1.Clinical study of Shenbao tablet in the treatment of kidney-yang deficiency syndrome
Xiu-Dian LI ; Ping CHENG ; Zhe CAO ; Qiong HUA ; Xiang-Xin MENG ; Qing-Gang ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(4):524-528
Objective To evaluate the efficacy and safety of Shenbao tablet in the treatment of kidney-yang deficiency syndrome.Methods Patients with kidney-yang deficiency syndrome,will were treated with Shenbao Tablets orally,3 tablets once,3 times a day,and the course of treatment was 56 days or 84 days,depending on the condition.By comparing the clinical efficacy,the changes of symptom scores and syndrome scores before and after treatment,and symptoms remission time,the effectiveness of Shenbao tablet in the treatment of kidney-yang deficiency syndrome was evaluated.The safety was evaluated by adverse reactions.Results There were 339 patients in the 56-day group and 345 patients in the 84-day group.After treatment,the clinical effective rates of the 56-day group and the 84-day group were 91.74%and 97.97%,respectively,and the difference was statistically significant(P<0.05).In the 56-day group and the 84-day group,the excellent rate were 58.41%and 59.13%,clinical control rates were 18.58%and 27.54%,and the progress rates were 14.75%and 11.30%,respectively.After treatment,the symptom scores of kidney-yang deficiency syndrome were significantly reduced respectively within both groups(P<0.05).In the 56-day group and the 84-day group,the nocturia scores of were 0.89±1.27 and 0.60±1.03,the soreness of waist scores were 1.31±1.19 and 0.72±1.00,the morning diarrhea scores were 0.28±0.74 and 0.19±0.61,the anaphrodisia scores were 0.65±1.13 and 0.53±0.98,the low spirits scores were 0.29±0.81 and 0.08±0.40,the cold limbs score were 1.09±1.20 and 0.55±0.93,the edema scores were 0.14±0.55 and 0.05±0.30,the bright pale complexion scores were 0.20±0.59 and 0.24±0.65,respectively.There were significant differences in the reduction of each symptom score between the two groups(P<0.05);the 56-day group had a more significant decrease in the score of cold limbs than the 84-day group.The remaining symptom scores decreased more significantly in the 84-day group.After treatment,the syndrome scores of kidney-yang deficiency syndrome in the two groups were significantly lower than those before treatment(all P<0.05);the change rates of score in the 56-day group and the 84-day group were(-72.33±24.57)%and(-78.77±19.53)%,respectively,and the difference was statistically significant(P<0.05).The self-reported time to first symptom relief was(14.85±7.18)days in the 56-day group and(14.10±7.78)days in the 84-day group,with no significant difference(P>0.05).The incidence of adverse reactions of Shenbao tablets was 5.37%,mainly reflected in hepatobiliary system diseases,gastrointestinal system diseases and various examination abnormalities.Conclusions After taking Shenbao tablets for 2 to 3 months,the clinical symptoms of kidney-yang deficiency were better improved,and the improvement was more significant after 3 months of treatment.The security of Shenbao Tablets was good.
2.Short-term results of sleeve wrapping technique using remnant aortic wall in modified Bentall procedure
MENG Maolong ; Yao WANG ; Pingfan LU ; Huapeng LI ; Rong REN ; Wen ZHANG ; Fengjie CHEN ; Xianmian ZHUANG ; Xiang WANG ; Gang LI ; Hongwei GUO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(02):283-287
Objective To evaluate the short-term results of sleeve wrapping technique using remnant aortic wall in modified Bentall procedure. Methods The patients undergoing modified Bentall procedure with the remnant aortic wall as a sleeve to cover the sewing area of composite valved graft and the aortic annulus for proximal hemostasis between March 2021 and March 2022 in Shenzhen Fuwai Hospital were enrolled. Short-term results were assessed by cardiopulmonary bypass time, aortic clamping time, mechanical ventilation time, ICU stay, postoperative hospital stay, effusion drainage on the first postoperative day, left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), and follow-up results. Results A total of 14 patients were collected, including 12 males and 2 females, with a mean age of 55.33±10.57 years. There was no postoperative or follow-up death. Cardiopulmonary bypass time was 147.90±21.29 min, aortic clamping time was 115.70±15.23 min, mechanical ventilation time was 19.42±8.98 h, ICU stay was 99.08±49.42 h, and postoperative hospital stay was 16.33±2.74 d. Thoracic drainage volume was 333.33±91.98 mL on the first postoperative day. Only 2 patients required blood transfusion (4.5 U and 2 U, respectively). During the follow-up of 6.17±3.69 months, there was no death, no aortic or valve-related complications. There was statistical difference in the LVEDD between preoperation and before discharge after surgery (P<0.001), and between half a year after surgery and before discharge after surgery (P<0.001). There was a little decrease of LVEF before discharge after surgery compared with preoperative LVEF, but there was no statistical difference (P=0.219). There was no statistical difference in the LVEF half a year after operation compared with that before operation (P=1.000). Conclusion Sleeve wrapping technique using remnant aortic wall in modified Bentall procedure has good short-term results. This modification may be a simple, effective way in controlling proximal bleeding.
