1.Disease burden of chronic kidney disease attributable to high BMI in China and trend prediction in 1992-2021
Hong LIU ; Guimao YANG ; Yan SUI ; Xia ZHANG ; Xuebing CHENG ; Yaxing WU ; Xu GUO ; Yanfeng REN
Journal of Public Health and Preventive Medicine 2025;36(1):27-31
Objective To analyze the disease burden of chronic kidney diseases (CKD) attributed to high body mass index (BMI) in China from 1992 to 2021 and predict the disease burden for the next decade, and to provide evidence for the prevention and treatment of CKD. Methods Using the Global Burden of Disease (GBD) database and the Joinpoint model, the average annual percentage rate change (AAPC) of the mortality rate and disability-adjusted life year (DALY) rate was calculated to describe and analyze the CKD disease burden attributed to high BMI in China from 1992 to 2021. The ARIMA model was employed to predict and analyze the change trend of the CKD disease burden. Results From 1992 to 2021, the mortality rate and DALY rate attributed to high BMI-induced chronic kidney disease showed an upward trend. Compared to 1992, the attributed number of deaths increased by 324.38%, and DALYs increased by 268.56%; the mortality rate increased by 64.00%, and the DALY rate grew by 51.62%. From 1992 to 2021, the mortality rate and DALY rate for males were lower than those for females, but the growth rate for males exceeded that of females. From 1992 to 2021, the mortality rate and DALY rate of chronic kidney disease attributed to high BMI in China increased with age. The average annual change rate of chronic kidney disease attributed to high BMI in China from 1992 to 2021 (mortality rate: 1.40 per 100,000 (95% CI: 1.04–1.76), DALY rate: 1.43 per 100 000 (95% CI: 1.17–1.70)) was higher than thHuaiyin Normal University, Huai'anher social demographic index (SDI) regions. The ARIMA model predicted that the age-standardized mortality rate increased from 2.91 per 100 000 in 2022 to 3.05 per 100 000 in 2026, and the age-standardized DALY rate increased from 69.65 per 100 000 in 2022 to 73.58 per 100 000 in 2026. Conclusion Chronic kidney disease attributed to high BMI in China is on the rise, and it will continue to grow in the future. The focus of CKD prevention and control should be on males and the elderly, while active measures should be taken to reduce the occurrence and progression of chronic kidney disease.
2.Establishment of a nomogram prediction model for poor prognosis of acute pancreatitis based on inflammatory factors, lung ultrasound, and CT scores
Xia REN ; Ye YE ; Luojie LIU ; Xiaodan XU ; Yan ZHANG
Journal of Clinical Hepatology 2025;41(4):713-721
ObjectiveTo investigate the independent risk factors for poor prognosis in patients with acute pancreatitis (AP) by analyzing inflammatory factors, lung ultrasound (LUS) scores, and CT scores, to establish a nomogram prediction model, and to provide a basis for early clinical intervention. MethodsA total of 409 patients with AP who were admitted to Changshu Hospital Affiliated to Soochow University from January 2021 to October 2023 were enrolled as subjects, and they were divided into modeling group with 288 patients and validation group with 121 patients using the simple random sampling method at a ratio of 7∶3. According to the prognosis, each group was further divided into poor prognosis group and good prognosis group. The levels of C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-α (TNF-α) were measured for both groups within 72 hours after admission, and LUS scores, modified CT severity index (MCTSI), and extrapancreatic inflammation on computed tomography (EPIC) scores were assessed within 48 — 72 hours after admission. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U rank sum test was used for comparison of non-normally distributed continuous data between groups; the chi-square test was used for comparison of categorical data between groups. A LASSO regression analysis was used to screen for the variables that were included in the multivariate logistic regression model to identify the independent risk factors for the poor prognosis of AP, and then a nomogram prediction model was established. The receiver operating characteristic (ROC) curve and the calibration curve were used to assess the discriminatory ability and goodness of fit of the nomogram model, and a decision curve analysis was used to assess the clinical applicability of the model. ResultsAmong the 288 patients with AP in the modeling group, there were 33 (11.46%) in the poor prognosis group and 255 (88.54%) in