1.Analysis of the impact of high progesterone ovulation induction protocols on embryo euploidy rates and clinical pregnancy outcomes in infertile patients
Minjie WANG ; Yongjing ZHANG ; Jin QIAN ; Chao WANG ; Yuping XU ; Tianjuan WANG ; Dawei CHEN ; Yan HAO ; Qiong XING
Acta Universitatis Medicinalis Anhui 2026;61(5):923-930
ObjectiveTo analyze the effects of the progestin-primed ovarian stimulation (PPOS) protocol on embryo euploidy rate and clinical pregnancy outcomes in infertile patients. MethodsWomen who underwent Preimplantation genetic testing for aneuploidy (PGT-A) cycles were selected as study participants (a total of 656 cycles and 3 081 blastocysts). Participants were divided into two age groups (≤35 years and >35 years) and further stratified by ovarian stimulation protocol: the Progestin-Primed Ovarian Stimulation (PPOS) group (n=48 and 60, respectively), the Luteal Phase Long Protocol (LP) group (n=160 and 57, respectively), and the Gonadotropin-Releasing Hormone Antagonist Protocol (AP) group (n=220 and 111, respectively). Baseline characteristics, ovarian stimulation outcomes, and embryo development parameters were compared among the three protocols within each age group. Additionally, clinical pregnancy outcomes of the first frozen embryo transfer (FET) cycle were compared. The primary outcome measure was the embryo euploidy rate. Results① In the ≤35 years age group, baseline follicle-stimulating hormone (bFSH) levels were significantly higher in the PPOS group compared to the LP and AP groups, and the bFSH/bLH ratio was significantly higher in the PPOS group than in the AP group (P < 0.05). In the >35 years age group, bFSH levels in both the PPOS and AP groups were significantly higher than in the LP group (P < 0.05).② In the ≤35 years group, there were no significant differences in the rates of metaphase II (MII) oocytes, 2-pronuclei (2 PN) zygotes, cleavage, 2 PN cleavage, blastocyst formation, high-quality embryos, or embryo euploidy between the PPOS group and either the LP or AP groups. However, the PPOS group showed significantly lower values for the following parameters compared to the other two groups: total oocytes retrieved, number of MII oocytes, number of 2 PN zygotes, number of cleaved embryos, number of 2 PN cleaved embryos, number of blastocysts formed, number of high-quality embryos, number of high-grade blastocysts, number of transferable embryos, number of cryopreserved embryos, number of biopsied blastocysts, number of euploid embryos, and the rate of obtaining at least one euploid embryo. In the >35 years group, no significant differences were observed among the PPOS, LP, and AP groups in the rates of MII oocytes, 2 PN cleavage, blastocyst formation, or in the number of euploid embryos, euploidy rate, and the rate of obtaining at least one euploid embryo. However, the PPOS group had significantly lower numbers of total oocytes retrieved, MII oocytes, 2 PN zygotes, cleaved embryos, 2 PN cleaved embryos, blastocysts formed, transferable embryos, and cryopreserved embryos compared to the LP group (P<0.05). The high-quality embryo rate was significantly lower in the PPOS group than in the AP group (P<0.05). The numbers of high-quality embryos, high-grade blastocysts, and biopsied blastocysts were significantly lower in the PPOS group than in both the LP and AP groups (P<0.05). Notably, the 2 PN fertilization rate was significantly higher in the PPOS group than in the AP group, and the cleavage rate was significantly higher in the PPOS group than in both the LP and AP groups (P<0.05).③ No significant differences were found among the three groups in the biochemical pregnancy rate, clinical pregnancy rate, live birth rate, early miscarriage rate, and late miscarriage rate following the first FET cycle. ConclusionCompared to the other two protocols, the PPOS protocol does not significantly affect embryo euploidy or clinical pregnancy rates. However, in freeze-all cycles with PGT-A, the PPOS protocol does not reduce the rate of chromosomally normal embryos but may decrease the total number of available embryos. It may not be the optimal choice for younger women, but it can be considered as a viable option for women of advanced maternal age.
