1.Effect of community comprehensive management model intervention among patients with dyslipidemia
GAO Hui ; XIE Liang ; YAO Chunyang ; WANG Linhong ; JIN Liu ; HU Jie
Journal of Preventive Medicine 2026;38(1):15-19
Objective:
To evaluate the effect of community comprehensive management model intervention among patients with dyslipidemia, so as to provide the reference for optimizing community management strategies and improving the target achievement rate for blood lipids among this population.
Methods:
From May to June 2023, a multi-stage stratified random sampling method was employed to select patients with dyslipidemia from primary healthcare institutions in Jiaxing City, Zhejiang Province. Eligible participants were randomly assigned to either a control group or an intervention group. The control group received routine management, while the intervention group was subjected to a community comprehensive management model in addition to the routine care. Both groups were followed up for 24 months. Data on demographic characteristics, lifestyle behaviors, physical examination indices, and blood biochemical indicators were collected at baseline and after the intervention through questionnaires, physical examinations, and laboratory tests. Changes in obesity rate, central obesity rate, target achievement rates for blood lipids, blood pressure, and blood glucose, as well as lifestyle modifications, were analyzed. Differences between the two groups before and after the intervention were assessed using generalized estimating equations (GEE).
Results:
The control group consisted of 560 patients, including 303 females (54.11%) and 430 individuals aged ≥65 years (76.79%). The intervention group also included 560 patients, with 300 females (53.57%) and 431 individuals aged ≥65 years (76.96%). Before the intervention, no statistically significant differences were observed between the two groups in terms of gender, age, educational level, history of chronic diseases, and atherosclerotic cardiovascular disease risk stratification (all P>0.05). After 24 months of intervention, interaction effects between group and time were observed for obesity rate, central obesity rate, target achievement rate for blood lipids, target achievement rate for blood glucose, composite target achievement rate, physical activity rate, and medication adherence (all P<0.05). Specifically, the intervention group demonstrated lower rates of obesity and central obesity, and higher target achievement rate of blood lipids, target achievement rate of blood glucose, composite target achievement rate, physical activity rate, and medication adherence compared to the control group.
Conclusion
The community comprehensive management model contributed to improvements in multiple metabolic parameters (including body weight, waist circumference, blood lipids, and blood glucose) among patients with dyslipidemia, and was associated with increased physical activity rate and medication adherence.
2.Mechanism of imperatorin in ameliorating doxorubicin resistance of breast cancer based on transcriptomics
Yiting LI ; Wei DONG ; Xinli LIANG ; Hu WANG ; Yumei QIU ; Xiaoyun DING ; Hao ZHANG ; Huiyun BAO ; Xianxi LI ; Xilan TANG
China Pharmacy 2025;36(5):529-534
OBJECTIVE To investigate the ameliorative effect and potential mechanism of imperatorin (IMP) on doxorubicin (DOX) resistance in breast cancer. METHODS The effects of maximum non-toxic concentration (100 μg/mL) of IMP combined with different concentrations of DOX (12.5, 25, 50, 75, 100 μg/mL) on the proliferation of MCF-7/DOX cells were determined by MTT method. MCF-7/DOX cells were divided into blank control group (1‰ dimethyl sulfoxide), DOX group (50 μg/mL), IMP+DOX group (100 μg/mL IMP+50 μg/mL DOX) and IMP group (100 μg/mL). mRNA and protein expressions of multidrug resistance protein 1 (MDR1) and multidrug resistance-associated protein 1 in each group were measured. The relevant pathways and targets involved in the improvement of DOX resistance in breast cancer cells by IMP were screened and validated by using transcriptome sequencing technology, along with gene ontology (GO) enrichment analyses and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses. RESULTS Compared with DOX alone, the combination of IMP and DOX reduced the half inhibitory concentration of DOX on MCF-7/DOX cells from 81.965 μg/mL to 43.170 μg/mL, the reverse fold was 1.90, and the mRNA expression of MDR1 was significantly down-regulated (P<0.05). The results of GO enrichment analyses and KEGG pathway enrichment analyses indicated that the reversal of DOX resistance in breast cancer by IMP was mainly associated with the regulation of biological processes such as detoxification, multiple biological processes, and cell killing. The main pathway involved was the p53 signaling pathway, and the key targets mainly included constitutively photomorphogenic protein 1 (COP1), cyclin E1 (CCNE1), growth arrest and DNA damage-inducible protein 45A E-mail:tangxilan1983@163.com (GADD45A) and GADD45B. The results of the verification experiments showed that compared with DOX group, there was a trend of up-regulation of COP1 mRNA, and significant down- regulation of CCNE1, GADD45A, and GADD45B mRNA expression in IMP+DOX group (P<0.05). CONCLUSIONS The effect of IMP in ameliorating DOX resistance in breast cancer is related to its regulation of COP1, CCNE1, GADD45A and GADD45B targets in the p53 signaling pathway.