3.Factors and Their Impact on Treatment Effect of Acupuncture in Different Outcomes: A Meta-Regression of Acupuncture Randomized Controlled Trials.
Wen-Cui XIU ; Wei-Juan GANG ; Qi ZHOU ; Lan-Jun SHI ; Xiang-Yu HU ; Tian-Yu MING ; Zhen LUO ; Yu-Qing ZHANG ; Xiang-Hong JING
Chinese journal of integrative medicine 2024;30(3):260-266
BACKGROUND:
The effects of acupuncture have varied in different randomized controlled trials (RCTs), and there are many factors that influence treatment effect of acupuncture in different outcomes, with conflicting results.
OBJECTIVE:
To identify factors and their impact on the treatment effect of acupuncture in different outcomes.
METHODS:
Acupuncture RCTs were searched from 7 databases including Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc between January 1st, 2015 and December 31st, 2019. Eligible studies must compare acupuncture to no acupuncture, sham acupuncture, or waiting lists, and report at least 1 patient-important outcome. A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables, even those excluded from the multivariable model due to collinearities. We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences (SMDs), categorising them as small (<0.2), moderate (0.2-0.4), or large (>0.4) effects.
RESULTS:
The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables. High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude, the difference of adjusted SMDs 0.46, 95% confidence interval (CI) 0.07 to 0.84; P=0.02]. The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables. Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture (0.30, 95% CI 0.06 to 0.53; P=0.01). The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables. Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects, compared to non-penetrating acupuncture and fixed regimen, respectively (0.40, 95% CI 0 to 0.80; P=0.05; 0.29, 95% CI 0.06 to 0.53; P=0.01).
CONCLUSIONS
High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms. Penetrating acupuncture demonstrated greater effect in relieving non-painful symptoms. Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes. Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes.
Humans
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Randomized Controlled Trials as Topic
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Acupuncture Therapy/methods*
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Pain
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Pain Management
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China
4.Structure-based development of potent and selective type-II kinase inhibitors of RIPK1.
Ying QIN ; Dekang LI ; Chunting QI ; Huaijiang XIANG ; Huyan MENG ; Jingli LIU ; Shaoqing ZHOU ; Xinyu GONG ; Ying LI ; Guifang XU ; Rui ZU ; Hang XIE ; Yechun XU ; Gang XU ; Zheng ZHANG ; Shi CHEN ; Lifeng PAN ; Ying LI ; Li TAN
Acta Pharmaceutica Sinica B 2024;14(1):319-334
Receptor-interacting serine/threonine-protein kinase 1 (RIPK1) functions as a key regulator in inflammation and cell death and is involved in mediating a variety of inflammatory or degenerative diseases. A number of allosteric RIPK1 inhibitors (RIPK1i) have been developed, and some of them have already advanced into clinical evaluation. Recently, selective RIPK1i that interact with both the allosteric pocket and the ATP-binding site of RIPK1 have started to emerge. Here, we report the rational development of a new series of type-II RIPK1i based on the rediscovery of a reported but mechanistically atypical RIPK3i. We also describe the structure-guided lead optimization of a potent, selective, and orally bioavailable RIPK1i, 62, which exhibits extraordinary efficacies in mouse models of acute or chronic inflammatory diseases. Collectively, 62 provides a useful tool for evaluating RIPK1 in animal disease models and a promising lead for further drug development.
5.Quality Standard of Tibetan Medicine "Yajima" (Chrysosplenium Axillare)
Gang REN ; Chaowei PU ; Jingjing WEN ; Wei JIANG ; Guoyue ZHONG ; Weizao LUO ; Zhen NI ; Jiamei XIANG
Chinese Journal of Modern Applied Pharmacy 2024;41(4):469-475
OBJECTIVE
To establish the quality standards of medicinal materials in light of related methods in the general principles of part four of Chinese Pharmacopoeia(2020 Edition), and to conduct systematic research on the Tibetan medicine "Yajima"(Chrysosplenium axillare).
METHODS
The powder characteristics of medicinal materials were described by microscopic identification method. Silica gel GF254 thin-layer plate was employed to establish a TLC identification method with 5-O-demethylapulein and oxyayanin A as reference substances. Loss on drying, total ash, acid-insoluble ash and ethanol-soluble extractives of 10 batches of Chrysosplenium axillare were determined according to the general principles of part four of Chinese Pharmacopoeia(2020 Edition). HPLC was used to establish the characteristic chromatogram of Chrysosplenium axillare, and the content determination method was established with chrysosplenoside I(CI) and chrysosplenoside A(CA) as the quality control index components of Chrysosplenium axillare.
