1.Mingshi Formula (明视方) for Low Myopia in Children with Heart Yang Insufficiency Syndrome: A Multicentre, Double-Blind, Randomised Placebo-Controlled Study
Jianquan WANG ; Xinyue HOU ; Zefeng KANG ; Yingxin YANG ; Xinquan LIU ; Zhihua SHEN ; Xiaoyi YU ; Jing YAO ; Fengming LIANG ; Fengmei ZHANG ; Jingsheng YU ; Ningli WANG ; Man SONG ; Hongrui SUN ; Xin YAN
Journal of Traditional Chinese Medicine 2024;65(6):587-593
ObjectiveTo observe the effectiveness and safety of the Chinese herbal medicine Mingshi Granules (明视方颗粒) for low myopia in children with heart yang insufficiency. MethodsA multicentre, prospective, double-blind randomised controlled study was conducted, in which 290 children with low myopia from 8 centres were randomly divided into 145 cases in the treatment group and 145 cases in the control group, and the treatment group was given education, dispensing glasses, and Chinese herbal medicine Mingshi Granules, while the control group was given education, dispensing glasses, and granules placebo. Both Mingshi Granules and placebo granules were taken orally, 1 bag each time, twice daily, 4 weeks of oral intake and 2 weeks of rest as 1 course of treatment, a total of 4 courses of treatment (24 weeks). Equivalent spherical lenses, best naked-eye distance visual acuity, ocular axis, corneal curvature K1, adjustment amplitude, traditional Chinese medicine (TCM) symptom scores, calculate the amount of progression of equivalent spherical lenses, were observed at the 12th and the 24th week of treatment, at the 36th week and 48th week of follow-up, resectively, the control rate of myopia progression was evaluated at the 24th week, and safety indexes were observed before treatment. ResultsThe amount of progression of equivalent spherical lenses was lower in the treatment group than in the control group at the 48-week follow-up (P<0.05). The control rate of myopia progression at 24 weeks after treatment in the treatment group was higher (57.60%, 72/125) than that in the control group (44.63%, 54/121) (P<0.05). The best naked-eye distance visual acuity at 36-week follow-up in the treatment group was higher than that in the control group (P<0.05). Equivalent spherical lenses were significantly lower in both groups at all observation time points compared with pre-treatment (P<0.05), and were higher in the treatment group than in the control group at the 48-week follow-up (P<0.05). The ocular axes of both groups were significantly higher at each observation time point after treatment and at follow-up compared with before treatment (P<0.05). The amount of eye axis growth in the treatment group was lower than that in the control group at 24 weeks after treatment and at the 48-week follow-up (P<0.05). Corneal curvature K1 was significantly lower in the treatment group at the 24th week of treatment compared to pre-treatment (P<0.05). The magnitude of adjustment in the treatment group was significantly higher at the 36-week follow-up and at the 48-week follow-up than before treatment (P<0.05). The scores of white/dark complexion, white coating thin pulse, fatigue and total TCM symptom scores of children in both groups at the 12th, 24th, 36th and 48th weeks of follow-up were significantly lower than those before treatment (P<0.05); the scores of blurred vision at the 24th and 36th weeks of follow-up were significantly lower than those before treatment (P<0.05); and the scores of blurred vision in the treatment group at the 48th week of follow-up were signi-ficantly lower than those before treatment (P<0.05). In the treatment group, the score of fatigue was higher than that of the control group at the 36-week follow-up, and the score of blurred vision was lower than that of the control group at the 48-week follow-up (P<0.05). No adverse reactions or obvious abnormalities of the safety indexes were observed of the two groups during the treatment. ConclusionChinese herbal medicine Mingshi Granules showed the effect of controlling the progression of low myopia, improving the best naked eye distance visual acuity, slowing down the growth of the eye axis, improving some of the TCM symptoms, with good safety.
2.Efficacy of group metacognitive training in refractory schizophrenia:three cases report
Cong WANG ; Xiaohong LI ; Yan LIU ; Zhihua GUO ; Xianbin LI
Sichuan Mental Health 2024;37(5):471-474
This article presents three detailed case reports of refractory schizophrenia with varying degrees of improvement in psychiatric symptoms,cognitive function,and insight after 16 sessions of group metacognitive training(MCT)across an 8-week period,and aims to explore the curative effect of group MCT in patients with refractory schizophrenia,thus to provide references for improving symptoms in refractory schizophrenia.
