1.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
2.Three new chalcone C-glycosides from Carthami Flos.
Jia-Xu BAO ; Yong-Xiang WANG ; Xian ZHANG ; Ya-Zhu YANG ; Yue LIN ; Jiao-Jiao YIN ; Yun-Fang ZHAO ; Hui-Xia HUO ; Peng-Fei TU ; Jun LI
China Journal of Chinese Materia Medica 2025;50(13):3715-3745
The chemical components of Carthami Flos were investigated by using macroporous resin, silica gel column chromatography, reversed-phase octadecylsilane(ODS) column chromatography, Sephadex LH-20, and semi-preparative high-performance liquid chromatography(HPLC). The planar structures of the compounds were established based on their physicochemical properties and ultraviolet-visible(UV-Vis), infrared(IR), high-resolution electrospray ionization mass spectrometry(HR-ESI-MS), and nuclear magnetic resonance(NMR) spectroscopic technology. The absolute configurations were determined by comparing the calculated and experimental electronic circular dichroism(ECD). Six flavonoid C-glycosides were isolated from the 30% ethanol elution fraction of macroporous resin obtained from the 95% ethanol extract of Carthami Flos, and identified as saffloquinoside F(1), 5-hydroxysaffloneoside(2), iso-5-hydroxysaffloneoside(3), isosafflomin C(4), safflomin C(5), and vicenin 2(6). Among these, the compounds 1 to 3 were new chalcone C-glycosides. The compounds 1, 2, 4, and 5 could significantly increase the viability of H9c2 cardiomyocytes damaged by oxygen-glucose deprivation/reoxygenation(OGD/R) at a concentration of 50 μmol·L~(-1), showing their good cardioprotective activity.
Glycosides/pharmacology*
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Flowers/chemistry*
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Drugs, Chinese Herbal/pharmacology*
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Carthamus tinctorius/chemistry*
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Chalcones/pharmacology*
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Animals
3.Clinical study on the effectiveness of bone acupuncture for alleviating pain and improving function in patients with degenerative lumbar spinal stenosis.
Chang-Xiao HAN ; Min-Shan FENG ; Jing-Hua GAO ; Xun-Lu YIN ; Guang-Wei LIU ; Hai-Bao WEN ; Jing LI ; Bo-Chen PENG ; Li-Guo ZHU
China Journal of Orthopaedics and Traumatology 2025;38(2):152-156
OBJECTIVE:
To assess the effectiveness of bone acupuncture in improving pain and function in degenerative lumbar spinal stenosis (DLSS) and compare it with Jiaji acupuncture.
METHODS:
From January to December 2023, 80 DLSS patients were treated with acupuncture and divided into bone acupuncture and Jiaji acupuncture groups. Among them, 40 patients in the bone acupuncture group included 15 males and 25 females, with a mean age of (60.60±6.98) years old;anthor 40 patients in the Jiaji acupuncture group included 16 males and 24 females, with a mean age of (61.48±9.55) years old. The Roland Morris disability questionnaire(RMDQ), walking distance, visual analogue scale(VAS), and the MOS item short from health survey(SF-36) of two groups at baseline, 2 weeks, 4 weeks, and 12 weeks post-treatment were compared.
RESULTS:
Eighty patients were followed up for 3 to 5 months with an average of (3.62±0.59) months. There was no significant differences in general data and the scores before treatment between two groups(P>0.05). The RMDQ scores in both groups decreased significantly at 2, 4 and 12 weeks after treatment compared with before treatment(P<0.05), at each time point after treatment, the decrease was more significant in the bone acupuncture group than in the Jiaji acupuncture group(P<0.05). The VAS of waist and leg in both groups was significantly lower at 2, 4 and 12 weeks after treatment that before treatment(P<0.05). At all time points after treatment, the waist VAS in the bone acupuncture group was reduced more significant than in the Jiaji acupuncture group(P<0.05);there was no significant difference in leg VAS at 2 and 12 weeks after treatment between two groups(P>0.05), the improvement was more significant in the bone acupuncture group in the 4 weeks after treatment than in the Jiaji acupuncture group. The SF-36 scores in both groups were significantly higher at 2, 4, and 12 weeks after treatment than before treatment(P<0.05);the SF-36 score raised more significant in the bone acupuncture group than in the Jiaji acupunture group(P<0.05). No significant difference in the walking distance between two groups at 2 weeks after treatment(P>0.05);the walking distance in the bone acupuncture group was significantly higher than that in the Jiaji acupuncture group at 4 and 12 weeks after treatment(P<0.05).
