such as the negative conversion time of pharyngeal swab nucleic acid, the negative conversion time of fecal nucleic acid, the duration of negative conversion of pharyngeal-fecal nucleic acid, and the improvement in the level of immune indicators such as T-cell subsets (CD3, CD4 and CD45) were monitored. RESULTS: COVID-19 patients in the treatment group, compared to the control group, had a shorter negative conversion time of fecal nucleic acid (4 vs. 9 days, P = 0.047) and a shorter interval of negative conversion of pharyngeal-fecal nucleic acid (0 vs. 2 days, P = 0.042). The level of CD3+ T cells increased in the treatment group compared to the control group ([317.09 ± 274.39] vs. [175.02 ± 239.95] counts/µL, P = 0.030). No statistically significant differences were detected in the median improvement in levels of CD4+ T cells (173 vs. 107 counts/µL, P = 0.208) and CD45+ T cells (366 vs. 141 counts/µL, P = 0.117) between the treatment and control groups. CONCLUSION: Significant reductions in the negative conversion time of fecal nucleic acid and the duration of negative conversion of pharyngeal-fecal nucleic acid were identified in the treatment group as compared to the control group, illustrating the potential therapeutic benefits of using TRQC as a complement to conventional medicine in patients with mild and moderate COVID-19. The underlying mechanism may be related to the improved levels of the immune indicator CD3+ T cells.

[Midnight-noon ebb-flow acupuncture combined with rehabilitation therapy for severe craniocerebral trauma patients with vegetative state: a randomized controlled trial].

OBJECTIVE: To compare the clinical therapeutic effect of midnight-noon ebb-flow acupuncture combined with rehabilitation therapy and simple rehabilitation therapy in severe craniocerebral trauma patients with vegetative state. METHODS: A total of 100 patients were randomized into an observation group and a control group, 50 cases in each one. Basic treatment of medication, hyperbaric oxygen therapy and specialized nursing were given in both groups. In the control group, rehabilitation therapy was adopted for 30 min each time, once a day. On the basis of the control group, midnight-noon ebb-flow acupuncture was applied in the observation group, the needles were sustained for 30 min, once a day, 5 times a week. The treatment was for 30 days in both groups. Before treatment and after 10, 20, 30 days of treatment, scores of Glasgow coma scale (GCS) and coma recovery scale-revised (CRS-R) were observed, and the conscious rate after treatment was calculated in both groups. RESULTS: Compared before treatment, the GCS and CRS-R scores after 10, 20, 30 days of treatment were increased in both groups (P<0.01), and the scores in the observation group were superior to those in the control group (P<0.01). After treatment, the conscious rate was 20.0% (10/50) in the observation group, which was superior to 12.0% (6/50) in the control group (P<0.01). CONCLUSION: Midnight-noon ebb-flow acupuncture combined with rehabilitation therapy can effectively treat the severe craniocerebral trauma patients with vegetative state, improve the consciousness level, and have superior therapeutic effect compared with simple rehabilitation therapy.

Efficacy and safety of CT-guided 125I seed implantation as a salvage treatment for locally recurrent head and neck soft tissue sarcoma after surgery and external beam radiotherapy: A 12-year study at a single institution.

OBJECTIVES: The objective of this study was to evaluate the efficacy and safety of CT-guided radioactive 125I seed implantation as a salvage treatment for locally recurrent head and neck soft tissue sarcoma (HNSTS) after surgery and external beam radiotherapy. METHODS AND MATERIALS: From December 2006 to February 2018, 25 patients with locally recurrent HNSTS after surgery and external beam radiotherapy were enrolled. All the patients successfully underwent CT-guided 125I seed implantation. The primary end points included the objective response rate (ORR) and local progression-free survival (LPFS). The secondary end points were survival (OS) and safety profiles. RESULTS: After 125I seed implantation, the ORR was 76.0%. The 1-, 3-, and 5-year LPFS rates were 65.6%, 34.4%, and 22.9%, respectively, with the median LPFS of 16.0 months. The 1-, 3-, and 5-year OS rates were 70.8%, 46.6%, and 34.0%, respectively, with the median OS of 28.0 months. Furthermore, univariate analyses showed that the recurrent T stage and histological grade were prognostic factors of LPFS, whereas only the histological grade was a predictor of OS. The major adverse events were skin/mucosal toxicities, which were generally of lower grade (≤Grade 2) and were well tolerated. CONCLUSIONS: Radioactive 125I seed implantation could be an effective and safe alternative treatment for locally recurrent HNSTS after failure of surgery and radiotherapy. Recurrent T stage and histological grade were the main factors influencing the efficacy.