1.A multicenter randomized controlled study on the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants
Clinical Research Collaborative Group
Chinese Journal of Pediatrics 2011;49(9):663-668
Objective Alarge-scale prospective multicenter randomized controlled tial was conducted to evaluate the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants. Yinzhihuang oral solution is a herbal extract with the main components of Herba Artemisiae Scopariae, Scutellaria, Lonicera Japonica and Gardenia jasminoides. Methods A total of 16 hospitals participated in this study. From March to September 2010, the term infants whose bilirubin level ≥ 40 th percentile for age in hours were enrolled, except for those who received exchange transfusion or had signs of bilirubin encephalopathy. All the 1177 cases were divided randomly into three groups: phototherapy group (409 cases ), phenobarbital combined with phototherapy group (373 cases) and Yinzhihuang oral liquid combined with phototherapy group (395 cases). Phenobarbital and Yinzhihuang oral liquid was started once the infants participated the study, and persisted for 5 days. Phototherapy was added as soon as the bilirubin level reached the lowest threshold ( the threshold for infants at higher risk). The demographic data of infants in each group were recorded, the serum bilirubin level before treatment, after treatment for 72 hours and after the treatment completion were checked. The reduction rate of serum bilirubin and the phototherapy rate in different groups were compared. The adverse events were assessed as well. Results Of the total of 1177 cases, 707 (60. 1% ) were male, 1119 cases (95. 1% ) were of Han ethnicity. The average total bilirubin level before treatment was ( 282. 0 ± 70. 9) μmol/L and the highest level was 626 μmol/L The severe hyperbilirubinemia (total bilirubin level at 342 μmoL/L to 427 μmol/L) accounted for 15.8% (186 cases), and the extremely severe hyperbilirubinemia (total bilirubin >427 μmol / L) accounted for 2. 5% (30 cases). After treatment for 72 hours, the reduction of bilirubin was not significantly different among three groups ( F =2. 89, P =0. 056). After completion of treatment, the reduction rate of bilirubin in Yinzhihuang group was higher than that of the other two groups (F =5.55, P =0. 004). The rate of infants who did not receive phototherapy in Yinzhihuang group was higher than that in phenobarbital group (x2 =47. 38, P=0. 000). In Yinzhihuang group, more infants had bowel movements more than five times a day. The incidence of rashes was higher than that in phenobarbital group (P =0. 019), but no significant difference was found as compared with that in phototherapy group (P =0. 339). Conclusions About 18% of the term infants who were admitted for jaundice had severe or extremely severe hyperbilirubinemia. Yinzhihuang oral solution combined with phototherapy is effective in bilirubin reduction. Early treatment with Yinzhihuang oral solution may inhibit further increase in bilirubin levels, reduce the phototherapy requirement.
2.A multicenter randomized parallel-controlled study on the efficacy and safety of ER XIE TING GRANULES in children with acute diarrhea
Clinical Research Collaborative Group of ER XIE TI
Chinese Journal of Pediatrics 2013;51(9):670-675
Objective To evaluate the efficacy and safety of ER XIE TING GRANULES in children with acute diarrhea.Method A multicenter,randomized,open-label,parallel-controlled clinical trial was carried out in 15 hospitals during March 2011 to July 2012.A total of 1489 children with acute diarrhea were enrolled and divided randomly into two groups and treated with ER XIE TING GRANULES (treatment group)and smectite powder (control group).The therapeutic efficacy and adverse drug reactions were evaluated after three-day and seven-day therapy.Superiority or non-inferiority test was done for effectiveness of the treatment based on efficacy differ by more than 10% regarded as the superiority.Result Totally 1458 children completed the study,in whom 726 children received ER XIE TING GRANULES and 732 received smectite powder.After three-day and seven-day therapy,cure rates and total efficacy rates of the treatment group were 44.2%,94.1%,88.8%,and 97.9% separately and higher than those of control group (39.3%,88.4%,83.9%,97.4%) (Z =3.2,P <0.01 ;Z =2.46,P <0.05).There were 520 children with rotavirus infection and in whom 266 cases received ER XIE TING GRANULES and 254 received smectite powder.For rotavirus enteritis,cure rates and total efficacy rates of the treatment group after three-day and seven-day therapy were 40.6%,95.1%,89.9%,and 98.9% separately and higher than those of control group (26.4%,84.3%,78.8%,and 96.8%) (Z=4.807,P<0.01;Z=3.519,P<0.01).The lower limits of the 95% confidence interval of difference of cure rate and total efficacy rates after three-day and seven-day therapy between two groups were less than 10%.No obvious drug related adverse reactions were found during the study.Conclusion ER XIE TING GRANULES has the same effect for treatment of acute diarrhea and rotavirus enteritis in children.No obvious drug related adverse reactions were found.
