1.Compilation Instruction for Expert Consensus on Clinical Application of Binghuang Fule Ointment
Xin CUI ; Yanping BAI ; Ping SONG ; Yuanyuan LI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):267-273
Compilation instruction for Expert Consensus on Clinical Application of Binghuang Fule Ointment elaborates on the formulation methods and evidence-based basis of the consensus. To address the problems of insufficient evidence on efficacy, vague indications, and a lack of uniform standard for Binghuang Fule Ointment in clinical application, 34 experts from 29 medical institutions across China participated in the compilation under the lead of the Institute of Basic Research in Clinical Medicine and Xiyuan Hospital, China Academy of Chinese Medical Sciences, as well as China-Japan Friendship Hospital. The compilation strictly adhered to the WHO Handbook for Guideline Development (GB/T 1.1—2020), and the Guidance of Instructions for Compiling Expert Consensus on Clinical Practice of Chinese Patent Medicine. Through multidisciplinary collaboration, the compilation was completed using the Grading of Recommendations Assessment, Development and Evaluations (GRADE) evidence grading system. The detailed workflow included various key links. In clinical question construction, 15 items were screened by the nominal group method. In evidence retrieval, Chinese and English databases, along with gray literature, were covered to obtain 116 clinical and 33 pharmaceutical studies. In safety assessment, drug monitoring data and clinical research results were integrated, clarifying local adverse skin reactions and contraindications. Ultimately, 8 recommendations were formed by the GRADE grid method, while 16 consensus suggestions were reached via the majority vote rule. The results showed that the Binghuang Fule Ointment was applicable to eczema, psoriasis, neurodermatitis, tinea pedis, and other diseases. The Consensus also elucidated the syndrome differentiation points, usage and dosage for different diseases (such as adjustment of course and application frequency), as well as the indications of combination medication. Additionally, safety assessment suggested that the Ointment should be used with caution in individuals with skin ulceration or hypersensitivity. To ensure methodological rigor, the compilation process went through three rounds of internal and external expert reviews, while a comprehensive analysis was conducted by literature analysis, the Delphi method, and other methods. This compilation instruction provided methodological support for the clinical transformation of the Consensus through key links, including project initiation, international registration, informed consent, conflict-of-interest statements, evidence evaluation, and popularization. The Consensus will be continuously improved through a dynamic revision mechanism in the future.
2.Compilation Instruction for Expert Consensus on Clinical Application of Binghuang Fule Ointment
Xin CUI ; Yanping BAI ; Ping SONG ; Yuanyuan LI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):267-273
Compilation instruction for Expert Consensus on Clinical Application of Binghuang Fule Ointment elaborates on the formulation methods and evidence-based basis of the consensus. To address the problems of insufficient evidence on efficacy, vague indications, and a lack of uniform standard for Binghuang Fule Ointment in clinical application, 34 experts from 29 medical institutions across China participated in the compilation under the lead of the Institute of Basic Research in Clinical Medicine and Xiyuan Hospital, China Academy of Chinese Medical Sciences, as well as China-Japan Friendship Hospital. The compilation strictly adhered to the WHO Handbook for Guideline Development (GB/T 1.1—2020), and the Guidance of Instructions for Compiling Expert Consensus on Clinical Practice of Chinese Patent Medicine. Through multidisciplinary collaboration, the compilation was completed using the Grading of Recommendations Assessment, Development and Evaluations (GRADE) evidence grading system. The detailed workflow included various key links. In clinical question construction, 15 items were screened by the nominal group method. In evidence retrieval, Chinese and English databases, along with gray literature, were covered to obtain 116 clinical and 33 pharmaceutical studies. In safety assessment, drug monitoring data and clinical research results were integrated, clarifying local adverse skin reactions and contraindications. Ultimately, 8 recommendations were formed by the GRADE grid method, while 16 consensus suggestions were reached via the majority vote rule. The results showed that the Binghuang Fule Ointment was applicable to eczema, psoriasis, neurodermatitis, tinea pedis, and other diseases. The Consensus also elucidated the syndrome differentiation points, usage and dosage for different diseases (such as adjustment of course and application frequency), as well as the indications of combination medication. Additionally, safety assessment suggested that the Ointment should be used with caution in individuals with skin ulceration or hypersensitivity. To ensure methodological rigor, the compilation process went through three rounds of internal and external expert reviews, while a comprehensive analysis was conducted by literature analysis, the Delphi method, and other methods. This compilation instruction provided methodological support for the clinical transformation of the Consensus through key links, including project initiation, international registration, informed consent, conflict-of-interest statements, evidence evaluation, and popularization. The Consensus will be continuously improved through a dynamic revision mechanism in the future.
