1.Dingchan Granule (定颤颗粒) for Paroxysmal Atrial Fibrillation with Syndrome of Qi Stagnation and Blood Stasis:A Randomized,Double-Blinded,Placebo-Controlled Clinical Trial
Xiaozhen CHENG ; Xingjuan CHEN ; Weina LI ; Lu XIAO ; Yunhan WANG ; Yun XU ; Yueyue NIU ; Ling FENG
Journal of Traditional Chinese Medicine 2025;66(12):1233-1240
ObjectiveTo observe the clinical effectiveness and safety of Dingchan Granule (定颤颗粒) for paroxysmal atrial fibrillation with syndrome of qi stagnation and blood stasis. MethodsUsing a randomised, double-blind, placebo controlled study method, 90 patients with paroxysmal atrial fibrillation with qi stagnation and blood stasis syndrome were divided into 45 cases each in the treatment group and the control group. Both groups were given conventional western medicine treatment, and the treatment group was additionally treated with Dingchan Granule, while the control group was treated with Dingchan Granule placebo, both of which were taken orally for 8 g each time twice a day. Both groups were treated for 8 weeks. We compared the clinical effectiveness, the improvement of traditional Chinese medicine (TCM) symptoms and the recovery rate of atrial fibrillation between the two groups. We compared the number and duration of atrial fibrillation episodes, TCM symptoms score, atrial fibrillation symptom classification, 24-hour average ventricular rate, Pittsburgh Sleep Quality Index (PSQI), anxiety index, depression index before and after treatment, and evaluated the safety of the two groups. ResultsThe total clinical effectiveness rate in the treatment group was 82.22% (37/45), which was better than 60.00% (27/45) in the control group (P<0.05). The total effective rate of TCM syndrome effectiveness in the treatment group was 88.89% (40/45), which was better than 66.67% (30/45) in the control group (P<0.05); and the rate of atrial fibrillation regression in the treatment group was 26.67% (12/45), better than 6.67% (3/45) in the control group (P<0.05). The number and duration of atrial fibrillation episodes in both groups were significantly decreased (P<0.01), and the number and duration of atrial fibrillation episodes in the treatment group were lower than those in the control group (P<0.01). The TCM syndrome scores of both groups after treatment were significantly lower than before treatment (P<0.01), and the scores of the treatment group was lower than those of the control group (P<0.05). The severity of atrial fibrillation symptoms and the grading of atrial fibrillation symptoms in both groups after treatment were improved (P<0.01), and the degree of symptom improvement in the treatment group was better than that in the control group (P<0.01). The 24-hour average ventricular rate of both groups after treatment was significantly lower (P<0.01). The PSQI, anxiety index and depression index of the treatment group were all lower than before treatment (P<0.01), while the PSQI and anxiety index of the control group were both lower than before treatment (P<0.01 or P<0.05), the PSQI, anxiety index and depression index of the treatment group being lower than those of the control group (P<0.05 or P<0.01). No adverse events occurred in both groups, and no abnormalities were observed in blood, urine, stool routine, liver and kidney function, and coagulation function indexes. ConclusionDingchan Granule for paroxysmal atrial fibrillation with qi stagnation and blood stasis syndrome can alleviate clinical symptom, improve TCM symptom scores, increase atrial fibrillation recovery rate, stabilise the average ventricular rate, and significantly improve the quality of sleep, alleviate the anxiety and depression, with a good safety profile.
2.Research progress on mechanism of interaction between traditional Chinese medicine and intestinal flora
Jing WU ; Wei-Yi TIAN ; Kun CAI ; Su-Fang ZHOU ; Yao-Feng LI ; Xiang-Yun CHEN ; Hai-Bing QIAN ; Sha-Sha YANG
Chinese Pharmacological Bulletin 2024;40(10):1823-1829
Modern Chinese medicine studies have confirmed that the interaction between traditional Chinese medicine(TCM)and intestinal flora is the key to the treatment of diseases with tradi-tional Chinese medicine.This interplay includes such activities as:traditional Chinese medicine can be metabolized by intestinal flora into effective components with different biological activities from its precursors;TCM chemicals improve the composition of gut microbiota,consequently ameliorating its dysfunction as well as associated pathological conditions;and gut microbiota mediate the interactions between the multiple chemicals in TCM.There-fore,it becomes an important way to understand the modern sci-entific connotation of traditional Chinese medicine theory to study the pharmacological mechanism of the efficacy of traditional Chi-nese medicine by targeting Gut microbiota.