3.The treatment of bromhidrosis with flap trimming through small axillary incisions combined with scraping techniques
Xirong LI ; Yulong WANG ; Chaoyong YUAN ; Hongtu ZHANG ; Yan LI ; Zhihua ZHANG
Chinese Journal of Plastic Surgery 2024;40(5):530-536
Objective:To conduct the clinical effect achieved by the combination of axillary flap trimming and scraping through small axillary incisions in treating bromhidrosis.Methods:From June 2021 to December 2022, a study was conducted on patients with bilateral bromhidrosis in the Department of Plastic Surgery, Jining First People’s Hospital. The study used a self-control method, with one side undergoing axillary flap trimming combined with scraping through small axillary incisions (designated as Group A), while the other side underwent direct axillary flap trimming through central axillary incisions (designated as Group B). Randomization was achieved using a number table method for both sides. In Group A, two short incision lines of 0.5-1.0 cm were designed on both sides of the armpit. These incisions separated all layers of the skin, and excised the sweat glands and fat tissue. Additionally, two drainage openings were left in the surgical area to maintain two drainage tubes through the surgical incision. In Group B, the incision lines of 2-3 cm were designed in the central axillary area. After incision and dissection, four drainage tubes were retained in the operation area. The efficacy evaluation consisted of three aspects: the surgical outcome one month post-operation, categorized as cure, effective, or ineffective; the recurrence of bromhidrosis six months post-operation; and the occurrence of surgical complications. SPSS 25.0 software was used for data analysis, and chi-square test was applied for the comparisons between the two groups in terms of response rate, recurrence rate, and complication rate. A statistically significant difference was determined at the P<0.05 level. Results:A study was conducted on 62 patients, aged between 16 and 35 years, with bilateral bromhidrosis, including 38 males and 24 females. In Group A, 55 patients achieved complete cure, while 7 patients experienced significant improvement, resulting in an overall effectiveness rate of 100%. However, 5 cases of recurrence were observed, with a recurrence rate of 8.1%. Additionally, there were 1 case of subflap hematoma, 2 cases of flap erosion, and 1 case of scar hypertrophy, resulting in a complication rate of 6.5%. In Group B, 58 patients achieved complete cure, while 4 patients experienced improvement, resulting in an overall effectiveness rate of 100%. Three cases of recurrence were reported within 6 months, with a recurrence rate of 4.8%. Furthermore, there were 4 cases of subflap hematoma, 4 cases of flap erosion, 2 cases of flap necrosis, and 4 cases of scar hypertrophy, resulting in a complication rate of 22.6%. Statistical analysis showed no significant difference in treatment response rate ( χ2=0.34, P=0.559) or postoperative recurrence rate ( χ2=0.53, P=1.000) between the two groups. However, the complication rate in Group A was significantly lower than that in Group B ( χ2=6.50, P=0.011). Conclusion:The clinical outcome is satisfactory, achieving a high rate of effectiveness by the combination of axillary flap trimming and scraping through small axillary incisions in treating bromhidrosis. And the complications are fewer compared to the direct axillary flap trimming through central axillary incisions.