CONCLUSION
Bone-penetrating acupuncture moderately improves functional impairment, pain, and quality of life in patients with DLSS, showing better efficacy than Jiaji acupuncture.
Humans
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Female
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Male
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Middle Aged
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Acupuncture Therapy/methods*
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Spinal Stenosis/physiopathology*
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Aged
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Lumbar Vertebrae/physiopathology*
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Pain Management
4.Causal relationship between five autoimmune diseases and intervertebral disc degeneration:a bidirectional Mendelian analysis.
Bao-Fei ZHANG ; Xun-Lu YIN ; Ze-Ling HUANG ; Shuai PEI ; Yu-Wei LI
China Journal of Orthopaedics and Traumatology 2025;38(8):856-866
OBJECTIVE:
To explore the potential causal relationship between intervertebral disc degeneration and certain autoimmune diseases.
METHODS:
Genome-wide association study (GWAS) data of 5 autoimmune diseases were obtained from large-scale GWAS databases. Data on internal vertebral disc degeneration (IVDD) were derived from the FinnGen consortium, which included 294, 770 controls and 41, 669 cases. A two-sample bidirectional Mendelian randomization (MR) analysis was performed to investigate the potential causal relationship between the 5 autoimmune diseases and IVDD. Multiple analytical methods were adopted, including MR methods such as inverse variance weighting(IVW), MR-Egger, weighted median, weighted mode, and simple mode. Cochran's Q test, leave-one-out analysis, and MR-Egger intercept test were conducted to assess heterogeneity, robustness, and pleiotropy. For the robustness of the results, MR-PRESSO was used to detect outliers, and MR analysis was re-conducted after removing the outliers.
RESULTS:
The MR analysis results showed that there might be a bidirectional causal relationship between ankylosing spondylitis(AS) and IVDD:AS on IVDD, OR=1.038, 95%CI (1.024, 1.053), P=0.000;and IVDD on AS, OR=2.117, 95%CI(1.065, 4.207), P=0.032. There might be a positive correlation between IVDD and rheumatoid arthritis(RA) as well as systemic lupus erythematosus(SLE):IVDD on RA, OR=1.184, 95%CI(1.071, 1.309), P=0.001;and IVDD on SLE, OR=1.678, 95%CI(1.187, 2.372), P=0.003. There was no significant correlation between ulcerative colitis(UC), autoimmune thyroiditis(ATD) and IVDD. After removing outliers by MR-PRESSO and re-conducting MR analysis, the results did not change qualitatively. Sensitivity analysis indicated that the results were robust to potential sources of bias.
CONCLUSION
AS and IVDD may be risk factors for each other, and IVDD may be a potential risk factor for RA and SLE. These findings provide a basis for guiding the prevention and combined diagnosis and treatment of IVDD, AS, RA, and SLE, while the specific underlying mechanisms still require further experimental basic research.
Humans
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Intervertebral Disc Degeneration/etiology*
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Mendelian Randomization Analysis
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Autoimmune Diseases/complications*
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Genome-Wide Association Study
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Spondylitis, Ankylosing/genetics*
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Arthritis, Rheumatoid/genetics*
5.Genetic screening and follow-up results in 3 001 newborns in the Yunnan region.