2.Treatment of Hyperthyroidism Combined with Atrial Fibrillation:from the Liver
Yao XU ; Yan ZHOU ; Hui LI ; Yifang HAO ; Jintao ZHANG ; Longmei YAN ; Yaxuan XING ; Jingchun ZHANG
Journal of Traditional Chinese Medicine 2026;67(11):1225-1230
Hyperthyroidism (HT) is frequently complicated by atrial fibrillation (AF) in clinical practice. Based on traditional Chinese medicine (TCM) zang-xiang (藏象) theory and clinical experience, both HT and AF are closely associated with dysfunction of the liver. The pathogenesis is initiated by the liver failing to govern the free flow of qi, and liver constraint and qi stagnation, with the key turning points being liver constraint transforming into fire and the internal stirring of liver wind, ultimately leading to liver blood depletion and insufficient nourishment of the heart spirit. Thus, it is proposed to treat the disease from the liver, with stage-specific therapeutic approaches according to the evolution of the disease. In the early stage, the treatment should focus on soothing the liver and relieving constraint to reduce goiter and calm the heart, while in the progressive stage, the method of clearing liver and draining fire is suggested to subdue yang and stabilize palpitations. In the acute stage, the strategy is calming the liver and nourishing yin to subdue yang and extinguish wind. In the later stage, it is suggested to soften the liver and benefit qi, so as to nourish yin and restore pulse. These methods are sequentially applied to synergistically reduce goiter and stabilize palpitations, providing a therapeutic approach for HT complicated by AF.
3.Mechanism of Jinyang Dingtong Plaster in Improving Peripheral Pain Sensitization and Synovial Fibrosis in Knee Osteoarthritis by Blocking Ion Channels of TRPs
Jinliang HE ; Lu ZHANG ; Shixin XING ; Xilu REN ; Jingxing JIANG ; Junfeng KANG ; Xuliang HAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):108-116
ObjectiveThis paper aims to investigate the mechanism of Jinyang Dingtong plaster in improving the peripheral pain sensitization and synovial fibrosis in rats with knee osteoarthritis (KOA) by blocking the ion channels of transient receptor potentials (TRPs). MethodsThe active components in the transdermal absorption solution of Jinyang Dingtong plaster were identified by using ultra-high performance liquid chromatography-electrospray ionization-quadrupole ion trap tandem mass spectrometry (UPLC-MS/MS) technology. A KOA rat model was established through intra-articular injection of monoiodoacetic acid. The rats were randomly divided into blank control group, KOA group, compound Nanxing Zhitong plaster Group, and Jinyang Dingtong plaster group, with eight rats per group. Among them, the rats in the compound Nanxing Zhitong plaster group and the Jinyang Dingtong plaster group were intervened with external application treatment. After the intervention period, the cold and mechanical stimulus pain thresholds of rats in each group were detected, and the transverse diameter of the knee joint was measured. The levels of inflammatory factors in the serum such as interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), nerve growth factor (NGF), and calcitonin gene-related peptide (CGRP) were determined by enzyme-linked immunosorbent assay (ELISA). Protein expression levels of transient receptor potential ankyrin 1 (TRPA1), transient receptor potential melastatin 8 (TRPM8), transient receptor potential vanilloid 1 (TRPV1), transient receptor potential vanilloid 4 (TRPV4), transforming growth factor-β (TGF-β), and vascular endothelial growth factor (VEGF) in synovial tissue were detected by Western blot. Histopathological changes in synovial tissue were observed by using hematoxylin and eosin (HE), Masson, and Sirius red staining, while the expression of type Ⅰ collagen and alpha-smooth muscle actin (α-SMA) was detected by multiplex immunofluorescence. ResultsA total of 35 active components in the transdermal absorption solution of Jinyang Dingtong plaster were identified by UPLC-MS/MS, including phenolic acids, flavonoids, quinones, alkaloids, terpenes, lignans, and coumarins. Among them, the constituents such as berberine, paeoniflorin, ferulic acid, and caffeic acid exhibit clear anti-inflammatory, analgesic, and anti-fibrotic pharmacological effects. Compared to the blank control group, rats in the KOA group showed a significant decrease in cold and mechanical stimuli pain thresholds (P<0.01). After 14 and 28 days of Jinyang