3.Expert Consensus on Clinical Application of SkinPro Ointment
Xin CUI ; Ping SONG ; Yuanyuan LI ; Yanping BAI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):163-170
SkinPro Ointment is an emulsion-based preparation derived from a traditional Tibetan medical empirical formula and developed using modern pharmaceutical technology. It is an exclusive patented product of Tibet Hairong Tangguo Pharmaceutical Co. Ltd. and has been listed as a National Protected Traditional Chinese Medicine Variety, the Pharmacopoeia of the People's Republic of China, and classified as a Category B product in the National Basic Medical Insurance Catalog. The ointment possesses the functions of clearing heat and drying dampness, activating blood circulation and dispelling wind, relieving itching and reducing inflammation. Clinically, it is used for skin pruritus caused by dampness-heat accumulation or blood-heat with wind-dryness, as well as pruritic skin diseases such as neurodermatitis, eczema, tinea pedis, and psoriasis. To clarify the standards for its clinical application and promote rational drug use, a consensus working group comprising 34 national experts in dermatology, evidence-based medicine, and pharmacy was established. Through expert interviews, the nominal group technique, and questionnaire surveys, 15 clinical issues were identified. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence grading system was employed to assess the quality of evidence, leading to the formulation of the Expert Consensus on the Clinical Application of SkinPro Ointment. This consensus specifies that the intended users are physicians and pharmacists in medical institutions at all levels. It standardizes the clinical application of the ointment, including syndrome characteristics, dosage and course of treatment, combination therapy, precautions, and contraindications. Recommendations and consensus suggestions were formed addressing the 15 clinical issues, covering the following key areas: ①Indications and TCM syndromes: In TCM, the ointment mainly treats conditions such as "damp sores" (Shichuang), "white scaling" (Baibi), "collar sores" (Shelingchuang), and "damp foot Qi" (Jiaoshiqi), corresponding to eczema, psoriasis, neurodermatitis, and tinea pedis in Western medicine. The relevant TCM syndromes are identified as dampness-heat accumulation or blood-heat with wind-dryness. ②Usage and dosage: For external use, apply to the affected area 3 times daily. The dosage should follow the fingertip unit (FTU) principle. A treatment course of 1-2 weeks is recommended for mild to moderate cases; for serious cases, the course should be followed as prescribed by a physician. ③Combined therapy: The ointment can be used as monotherapy for mild cases. For moderate to severe cases, combination therapy is recommended, with reference to relevant clinical guidelines. ④Safety: Common adverse reactions include skin rashes, pruritus, and erythema. The ointment is contraindicated in patients with broken skin or obvious exudation at the affected area, as well as in patients with known hypersensitivity to any of its components. Contact with sensitive areas such as the eyes and oral mucosa should be avoided. Modern research shows that the ointment also has potential efficacy in other dermatological conditions, such as adult atopic dermatitis, tinea cruris, exfoliative keratolysis, acne vulgaris, and Malassezia folliculitis. This consensus provides a scientific basis for promoting the rational clinical use of SkinPro Ointment, improving its therapeutic efficacy, and reducing medication risks. Future updates will be dynamically revised according to emerging clinical issues and new evidence.