3.Single mini-incision combined with honeycomb titanium plate in treatment of acute acromioclavicular joint disloca-tion
Yu-Chen WANG ; Wei-Zhong YU ; Yun-Feng LI ; Wen-Ke ZHU ; Chuan JIA ; Jun-Qi WU ; Hua GAO ; Lin JI
China Journal of Orthopaedics and Traumatology 2024;37(6):576-582
Objective To explore clinical effect of single small incision with honeycomb titanium plate in treating acute acromioclavicular dislocation.Methods The clinical data of 40 patients with acute acromioclavicular dislocation admitted from December 2019 to December 2021 were retrospectively analyzed and divided into two groups according to different surgical methods.Among them,20 patients were fixed with single small incision with honeycomb titanium plate(titanium plate group),including 11 males and 9 females,aged from 23 to 65 years old with an average of(47.40±12.58)years old;12 patients on the left side,8 patients on the right side;11 patients with type Ⅲ,3 patients with type Ⅳ,and 6 patients with type Ⅴ according to Rockwood classification.Twenty patients were fixed with clavicular hook plate(clavicular hook group),including 8 males and 12 females,aged from 24 to 65 years old with an average of(48.40±12.08)years old;12 patients on the left side,8 patients on the right side;10 patients with type Ⅲ,2 patients with type Ⅳ,and 8 patients with type V according to Rockwood classifica-tion.Operative time,incision length,intraoperative blood loss,hospital stay,visual analogue scale(VAS)and Constant-Murley score of shoulder joint function were compared between two groups.Anteroposterior radiographs of the affected shoulder joint were recorded before,immediately and 6 months after surgery,and the coracoclavicular distance was measured and compared.Results Both groups of patients were successfully completed operation without serious complications.All patients were fol-lowed up for 6 to 15 months with an average of(11.9±4.8)months.There were no incisional infection,internal plant fracture or failure,bone tunnel fracture and other complications occurred.The incision length of titanium plate group(35.90±3.14)mm was significantly shorter than that of clavicular hook group(49.30±3.79)mm(P<0.05).There were no significant difference in operative time,intraoperative blood loss and hospital stay between two groups(P>0.05).At 1 and 3 months after operation,VAS of titanium plate group was lower than that of clavicular hook group(P<0.05).Connstant-Murley scores in titanium plate group at 1,3 and 6 months after operation were(86.80±1.36),(91.60±2.32)and(94.90±2.22),respectively;and in clavicular hook group were(78.45±5.47),(85.55±2.01)and(90.25±1.92),which were higher than that of clavicular hook group(P<0.05).There was no significant difference in coracoclavicular distance between two groups immediately and 6 months after op-eration(P>0.05).Conclusion For the treatment of acute acromioclavicular joint dislocation,single small incision combined with honeycomb titanium plate have advantages of shorter incision,fast recovery of shoulder joint function without the second operation,and has good satisfaction of patient.