RESULTS
The water content, total ash, acid-insoluble ash, ethanol-soluble extractive and the content of CI and CA of all samples varied in the ranges of 9.17%−12.52%, 14.11%−16.74%, 1.50%−4.72%, 32.77%−40.30%, 0.30%−0.99% and 0.28%−0.88%, respectively.
CONCLUSION
The identification and content determination methods of Yajima(Chrysosplenium axillare) are established for the first time. The methods are easy to operate and exclusive, which is of great significance to accurately evaluate the internal quality of medicinal materials and ensure the quality of drug used.
6.Study on the Optimal Harvesting Period of Platycodonis Radix by Grey Correlation Method and TOPSIS Method Based on Entropy Weight Method
Yajiang JING ; Jianping HUANG ; Qilong WANG ; Jia AN ; Xiang WANG ; Yupeng WANG ; Gang ZHANG ; Liang PENG ; Jing GAO ; Changli WANG ; Yonggang YAN
Chinese Journal of Modern Applied Pharmacy 2024;41(9):1229-1237
OBJECTIVE
To improve the quality evaluation method of Platycodonis Radix, to study the differences in the quality of three-years-old Platycodonis Radix under different harvesting periods, and to determine the optimal harvesting period of Platycodonis Radix.
METHODS
The leachate, ash, moisture, refractive index and the content of six saponins were used as the quality evaluation indexes. The differences between the herbs of Platycodonis Radix at different harvesting periods were characterized with the help of mathematical and statistical methods. And link the entropy weight method, gray correlation analysis and TOPSIS method were combined to obtain the statistical analysis of the relevant indexes and the quality ranking information of the herbs in different harvesting periods.
RESULTS
There were significant differences between the quality evaluation indexes of three-years-old Platycodonis Radix at different harvesting periods. The added multi-indicator testing had improved the quality evaluation system of Platycodonis Radix and enhanced the "Drug properties-Effectiveness" linkage of the herbs. And the results of the comprehensive quality evaluation model showed that the herbs harvested around October 21 (Frost’s Descent) were ranked best in terms of comprehensive index.
CONCLUSION
In order to ensure the quality of Platycodonis Radix, the best harvesting period for three-years-old Platycodonis Radix is determined around the "Frost’s Descent" season, taking into account the characteristics of the herbs' appearance and the material basis of herbs.
7.A reporter gene assays for bioactivity determination of human chorinonic gonadotropin
Ying HUANG ; Xiao-ming ZHANG ; He-yang LI ; Lü-yin WANG ; Hui ZHANG ; Ping LÜ ; Jing LI ; Xiang-dong GAO ; Cheng-gang LIANG
Acta Pharmaceutica Sinica 2024;59(2):432-438
This study constructed a LHCGR-CRE-luc-HEK293 transgenic cell line according to the activation of the cAMP signaling pathway after recombinant human chorionic gonadotropin binding to the receptor. The biological activity of recombinant human chorionic gonadotropin was assayed using a luciferase assay system. The relative potency of the samples was calculated using four-parameter model. And the method conditions were optimized to validate the specificity, relative accuracy, precision and linearity of the method. The results showed that there was a quantitative potency relationship of human chorinonic gonadotropin (hCG) in the method and it was in accordance with the four-parameter curve. After optimization, the conditions were determined as hCG dilution concentration of 2.5 μg·mL-1, dilution ratio of 1∶4, cell number of 10 000-15 000 cells/well, and induction time of 6 h. The method had good specificity, relative accuracy with relative bias ranging from -8.9% to 3.4%, linear regression equation correlation coefficient of 0.996, intermediate precision geometric coefficient of variation ranging from 3.3% to 15.0%, and linearity range of 50% to 200%. This study successfully established and validated a reporter gene method to detect hCG biological activity, which can be used for hCG biological activity assay and quality control.