Dingtong plaster intervention, the pain threshold in this group was significantly increased compared to that in KOA group (P<0.01), showing no significant difference from that in compound Nanxing Analgesic plaster group. Additionally, Jinyang Dingtong plaster reduced the levels of IL-1β, TNF-α, NGF, and CGRP in the serum of KOA rats (P<0.01), lowered the expression of TRPA1, TRPM8, TRPV1, TRPV4, TGF-β, and VEGF proteins in synovial tissue (P<0.01), improved synovial pathological damage in KOA rats, and significantly decreased fluorescence intensity of type Ⅰ collagen and α-SMA (P<0.01). ConclusionJinyang Dingtong plaster can improve the peripheral pain sensitization and synovial fibrosis in KOA rats by downregulating the expression of ion channels of TRPs and related inflammatory and fibrotic factors.
4.Mechanism of Jinyang Dingtong Plaster in Improving Peripheral Pain Sensitization and Synovial Fibrosis in Knee Osteoarthritis by Blocking Ion Channels of TRPs
Jinliang HE ; Lu ZHANG ; Shixin XING ; Xilu REN ; Jingxing JIANG ; Junfeng KANG ; Xuliang HAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):108-116
ObjectiveThis paper aims to investigate the mechanism of Jinyang Dingtong plaster in improving the peripheral pain sensitization and synovial fibrosis in rats with knee osteoarthritis (KOA) by blocking the ion channels of transient receptor potentials (TRPs). MethodsThe active components in the transdermal absorption solution of Jinyang Dingtong plaster were identified by using ultra-high performance liquid chromatography-electrospray ionization-quadrupole ion trap tandem mass spectrometry (UPLC-MS/MS) technology. A KOA rat model was established through intra-articular injection of monoiodoacetic acid. The rats were randomly divided into blank control group, KOA group, compound Nanxing Zhitong plaster Group, and Jinyang Dingtong plaster group, with eight rats per group. Among them, the rats in the compound Nanxing Zhitong plaster group and the Jinyang Dingtong plaster group were intervened with external application treatment. After the intervention period, the cold and mechanical stimulus pain thresholds of rats in each group were detected, and the transverse diameter of the knee joint was measured. The levels of inflammatory factors in the serum such as interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), nerve growth factor (NGF), and calcitonin gene-related peptide (CGRP) were determined by enzyme-linked immunosorbent assay (ELISA). Protein expression levels of transient receptor potential ankyrin 1 (TRPA1), transient receptor potential melastatin 8 (TRPM8), transient receptor potential vanilloid 1 (TRPV1), transient receptor potential vanilloid 4 (TRPV4), transforming growth factor-β (TGF-β), and vascular endothelial growth factor (VEGF) in synovial tissue were detected by Western blot. Histopathological changes in synovial tissue were observed by using hematoxylin and eosin (HE), Masson, and Sirius red staining, while the expression of type Ⅰ collagen and alpha-smooth muscle actin (α-SMA) was detected by multiplex immunofluorescence. ResultsA total of 35 active components in the transdermal absorption solution of Jinyang Dingtong plaster were identified by UPLC-MS/MS, including phenolic acids, flavonoids, quinones, alkaloids, terpenes, lignans, and coumarins. Among them, the constituents such as berberine, paeoniflorin, ferulic acid, and caffeic acid exhibit clear anti-inflammatory, analgesic, and anti-fibrotic pharmacological effects. Compared to the blank control group, rats in the KOA group showed a significant decrease in cold and mechanical stimuli pain thresholds (P<0.01). After 14 and 28 days of Jinyang Dingtong plaster intervention, the pain threshold in this group was significantly increased compared to that in KOA group (P<0.01), showing no significant difference from that in compound Nanxing Analgesic plaster group. Additionally, Jinyang Dingtong plaster reduced the levels of IL-1β, TNF-α, NGF, and CGRP in the serum of KOA rats (P<0.01), lowered the expression of TRPA1, TRPM8, TRPV1, TRPV4, TGF-β, and VEGF proteins in synovial tissue (P<0.01), improved synovial pathological damage in KOA rats, and significantly decreased fluorescence intensity of type Ⅰ collagen and α-SMA (P<0.01). ConclusionJinyang Dingtong plaster can improve the peripheral pain sensitization and synovial fibrosis in KOA rats by downregulating the expression of ion channels of TRPs and related inflammatory and fibrotic factors.
