Pediatric sepsis is the most common disease in pediatric critical illness, because the main reason for the disease is that children's immune level is not high or the immune system is not perfect, when children's lung, abdominal cavity and blood system are infected, it will cause systemic inflammation and immune dysfunction. Early clinical symptoms are mainly irregular and intermittent fever. When the disease develops to severe sepsis, the children will suffer from acute heart failure, oliguria, respiratory alkalosis and even multiple organ failure. The incidence of death is high. It is reported that the incidence rate of sepsis in children can reach 0.3%, and the mortality rate is 50%. High incidence rate, high mortality rate and high treatment cost are the biggest problems in the pediatric field. In the past, the clinical hope of clearing away heat and toxin, promoting blood circulation and removing stasis, strengthening inflammation and other methods in traditional Chinese medicine, but the treatment effect is not ideal. With the improvement of modern medical understanding of sepsis, continuous blood purification therapy is introduced into the treatment of children with severe sepsis. In order to further explore the effect of continuous blood purification in the treatment of children with severe sepsis, the author summarizes the clinical practice experience and relevant literature, hoping to provide reference for relevant medical staff.
Background Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) formulations, has been commonly used in clinical practice to treat gynecological disorders in China. In recent years, a growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on specific TCM syndromes of GFW for PD. Therefore, we plan to conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome. Methods and analysis The clinical study is a randomized, double-blinded, placebo-controlled trial. Eligible patients will be randomly assigned to the GFW group (treated with GFW) and the control group (treated with a matching placebo) in a 1:1 ratio for three menstrual cycles with a 3-month follow-up. The primary outcome will be the mean change of pain intensity measured by the visual analog scale (VAS). The secondary outcomes will include the Cox Menstrual Symptom Scale (CMSS), the Self-rating Depression Scale (SDS), the Self-rating Anxiety Scale (SAS), and the TCM syndrome scale. Adverse events will also be reported. Discussion This randomized trial will be the first rigorous study designed to assess the efficacy and safety of GFW in treating PD with heat-burning blood-stasis syndrome. The finding of this study will provide an objective clinical basis for the use of GFW for PD in the future. Trial registration Chinese Clinical Trial Registry ChiCTR2000034118. Registered on 24 June 2020
BackgroundPrimary dysmenorrhea (PD) is one of main gynecological complaints in women of child-bearing age, but there are limited effective treatments available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) herbal formulas, has been the treatment of choice for gynecological disease in China. A growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on the treatment of PD by GFW with specific TCM syndromes. Therefor we will conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome.Methods and analysisThis study is designed as a randomized, double-blinded, placebo-controlled clinical trial. Eligible patients will be randomly assigned to the GFW group (patients receive GFW) and the control group (patients receive a matching placebo) in a 1:1 ratio. The participants will receive either GFW or placebo, twice daily for 3 menstrual cycles with a 3-month follow-up. The primary outcome is the pain intensity reduction measured by a Visual Analog Scale. The secondary outcomes is the Cox Menstrual Symptom Scale, the Self-rating Depression Scale, the Self-rating Anxiety Scale, the 12-item Short-Form Health Survey and the dysmenorrhea diarymenstrual pain.. All outcomes are assessed at baseline, and the 4th, 8th, and 12th week during the interventions, as well as at the 16th, 20th and 24th week follow-up. Any adverse events will be recorded throughout the study.DiscussionThis is the first double-blinded RCT to assess the effectiveness and safety of GFW in treating PD with the heat-burning blood-stasis syndrome. The scientific and rigorous methodology design of this trial will provide significant evidence regarding the use of GFW to treat PD in future.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2000034118. Regisrered on 25 June 2020.
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