3.Textual Research on Key Information and Modern Clinical Application of Classical Famous Formula Liumotang
Xinyu ZHANG ; Chong LI ; Yixuan HU ; Luming LIANG ; Ye ZHAO ; Xiaoting LU ; Yu WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):201-212
Liumotang comes from the Yuan dynasty's Effective Prescription Handed Down for Generations of Physicians. It is composed of six medicinal materials: Arecae Semen, Aquilariae Lignum Resinatum, Aucklandiae Radix, Linderae Radix, Rhei Radix et Rhizoma, and Aurantii Fructus. It is a classical formula for treating abdominal pain due to Qi stagnation and constipation accompanied by heat. This study systematically collated the records of Liumotang in ancient medical books and modern clinical literature and conducted in-depth analysis and textual research on its formula source, main diseases, composition, dosage, medical books, container capacity, processing, preparation method, usage, drug basis, formula meaning, and other key information, so as to provide a powerful reference for the development and clinical application of compound preparations of the classical formula Liumotang. The results show that Liumotang was first seen in Effective Prescription Handed Down for Generations of Physicians, and many medical books of the past dynasties have imitated this. In terms of drug basis, the dried and mature seeds of the palm plant Areca catechu, resin-containing wood of the Daphneaceae plant Aquilaria sinensis, the dried roots of the Asteraceae plant woody Aucklandia lappa, the dried tuber root of the Lauraceae plant Lindera aggregata, the dried roots and rhizomes of the knotweed plant, R. palmatum, R.tangutikum, and R. officinale, and the dried and unripe fruits of the citrus genus C. aurantium and its cultivated varieties from the family Rutaceae were selected. In terms of dosage, through the textual research on bowls in the Ming and Qing dynasties, combined with the conversion of medicines and bowl capacity in the Qing dynasty, it was estimated that the dosage of each drug in the Yuan dynasty was 10.86 g. In the Ming and Qing dynasties, the dosage of drugs was mostly equal, but the dosage of drugs was somewhat different. In terms of processing, preparation method, and usage, in the medical books of the past dynasties, the processing of drugs has slightly changed, but raw drugs are used in all preparations. The preparation method and usage did not change much during the Yuan, Ming, and Qing dynasties, except for certain differences in dosage. In terms of syndrome, Liumotang was first used to treat abdominal pain due to Qi stagnation and constipation accompanied by heat. Medical books of the past dynasties often omit the symptoms of heat. In modern clinical practice, Liumotang is mainly used in the digestive system and urinary system diseases and is mostly used to treat constipation-predominant irritable bowel syndrome, biliary reflux gastritis, functional constipation, slow transit constipation, and other diseases, with no adverse reactions found yet. The above results provide a reliable scientific basis for the development and clinical treatment of Liumotang compound preparations.