5.Imaging Measurement of the Safe Distances of Acupuncture at Fengfu (GV 16) in Children Aged 4 to 8 Based on CT Three-Dimensional Reconstruction
Kun LI ; Tianyi WANG ; Xing WANG ; Zhijun LI ; Peng WU ; Yang YANG ; Yunteng HAO ; Hailong ZHAO ; Yuan MA ; Shaojie ZHANG
Journal of Traditional Chinese Medicine 2026;67(14):1523-1527
ObjectiveTo measure the distance from the surface of Fengfu (GV 16) to the deep important bony structures in children aged 4 to 8 years based on CT three-dimensional reconstruction technology, thereby providing imaging reference data for clinical acupuncture safe operations in terms of different age groups and needle insertion angles. MethodsCervical CT image data were collected from healthy children aged 4 to 8 years with five age groups (4-, 5-, 6-, 7-, 8-year-old groups), 20 cases in each group. The images were imported into Mimics 21.0 software for three-dimensional reconstruction. The straight-line distances from the skin model surface of the Fengfu (GV 16) to the first underlying bony barrier (such as the lower edge of the occipital bone, the posterior arch of the atlas vertebra) were measured at intervals of 5° on both the transverse section (0° ± 35°) and the sagittal section (40° upward to 40° downward on the diagonal). The correlation between the measured distance, age, and angle was analyzed. ResultsIn the transverse and sagittal sections, the measured distance from the skin surface to the underlying bone of Fengfu (GV 16) at each angle increased with age. In the transverse section, the increase was relatively small within the 0° to 20° angle range, whereas a more pronounced increase was observed when the angle exceeded 20°; at measurement angles of 30° to 35°, the distance of the skin surface to the bone at Fengfu (GV 16) in the 7- and 8-year-old groups was significantly greater than that in the 4-year-old group (P<0.05). In the sagittal section, the measured distance from the skin surface to the bone at Fengfu (GV 16) was shortest and changed greatly at oblique upward angles of 15° to 40° within each age group, and increased markedly at near-vertical angles of 0° to 10°; it was longest at oblique downward angles of -40° to -5° and showed relatively gradual changes. ConclusionThis study obtained the imaging distance data from Fengfu (GV 16) to the surrounding bony structures in children aged 4 to 8 years through three-dimensional modeling, finding that this distance has clear age and angle dependence, which can provide quantitative evidence for developing individualized and precise safe acupuncture schemes at Fengfu (GV 16) in pediatric clinical practice.