4.Clinical study of percutaneous transluminal coronary intravascular lithotripsy angioplasty for severe left main coronary artery calcification guided by intravascular ultrasound percutaneous coronary
Feng-Qi LIU ; Jun BAO ; Bai-Hong LI ; Chong-Hao CHEN ; Chang-Zheng GAO ; Yun-Feng GUO ; Xin GU ; Jian-Bin GU ; Xiao-Yan WANG
Chinese Journal of Interventional Cardiology 2024;32(7):383-389
Objective To explore the effectiveness and safety of percutaneous coronary artery shock wave balloon angioplasty(IVL)under the guidance of intravascular ultrasound(IVUS)for the treatment of severe calcification lesions in the left main artery(LM).Methods A total of 26 patients with severe LM(mouth,body,bifurcation)calcification admitted to Jiangnan University Affiliated Hospital from October 2022 to April 2024 were included,with an average age of 72.0(61.8,75.4)years.Under the guidance of IVUS,IVL was used for pre-treatment of calcified lesions,followed by percutaneous coronary intervention(PCI)with stent/drug balloon implantation.All patients were evaluated using IVUS before and after the use of IVL and after PCI.And compare the IVUS intracavity related data before and after treatment[plaque burden(PB)、minimum lumen area(MLA)、minimum lumen diameter(MLD)]and calcification fracture number,minimum stent area(MSA),stent expansion coefficient(expansion,EXP),etc.Results There were 26 patients(2 with opening lesions,7 with body lesions,and 17 with bifurcation lesions at the end of the main trunk),including 7 with stable angina pectoris(SAP),10 with unstable angina(UA),4 with acute ST-segment elevation myocardial infarction(STEMI),and 5 with non ST-segment elevation myocardial infarction(NSTEMI).The PB at the most severe site of calcification decreased by 79.50(76.00,83.75)%compared to 80.00(76.00,83.75)%after IVL(P=0.001),MLA increased by 3.39(3.14,3.68)mm2 compared to 3.38(3.14,3.67)mm2 after IVL(P=0.039),MLD increased by 3.21(3.07,3.30)mm compared to 3.20(3.07,3.30)mm after IVL(P=0.024),and there was 100%calcification rupture(1/2 cases,2/9 cases,≥3/15 cases).The stent/drug ball was successfully implanted 100%,with EXP of(89.15±4.42)%and an MSA of 7.20(6.46,7.45)mm2.No adverse events such as death,angina or recurrent myocardial infarction occurred during the 3 months follow-up after surgery.Conclusions After evaluation by IVUS and pre-treatment with IVL,PCI was successfully completed for severe calcification lesions in LM,and IVL can be used as an option for the treatment of severe calcification in LM.
5.Evaluation of the Promoter Activity of the CHO Cell Expression System Based on Site-specific Integration
Chen LU ; Zi-Yu WANG ; Yan-Fei CAI ; Yong-Qiang DENG ; Jian JIN ; Xue-Feng DING ; Yun CHEN
Chinese Journal of Biochemistry and Molecular Biology 2024;40(10):1400-1408
In industrial production,the expression level of drug proteins in Chinese hamster ovary cells(CHO)is influenced by many factors:the regulatory elements on transcription and translation,the ge-nomic integration sites,and the expression system.Transcription,as the first step of gene expression,largely affects protein expression,and the promoter plays a crucial role in the initiation of transcription.Most of the promoters were screened through transient transfection or random integration,but the presence of unclear copy number or random integration sites makes it difficult to accurately evaluate the promoter activity.To some extent,site-specific integration can reduce the impact of positional effects on exogenous genes and may potentially increase the expression level of exogenous genes.In the early stage of our re-search,multiple sites that can stably express exogenous proteins were identified and verified in the CHO cell genome.In this study,one of these sites(2c6)was selected for the evaluation of promoter activity.The CRISPR/Cas9 gene editing technique was used to site-specifically integrate the reporter gene(EG-FP)regulated by the simian virus early promoter(SV40),mouse elongation factor-1α(mEF-1α),chicken β-actin(cACTB)promoter,and human phosphoglycerate kinase promoter(hPGK)into the 2c6 site,respectively.The mean fluorescence intensity of the cells was analyzed by flow cytometry,and the mRNA level of EGFP was detected by qPCR to comprehensively evaluate the activity of the promoter.The results showed that the activities of the mEF-1α and mACTB promoters were better than those of SV40 and hPGK.The results of the secondary flow cytometry sorting showed that site-specific integration can more accurately evaluate the activity of the promoter in the CHO cell expression system.
