1.Determination of rifapentine concentration in human serum by two-dimensional liquid chromatography
Tao KE ; Tian HE ; Pei-Ze ZHANG ; Wei LI ; Yang ZHOU ; Feng WANG ; Miao-Na LIU
The Chinese Journal of Clinical Pharmacology 2024;40(11):1638-1641
Objective To develop a two-dimensional liquid chromatographic method for rifapentine blood concentration determination.Methods The blood concentration of rifapentine was determined by a novel two-dimensional liquid chromatography(2D-LC)with a one-dimensional column:Aston SC2T(3.5 mm ×50.0 mm,5 μm);a two-dimensional column:Aston SCB(4.6 mm ×250.0 mm,5 μm);the temperature of the column was 40 ℃;the flow rate was 1.0 mL·min-1;the detection wavelength was 335 nm;the injection volume was 300 μL.The specificity,standard curve and lower limit of quantification,precision and recovery,and stability of the method were investigated.The method was used to determine the blood concentration of rifapentine in tuberculosis patients.Results Rifapentine showed good linearity within 0.33-18.62 μg·mL-1 with the standard curve equation of y=2.68 x 105x-5 850.36(r=0.997),the recoveries were 99.81%-105.08%,and the intra-and inter-day precision were ≤4.84%.The results of rifapentine blood concentration measurements in tuberculosis patients were in the range of 0.10-54.70μg·mL-1,and 64.74%were within the therapeutic window concentration range(8-30 μg·mL-1).Conclusion The method is easy to operate,has high sensitivity,low detection limit and high specificity,and is suitable for clinical blood concentration determination.Individual differences in the administration of rifapentine in tuberculosis patients are large,and blood concentration monitoring is required for individualized treatment.
2.Analgesia effect of multimodal analgesia with nalbuphine combined with transversus abdominis plane block on patients after radical resection of liver cancer
Pei-Zhong ZHANG ; Guo-Ting XU ; Miao-Ji WANG
The Chinese Journal of Clinical Pharmacology 2024;40(18):2635-2639
Objective To evaluate the analgesia effect of nalbuphine combined with transversus abdominis plane block(TAPB)multimodal analgesia on patients after radical resection of liver cancer,and to observe its safety.Methods The clinical data of patients who underwent radical resection of liver cancer were retrospectively collected.According to different postoperative anesthesia regimens,they were divided into control group and treatment group by the cohort method.The control group was treated with TAPB combined with 2 μg·kg-1 sufentanil+ondansetron 16 mg for patient-controlled intravenous analgesia(PCIA),while the treatment group was given TAPB combined with 2 mg·kg-1 nalbuphine+ondansetron 16 mg for PCIA.The perioperative anesthetic dosage,heart rate(HR),anesthesia effect,postoperative visual analogue scale(VAS)and Bruggman comfort score(BCS)were compared,and the total number of analgesia pump compressions,the number of effective compressions,remedial analgesia rate,postoperative ambulation time,postoperative exhaust time and occurrence of drug-related adverse reactions were recorded in the two groups.Results 57 cases in control group and 53 cases in treatment group were included for analysis.The HR values at 5 min after tracheal extubation in treatment group and control group were(66.38±7.65)and(70.74±8.12)beat·min-1,VAS scores at 48 h after surgery were(1.14±0.36)and(1.75±0.69)points,BCS scores were(2.51±0.45)and(2.30±0.55)points,the total number of analgesia pump compressions after PCIA were(6.89±1.75)and(12.61±2.39)times,the number of effective compressions were(3.64±0.91)and(8.27±1.15)times,the remedial analgesia rates were 5.66%(3 cases/53 cases)and 19.30%(11 cases/57 cases),the incidence rates of nausea and vomiting were 5.66%(3 cases/53 cases)and 19.30%(11 cases/57 cases),respectively(all P<0.05).The overall excellent and good rates of anesthesia in treatment group and control group were 96.23%(51 cases/53 cases)and 89.47%(51 cases/57 cases),the total incidence rates of adverse drug reactions were 11.32%(6 cases/53 cases)and 22.81%(13 cases/57 cases),respectively(all P>0.05).Conclusion Nalbuphine combined with TAPB multimodal analgesia has good analgesia effect after radical resection of liver cancer,and it is beneficial to reducing the occurrence of postoperative nausea and vomiting,and it is safe and effective.
