1.Application of blunt-tip needle technique in CT-guided percutaneous biopsy of pancreatic lesions
Meng WANG ; Zhigang ZHOU ; Kepu DU ; Shuai LI ; Fei GAO ; Yadan LI ; Mengyu GAO
Chinese Journal of Hepatobiliary Surgery 2025;31(2):121-125
Objective:To validate the application value and safety of blunt-tip needle technique for computer tomography (CT)-guided percutaneous biopsy of pancreatic lesions.Methods:Clinical data of 103 patients with pancreatic lesions undergoing CT-guided percutaneous biopsy with blunt-tip needle approach in the First Affiliated Hospital of Zhengzhou University from October 2021 to October 2023 were retrospectively analyzed, including 64 males and 39 females, aged (61.5±12.3) years. According to the access routes, procedures were divided into regular group ( n=70) and hard-to-reach group ( n=33). Technical data such as the duration of procedure, number of needle correction scans, and the incidence of complications were recorded. The technical success rate, diagnostic yield, accuracy, sensitivity, specificity, and false-negative rates were compared between groups. Results:The overall technical success rate was 100%(103/103). According to postoperative pathology and clinical follow-ups, the final diagnosis of 103 patients was 98 cases with neoplastic lesions and 5 with non-neoplastic lesions. The overall diagnostic rate of percutaneous biopsy was 91.3%(94/103), with a false negative rate of 5.8%(6/103), sensitivity of 92.9%(90/98), and specificity of 100%(90/90). Duration of procedure [(22.8±6.3) min vs. (22.4±7.9) min], number of needle correction scans [5.0 (3.0, 6.0) times vs. 5.0 (4.0, 7.5) times], length of target access [(69.9±15.4) mm vs. (73.7±17.4) mm], diagnostic yield [90.0%(63/70) vs. 93.9%(31/33)], and accuracy rate [90.0%(63/70) vs. 93.9%(31/33)] were comparable between regular group and hard-to-reach group (all P>0.05). Complications occurred in 8 patients, including 5 patients with hemorrhage and 3 with pancreatitis, which were successfully managed with conventional therapy. The incidence of complications were similar between the hard-to-reach and regular group [9.1%(3/33) vs. 7.1%(5/70), χ2=0.12, P=0.730]. Conclusion:CT-guided percutaneous biopsy in the diagnosis of pancreatic lesions with blunt-tip needle approach has a satisfactory technical success rate, diagnostic yield, accuracy, and safety, which can be used in patients with hard-to-reach lesions.
2.Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures (version 2025)
Yong YANG ; Xiaoguang ZHOU ; Qixin CHEN ; Jian CHEN ; Jian DONG ; Liangjie DU ; Shunwu FAN ; Jin FAN ; Zhong FANG ; Haoyu FENG ; Shiqing FENG ; Haishan GUAN ; Aiguo GAO ; Yanzheng GAO ; Yong HAI ; Da HE ; Dengwei HE ; Haiyi HE ; Dianming JIANG ; Xuewen KANG ; Bin LIN ; Baoge LIU ; Changqing LI ; Fang LI ; Li LI ; Fangcai LI ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Xinyu LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Xuhua LU ; Fei LUO ; Yuhai MA ; Keya MAO ; Xuexiao MA ; Bin MENG ; Xu NING ; Limin RONG ; Hongxun SANG ; Jun SHU ; Tiansheng SUN ; Dasheng TIAN ; Zheng WANG ; Bing WANG ; Linfeng WANG ; Qingde WANG ; Qinghe WANG ; Lan WEI ; Jigong WU ; Baoshan XU ; Youjia XU ; Guoyong YIN ; Jinglong YAN ; Feng YAN ; Cao YANG ; Huilin YANG ; Qiang YANG ; Bin ZHAO ; Jie ZHAO ; Yue ZHU ; Jianguo ZHANG ; Wenzhi ZHANG ; Zhongmin ZHANG ; Zhaomin ZHENG ; Yan ZENG ; Baorong HE ; Wei MEI
Chinese Journal of Trauma 2025;41(7):613-626
