1.Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis
Jian LIU ; Hongchun ZHANG ; Chengxiang WANG ; Hongsheng CUI ; Xia CUI ; Shunan ZHANG ; Daowen YANG ; Cuiling FENG ; Yubo GUO ; Zengtao SUN ; Huiyong ZHANG ; Guangxi LI ; Qing MIAO ; Sumei WANG ; Liqing SHI ; Hongjun YANG ; Ting LIU ; Fangbo ZHANG ; Sheng CHEN ; Wei CHEN ; Hai WANG ; Lin LIN ; Nini QU ; Lei WU ; Dengshan WU ; Yafeng LIU ; Wenyan ZHANG ; Yueying ZHANG ; Yongfen FAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):182-188
The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis (GS/CACM 337-2023) was released by the China Association of Chinese Medicine on December 13th, 2023. This expert consensus was developed by experts in methodology, pharmacy, and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine (CACM) and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine (pulmonary diseases) and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung, acute bronchitis, and acute attack of chronic bronchitis from the aspects of applicable populations, efficacy evaluation, usage, dosage, drug combination, and safety. It is expected to guide the rational drug use in medical and health institutions, give full play to the unique value of Qinbaohong Zhike oral liquid, and vigorously promote the inheritance and innovation of Chinese patent medicines.
2.A Randomized Controlled,Double-Blind Study on Huaban Jiedu Formulation (化斑解毒方) in the Treatment of Psoriasis Vulgaris with Blood-Heat Syndrome
Xuewen REN ; Yutong DENG ; Huishang FENG ; Bo HU ; Jianqing WANG ; Zhan CHEN ; Xiaodong LIU ; Xinhui YU ; Yuanwen LI
Journal of Traditional Chinese Medicine 2025;66(16):1679-1686
ObjectiveTo evaluate the clinical efficacy and safety of Huaban Jiedu Formulation (化斑解毒方, HJF) in treating psoriasis vulgaris with blood-heat syndrome. MethodsA randomized, double-blind, placebo-controlled study was conducted with 60 patients diagnosed with psoriasis vulgaris of blood-heat syndrome. Patients were randomly assigned to either a treatment group or a control group, with 30 cases in each. The treatment group received HJF granules orally, one dose a day, combined with topical Qingshi Zhiyang Ointment (青石止痒软膏), while the control group received placebo granules, one dose a day, combined with the same topical ointment. Both groups were topically treated twice daily of 28 days treatment cours. Psoriasis area and severity index (PASI), visual analogue scale for pruritus (VAS), traditional Chinese medicine (TCM) syndrome scores, dermatology life quality index (DLQI), and psoriasis life stress inventory (PLSI) were assessed before treatment and on day 14 and day 28. Response rates for PASI 50 (≥50% reduction) and PASI 75 (≥75% reduction), as well as overall clinical efficacy, were compared between groups. Serum levels of interleukin-6 (IL-6) and interleukin-17 (IL-17) were measured before and after 28 days of treatment. Adverse reactions during treatment were recorded. ResultsAfter 28 days of treatment, both groups showed significant reductions in PASI total score, lesion area score, erythema, scaling, and infiltration scores, pruritus VAS score, TCM syndrome score, DLQI, PLSI, and serum IL-6 and IL-17 levels (P<0.05). Compared to the control group, the treatment group had significantly greater improvements in PASI total score and erythema score, TCM syndrome score, serum IL-6 and IL-17 levels, and PASI 50 response rate after 28 days (P<0.05). Between-group comparisons of score differences before and after 28-day treatment revealed that the treatment group showed significantly better improvements in PASI total, lesion area score, erythema score, TCM syndrome score, DLQI, PLSI, and inflammatory markers (P<0.05 or P<0.01). The total effective rate on day 14 and day 28 was 40.00% (12/30) and 83.33% (25/30) in the treatment group, versus 6.90% (2/29) and 41.38% (12/29) in the control group, respectively. The clinical efficacy in the treatment group was significantly superior to that in the control group (P<0.05). Mild gastric discomfort occurred in 3 patients in the treatment group and 1 in the control group. ConclusionHJF can effectively improve skin lesions and TCM symptoms relieve pruritus, enhance quality of life, and reduce inflammatory markers IL-6 and IL-17, in patients with blood-heat syndrome of psoriasis vulgaris, with a good safety profile.
3.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
4.Spicy food consumption and risk of vascular disease: Evidence from a large-scale Chinese prospective cohort of 0.5 million people.