Ao-Yu LI ; Bao-Sheng ZHU ; Jin-Man ZHANG ; Ying CHAN ; Jun-Yue LIN ; Jie ZHANG ; Xiao-Yan ZHOU ; Hong CHEN ; Su-Yun LI ; Na FENG ; Yin-Hong ZHANG
Chinese Journal of Contemporary Pediatrics 2025;27(6):654-660
OBJECTIVES:
To evaluate the application value of genetic newborn screening (gNBS) in the Yunnan region.
METHODS:
A prospective study was conducted with a random selection of 3 001 newborns born in the Yunnan region from February to December 2021. Traditional newborn screening (tNBS) was used to test biochemical indicators, and targeted next-generation sequencing was employed to screen 159 genes related to 156 diseases. Positive-screened newborns underwent validation and confirmation tests, and confirmed cases received standardized treatment and long-term follow-up.
RESULTS:
Among the 3 001 newborns, 166 (5.53%) were initially positive for genetic screening, and 1 435 (47.82%) were genetic carriers. The top ten genes with the highest variation frequency were GJB2 (21.29%), DUOX2 (7.27%), HBA (6.14%), GALC (3.63%), SLC12A3 (3.33%), HBB (3.03%), G6PD (2.94%), SLC25A13 (2.90%), PAH (2.73%), and UNC13D (2.68%). Among the initially positive newborns from tNBS and gNBS, 33 (1.10%) and 47 (1.57%) cases were confirmed, respectively. A total of 48 (1.60%) cases were confirmed using gNBS+tNBS. The receiver operating characteristic curve analysis demonstrated that the areas under the curve for tNBS, gNBS, and gNBS+tNBS in diagnosing diseases were 0.866, 0.982, and 0.968, respectively (P<0.05). DeLong's test showed that the area under the curve for gNBS and gNBS+tNBS was higher than that for tNBS (P<0.05).
CONCLUSIONS
gNBS can expand the range of disease detection, and its combined use with tNBS can significantly shorten diagnosis time, enabling early intervention and treatment.
Humans
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Infant, Newborn
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Neonatal Screening
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Genetic Testing
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Female
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Male
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Follow-Up Studies
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Prospective Studies
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China
6.Exploring the causal relationship between leukocyte telomere length and prostatitis, orchitis, and epididymitis based on a two-sample Mendelian randomization.
Dan-Yang LI ; Shun YU ; Bo-Hui YANG ; Jun-Bao ZHANG ; Guo-Chen YIN ; Lin-Na WU ; Qin-Zuo DONG ; Jin-Long XU ; Shu-Ping NING ; Rong ZHAO
National Journal of Andrology 2025;31(4):306-312
OBJECTIVE:
To investigate the genetic causal relationship of leukocyte telomere length (LTL) with prostatitis, orchitis and epididymitis by two-sample Mendelian randomization (MR).
METHODS:
Using LTL as the exposure factor and prostatitis, orchitis and epididymitis as outcome factors, we mined the Database of Genome-Wide Association Studies (GWAS). Then, we analyzed the causal relationship of LTL with prostatitis, orchitis and epididymitis by Mendelian randomization using inverse variance weighting (IVW) as the main method and weighted median and MR-Egger regression as auxiliary methods, determined the horizontal multiplicity by MR-Egger intercept test, and conducted sensitivity analysis using the leaving-one-out method.
RESULTS:
A total of 121 related single nucleotide polymorphisms (SNPs) were identified in this study. IVW showed LTL to be a risk factor for prostatitis (OR = 1.383, 95% CI: 1.044-1.832, P = 0.024), and for orchitis and epididymitis as well (OR = 1.770, 95% CI: 1.275-2.456, P = 0.000 6).
CONCLUSION
Genetic evidence from Mendelian randomized analysis indicates that shortening of LTL reduces the risk of prostatitis, orchitis and epididymitis.
