Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection

Author(s):  
XIAO Ying
2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Cheng Jiang ◽  
Jie Shen ◽  
Dan Shou ◽  
Nani Wang ◽  
Jing Jing ◽  
...  

Abstract The adverse drug reaction (ADR) of traditional Chinese medicine injection (TCMI) has become one of the major concerns of public health in China. There are significant advantages for developing methods to improve the use of TCMI in routine clinical practice. The method of predicting TCMI-induced ADR was illustrated using a nested case-control study in 123 cases and 123 controls. The partial least squares regression (PLSR) models, which mapped the influence of basic characteristics and routine examinations to ADR, were established to predict the risk of ADR. The software was devised to provide an easy-to-use tool for clinic application. The effectiveness of the method was evaluated through its application to new patients with 95.7% accuracy of cases and 91.3% accuracy of controls. By using the method, the patients at high-risk could be conveniently, efficiently and economically recognized without any extra financial burden for additional examination. This study provides a novel insight into individualized management of the patients who will use TCMI.


2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Yueh-Hsiang Liao ◽  
Jaung-Geng Lin ◽  
Cheng-Chieh Lin ◽  
Chin-Chuan Tsai ◽  
Hui-Lien Lai ◽  
...  

Background. Traditional Chinese medicine (TCM) for the treatment of female infertility remains ambiguous. The aim of the present case-control study was to examine the association between TCM treatment and successful pregnancy among infertile women. Methods. This population-based case-control study included the data from 2,627 infertile women with successful pregnancy and 2,627 infertile women without successful pregnancy using datasets from the Longitudinal Health Insurance Database 2000 of the National Health Insurance Research Database during 2000–2010. The odds ratios (ORs) and 95% confidence intervals (CIs) for the relationship between TCM use and successful pregnancy in infertility women were estimated using logistic regression. Results. Patients who received TCM treatment significantly increased in successful pregnancy (OR = 1.48; 95% CI = 1.31–1.66), compared with patients without TCM. Si-Wu-Tang (OR = 4.25; 95% CI = 2.18, 8.30), Gui-Zhi-Fu-Ling-Wan (OR = 3.27; 95% CI = 2.13, 5.02), and Jia-Wei-Xiao-Yao-San (OR = 3.17; 95% CI = 2.35, 4.28) were the TCM agents that were most strongly associated with successful pregnancy among infertile women. Conclusions. Our study findings indicate that TCM is associated with higher likelihood of successful pregnancy in infertile women, which is worthy of further investigation by randomized control trial.


2020 ◽  
Author(s):  
Yun-Tzu Liang ◽  
Chia-Yang Lin ◽  
Yu-Hsun Wang ◽  
Hsi-Hsien Chou ◽  
James Cheng-Chung Wei

Abstract Background Patients who have Parkinson’s disease (PD) comorbid with dementia is common. With the prolonged life expectancy, dementia is gradually becoming prevalent and affects most patients’ life qualities. However, the efficacy of current treatments in dementia of Parkinson’s disease is limited. Previous studies indicated the potential roles of Traditional Chinese Medicine (TCM) in treating dementia, yet its effects in preventing dementia from Parkinson’s patients are unknown.Methods This case–control study was nested within a national health insurance database of patients over 50 years old with newly diagnosed Parkinson’s disease from year 2000 to 2010. Among these PD patients, dementia and non-dementia groups were discussed respectively in terms of the duration of taking TCM (≥ 90 days versus < 90 days), age (50–64 versus ≥ 65) and gender.Results The risk of dementia in patients with Parkinson's disease is decreased by using TCM for < 90 days and ≥ 90 days, especially in the group who took TCM for more than 90 days. The use of TCM significantly reduces the risk of dementia in the subgroups of age ≥ 65 years, female patients using TCM for both < 90 days and ≥ 90 days, and male patients using TCM for < 90 days. Overall, we can see the protection tendency among all of the target population under TCM use.Conclusions The results showed that there is a significant reduction of nearly 38% in the risk of dementia for patients with Parkinson’s disease after the usage of Traditional Chinese Medicine. The beneficial effects for using TCM ≥ 90 days in women age ≥ 65 years are most prominent.Trial registration The study data were acquired from the Taiwan’s National Health Insurance (NHI) Research Database. The NHI-claimed data provide clinical information for population-based epidemiologic research. This study was approved by the Institutional Review Board of Chung Shan Medical University Hospital.


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