6.Protective Effect of Endogenous ω-3 Polyunsaturated Fatty Acid Against Cisplatin-Induced Myelosuppression
Qi-Hua XU ; Zong-Meng ZHANG ; Chao-Feng XING ; Han-Si CHEN ; Ke-Xin ZHENG ; Yun-Ping MU ; Zi-Jian ZHAO ; Fang-Hong LI
Journal of Experimental Hematology 2024;32(5):1601-1607
Objective:To investigate the protective effect of endogenous ω-3 polyunsaturated fatty acid(PUFA)against cisplatin-induced myelosuppression and the mechanism of reducing apoptosis in bone marrow nucleated cells using mfat-1 transgenic mice.Methods:The experimental animals were divided into 4 groups:wild-type mice normal control group,mfat-1 transgenic mice normal control group,wild-type mice model group and mfat-1 transgenic mice model group.The mice in the model group were injected intraperitoneally with 7.5 mg/kg cisplatin on day 0 and day 7 to construct a myelosuppression model,while the mice in the normal control group were injected intraperitoneally with an equal amount of saline,and their status was observed and their body weight was measured daily.Peripheral blood was taken after 14 day for routine blood analysis,and the content and proportion of PUFA in peripheral blood were detected using gas chromatography.Bone marrow nucleated cells in the femur of mice were counted.The histopathological changes in bone marrow were observed by histopathological staining.The apoptosis of nucleated cells and the expression level changes of apoptosis-related genes in the bone marrow of mice were detected by flow cytometry and fluorescence quantitative PCR.Results:Compared with wild-type mice,mfat-1 transgenic mice showed significantly increased levels of ω-3 PUFA in peripheral blood and greater tolerance to cisplatin.Peripheral blood analysis showed that endogenous ω-3 PUFA promoted the recovery of leukocytes,erythrocytes,platelets and haemoglobin in peripheral blood of myelosuppressed mice.The results of HE staining showed that endogenous ω-3 PUFA significantly improved the structural damage of bone marrow tissue induced by cisplatin.Flow cytometry and PCR showed that,compared with wild-type mice model group,the apoptosis rate of bone marrow nucleated cells in mfat-1 transgenic mice was significantly reduced(P<0.001),and the expression of anti-apoptotic genes Bcl-2 mRNA was significantly increased(P<0.01),while the expressions of pro-apoptotic genes Bax and Bak mRNA were significantly reduced(P<0.001,P<0.05).Conclusion:Endogenous ω-3 PUFA can reduce cisplatin-induced apoptosis in bone marrow nucleated cells,increase the number of peripheral blood cells and exert a protective effect against cisplatin-induced myelosuppression by regulating the expression of apoptosis-related genes.
7.Genetic analysis and PGT-SR outcome of a male carrier of exceptional complex chromosome rearrangement
Dun LIU ; Yun-Qiao DONG ; Chuang-Qi CHEN ; Xing-Su YU ; Jin YAN ; Feng-Hua LIU ; Xi-Qian ZHANG
National Journal of Andrology 2024;30(7):627-633
Objective:To investigate the clinical and genetic characteristics of a male carrier of exceptional complex chromo-some rearrangement(CCR)and the outcome of preimplantation genetic testing for chromosomal structural rearrangement(PGT-SR).Methods:Using the modified high resolution G banding technique and whole-genome low-coverage sequencing(WGLCS),we analyzed the cellular karyotype and molecular karyotype of a male carrier of CCR,performed an analysis of the single-sperm chromosome copy number and conducted PGT-SR for the patient by next-generation sequencing(NGS).In addition,we reviewed the literature on repor-ted male carriers of CCRs and summarized their normal/balanced sperm ratios and PGT-SR outcomes.Results:The karyotype of the patient was 46,XY,der(5)inv(5)(q14.3q23.2)t(5;14;11)(q23.2;q31.1;q21),der(11)t(5;14;11);der(14)t(5;14;11),with the translocation breakpoints located in the intergenic region.Single-sperm sequencing revealed 20.0%(7/35)of normal haploids in the male's spermatozoa,and the results PGT-SR showed a proportion of 25.0%(4/16)of normal/balanced embryos.After thawing and transferring of 2 euploid blastocysts,a healthy male infant was successfully delivered.Conclusion:The proportion of normal hap-loids in the spermatozoa of male CCR carriers may be higher than theoretically predicted,and PGT-SR can effectively improve the preg-nancy outcome in male CCR carriers and provide valuable data for genetic counseling.
