Background GW117(N-(2-(6-chloro-7-deuteromethoxynaphthalen-1-yl)ethyl)acetamide)is a dual-acting agent(MT1/MT2 agonist,5-HT_(2C)antagonist)with prior evidence of antidepressant efficacy and favourable safety.Aims To p...Background GW117(N-(2-(6-chloro-7-deuteromethoxynaphthalen-1-yl)ethyl)acetamide)is a dual-acting agent(MT1/MT2 agonist,5-HT_(2C)antagonist)with prior evidence of antidepressant efficacy and favourable safety.Aims To preliminarily evaluate the efficacy and safety of GW117 in major depressive disorder(MDD)and to explore the optimal dosing.Methods A total of 280 eligible patients aged 18-65years with MDD were randomly assigned(1:1:1:1)to8 weeks of double-blind treatment with fixed doses of GW117 tablets(20,40,60 mg/day)or placebo.The primary endpoint was the change from baseline to Week 8 in the total score of the Hamilton Rating Scale for Depression-17item(HAMD-17).Key secondary endpoints included changes in the Montgomery-?sberg Depression Rating Scale(MADRS)total score over the same period.Results In the full analysis set(n=276),GW117 showed numerically greater reductions versus placebo in the HAMD-17 and MADRS total scores,as well as higher response rates at Week 8.However,these differences did not reach statistical significance,potentially due to a high placebo response and other contributing factors.In a post hoc analysis of an optimal subgroup(baseline HAMD-17>24 or insomnia factor>4),GW117 showed efficacy in improving multidimensional symptoms,including insomnia.The 20 mg dose demonstrated a significant3.66-point greater reduction in MADRS(p=0.026)and a23.16%higher response rate(p=0.013)compared with placebo.GW117 was well-tolerated,with no cases of alanine aminotransferase or aspartate aminotransferase exceeding 3×the upper limit of normal and no concerning safety signals reported.Conclusions This exploratory study found that GW117demonstrated encouraging antidepressant efficacy and a favourable safety profile in patients with MDD.Although differences versus placebo did not reach statistical significance in the overall population,GW11720 mg monotherapy showed significant improvements in multidimensional depressive symptoms,including insomnia,in the optimal response subgroup.No hepatotoxicity was reported,supporting its promising therapeutic potential for further clinical development.展开更多
Air pollution has environmental issue owing become a serious to its diverse harmful effects on the physical and biological environment. According to the Environmental Protection Agency (EPA) and the World Health Org...Air pollution has environmental issue owing become a serious to its diverse harmful effects on the physical and biological environment. According to the Environmental Protection Agency (EPA) and the World Health Organization (WHO), air pollution affects millions of people worldwide. Hundreds of thousands of deaths each year and a range of diseases, particularly among vulnerable groups (i.e., children, the elderly, and people with special medical conditions), are attributed to air pollution. These effects are not always caused by single pollutant in the air; rather, they are considered consequences of the multi-pollutants to which people are simultaneously exposed.展开更多
A dose-finding study was performed with respect to the clinical applicability and tolerability of three different concentrations of propolis special extract GH 2002 in a lip balm (0.1%, 0.5% and 1%). The trial was des...A dose-finding study was performed with respect to the clinical applicability and tolerability of three different concentrations of propolis special extract GH 2002 in a lip balm (0.1%, 0.5% and 1%). The trial was designed as a double-blind, randomized dermatological study in 150 outpatients with Herpes labialis. The primary parameter was the duration in days until painless incrustation in 50% or 90% of the patients (observable in 121 patients). Secondary parameters were local pain (assessed on a visual analogue scale), itching, burning and tension/ swelling on a verbal rating scale, and tolerability. Visits were performed on days 2/3, 5/6 and 8/9. Best efficacy results with shortest healing time (3.4 and 5.4 days in the 50th and 90th percentile, respectively;p = 0.008 vs. 1% and 0.09 vs. 0.1%) and good tolerability were observed with the 0.5% concentration. All three concentrations achieved highly significant therapeutic results in comparison with baseline values (p < 0.0005) for all secondary parameters as early as day 2/3. Analgesia was the most prominent effect for the patients. Conclusion: The 0.5 % concentration of propolis special extract GH 2002 in a lip balm was found to have the best risk-benefit ratio for the treatment of Herpes labialis.展开更多
