1.Introduction of the main addition and revision of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅱ)
ZHOU Yi ; WANG Zhijun ; YUE Zhihua ; CHENG Qilei ; YUE Ruiqi ; YANG Xi ; GUO Wei ; MA Shuangcheng
Drug Standards of China 2025;26(1):023-027
The Pharmacopeia of the People’s Republic of China 2025 Edition (referred to as the Chinese Pharmacopoeia 2025 Edition, ChP 2025) will be promulgated and implemented. This article introduces the process of development of ChP 2025 Edition (Volume Ⅱ), including the selection, the revision of general notices,the addition and revision of drug monographs, etc., and provides some analysis and examples to illustrate,which can facilitate the readers to understand and implement the ChP 2025 Edition (Volume Ⅱ).
2.Application of early screening scale and evaluation of behavioral intervention effect in children with autism spectrum disorder
Bin ZHANG ; Chunwei HU ; Zhihua LIU ; Huiting YANG ; Canjun WANG ; Xineng FENG
Journal of Public Health and Preventive Medicine 2025;36(4):77-80
Objective To understand the application effect of early screening scale and behavioral intervention effect in children with autism spectrum disorder (ASD). Methods A total of 348 children with suspected ASD were selected and evaluated using the Modified Checklist for Autism in Toddlers (M-CHAT) and Autism Behavior Checklist (ABC). The evaluation results were compared with those from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Children enrolled were given Early start Denver model (ESDM) intervention. The evaluation results of Gesell Developmental Scale and Autism Treatment Evaluation Checklist (ATEC) scores were compared before and after intervention. Results The sensitivity, specificity, accuracy and Kappa value of M-CHAT for evaluating ASD in children aged 1-3 years were 89.53%, 90.70%, 89.92% and 0.78. The corresponding values of ABC were 78.49%, 81.40%, 79.46% and 0.56. The sensitivity, specificity, accuracy and Kappa value of M-CHAT for evaluating children aged >3-6 years were 87.30%, 77.78%, 84.44% and 0.64. The corresponding values of ABC were 85.71%, 77.78%, 83.33% and 0.62. The sensitivity and accuracy of M-CHAT were higher than ABC for evaluating ASD in children aged 1-3 years (P<0.05). There were no significant differences in sensitivity, specificity and accuracy between M-CHAT and ABC for evaluating ASD in children aged 3-6 years (P>0.05). After intervention, development quotients (DQ) of personal-social aspects, adaptability, language, gross motor, and fine motor of children with ASD were higher than those before intervention (P<0.05). ATEC scores for language, behavior, sensation, and social contact of children with ASD were lower than those before intervention (P<0.05). Conclusion M-CHAT and ABC both can be used for early screening of ASD in children, especially M-CHAT. Early behavioral intervention can effectively improve the condition and developmental level of children with ASD.