the good prognosis group; among the 121 patients with AP in the validation group, there were 13 (10.74%) in the poor prognosis group and 108 (89.26%) in the good prognosis group. Compared with the good prognosis group, the poor prognosis group had significantly higher levels of CRP (Z=3.607, P<0.05), IL-6 (Z=4.189, P<0.05), and TNF-α (t=2.584, P<0.05), and significantly higher scores of LUS (t=8.075, P<0.05), MCTSI (t=5.929, P<0.05), and EPIC (t=8.626, P<0.05). The multivariate logistic regression analysis showed that CRP (odds ratio [OR]=3.592, 95% confidence interval [CI]: 1.272 — 10.138, P<0.05), IL-6 (OR=4.225, 95%CI: 1.468 — 12.156, P<0.05), TNF-α (OR=3.540, 95%CI: 1.205 — 10.401, P<0.05), LUS (OR=7.094, 95%CI: 2.398 — 20.986, P<0.05), MCTSI (OR=7.612, 95%CI: 2.832 — 20.462, P<0.05), and EPIC (OR=11.915, 95%CI: 4.007 — 35.432, P<0.05) were independent risk factor for poor prognosis in patients with AP. A nomogram prediction model was established based on the above 6 indicators, which had an area under the ROC curve of 0.924 (95%CI: 0.883 — 0.964), and the Youden index for the optimal cut-off value was 0.670, with a sensitivity of 0.909 and a specificity of 0.761. The calibration curve showed good consistency between the predicted and observed results in both the modeling group and the validation group. The decision curve analysis showed that the predictive model had certain clinical effectiveness. ConclusionThe nomogram model for predicting the risk of poor prognosis in AP patients based on CRP, IL-6, TNF-α, LUS score, MCTSI score, and EPIC score has relatively good predictive performance and can provide important strategic guidance for developing early intensified treatment regimens for AP patients in clinical practice.
3.Quality evaluation of Bidentis Herba derived from different original plants based on HPLC fingerprints, characteristic chromatograms, multi-component content determination combined with chemical pattern recognition.
Guo-Li SHI ; Yun MA ; Feng-Xia SHEN ; Han-Wen DU ; Cong-Min LIU ; Rui-Xia WEI ; Yan-Fang LI ; Jian-Wei FAN ; Yong-Xia GUAN
China Journal of Chinese Materia Medica 2025;50(15):4284-4292
This study established the HPLC fingerprints, characteristic chromatograms, and a multi-component content determination method for Bidens bipinnata and B. biternata. The chemical pattern recognition analysis was then employed to clarify the characteristic indexes of quality differences between the two original plants of Bidentis Herba, providing a reference for establishing the quality standards of Bidentis Herba. HPLC was launched on an Agilent Poroshell 120 EC-C_(18) chromatographic column(4.6 mm×250 mm, 4 μm) by gradient elution with a mobile phase of 0.1% aqueous phosphoric acid-acetonitrile at a flow rate of 0.7 mL·min~(-1), detection wavelength of 270 nm, column temperature of 25 ℃, and an injection volume of 5 μL. The similarity between the fingerprints of 18 batches of Bidentis Herba samples and the common pattern(R) ranged from 0.572 to 0.933. A total of 23 chromatographic peaks were calibrated. Through comparison with the reference substances, six components(neochlorogenic acid, chlorogenic acid, isochlorogenic acid A, isochlorogenic acid B, rutin, and hyperoside) were identified and subjected to quantitative analysis. The characteristic fingerprints of B. bipinnata and B. biternata were calibrated with 20 and 17 characteristic peaks, respectively. Among them, peaks 8, 9, 22, and 23 were the characteristic peaks of B. bipinnata, and peak 7 was the characteristic peak of B. biternata, which can be used to distinguish the two original plants of Bidentis Herba. The relative standard deviation of the content of the above-mentioned six components ranged from 36% to 123%. The cluster analysis, principal component analysis, and orthogonal partial least squares-discriminant analysis(OPLS-DA) classified the 18 batches of Bidentis Herba samples into two categories. Additionally, through the analysis of variable importance in projection(VIP) under OPLS-DA, three characteristic indexes, rutin, isochlorogenic acid A, and isochlorogenic acid B, were identified. The analytical method established in this study can comprehensively evaluate the consistency of Bidentis Herba samples derived from different original plants, specifically identify the differential components between them, and effectively distinguish the two original plants of Bidentis Herba, providing a basis for the differentiation between different original plants and the quality control of Bidentis Herba.
