Efficacy and safety of Chinese herbal medicine children's Zibei Xuanfei syrup in treating acute trachea-bronchitis with wind-heat invading lung syndrome: A randomized, double-blind, multicentre, controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Children's Zibei Xuanfei syrup is an herbal preparation from a lifetime professor, famous old Chinese doctor, and postgraduate supervisor of medical doctor of Shandong University of Traditional Chinese Medicine. This herbal preparation promotes lung health, relieves cough, reduces phlegm, and benefits pharynx. AIM OF THE STUDY: To verify the clinical efficacy and safety of Zibei Xuanfei syrup for children in treatment of acute trachea bronchitis with wind-heat invading lung syndrome. MATERIALS AND METHODS: This was an age-stratified, block randomized, double-blind, extremely low dose parallel control, multi-center clinical trial. A total of 453 pediatric patients diagnosed with acute tracheal bronchitis in Western medicine and cough due to exogenous factors with wind-heat invading lung syndrome in Chinese medicine were enrolled. They were divided into three subgroups based on age 1∼3, 4-7, and 8-14 years old, and randomly assigned to children's Zibei Xuanfei syrup and extremely low doses of children's Zibei Xuanfei syrup (control) in a 3:1 ratio. The primary outcome was the decreased values of cough Visual Analogue Scale (VAS) score after 7 days of administration. Secondary outcomes included a decrease in cough VAS score after 3 and 5 days of the administration, and the total score of Traditional Chinese Medicine(TCM) syndrome after 3, 5, and 7 days of treatment. The chest X-ray and blood C-reactive protein were examined during screening. The safety assessment included blood urine, and stool routine, liver and kidney function of laboratory tests, and an electrocardiogram at the screening and the last visit. RESULTS: The subjects of two groups had high administration adherence (completion over 80%) (299/323, 92.6% in children's Zibei Xuanfei syrup group vs 103/107, 96.3% in the control group; p > 0.05). The children's Zibei Xuanfei syrup group was significantly better than the control group in the decreased values of cough VAS score after 7 days of administration(6.35 ± 3.45 vs 3.73 ± 3.98, p < 0.001). The subgroup analysis of the decreased value of cough VAS scores aged 1-3 years old were 5.80 ± 3.43 vs 3.75 ± 4.38 (P = 0.003), 4-7 years old was 6.30 ± 3.69 vs 2.73 ± 3.65 (P < 0.001), and 8-14 years old were 6.91 ± 3.12 vs 4.69 ± 3.75(P = 0.001)respectively. The secondary outcomes decrease values of cough VAS score of children's Zibei Xuanfei syrup group vs control group after 5 days of administration were 5.88 ± 2.90 vs 3.55 ± 3.41(P < 0.001), after 3 days of administration were 3.61 ± 2.53 vs 2.43 ± 2.56 (P < 0.001). The effective rate of the TCM symptom total score of children's Zibei Xuanfei syrup group vs control group was 91.38% vs 54.95%after 7 days of the administration, 86.93% vs 50.94% after 5 days of the administration, and 64.78% vs 40.19% after 3 days administration(each p < 0.001). There was no significant difference in Adverse Event between the two groups (59/331, 17.82% vs 15/111, 13.51%, P > 0.05). The children's Zibei Xuanfei syrup group had 5 Serious Adverse Events (incidence rate 1.21%), all of which were unrelated to the trial drug. CONCLUSION: Children's Zibei Xuanfei syrup appears to be extremely effective and safe in the treatment of acute trachea bronchitis with wind-heat invading lung syndrome. Future studies with large sample sizes will need to collect more safety data use for children.

Effect of Jiuwei Zhuhuang Powder on Cough Resolution in Children with Upper Respiratory Tract Infections: A Multicenter Randomized Controlled Trial.