4.A retrospective study of pedicled upper lip mucosal flap in repairing nasal septal mucosa defect after rhinoplasty
Yiwen DENG ; Xiancheng WANG ; Hongli ZHAO ; Zhihua QIAO ; Yi TIAN ; Weiliang ZENG ; Kai YANG ; Chunjie LI ; Quanding YAN ; Yang SUN
Chinese Journal of Plastic Surgery 2024;40(8):838-845
Objective:To investigate the surgical effect of pedicled upper lip mucosal flap in repairing nasal septal mucosal defects after rhinoplasty.Methods:A retrospective analysis was performed from January 2016 to October 2022, the clinical data of patients with nasal septal mucosal defects after rhinoplasty were collected in the Department of Plastic and Aesthetic (Burn) Surgery at the Second Xiangya Hospital of Central South University. The pedicled upper lip mucosal flap was utilized for repair based on the patient’s medical history and wound condition. The pedicle of the flap was designed 1 cm adjacent to the frenulum of the upper lip, and an appropriate flap was incised based on the size of the wound, with dissection performed up to the superficial layer of the orbicularis oris muscle. The dissection establishes an upper lip tunnel that connects the gingival-buccal groove to the nasal cavity. The pedicled upper lip mucosal flap was elevated and transposed into the nasal cavity via the upper lip tunnel. The position of the flap was adjusted to ensure complete coverage and fixation of the nasal septal defect wound using 5-0 absorbable suture. The visual analogue scale (VAS) and the nasal obstruction symptom evaluation (NOSE) scale were utilized to facilitate patients’ satisfaction evaluation and assessment of nasal obstruction symptoms before surgery and at 6 months post-surgery. The VAS total score was 10 points, with higher scores indicating greater levels of patient satisfaction. The NOSE scale comprises of 5 items, each assigned a score ranging from 0 to 4, denoting absence of symptoms, very mild presence, moderate intensity, relatively severe manifestation, and highly severe indication respectively. The measurement data of VAS and NOSE scores before surgery and at 6 months post-surgery was expressed by Mean±SD, using paired t-test. The score distribution of the NOSE scale was represented by the number of cases, using Mann-Whitney U test. Results:The study included a total of 15 female patients, with an average age of (27.6±2.9) years (ranging from 23 to 33 years). Eleven cases presented with preoperative cartilage exposure, and the size of tissue defect ranged from 0.9 cm×0.5 cm to 1.5 cm×0.7 cm. Nine patients had a history of smoking. Skin grafting was performed in 9 patients, while nasal mucosal metastasis was observed in 8 patients. The dimensions of the flap varied from 4.0 cm×1.2 cm to 7.0 cm×1.5 cm. The postoperative recovery was satisfactory, with successful survival of the skin flaps and no occurrences of infection, hematoma, wound dehiscence, or flap necrosis. The average duration of follow-up was (8.2±2.1) months (ranging from 6 to 12 months). The postoperative VAS score (7.73±0.88) was significantly higher compared to the preoperative score (1.86±0.74) ( P<0.01). Additionally, the postoperative NOSE score (4.66±1.71) showed a significant decrease from the preoperative score (10.73±2.68), with a statistically significant difference ( P<0.01). Among them, after surgery items of stuffy or unbreathable nose (2 cases vs. 15 cases), nasal obstruction (1 case vs. 14 cases), and feeling that the nose was not enough to breathe during exercise or exertion (4 cases vs. 14 cases) scored≥2 points were significantly less than those before operation (all P<0.01). Conclusion:The utilization of pedicled upper lip mucosal flap in the reconstruction of severe nasal septal mucosal defects following rhinoplasty has proven to be highly effective. The postoperative satisfaction of patients is remarkably high, the ventilation function exhibits significant improvement, and no severe complications are observed.
5.Clinical validation of the safety and efficacy of sodium hyaluronate gel DX23 in the treatment of midface depression
Yan JIN ; Zhensheng HU ; Zhihua ZHANG ; Pei LIU ; Wenzhi LI
Chinese Journal of Plastic Surgery 2024;40(11):1175-1183
Objective:To investigate the efficacy and safety of injectable modified sodium hyaluronate gel DX23 in filling and treating midface depression.Methods:A prospective, randomized, multicenter, "no treatment" controlled study was conducted. Patients with midface depression who were treated from March 2019 to February 2021 at Beijing Anzhen Hospital Affiliated to Capital Medical University, Qilu Hospital of Shandong University, and Jining First People’s Hospital were enrolled. Patients were randomized using a stratified block randomization method with a random function list. The experimental group received injectable modified sodium hyaluronate gel DX23 to treat midface depression. The concentration of sodium hyaluronate in DX23 was 23 mg/ml. The syringe was inserted perpendicularly to the skin at a 90-degree angle, and the injection layers were the superficial periosteum or the subcutaneous layer. The injection volume ranged from 1 to 6 ml. The control group received no treatment. The upper boundary of the midface extended outward from the zygomatic arch to the upper margin of the helix and inward to the line connecting the outer canthus. The