Randomised controlled trial of Jiandu granule in preventing chemoradiotherapy-induced oral mucositis.

OBJECTIVE: This clinical trial aimed to evaluate the efficacy and safety of Jiandu granule, a Chinese herbal medicine formula, for preventing oral mucositis in patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy. MATERIALS AND METHODS: A single-centre, open-label, randomised controlled trial was conducted, enrolling 138 patients with locally advanced nasopharyngeal carcinoma. Patients were randomly allocated to either the experimental group (n = 69) or the control group (n = 69). Both groups received concurrent chemoradiotherapy and standard care for oral mucositis, with the experimental group additionally receiving Jiandu granule intervention. The primary outcome was the incidence of severe oral mucositis (grade III to IV). RESULTS: In the full-analysis set, severe oral mucositis occurred in 14 of 69 (20.3%) patients in the experimental group and 31 of 69 (44.9%) patients in the control group (absolute risk reduction: 24.6%; relative risk reduction: 54.8%; p = 0.002; number needed to treat: 4). Jiandu granule was associated with mild/moderate gastrointestinal reactions, with an overall incidence of 5.9%. CONCLUSION: Jiandu granule reduced the incidence of severe oral mucositis in nasopharyngeal carcinoma patients during concurrent chemoradiotherapy and had an acceptable safety profile.

Usage of Chinese Herbs in Cancer Patients in Southern China: A Survey.

OBJECTIVE: To study the use of Chinese medicine (CM) in cancer patients in southern China. METHODS: A total of 1,950 cancer patients finished questionnaires in four provinces in southern China. The survey included socio-demographic and clinical characteristics of participants, dosage forms, efficacy, and side effects. RESULTS: The study results showed that cancer patients with higher education (>12 years) were more likely to accept the treatment of Chinese herbs. There were 54.61% (1,065 cases) of patients chose Chinese herbs for the initial treatment and 14.46% (282 cases) chose Chinese herbs as monotherapy. Most patients (54.51%, 1,063 cases) continuously used CM for more than 6 months, and a few of them (212 cases) used CM for up to 3 years. All kinds of dosage forms of CM had been used, including CM decoction, CM patent prescription and CM injection. Concerning the efficacy in the view of patients, 40.31% (786 cases) believed that it would be effective to take Chinese herbs before they starting the anti-cancer treatment, and the percentage increased to 81.08% after 1-month CM treatment. The effect of Chinese herbs was mainly demonstrated by symptom relief and improvement of quality of life, and 8.31% (162 cases) of patients experienced control of tumor growth and decreased tumor markers. Furthermore, only 14.31% (279 cases) participants reported that they experienced side effects during CM treatment. CONCLUSION: This large scale investigation reflects the current situation of domestic CM usage objectively and comprehensively, which might provide new ways for cancer treatment.

Efficacy and Safety of Banxia XieXin Decoction, a Blended Traditional Chinese Medicine, as Monotherapy for Patients With Advanced Hepatocellular Carcinoma.

PURPOSE: To explore a new therapeutic option for patients with hepatocellular carcinoma (HCC), the efficacy and safety of a group of traditional Chinese medicines (Banxia XieXin recipe) as monotherapy for patients with advanced HCC was studied. MATERIALS AND METHODS: The study included 68 patients with advanced HCC from August 16,2016 to August 15,2019 for analysis. These eligible patients received treatment with Banxia XieXin recipe for at least 1 month. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The secondary efficacy endpoints included objective response rate (ORR) and disease control rate (DCR). In addition, safety was also assessed. RESULTS: The median treatment duration of these 68 patients was 10.3 months (range = 1.6-33.5 months), and follow-up is still ongoing. The median PFS was 6.07 months (95% confidence interval [CI] = 3.748-8.392 months), and the median OS was 12.60 months (95% CI = 8.019-17.181 months). The ORR was 10.3% and the DCR was 41.2%. In the subgroup analysis, the median OS in the transcatheter arterial chemoembolization (TACE) group was not reached, and the median OS in the NO TACE group was 11.30 months (95% CI = 3.219-19.381 months). In addition, no drug-related serious adverse events were observed during the study. CONCLUSION: This is the first clinical analysis of traditional Chinese medicine as a single treatment for advanced HCC. The obtained results are encouraging as they suggest that this panel of Chinese herbs is safe and it may be effective for patients with advanced HCC in a real-world clinical setting.

Experimental Study of Shenfu Injection on the Prevention and Treatment of Paclitaxel Chemotherapy DRG Neuron Injury.