Chromatography, High Pressure Liquid/methods*
;
Drugs, Chinese Herbal/chemistry*
;
Quality Control
;
Bidens/chemistry*
4.Quality evaluation of Xinjiang Rehmannia glutinosa and Rehmannia glutinosa based on fingerprint and multi-component quantification combined with chemical pattern recognition.
Pan-Ying REN ; Wei ZHANG ; Xue LIU ; Juan ZHANG ; Cheng-Fu SU ; Hai-Yan GONG ; Chun-Jing YANG ; Jing-Wei LEI ; Su-Qing ZHI ; Cai-Xia XIE
China Journal of Chinese Materia Medica 2025;50(16):4630-4640
The differences in chemical quality characteristics between Xinjiang Rehmannia glutinosa and R. glutinosa were analyzed to provide a theoretical basis for the introduction and quality control of R. glutinosa. In this study, the high performance liquid chromatography(HPLC) fingerprints of 6 batches of Xinjiang R. glutinosa and 10 batches of R. glutinosa samples were established. The content of iridoid glycosides, phenylethanoid glycosides, monosaccharides, oligosaccharides, and polysaccharides in Xinjiang R. glutinosa and R. glutinosa was determined by high performance liquid chromatography-diode array detection(HPLC-DAD), high performance liquid chromatography-evaporative light scattering detection(HPLC-ELSD), and ultraviolet-visible spectroscopy(UV-Vis). The determination results were analyzed with by chemical pattern recognition and entropy weight TOPSIS method. The results showed that there were 19 common peaks in the HPLC fingerprints of the 16 batches of R. glutinosa, and catalpol, aucubin, rehmannioside D, rehmannioside A, hydroxytyrosol, leonuride, salidroside, cistanoside A, and verbascoside were identified. Hierarchical cluster analysis(HCA) and principal component analysis(PCA) showed that Qinyang R. glutinosa, Mengzhou R. glutinosa, and Xinjiang R. glutinosa were grouped into three different categories, and eight common components causing the chemical quality difference between Xinjiang R. glutinosa and R. glutinosa in Mengzhou and Qinyang of Henan province were screened out by orthogonal partial least squares discriminant analysis(OPLS-DA). The results of content determination showed that there were glucose, sucrose, raffinose, stachyose, polysaccharides, and nine glycosides in Xinjiang R. glutinosa and R. glutinosa samples, and the content of catalpol, rehmannioside A, leonuride, cistanoside A, verbascoside, sucrose, and glucose was significantly different between Xinjiang R. glutinosa and R. glutinosa. The analysis with entropy weight TOPSIS method showed that the comprehensive quality of R. glutinosa in Mengzhou and Qinyang of Henan province was better than that of Xinjiang R. glutinosa. In conclusion, the types of main chemical components of R. glutinosa and Xinjiang R. glutinosa were the same, but their content was different. The chemical quality of R. glutinosa was better than Xinjiang R. glutinosa, and other components in R. glutinosa from two producing areas and their effects need further study.
Rehmannia/classification*
;
Drugs, Chinese Herbal/chemistry*
;
Chromatography, High Pressure Liquid/methods*
;
Quality Control
5.Clinical efficacy of minimally invasive tendon blade technique in the treatment of moderate and severe gluteal muscle contracture.
Jia-Kai GAO ; Tao-Ran WANG ; Long BI ; Xiao-Chao CHEN ; Yan-Wu LIU ; Yao-Ping WU ; Xiang HE ; Zhi-Xia NIU
China Journal of Orthopaedics and Traumatology 2025;38(4):420-423
OBJECTIVE:
To investigate the clinical effect of minimally invasive technique in the treatment of moderate and severe gluteal muscle contracture.
METHODS:
A retrospective study was conducted on 85 patients (170 sides) with bilateral gluteal muscle contracture admitted from January 2016 to December 2019. All patients were treated with minimally invasive release of tendon knife. There were 32 males and 53 females, ranging in age from 15 to 37 years old, with an average age of (22.3±6.3) years old. Operation time, intraoperative blood loss, incision length, first postoperative ambulation time, complication rate, recurrence rate, and Harris hip score (HHS) were analyzed and evaluated.