8.Application of amniotic fluid in situ culture combined with chromosome microarray analysis in prenatal diagnosis
Chinese Journal of Clinical Laboratory Science 2024;42(2):85-89
Objective To evaluate the effects combining in situ amniotic fluid culture with chromosomal microarray analysis(CMA)in prenatal diagnosis of fetal chromosomal abnormalities.Methods A retrospective analysis was conducted on 3 133 pregnant women who underwent amniocentesis at Huaihua Maternal and Child Health Hospital from October 2018 to February 2023 due to different indica-tions for prenatal diagnosis.The detection rates and differences of in situ amniotic fluid culture and CMA in detecting fetal chromosomal abnormalities were compared.Results Among the 3 133 samples,the detection rates increased by 0.95%(in situ culture)and 2.36%(CMA)in the double-indication group compared with the single-indication group.The combined testing detected 796 abnormal cases(25.41%),including 300 cases(9.58%)by in situ culture and 706 cases(22.53%)by CMA.Both techniques detected 145 aneu-ploidies and 31 large segmental structural abnormalities,while CMA additionally detected 169 copy number variants(CNV),loss of heterozygosity(LOH),absence of heterozygosity(AOH)/region of homozygosity(ROH)and uniparental disomy(UPD),and in si-tu culture additionally detected 11 balanced rearrangements.They jointly detected 23 cases of mosaicism(0.73%).Conclusion In si-tu amniotic fluid culture and CMA complement each other.Their combined application can significantly improve the detection rate of fe-tal chromosomal abnormalities and provide more detailed and accurate information for prenatal genetic counseling,thus facilitating preg-nant women to decide continuing or terminating the pregnancy.
9.The value of high-throughput sequencing data reanalysis in identifying ERBB2 amplification in colorectal cancer patients
Min-Na SHEN ; Li ZHANG ; Xin-Ning CHEN ; Fei HUANG ; Chao-Gang BAI ; Li-Meng CHEN ; Hai-Xiang PENG ; Yan ZHOU ; Bei-Li WANG ; Bai-Shen PAN ; Wei GUO
Fudan University Journal of Medical Sciences 2024;51(2):166-171
Objective To evaluate the value of high-throughput sequencing(HTS)data reanalysis that does not include ERBB2 copy number variation(CNV)analysis,in identifying ERBB2 amplification in patients with colorectal cancer.Methods The HTS data of 252 cases of colorectal cancer diagnosed by pathological biopsy who received peripheral blood cfDNA HTS detection samples were retrospectively analyzed.According to the HTS data of ERBB2 non-amplified samples judged by immunohistochemistry(IHC)and/or fluorescence in situ hybridization(FISH),the number of chromosome 17(Chr17)reads in the total number of reads was calculated the range of the ratio was initially determined as the threshold for prompting ERBB2 amplification.Suspected positive samples were screened according to thresholds and verified by digital PCR,IHC and FISH.Results The proportion of the number of Chr17 reads accounts for the number of total reads in the 89 cases of ERBB2 non-amplified samples determined by IHC and/or FISH ranged from 0.188 to 0.299(0.239±0.192).Using 0.298(1.25 times the mean)as the threshold indicating ERBB2 amplification,the data of 163 samples were analyzed,of which 7 cases were suspected to be positive,and the ratio ranged from 0.302 to 0.853.Among them,5 cases were determined to be positive by IHC and/or FISH,and 6 cases were confirmed to be positive by digital PCR.The ratio of the number of Chr17 reads to the number of total reads was positively correlated with the ratio of ERBB2/EIF2C1,and the correlation was good(r2=0.909).Conclusion The high-throughput sequencing data that does not cover the ERBB2 CNV analysis has a certain hint value for ERBB2 amplification in patients with colorectal cancer.
10.Guidelines for clinical diagnosis and treatment of delayed graft function in kidney transplant recipients in China
Branch of Organ Transplantation of Chinese Medical Association ; Branch of Kidney Transplantation of China International Exchange and Promotive Association for Medical and Health Care ; Heli XIANG ; Wei WANG ; Jianning WANG ; Xiaosong XU ; Gang WANG ; Wujun XUE
Organ Transplantation 2024;15(5):684-699
Delayed graft function in kidney transplant recipients is one of the common early complications after kidney transplantation,which is an independent risk factor affecting the short-term and long-term survival of renal allografts.Branch of Organ Transplantation of Chinese Medical Association and Branch of Kidney Transplantation of China International Exchange and Promotive Association for Medical and Health Care organized well-known Chinese experts in organ transplantation and related disciplines to formulate and discuss the determination of the scope and clinical problems,evidence retrieval and screening,and the formation of recommendations based on"Technical Specification for the Diagnosis and Treatment on Delayed Graft Function After Renal Transplantation(2019 edition)".After two rounds of collective examination and approval by Chinese Medical Association and China International Exchange and Promotive Association for Medical and Health Care,"Guidelines for Clinical Diagnosis and Treatment of Delayed Graft Function in Kidney Transplant Recipients in China"was finally formulated.This guideline puts forward recommendations and explanations regarding 21 clinical problems including the concept,mechanism,risk factors,diagnosis,prevention,treatment and application of immunosuppressive drugs for delayed graft function in kidney transplant recipients,aiming to standardize the diagnosis,prevention and treatment of delayed graft function in kidney transplant recipients,enhance clinical efficacy of kidney transplantation,prolong short-term and long-term survival of kidney transplant recipients and renal allografts and promote the development of the discipline of transplantation.


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