4.Efficacy of MitraClip in functional versus degenerative mitral regurgitation: A systematic review and meta-analysis
Xuhua LI ; Qiyuan BAI ; Zhili WEI ; Shidong LIU ; Hao CHEN ; Yang CHEN ; Bing SONG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(05):807-814
Objective To systematically evaluate the differences in outcomes between functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR) in patients treated with transcatheter edge-to-edge repair (TEER) using the MitraClip device. Methods A systematic literature search was conducted in PubMed, Embase, the Cochrane Library, Web of Science, the CNKI, Wanfang Database, VIP Database, and the CBM from their inception to January 2024. Two researchers independently performed study selection, data extraction, and risk of bias assessment. The quality of cohort studies was evaluated using the Newcastle-Ottawa Scale (NOS). A meta-analysis was performed using Stata 18.0 software. Results A total of 13 cohort studies involving 6 402 patients were included, comprising 4 161 patients in the FMR group and 2 241 in the DMR group. All included studies had NOS scores of ≥6 points. The meta-analysis revealed that compared to the DMR group, the FMR group had a higher 1-year all-cause mortality rate [OR=1.53, 95%CI (1.30, 1.81), P<0.01] and a higher 1-year rehospitalization rate for heart failure [OR=1.90, 95%CI (1.60, 2.26), P<0.01]. Conversely, the FMR group had a lower post-procedural mean transmitral gradient [SMD=–0.47, 95%CI (–0.65, –0.30), P<0.01] and a lower rate of subsequent mitral valve surgery [OR=0.41, 95%CI (0.20, 0.83), P=0.01]. Conclusion Following MitraClip therapy, patients with FMR exhibit favorable short-term outcomes, but their mid- to long-term outcomes are inferior to those of patients with DMR. When determining the treatment strategy with MitraClip, the specific etiology of mitral regurgitation should be considered for a more accurate prediction of therapeutic efficacy and prognosis.
5.Correlation between depressive symptom and traditional Chinese medicine constitution among school aged children and adolescents
Chinese Journal of School Health 2025;46(9):1222-1225
Objective:
To explore the correlation between traditional Chinese medicine (TCM) constitution and depressive symptom among school aged children and adolescents, so as to provide evidences for informing constitution based regulation and prevention of depressive symptom.
Methods:
From June to December 2024, a total of 4 729 students aged 6-14 were recruited by cluster random sampling from 10 primary schools in Baoding (Hebei Province), Heze and Liaocheng (Shandong Province). General information, TCM constitution and depressive symptom were collected. Restricted cubic spline (RCS) models were used to analyze related factors and threshold effects of depressive symptom. Binary Logistic regression was applied to examine the association between depressive symptom and TCM constitution, with subgroup analyses conducted.
Results:
The detection rate of depressive symptom among the included children and adolescents was 25.82%. RCS analyses indicated non linear associations between depressive symptom and age (inflection point at 10 years old), bedtime (inflection point at 22:00), and wake up time (inflection point at 6:30 ) (all P non linearity <0.01). Linear associations were observed with body mass index (BMI) and sleep duration (all P non linearity > 0.05 ). After adjusting for covariates such as age, BMI and sleep status, binary Logistic regression analyses showed that Yin deficient constitution ( OR =1.26, 95% CI =1.09-1.45) and Phlegm-dampness constitution ( OR =1.42, 95% CI =1.11-1.82) were significantly associated with depressive symptom among children and adolescents (all P <0.05).
Conclusions
Depressive symptom among school aged children and adolescents is primarily associated with Yin deficiency and Phlegm dampness constitutions in TCM constitution. Active attention should be paid to susceptible TCM constitution among children and adolescents. Targeted health guidance and interventions should be implemented to improve TCM constitution health status for preventing the occurrence of depressive symptom.