3.Surgical techniques for pollybeak deformity correction
Hongli ZHAO ; Xiancheng WANG ; Yang SUN ; Xiang XIONG ; Xianxi MENG ; Wenbo LI ; Zhihua QIAO ; Kai YANG ; Weiliang ZENG ; Yi TIAN
Chinese Journal of Plastic Surgery 2024;40(2):156-162
Objective:To evaluate the effectiveness of surgical methods for correcting pollybeak deformity in Chinese rhinoplasty.Methods:A retrospective chart review was conducted for patients who underwent pollybeak correction between January 2021 and December 2022 at the Department of Plastic and Aesthetic (Burn) Surgery, the Second Xiangya Hospital of Central South University. Individualized correction was tailored based on the etiology and severity of the nasal deformity of each patient, involving techniques such as resection of the anterior part of the nasal septum, reconstruction of nasal tip support, reconstruction of the middle part of the nasal vault, and excision of skin in the upper region of the nasal tip. A modified classification system for pollybeak deformity, the supratip fullness rating scale (SFRS), was developed to evaluate supratip fullness (0-3 points, with higher scores indicating more apparent deformity). The patients aesthetic outcomes were assessed by surgeons using the visual analogue scale (VAS) (0-10 points, with higher scores indicating more apparent deformity), and patient self-assessed using the rhinoplasty outcome evaluation (ROE) questionnaire (0-100 points, with higher scores indicating higher satisfaction). The measurement data of normal distribution was expressed as Mean±SD and analyzed by paired t-test; the measurement data of non-normal distribution was expressed as M( Q1, Q3) and analyzed by Wilcoxon signed rank test. Results:In a cohort study of 53 rhinoplasty patients (7 male, 46 female; age range 19-45 years, mean 29 years), comprising 15 primary and 38 secondary surgeries, nasal tip deformities were evaluated. Deformities were classified as mild (5 cases), moderate (25 cases), and severe (23 cases). Over a follow-up period of 6-17 months (mean 9.5 months), significant aesthetic improvements in the nasal tip region were observed. The SFRS scores decreased from 2(2, 3) preoperatively to 0(0, 0) postoperatively ( Z = -6.58, P < 0.001), and VAS scores decreased from 7.47±1.73 to 1.79±1.67 ( t = -25.61, P < 0.001). High patient satisfaction was indicated by a mean ROE score of 82.45±11.55. No significant complications, such as nasal tip ptosis, skin necrosis, or scar hyperplasia, were reported. Conclusion:Selecting an appropriate surgical method based on the severity and cause of pollybeak deformity can achieve satisfactory outcomes. Post-operative patients exhibit significant aesthetic improvement in the upper nasal tip area, resulting in high patient satisfaction.
4.Modified superomedial pedicle technique for reduction mammaplasty with inverted T-shaped incision
Kai YANG ; Xiancheng WANG ; Yang SUN ; Xiang XIONG ; Xianxi MENG ; Wenbo LI ; Zhongjie YI ; Hongli ZHAO ; Zhihua QIAO
Chinese Journal of Plastic Surgery 2024;40(5):491-498
Objective:To explore the clinical efficacy of modified superomedial pedicle technique using an inverted T-shaped incision for reduction mammaplasty and mastopexy.Methods:A retrospective analysis was conducted on clinical data of patients who underwent modified superomedial pedicle technique for breast reduction surgery with inverted T-shaped incision between March 2021 and March 2023 at the Department of Plastic and Aesthetic (Burn) Surgery, Second Xiangya Hospital of Central South University. Preoperatively, a handheld Doppler ultrasound blood flow detector was used to detect and mark the exit points of the 2nd to 4th perforating vessels of the internal thoracic artery, and a superomedial pedicle containing at least two perforators was designed based on the perforator locations, with a pedicle width generally about 6 cm. Intraoperatively, the pedicle was rotated superolaterally, moving the nipple-areola complex (NAC) upwards to construct a fuller upper pole of the breast and removing excess skin in the lower fold to form a inverted T-shaped incision. Postoperatively, the blood supply of the NAC, breast morphology, and incidence of