Dongfang YOU ; Dianjianyi SUN ; Ziyu ZHAO ; Mingyu SONG ; Lulu PAN ; Yaqian WU ; Yingdan TANG ; Mengyi LU ; Fang SHAO ; Sipeng SHEN ; Jianling BAI ; Honggang YI ; Ruyang ZHANG ; Yongyue WEI ; Hongxia MA ; Hongyang XU ; Canqing YU ; Jun LV ; Pei PEI ; Ling YANG ; Yiping CHEN ; Zhengming CHEN ; Hongbing SHEN ; Feng CHEN ; Yang ZHAO ; Liming LI
Chinese Medical Journal 2025;138(14):1696-1704
BACKGROUND:
Spicy food consumption has been reported to be inversely associated with mortality from multiple diseases. However, the effect of spicy food intake on the incidence of vascular diseases in the Chinese population remains unclear. This study was conducted to explore this association.
METHODS:
This study was performed using the large-scale China Kadoorie Biobank (CKB) prospective cohort of 486,335 participants. The primary outcomes were vascular disease, ischemic heart disease (IHD), major coronary events (MCEs), cerebrovascular disease, stroke, and non-stroke cerebrovascular disease. A Cox proportional hazards regression model was used to assess the association between spicy food consumption and incident vascular diseases. Subgroup analysis was also performed to evaluate the heterogeneity of the association between spicy food consumption and the risk of vascular disease stratified by several basic characteristics. In addition, the joint effects of spicy food consumption and the healthy lifestyle score on the risk of vascular disease were also evaluated, and sensitivity analyses were performed to assess the reliability of the association results.
RESULTS:
During a median follow-up time of 12.1 years, a total of 136,125 patients with vascular disease, 46,689 patients with IHD, 10,097 patients with MCEs, 80,114 patients with cerebrovascular disease, 56,726 patients with stroke, and 40,098 patients with non-stroke cerebrovascular disease were identified. Participants who consumed spicy food 1-2 days/week (hazard ratio [HR] = 0.95, 95% confidence interval [95% CI] = [0.93, 0.97], P <0.001), 3-5 days/week (HR = 0.96, 95% CI = [0.94, 0.99], P = 0.003), and 6-7 days/week (HR = 0.97, 95% CI = [0.95, 0.99], P = 0.002) had a significantly lower risk of vascular disease than those who consumed spicy food less than once a week ( Ptrend <0.001), especially in those who were younger and living in rural areas. Notably, the disease-based subgroup analysis indicated that the inverse associations remained in IHD ( Ptrend = 0.011) and MCEs ( Ptrend = 0.002) risk. Intriguingly, there was an interaction effect between spicy food consumption and the healthy lifestyle score on the risk of IHD ( Pinteraction = 0.037).
CONCLUSIONS
Our findings support an inverse association between spicy food consumption and vascular disease in the Chinese population, which may provide additional dietary guidance for the prevention of vascular diseases.
Humans
;
Male
;
Female
;
Prospective Studies
;
Middle Aged
;
Aged
;
Vascular Diseases/etiology*
;
Risk Factors
;
China/epidemiology*
;
Adult
;
Proportional Hazards Models
;
Cerebrovascular Disorders/epidemiology*
;
East Asian People
5.Efficacy and Safety of Zanubrutinib in the Treatment of Autoimmune Cytopenia Secondary to Indolent B-Cell Lymphoma.
Xiao-Pei WANG ; Wei-Wei ZHANG ; Wei SUN ; Jia-Feng CHENG
Journal of Experimental Hematology 2025;33(4):1023-1028
OBJECTIVE:
To investigate the efficacy and safety of zanubrutinib in the treatment of autoimmune cytopenia (AIC) secondary to indolent B-cell lymphoma (iBCL).
METHODS:
A total of 23 patients with iBCL complicated with AIC who were admitted to our hospital from December 2019 to September 2023 were selected as the research subjects. All patients were administered zanubrutinib 160 mg, twice daily, and continued oral administration. The objective response rate (ORR) of AIC, the therapeutic effect on lymphoma, and the incidence of adverse reactions were observed.