8.Treatment of asthenoteratozoospermia with Jujing Decoction by improving the structure and function of sperm mitochondria via antioxidant stress based on the theory of"Yang-Qi transformation and Yin morphologization"
Qian FAN ; Yun CHEN ; Jian-Guo XUE ; Zhi-Xing SUN ; Qing WANG ; Hao-Ting CAI ; Feng-Juan CHANG
National Journal of Andrology 2024;30(9):813-818
Objective:To observe the clinical efficacy and action mechanism of Jujing Decoction(JJD)in the treatment of as-thenoteratozoospermia(ATZ)by comparing JJD with combined administration of the antioxidant stress drug and sperm energy metabo-lism agent.Methods:According to the inclusion criteria,we enrolled 67 male patients with ATZ in this randomized controlled clini-cal study and treated them by oral administration of JJD(the JJD group,n=34)or natural vitamin E combined with L-carnitine solu-tion(the positive control group,n=33),both for 12 weeks.We collected the semen parameters,sperm DNA fragmentation index(DFI),sperm mitochondrial membrane potential(MMP),seminal plasma reactive oxygen species(ROS)and superoxide dismutase(SOD)levels from the patients,observed the ultrastructure of sperm mitochondria under the transmission electron microscope(TEM)before and after treatment,and analyzed the clinical efficacy and action mechanism of JJD by comparing the data obtained between the two groups.Results:Treatment and follow-up were completed in 60 of the cases,30 in the JJD and 30 in the positive control group.The total rate of clinical effectiveness was significantly higher in the JJD than in the positive control group(76.8%vs 43.3%,P<0.05).Compared with the baseline,the percentages of progressively motile sperm(PMS)and morphologically normal sperm(MNS),DFI and MMP were significantly improved(P<0.05),the level of seminal plasma ROS decreased(P>0.05),and that of SOD re-markably increased(P<0.05)after treatment with JJD;PMS,MNS,DFI and MMP were also improved(P>0.05),seminal plas-ma ROS decreased(P>0.05)and SOD increased(P<0.05)in the positive controls after medication.In comparison with the posi-tive controls,the patients treated with JJD showed even more significant improvement in PMS([29.37±14.56]%vs[42.68±15.86]%,P<0.05),MNS([1.84±1.32]%vs[3.66±1.72%]%,P<0.05),DFI([32.66±5.23]%vs[16.61±4.20]%,P<0.05)and MMP([46.47±9.48]%vs[61.79±8.61]%,P<0.05),ROS([7.08±0.51]vs[5.06±0.52]μmol/L,P>0.05),and SOD([100.65±10.59]vs[139.05±14.71]U/ml,P<0.05).TEM revealed significantly improved ultrastructure of sperm mitochondria after treatment with JJD.No serious adverse reactions were observed in either group dur-ing follow-up.Conclusion:JJD,superior to natural vitamin E and L-carnitine oral solution,can safely and effectively increase the percentages of PMS and MNS,MMP and the level of seminal plasma SOD,reduce sperm DFI and seminal plasma ROS,and improve the ultrastructure of sperm mitochondria in patients with ATZ.The underlying mechanism of action may be related to its ability of im-proving the structure and function of sperm mitochondria via antioxidant stress.
