1.Analysis of Quality Uniformity of Hengzhi Kechuan Capsules Based on HPLC-DAD-CAD
Qian MA ; An LIU ; Qingxia XU ; Cong GUO ; Jun ZHANG ; Maoqing WANG ; Xiaodi KOU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):168-174
ObjectiveTo establish the fingerprints of 15 batches of Hengzhi Kechuan capsules, to quantitatively analyze 10 index components, and to evaluate the quality uniformity of samples from different batches. MethodsThe fingerprints and quantitative analysis of Hengzhi Kechuan capsules were established by a combination method of high performance liquid chromatography coupled with diode array detector and charged aerosol detector(HPLC-DAD-CAD), adenosine, guanosine, vanillic acid, safflomin A, agarotetrol, naringin, hesperidin, militarine, ginsenoside Rb1, and glycyrrhizic acid were selected as quality attribute indexes. A total of 15 batches of Hengzhi Kechuan capsules from 2022 to 2024(3 boxes per batch) were qualitatively and quantitatively analyzed, and the quality uniformity level of the manufacturers was characterized by parameters of intra-batch consistency(PA) and inter-batch consistency(PB). The homogeneity and difference of quality attribute indexes of samples from different years were analyzed by heatmap clustering analysis. ResultsHPLC fingerprints and quantitative method of Hengzhi Kechuan capsules were established, and the methods could be used for qualitative and quantitative analysis of this preparation, which was found to be stable and reliable by method validation. The similarity of fingerprints of 15 batches of samples was 0.887-0.975, a total of 13 common peaks were calibrated, and 10 common peaks were designated, all of which were quality attribute index components. The results of quantitative analysis showed that the contents of the above 10 ingredients in the samples were 0.038-0.078, 0.115-0.251, 0.007-0.018, 0.291-0.673, 0.122-0.257, 0.887-1.905, 1.841-3.364, 1.412-2.450, 2.207-3.112, 0.650-1.161, respectively. And the contents of ginsenoside Rb1 and glycyrrhizic acid met the limit requirements in the 2020 edition of Chinese Pharmacopoeia. For the samples from 15 batches, the PA values of the 10 index components were all <10%, indicating good intra-batch homogeneity, and the PB values ranged from 33.86% to 92.97%, suggesting that the inter-batch homogeneity was poor. Heatmap clustering analysis showed that the samples from different years were clustered into separate categories, and adenosine, guanosine, safflomin A, naringin, hesperidin and agarotetrol were the main differential components. ConclusionThe intra-annual quality uniformity of Hengzhi Kechuan capsules is good and the inter-annual quality uniformity is insufficient, which may be related to the quality difference of Pinellinae Rhizoma Praeparatum, Carthami Flos, Citri Sarcodactylis Fructus, Citri Reticulatae Pericarpium, Aquilariae Lignum Resinatum, Citri Fructus, etc. In this study, the fingerprint and multi-indicator determination method of Hengzhi Kechuan capsules was established, which can be used for more accurate and efficient quality control and standardization enhancement.