6.Imaging Measurement of the Safe Distances of Acupuncture at Fengfu (GV 16) in Children Aged 4 to 8 Based on CT Three-Dimensional Reconstruction
Kun LI ; Tianyi WANG ; Xing WANG ; Zhijun LI ; Peng WU ; Yang YANG ; Yunteng HAO ; Hailong ZHAO ; Yuan MA ; Shaojie ZHANG
Journal of Traditional Chinese Medicine 2026;67(14):1523-1527
ObjectiveTo measure the distance from the surface of Fengfu (GV 16) to the deep important bony structures in children aged 4 to 8 years based on CT three-dimensional reconstruction technology, thereby providing imaging reference data for clinical acupuncture safe operations in terms of different age groups and needle insertion angles. MethodsCervical CT image data were collected from healthy children aged 4 to 8 years with five age groups (4-, 5-, 6-, 7-, 8-year-old groups), 20 cases in each group. The images were imported into Mimics 21.0 software for three-dimensional reconstruction. The straight-line distances from the skin model surface of the Fengfu (GV 16) to the first underlying bony barrier (such as the lower edge of the occipital bone, the posterior arch of the atlas vertebra) were measured at intervals of 5° on both the transverse section (0° ± 35°) and the sagittal section (40° upward to 40° downward on the diagonal). The correlation between the measured distance, age, and angle was analyzed. ResultsIn the transverse and sagittal sections, the measured distance from the skin surface to the underlying bone of Fengfu (GV 16) at each angle increased with age. In the transverse section, the increase was relatively small within the 0° to 20° angle range, whereas a more pronounced increase was observed when the angle exceeded 20°; at measurement angles of 30° to 35°, the distance of the skin surface to the bone at Fengfu (GV 16) in the 7- and 8-year-old groups was significantly greater than that in the 4-year-old group (P<0.05). In the sagittal section, the measured distance from the skin surface to the bone at Fengfu (GV 16) was shortest and changed greatly at oblique upward angles of 15° to 40° within each age group, and increased markedly at near-vertical angles of 0° to 10°; it was longest at oblique downward angles of -40° to -5° and showed relatively gradual changes. ConclusionThis study obtained the imaging distance data from Fengfu (GV 16) to the surrounding bony structures in children aged 4 to 8 years through three-dimensional modeling, finding that this distance has clear age and angle dependence, which can provide quantitative evidence for developing individualized and precise safe acupuncture schemes at Fengfu (GV 16) in pediatric clinical practice.
7.Observation on the clinical efficacy of different administration methods of G-CSF in the treatment of patients with unexplained repeated implantation failure
Yongjing ZHANG ; Minjie WANG ; Yifei WANG ; Jianye WANG ; Chao WANG ; Yuping XU ; Tianjuan WANG ; Yan HAO ; Qiong XING
Acta Universitatis Medicinalis Anhui 2026;61(7):1283-1288
ObjectiveTo focused on patients with unexplained repeated implantation failure (URIF) and compare the clinical efficacy of different administration routes of granulocyte colony-stimulating factor (G-CSF) in patients undergoing frozen-thawed embryo transfer cycles. MethodsA retrospective case-control study was conducted. A total of 187 patients with URIF who received medical treatment were enrolled in this study. According to whether G-CSF was used on the day of endometrial transformation and its administration route in frozen-thawed embryo transfer cycles, the patients were divided into three groups: control group (without G-CSF, n=71), subcutaneous injection group (subcutaneous G-CSF, n=72), and intrauterine infusion group (intrauterine G-CSF infusion, n=44). The pregnancy outcomes among the three groups were compared, and Logistic regression analysis was performed. ResultsThere were significant differences in biochemical pregnancy rates among the three groups (P<0.05), indicating statistical significance in the overall comparison. In terms of numerical trend, the biochemical pregnancy rate was in the order: subcutaneous injection group > intrauterine infusion group > control group. Further pairwise comparison showed that only the difference between the subcutaneous injection group and the control group was statistically significant (P<0.017), while no significant differences were found between the other groups (P>0.017). The overall comparison of early miscarriage rates among the three groups also showed a significant difference (P<0.05), indicating a statistically significant difference in the distribution among the groups. The numerical trend was: intrauterine perfusion group > subcutaneous injection group > control group. Pairwise comparison results showed that only the difference between the intrauterine perfusion group and the control group was statistically significant (P<0.017), while there was no statistically significant difference between any other two groups (P>0.017).Multivariate Logistic regression analysis showed that endometrial thickness on the day of transformation, number of transferred embryos, and subcutaneous G-CSF injection were independent factors associated with an increased biochemical pregnancy rate, where as age was an independent factor for a decreased biochemical pregnancy rate. For clinical pregnancy outcome, endometrial thickness on the day of transformation, number of transferred embryos, and subcutaneous G-CSF injection were also independent factors for an increased clinical pregnancy rate, while BMI was an independent factor for a decreased clinical pregnancy rate. ConclusionSubcutaneous injection of G-CSF only improved the biochemical pregnancy rate in URIF patients. Multivariate Logistic regression analysis showed that subcutaneous G-CSF injection was a favorable factor for clinical pregnancy rate in URIF patients; however, no significant improvement in clinical pregnancy rate was observed among the three groups. Both the comparison of pregnancy outcomes and the results of multivariate logistic regression analysis indicates that intrauterine perfusion of G-CSF has no significant therapeutic effect in the treatment of patients with URIF.