Vertebral refracture following percutaneous vertebral augmentation (PVA) is commonly seen in elderly patients with osteoporotic thoracolumbar compression fractures (OTLCF). It can lead to recurrent pain, loss of vertebral height, progression of kyphosis, and even neurological dysfunction, significantly impairing patients′ quality of life. Current diagnosis and treatment face multiple challenges, including high misdiagnosis rate, difficulty in choosing between surgical and non-surgical treatment options, lack of standardized surgical protocols, interference from intralesional bone cement during procedures, inadequate stability of internal fixation in osteoporotic bone, and suboptimal compliance of anti-osteoporotic therapy. Establishing a standardized diagnostic and therapeutic framework is urgently needed. To standardize the management process and improve outcomes for vertebral refractures after PVA in elderly OTLCF patients, Spinal Trauma Group of the Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field to develop Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures ( version 2025), based on current literature and clinical experience, and adhering to principles of scientific rigor and clinical applicability. A total of 11 recommendations were proposed, encompassing diagnosis, treatment, and rehabilitation of vertebral refracture after PVA in elderly patients with OTLCF, aiming to provide a foundation for a standardized management.
3.Lentivirus-modified hematopoietic stem cell gene therapy for advanced symptomatic juvenile metachromatic leukodystrophy: a long-term follow-up pilot study.
Zhao ZHANG ; Hua JIANG ; Li HUANG ; Sixi LIU ; Xiaoya ZHOU ; Yun CAI ; Ming LI ; Fei GAO ; Xiaoting LIANG ; Kam-Sze TSANG ; Guangfu CHEN ; Chui-Yan MA ; Yuet-Hung CHAI ; Hongsheng LIU ; Chen YANG ; Mo YANG ; Xiaoling ZHANG ; Shuo HAN ; Xin DU ; Ling CHEN ; Wuh-Liang HWU ; Jiacai ZHUO ; Qizhou LIAN
Protein & Cell 2025;16(1):16-27
Metachromatic leukodystrophy (MLD) is an inherited disease caused by a deficiency of the enzyme arylsulfatase A (ARSA). Lentivirus-modified autologous hematopoietic stem cell gene therapy (HSCGT) has recently been approved for clinical use in pre and early symptomatic children with MLD to increase ARSA activity. Unfortunately, this advanced therapy is not available for most patients with MLD who have progressed to more advanced symptomatic stages at diagnosis. Patients with late-onset juvenile MLD typically present with a slower neurological progression of symptoms and represent a significant burden to the economy and healthcare system, whereas those with early onset infantile MLD die within a few years of symptom onset. We conducted a pilot study to determine the safety and benefit of HSCGT in patients with postsymptomatic juvenile MLD and report preliminary results. The safety profile of HSCGT was favorable in this long-term follow-up over 9 years. The most common adverse events (AEs) within 2 months of HSCGT were related to busulfan conditioning, and all AEs resolved. No HSCGT-related AEs and no evidence of distorted hematopoietic differentiation during long-term follow-up for up to 9.6 years. Importantly, to date, patients have maintained remarkably improved ARSA activity with a stable disease state, including increased Functional Independence Measure (FIM) score and decreased magnetic resonance imaging (MRI) lesion score. This long-term follow-up pilot study suggests that HSCGT is safe and provides clinical benefit to patients with postsymptomatic juvenile MLD.
Humans
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Leukodystrophy, Metachromatic/genetics*
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Pilot Projects
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Genetic Therapy/methods*
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Hematopoietic Stem Cell Transplantation
;
Male
;
Follow-Up Studies
;
Female
;
Lentivirus/genetics*
;
Child
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Child, Preschool
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Hematopoietic Stem Cells/metabolism*
;
Cerebroside-Sulfatase/metabolism*
;
Adolescent
4.Vonoprazan-based quadruple therapy is non-inferior to esomeprazole-based quadruple therapy for Helicobacter pylori eradication: A multicenter, double-blind, randomized, phase 3 study.