3.Trajectory, Perceived Causes and Efforts in Diabetes Selfmanagement: A Qualitative Study Among Young People With Type 2 Diabetes Mellitus and Caregivers
Nursyuhadah Othman ; Qi Ying Lean ; Chin Fen Neoh ; Mohd Shahezwan Abd Wahab ; Nurain Mohd Noor ; Shueh Lin Lim ; Yuet Yen Wong
Malaysian Journal of Medicine and Health Sciences 2024;20(No.1):242-252
Introduction: Previous studies have suggested that young individuals with type 2 diabetes mellitus (T2DM) face
challenges in achieving optimal diabetes self-management, leading to difficulties in attaining the recommended
glycaemic target. The reasons behind these suboptimal practices remain unclear due to the limited number of studies conducted in Malaysia that focused on diabetes self-management among young people. This qualitative study
aimed to understand the lived experience of young people with T2DM on self-management in Malaysia. Methods:
Young people at the age of 10 to 24 years, who had been diagnosed with T2DM and the caregivers who managing
young people with T2DM were interviewed. Data were thematically analysed with the aid of QSR NVivo version 12.
Results: Sixteen young informants and eleven caregivers participated in this study. Three major themes conceptualised the lived experience of diabetes self-management: (1) the trajectory to T2DM diagnosis; (2) perceived causes of
T2DM; (3) the efforts in diabetes self-management. The route of diagnosis and experiential knowledge about T2DM
might determine their efforts in the self-management among the young people. Healthy eating, medication taking
and physical activity were perceived as important tasks in diabetes self-management. The involvement of the caregivers in diabetes self-management evolved over time. Conclusion: The study highlighted the experience of young
people and caregivers since the beginning of the diagnosis and their strategies in diabetes self-management. More
understanding of the lived experiences of patients and caregivers in disease management within the socio-ecological
context could help to improve health-care services and intervention for this population.
4.Change laws of water absorption in Chinese herbal pieces and prediction model of relative density for Chinese medicine decoction.
Lu ZHANG ; Xin-Jing GUI ; Fei MENG ; Meng-di XIE ; Jing YAO ; Xiao-Jia HAO ; Bin YAN ; Hong-Yan CHEN ; Shu-He CHEN ; Chun ZHAO ; Ya-Ting AN ; Xin-Jian YANG ; Xue-Lin LI ; Rui-Xin LIU
China Journal of Chinese Materia Medica 2020;45(15):3681-3688
This study aims to explore the change laws of water absorption in Chinese herbal pieces and establish the prediction model of relative density for Chinese medicine compound decoction. Firstly, fitted equations of water absorption and decocting time was established by observing the change laws of water absorption in 36 kinds of Chinese herbal pieces in 12 groups(according to the drug-parts) with decocting time. The r value of the mineral group and other type group was 0.691 2 and 0.663 3, respectively. The r value of the remaining 10 groups was 0.802 2-0.925 4. All P values were less than 0.05(n=21). The formula of the amount of water added was optimized by combining the fitted equations with determined water absorption, and the liquid yield could be controlled in a range of 100%±10%. Secondly, it was determined that the liquid density tester could be used for the rapid determination of relative density of Chinese medicine decoction after methodological study and comparison with the pycnometer method. The linear regression equation between the corrected relative density(y) and extraction ratio(%, x) was built by measuring and analyzing the related parameters such as liquid yield, relative density and extraction ratio in 46 kinds of Chinese herbal pieces. The established equation was y=0.041 3x+1.003 7, r=0.930 9(P <0.01, n=46), with linear range of 1.94%-65.75%. Based on this, the prototype model for predicting relative density of Chinese medicine decoction was established, and the relative densities of 8 Chinese medicine decoctions were within the prediction interval of this model in verification. This study lays a foundation for database construction of Chinese medicine decoction, implementation of personalized decocting mode and rapid quality control of Chinese medicine decoction.
Drugs, Chinese Herbal
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Medicine, Chinese Traditional
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Quality Control
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Specific Gravity
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Water