6.Ultrasound-guided needle knife release with different pathways for carpal tunnel syndrome: a randomized controlled trial.
Zhaobao LI ; Song HE ; Longyu XIE ; Hehuizi BAI ; Dejun CHENG ; Wenchao ZHANG ; Mingyong HUANG
Chinese Acupuncture & Moxibustion 2025;45(1):21-26
OBJECTIVE:
To evaluate the clinical efficacy of ultrasound-guided needle knife release with different pathways for carpal tunnel syndrome (CTS).
METHODS:
Sixty CTS patients were randomly divided into a transverse group and a longitudinal group, with 30 patients in each group. The transverse group received the needle knife release under ultrasound above and below the median nerve along the short axis, while the longitudinal group received the needle knife release under ultrasound above the median nerve along the long axis. The patients' visual analogue scale (VAS) scores, Levine scores, and median nerve cross-section area (CSA) were assessed before treatment, on the 7th, 14th, and 30th days after treatment. The median nerve conduction indexes (motor conduction: latency [Lat], amplitude[Amp], motor conduction velocity [MCV]; sensory conduction: Lat, Amp, sensory conduction velocity [SCV]) were evaluated before treatment and on the 30th day after treatment.
RESULTS:
Compared before treatment, the VAS scores, Levine scores, and median nerve CSA were reduced in both groups on the 7th, 14th, and 30th days after treatment (P<0.05); the transverse group showed lower VAS and Levine scores and smaller CSA than those in the longitudinal group (P<0.05). On the 30th day after treatment, motor and sensory Lat was reduced (P<0.05), motor and sensory Amp was increased (P<0.05), and MCV and SCV were faster (P<0.05) in both groups. The transverse group had shorter Lat, higher Amp, and faster MCV and SCV than those in the longitudinal group (P<0.05).
CONCLUSION
The ultrasound-guided needle knife release with transverse and longitudinal pathways could both effectively alleviate pain and improve median nerve conduction in CTS patients, with the transverse pathway showing superior efficacy to longitudinal pathway.
Humans
;
Carpal Tunnel Syndrome/therapy*
;
Female
;
Middle Aged
;
Male
;
Adult
;
Median Nerve/physiopathology*
;
Acupuncture Therapy/instrumentation*
;
Treatment Outcome
;
Neural Conduction
;
Aged
;
Ultrasonography
7.Analysis of the Application Effect of Curved Incision Surgery in the Treatment of Hammock Finger Tendon
Huan LUO ; Hao PENG ; Wei-hao ZHENG ; Peng-yu XU ; Song-bai WANG ; Zi-yi GUO
Progress in Modern Biomedicine 2025;25(9):1542-1548
Objective:To investigate the application effect of curved incision surgery in the treatment of hammock finger tendon.Methods:45 patients with hammock finger tendon who were admitted to Pingle Orthopedics and Traumatology Hospital in Shenzhen were selected from May 2022 to May 2023,all of whom were treated with curved incision surgery.Wound healing,functional recovery and complication rate were observed after surgery.Results:In this study,45 patients with hammock finger tendon were successfully followed up for 3 to 18 months,with an average follow-up of 1 year.The results of follow-up showed that all the incisions healed in one stage,and there were no complications such as skin infection and necrosis,exposed knots and skin irritation.X-ray reexamination before and after the operation showed,no complications such as loosening of the Kirkner needle,redisplacement of bone mass and nonunion of bone.During the follow-up period,there was no significant recurrence of vertical deformity.Crawford grading showed that,35 cases were excellent,9 were good,and 1 was fair.Conclusion:Using curved incision surgery to treat hammock finger tendon,which has the advantages of less trauma,faster recovery and fewer complications,and the effect is good.