8.Association between insulin resistance and cardiovascular metabolic indicators in middle-aged adults
Rui TIAN ; Jie ZHANG ; Ting ZHENG ; Aixia ZHANG ; Xing LIU ; Hao KANG ; Qingfang DENG ; Sufang WANG
Acta Universitatis Medicinalis Anhui 2026;61(7):1305-1310
ObjectiveTo investigate the association between insulin resistance (IR) and cardiovascular metabolic indicators, including blood pressure, blood lipids, and serum uric acid, in a middle-aged population. MethodsBased on the baseline survey of the Hong Sifang cohort of China National Salt Industry Group, a total of 575 participants were included. According to the homeostasis model assessment of insulin resistance, the participants were divided into an IR group (n=116) and a non-IR group (n=459). Differences between the two groups were compared using the t-test and chi-square test. Multivariate logistic regression analysis was performed to evaluate the associations between IR and abnormalities in metabolic indicators. ResultsA total of 575 participants were included, including 390 men and 185 women, with a mean age of (48.58 ± 5.14) years and a mean body mass index (BMI) of (24.16 ± 2.97) kg/m². Blood pressure, serum uric acid, and blood lipid levels were significantly higher in the IR group than in the non-IR group (P<0.001). After adjusting for potential confounders including age, sex, and BMI, IR was independently associated with hypertension, dyslipidemia, and hyperuricemia, with odds ratios (OR) and 95% confidence intervals (CI) of 2.57 (1.61-4.09), 3.81 (2.36-6.17), and 2.68 (1.53-4.71), respectively (all P<0.001). ConclusionInsulin resistance is significantly associated with multiple cardiovascular metabolic risk factors in the middle-aged population. Monitoring IR may contribute to the early prevention and control of cardiovascular diseases.
9.Clinical efficacy of laparoscopic left hemi-fundoplication for gastroesophageal reflux disease
Weixue ZHANG ; Guolei LI ; Hao FENG ; Yuan LIU ; Lihui JIA ; Haiyan BAI ; Wei XING ; Zhao XU
Chinese Journal of Digestive Surgery 2025;24(10):1333-1337
Objective:To explore the clinical efficacy of laparoscopic left hemi-fundoplica-tion for gastroesophageal reflux disease (GERD).Method:The retrospective and descriptive study was conducted. The clinical data of 45 patients with GERD who were admitted to Hebei Provincial Hospital of Traditional Chinese Medicine from July 2019 to July 2022 were collected. There were 26 males and 19 females, aged (46±12) years. All patients underwent laparoscopic left hemi-fundoplication. Observation indicators: (1) intraoperative and postoperative conditions; (2) follow-up. Measurement data with normal distribution were expressed as Mean± SD. Count data were expressed as absolute numbers. The paired samples t-test was used for comparison of indicators before and after surgery. Result:(1) Intraoperative and postoperative conditions. All 45 patients successfully underwent the operation, with no conversion to open surgery or intraoperative complications. The operation time was (86±8)minutes, volume of intraoperative blood loss was (12±3)mL, and time to postoperative first flatus was (2.2±0.8)days. Among the 45 patients after surgery, 4 cases had fever, 3 cases had retrosternal dull pain and discomfort, 4 cases had dysphagia, 3 cases had abdominal distension, and 5 cases had constipation. All these symptoms were cured or relieved spontaneously after sympto-matic treatment. The duration of postoperative hospital stay was (3.5±0.5)days. There was no patient with infection, delayed bleeding or perforation.