Improvement of high-quality evaluation criteria of Chinese patent medicines based on whole process control / 中国中药杂志

Chinese patent medicines(CPMs) are unique therapeutic drugs in China. Establishing and improving the evaluation criteria is an important measure to promote the high-quality development of CPMs. Based on the "evaluation criteria of high-grade CPMs with quality as the core index" established by our group in 2018, the "high-quality evaluation criteria for CPMs based on whole process control" was proposed in the present study in 2022. The scope of application and basic principles of the new criteria were clarified. A quality evaluation scoring table was established in the new criteria, including five parts: raw material selection, production process, quality control, efficacy evaluation, and brand building. The technical evaluation indexes involved have increased from 20% in the original criteria to 70% in the new criteria, and efficacy evaluation has been added in the new criteria. The subjective evaluation indicators account for a large proportion in the original criteria, which is prone to bias. The improved criteria overcome this shortcoming. It is expected that the new criteria as a basis can play a better role in the selection of high-quality products of CPMs, guide enterprises and institutions to participate actively in the evaluation and research of high-quality CPMs, and promote the high-quality development of CPMs.

Glaucocalyxin A attenuates allergic responses by inhibiting mast cell degranulation through HMGB1/TLR4/NF-κB signaling pathways / 药学学报

The study is to investigate the effect of glaucocalyxin A (GLA) on mast cell-mediated anaphylaxis. The animal welfare and experimental process of this experiment followed the regulations of the Animal Ethics Committee of Yanbian University. BALB/c mice were used in the animal experiment and randomly divided into five groups, control group, model group, and GLA low, medium, and high dose groups (10, 20, and 40 mg·kg-1). Mice were sensitized by intradermal injection of anti-dinitrophenyl-immunoglobulin E (DNP-IgE) into the ears and challenged with a mixture of DNP-human serum albumin (HSA) and 4% evans blue into the tail veins to prepare an animal skin passive cutaneous anaphylaxis (PCA) model, which was collected from both ears for measurement of dye staining and histology. Rat peritoneal mast cells (RPMCs) were used in the cell experiment and divided into control, IgE + antigen (Ag), and IgE + Ag + GLA groups to determine histamine release as well as calcium influx levels. High-affinity IgE receptor (FcεRI)-mediated signaling pathway proteins and HMGB1/TLR4/NF-κB (high mobility group box 1/toll like receptor 4/nuclear transcription factor kappa B) signaling proteins were detected by Western blot. The results of animal experiments suggest that GLA inhibits PCA, reduces evans blue dye exudation, and reduces ear inflammation and ear thickness in mice. The results of cellular experiments suggested that GLA could reduce histamine release and calcium influx, and inhibit tumor necrosis factor-α (TNF-α), interleukin (IL)-4, IL-13, and IL-1β production; Western blot results showed that GLA inhibited FcεRI-mediated phosphorylation levels of spleen tyrosine kinase (Syk), Lck/Yes novel tyrosine kinase (Lyn), tyrosine kinase Fyn (Fyn), growth-factor receptor-bound protein 2 (Gab2), and phospholipase C (PLC) γ1, while GLA inhibited HMGB1/TLR4 signaling pathway to limit NF-κB p65 nuclear metastasis. The results indicate that GLA inhibits mast cell degranulation and attenuates allergic inflammation through the HMGB1/TLR4/NF-κB signaling pathway.

Arctigenin attenuates airway inflammation in asthmatic mice via SIRT1/NLRP3 pathway / 中国药理学通报

Aim To investigate the efficacy of arctigenin on airway inflammation in a mouse model of asthma and the mechanism related to the SIRT1/NLRP3 signaling pathway. Methods Forty female BALB/c mice of clean grade were selected and divided into control group, OVA model group and ATG group (5, 10 and 20 mg · kg

Evaluation and analysis of high-quality products of Liuwei Dihuang Pills / 中国中药杂志