2.Analysis of Quality Difference Factors of Perillae Caulis Based on Chemometrics Combined with TOPSIS Model
Maoqing WANG ; Sha CHEN ; Qian MA ; Jun ZHANG ; Qingxia XU ; Cong GUO ; Rui SHEN ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):168-175
ObjectiveTo explore quality difference factors of Perillae Caulis based on the contents of multiple chemical components and comprehensively evaluate the quality. MethodsA total of 32 batches of Perillae Caulis samples were collected from 12 producing areas such as Hebei, Anhui and Guangdong, and their diameter range, epidermis color and producing areas were recorded. Total flavonoids, total phenols, volatile oils, 5 active components and 84 volatile components in 32 batches of samples were quantitatively or semi-quantitatively determined by colorimetry, ultra performance liquid chromatography-photodiode array detector(UPLC-PDA) and gas chromatography-mass spectrometry(GC-MS). Then the differences between the contents of these components were analyzed by principal component analysis(PCA) and non-parametric test. According to the weights of the index components determined by PCA model, entropy weight-technique for order preference by similarity to ideal solution(TOPSIS) model was constructed to evaluate the quality of Perillae Caulis with different characters and origins. ResultsThere were significant differences in the composition of Perillae Caulis with different diameters, epidermis colors and producing areas, and 9 differential components were screened out, including 6 index constituents(total flavonoids, total phenols, caffeic acid, scutellarin, rosmarinic acid and luteolin) and 3 volatile components(caryophyllene oxide, (-)-humulene epoxide Ⅱ, 14-hydroxycaryophyllene), of which 6 index constituents were higher in samples with small diameter, purple-brown epidermis and southern origin, while the contents of 3 volatile components were higher in samples with large diameter, dark-brown epidermis and northern origin. A significant difference was shown in the model scores of different diameters, epidermis colors and origins(P<0.05), and the scores of Perillae Caulis with small diameter and purple-brown epidermis from southern area, especially Guangdong, had a high score. ConclusionThere are significant differences in the composition and content of chemical constituents between different diameters, epidermal colors and production areas of Perillae Caulis, samples showing small diameter, owing purple-brown epidermis, and originating from Guangdong were of higher-quality due to their higher content of 8 key indices.
3.Analysis of Quality Difference Factors of Perillae Caulis Based on Chemometrics Combined with TOPSIS Model
Maoqing WANG ; Sha CHEN ; Qian MA ; Jun ZHANG ; Qingxia XU ; Cong GUO ; Rui SHEN ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):168-175
ObjectiveTo explore quality difference factors of Perillae Caulis based on the contents of multiple chemical components and comprehensively evaluate the quality. MethodsA total of 32 batches of Perillae Caulis samples were collected from 12 producing areas such as Hebei, Anhui and Guangdong, and their diameter range, epidermis color and producing areas were recorded. Total flavonoids, total phenols, volatile oils, 5 active components and 84 volatile components in 32 batches of samples were quantitatively or semi-quantitatively determined by colorimetry, ultra performance liquid chromatography-photodiode array detector(UPLC-PDA) and gas chromatography-mass spectrometry(GC-MS). Then the differences between the contents of these components were analyzed by principal component analysis(PCA) and non-parametric test. According to the weights of the index components determined by PCA model, entropy weight-technique for order preference by similarity to ideal solution(TOPSIS) model was constructed to evaluate the quality of Perillae Caulis with different characters and origins. ResultsThere were significant differences in the composition of Perillae Caulis with different diameters, epidermis colors and producing areas, and 9 differential components were screened out, including 6 index constituents(total flavonoids, total phenols, caffeic acid, scutellarin, rosmarinic acid and luteolin) and 3 volatile components(caryophyllene oxide, (-)-humulene epoxide Ⅱ, 14-hydroxycaryophyllene), of which 6 index constituents were higher in samples with small diameter, purple-brown epidermis and southern origin, while the contents of 3 volatile components were higher in samples with large diameter, dark-brown epidermis and northern origin. A significant difference was shown in the model scores of different diameters, epidermis colors and origins(P<0.05), and the scores of Perillae Caulis with small diameter and purple-brown epidermis from southern area, especially Guangdong, had a high score. ConclusionThere are significant differences in the composition and content of chemical constituents between different diameters, epidermal colors and production areas of Perillae Caulis, samples showing small diameter, owing purple-brown epidermis, and originating from Guangdong were of higher-quality due to their higher content of 8 key indices.