(2) Follow-up. All 45 patients were followed up for 1 year after surgery, with no recurrence of GERD. Gastroscopy showed no esophageal mucosal damage such as erosion or ulcer, and no hiatal hernia occurred. Before surgery, the reflux symptom index score, GERD questionnaire score, reflux disease questionnaire score, lower esophageal sphincter resting pressure, and DeMeester score of 24-hour esophageal pH monitoring were 24.3±1.9, 12.5±2.1,20.1±4.5, (7.1±1.1)mmHg (1 mmHg=0.133 kPa), and 31.4±6.4, respectively. At 1 year after surgery, the above indicators were 2.2±0.7, 6.5±0.5, 4.0±2.6, (23.2±2.9)mmHg, and 6.0±1.4, respectively. There were significant differences before and after surgery ( t=80.75, 18.70,20.09, -33.45, 26.15, P<0.05). Conclusion:Laparoscopic left hemi-fundoplication is safe and feasible for GERD, which can improve the clinical symptoms of patients.
10.Clinical Efficacy of Tangning Tongluo Tablets for Nonproliferative Diabetic Retinopathy
Fuwen ZHANG ; Junguo DUAN ; Wen XIA ; Tiantian SUN ; Yuheng SHI ; Shicui MEI ; Xiangxia LUO ; Xing LI ; Yujie PAN ; Yong DENG ; Chuanlian RAN ; Hao CHEN ; Li PEI ; Shuyu YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):132-139
ObjectiveTo observe the clinical efficacy and safety of Tangning Tongluo tablets in the treatment of nonproliferative diabetic retinopathy (DR). MethodsFourteen research centers participated in this study, which spanned a time interval from September 2021 to May 2023. A total of 240 patients with nonproliferative DR were included and randomly assigned into an observation group (120 cases) and a control group (120 cases). The observation group was treated with Tangning Tongluo tablets, and the control group with calcium dobesilate capsules. Both groups were treated for 24 consecutive weeks. The vision, DR progression rate, retinal microhemangioma, hemorrhage area, exudation area, glycosylated hemoglobin (HbA1c) level, and TCM syndrome score were assessed before and after treatment, and the safety was observed. ResultsThe vision changed in both groups after treatment (P<0.05), and the observation group showed higher best corrected visual acuity (BCVA) than the control group (P<0.05). The DR progression was slow with similar rates in the two groups. The fundus hemorrhage area and exudation area did not change significantly after treatment in both groups, while the observation group outperformed the control group in reducing the fundus hemorrhage area and exudation area. There was no significant difference in the number of microhemangiomas between the two groups before treatment. After treatment, the number of microhemangiomas decreased in both the observation group (Z=-1.437, P<0.05) and the control group (Z=-2.238, P<0.05), and it showed no significant difference between the two groups. As the treatment time prolonged, the number of microhemangiomas gradually decreased in both groups. There was no significant difference in the HbA1c level between the two groups before treatment. After treatment, the decline in the HbA1c level showed no significant difference between the two groups. The TCM syndrome score did not have a statistically significant difference between the two groups before treatment. After treatment, neither the TCM syndrome score nor the response rate had significant difference between the two groups. With the extension of the treatment time, both groups showed amelioration of TCM syndrome compared with the baseline. ConclusionTangning Tongluo tablets are safe and effective in the treatment of nonproliferative DR, being capable of improving vision and reducing hemorrhage and exudation in the fundus.

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