Zhiqiang SONG ; Qin DU ; Guoxin ZHANG ; Zhenyu ZHANG ; Fei LIU ; Nonghua LU ; Liqun GU ; Shingo KURODA ; Liya ZHOU
Chinese Medical Journal 2025;138(22):2938-2946
BACKGROUND:
Owing to the high prevalence of antibiotic resistance in Helicobacter pylori ( H. pylori ) in China, bismuth-containing quadruple therapies have been recommended for H. pylori eradication. This study compared the efficacy and safety of quadruple regimens containing vonoprazan vs . esomeprazole for H. pylori eradication in a patient population in China.
METHODS:
This was a phase 3, multicenter, randomized, double-blind study. Patients with confirmed H. pylori infection were randomized 1:1 to receive quadruple therapy for 14 days: amoxicillin 1000 mg and clarithromycin 500 mg after meals, bismuth potassium citrate 600 mg before meals, plus either vonoprazan 20 mg or esomeprazole 20 mg before meals, all twice daily. The primary outcome was the eradication rate of H. pylori , evaluated using a 13 C urea breath test at 4 weeks after treatment. The non-inferiority margin was at 10%.
RESULTS:
The study included 510 patients, 506 of whom completed the follow-up assessment. The primary analysis revealed eradication rates of 86.8% (210/242) and 86.7% (208/240) for vonoprazan and esomeprazole therapy, respectively (treatment difference: 0.1%; 95% confidence interval [CI]: -5.95, 6.17; non-inferiority P = 0.0009). Per-protocol analysis showed eradication rates of 87.4% for vonoprazan and 86.3% for esomeprazole (treatment difference: 1.2%; 95% CI: -5.03, 7.36; non-inferiority P = 0.0004). Vonoprazan and esomeprazole were well tolerated, with similar safety profiles.
CONCLUSION:
Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H. pylori in patients from China.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT04198363.
Humans
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Esomeprazole/therapeutic use*
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Double-Blind Method
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Helicobacter Infections/drug therapy*
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Male
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Female
;
Middle Aged
;
Helicobacter pylori/pathogenicity*
;
Pyrroles/therapeutic use*
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Sulfonamides/therapeutic use*
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Adult
;
Clarithromycin/therapeutic use*
;
Amoxicillin/therapeutic use*
;
Aged
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Anti-Bacterial Agents/therapeutic use*
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Pyrrolidines/therapeutic use*
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Drug Therapy, Combination
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Proton Pump Inhibitors/therapeutic use*
5.Epidemiological characteristics of Mycoplasma pneumoniae infection among hospitalized children with respiratory tract infections at Children's Hospital of Hebei Province,2016-2024
Hong-Fei DU ; Meng-Chuan ZHAO ; Xiao-Shuang ZHANG ; Shan-Shan ZHOU ; Jing HUANG ; Xin-Guang LIU ; Le WANG
Medical Journal of Chinese People's Liberation Army 2025;50(9):1097-1102
Objective To investigate the epidemiological characteristics of Mycoplasma pneumoniae(MP)infection among pediatric inpatients with respiratory tract infections(RTIs)at Children's Hospital of Hebei Province,providing evidence for clinical diagnosis and treatment.Methods A retrospective analysis was conducted on 79 546 children hospitalized for RTIs between January 2016 and February 2024.Nasopharyngeal aspirates or deep sputum samples were collected,and polymerase chain reaction(PCR)was used to detect nucleic acids of 13 respiratory pathogens,including MP and adenovirus.The epidemiological trends across different years,seasons,genders,and age groups were analyzed.Results Among the 79 546 enrolled cases(male:47 437,59.6%;female:32 109,40.4%),the MP-positive rate was 17.7%(14 106/79 546),peaking in 2023(28.8%)and reaching the lowest in 2021(7.0%).Except for the period from July 2020 to March 2021 with exceptionally low MP positivity,epidemic peaks consistently occurred between August and February or March of the following year.Seasonal analysis revealed significantly higher MP positivity in autumn and winter compared to spring(P<0.001).Female children exhibited a higher MP-positive rate(20.1%,6444/32 109)than males(16.2%,7662/47 437)(P<0.001).The MP-positive rate increased with age:infancy(3.2%,849/26 741),toddlerhood(9.3%,1935/20 763),preschool(21.2%,3918/18 448),and school-age(54.5%,7404/13 594)(P<0.001).Co-infections with other respiratory pathogens were observed in 37.3%(5264/14 106)of MP-positive cases,with human rhinovirus(HRV)being the most frequent co-pathogen(43.3%,2279/5264 of mixed infections).Conclusion MP is a major pathogen of RTIs in hospitalized children at Children's Hospital of Hebei Province.Infections occur year-round but predominantly in autumn,with higher susceptibility in females and school-age children.Targeted preventive measures should be implemented during peak seasons to mitigate transmission risks.