Liuwei Dihuang Pills is a typical traditional Chinese medicine with "the same product made by many manufacturers". The quality and price of products made in various factories was different obviously. In this study, the quality differences of Liuwei Dihuang Pills were evaluated over multi-dimensions and throughout the whole production cycle involving raw materials, production process, quality control and post-marketing re-studies based on the "Chinese patent medicine evaluation standard with quality at the core" established earlier by our research group. The research results showed that the product quality of various manufacturers was significantly different, and the product quality was positively correlated with the market shares of enterprises, indicating that enterprises with more market shares paid more attention to product quality; and the sales determined the concern degree of enterprises on products, which was in line with general cognition. During the single-item evaluation of Liuwei Dihuang Pills, the score of raw material selection was relatively low, and the enterprises paid less attention to the initial raw materials. The whole production process was better, and the national compulsory implementation of "Production Quality Management Standard"(GMP) had a positive effect in improving product quality. Quality control could basically guarantee product quality. Intelligent manufacturing promoted by the government was beneficial to ensure product uniformity. The score rate of "quality evaluation" item was basically qualified, which indicated that the quality control level of Liuwei Dihuang Pills was acceptable as a whole, but there was still room for improvement. "Re-evaluation and Brand Construction" had the lowest scores, reflecting that enterprises did not pay enough attention to in-depth study and re-evaluation of "the same product made by many manufacturers". The evaluation results were in line with expectations, provided a reference example for the evaluation of high-quality Chinese patent medicine, a basis for the high-quality and good price of Chinese patent medicine, scientific data for improving medical insurance bidding, and thus facilitated promoting the healthy development of the traditional Chinese medicine industry.

Clinical Efficacy of Duhuo Xuduan Tang in Treatment of Lumbar Disc Herniation / 中国实验方剂学杂志

Objective: To investigate clinical efficacy of Duhuo Xuduan Tang in treatment of lumbar disc herniation with different syndrome types and its effect on serum pain factors, bone morphogenetic protein-7 (BMP-7) and Aggrecan. Method: A total of 121 patients with non-emergency lumbar disc herniation admitted to the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2017 to June 2018 were randomly divided into observation group (62 cases) and control group (59 cases). The two groups of patients were treated by repositioning maneuver before absolute bed rest. observation group was given Duhuo Xuduan Tang, 150 mL·time-1, 3 times·d-1 orally, while control group was orally given ibuprofen, 300 mg·time-1, vitamin B1, 10 mg·time-1, 2 times·d-1, drugs were taken for 5 days a week, and then stopped for 2 days. Both groups were treated continuously for 4 weeks. changes in visual analogue score (VAS), modified Oswestry dysfunction index (MODI), serum substance P (SP), dopamine (DA), serotonin (5-HT), BMP-7 and Aggrecan were observed before and after treatment with enzyme-linked immunosandwich assay (ELISA). Result: Compared with before treatment, VAS and modified Oswestry dysfunction index scores were lower in both groups (PPPPPConclusion: Duhuo Xuduan Tang has a certain efficacy on different types of lumbar disc herniation, with best efficacy for patients with liver and kidney yin deficiency.

Clinical Efficacy and Serum Metabonomics of Duhuo Xuduan Tang in Treating Lumbar Disc Herniation Due to Liver and Kidney Yin Deficiency / 中国实验方剂学杂志

Objective:To observe the efficacy of Duhuo Xuduan Tang in treating patients with liver and kidney Yin-deficiency type of lumbar disc herniation, and explore the changes of metabolomics in serum. Method:Totally 68 cases of non-emergency lumbar disc herniation admitted to the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from January 2017 to September 2018 were randomly divided into observation group (38 cases) and routine group (30 cases). All of patients in both groups rest in bed after reduction maneuver. The observation group was orally treated with Duhuo Xuduan Tang, 150 mL/time, 2 times/d, and the control group was orally given ibuprofen, 300 mg/time, and vitamin B1, 10 mg/time, 2 times/d. The drugs were administered for 5 days a week and then stopped for 2 days. Both groups were treated continuously for 4 weeks. Before and after treatment, the visual analogue scale (VAS), the Japanese Orthopaedic Association assessment treatment (JOA) score and the clinical efficacy were observed. The serum metabolomics changes of two groups before and after treatment were compared by ultra-high liquid chromatography-mass spectrometry. Result:Compared with before treatment, the VAS scores of two groups were lower, while the JOA scores were increased (PPPβ-cryptoxanthin in serum were increased (PConclusion:Duhuo Xuduan Tang has a clear curative effect in treating lumbar disc herniation with liver and kidney Yin deficiency. The mechanism may be related to the enhancement of energy metabolism, anti-oxidation and anti-inflammation.