Humans
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Male
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Mendelian Randomization Analysis
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Epididymitis/genetics*
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Prostatitis/genetics*
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Polymorphism, Single Nucleotide
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Leukocytes
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Orchitis/genetics*
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Genome-Wide Association Study
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Telomere
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Risk Factors
7.Efficacy and Safety of Erzhu Jiedu Decoction Granules in Treating Mid-advanced Hepatitis B Virus-Associated Primary Liver Cancer Patients with Pi (Spleen)-Deficiency and Dampness-Heat Syndrome.
Yang CHENG ; Hao-Yi WANG ; Cheng-Yi WAN ; Jie-Wen SHI ; Yuan-Yuan JIN ; Sheng-Li HE ; Bao-Bing YIN ; Jian-Jie CHEN
Chinese journal of integrative medicine 2025;31(5):394-401
OBJECTIVE:
To assess the efficacy and safety of Erzhu Jiedu Decoction (EZJDD) Granules in treating mid-advanced hepatitis B virus-associated primary liver cancer (HBV-PLC) patients with Pi (Spleen)-deficiency and dampness-heat syndrome.
METHODS:
From January 2021 to June 2023, a cohort of 132 patients were enrolled and randomly assigned to a control group or a EZJDD group according to the random numbers, with 66 patients in each group. The patients in the control group received conventional treatment for 3 months, followed by a 3-month follow-up. In addition to the conventional treatment, patients in the EZJDD group were administered EZJDD Granules (10.9 g/pack, 2 packs twice per day) orally for same duration. Progression-free survival (PFS) as primary outcome was evaluated by Kaplan Meier method. Karnofsky performance status (KPS) scores were used to assess the quality of life in two groups before and after treatment, and survival rates were determined as well. The efficacy of Chinese medicine syndrome was calculated with Nimodipine method. Liver function, tumor indicators and T lymphocyte subsets were measured, respectively. Safety indicators were recorded and assessed.
RESULTS:
Of the 116 patients who completed the study, 57 were in the control group and 59 in the EZJDD group. The median PFS was 3.53 months (106 days) in the EZJDD group compared to 2.33 months (70 days) in the control group (P=0.005). Six-month survival rate was 52.63% (30/57) in the control group and 69.49% (41/59) in the EZJDD group (P=0.039). The median KPS score in the EZJDD group [70(63, 90)] was higher than that in the control group [70(60, 80)] (P=0.013). The total effective rate of CM syndrome was 52.63% (30/57) in the control group and 77.97% (46/59) in the EZJDD group (P=0.005). The levels of alpha fetoprotein, alpha fetoprotein-L3, alpha-L-fucosidase and protein induced by Vitamin K absence or antagonist- II in the EZJDD group increased less than the control group (P>0.05). CD8+ levels were decreased, while CD3+ and CD4+ levels, as well as CD4+/CD8+ ratio were significantly increased in the EZZJD group (P<0.05). No treatment-related adverse reactions were observed during the study.
CONCLUSION
EZJDD Granules significantly prolonged the median PFS and improved 6-month survival rate in patients with mid-advanced HBV-PLC (Registration No. ChiCTR2200056922).
Humans
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Drugs, Chinese Herbal/adverse effects*
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Male
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Female
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Middle Aged
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Liver Neoplasms/complications*
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Hepatitis B virus/physiology*
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Hepatitis B/complications*
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Treatment Outcome
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Adult
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Spleen/drug effects*
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Quality of Life
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Medicine, Chinese Traditional
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Aged
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Syndrome
8.Influence of Outdoor Light at Night on Early Reproductive Outcomes of In Vitro Fertilization and Its Threshold Effect: Evidence from a Couple-Based Preconception Cohort Study.