6.Cumulative sum analysis of the learning curve for CT-guided percutaneous lung biopsy
Yadan LI ; Meng WANG ; Kepu DU ; Shuai LI ; Fei GAO ; Mengyu GAO ; Qingbo HUANG ; Lin CHEN ; Zhigang ZHOU
Journal of Interventional Radiology 2025;34(7):784-788
Objective To investigate the learning curve of CT-guided percutaneous lung biopsy.Methods Using cumulative sum(CUSUM)analysis method,the clinical data from 110 patients,who underwent CT-guided percutaneous lung biopsy performed by the same physician at the First Affiliated Hospital of Zhengzhou University of China between May 2024 and October 2024,were retrospectively analyzed.The CUSUM learning curve was fitted,and R2 was used to assess the goodness of fit.The baseline and perioperative data were compared between different stages of the learning curve so as to determine the number of accomplished surgical cases that was required for a physician to reach the proficiency stage from the learning stage in performing CT-guided percutaneous lung biopsy.Results Successful CT-guided percutaneous lung biopsy was accomplished in all patients,with a mean operation time of(20.2+3.4)minutes(range of 15-29 minutes).With the accumulation of surgical cases,the operation time showed a gradual downward trend.The learning curve was best fitted with a cubic equation,the equation was as follows:CUSUM(110)=0.000 3x3-0.081 3x2+5.597 9x+0.774 3(where x representing the number of cases),with a goodness-of-fit coefficient R2=0.991.The fitted curve reached its peak at the performance of the 46th case,which was used as the cutoff point to divide the learning curve into two phases.Compared with the learning phase,in the proficiency phase the incidence of complications was significantly lower(pneumothorax:18.8%vs 37.0%,P=0.033)and the mean operation time was obviously shorter[(18.33+2.31)min vs(22.80±3.02)min,P<0.001].Conclusion Through precise CUSUM analysis of the learning curves obtained from 110 patients receiving CT-guided percutaneous lung biopsy,the results of this study indicates that it requires to accomplish 46 operations before a physician can skillfully master the technique of CT-guided percutaneous lung biopsy.