complications were observed and followed up. Canfield Mirror 7.1.1 software was utilized to measure pre- and post-operative breast morphology data from lateral photographs at 6 months, including total breast area, maximum breast protrusion, upper pole protrusion, lower pole height, and nipple elevation height. The BREAST-Q questionnaire was used to survey patient satisfaction with breast appearance, psychosocial well-being, sexual well-being, and physical health before surgery and 6-12 months after surgery, with each dimension scoring 0-100 points, where higher scores indicate greater satisfaction and health. SPSS 28.0 software was used for data analysis, with normally distributed measurement data expressed as Mean±SD, and paired t-test was applied for comparisons of pre- and post-operative breast morphology data (the first 4 indicators) and BREAST-Q scores, with P<0.05 considered statistically significant. Results:A total of 56 female patients were included, with an age of (32.0±6.7) years and a body mass index of (29.1±5.7) kg/m 2. Preoperative Doppler ultrasound blood flow detection showed that none of the patients had missing or significantly variant perforators of the superomedial pedicle. The volume of breast tissue removed ranged from 890 to 1 800 ml, averaging 1 250 ml, with an average pedicle width of 5.4 cm (4.0-7.0 cm). The follow-up period was (13.3±2.5) months, during which all patients exhibited good blood supply to the NAC and favorable breast morphology, with universal high satisfaction with surgical outcomes. Postoperatively, one case developed incisional seroma, which resolved naturally within 3 months; two cases experienced minor incision dehiscence, which healed well after dressing changes; all other patients recovered well without any complications such as flap necrosis or hematoma. Comparison of breast morphology data showed significant reductions in postoperative left and right total breast area ( P<0.05 for both), and increases in maximum breast protrusion and lower pole height postoperatively ( P<0.05 for both), while the difference in upper pole protrusion was not statistically significant ( P>0.05 for both); postoperative left and right nipple elevation heights were (6.30±1.84) cm and (6.52±1.66) cm, respectively. Among the 44 patients who completed the BREAST-Q survey both before and after surgery, scores showed significant improvements in postoperative breast satisfaction [(50.30±10.30) points vs. (83.20±6.02) points] ( t=5.17, P=0.008) and psychosocial well-being [(56.20±17.20) points vs. (89.70±2.70) points] ( t=5.09, P=0.010), while sexual well-being and physical health scores did not differ significantly from preoperative scores ( P>0.05 for both). Conclusion:Preoperative identification of perforator locations using a handheld Doppler blood vessel detector, followed by the design of a modified superomedial pedicle technique for reduction mammaplasty with inverted T-shaped incision, can not only ensure NAC blood supply, avoiding ischemic necrosis due to vascular anomalies, but also maximally reduce pedicle width and increase pedicle rotation flexibility, achieving desirable breast shaping effects.
5.Severe subcutaneous hematoma after injection of botulinum toxin into the masseter muscle: a case report and literature review
Kemin YI ; Xiancheng WANG ; Yang SUN ; Xiang XIONG ; Xianxi MENG ; Wenbo LI ; Zhongjie YI ; Zhihua QIAO ; Xiaoting LI ; Naixin XIONG
Chinese Journal of Plastic Surgery 2024;40(6):668-673
The patient was a 29-year-old male with a history of hemophilia for more than 10 years. After 6 hours of botulinum toxin injection into the masseter muscle, the redness and swelling of the right face gradually worsened, accompanied by local pain, and restricted mouth opening, etc. The hematoma was absorbed and the swelling subsided significantly after the infusion of coagulation factor Ⅸ. Such cases of large-scale hematomas after botulinum toxin injection in hemophiliacs is rarely reported. This article summarized the diagnosis and treatment process of this case and combines with literature review to provide clinical experience for diagnosis, treatment and prevention of similar complications.