Wen Bin FANG ; Ying TANG ; Ya Ning SUN ; Yan Lan TANG ; Yin Yin CHEN ; Ya Wen CAO ; Ji Qi FANG ; Kun Jing HE ; Yu Shan LI ; Ya Ning DAI ; Shuang Shuang BAO ; Peng ZHU ; Shan Shan SHAO ; Fang Biao TAO ; Gui Xia PAN
Biomedical and Environmental Sciences 2025;38(8):1009-1015
9.Optimized pain control with standard analgesia plus duloxetine hydrochloride for patients undergoing lumbar fusion surgery and its effect on prognostic quality of life
Shuo CHEN ; Li XUE ; Bao YIN ; Ling CHEN
Journal of Clinical Surgery 2024;32(10):1105-1108
Objective To discuss the optimized pain control with standard analgesia plus duloxetine hydrochloride for patients undergoing lumbar fusion surgery,and to analyze its effect on prognostic quality of life.Methods A prospective study was conducted on 106 patients who underwent lumbar fusion surgery in our hospital from May 2019 to December 2020.Patients were randomly assigned into two groups according to analgesic methods.Control group(n=52)was given standard analgesia,while observation group(n=54)received standard analgesia plus duloxetine hydrochloride.Then the degree of postoperative pain,the use of analgesics(the time of the first additional analgesic drugs,effective pressing times within 48 hours after operation),the improvement of psychological emotions,quality of life,and the occurrence of adverse reactions were compared between two groups.Results Observation group scored(4.19±0.78),(2.84±0.61)and(1.73±0.42)on visual analogue scale(VAS)at postoperative 1 d,3 d and 7 d,which were lower than(5.24±0.80),(3.51±0.57)and(2.49±0.56)in control group(P<0.05).Compared with control group,observation group had delayed time of the first additional analgesic drugs[(12.33±2.34)h vs(7.61±0.85)h]and less effective pressing times within 48 hours after operation[(3.78±0.92)vs(10.44±3.27)]than those of control group(P<0.05).Observation group scored lower on Self-rating Anxiety Scale(SAS)at postoperative 7 d[(52.44±6.71)vs(57.39±6.43)]and 14 d[(37.85±6.49)vs(42.66±5.25)],lower on Self-rating Depression Scale(SDS)at postoperative 7 d[(51.16±5.43)vs(55.37±5.25)]and 14 d[(35.64±5.36)vs(40.18±5.22)],and higher on 36-item Short-Form Health Survey(SF-36)at postoperative 4w[(83.44±6.72)vs(78.63±5.11)]than those of control group,with statistical difference(all P<0.05).The adverse reaction rate was 7.41%in observation group,which was lower than 21.15%in control group(P<0.05).Conclusion The optimized pain control with standard analgesia plus duloxetine hydrochloride for patients undergoing lumbar fusion surgery can effectively can effectively improve the analgesic effect,reduce the use of opioids,alleviate negative emotions and improve quality of life with less adverse reactions,which is worth promoting.
10.Interpretation of key points from the "Expert Consensus on Diagnosis and Management of Neonatal Cow Milk Protein Allergy (2023)"
Xin-Yin ZHANG ; Li-Ting LIU ; Lei BAO ; Yuan SHI
Chinese Journal of Contemporary Pediatrics 2024;26(11):1127-1134
The clinical manifestations of cow's milk protein allergy (CMPA) in neonates are non-specific and involve multiple organ systems. CMPA may also adversely affect physical growth and central nervous system development in neonates,lead to functional disorders,and increase anxiety and stress among family members. Due to the lack of specific clinical manifestations and diagnostic methods,the diagnosis and management of CMPA in neonates continue to pose significant clinical challenges. To facilitate standardized diagnosis and treatment of CMPA in neonates,the Neonatology Group of the Pediatric Branch of the Chinese Medical Association and the Editorial Committee of the Chinese Journal of Pediatrics have jointly developed the "Expert Consensus on Diagnosis and Management of Neonatal Cow's Milk Protein Allergy (2023)". This article presents and interprets the key points of the consensus regarding dietary and nutritional management of CMPA in neonates.

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