7.Application of blunt-tip needle technique in CT-guided percutaneous biopsy of pancreatic lesions
Meng WANG ; Zhigang ZHOU ; Kepu DU ; Shuai LI ; Fei GAO ; Yadan LI ; Mengyu GAO
Chinese Journal of Hepatobiliary Surgery 2025;31(2):121-125
Objective:To validate the application value and safety of blunt-tip needle technique for computer tomography (CT)-guided percutaneous biopsy of pancreatic lesions.Methods:Clinical data of 103 patients with pancreatic lesions undergoing CT-guided percutaneous biopsy with blunt-tip needle approach in the First Affiliated Hospital of Zhengzhou University from October 2021 to October 2023 were retrospectively analyzed, including 64 males and 39 females, aged (61.5±12.3) years. According to the access routes, procedures were divided into regular group ( n=70) and hard-to-reach group ( n=33). Technical data such as the duration of procedure, number of needle correction scans, and the incidence of complications were recorded. The technical success rate, diagnostic yield, accuracy, sensitivity, specificity, and false-negative rates were compared between groups. Results:The overall technical success rate was 100%(103/103). According to postoperative pathology and clinical follow-ups, the final diagnosis of 103 patients was 98 cases with neoplastic lesions and 5 with non-neoplastic lesions. The overall diagnostic rate of percutaneous biopsy was 91.3%(94/103), with a false negative rate of 5.8%(6/103), sensitivity of 92.9%(90/98), and specificity of 100%(90/90). Duration of procedure [(22.8±6.3) min vs. (22.4±7.9) min], number of needle correction scans [5.0 (3.0, 6.0) times vs. 5.0 (4.0, 7.5) times], length of target access [(69.9±15.4) mm vs. (73.7±17.4) mm], diagnostic yield [90.0%(63/70) vs. 93.9%(31/33)], and accuracy rate [90.0%(63/70) vs. 93.9%(31/33)] were comparable between regular group and hard-to-reach group (all P>0.05). Complications occurred in 8 patients, including 5 patients with hemorrhage and 3 with pancreatitis, which were successfully managed with conventional therapy. The incidence of complications were similar between the hard-to-reach and regular group [9.1%(3/33) vs. 7.1%(5/70), χ2=0.12, P=0.730]. Conclusion:CT-guided percutaneous biopsy in the diagnosis of pancreatic lesions with blunt-tip needle approach has a satisfactory technical success rate, diagnostic yield, accuracy, and safety, which can be used in patients with hard-to-reach lesions.
8.Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures (version 2025)
Yong YANG ; Xiaoguang ZHOU ; Qixin CHEN ; Jian CHEN ; Jian DONG ; Liangjie DU ; Shunwu FAN ; Jin FAN ; Zhong FANG ; Haoyu FENG ; Shiqing FENG ; Haishan GUAN ; Aiguo GAO ; Yanzheng GAO ; Yong HAI ; Da HE ; Dengwei HE ; Haiyi HE ; Dianming JIANG ; Xuewen KANG ; Bin LIN ; Baoge LIU ; Changqing LI ; Fang LI ; Li LI ; Fangcai LI ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Xinyu LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Xuhua LU ; Fei LUO ; Yuhai MA ; Keya MAO ; Xuexiao MA ; Bin MENG ; Xu NING ; Limin RONG ; Hongxun SANG ; Jun SHU ; Tiansheng SUN ; Dasheng TIAN ; Zheng WANG ; Bing WANG ; Linfeng WANG ; Qingde WANG ; Qinghe WANG ; Lan WEI ; Jigong WU ; Baoshan XU ; Youjia XU ; Guoyong YIN ; Jinglong YAN ; Feng YAN ; Cao YANG ; Huilin YANG ; Qiang YANG ; Bin ZHAO ; Jie ZHAO ; Yue ZHU ; Jianguo ZHANG ; Wenzhi ZHANG ; Zhongmin ZHANG ; Zhaomin ZHENG ; Yan ZENG ; Baorong HE ; Wei MEI
Chinese Journal of Trauma 2025;41(7):613-626
Vertebral refracture following percutaneous vertebral augmentation (PVA) is commonly seen in elderly patients with osteoporotic thoracolumbar compression fractures (OTLCF). It can lead to recurrent pain, loss of vertebral height, progression of kyphosis, and even neurological dysfunction, significantly impairing patients′ quality of life. Current diagnosis and treatment face multiple challenges, including high misdiagnosis rate, difficulty in choosing between surgical and non-surgical treatment options, lack of standardized surgical protocols, interference from intralesional bone cement during procedures, inadequate stability of internal fixation in osteoporotic bone, and suboptimal compliance of anti-osteoporotic therapy. Establishing a standardized diagnostic and therapeutic framework is urgently needed. To standardize the management process and improve outcomes for vertebral refractures after PVA in elderly OTLCF patients, Spinal Trauma Group of the Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field to develop Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures ( version 2025), based on current literature and clinical experience, and adhering to principles of scientific rigor and clinical applicability. A total of 11 recommendations were proposed, encompassing diagnosis, treatment, and rehabilitation of vertebral refracture after PVA in elderly patients with OTLCF, aiming to provide a foundation for a standardized management.