lower boundary was the line connecting the corner of the mouth to the earlobe. Researchers used the midface aesthetic scales (MAS) response rate at 6 months post-injection as the primary indicator to evaluate the efficacy in improving the severity of midface depression. A reduction of 1 point in the MAS score compared to pre-treatment was considered a response, i. e., effective. Secondary indicators included the MAS response rates at 6 and 12 months after the last treatment (MAS response rate=number of MAS responders/total cases × 100%), the average change in three-dimensional midface volume images, the global aesthetic improvement scale (GAIS) response rate, patient satisfaction regarding the degree of improvement in midface volume, and monitoring of adverse reactions. Data analysis was performed using SPSS 25.0, SAS 9.04, and StataIC 15.0 software. The full analysis set (FAS) and the per-protocol set (PPS) were selected for analysis. Inferential analysis used t-tests and chi-square tests, with P<0.05 considered statistically significant. Results:A total of 164 patients were enrolled. The experimental group included 134 patients (7 males and 127 females) with an average age of 43.0±9.7 years (ranging from 21.6 to 66.6 years). The control group included 30 patients (5 males and 25 females) with an average age of 39.3±11.1 years (ranging from 25.6 to 43.5 years). The experimental group received bilateral midface depression filling, with an initial use of injectable modified sodium hyaluronate gel DX23 at a volume of (4.07±1.28) ml. In the experimental group, 3 cases were lost to follow-up at 30 days, 2 cases at 60 days, and 10 cases were excluded due to protocol violations. Fifteen patients entered FAS but not PPS. Ultimately, 119 patients completed the trial. The MAS response rates in the experimental group at 6 and 12 months post-treatment were 94.96% (113/119) and 56.30% (67/119), respectively. The control group’s MAS response rate at 6 months was 3.33% (1/30). At the 6-month follow-up post-treatment, the GAIS response rates evaluated by researchers and patients in the experimental group were 97.48% (116/119) (PPS) and 97.69% (27/30) (FAS), respectively. In the control group, the GAIS response rate evaluated by researchers was 3.33% (1/30) (FAS, PPS), and the patient GAIS response rate was 0% (0/30) (FAS, PPS). There were statistically significant differences between the two groups in both researcher and patient GAIS response rates (both P<0.01). At 6 months post-injection, comparisons of midface volume changes from baseline between the experimental and control groups showed statistically significant differences [(1.65±1.40) ml (PPS) vs. (0.12±0.85) ml; (1.55±1.44) ml (FAS) vs. (0.12±0.85) ml; both P<0.001]. At the 6-month follow-up in the experimental group, 1 case was lost to follow-up. In the PPS, 81 patients were "satisfied, " 34 were "very satisfied, " and 3 were "neutral." In the control group, 29 patients were "neutral, " and 1 was "dissatisfied." A total of 128 patients in the experimental group experienced injection site reactions, including swelling, hardness, tenderness, pain, lumps (protrusions), and bruising. Over 75% of patients resolved spontaneously within 8 days. Three cases received hot compress treatment and resolved within 28 days. One case experienced swelling of the left lower eyelid 1 day after injection, which resolved after local compression for 3 months. In the control group, 1 case developed circulatory ischemia and carotid atherosclerosis 12 months after the trial began. Conclusion:Injectable modified sodium hyaluronate gel DX23 corrects midface depression through local volume augmentation and is characterized by safety and durability.
6.Genetic analysis and prenatal diagnosis for a Chinese pedigree affected with Autosomal dominant polycystic kidney disease
Zhihua TANG ; Chunlan ZHENG ; Wenwen WANG ; Zhengxia HE ; Chanli ZHANG ; Yan WANG ; Qian MA ; Hongjun GUO
Chinese Journal of Medical Genetics 2024;41(9):1072-1076
Objective:To explore the clinical phenotype and genetic etiology for a Chinese pedigree affected with Autosomal dominant polycystic kidney disease (ADPKD).Methods:A pedigree with ADPKD diagnosed at the Department of Gynaecology of the First Affiliated Hospital of Zhengzhou University in December 2020 was selected as the study subject. Clinical data of the pedigree was collected, and whole exome sequencing (WES) was carried out for the proband. Candidate variants were verified by Sanger sequencing of the proband and her relatives. This study was approved by the First Affiliated Hospital of Zhengzhou University (Ethics No. KS-2018-KY-36).Results:Fetal ultrasonography showed increased volume and parenchymal echogenicity in both kidneys. The fetus was found to harbor c. 11098C>T (p.R3700C) and c.11039T>C (p.F3680S) compound heterozygous variants of the PKD1 gene, which were respectively inherited from its mother and father. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), both variants were predicted to be likely pathogenic (PM1+ PM2_Supporting+ PP3). Conclusion:The c. 11098C>T (p.R3700C) and c. 11039T>C (p.F3680S) compound heterozygous variants of the PKD1 gene probably underlay the ADPKD in the fetus. Above finding has provided guidance for the genetic counseling and prenatal diagnosis for this pedigree.