4.Four intravenous iron formulations in the treatment of iron deficiency anemia:a rapid health technology assessment
Zhicong XING ; Fudong SUN ; Qingxia XUE ; Bei ZHANG ; Shengjun MU ; Quan ZHAO
Chinese Journal of Pharmacoepidemiology 2024;33(9):1030-1043
Objective To evaluate the efficacy,safety,and economy of 4 intravenous iron formulations in the treatment of iron deficiency anemia(IDA)by rapid health technology assessment,and to provide evidence for clinical decision-making.Methods PubMed,Embase,the Cochrane Library,CNKI,WanFang,SinoMed,and official websites of international health technology assessment agencies were electronically searched to collect health technology assessment reports,systematic reviews/Meta-analysis,and pharmacoeconomic studies concerning the treatment of IDA with iron sucrose(IS),iron dextran(ID),ferric carboxymaltose(FCM),and iron isomaltoside(IIM)from the inception to August 15,2024.Two researchers independently screened the studies,extracted data and assessed the quality of included studies.The results were then qualitatively described and analyzed.Results A total of 32 studies were included,including one health technology assessment report,16 systematic reviews/Meta-analysis,and 15 pharmacoeconomic evaluations.In terms of effectiveness,FCM had a higher response rate than that of IS(P<0.05),FCM and IIM had no statistical difference(P>0.05).Regarding hemoglobin level change,patients treated with FCM had higher hemoglobin levels than those treated with IS(P<0.05);the improvement in hemoglobin levels between IIM and FCM was inconclusive.In terms of ferritin level change,FCM might be superior to the other three intravenous iron formulations.In terms of safety,the adverse event rates for FCM,IS,ID and IIM were 12.0%,15.3%,12.0%and 17.0%,respectively;IIM was significantly associated with a lower rate of cardiovascular adverse events compared to FCM and IS(P<0.05);FCM had the highest rate of hypophosphatemia among the four formulations(P<0.05),and there was no significant difference among IIM,IS and ID(P>0.05);IIM had a lower risk of severe or serious hypersensitivity reactions compared to FCM and IS.In terms of economy,FCM and IIM had an economic advantage compared to IS.The economic efficiency ranking among IS,ID,and FCM was in the order of FCM,ID,and IS,the economic comparison between FCM and IIM remains inconclusive and needs to be further demonstrated.Conclusion FCM and IIM have good efficacy,safety and economy in the treatment of IDA,but most of the included economy studies based on foreign populations,and domestic economic studies need to be further demonstrated.
5.Therapeutic efficacy of Jiawei Liujunzi decoction in treatment of volume overload with peritoneal dialysis
Shuhan YU ; Sha CHEN ; Qingxia ZHANG ; Hong PAN ; Zhijie LIU
China Modern Doctor 2024;62(28):76-79
Objective To explore the effect of Jiawei Liujunzi decoction in improving volume overload and residual renal protection in continuous ambulatory peritoneal dialysis(CAPD)patients with spleen deficiency.Methods A total of 82 patients treated in the Peritoneal Dialysis Center of Dongyang Hospital of Traditional Chinese Medicine of Affiliated to Wenzhou Medical University from July 2022 to April 2023 were selected as study objects.According to random number table method,the patients were divided into control group and treatment group,41 cases in each group.The control group was given basic western medicine treatment,and the treatment group was given supplemented with Jiawei Liujunzi decoction on the basis of control group,and the treatment course was 8 weeks.The percentage of extracellular water to total body water(ECW%),urea clearance index of residual kidney(Kt/V)and brain natriuretic peptide(BNP)of two groups were compared,and safety of the drug was evaluated.Results After treatment,ECW%and BNP in two groups were significantly lower than before treatment(P<0.05).The urine volume of control group was significantly lower than that before treatment(P<0.05).After treatment,there were no significant differences in ECW%,BNP,Kt/V and urine volume between two groups(P>0.05).After treatment,there were no significant differences in alanine aminotransferase,aspartate aminotransferase,albumin,phosphorus,calcium and potassium between two groups(P>0.05),indicating good safety.After 12 months of follow-up,the survival rate of treatment group was significantly higher than that of control group(P<0.05).Conclusion Jiawei Liujunzi decoction can improve the volume overload of CAPD patients with spleen deficiency to a certain extent,with good safety,and can improve the long-term survival rate of patients.