9.Clinical Observation on Navel Application of Jianpi Hewei Adhesive Plaster Combined with Oral Use of Modified Sini Hewei Anshen Decoction for the Treatment of Diabetic Gastroparesis Accompanied by Anxiety in Type 2 Diabetes
Xiao-Qian HUANG ; Jun-Huai ZHOU ; Xue-Fei CHU ; Ying LIU ; Xi DU
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(3):589-597
Objective To evaluate the clinical efficacy of navel application of Jianpi Hewei Adhesive Plaster combined with oral use of modified Sini Hewei Anshen Decoction in treating diabetic gastroparesis(DGP)accompanied by anxiety of liver-stomach disharmony type in type 2 diabetes patients.Methods One hundred patients with DGP accompanied by anxiety of liver-stomach disharmony type were randomly divided into a treatment group and a control group,with 50 patients in each group.The control group was given oral use of Mosapride Citrate Tablets orally,and the treatment group was given navel application of Jianpi Hewei Adhesive Plaster combined with oral use of modified Sini Hewei Anshen Decoction.The course of treatment for the two groups covered 4 weeks.The two groups were observed in the changes of the traditional Chinese medicine(TCM)syndrome scores,Gastroparesis Cardinal Symptom Index(GCSI)scores,Hamilton Anxiety Scale(HAMA)scores,gastric emptying time,and levels of fasting blood glucose(FBG),2-hour postprandial blood glucose(2hPG),glycated hemoglobin(HbA1c),plasma motilin(MOT),gastrin(GAS),and serum tumor necrosis factor alpha(TNF-α)and interleukin 6(IL-6)before and after the treatment.After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)During the trial,4 patients in the treatment group and 3 patients in the control group fell off,and eventually a total of 93 patients were included for the efficacy statistics,including 46 patients in the treatment group and 47 patients in the control group.(2)After 4 weeks of treatment,the total effective rate of the treatment group was 95.65%(44/46)and that of the control group was 76.60%(36/47).The intergroup comparison(tested by chi-square test)showed that the therapeutic effect of the treatment group was significantly superior to that of the control group(P<0.01).(3)After treatment,the TCM syndrome scores(including epigastric and abdominal congestion,depression or irritability,and poor appetite)and GCSI scores in the two groups were decreased compared with those before treatment(P<0.05)and the gastric emptying time was shortened compared with that before treatment(P<0.05),and the effect of the treatment group on decreasing TCM syndrome scores and GCSI scores and on shortening the gastric emptying time were significantly superior to that of the control group(P<0.01).(4)After treatment,the plasma MOT and GAS levels of the two groups were increased compared with those before treatment(P<0.05),and the increase in the treatment group was significantly superior to that in the control group(P<0.01).(5)After treatment,the levels of glucose metabolism indicators of FBG,2hPG,and HbA1c in the two groups were decreased compared with those before treatment(P<0.05),but the differences of all glucose metabolism indicators between the two groups after treatment were not statistically significant(P>0.05).(6)After treatment,the serum TNF-α and IL-6 levels in the two groups were decreased compared with those before treatment(P<0.05),and the decrease in the treatment group was significantly superior to that in the control group(P<0.05).(7)After treatment,the total HAMA scores and the scores of mental anxiety factor and somatic anxiety factor of HAMA in the two groups were decreased compared with those before treatment(P<0.05),and the effect on lowering the scores in the treatment group was significantly superior to that in the control group(P<0.05).(8)During the treatment period,no significant adverse reactions occurred in the two groups of patients,which has high safety.Conclusion Navel application of Jianpi Hewei Adhesive Plaster combined with oral use of modified Sini Hewei Anshen Decoction exerts certain efficacy in treating DGP accompanied by anxiety of liver-stomach disharmony type.The therapy is effective on relieving clinical symptoms,enhancing gastric motility,inhibiting inflammatory response,and improving anxiety emotion and the quality of life of the patients.