RESULTS:
After a median follow-up of 20 (5 to 48) months, the median duration of response was 9 (interquartile range [IQR] 5-24)months. AICA efficacy assessment showed that there were 10 cases of complete remission (CR), 9 cases of partial remission (PR), and 4 cases of no response (NR), and the ORR was 82.6% (19/23) (95%CI : 61.2-95.0). Among them, for the 14 patients with autoimmune hemolytic anemia (AIHA), 7 achieved CR, 5 had PR, and 2 had NR. For the 4 patients with immune thrombocytopenia (ITP), 1 reached CR, 2 had PR, and 1 had NR. Regarding the 5 patients with Evans syndrome (ES), 2 achieved CR, 2 had PR, and 1 had NR. The assessment of lymphoma efficacy showed that there were 10 cases of CR , 7 cases of PR , 6 cases of stable disease (SD), and no progressive cases, with an ORR of 73.9% (17/23) (95%CI : 51.6-89.8). The main adverse reactions during the treatment were infection, hemorrhage, neutropenia, elevated lymphocyte count, rash, and anemia. Most of these adverse reactions were grade 1-2 and tolerable. No arrhythmia and hypertension occurred, and no deaths due to adverse reactions.
CONCLUSION
Zanubrutinib is effective and safe for AIC secondary to iBCL.
Humans
;
Pyrazoles/therapeutic use*
;
Lymphoma, B-Cell/complications*
;
Pyrimidines/therapeutic use*
;
Piperidines/therapeutic use*
;
Female
;
Male
;
Anemia, Hemolytic, Autoimmune/etiology*
;
Thrombocytopenia/etiology*
;
Middle Aged
;
Purpura, Thrombocytopenic, Idiopathic/etiology*
;
Treatment Outcome
;
Adult
;
Aged
;
Cytopenia
6.The emulation of clinical trials with real-world data: development and application of target trial
Jiawei ZHOU ; Lihong HUANG ; Dongfang YOU ; Feng CHEN ; Yang ZHAO
Chinese Journal of Epidemiology 2024;45(2):279-285
Clinical trial is the gold standard for evaluating the efficacy and safety of interventions; however, it is limited by high costs and long time. Real-world data (RWD) can provide a robust data basis for comparative research, but the quality is uneven. This review introduces the target trial emulation, in which researchers, using RWD and following the design of clinical trials, define exposure and outcome in advance, set eligibility criteria, determine the time zero, estimate sample size, and plan statistical analysis, to enhance the quality of evidence for observational studies. This review preliminarily discusses the standard of evidence quality evaluation in target trial emulation. Then, the target trial emulation is shown through case interpretation.
7.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine:Aural Vertigo
Yingdi GONG ; Zhanfeng YAN ; Wei FENG ; Daxin LIU ; Jiaxi WANG ; Jianhua LIU ; Yu ZHANG ; Shusheng GONG ; Guopeng WANG ; Chunying XU ; Xin MA ; Bo LI ; Shuzhen GUO ; Mingxia ZHANG ; Jinfeng LIU ; Jihua GUO ; Zhengkui CAO ; Xiaoxiao ZHANG ; Zhonghai XIN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(8):215-222
Aural vertigo frequently encountered in the otolaryngology department of traditional Chinese medicine (TCM) mainly involves peripheral vestibular diseases of Western medicine, such as Meniere's disease, benign paroxysmal positional vertigo, vestibular neuritis, and vestibular migraine, being a hot research topic in both TCM and Western medicine. Western medical therapies alone have unsatisfactory effects on recurrent aural vertigo, aural vertigo affecting the quality of life, aural vertigo not relieved after surgery, aural vertigo with complex causes, and children's aural vertigo. The literature records and clinical practice have proven that TCM demonstrates unique advantages in the treatment of aural vertigo. The China Association of Chinese medicine sponsored the "17th youth salon on the diseases responding specifically to TCM: Aural vertigo" and invited vertigo experts of TCM and Western medicine to discuss the difficulties and advantages of TCM diagnosis and treatment of aural vertigo. The experts deeply discussed the achievements and contributions of TCM and Western medicine in the diagnosis and treatment of aural vertigo, the control and mitigation of the symptoms, and the solutions to disease recurrence. The discussion clarified the positioning and advantages of TCM treatment and provided guidance for clinical and basic research on aural vertigo.