7.A consistency comparison between next-generation sequencing and the FISH method for gene rearrangement detection in B-cell lymphomas
Zheng YAN ; Zhihua YAO ; Shuna YAO ; Shuang ZHAO ; Haiying WANG ; Junfeng CHU ; Yuanlin XU ; Jiuyang ZHANG ; Bing WEI ; Jiawen ZHENG ; Qingxin XIA ; Daoyuan WU ; Xufeng LUO ; Wenping ZHOU ; Yanyan LIU
Chinese Journal of Hematology 2024;45(6):561-565
Objective:To compare the consistency of lymphoma multigene detection panels based on next-generation sequencing (NGS) with FISH detection of B-cell lymphoma gene rearrangement.Methods:From January 2019 to May 2023, fusion genes detected by lymphoma-related 413 genes that targeted capture sequencing of 489 B-cell lymphoma tissues embedded in paraffin were collected from Henan Cancer Hospital, and the results were compared with simultaneous FISH detection of four break/fusion genes: BCL2, BCL6, MYC, and CCND1. Consistency was defined as both methods yielding positive or negative results for the same sample. The relationship between fusion mutation abundance in NGS and the positivity rate of cells in FISH was also analyzed.Results:Kappa consistency analysis revealed high consistency between NGS and FISH in detecting the four B-cell lymphoma-related gene rearrangement ( P<0.001 for all) ; however, the detection rates of positive individuals differed for the four genes. Compared with FISH, NGS demonstrated a higher detection rate for BCL2 rearrangement, a lower detection rate for BCL6 and MYC rearrangement, and a similar detection rate for CCND1 rearrangement. No correlation was found between fusion mutation abundance in NGS and the positivity rate of cells in FISH. Conclusions:NGS and FISH detection of B-cell lymphoma gene rearrangement demonstrate overall good consistency. NGS is superior to FISH in detecting BCL2 rearrangement, inferior in detecting MYC rearrangement, and comparable in detecting CCND1 rearrangement.
8.Enhancement of anti-tumor effect of immune checkpoint inhibitor anti-PD-L1 by shenqifuzheng injection and the mechanism study
Zhihua ZHOU ; Jingwen CHANG ; Yuanyuan YAN ; Yanan QI ; Jingjing HAN ; Xinyi ZHU ; Chen YU ; Hongyan WU ; Fangtian FAN
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(7):792-799
AIM:To investigate of the effect of Shenqifuzheng injection(SFI)combined with PD-L1 antibody on tumor immune microenvironment and its efficacy.METHODS:A subcutaneous transplanta-tion tumor model for B16F10-LUC melanoma was created.The expression of Ki67,CD31,CD8,CD16,CD163,FOXP3,LY6C,LY6G with labeling antibodies was used to detect CD8+T cells,Treg cells,NK cells,MDSCs cells,centrocytes,and granulocytes in the tumor tissues via immunohistochemistry.Flow cy-tometry was used to measure the ratios of CD11c+,IA/IE+,and CD80+cells in splenic tissue,as well as the ratios of CD8+T,CD4+T,and Treg cells in tumor tissue.Additionally,granulocyte count and NK cell expression were analyzed.RESULTS:The immuno-histochemistry results indicate that the drug admin-istration group effectively suppressed tumor angio-genesis and cell proliferation,while decreasing the expression level of immunosuppressive cytokines CD4+T cells,Treg cells,MDSCs and centroblasts.Ad-ditionally,CD8 and NK cell infiltration was promot-ed compared to the control group.The results of the flow analysis demonstrated a significant in-crease in the expression level of CD8+T cells within tumor tissues,as well as inhibition of CD4+T,Treg,and DC cell infiltration within the spleen in the drug administration group.Additionally,the tumor volume analysis indicated that the drug administra-tion group effectively inhibited tumor growth.The flow results illustrate that the group administering treatment exhibited significant increases in CD8+T cell expression levels in tumor tissue and DC cells in the spleen.Furthermore,the treatment effec-tively inhibited the infiltration of CD4+T and Treg cells.The results also indicate that the treatment significantly reduced tumor growth,with the tumor inhibition rate being better with PD-L1 antibody alone than with the SFI group.Additionally,combin-ing drugs resulted in superior results compared to the PD-L1 antibody group alone.CONCLUSION:SFI combined with a PD-L1 antibody can have synergis-tic anti-tumor effects,potentially enhancing DC cell infiltration and promoting T cell activation.Immu-nohistochemistry results indicate a positive impact on the tumor immune microenvironment.