4.Evaluation of the comprehensive intervention effect on lunch for primary and secondary school students in Minhang District of Shanghai
HU Yuhuan, ZANG Jiajie, XU Huilin, GUO Qi, HAN Yan, TANG Hongmei, YING Fangjia, LIANG Hao
Chinese Journal of School Health 2025;46(2):191-195
Objective:
To evaluate the comprehensive intervention effect of lunch for primary and secondary school students in Minhang District, so as to provide a theoretical and practical basis for lunch intervention in school.
Methods:
From October to December 2023, a convenience sampling method was used to select 1 937 students from one primary and secondary school in Minhang District.A comprehensive intervention measure focusing on "reducing oil and salt" for lunch recipe optimization and nutrition education was carried out, and a questionnaire survey was conducted to evaluate the intervention effect three months later. Chi square test and Wilcoxon rank test were used to compare the data before and after the intervention.
Results:
After intervention, the use of cooking oil and salt, the supply of protein and fat in primary and secondary school lunches were reduced, and had no obvious impact on energy and other major nutrients. After intervention, compared to before intervention, the proportion of primary school students who felt that lunch was greasy decreased (8.9%, 6.2%, χ 2=4.35), and the proportion of primary and secondary school students who felt that lunch were delicious decreased significantly (33.2%, 23.2%; 63.9%, 53.5%, χ 2=26.39, 17.52) ( P < 0.05 ). Secondary school students also felt reduced variety of food ingredients (46.9%, 38.3%, χ 2=16.05, P <0.05). In addition, after intervention, the total surplus rate of primary school students meals decreased (7.4%, 4.4%, χ 2=5.73), mainly reflected in the decrease of the surplus rate of staple foods (7.1%, 2.4%, χ 2=17.39), while the surplus rate of vegetable dishes increased ( 16.0 %, 21.2%, χ 2=6.01) ( P <0.05). Although there was no significant change in the total surplus rate of meals for secondary school students, the surplus rate of staple foods decreased (12.9%, 5.4%, χ 2=33.52), while the surplus rates of meat and vegetable dishes increased (11.2%, 26.9%; 17.5%, 33.2%, χ 2=74.26, 61.88) ( P <0.05). After intervention, there was no statistically significant difference in the overweight and obesity rates of primary school students ( χ 2=0.11,0.43) and secondary school students ( χ 2=0.01,0.00) compared to before intervention( P >0.05). After intervention, the lung capacity of primary school students [1 564 (1 269,1 890) mL] and sitting forward flexion [11.3 (7.6, 15.2) cm] increased compared to before intervention [1 522 (1 259, 1 819 ) mL, 10.5 (6.3, 13.5) cm] ( Z =2.20, 4.68, P <0.01), but there was no statistically significant difference in lung capacity and sitting forward flexion of secondary school students before and after intervention ( Z =-0.46, -0.08, P >0.05).
Conclusion
The comprehensive intervention of school lunch has promoted a significant decrease in the use of oil and salt in lunch and improved the quality of recipes, and has a positive impact on the situation of leftover lunch and the health of students to a certain extent.
