Efficacy and safety of Qinxiang Qingjie oral solution for the treatment of influenza in children: a randomized, double-blind, multicenter clinical trial.

Background: Qinxiang Qingjie (QXQJ), an oral solution containing various Chinese herbs, is indicated for pediatric upper respiratory tract infections. The treatment of influenza also shows potential advantages in shortening the duration of illness and improving symptoms. However, there is still a lack of high-quality clinical evidence to support this. The trial was to explore the efficacy and safety of QXQJ for treating pediatric influenza and provide an evidence-based basis for expanding its applicability. Methods: A randomized, double-blind, double-dummy, positive-controlled, multicenter clinical trial was conducted in 14 hospitals in China. Children aged 1-13 years with influenza and "exterior and interior heat syndromes" as defined by traditional Chinese medicine (TCM) were randomly assigned to two groups with 1:1 radio. Children in the test group received QXQJ oral solution and oseltamivir simulant, while the control group received oseltamivir phosphate granules and QXQJ simulant. The duration of treatment was five days, followed by a two-day follow-up period. The primary endpoint was the clinical recovery time. Secondary endpoints included the time to defervescence, incidences of complications and severe or critical influenza, negative conversion rate, improvement of TCM syndromes, and safety profiles of the therapeutics, which mainly contained the adverse clinical events and adverse drug reactions. Results: A total of 231 children were randomized to either the QXQJ (n=117) or oseltamivir (n=114) group. The FAS and PPS results showed that both groups experienced a median clinical recovery time of three days (P>0.05). The median time to defervescence of both groups were 36 hours in FAS and PPS (P>0.05), and two groups did not differ in terms of the other secondary endpoints (P>0.05). 14 patients (12.39%) in the QXQJ group and 14 patients (12.50%) in the oseltamivir group reported at least one adverse event, respectively. One serious adverse event occurred in the QXQJ group. There was no significant difference in the incidence of adverse events or adverse drug reactions between the groups. Conclusions: The efficacy of QXQJ oral solution was comparable to that of oseltamivir for treating influenza in children, with an acceptable safety profile. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900021060.

[Analysis of flavonoids in Coreopsis tinctoria by integrating 2D-TLC and HPLC-IT-TOF-MS].

The qualitative analysis of flavonoids in Coreopsis tinctoria was carried out by a combination of 2 D-TLC and HPLC-IT-TOF-MS. The separation was conducted on 2 D-TLC and a Phenomenex Kinetex Evo C_(18) column(2.1 mm×100 mm, 2.6 µm) with methanol-0.05% aqueous formic acid by gradient elution. Electrospray ionization-(ESI) source was applied and operated in both positive and negative ionization modes. Eighteen flavonoids including three flavonoids, one flavonol, nine flavonones, one flavanonol and four chalcones, were putatively identified from the flavone-enriched fraction of C. tinctoria. 2 D-TLC could separate the flavonoids from C. tinctoria. HPLC-IT-TOF-MS was able to quickly and accurately analyze the flavonoids in C. tinctoria. The results would provide experimental information for the efficacy material basis clarification of C. tinctoria.

Randomized controlled trial of mindfulness-based stress reduction (MBSR) on posttraumatic growth of Chinese breast cancer survivors.

Breast cancer (BC) patients in China suffered from a variety of psychology stress such as perceived stress and anxiety, posttraumatic growth (PTG) as a positive factor could promote their psychology health and quality of life. This study aimed to investigate the efficacy of mindfulness-based stress reduction (MBSR) on promoting PTG, decreasing perceived stress and anxiety of Chinese BC patients. A randomized controlled trial of 60 BC patients (Stages I-III) was conducted. They were randomly divided to the 8-week MBSR group or usual care (UC) group. PTG inventory, Perceived Stress Scale of Chinese version (CPSS) and State Trait Anxiety Inventory (STAI) evaluated the PTG level, perceived stress and anxiety at three times(before intervention-T1, after intervention-T2 and follow up at 3 months-T3). A repeated-measures analysis of variance model was used to compare each outcome measure of two groups at the three times. There was one patient discontinued the intervention and one lose to follow up in MBSR group, finally 58 BC patients completed the research. There was no difference between two groups before the intervention. The results showed significant improvements in MBSR group comparing with the UC group that PTG level was much higher after the 8-week intervention and the follow up (F = 34.73, p < .00). At the same time, CPSS (F = 14.41, p < .00) and STAI (F = 15.24, p < .00) scores were significant decreased at T2 and T3. The results showed that MBSR promoted the level of PTG and decreased perceived stress and anxiety state of Chinese BC patients, and the results persisted at three months after intervention. The research preliminary proved that MBSR was suitable to Chinese BC patients. MBSR should be recommending to BC survivors in China.