10.Clinical Observation on Yiqi Yangyin Jiangtang Prescription Combined with Acupoint Injection in the Treatment of Newly-diagnosed Type 2 Diabetes Mellitus
Xi DU ; Jun-Huai ZHOU ; Xue-Fei CHU ; Xiao-Qian HUANG ; Ying LIU
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(4):847-855
Objective To observe the clinical efficacy of Yiqi Yangyin Jiangtang Prescription(mainly composed of Astragali Radix,Rehmanniae Radix,Imperatae Rhizoma,Ophiopogonis Radix,and Puerariae Lobatae Radix)combined with acupoint injection in the treatment of newly-diagnosed type 2 diabetes mellitus(T2DM).Methods One hundred patients with newly-diagnosed T2DM of qi-yin deficiency complicated with blood stasis type were randomly divided into a treatment group and a control group,with 50 patients in each group.The control group was given oral use of Metformin Hydrochloride Tablets,and the treatment group was given the granules of Yiqi Yangyin Jiangtang Prescription orally combined with acupoint injection at unilateral points of Zusanli(ST36),Shenshu(BL23)and Qihai(CV6)on the basis of treatment for the control group.The course of treatment lasted for 4 weeks.Before and after the treatment,the two groups were observed in the changes of traditional Chinese medicine(TCM)syndrome scores,fasting plasma glucose(FPG),2-hour postprandial blood glucose(2hPG),glycated hemoglobin(HbA1c),total cholesterol(TC),triglyceride(TG),and serum levels of inflammatory factors of interleukin 6(IL-6),C-reactive protein(CRP),tumor necrosis factor α(TNF-α),as well as the hemorheology indicators of whole blood low-shear viscosity and whole blood high-shear viscosity.After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)During the trial,5 cases fell off from the treatment group and 4 cases fell off from the control group,and a total of 91 patients were eventually included in the efficacy statistics,of which 45 cases were in the treatment group and 46 cases were in the control group.(2)After 4 weeks of treatment,the total effective rate of the treatment group was 93.33%(42/45),and that of the control group was 71.74%(33/46).The intergroup comparison(tested by chi-square test)showed that the therapeutic effect of the treatment group was significantly superior to that of the control group(P<0.01).(3)After treatment,the scores of TCM symptoms of dry mouth and throat,frequent nocturia,shortness of breath and fatigue,hot flushes and night sweating as well as the total TCM syndrome scores in the two groups were significantly lower than those before the treatment(P<0.05),and the reduction of the scores in the treatment group was significantly superior to that of the control group(P<0.01).(4)After treatment,the levels of blood glucose and lipid indicators of FPG,2hPG,HbA1c,TC and TG of patients in the two groups were decreased compared with those before treatment(P<0.05),and the decrease in the treatment group was significantly superior to that in the control group(P<0.05 or P<0.01).(5)After treatment,the serum levels of inflammatory factors of IL-6,CRP,and TNF-α in the two groups were all lower than those before treatment(P<0.01),and the reduction in the treatment group was significantly superior to that in the control group(P<0.01).(6)After treatment,the levels of hemorheology indicators such as whole blood low-shear viscosity and high-shear viscosity in the two groups were all lower than those before treatment(P<0.05),and the reduction in the treatment group was significantly superior to that in the control group(P<0.05).(7)The incidence of adverse reactions in the treatment group was 8.89%(4/45),which was significantly lower than that of the control group(21.74%,10/46),and the difference was statistically significant(P<0.01).Conclusion Yiqi Yangyin Jiangtang Prescription combined with acupoint injection exerts certain effect in treating patients with newly-diagnosed T2DM of qi-yin deficiency complicated with blood stasis syndrome type.The combined therapy can effectively alleviate the early clinical manifestations,decrease the levels of blood glucose,blood lipids,and inflammatory factors,and improve the hematological indicators and the quality of life of the patients.

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