5.Yijingtang Reduces Ovarian Inflammatory Responses in Rat Model of Diminished Ovarian Reserve via TLR4/MyD88/NF-κB Signaling Pathway
Heng HU ; Jijun CHU ; Zhe LI ; Haijing CHU ; Jing YU ; Chengcheng LIANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):20-30
ObjectiveTo investigate the effect and mechanism of Yijingtang (YJT) in treating diminished ovarian reserve (DOR) in rats by regulating the Toll-like receptor 4 (TLR4)/myeloid differentiation factor 88 (MyD88)/nuclear factor-κB (NF-κB) signaling pathway. MethodsFifty female SD rats with normal estrous cycles were randomly allocated into blank, model, low- and high-dose (12.579 and 25.158 g·kg-1, respectively) YJT, and dehydroepiandrosterone (7.487 5 mg·kg-1) groups, with 10 rats in each group. The rats in other groups except the blank group were administrated with the tripterygium glycosides tablet suspension (5 mg·kg-1) by gavage for 14 days for the modeling of DOR. The rats in the drug treatment groups were administrated with corresponding drugs by gavage from day 15 for 30 consecutive days, and those in the blank and model groups received equal volumes of distilled water. The vaginal exfoliated cell smears were observed to assess the changes in the estrous cycle. The wet weight of bilateral ovaries was weighed for calculation of the ovarian index. Hematoxylin-eosin staining was performed to observe the histopathological changes in the ovaries and the proportions of follicles at various levels were calculated. The serum levels of sex hormones [follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), and anti-Müllerian hormone (AMH)] and inflammatory factors [tumor necrosis factor-alpha (TNF-α), interleukin-1beta (IL-1β), and interleukin-10 (IL-10)] were determined by enzyme-linked immunosorbent assay. Real-time quantitative polymerase chain reaction(Real-time PCR) was conducted to determine the mRNA levels of TLR4, MyD88, NF-κB profilin α (IκBα), NF-κB and inflammatory factors in the ovarian tissue. Western blot was employed to measure the protein levels of factors related to the TLR4/MyD88/NF-κB signaling pathway in the ovarian tissue. Immunofluorescence (IF) was used to detect the nuclear translocation of NF-κB p65 in the ovarian tissue. ResultsCompared with the blank group, the model group showed disturbed estrous cycles, increased inflammatory infiltration in the ovarian tissue, decreases in ovarian index and proportion of presinusoidal follicles, and an increase in the proportion of atretic follicles (P<0.05, P<0.01). In addition, the model group showed elevated serum levels of FSH, LH, TNF-α, and IL-1β, up-regulated mRNA levels of TLR4, MyD88, IκBα, NF-κB, TNF-α, and IL-1β and protein levels of TLR4, MyD88, p-IκBα, and p-NF-κB p65 (P<0.01), lowered serum levels of AMH, E2, and IL-10, down-regulated mRNA level of IL-10 (P<0.01), and massive nuclear translocation of NF-κB p65 in the ovarian tissue. Compared with the model group, dehydroepiandrosterone and low and high doses of YJT restored the disturbed estrous cycle, reduced inflammatory infiltration in the ovarian tissue, increased the ovarian index (P<0.01), and changed the follicular composition ratio (P<0.01). Furthermore, the drugs lowered the serum levels of FSH, LH, TNF-α, and IL-1β, down-regulated the mRNA levels of TLR4, MyD88, IκBα, NF-κB, TNF-α, and IL-1β and the protein levels of TLR4, MyD88, p-IκBα, and p-NF-κB p65 (P<0.05, P<0.01), raised the serum levels of AMH, E2, and IL-10, up-regulated the mRNA level of IL-10 (P<0.05, P<0.01), and reduced the nuclear translocation of NF-κB p65 in the ovarian tissue. ConclusionYJT may inhibit the release and expression of inflammatory factors by regulating the TLR4/MyD88/NF-κB signaling pathway to attenuate the inflammatory responses in the ovarian tissue, thereby improving the ovarian function in DOR rats.