6.A novel bionic stent for external septal retention in East Asian rhinoplasty
Xiancheng WANG ; Shuyuan WANG ; Xingyu XIANG ; Dandan SONG ; Zidi YU ; Yang SUN ; Xiang XIONG ; Xianxi MENG ; Wenbo LI ; Zhongjie YI ; Zhihua QIAO
Chinese Journal of Plastic Surgery 2024;40(7):779-786
Objective:To investigate the application effects of a novel framework: the external septal retention bionic framework in East Asian rhinoplasty.Methods:A retrospective analysis was performed based on the clinical data of the patients who received treatments in Department of Plastic and Aesthetic ( Burn) Surgery, the Second Xiangya Hospital, Central South University from January 2022 to July 2023 using an external septal retention bionic framework with autologous costal cartilage rhinoplasty. The patients were all treated with a V-shaped incision at the nasal columella, which continued to both sides of the nose to form a bird-shaped incision. During the operation, the sixth or seventh costal cartilage was sculpted to form the nasal columella support grafts (sturt), external nasal septal graft, cap grafts, and shield grafts, in which the nasal column support graft and external nasal septal graft were implanted in a mortise-and-tenon joint structure to form a septum bionic retained external stent in order to lengthen the nasal columellar column and strengthen the septum. A capsular graft was used to shape the tip of the nose and the rectus abdominis fascia was covered to soften the tip of the nose, and the shield grafts were used to fill out the subnasal lobules. A bulb was sculpted, shaped and implanted in the dorsal space to elevate the nasal dorsum. To observe the postoperative results and complications, a postoperative satisfaction survey was completed using the rhinoplasty outcome evaluation (ROE) and the visual analogue scale (VAS) with regular follow-up. Comparison of preoperative and postoperative scale scores was performed using paired samples t-test. Nasal stent stability was assessed by measuring the patients’ preoperative and postoperative nasolabial angle and nasal tip protrusion. The comparison of preoperative and postoperative nasolabial angle was performed using the paired-sample t-test, and the comparison of nasal tip protrusion was performed using the Wilcoxon signed rank-sum test, P<0.05 considered a statistically significant difference. Results:A total of 33 patients were enrolled, including 4 males and 29 females, with average age of 23.8 years(15-42 years). The follow-up period is (14.52 ± 4.72) months (3 to 21 months). Thirty-three patients recovered well after surgery, and no short-term complications such as infection or bleeding occurred. The patients' nasal aesthetic problems such as saddle nose, deviated nasal columella, bilateral asymmetry of the nose, bilateral nasal base depression, and rounded shield of the nasal tip were improved after surgery. Satisfaction survey results: ROE and VAS scores were significantly higher than those before surgery, which were [(17.92±2.56) vs.(12.78±3.14)] and [(8.08±1.66)vs(5.15±1.99)], ( P<0.05), 87.9% (27/33)of the patients were satisfied with the aesthetic and functional outcomes of the nose. Comparisons of nasolabial angle [(87.28±2.58)° vs. (97.64±1.95)°] and tip protrusion [1.88 (1.78, 1.95) cm vs. 2.16(2.01, 2.32) cm] measurements between preoperative and postoperative period of the 33 patients, the differences were statistically significant ( P<0.05). Conclusion:Rhinoplasty for East Asians employs an external septal retention bionic framework to retain the nasal septum. This technique can avoid septal cartilage resorption caused by compression of grafts transplanted in the future, and cause less damage to the anatomy and physiology of the nose. The framework is relatively easy to construct, with a stable and strong stent, and good patient satisfaction. It can achieve a more desirable aesthetic effect of the nose.
7.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.
8.Preparation and immunogenicity evaluation of two PreF trimer recombinant protein vaccines against respiratory syncytial virus
Heng ZHANG ; Hongjian XIAO ; Haiwei LI ; Yaoyun YANG ; Jinmei DUAN ; Zhihua LI
Chinese Journal of Microbiology and Immunology 2024;44(2):101-109
Objective:To construct and purify four respiratory syncytial virus (RSV) PreF proteins through gene sequence design and optimization and evaluate their immunogenicity.Methods:Coronin-1A and T4 trimer protein gene sequences were optimized with Human and CHO codons, and then added to RSV F protein sequence. The above plasmids were transfected into Expi293F cells for protein expression. After purification by nickel column, four trimer proteins were prepared. SDS-PAGE and Western blot were performed for protein identification. BALB/c mice were immunized at week 0 and week 3, and blood samples were collected to measure the activities of binding and neutralizing antibodies in serum.Results:SDS-PAGE and Western blot showed that the four proteins had stable trimer structure. Antigen-antibody affinity test showed that the four trimer proteins had strong affinity with RSV-specific monoclonal antibodies 8897, D25, Motavizumab, AM14 and Palivizumab. The titers of antibodies induced by the two T4 trimers were higher after the initial immunization, while there was a substantial increase in the titers of antibodies induced by Human codon-optimized trimer protein after the second immunization.Conclusions:PreF trimer protein can be prepared by adding any of the two different heterotrimer motifs, and induce effective binding and neutralizing antibodies in mice.