文摘Background GW117(N-(2-(6-chloro-7-deuteromethoxynaphthalen-1-yl)ethyl)acetamide)is a dual-acting agent(MT1/MT2 agonist,5-HT_(2C)antagonist)with prior evidence of antidepressant efficacy and favourable safety.Aims To preliminarily evaluate the efficacy and safety of GW117 in major depressive disorder(MDD)and to explore the optimal dosing.Methods A total of 280 eligible patients aged 18-65years with MDD were randomly assigned(1:1:1:1)to8 weeks of double-blind treatment with fixed doses of GW117 tablets(20,40,60 mg/day)or placebo.The primary endpoint was the change from baseline to Week 8 in the total score of the Hamilton Rating Scale for Depression-17item(HAMD-17).Key secondary endpoints included changes in the Montgomery-?sberg Depression Rating Scale(MADRS)total score over the same period.Results In the full analysis set(n=276),GW117 showed numerically greater reductions versus placebo in the HAMD-17 and MADRS total scores,as well as higher response rates at Week 8.However,these differences did not reach statistical significance,potentially due to a high placebo response and other contributing factors.In a post hoc analysis of an optimal subgroup(baseline HAMD-17>24 or insomnia factor>4),GW117 showed efficacy in improving multidimensional symptoms,including insomnia.The 20 mg dose demonstrated a significant3.66-point greater reduction in MADRS(p=0.026)and a23.16%higher response rate(p=0.013)compared with placebo.GW117 was well-tolerated,with no cases of alanine aminotransferase or aspartate aminotransferase exceeding 3×the upper limit of normal and no concerning safety signals reported.Conclusions This exploratory study found that GW117demonstrated encouraging antidepressant efficacy and a favourable safety profile in patients with MDD.Although differences versus placebo did not reach statistical significance in the overall population,GW11720 mg monotherapy showed significant improvements in multidimensional depressive symptoms,including insomnia,in the optimal response subgroup.No hepatotoxicity was reported,supporting its promising therapeutic potential for further clinical development.
文摘Air pollution has environmental issue owing become a serious to its diverse harmful effects on the physical and biological environment. According to the Environmental Protection Agency (EPA) and the World Health Organization (WHO), air pollution affects millions of people worldwide. Hundreds of thousands of deaths each year and a range of diseases, particularly among vulnerable groups (i.e., children, the elderly, and people with special medical conditions), are attributed to air pollution. These effects are not always caused by single pollutant in the air; rather, they are considered consequences of the multi-pollutants to which people are simultaneously exposed.
文摘A dose-finding study was performed with respect to the clinical applicability and tolerability of three different concentrations of propolis special extract GH 2002 in a lip balm (0.1%, 0.5% and 1%). The trial was designed as a double-blind, randomized dermatological study in 150 outpatients with Herpes labialis. The primary parameter was the duration in days until painless incrustation in 50% or 90% of the patients (observable in 121 patients). Secondary parameters were local pain (assessed on a visual analogue scale), itching, burning and tension/ swelling on a verbal rating scale, and tolerability. Visits were performed on days 2/3, 5/6 and 8/9. Best efficacy results with shortest healing time (3.4 and 5.4 days in the 50th and 90th percentile, respectively;p = 0.008 vs. 1% and 0.09 vs. 0.1%) and good tolerability were observed with the 0.5% concentration. All three concentrations achieved highly significant therapeutic results in comparison with baseline values (p < 0.0005) for all secondary parameters as early as day 2/3. Analgesia was the most prominent effect for the patients. Conclusion: The 0.5 % concentration of propolis special extract GH 2002 in a lip balm was found to have the best risk-benefit ratio for the treatment of Herpes labialis.