6.Current status of missed nursing care during labor and its influencing factors
Shenglan DING ; Yilan ZHANG ; Qingxia WANG ; Xiujuan FU ; Xin WANG
Chinese Journal of Practical Nursing 2024;40(34):2673-2681
Objective:To investigate the current state of missed nursing care during labor, explore the reasons why nursing care was missed, and examine the influencing factors of missed nursing care.Methods:Data were collected from 14 medical institutions of different levels in southwest China using a convenience sampling from February to April, 2023. A total of 491 midwives were included. A cross-sectional survey was conducted using a general information questionnaire and the Chinese version of the Perinatal Missed Care. Multiple linear regression analysis was conducted to identify the influencing factors on missed nursing care.Results:Among 491 midwives, there are 6 males and 485 females. 194 midwives aged ≤ 30, 205 midwives aged 31-40 years, and 92 midwives aged ≥41 years. 80.45%(395/491) of midwives reported missing at least one item of nursing care during labor in the past week, and the missing rate of single item ranged from 13.24% (65/491) to 53.36% (262/491). The average score across 23 items of missed nursing care during labor was 1.49 ± 0.58. The average scores of items spanning the three dimensions of basic care, necessary care and postnatal care were 1.67 ± 0.68, 1.36 ± 0.56, and 1.51 ± 0.70, respectively. The average score of 13 items representing reasons for missed nursing care was 1.82 ± 0.71. The average scores of items in three dimensions of communication, labor resources, and material resources were 1.75 ± 0.73, 1.97 ± 0.87, and 1.74 ± 0.83, respectively. The multiple linear regression analyses showed that gender, monthly average income level, and whether overtime hours were included in total working hours were independently associated with missed nursing care (all P<0.05). Conclusions:The current state of missed nursing care during labor needs to be improved. Missed basic care is common, and labor resources are the significant reasons, and is influenced by factors such as demographic and sociological factors. Human resource factors are an important reason for nursing deficiency, and targeted measures should be taken to reduce the occurrence of nursing deficiency.
7.Predictive value of CALLY index for depression after ischemic stroke
Jingjing ZHANG ; Wendong ZHAO ; Yuan ZHAO ; Qingxia ZHANG ; Jia DU ; Yanxia LIU
Tianjin Medical Journal 2024;52(12):1300-1304
Objective To investigate the predictive value of CALLY index for ischemic post-stroke depression(PSD).Methods The clinical data of 179 patients with ischemic stroke were included,and the demographic information,medical history,stroke severity and laboratory indicators at admission were collected.After 6 months of follow-up,all patients were assessed for depressive symptoms using the 17-item Hamilton Depression Scale(HAMD-17).Patients were divided into the PSD group(48 cases)and the non-PSD group(131 cases).Differences in clinical characteristics were compared between the PSD group and the non-PSD group.CALLY index was calculated from C-reactive protein(CRP),albumin(ALB)and lymphocyte counts.Receiver operating characteristic(ROC)curve was used to analyze the predictive value of CALLY index to PSD.Spearman correlation analysis was used for the correlation between CALLY index and neurological and cognitive function in PSD patients.K-M curve and Cox regression were used for analyzing the influence of CALLY index on PSD.Results The CALLY index of 179 patients ranged from 0.54 to 1.79,with a median of 1.08.ROC curve analysis showed that the optimal critical value of CALLY index to predict PSD was 1.09,and the area under ROC curve was 0.757(95%CI:0.687-0.818).Compared with the non-PSD group,the proportion of females was higher in the PSD group,and the proportion of patients with hyperlipidemia was increased with shorter years of education.The serum C-reactive protein(CRP)was higher,and albumin(ALB)and CALLY index were lower(P<0.05).The K-M curve showed that the incidence of PSD was significantly higher in the low CALLY index group(CALLY≤1.08)than that in the higher CALLY index group(CALLY>1.08,33.0%vs.20.5%,Log rank χ2=8.553,P=0.004).Cox regression analysis showed that after adjusting for other covariates,the decreased CALLY index was an independent risk factor for PSD(HR=2.651,95%CI:1.269-5.540,P<0.05).Conclusion CALLY index has a certain predictive value for PSD in acute ischemic stroke patients,which is helpful for early identification and timely intervention to improve the prognosis of patients.