RESULTS:
The average follow-up time was (16.2±4.6) months, ranging from 12 to 30 months. The operation time ranged from 7 to 15 min, with an average of (10.2±3.1) min. Intraoperative blood loss ranged from 2 to 20 ml, with an average of (8.4±2.2) ml. The incision length ranged from 0.6 to 2.0 cm, with an average of (0.8±0.3) cm. The time to postoperative ambulation ranged from 12 to 28 h, with an average of (20.0±3.2) h. All patients achieved primary wound healing without sciatic nerve injury or recurrence. HHS hip function scores ranged from 90 to 98, with an average score of (96.2±1.4). Complications included intraoperative tendon blade tip fracture in two cases (removed under fluoroscopic guidance) and subcutaneous hematoma in three cases-two resolved with compression and one with open evacuation.. Twenty-nine patients exhibited transient swaying gait postoperatively, of which 24 patients returned to normal after 4 weeks and 5 patients returned to normal after 6 weeks.
CONCLUSION
Minimally invasive tendon blade release is a safe and effective technique for treating gluteal muscle contracture, offering minimal trauma, rapid recovery, and excellent cosmetic and functional outcomes. However, it exhibits a low risk of blade tip fracture and sciatic nerve injury, warranting experienced surgical handling.
Humans
;
Male
;
Female
;
Adult
;
Minimally Invasive Surgical Procedures/methods*
;
Adolescent
;
Retrospective Studies
;
Buttocks/surgery*
;
Young Adult
;
Contracture/surgery*
;
Tendons/surgery*
;
Muscle, Skeletal/surgery*
6.Avatrombopag for platelet engraftment after allogeneic hematopoietic stem cell transplantation in children: a retrospective clinical study.
Xin WANG ; Yuan-Yuan REN ; Xia CHEN ; Chao-Qian JIANG ; Ran-Ran ZHANG ; Xiao-Yan ZHANG ; Li-Peng LIU ; Yu-Mei CHEN ; Li ZHANG ; Yao ZOU ; Fang LIU ; Xiao-Juan CHEN ; Wen-Yu YANG ; Xiao-Fan ZHU ; Ye GUO
Chinese Journal of Contemporary Pediatrics 2025;27(10):1233-1239
OBJECTIVES:
To evaluate the efficacy and safety of avatrombopag in promoting platelet engraftment after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in children, compared with recombinant human thrombopoietin (rhTPO).
METHODS:
A retrospective analysis was conducted on 53 pediatric patients who underwent allo-HSCT at the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences from April 2023 to August 2024. Based on medications used during the periengraftment period, patients were divided into two groups: the avatrombopag group (n=15) and the rhTPO group (n=38).
RESULTS:
At days 14, 30, and 60 post-transplant, platelet engraftment was achieved in 20% (3/15), 60% (9/15), and 93% (14/15) of patients in the avatrombopag group, and in 39% (15/38), 82% (31/38), and 97% (37/38) in the rhTPO group, respectively. There were no significant differences between the two groups in platelet engraftment rates at each time point, cumulative incidence of platelet engraftment, overall survival, and relapse-free survival (all P>0.05). Multivariable Cox proportional hazards analysis indicated that acute graft-versus-host disease was an independent risk factor for delayed platelet engraftment (P=0.043).
CONCLUSIONS
In children undergoing allo-HSCT, avatrombopag effectively promotes platelet engraftment, with efficacy and safety comparable to rhTPO, and represents a viable therapeutic option.
Humans
;
Retrospective Studies
;
Hematopoietic Stem Cell Transplantation/adverse effects*
;
Male
;
Female
;
Child
;
Child, Preschool
;
Infant
;
Adolescent
;
Transplantation, Homologous
;
Blood Platelets/drug effects*
;
Thiazoles/therapeutic use*
;
Thrombopoietin/therapeutic use*
;
Thiophenes
7.Clinical Characteristics and Prognostic Analysis of Newly Diagnosed Acute Myeloid Leukemia Patients with NRAS and KRAS Gene Mutations.
Zhang-Yu YU ; Bo CAI ; Yi WANG ; Yang-Yang LEI ; Bing-Xia LI ; Yu-Fang LI ; Yan-Ping SHI ; Jia-Xin CHEN ; Shu-Hong LIU ; Chang-Lin YU ; Mei GUO
Journal of Experimental Hematology 2025;33(3):682-690
OBJECTIVE:
To retrospectively analyze the clinical characteristics, co-mutated genes in newly diagnosed acute myeloid leukemia (AML) patients with NRAS and KRAS gene mutations, and the impact of NRAS and KRAS mutations on prognosis.