6.Characteristic ion Identification of Different Original Haliotidis Concha and Its Counterfeits
Xiaojie LIANG ; Guowei LI ; Lin ZHOU ; Qiping HU ; Muxiang LUO ; Jiehao TANG ; Xiangdong CHEN ; Liye PAN ; Dongmei SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):263-269
ObjectiveTo establish a method for the identification of Haliotidis Concha and its counterfeits, and to improve its quality evaluation method. MethodsA total of 17 batches of Haliotis discus hannai, 4 batches of H. ruber, 3 batches of H. laevigata, 3 batches of H. ovina, 3 batches of H. diversicolor, 3 batches of H. asinina, 3 batches of H. iris were collected. Ultra-high performance liquid chromatography-quadrupole/electrostatic field orbitrap high-resolution mass spectrometry(UPLC-Q-Exactive-Orbitrap-MS/MS) was used to analyze the hydrolysates of different original Haliotidis Concha and its counterfeits, and the potential characteristic ions of each species were screened by Venn diagram. UPLC-triple quadrupole tandem mass spectrometry(UPLC-QqQ-MS/MS) was used to validate the characteristic ions, and the specific detection method of the characteristic ions was established. ResultsA total of 1 182, 167, 47, 89, 104, 203, 424 potential characteristic ions were screened from H. discus hannai, H. ruber, H. laevigata, H. ovina, H. diversicolor, H. asinina and H. iris, respectively. And 9 characteristic ions were selected. The precision, stability and repeatability of the 9 characteristic ions in the established identification method met the requirements. Different original Haliotidis Concha and its counterfeits could detect their own characteristic ions, including m/z 631.83-886.48(double charge) and m/z 631.83-443.74(double charge) of H. discus hannai, m/z 699.28-232.11(double charge) and m/z 699.28-544.27(double charge) of H. ruber, m/z 535.76-752.37(double charge) and m/z 535.76-548.28(double charge) of H. laevigata, m/z 708.35-442.28(double charge) and m/z 708.35-215.14(double charge) of H. ovina, m/z 561.33-614.86(triple charge), m/z 561.33-468.28(triple charge), m/z 608.29-618.32(double charge) and m/z 608.29-390.21(double charge) of H. diversicolor, m/z 769.85-274.10(double charge), m/z 769.85-532.75(double charge), m/z 827.43-646.36(single charge), m/z 827.43-257.12(single charge) of H. asinina, and m/z 468.24-576.29(double charge) and m/z 468.24-505.26(double charge) of H. iris. ConclusionIn this study, a total of 9 characteristic ions are screened from 6 kinds of original Haliotidis Concha and its counterfeits, and a specific identification method is established, which is helpful to solve the limitations of the existing quality evaluation methods of Haliotidis Concha, and provide a basis for the production, circulation and medication quality.
7.Yijingtang Reduces Ovarian Inflammatory Responses in Rat Model of Diminished Ovarian Reserve via TLR4/MyD88/NF-κB Signaling Pathway
Heng HU ; Jijun CHU ; Zhe LI ; Haijing CHU ; Jing YU ; Chengcheng LIANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):20-30
ObjectiveTo investigate the effect and mechanism of Yijingtang (YJT) in treating diminished ovarian reserve (DOR) in rats by regulating the Toll-like receptor 4 (TLR4)/myeloid differentiation factor 88 (MyD88)/nuclear factor-κB (NF-κB) signaling pathway. MethodsFifty female SD rats with normal estrous cycles were randomly allocated into blank, model, low- and high-dose (12.579 and 25.158 g·kg-1, respectively) YJT, and dehydroepiandrosterone (7.487 5 mg·kg-1) groups, with 10 rats in each group. The rats in other groups except the blank group were administrated with the tripterygium glycosides tablet suspension (5 mg·kg-1) by gavage for 14 days for the modeling of DOR. The rats in the drug treatment groups were administrated with corresponding drugs by gavage from day 15 for 30 consecutive days, and those in the blank and model groups received equal volumes of distilled water. The vaginal exfoliated cell smears were observed to assess the changes in the estrous cycle. The wet weight of bilateral ovaries was weighed for calculation of the ovarian index. Hematoxylin-eosin staining was performed to observe the histopathological changes in the ovaries and the proportions of follicles at various levels were calculated. The serum levels of sex hormones [follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), and anti-Müllerian hormone (AMH)] and inflammatory factors [tumor necrosis factor-alpha (TNF-α), interleukin-1beta (IL-1β), and interleukin-10 (IL-10)] were determined by enzyme-linked immunosorbent assay. Real-time quantitative polymerase chain reaction(Real-time PCR) was conducted to determine the mRNA levels of TLR4, MyD88, NF-κB