9.A retrospective study of pedicled upper lip mucosal flap in repairing nasal septal mucosa defect after rhinoplasty
Yiwen DENG ; Xiancheng WANG ; Hongli ZHAO ; Zhihua QIAO ; Yi TIAN ; Weiliang ZENG ; Kai YANG ; Chunjie LI ; Quanding YAN ; Yang SUN
Chinese Journal of Plastic Surgery 2024;40(8):838-845
Objective:To investigate the surgical effect of pedicled upper lip mucosal flap in repairing nasal septal mucosal defects after rhinoplasty.Methods:A retrospective analysis was performed from January 2016 to October 2022, the clinical data of patients with nasal septal mucosal defects after rhinoplasty were collected in the Department of Plastic and Aesthetic (Burn) Surgery at the Second Xiangya Hospital of Central South University. The pedicled upper lip mucosal flap was utilized for repair based on the patient’s medical history and wound condition. The pedicle of the flap was designed 1 cm adjacent to the frenulum of the upper lip, and an appropriate flap was incised based on the size of the wound, with dissection performed up to the superficial layer of the orbicularis oris muscle. The dissection establishes an upper lip tunnel that connects the gingival-buccal groove to the nasal cavity. The pedicled upper lip mucosal flap was elevated and transposed into the nasal cavity via the upper lip tunnel. The position of the flap was adjusted to ensure complete coverage and fixation of the nasal septal defect wound using 5-0 absorbable suture. The visual analogue scale (VAS) and the nasal obstruction symptom evaluation (NOSE) scale were utilized to facilitate patients’ satisfaction evaluation and assessment of nasal obstruction symptoms before surgery and at 6 months post-surgery. The VAS total score was 10 points, with higher scores indicating greater levels of patient satisfaction. The NOSE scale comprises of 5 items, each assigned a score ranging from 0 to 4, denoting absence of symptoms, very mild presence, moderate intensity, relatively severe manifestation, and highly severe indication respectively. The measurement data of VAS and NOSE scores before surgery and at 6 months post-surgery was expressed by Mean±SD, using paired t-test. The score distribution of the NOSE scale was represented by the number of cases, using Mann-Whitney U test. Results:The study included a total of 15 female patients, with an average age of (27.6±2.9) years (ranging from 23 to 33 years). Eleven cases presented with preoperative cartilage exposure, and the size of tissue defect ranged from 0.9 cm×0.5 cm to 1.5 cm×0.7 cm. Nine patients had a history of smoking. Skin grafting was performed in 9 patients, while nasal mucosal metastasis was observed in 8 patients. The dimensions of the flap varied from 4.0 cm×1.2 cm to 7.0 cm×1.5 cm. The postoperative recovery was satisfactory, with successful survival of the skin flaps and no occurrences of infection, hematoma, wound dehiscence, or flap necrosis. The average duration of follow-up was (8.2±2.1) months (ranging from 6 to 12 months). The postoperative VAS score (7.73±0.88) was significantly higher compared to the preoperative score (1.86±0.74) ( P<0.01). Additionally, the postoperative NOSE score (4.66±1.71) showed a significant decrease from the preoperative score (10.73±2.68), with a statistically significant difference ( P<0.01). Among them, after surgery items of stuffy or unbreathable nose (2 cases vs. 15 cases), nasal obstruction (1 case vs. 14 cases), and feeling that the nose was not enough to breathe during exercise or exertion (4 cases vs. 14 cases) scored≥2 points were significantly less than those before operation (all P<0.01). Conclusion:The utilization of pedicled upper lip mucosal flap in the reconstruction of severe nasal septal mucosal defects following rhinoplasty has proven to be highly effective. The postoperative satisfaction of patients is remarkably high, the ventilation function exhibits significant improvement, and no severe complications are observed.