3.Bioequivalence study of olmesartan medoxomil tablet in Chinese healthy subjects
Na SHAN ; Da-Hai JIANG ; Lin-Lin MIAO ; Zhen-Li REN ; Peng-Bo JIN ; Pei-Qi HAO ; Li AN ; Hong ZHU ; Yong XIN ; Guang-De YANG ; Feng LIU
The Chinese Journal of Clinical Pharmacology 2024;40(20):3033-3037
Objective To study the bioequivalence of test and reference olmesartan tablet in Chinese healthy subjects after single dose under fasting and fed conditions.Methods A single-center,random,open,single-dose,two-preparations,double-period,crossover study was adopted.A total of 48 healthy adult male and female subjects(24 cases of fasting test and 24 cases of fed test)were included in the random crossover administration.Single oral dose 20 mg of test and reference were taken under fasting and postprandial conditions,respectively.Plasma concentration of olmesartan in plasma were determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main pharmacokinetic parameters of the test and reference preparations of olmesartan tablets in the fasting group were as follows:Cmax were(653.06±133.53)and(617.37±151.16)ng·mL-1,AUC0-t were(4 201.18±1 035.21)and(4 087.38±889.99)ng·mL-1·h,AUC0-∞ were(4 254.30±1 058.90)and(4 135.69±905.29)ng·mL-1·h.The main pharmacokinetic parameters of the test and reference preparations of olmesartan tablets in the postprandial group were as follows:Cmax were(574.78±177.05)and(579.98±107.74)ng·mL-1,AUC0-t were(3 288.37±866.06)and(3 181.51±801.06)ng·mL-1·h,AUC0-∞ were(3 326.11±874.26)and(3 242.01±823.09)ng·mL-1·h.Under fasting and postprandial conditions,the 90%confidence intervals of the main pharmacokinetic parameters of the test and reference preparations are both 80.00%-125.00%.Conclusion Under fasting and postprandial conditions,a single oral dose of test and reference preparations olmesartan tablets in Chinese healthy adult volunteers showed bioequivalence.
4.Characteristics of Blood Pressure in Elderly Patients with Hypertensive Cerebral Small Vessel Disease and Their Correlation with Traditional Chinese Medicine Syndrome Types
Shi-Xing HAO ; Hui-Pei AO ; Hui-Cong LI ; Wei-Sen ZHONG ; Jia-Cheng HUANG ; Xiao-Lu MIAO
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(8):1962-1970
Objective To explore the characteristics of blood pressure in the elderly patients with hypertensive cerebral small vessel disease(CSVD)and their correlation with traditional Chinese medicine(TCM)syndrome types.Methods A retrospective analysis was conducted in 189 elderly patients with essential hypertension.With reference to the presence or absence of CSVD,the patients were divided into CSVD group(87 cases)and non-CSVD group(102 cases).The blood pressure related parameters and clinical data obtained by four diagnostic methods of TCM in the two groups were collected,and then the characteristics of blood pressure and their correlation with TCM syndromes were analyzed with statistical methods.Results(1)CSVD group had higher values than non-CSVD group in the ambulatory blood pressure parameters of 24-hour systolic blood pressure(24hSBP),24-hour diastolic blood pressure(24hDBP),daytime systolic blood pressure(DSBP),daytime diastolic blood pressure(DDBP),nighttime systolic blood pressure(NSBP),nighttime diastolic blood pressure(NDBP),24-hour pulse pressure(24hPP),daytime pulse pressure(DPP),nighttime pulse pressure(NPP),maximum SBP,morning SBP,daytime SBP load and nighttime SBP load(P<0.01).(2)The analysis of blood pressure variability showed that the mean value of nighttime SBP standard deviation(NSSD)in CSVD group was higher than that in the non-CSVD group(P<0.01).(3)The analysis of circadian rhythm of blood pressure showed that there was significant difference in the comparison of circadian rhythm of ambulatory blood pressure between the two groups(P<0.05):non-CSVD group was predominated by non-dipper type blood pressure(50 cases,49.02%)and dipper type blood pressure(31 cases,30.39%),and CSVD group was predominated by non-dipper type blood pressure(38 cases,43.68%)and super-dipper type blood pressure(31 cases,35.63%).