9.Immunogenicity of PreF and PostF recombinant protein vaccines against respiratory syncytial virus
Jiamin CHEN ; Hongjian XIAO ; Yaoyun YANG ; Heng ZHANG ; Zhihua LI ; Qianqian LI
Chinese Journal of Microbiology and Immunology 2024;44(2):110-119
Objective:To compare the immunogenicity of the prefusion (PreF) and postfusion (PostF) conformations of the respiratory syncytial virus (RSV) F protein.Methods:The expression of PreF and PostF recombinant proteins was analyzed by SDS-PAGE and Western blot. The binding affinity between F protein and its specific antibodies was detected by Octet. The binding antibodies and neutralizing antibodies in immune serum were detected after immunizing mice with PreF or PostF recombinant protein.Results:PreF protein was stable in the form of a trimer after modification with higher binding affinity with monoclonal antibodies such as D25, 8897, AM14, Palivizumab and Motavizumab. PostF protein lacked the antigenic site ? and showed a monomer conformation. Besides, it was unable to bind to D25, 8897 and AM14 antibodies. Animal experiments showed that AS01 adjuvant was better than aluminum adjuvant in inducing binding antibodies and neutralizing antibodies against RSV Long strains. The binding antibodies induced by PreF and PostF recombinant proteins had similar binding ability to PreF protein, while the binding antibodies induced by PostF recombinant protein showed stronger binding ability to PostF than to PreF.Conclusions:PreF has more epitopes and the trimer form of PreF recombinant protein after modification is more stable and can induce stronger neutralizing antibodies. Moreover, the immunopotentiating effect of AS01 adjuvant is better than that of aluminum adjuvant. Therefore, stabilization-based trimer structure modification of PreF and the development of adjuvants are crucial for the development of RSV vaccines.
10.The effects of attenuated Salmonella carrying IL-2/NK4 double gene on immune function in mice
Chinese Journal of Biologicals 2024;37(5):571-576
Objective To study the effects of attenuated Salmonella(Ty21a-pIRES-IL-2-NK4,TPIN)carrying interleukin-2(IL-2)/4-kringle antagonist of hepatocyte growth factor(NK4)double gene on humoral and cellular immune function.Methods Eighteen BALB/c mice,half male and half female,were randomly divided into control group(1. 5 mL 10%NaHCO3 by gastric tube feeding),Ty21a group(0. 1 mL Ty21a by gastric tube feeding)and TPIN group(0. 1 mL TPIN by gastric tube feeding),with 6 mice in each group. The immunization was boosted twice 7 d after the initial immunization. At 21d after administration,the blood samples were collected from eyeballs and the serum was separated,which was detected for the serum IgG antibody level by ELISA. The thymus and spleen of mice were isolated aseptically,and the spleen cells were stimulated by Ty21a and TPIN respectively in vitro. After 72 h,the proliferation ability of spleen cells was measured by CCK-8 assay,and the expression level of cytokines in spleen cells was detected by ELISA. The spleen and thymus were weighed,the spleen and thymus indexes were analyzed,and HE staining was performed.Results Compared with the control group and Ty21a group,the serum IgG level(F = 111. 74,P < 0. 01)and the contents of IFNγ,IL-4 and IL-10 in spleen cell supernatant(F = 38. 21,11. 37 and 26. 92,respectively,each P < 0. 05)increased significantly,as well as the spleen and thymus indexes(F = 10. 419 and 5. 859,respectively,each P < 0. 05)showed significant increase. In mice of Ty21a and TPIN group,the thymus cortex widened,lymphocytes increased,and there was mild inflammatory reaction;the white pulp and lymphocytes in spleen increased with neutrophil infiltration.Conclusion TPIN has a good immune protective effect,and can significantly stimulate the body to produce humoral immunity and cellular immunity,which may have a good therapeutic effect on tumors.


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