Relationships between use of statins and arterial stiffness in normotensive and hypertensive patients with coronary artery disease / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Statins improve arterial stiffness in patients with coronary artery disease (CAD). Hypertension is a predominant contributor of arterial stiffening. However, the influence of hypertension on the effect of statins for improving arterial stiffness in CAD patients has seldom been investigated. Therefore, in this study, we investigated the relationships between statin use and arterial stiffness in normotensive and hypertensive CAD patients.</p><p><b>METHODS</b>Brachial-ankle pulse wave velocity (ba-PWV) was measured in 437 patients, including 220 hypertensive CAD patients (121 used statins, 99 did not) and 217 normotensive CAD patients (105 used statins, 112 did not). The normotensive and hypertensive CAD patients were matched according to age, sex, and body mass index (BMI).</p><p><b>RESULTS</b>In the normotensive and hypertensive CAD patients, lipid profiles were significantly improved in the statin group compared with the non-statin group. No significant differences in the administered statins (i.e., atorvastatin, simvastatin, rosuvastatin, and pravastatin) and statin therapy duration were found between normotensive and hypertensive CAD patients (all P > 0.05). No significant correlation of ba-PWV and statin therapy duration was found in all CAD patients, normotensive CAD patients, or hypertensive CAD patients (all P > 0.05). ba-PWV in the statin group was significantly lower than that in the non-statin group in normotensive CAD patients ((1331.68 ± 167.52) cm/s vs. (1468.61 ± 244.54) cm/s, P = 0.002) but not in hypertensive CAD patients (P > 0.05). In multiple linear regression analyses, statin therapy was significantly associated with ba-PWV after adjusting for confounding variables in normotensive CAD patients (P = 0.018) but not in hypertensive CAD patients (P > 0.05).</p><p><b>CONCLUSIONS</b>Statins may significantly improve arterial stiffness in CAD patients, and hypertension may probably influence the effectiveness of statin therapy in improving arterial stiffness in this population. Further studies are required to investigate the effect of statins on arterial stiffness in normotensive and hypertensive CAD patients.</p>

A prevalence study on mild cognitive impairment among the elderly populations of Mongolian and Han nationalities in a pastoral area of Inner Mongolia / 中华流行病学杂志

Objective To understand the epidemiological characteristics and distribution of mild cognitive impairment (MCI) in elderly populations from Mongolian and Han nationalities living in the pastoral areas of Inner Mongolia Autonomous Region of China.Methods According to the MCI clinical diagnostic criteria from Diagnostic and Statistical Manual of Mental Disorders 4th revised edition (DSM-Ⅳ ) by American Psychiatric Association,the individuals under study were at the age of 55 or over,with Mongolian or Han ethnicities and living in the pastoral area of Inner Mongolia.Results The crude MCI morbidity rates of Mongolian and Han of the study populations in the pastoral area of Inner Mongolia Autonomous Region of China was 19.48％ (1782/9146)and the standardization morbidity was 18.98％.The crude MCI morbidity rates of both Mongolian and Han cthnicities were 17.46％ (the standardization morbidity was 16.99％) and 20.60％ (the standardization morbidity was 19.98％ ),respectively.There showed a significant positive correlation between the crude morbidities and age,also significantly increasing with the latter.In the Mongolian population,the morbidity increased from 12.17％ at the age 55-59 to 27.78％ at 85 while in the Han population,the morbidity increased from 15.50％ at the age 55-59 to 23.53％ at 85.In both the populations of Mongolian and Han,there was a statistically difference found between the morbidities of MCI ( x2=13.229,P=0.000).The morbidity was higher in Hans than in the Mongolians.However,there was no statistically significant difference noticed between the morbidities of MCI in the Mongolian males and females ( x 2 =2.376,P =0.123 ).There was statistically significant difference found between the morbidities of MCI in the Han males and females,with females having higher risk than males (x2=24.470,P=0.000).Conclusion The morbidity of MCI in the elderly Mongolian and Han populations from the pastoral area of Inner Mongolia Autonomous Region of China was considered to be quite high and correlated to age and gender.