METHODS:
The clinical data and next-generation sequencing results of 80 newly diagnosed AML patients treated at our hospital from December 2018 to December 2023 were collected. The clinical characteristics, co-mutated genes of NRAS and KRAS , and the impact of NRAS and KRAS mutations on prognosis in newly diagnosed AML patients were analyzed.
RESULTS:
Among 80 newly diagnosed AML patients, NRAS mutations were detected in 20 cases(25.0%), and KRAS mutations were detected in 9 cases(11.3%). NRAS mutations predominantly occurred at codons 12 and 13 of exon 2, as well as codon 61 of exon 3, while KRAS mutations were most commonly occurred at codons 12 and 13 of exon 2, all of which were missense mutations. There were no statistically significant differences observed in terms of age, sex, white blood cell count(WBC), hemoglobin(Hb), platelet count(PLT), bone marrow blasts, first induction chemotherapy regimen, CR1/CRi1 rates, chromosome karyotype, 2022 ELN risk classification and allogeneic hematopoietic stem cell transplantation(allo-HSCT) among the NRAS mutation group, KRAS mutation group and NRAS/KRAS wild-type group (P >0.05). KRAS mutations were significantly correlated with PTPN11 mutations (r =0.344), whereas no genes significantly associated with NRAS mutations were found. Survival analysis showed that compared to the NRAS/KRAS wild-type group, patients with NRAS mutation had a relatively higher 5-year overall survival (OS) rate and relapse-free survival (RFS) rate, though the differences were not statistically significant (P =0.097, P =0.249). Compared to the NRAS/KRAS wild-type group, patients with KRAS mutation had a lower 5-year OS rate and RFS rate, with no significant differences observed (P =0.275, P =0.442). There was no significant difference in the 5-year RFS rate between the KRAS mutation group and NRAS mutation group (P =0.157), but the 5-year OS rate of patients with KRAS mutation was significantly lower than that of patients with NRAS mutation (P =0.037).
CONCLUSION
In newly diagnosed AML patients, KRAS mutation was significantly correlated with PTPN11 mutation. Compared to patients with NRAS/KRAS wild-type, those with NRAS mutation showed a more favorable prognosis, while patients with KRAS mutation showed a poorer prognosis; however, these differences did not reach statistical significance. Notably, the prognosis of AML patients with KRAS mutation was significantly inferior compared to those with NRAS mutation.
Humans
;
Leukemia, Myeloid, Acute/diagnosis*
;
Mutation
;
Prognosis
;
Proto-Oncogene Proteins p21(ras)/genetics*
;
GTP Phosphohydrolases/genetics*
;
Retrospective Studies
;
Membrane Proteins/genetics*
;
Female
;
Male
;
Middle Aged
;
Adult
;
Aged
8.Improvement effect of rehabilitation nursing based on IKAP theory on patients with urinary incontinence after radical prostatectomy.
Ting-Ting XIA ; Wen-Fang CHEN ; Jie LIU ; Xiao-Wen TAN ; Juan LI ; Yan-Yan ZHANG ; Yu-Mei CAO ; Song XU ; Ting-Ling ZHANG
National Journal of Andrology 2025;31(5):438-443
OBJECTIVE:
To explore the improvement effect of rehabilitation nursing based on information-knowledge-belief-behavior (IKAP) theory on urinary incontinence patients after radical prostatectomy.
METHODS
Sixty-six patients with urinary incontinence who received robot-assisted laparoscopic radical prostatectomy in General Hospital of Eastern Theater Command from January 2021 to January 2023 were selected and divided into control group (n=33) and observation group (n=33) according to random number table method. The patients in the control group were treated with rehabilitation nursing. The patients in the observation group were treated with rehabilitation nursing guided by IKAP theory. The recovery of urinary incontinence, duration of urinary incontinence, subjective well-being, quality of life, psychological and emotional indexes of patients in the two groups were compared. Results: The total effective rate of urinary incontinence recovery in the observation group was significantly higher than that in the control group (90.91% vs 60.61%,P<0.05). The duration of urinary incontinence in the observation group was significantly shorter than that in the control group ([3.36±1.54]d vs [4.15±1.36]d,P<0.05). And the subjective well-being score in observation group was significantly higher than that in the control group ([19.36±2.69]points vs [11.65±2.65]points, P<0.05). There was no significant difference in preoperative physical function, social function,and mental health scores between the two groups (P>0.05). And all scores in the observation group were significantly higher than those in the control group after surgery (P<0.05). There was no significant difference in the preoperative SAS and SDS scores between the two groups of patients (P>0.05). And the scores of SAS and SDS in observation group were lower than those of the control group after the operation (P<0.05). Conclusion: Rehabilitation nursing based on IKAP theory can significantly improve urinary incontinence in patients with prostate cancer after surgery, which promotes the recovery of urinary incontinence, shortens the time of urinary incontinence, and improves the subjective well-being and quality of life, as well as reduces the negative impact of negative emotions. Therefore, it can be widely promoted and implemented in clinical practice.