profilin α (IκBα), NF-κB and inflammatory factors in the ovarian tissue. Western blot was employed to measure the protein levels of factors related to the TLR4/MyD88/NF-κB signaling pathway in the ovarian tissue. Immunofluorescence (IF) was used to detect the nuclear translocation of NF-κB p65 in the ovarian tissue. ResultsCompared with the blank group, the model group showed disturbed estrous cycles, increased inflammatory infiltration in the ovarian tissue, decreases in ovarian index and proportion of presinusoidal follicles, and an increase in the proportion of atretic follicles (P<0.05, P<0.01). In addition, the model group showed elevated serum levels of FSH, LH, TNF-α, and IL-1β, up-regulated mRNA levels of TLR4, MyD88, IκBα, NF-κB, TNF-α, and IL-1β and protein levels of TLR4, MyD88, p-IκBα, and p-NF-κB p65 (P<0.01), lowered serum levels of AMH, E2, and IL-10, down-regulated mRNA level of IL-10 (P<0.01), and massive nuclear translocation of NF-κB p65 in the ovarian tissue. Compared with the model group, dehydroepiandrosterone and low and high doses of YJT restored the disturbed estrous cycle, reduced inflammatory infiltration in the ovarian tissue, increased the ovarian index (P<0.01), and changed the follicular composition ratio (P<0.01). Furthermore, the drugs lowered the serum levels of FSH, LH, TNF-α, and IL-1β, down-regulated the mRNA levels of TLR4, MyD88, IκBα, NF-κB, TNF-α, and IL-1β and the protein levels of TLR4, MyD88, p-IκBα, and p-NF-κB p65 (P<0.05, P<0.01), raised the serum levels of AMH, E2, and IL-10, up-regulated the mRNA level of IL-10 (P<0.05, P<0.01), and reduced the nuclear translocation of NF-κB p65 in the ovarian tissue. ConclusionYJT may inhibit the release and expression of inflammatory factors by regulating the TLR4/MyD88/NF-κB signaling pathway to attenuate the inflammatory responses in the ovarian tissue, thereby improving the ovarian function in DOR rats.
8.Characteristic ion Identification of Different Original Haliotidis Concha and Its Counterfeits
Xiaojie LIANG ; Guowei LI ; Lin ZHOU ; Qiping HU ; Muxiang LUO ; Jiehao TANG ; Xiangdong CHEN ; Liye PAN ; Dongmei SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):263-269
ObjectiveTo establish a method for the identification of Haliotidis Concha and its counterfeits, and to improve its quality evaluation method. MethodsA total of 17 batches of Haliotis discus hannai, 4 batches of H. ruber, 3 batches of H. laevigata, 3 batches of H. ovina, 3 batches of H. diversicolor, 3 batches of H. asinina, 3 batches of H. iris were collected. Ultra-high performance liquid chromatography-quadrupole/electrostatic field orbitrap high-resolution mass spectrometry(UPLC-Q-Exactive-Orbitrap-MS/MS) was used to analyze the hydrolysates of different original Haliotidis Concha and its counterfeits, and the potential characteristic ions of each species were screened by Venn diagram. UPLC-triple quadrupole tandem mass spectrometry(UPLC-QqQ-MS/MS) was used to validate the characteristic ions, and the specific detection method of the characteristic ions was established. ResultsA total of 1 182, 167, 47, 89, 104, 203, 424 potential characteristic ions were screened from H. discus hannai, H. ruber, H. laevigata, H. ovina, H. diversicolor, H. asinina and H. iris, respectively. And 9 characteristic ions were selected. The precision, stability and repeatability of the 9 characteristic ions in the established identification method met the requirements. Different original Haliotidis Concha and its counterfeits could detect their own characteristic ions, including m/z 631.83-886.48(double charge) and m/z 631.83-443.74(double charge) of H. discus hannai, m/z 699.28-232.11(double charge) and m/z 699.28-544.27(double charge) of H. ruber, m/z 535.76-752.37(double charge) and m/z 535.76-548.28(double charge) of H. laevigata, m/z 708.35-442.28(double charge) and m/z 708.35-215.14(double charge) of H. ovina, m/z 561.33-614.86(triple charge), m/z 561.33-468.28(triple charge), m/z 608.29-618.32(double charge) and m/z 608.29-390.21(double charge) of H. diversicolor, m/z 769.85-274.10(double charge), m/z 769.85-532.75(double charge), m/z 827.43-646.36(single charge), m/z 827.43-257.12(single charge) of H. asinina, and m/z 468.24-576.29(double charge) and m/z 468.24-505.26(double charge) of H. iris. ConclusionIn this study, a total of 9 characteristic ions are screened from 6 kinds of original Haliotidis Concha and its counterfeits, and a specific identification method is established, which is helpful to solve the limitations of the existing quality evaluation methods of Haliotidis Concha, and provide a basis for the production, circulation and medication quality.