8.Effects of high-fat diet intake on pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects
Cai-hui GUO ; Yu-fang XU ; Cong-yang DING ; Guang-tao HAO ; Hao-jing SONG ; Xue SUN ; Zhan-jun DONG ; Wan-jun BAI
The Chinese Journal of Clinical Pharmacology 2025;41(2):225-229
Objective To evaluate the effects of fasting and high-fat diet on the pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects.Methods A single-center,randomized,open,two-agent,two-sequence,four-cycle,fully repeated crossover,single-dose trial design was used in this study,healthy subjects were assigned to receive single dose of rabeprazole sodium enteric-coated tablets 0.1 g in either fasting or high-fat diet state,and blood samples were taken at different time points,respectively.The concentrations of rabeprazole sodium enteric-coated in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS),the model method of the non-compartmental was used to calculate the pharmacokinetic parameters by Phoenix WinNonlin 8.2.Results The main pharmacokinetic parameters of rabeprazole sodium enteric-coated tablets in fasting state and high-fat diet state were as follows:Cmax were(339.63±156.47)and(318.86±132.13)ng·mL-1;t1/2 were(2.34±0.68)and(3.60±2.40)h;AUC0_t were(556.62±251.65)and(528.50±201.78)ng·mL-1·h;AUC0-∞ were(563.39±255.69)and(535.15±203.24)ng·mL-1·h;tmax were 3.65 and 6.99 h.After high-fat diet,the Cmax and AUC of rapeprazole sodium after high-fat and high-calorie diet decreased,Cmax decreased by 6.12%,AUC0-t decreased by 5.05%,AUC0-∞ decreased by 5.01%,andtmaxwas delayed by about 3.34 h.Cmax,AUC0-t and AUC0-∞ 90%confidence interval were 73.13%-115.10%,83.22%-112.28%and 83.40%-112.13%,respectively.Neither was between 85.00%-125.00%.Conclusion High-fat diet affects the absorption rate and degree of rabeprazole sodium enteric-coated,so it is suitable to be administered on an empty stomach.
9.Effects of myocardial extracellular matrix remodeling on connexin 43 and its Ser368 phosphorylation and electrical conduction
Yuting SONG ; Chunlei WEN ; Yi LI ; Xue BAI ; Hong GAO ; Tingju HU ; Zijun WANG ; Xu YAN
Chinese Journal of Tissue Engineering Research 2025;29(29):6212-6218
BACKGROUND:Our previous studies found that decreased expression of connexin 43 and its Ser368 phosphorylation after myocardial hypothermic ischemia-reperfusion was closely associated with decreased cardiac conduction velocity and reperfusion arrhythmia.OBJECTIVE:To observe the effect of changes in membrane-type matrix metalloproteinase 2,matrix metalloproteinase 2 and collagen type Ⅳ on the expression of connexin 43 and its Ser368 phosphorylation and electrical conduction in the myocardial extracellular matrix after hypothermic ischemia-reperfusion.METHODS:Sixteen Langendorff extracorporeal cardiac perfusion models were successfully established from SD rats and randomly divided into a control group(n=8)and a hypothermic ischemia-reperfusion group(n=8).The control group was balanced perfused with 37 ℃ Krebs-Henseleit solution for 15 minutes and then continued to be perfused with 37 ℃ Krebs-Henseleit solution for 90 minutes.The hypothermic ischemia-reperfusion group was balanced perfused with 37 ℃ Krebs-Henseleit solution for 15 minutes,and then the heart was arrested for 60 minutes by injection of 4 ℃ Thomas solution.During the cardiac arrest,the periphery was protected by 4 ℃ Krebs-Henseleit solution.Half-volume 4 ℃ Thomas solution was reperfused 30 minutes after the arrest.After stopping the arrest,the heart was reperfused with 37 ℃ Krebs-Henseleit solution for 30 minutes.The occurrence of arrhythmias,rebeating time,and the duration of arrhythmias were recorded from the immediate time point to the end of the reperfusion period.Conduction velocity,absolute inhomogeneity,and inhomogeneity index were measured using the Mapping Lab multi-channel electrophysiological mapping system at the time of balanced perfusion for 15 minutes(T1),reperfusion for 15 minutes/continuous perfusion for 90 minutes(T2),and reperfusion for 30 minutes/continuous perfusion for 105 minutes(T3).The relative expression levels of membrane-type matrix metalloproteinase 2,matrix metalloproteinase 2,collagen type Ⅳ,connexin 43,and its Ser368 phosphorylation in ventricular tissue were detected by western blot assay.RESULTS AND CONCLUSION:(1)No arrhythmia occurred in the control group.There were six cases of arrhythmia in the hypothermic ischemia-reperfusion group during reperfusion.Rebeating time and duration of arrhythmias were(25.38+12.02)and(158.67±67.68)seconds,respectively.