(4)Logistic regression analysis showed that 24hSBP(OR=1.296,95%CI:1.112-1.511),maximum SBP(OR=1.074,95%CI:1.006-1.146),morning SBP(OR=1.064,95%CI:1.013-1.118),abnormal circadian rhythm of blood pressure(OR=3.736,95%CI:1.663-8.390)were the influence factors of CSVD(P<0.05 or P<0.01).(5)The analysis of the distribution of TCM syndrome types showed that non-CSVD group was dominated by accumulation of excess phlegm-damp syndrome(58.82%)and yin deficiency and yang hyperactivity syndrome(21.57%),and CSVD group was dominated by yin deficiency and yang hyperactivity syndrome(51.72%)and accumulation of excess phlegm-damp syndrome(21.84%).(6)The analysis of blood pressure in patients with various syndrome types showed that the DPP of patients with accumulation of excess phlegm-damp syndrome in the CSVD group was significantly higher than that in the non-CSVD group(P<0.01),and the 24hDBP and NDBP of patients with yin deficiency and yang hyperactivity syndrome in the CSVD group were significantly higher than those in the non-CSVD group(P<0.01).Conclusion It is indicated that 24hSBP,maximum SBP,elevated morning SBP,and abnormal blood pressure circadian rhythms may be the important risk factors for the hypertensive CSVD in the elderly.Elderly hypertensive patients with accumulation of excess phlegm-damp syndrome should pay more attention to the mean daytime pulse pressure,and elderly hypertensive patients with yin deficiency and yang hyperactivity syndrome should pay more attention to monitoring DBP.The dynamic observation and early control of the blood pressure is helpful for the prevention and treatment of CSVD in the elderly patients with hypertension.
5.Exploration of Traditional Chinese Medicine Interventions for Inflammation-to-Tumor Transition in Cervical High-Risk Human Papillomavirus Infection from the Perspective of Damp-Heat Accumulation Resulting into Toxin
Yu-Xi MIAO ; Gen-Ping ZENG ; Pei-Yin LI ; Xi-Jing LU ; Song-Ping LUO ; Lei ZENG
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(9):2472-2478
Inflammation-to-tumor transition is one of the important mechanisms by which the cervical high-risk human papillomavirus(HR-HPV)infection develops into cervical cancer.Persistent cervical HR-HPV infection is an important cause of cervical cancer,and the focal uncontrolled inflammatory microenvironment caused by persistent cervical HR-HPV infection is the underlying mechanism of cervical cancer.The macroscopic and microscopic pathological process of inflammation-to-tumor transition is consistent with the pathogenesis evolution of damp-heat accumulation resulting into toxin in traditional Chinese medicine(TCM):the accumulation of damp-heat is the driving factor of inflammation-to-tumor transition,long-term retention of damp-heat leading to spleen deficiency and liver depression contributes to the characteristics of pathogenesis evolution,and long-term retention of damp-heat toxin causes the disorder of liver and spleen and then blood stasis accumulates in the cervical orifice,which eventually becomes cancer toxin.The process of inflammation-to-tumor transition caused by persistent cervical HR-HPV infection is due to the pathological factors of damp,heat,deficiency and toxin in TCM.Therefore,the regulation of inflammatory microenvironment caused by persistent cervical HR-HPV infection is the key approach to the prevention and treatment of cervical cancer.For the treatment of cervical cancer,methods of clearing heat and drying dampness,strengthening the spleen and soothing the liver are the key therapies.By intervention with the proper pathogen-eliminating methods and with simultaneous regulation of the interior and exterior,the process of inflammation-to-tumor transition can be interrupted.The exploration of inflammation-to-tumor transition caused by persistent cervical HR-HPV infection from the perspective of damp-heat accumulation resulting into toxin will provide thoughts for the prevention and treatment of cervical cancer with TCM and for Chinese medicine in intervening inflammation-to-tumor transition.