9.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
;
Child
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Child, Preschool
;
Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
10.Processing technology of calcined Magnetitum based on concept of QbD and its XRD characteristic spectra.
De-Wen ZENG ; Jing-Wei ZHOU ; Tian-Xing HE ; Yu-Mei CHEN ; Huan-Huan XU ; Jian FENG ; Yue YANG ; Xin CHEN ; Jia-Liang ZOU ; Lin CHEN ; Hong-Ping CHEN ; Shi-Lin CHEN ; Yuan HU ; You-Ping LIU
China Journal of Chinese Materia Medica 2025;50(9):2391-2403
Guided by the concept of quality by design(QbD), this study optimizes the calcination and quenching process of calcined Magnetitum and establishes the XRD characteristic spectra of calcined Magnetitum, providing a scientific basis for the formulation of quality standards. Based on the processing methods and quality requirements of Magnetitum in the Chinese Pharmacopoeia, the critical process parameters(CPPs) identified were calcination temperature, calcination time, particle size, laying thickness, and the number of vinegar quenching cycles. The critical quality attributes(CQAs) included Fe mass fraction, Fe~(2+) dissolution, and surface color. The weight coefficients were determined by combining Analytic Hierarchy Process(AHP) and the criteria importance though intercrieria correlation(CRITIC) method, and the calcination process was optimized using orthogonal experimentation. Surface color was selected as a CQA, and based on the principle of color value, the surface color of calcined Magnetitum was objectively quantified. The vinegar quenching process was then optimized to determine the best processing conditions. X-ray diffraction(XRD) was used to establish the characteristic spectra of calcined Magnetitum, and methods such as similarity evaluation, cluster analysis, and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to evaluate the quality of the spectra. The optimized calcined Magnetitum preparation process was found to be calcination at 750 ℃ for 1 h, with a laying thickness of 4 cm, a particle size of 0.4-0.8 cm, and one vinegar quenching cycle(Magnetitum-vinegar ratio 10∶3), which was stable and feasible. The XRD characteristic spectra analysis method, featuring 9 common peaks as fingerprint information, was established. The average correlation coefficient ranged from 0.839 5-0.988 1, and the average angle cosine ranged from 0.914 4 to 0.995 6, indicating good similarity. Cluster analysis results showed that Magnetitum and calcined Magnetitum could be grouped together, with similar compositions. OPLS-DA discriminant analysis identified three key characteristic peaks, with Fe_2O_3 being the distinguishing component between the two. The final optimized processing method is stable and feasible, and the XRD characteristic spectra of calcined Magnetitum was initially established, providing a reference for subsequent quality control and the formulation of quality standards for calcined Magnetitum.
X-Ray Diffraction/methods*
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Drugs, Chinese Herbal/chemistry*
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Quality Control
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Particle Size


Result Analysis
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