Humans
;
Prostatectomy/adverse effects*
;
Urinary Incontinence/etiology*
;
Male
;
Quality of Life
;
Rehabilitation Nursing
;
Middle Aged
;
Aged
9.Clinical dilemma and indication selection of restoration for permanent tooth defects in adolescents.
Yawen CHENG ; Deli LI ; Yan ZHAO ; Bin XIA ; Yunsong LIU
Journal of Peking University(Health Sciences) 2025;57(1):208-213
Adolescence is defined as a population ranging from ten to nineteen years old. Permanent teeth in adolescents are of critical significance as they are actively involved in mastication, contribute to aesthetic appearance, play a role in pronunciation, and are integral to the growth and development of the stomatognathic system. Specifically, permanent teeth in adolescents comprise those with incomplete root development and those with complete root development but unstable gingival margin positions. However, the prevalence of permanent tooth defects among adolescents remains high, primarily due to their insufficient awareness of oral health care and poor compliance with preventive measures. Therefore, it is very important to emphasize the necessity for timely and appropriate restoration of permanent tooth defects in adolescents. Given the distinct physiological characteristics of adolescent permanent teeth compared with mature permanent teeth, interim restoration approaches are required. The field of adolescent permanent tooth restoration is an interdisciplinary area, involving both prosthodontics and pediatric dentistry. Currently, a comprehensive and standardized principle for the selection of restoration indications is lacking, which poses challenges for clinicians in making optimal treatment decisions. Therefore, this article aims to comprehensively summarize the clinical dilemmas associated with the restoration of adolescent permanent teeth, and propose a set of principles for the selection of restoration methods and materials, aiming to offer practical clinical guidelines for dentists when dealing with permanent tooth defects in adolescent patients. In particular, because of the different restoration dilemmas of anterior and posterior permanent teeth, a variety of interim restoration methods, their applicable conditions, advantages, and disadvantages are introduced respectively. Additionally, it provides an in-depth discussion of different interim restoration materials, including direct restoration materials like light-cured composite resin and dual-cured temporary crown resin, as well as indirect restoration materials such as polymeric porcelain and CAD/CAM resin-matrix ceramics. The goal of this research is to provide a foundation for the development of evidence-based restoration plans in clinical practice and to contribute to the establishment of future standards in the field of adolescent permanent tooth restoration. This will enhance the quality of dental care for adolescents and promote better oral health outcomes in this population.
Humans
;
Adolescent
;
Dentition, Permanent
;
Dental Restoration, Permanent/methods*
;
Child
10.Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial.
Fan WANG ; Hai-Qing GAO ; Zhe LYU ; Xiao-Ming WANG ; Hui HAN ; Yong-Xia WANG ; Feng LU ; Bo DONG ; Jun PU ; Feng LIU ; Xiu-Guang ZU ; Hong-Bin LIU ; Li YANG ; Shao-Ying ZHANG ; Yong-Mei YAN ; Xiao-Li WANG ; Jin-Han CHEN ; Min LIU ; Yun-Mei YANG ; Xiao-Ying LI
Chinese journal of integrative medicine 2025;31(3):195-205
OBJECTIVE:
To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension.
METHODS:
This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups.
RESULTS:
A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period.
CONCLUSIONS
Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans
;
Amlodipine/adverse effects*
;
Drugs, Chinese Herbal/adverse effects*
;
Male
;
Female
;
Hypertension/complications*
;
Middle Aged
;
Treatment Outcome
;
Drug Therapy, Combination
;
Adult
;
Blood Pressure/drug effects*
;
Double-Blind Method
;
Aged
;
Antihypertensive Agents/adverse effects*


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