OBJECTIVE: To assess the effectiveness of Jiuwei Zhuhuang Powder (JWZH), a Tibetan patent medicine in treating upper respiratory tract infection (URTI) associated cough in children. METHODS: The study was a multicenter, randomized, open-label, controlled trial. A total of 142 children aged 2 to 14 years old, with URTI-associated cough within 48 h of onset, were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence. Children were treated with JWZH (1 to 1.5 g, twice to thrice daily) in the treatment group or conventional treatment (Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules, 0.25 to 1 g, thrice daily) in the control group for 5 days. The primary endpoints were the time to cough resolution and 4-day cough resolution rate. The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period. RESULTS: A total of 138 children were included in the intention-to-treat analysis, with 71 cases in the treatment group and 67 cases in the control group. Compared with the conventional treatment, the children receiving JWZH had a shorter time to cough resolution [hazard ratio, 2.10; 95% confidence interval (CI), 1.29-3.40; P=0.003]. The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment (2 days vs. 3 days; P<0.001). The 4-day cough resolution rate in the JWZH group was higher than that of the control group (94.4% vs. 74.6%; risk difference: 19.8%, 95% CI: 8.1%-31.5%; relative risk: 1.265, 95% CI: 1.088-1.470; P=0.001). There were no statistically significant differences in the improvement of other symptoms caused by URTI (P>0.05). Adverse events was reported in 5.6% (4/71) and 4.5% (3/67) in participants of JWZH and PPACCM groups (P>0.05), respectively, which were all mild and resolved without treatment. CONCLUSION: JWZH seemed to be a safe and effective therapy for URTI-associated cough in children. (Trial registration No. ChiCTR2000039421).

Significance of Patient Participation in Nursing Care.

Patient participation, an international requirement according to the World Health Organization and other international bodies, is a must in nursing care. It involves patient engagement in making their own treatment decisions, participating in the development and evaluation of services and taking part in policy development. Patient participation on the individual, organizational and policy development levels has been discussed. Facilitators of and barriers to active patient participation, as well as ways to enhance it, were also included in this review. Poor communication, a paternalistic approach, time constraints, lack of encouragement and lack of information-sharing are some of the challenges associated with poor patient participation in nursing care. Facilitators of patient participation include empowering patients, involving them in making decisions and policy making, understanding their perspective about their role in their care and empowerment through leadership. Patient participation in nursing care has numerous benefits including effective healthcare services, improved patient safety, enhanced quality of care, fewer medication errors, more medication adherence and assessment of the care services received.

Neuroprotective effect of CPDT on THA-induced cortical motor neuron death in an organotypic culture model.

Brain stroke, trauma, and motor neuron disease each can result in cortical motoneuron (CMN) death or impairment. Glutamate excitotoxicity induces motor neuron damage in both acute motor neuron loss and chronic motor neuron degeneration. It is necessary to find effective strategies to protect CMNs from excitotoxicity in a variety of pathological conditions. 5,6-Dihydrocyclopenta-1,2-dithiole-3-thione (CPDT) is one of the phase II enzyme inducers. In our previous report, CPDT was shown to have neuroprotective effects on the spinal cord, by activating the Nrf2/ARE pathway to increase antioxidative capacity. In this study, in order to figure out whether CPDT can prevent CMN's from THA-induced death, we set up an organotypic brain slice culture system. Threo-hydroxyaspartate (THA), a glutamate transport inhibitor, was added to the culture medium to induce CMN death by glutamate excitotoxicity. Brain slices were pretreated with CPDT for 48h, then treated with CPDT and THA simultaneously for 3 weeks. We found that pretreatment with CPDT significantly increased CMN survival. Glutamate concentration in the culture medium was significantly greater following THA treatment, whereas no significant decrease was found in the CPDT pretreatment group. However, both Nrf2 and HO-1 protein expression was significantly elevated in the CPDT pretreatment group, and Nrf2 protein translocated to the nucleus after CPDT stimulation. These findings suggest that CPDT can protect CMNs from THA-induced motor neuron death by activating the Nrf2 pathway and increasing HO-1 protein expression. Therefore, increasing antioxidative defense capacity should benefit to upper motor neuron survival following a glutamate excitotoxicity insult.