8.Complex genetic relationship analysis of aged bones and teeth
Yanan WANG ; Qingxia ZHANG ; Jie WANG
Chinese Journal of Forensic Medicine 2024;39(4):416-421,424
Objective To identify the complex relationship by extracting DNA from old bones and teeth.Methods The femurs and teeth of No.1-4 remains were pretreated,and DNA was extracted by using a large system difficult material DNA extraction instrument,and quantitated.The blood samples were extracted on the 96 fully automated workstations.all samples were amplified by using 5 different kits,such as VeriFiler Plus.The mtDNA of No.1 remains and Sun1 were sequenced.Results Based on the results of autosomal STR genotypes,the parental relationship between No.1 remains and No.2 remains was found.And grandparental relationships among No.1 remains and Jia 1,Jia 2,Jia 3 and Sun 1 were found.According to the results of Y chromosome STR genotypes,the No.2 and No.3 remains were tended to come from the same paternal lineage as Jia 1,Jia 2 and Jia 3,while the relationship of No.4 remains and Jia 1 et al,were excluded,and did not conform to the genetic characteristics of the same paternal line.Based on the results of mtDNA whole genome genotypes,it cannot be ruled out that the No.1 remains and Sun 1 come from the same maternal line.Conclusion By Optimizing the pretreatment and extraction methods,combined analysis of multi-genotyping system and multiple detection methods and based on multiple judging criteria of kinship could help to address more complex kinship tests in difficult specimens such as aged bones,teeth and so on.
9.Influencing factors of genotypic drug resistance in people living with human immunodeficiency virus/acquired immunodeficiency syndrome who failed anti-retroviral therapy in Henan Province from 2018 to 2022
Yan SUN ; Zhaoyun CHEN ; Yuqi HUO ; Mengyao FENG ; Jinjin LIU ; Xuan YANG ; Qingxia ZHAO ; Xiaohua ZHANG ; Shuxian ZHAO ; Xue ZHANG ; Yan WANG
Chinese Journal of Infectious Diseases 2024;42(4):219-224
Objective:To analyze the influencing factors of genotypic drug resistance mutations in people living with human immunodeficiency virus and acquired immunodeficiency syndrome(PLWHA) who failed anti-retroviral therapy (ART) in Henan Province, in order to provide a basis for adjusting ART regimens and reducing drug resistance.Methods:PLWHA with virological failure (human immunodeficiency virus (HIV) RNA≥500 copies/mL) after receiving ART for more than 24 weeks were included in Henan Province from January 2018 to December 2022. Baseline CD4 + T lymphocyte counts, ART regimens and other clinical data were collected. HIV-1 gene subtypes and their drug resistance sequence mutations were detected in the Sixth People′s Hospital of Zhengzhou, and the sequences were submitted to the HIV Drug Resistance Interpretation System of Stanford University for comparison of test results. Genotypic drug resistance to nucleotide reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI) and integrase inhibitors (INSTI) was determined. Multivariate logistic regression was used to analyze the influencing factors of drug resistance in patients with ART failure. Results:Among 982 PLWHA, the sequences of 899 cases were successfully amplified, and drug resistance was detected in 737 cases, with the drug resistance rate of 81.98%(737/899). The rates of resistance to NRTIs, NNRTIs, PIs and INSTIs were 71.97%(647/899), 79.31%(713/899), 5.23%(47/899) and 2.72%(20/734), respectively.The largest number of those who developed concomitant resistance to two classes of drugs was 588 cases (79.78%), mainly NRTI and NNRTI concomitant resistance in 583 cases (79.10%). There were 99 cases (13.43%) who developed resistance to only one class of drugs, and those who developed concurrent resistance to three classes of drugs were 