9.A randomized positive parallel-controlled clinical study of Dibai Yijing Formula for the treatment of male infertility with essence deficiency in the kidney and damp-heat type in the essence chamber
Shuang WU ; Chao-Qian CHEN ; Yun-Zhi LI ; Qiu-Jian FENG ; Hui LÜ ; Xiao-Jing AN ; Jun GUO
National Journal of Andrology 2024;30(11):1019-1024
Objective:This study aims to evaluate the clinical efficacy and safety of Dibai Yijing Formula(DYF)in the treat-ment of male infertility with essence deficiency in the kidney and damp-heat in the essence chamber(Abbreviation:kidney deficiency and damp-heat type).Methods:This study employed a randomized,controlled clinical trial design,recruiting 72 male patients with infertility due to kidney deficiency and damp-heat type.Patients were randomly assigned to an treatment group(36 patients)and a control group(36 patients)using a random number table.The control group received oral Clomiphene Citrate Capsules(50 mg,twice daily),while the treatment group received oral DYF(one dose daily,200 ml each time,30 minutes after breakfast and dinner).Both groups underwent a 12-week treatment period.After treatment,sperm concentration(SC),percentage of progressively motile sperms(PR),total sperm motility[PR+percentage of non-progressively motile sperms(NP)],and semen volume(SV)were compared between the two groups before and after treatment.Additionally,the total score of Traditional Chinese Medicine(TCM)syndrome score and sperm DNA fragmentation index(DFI)and pregnancy outcomes of the patients'spouses were compared between the two groups.Results:Three patients dropped out from the treatment group and four from the control group.There were no statistically sig-nificant differences in semen parameters between the two groups(P>0.05).After treatment,the patients in the treatment group showed significant difference in the percentage of SC([19.42±5.30]x 106/ml vs[10.75±2.41]x 106/ml),PR([27.72±6.62]%vs[20.04±4.10]%),PR+NP([49.86±10.68]%vs(33.74±5.58)%],DFI([12.33±3.43]%vs[15.06±3.98]%)and TCM symtom score([7.45±1.82]vs[13.85±1.91]),and the difference was statistically significant(P<0.05).The patients in the control group showed significant difference in the percentage of SC([19.56±5.24]× 106/ml vs[11.31±2.08]× 106/ml)and TCM symptom score([12.81±1.86]vs[14.06±1.64]).But no significant changes were observed in the PR([21.75±5.93]%vs[20.05±4.67]%),PR+NP([34.23±7.15]%vs[32.35±4.09]%),SV([3.19±1.08]ml vs[3.12±1.13]ml),and DFI([15.11±4.76]%vs[15.51±4.35]%)were not statistically significant(P>0.05).Improve-ments in PR,PR+NP,TCM symptom score and DFI in the treatment group were better than those in the control group after treatment(P<0.05);the differences in SC and SV and spousal pregnancy in the treatment group were not statistically significant compared with those in the control group(P>0.05).No serious adverse events occurred in both groups during the treatment period.Conclusion:The treatment of male infertility with DYF is effective and safe.
10.Effects of Moluodan Dami Pills on chronic atrophic gastritis rats
Meng-Lei WANG ; Yi-Feng WU ; Jian-Liang SUI ; Miao-Miao YIN ; Hui-Yun LIU ; Qi-Chao LIU ; Zhuo-Chen WU ; Zhen WANG
Chinese Traditional Patent Medicine 2024;46(5):1476-1482
AIM To investigate the effects of Moluodan Dami Pills on chronic atrophic gastritis(CAG)rats and their mechanism.METHODS The rat models were randomly divided into the model group,the low-dose group and high-dose Moluodan Dami Pills groups(2.43 g/kg and 4.86 g/kg),and vitamin A group(0.32 g/kg),following the 16 weeks successful induction of CAG by five-factor modeling method,in contrast to another 10 normal rats of the control group.After 8 weeks corresponding administration,the rats of each group had their general physiological status and pH value of gastric juice assessed;their pathological changes of gastric mucosa observed by naked eyes combined with HE staining;their changes of gastrin-secreting cells(G cells)and somatostatin-secreting cells(D cells)in gastric mucosa observed by immunohistochemistry;and their serum levels of pepsinogen Ⅰ/pepsinogen Ⅱ(PG Ⅰ/PG Ⅱ)ratio,TNF-α and IL-6 detected by ELISA.RESULTS Compared with the model group,the groups intervened with Moluodan Damei Pills and vitamin A displayed lower pH values of gastric juice(P<0.05),improved pathological changes of gastric mucosa,increased G and D cells counts(P<0.05,P<0.01),increased ratio of serum PGⅠ/PGⅡ,and decreased levels of IL-6 and TNF-α(P<0.05,P<0.01).CONCLUSION Moluodan Dami Pills can effectively improve the symptoms of CAG rats through its influence on the number and secretion abilityof G and D cells,the levels of serum PG Ⅰ/PG Ⅱ ratio and inflammatory factors.

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