(2)The conduction sochronal diagrams at T1,T2,and T3 in the control group were uniform and regular in direction,and the conduction velocity at T2 and T3 was not different from that at T1(P>0.05).The conduction isochronal diagrams at T2 and T3 in the hypothermic ischemia-reperfusion group were uneven and irregular in direction,and the conduction velocity was slower than that at T1(P<0.01).The conduction velocity at T2 and T3 in the hypothermic ischemia-reperfusion group was slower than that in the control group(P<0.01).Conduction dispersion was greater in the hypothermic ischemia-reperfusion group than that in the control group at T2 and T3(P<0.05).(3)Compared with the control group,the protein expressions of membrane-type matrix metalloproteinase 2 and matrix metalloproteinase 2 in the hypothermic ischemia-reperfusion group were increased(P<0.05 or P<0.01),and the protein expression levels of type Ⅳ collagen,connexin 43 and its Ser368 phosphorylation were decreased(P<0.05 or P<0.01).(4)The results indicate that after hypothermic ischemia-reperfusion,myocardial extracellular matrix remodeling may mediate the downregulation of myocardial connexin 43 and its Ser368 phosphorylation,slowed conduction velocity and increased conduction dispersion,thereby increasing the risk of arrhythmia.
10.Analysis of Characteristics in Chinese-Registered Clinical Trials for Weight-Loss Medications
Bo QIU ; Runxuan DU ; Haotian YANG ; Haojing SONG ; Xue SUN ; Congyang DING ; Wanjun BAI ; Zhanjun DONG
Herald of Medicine 2025;44(9):1516-1520
Objective To investigate the status and developmental trends of clinical trials for weight control drugs in China,and to provide data support for sponsors,researchers,and regulatory authorities.Methods The drug clinical trial registration and information platform of the National Medical Products Administration was utilized to search for registered clinical trials of weight control drugs from November 2012 to June 2024.The search employed"overweight","obesity",and"weight loss"as keywords.The information collected included project registration time,drug name,dosage form,drug classification,indications,trial staging,study progress,design type,lead unit,and sponsor.Microsoft Office Excel software was employed for data entry,organization,and extraction.Results A total of 95 registered clinical trials of weight control drugs were identified,comprising 40 domestic multicenter trials,47 domestic single-center trials,and 8 international multicenter trials.Regarding trial phasing,46(48.4%)were phase Ⅰ clinical trials,17(17.9%)were phase Ⅱ clinical trials,19(20.0%)were phase Ⅲ clinical trials,and 13(13.7%)were bioequivalence trials.The drug categorization encompassed 22 chemical drugs,20 biological products,and 1 traditional Chinese medicine/natural drug.Concerning drug dosage forms,there were 32 items of injectable dosage forms,8 items of tablets,2 items of capsules,and 1 item of chewable tablets.Conclusions Registered clinical trials for weight-loss medications in China are predominantly concentrated in regions with developed medical resources.Injectable biologics constitute most test drugs,with most drugs in the early stages of research and development.The examination of the safety and efficacy of these drugs remains to be substantiated,and it is anticipated that a considerable period will elapse before their approval and market introduction.


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