48 cases (6.51%), and two cases (0.27%) were found to be resistant to all four classes of drugs mentioned above. A total of 10 HIV genotypes were detected, among which subtype B accounted for the most (59.73%(537/899)), followed by circulating recombinant form (CRF)01_AE subtype (21.91%(197/899)) and CRF07_BC subtype (9.45%(85/899)). The risk factors affecting the development of drug resistance were baseline CD4 + T lymphocyte counts, ART regimens and HIV-1 genotypes. The risk of drug resistance in patients with baseline CD4 + T lymphocyte counts <100/μL was 4.55 times (95% confidence interval ( CI) 2.69 to 7.70) higher than patients with CD4 + T lymphocyte counts≥250/μL, the risk of drug resistance in patients using 2NRTIs+ NNRTI regimen was 4.51 times (95% CI 1.75 to 11.63) higer than those using 2NRTIs+ INSTI regimen, and patients infected with B and CRF01_AE subtype was 2.18 times (95% CI 1.10 to 4.29) and 2.70 times (95% CI 1.26 to 5.78) higer than those with CRF07_BC subtype, respectively. Conclusions:The incidence of genotypic drug resistance in PLWHA with ART failure in Henan Province is high. Low baseline CD4 + T lymphocyte counts, 2NRTIs+ NNRTI regimens, and genotype B and CRF01_AE are risk factors for drug resistance in PLWHA.
10.Characteristics of pretreatment drug resistance mutations in people living with human immunodeficiency virus type 1 in Henan Province, 2023
Jinjin LIU ; Qingxia ZHAO ; Xiaohua ZHANG ; Shuguang WEI ; Yuqi HUO
Chinese Journal of Infectious Diseases 2024;42(6):338-343
Objective:To monitor the subtype distributions and drug resistance mutations of human immunodeficiency virus (HIV)-1 in people living with human immunodeficiency virus-1 (PLWH) who had not experienced anti-retroviral therapy (ART) in Henan Province in 2023, so as to provide valuable data for understanding the transmission of HIV-1 resistant strains and selection of ART regimens in Henan Province.Methods:The clinical data and drug resistance of PLWHs who had not experienced ART in the Sixth People′s Hospital of Zhengzhou from January to December 2023 were collected. This study was a cross-sectional study. Plasma samples were collected from patients, and the partial HIV pol gene sequence and the full integrase gene sequence were amplified by reverse transcription-nested polymerase chain reaction. The subtypes of HIV-1 isolates were determined using the online REGA HIV-1 Subtyping Tool. Drug resistance mutations and antiviral drug susceptibility were analyzed by submitting the determined sequences to the Stanford HIV-1 drug resistance database.Results:Among the 1 073 PLWHs who had not experienced ART, sequences in 1 042 were successfully amplified, giving a success rate of 97.11%. A total of 12 subtypes were detected, and the top five subtypes were circulating recombinant form (CRF)07_BC (43.76%, 456/1 042), CRF01_AE (25.91%, 270/1 042), B (20.92%, 218/1 042), CRF55_01B (5.28%, 55/1 042) and CRF08_BC (1.25%, 13/1 042). The incidence of drug resistance mutation was 28.89% (301/1 042). Drug resistance mutation of non-nucleoside reverse transcriptase inhibitors (NNRTI), nucleotide reverse transcriptase inhibitors (NRTI), protease inhibitors (PI) and integrase inhibitors (INSTI) were 20.92%(218/1 042), 4.03%(42/1 042), 3.84%(40/1 042) and 2.98%(31/1 042), respectively. V179 (12.96%, 135/1 042), M184 (2.40%, 25/1 042), Q58 (2.78%, 29/1 042), and E157 (1.44%, 15/1 042) were the most common drug resistance mutation for NNRTIs, NRTIs, PIs and INSTIs, respectively.Conclusions:The distribution of HIV-1 subtypes is diverse, and the incidence of drug resistance mutation is moderate prevalent in PLWHs who have not experienced ART. Drug resistance testing in PLWHs before ART should be closely monitored.

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