PURPOSE: The purpose of this paper is investigating the effect and mechanism of Shenfu injection (a Traditional Chinese Medicine injection form) on prevention and treatment of paclitaxel chemotherapy in peripheral nerve injury. METHODS: Wistar rat dorsal root ganglion cells were cultured in vitro and divided into groups of MOCK, PT, PT + LD, and PT + HD. Each group was cultured at a total serum concentration of 10%, including 10% blank serum in the MOCK group, 0.73 (IC30) µmol/L paclitaxel + 10% blank serum in the PT group, and 10% and 5% drug-containing serum and equal amount of paclitaxel were added into the high- and low-dosage groups, respectively. After culturing for 24 hours, the following tests were performed: (1) cell proliferation detected by using CCK-8 and a microplate reader; (2) axon length detected by cellular immunostaining and detection analysis on antibody ß-tubulin III; and (3) changes in mitochondrial membrane potential by analyzing immunofluorescence staining with JC-1 probe. RESULTS: (1) Cell proliferation: OD values of the MOCK group and PT group were 0.43 ± 0.02 and 0.25 ± 0.03, respectively (P < 0.05), while OD values of groups PT + LD and PT + HD were 0.41 ± 0.05 and 0.46 ± 0.03, respectively, higher than group PT (P < 0.05), while OD values of groups PT + LD and PT + HD were 0.41 ± 0.05 and 0.46 ± 0.03, respectively, higher than group PT (µmol/L paclitaxel + 10% blank serum in the PT group, and 10% and 5% drug-containing serum and equal amount of paclitaxel were added into the high- and low-dosage groups, respectively. After culturing for 24 hours, the following tests were performed: (1) cell proliferation detected by using CCK-8 and a microplate reader; (2) axon length detected by cellular immunostaining and detection analysis on antibody µmol/L paclitaxel + 10% blank serum in the PT group, and 10% and 5% drug-containing serum and equal amount of paclitaxel were added into the high- and low-dosage groups, respectively. After culturing for 24 hours, the following tests were performed: (1) cell proliferation detected by using CCK-8 and a microplate reader; (2) axon length detected by cellular immunostaining and detection analysis on antibody P < 0.05), while OD values of groups PT + LD and PT + HD were 0.41 ± 0.05 and 0.46 ± 0.03, respectively, higher than group PT (P < 0.05), while OD values of groups PT + LD and PT + HD were 0.41 ± 0.05 and 0.46 ± 0.03, respectively, higher than group PT (. CONCLUSION: Shenfu injection can prevent the toxicity of DRG neurons induced by paclitaxel, and its mechanism may be related to the alleviation of mitochondrial dysfunction.

[The Anti-virus Effect of AY358935 Gene on Vesicular Stomatitis Virus and the Mechanism Study].

OBJECTIVE: To explore the anti-virus effect of AY358935 gene cloned by our research team on vesicular stomatitis virus (VSV), and studytheanti-virus mechanism. METHODS: HEK293 cells were stably transfected by the AY358935 gene recombinant plasmid pcDNA3.1-AY358935 or pcDNA3.1 blank plasmid respectively. Then VSV was added into the cell wells to infect the above cells at the multiplicity of infection (MOI) of 0.001. The virus titers in the liquid supernatant of the above three groups of cells were detected on different time, and the mortality of cells of each group was tested with trypan blue exclusion test at 24 h post VSV infection. Total RNA was extracted from the cells that stably transfected with target gene for the whole genome-wide cDNA microarray analysis. RESULTS: ① Virus titer:The virus titer in the liquid supernatant of pcDNA-3.1-AY358935 transfection cells group was obviously lower than those in pcDNA-3.1 transfection cell group and blank control cell group at 12 h post infection. The virus titerin the liquid supernatant of three groups were (7.16±2.33)×105 PFU/mL, (6.25±2.05)×106 PFU/mL and (7.75±2.54)×106 PFU/mL respectively at 18 h post infection. At that time, the virus titerin the liquid supernatant of pcDNA3.1-AY358935 group was nearly 10 times lower than those of other two groups (P < 0.01). ②Mortality of cells:The cell mortality of pcDNA3.1-AY358935 group, pcDNA3.1 group and blank group were (35.00±6.68)%, (78.33±15.03)% and (83.34±14.98)% respectively at 24 h post infection.The cell mortality of pcDNA3.1-AY358935 group was significantly decreased comparing with other two groups (P < 0.01). ③Result of genes chip analysis: compared with pcDNA3.1 group, 30 cell genes were up-regulated by more than 3 times in pcDNA3.1-AY358935 group. Among them, the proportion of interferon-activating gene, interferon-effect gene, cytokine and chemokine was 27%, 17%, and 20%, respectively. CONCLUSION: AY358935 gene hasan anti-VSV effect, and its anti-virus mechanism may involve the interferon-associated natural immune response.