6.Clinical Efficacy of Xuanfei Yipi Formula in Treating Senile Sarcopenia and Its Effect on Chronic Low-Grade Inflammation of the Patients
Hui-Pei AO ; Shi-Xing HAO ; Hui-Cong LI ; Zhao-Bang CHEN ; Ji-Ying HAI ; Yu-Qing LIU ; Xiao-Lu MIAO
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(11):2931-2936
Objective To investigate the clinical efficacy of Xuanfei Yipi Formula,a prescription derived from modified Jianpi Pill recorded in Yi Fang Ji Jie(A Collection of Prescriptions with Expositions),in treating senile sarcopenia with spleen-stomach weakness type,and to observe its effect on chronic low-grade inflammation of the patients.Methods Seventy cases of senile sarcopenia patients of spleen-stomach weakness type were randomly divided into an observation group and a control group,with 35 cases in each group.The control group was given exercise and nutritional guidance,while the observation group was treated with Xuanfei Yipi Formula orally on the basis of the control group,and the intervention time of both groups was eight weeks.The changes of traditional Chinese medicine(TCM)syndrome scores,appendicular skeletal muscle mass index(ASMI),grip strength,6-meter walking pace,and the serum levels of C-reactive protein(CRP),interleukin 6(IL-6),tumor necrosis factor α(TNF-α)in the two groups before and after treatment were observed.After treatment,the clinical efficacy and safety of the patients in the two groups were evaluated.Results(1)After eight weeks of treatment,the total effective rate in the observation group was 94.29%(33/35),and that in the control group was 77.14%(27/35),the intergroup comparison(by chi-square test)showed that the efficacy of the observation group was significantly superior to that of the control group(P<0.05).(2)After treatment,the TCM syndrome scores in the two groups were significantly lower than those before treatment(P<0.05),and the decrease of TCM syndrome score in the observation group was more obviously than that in the control group(P<0.01).(3)After eight weeks of treatment,the ASMI,grip strength and 6-meter walking pace in the two groups were significantly higher than those before treatment,and the increase of ASMI and grip strength in the observation group was more obviously than that in the control group(P<0.05).(4)After eight weeks of treatment,the levels of serum CRP,IL-6,and TNF-α in the two groups were decreased significantly compared with those before treatment(P<0.05),and the decrease of serum CRP level in the observation group was more obviously than that in the control group(P<0.05).(5)During the treatment,no obvious adverse reactions occurred in both groups,and the safety indexes of liver and kidney functions of the patients were all within the normal range.Conclusion Xuanfei Yipi Formula can improve the clinical symptoms of senile sarcopenia patients,and its mechanism is probably related with the regulation of chronic low-grade inflammation.
7.Summary of the best evidences for the placement and maintenance of adult infusion ports
Pei GAO ; Huohong QIAN ; Minghui XIE ; Yueyuan LI ; Yingxia MIAO ; Jie CAO
Journal of Interventional Radiology 2024;33(8):902-909
Objective To summarize the best evidences for the placement and maintenance of adult infusion ports,and to provide a basis for clinical medical staff to carry out the placement and maintenance of infusion ports.Methods The evidence-based questions were constructed using PIPOST mode.According to the"6S"classification model of evidence,a computerized retrieval of academic papers concerning the best evidence for the placement and maintenance of adult infusion ports from the databases of UpToDate,BMJ Best Practice,Cochrane Library,JBI evidence-based healthcare center database,National Guidelines Clearinghouse(NGC),Center for Disease Control and Prevention(CDC),National Institute for Health and Care Excellence(NICE),Guidelines International Network(GIN),the Registered Nurses'Association of Ontario(RNAO),CINAHL,EMbase,PubMed,Intravenous Nurses Society(INS),Wanfang,CNKI,VIP,SinoMed and Yimaitong was conducted.The retrieval time period was from the establishment of the database to July 6,2023.Two researchers,who had received training in evidence-based nursing,independently evaluated the quality of the literature,screened and summarized the evidences.Results A total of 12 papers,including one paper of clinical decision analysis,5 papers of expert consensus,3 papers of clinical practice guideline,and 3 papers of evidence summary,were finally enrolled in this study.A total of 96 pieces of evidence were extracted from the included literature,and 66 pieces of evidence were ultimately synthesized,which were classified into 5 dimensions,including personnel qualifications,indications and contraindications,perioperative care,PORT maintenance,and health education.Conclusion Clinical healthcare professionals should formulate the nursing strategies based on the evidence so as to improve the safety of infusion port placement and maintenance in adult patients.