Prevalence, detection, management, and control of hypertension in the population of Mongolian and Han nationalities with age ≥ 55 years in a pastoral area of Inner Mongolia Autonomous Region / 中华心血管病杂志

<p><b>OBJECTIVE</b>To know about the status of hypertension among Mongolian and Han aged older than 55 years living in pastoral area of the Inner Mongolia Autonomous Region.</p><p><b>METHODS</b>Stratified sampling method was adopted and 9146 people aged 55 years or older were selected, blood pressure measurement and related information were collected, prevalence, awareness, treatment and control rates of hypertension were analyzed.</p><p><b>RESULTS</b>The hypertension crude prevalence rate of Mongolian and Han subjects was 54.10% (standardized prevalence rate was 53.93%), in which, the Mongolian and Han subjects crude hypertension prevalence rate was 52.96% and 54.73% respectively (standardized prevalence rate was 53.44% and 55.08% respectively), and there was no statistically significant (P = 0.104). Among the male gender, awareness rate, treatment rate and control rate of hypertension was 61.03%, 46.73% and 11.87% respectively. Among the female gender, awareness rate, treatment rate and control rate of hypertension was 67.58%, 56.55% and 14.03% respectively. Among Mongolian and Han subjects, difference of hypertension prevalence of different age groups was statistically significant (P values were 0.032 and 0.000), Among Mongolian subjects, difference of hypertension awareness of different age groups was statistically significant (P = 0.000). Among Han subjects, difference of hypertension awareness rates, treatment rates, and control rates of different age groups were statistically significant (P values were 0.000, 0.047 and 0.043).</p><p><b>CONCLUSION</b>Hypertension prevalence rate among Han and Mongolian people older than 55 years living in pastoral area of Inner Mongolia Autonomous Region is high while the awareness, treatment and control rates of hypertension are rather low.</p>

A clinical study on global TCM therapy in treating senile advanced non-small cell lung cancer / 中国结合医学杂志

<p><b>OBJECTIVE</b>To assess the clinical efficacy of global traditional Chinese medicine (TCM) therapy in treating senile advanced non-small cell lung cancer (NSCLC), with the aim of seeking a standardized, rational and economical way to treat advanced NSCLC in old patients.</p><p><b>METHODS</b>A retrospective analysis and comparison was carried out in 86 patients with senile advanced NSCLC, 44 treated by global TCM (TCM group) and 42 by chemotherapy (control group) through dynamical observation on related indexes including tumor size, quality of life and the survival time, as well as on the fee for medical service at various time points in the course of the treatment.</p><p><b>RESULTS</b>The changes of tumor size, score of clinical main symptoms and behavior condition (by ZPS scoring), as well as survival rates in the two groups at corresponding time points, were not different significantly (P>0.05). The mean survival time in the TCM group was 13.20+/-1.52 months and that in the chemotherapy group was 13.45+/-1.94 months, showing insignificant difference between them. However, the median survival time in the TCM group (12 months) was actually longer than that in the chemotherapy group (9 months, P<0.05). The mean daily expense and the mean expense (RMB yuan) for each patient in the TCM group were significantly lower than that in the control group, which was 180.73+/-93.21 vs 825.84+/-329.63 for the mean daily expense and 34077.21+/-14638.04 vs 58516.59+/-45429.76 for the mean expense for each patient (both P<0.01).</p><p><b>CONCLUSION</b>Treatment of senile advanced NSCLC with TCM alone has its apparent superiority in stabilizing tumor focus, improving clinical symptoms, elevating quality of life and prolonging the survival time. TCM is also less expensive, making it a good alternative therapeutic approach for this specific group of people.</p>