10.Clinical validation of the safety and efficacy of sodium hyaluronate gel DX23 in the treatment of midface depression
Yan JIN ; Zhensheng HU ; Zhihua ZHANG ; Pei LIU ; Wenzhi LI
Chinese Journal of Plastic Surgery 2024;40(11):1175-1183
Objective:To investigate the efficacy and safety of injectable modified sodium hyaluronate gel DX23 in filling and treating midface depression.Methods:A prospective, randomized, multicenter, "no treatment" controlled study was conducted. Patients with midface depression who were treated from March 2019 to February 2021 at Beijing Anzhen Hospital Affiliated to Capital Medical University, Qilu Hospital of Shandong University, and Jining First People’s Hospital were enrolled. Patients were randomized using a stratified block randomization method with a random function list. The experimental group received injectable modified sodium hyaluronate gel DX23 to treat midface depression. The concentration of sodium hyaluronate in DX23 was 23 mg/ml. The syringe was inserted perpendicularly to the skin at a 90-degree angle, and the injection layers were the superficial periosteum or the subcutaneous layer. The injection volume ranged from 1 to 6 ml. The control group received no treatment. The upper boundary of the midface extended outward from the zygomatic arch to the upper margin of the helix and inward to the line connecting the outer canthus. The lower boundary was the line connecting the corner of the mouth to the earlobe. Researchers used the midface aesthetic scales (MAS) response rate at 6 months post-injection as the primary indicator to evaluate the efficacy in improving the severity of midface depression. A reduction of 1 point in the MAS score compared to pre-treatment was considered a response, i. e., effective. Secondary indicators included the MAS response rates at 6 and 12 months after the last treatment (MAS response rate=number of MAS responders/total cases × 100%), the average change in three-dimensional midface volume images, the global aesthetic improvement scale (GAIS) response rate, patient satisfaction regarding the degree of improvement in midface volume, and monitoring of adverse reactions. Data analysis was performed using SPSS 25.0, SAS 9.04, and StataIC 15.0 software. The full analysis set (FAS) and the per-protocol set (PPS) were selected for analysis. Inferential analysis used t-tests and chi-square tests, with P<0.05 considered statistically significant. Results:A total of 164 patients were enrolled. The experimental group included 134 patients (7 males and 127 females) with an average age of 43.0±9.7 years (ranging from 21.6 to 66.6 years). The control group included 30 patients (5 males and 25 females) with an average age of 39.3±11.1 years (ranging from 25.6 to 43.5 years). The experimental group received bilateral midface depression filling, with an initial use of injectable modified sodium hyaluronate gel DX23 at a volume of (4.07±1.28) ml. In the experimental group, 3 cases were lost to follow-up at 30 days, 2 cases at 60 days, and 10 cases were excluded due to protocol violations. Fifteen patients entered FAS but not PPS. Ultimately, 119 patients completed the trial. The MAS response rates in the experimental group at 6 and 12 months post-treatment were 94.96% (113/119) and 56.30% (67/119), respectively. The control group’s MAS response rate at 6 months was 3.33% (1/30). At the 6-month follow-up post-treatment, the GAIS response rates evaluated by researchers and patients in the experimental group were 97.48% (116/119) (PPS) and 97.69% (27/30) (FAS), respectively. In the control group, the GAIS response rate evaluated by researchers was 3.33% (1/30) (FAS, PPS), and the patient GAIS response rate was 0% (0/30) (FAS, PPS). There were statistically significant differences between the two groups in both researcher and patient GAIS response rates (both P<0.01). At 6 months post-injection, comparisons of midface volume changes from baseline between the experimental and control groups showed statistically significant differences [(1.65±1.40) ml (PPS) vs. (0.12±0.85) ml; (1.55±1.44) ml (FAS) vs. (0.12±0.85) ml; both P<0.001]. At the 6-month follow-up in the experimental group, 1 case was lost to follow-up. In the PPS, 81 patients were "satisfied, " 34 were "very satisfied, " and 3 were "neutral." In the control group, 29 patients were "neutral, " and 1 was "dissatisfied." A total of 128 patients in the experimental group experienced injection site reactions, including swelling, hardness, tenderness, pain, lumps (protrusions), and bruising. Over 75% of patients resolved spontaneously within 8 days. Three cases received hot compress treatment and resolved within 28 days. One case experienced swelling of the left lower eyelid 1 day after injection, which resolved after local compression for 3 months. In the control group, 1 case developed circulatory ischemia and carotid atherosclerosis 12 months after the trial began. Conclusion:Injectable modified sodium hyaluronate gel DX23 corrects midface depression through local volume augmentation and is characterized by safety and durability.

Result Analysis
Print
Save
E-mail