8.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Threatened Abortion
Xinchun YANG ; Shuyu WANG ; Huilan DU ; Songping LUO ; Zhe JIN ; Rong LI ; Xiangyan RUAN ; Qin ZHANG ; Xiaoling FENG ; Shicai CHEN ; Fengjie HE ; Shaobin WEI ; Qun LU ; Yanqin WANG ; Yang LIU ; Qingwei MENG ; Zengping HAO ; Ying LI ; Mei MO ; Xiaoxiao ZHANG ; Ruihua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):241-246
Threatened abortion is a common disease of obstetrics and gynecology and one of the diseases responding specifically to traditional Chinese medicine (TCM). The China Association of Chinese Medicine organized experts in TCM obstetrics and gynecology, Western medicine obstetrics and gynecology, and pharmacology to deeply discuss the advantages of TCM and integrated Chinese and Western medicine treatment as well as the medication plans for threatened abortion. After discussion, the experts concluded that chromosome, endocrine, and immune abnormalities were the key factors for the occurrence of threatened abortion, and the Qi and blood disorders in thoroughfare and conception vessels were the core pathogenesis. In the treatment of threatened abortion, TCM has advantages in preventing miscarriages, alleviating clinical symptoms and TCM syndromes, relieving anxiety, regulating reproductive endocrine and immune abnormalities, personalized and diversified treatment, enhancing efficiency and reducing toxicity, and preventing the disease before occurrence. The difficulty in diagnosis and treatment of threatened abortion with traditional Chinese and Western medicine lies in identifying the predictors of abortion caused by maternal factors and the treatment of thrombophilia. Recurrent abortion is the breakthrough point of treatment with integrated traditional Chinese and Western medicine. It is urgent to carry out high-quality evidence-based medicine research in the future to improve the modern diagnosis and treatment of threatened abortion with TCM.
9.Mechanism of Bushen Yijing Method in Treatment of Oligoasthenozoospermia Based on Intestinal Microbiota
Nianwen HUANG ; Haisong LI ; Huanzhou BI ; Bin WANG ; Juanlong FENG ; Longji SUN ; Jisheng WANG ; Chengli WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):170-175
Oligoasthenozoospermia is the main cause of male infertility, with complex and diverse causes. Currently, there are still some unclear causes of oligoasthenozoospermia in clinical practice, known as idiopathic oligoasthenozoospermia. With the development of high-throughput sequencing technology, it has been found that intestinal microbiota disorder may be an important promoting factor for the onset of oligoasthenozoospermia. Traditional Chinese medicine believes that "deficiency of kidney essence" is the core pathogenesis of oligoasthenozoospermia. In clinical practice, the method of tonifying the kidney and strengthening the essence has a significant therapeutic effect on oligoasthenozoospermia, but its mechanism of action has not been fully elucidated. Based on the basic theories of traditional Chinese medicine and molecular biology research, it has been found that there is a similarity between "kidney essence" and intestinal microbiota. During the onset of oligoasthenozoospermia, the disorder of intestinal microbiota has similarities with the pathogenesis of "deficiency of kidney essence" in traditional Chinese medicine. Moreover, traditional Chinese medicine for tonifying the kidney and strengthening the essence can regulate the disorder of intestinal microbiota, which may be one of the effective mechanisms for the treatment of oligoasthenozoospermia with the Bushen Yijing method. Based on this, this article explored the mechanism of Bushen Yijing method of traditional Chinese medicine in treating oligoasthenozoospermia from the perspective of intestinal microbiota, so as to provide new ideas for the treatment of oligoasthenozoospermia with traditional Chinese medicine.
10.Discussion on the Treatment of Heart Failure from the Theory of "Sweat Pore-Collaterals-Zang and Fu Organs" Based on Mitochondrial Function
Yuxuan LI ; Wujiao WANG ; Peng LI ; Yuanyuan ZHANG ; Xingxing LI ; Junyan XIA ; Ruli FENG ; Dong LI ; Qian LIN ; Yan LI
Journal of Traditional Chinese Medicine 2024;65(13):1346-1352
Mitochondria are the main site of energy metabolism in cardiomyocytes, and at the same time mediate apoptosis and immune response, so mitochondrial dysfunction is closely related to the development of heart failure. Combined with the pathogenesis of mitochondrial dysfunction and heart failure, it is proposed that the mitochondrial function is similar to "sweat pore - collaterals - zang and fu organs", according to which the treatment of heart failure is based on the theory of "sweat pore - collaterals - zang and fu organs". It is believed that the core mechanism of heart failure is qi deficiency, and qi deficiency leads to the weakness of the sweat pore opening and closing, or even the sweat pore closure, then resulting in qi deficiency and blood stasis, collaterals stagnation fail to flourish, and qi, blood, and body fluids can not infiltrate and nourish zang-fu organs, so that the heart fail to be nourished, and the disease will develop. The treatment should be based on the method of boosting qi and opening sweat pore, using acridity to unblock the collaterals, and invigorating blood and draining water, with medicinal of boosting qi, invigorating blood, and draining water as treatment.


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