8.Clinical practice of sepsis-induced immunosuppression: Current immunotherapy and future options
Fei PEI ; Bin GU ; Shu-Min MIAO ; Xiang-Dong GUAN ; Jian-Feng WU
Chinese Journal of Traumatology 2024;27(2):63-70
Sepsis is a potentially fatal condition characterized by the failure of one or more organs due to a disordered host response to infection. The development of sepsis is closely linked to immune dysfunction. As a result, immunotherapy has gained traction as a promising approach to sepsis treatment, as it holds the potential to reverse immunosuppression and restore immune balance, thereby improving the prognosis of septic patients. However, due to the highly heterogeneous nature of sepsis, it is crucial to carefully select the appropriate patient population for immunotherapy. This review summarizes the current and evolved treatments for sepsis-induced immunosuppression to enhance clinicians' understanding and practical application of immunotherapy in the management of sepsis.
9.Study on the Quality Standard of Desalted Aconiti Lateralis Radix Praeparata Standard Decoction
Le SHENTU ; Yingying LI ; Yajun PEI ; Yuanyuan MIAO
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(6):136-140
Objective To prepare desalted Aconiti Lateralis Radix Praeparata(Danfupian)standard decoction for HPLC content determination and fingerprint analysis.Methods 15 batches of Danfupian standard decoction were prepared,and the transfer rate of monoester alkaloids was calculated by detecting their content.The transfer rates of monoester alkaloids of 15 batches of Danfupian standard decoction were calculated.The fingerprints of Danfupian standard decoction were established by HPLC,and the similarity values of fingerprints were calculated.Results According to the measurement of 15 batches of Danfupian standard decoction,the average transfer rate of monoester alkaloids was 78.03%with a rage from 56.93%to 94.06%.Besides,9 common peaks were determined and 3 peaks were calibrated.Moreover,the similarity was over 0.95 between fingerprints of standard decoction and the control fingerprint of the 15 batches of Danfupian standard decoction.Conclusion This study establishes an HPLC content determination and fingerprint analysis method of Danfupian standard decoction,which can provide reference for the quality control of the TCM granules of Danfupian.
10.Study on Suitability Zoning of Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao in Shanxi Province Based on MaxEnt and ArcGIS
Zihao XU ; Lei HOU ; Yanhui WU ; Ziying LEI ; Jun ZHANG ; Miao WANG ; Xiaobo ZHANG ; Tingting SHI ; Shuosheng ZHANG ; Chenhui DU ; Xiangping PEI ; Runli HE
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(9):1-7
Objective To grasp the main environmental factors affecting the growth of Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao;To predict the distribution of suitable areas of Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao in Shanxi Province;To provide references for the rational distribution of the resources in Shanxi Province.Methods This study utilized the sample point longitude and latitude information collected in the"Fourth Survey of Chinese Materia Medica Resources"database in Shanxi Province.The data were supplemented by searching the China Digital Herbarium and retrieving related literature records.347 sample points distribution data and environmental factors were added to the MaxEnt model.The main environmental factors and contribution rates affecting the geographical distribution of Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao were screened out.The ArcGIS software was used to divide the ecological suitable area of Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao in Shanxi Province.Results The area under the ROC curve of the established MaxEnt model was 0.909,indicating that the model prediction results were accurate.The model screened 19 environmental factors.Among them,climate factor was the most important environmental factor,followed by biological factor and topographic factor,and soil factor had the least influence.The potential suitable areas of Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao in Shanxi Province were mainly distributed in the northern mountainous areas,presenting a trend of gradually decreasing suitability levels from north to south.Under the current climate conditions,the most suitable area for Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao in Shanxi Province was 15 424 km2,the suitable area was 19 856 km2,the sub suitable area was 59 436 km2,and the unsuitable area was 61 894 km2.Conclusion Based on MaxEnt model and ArcGIS software,this study predicts the distribution of suitable areas of Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao in Shanxi Province,which has certain reference value for the protection and rational distribution of Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao resources in Shanxi Province.

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