1.Cost-effectiveness of second-line treatment of advanced gastrointestinal stromal tumors with ripretinib versus sunitinib
Yong CHEN ; Longzhuan HUANG ; Hangye GU ; Yaqing CHEN ; Jisheng CHEN
China Pharmacy 2025;36(6):710-714
OBJECTIVE To evaluate the cost-effectiveness of ripretinib versus sunitinib as a second-line treatment option for patients with advanced gastrointestinal stromal tumors (GIST). METHODS Based on the data of INTRIGUE study, a dynamic Markov model was constructed, with a cycle of 6 weeks; this model was used to simulate patients’ direct medical costs and quality- adjusted life years (QALYs) over 15 years. Using the incremental cost-effectiveness ratio (ICER) as the evaluation metric, a comparison was made between the ICER and the willingness-to-pay (WTP) threshold (3 times the per capita gross domestic product, which amounts to 268 200 yuan/QALY). One-way sensitivity analyses and probabilistic sensitivity analyses were performed on the model outputs to examine the stability of the model. RESULTS The health benefits of ripretinib were lower than those of sunitinib (1.21 QALYs vs. 1.31 QALYs). Still, the costs were higher (323 401.88 yuan vs. 227 532.40 yuan), making it an inferior regimen. The results of the one-way sensitivity analysis suggested that the cost of ripretinib and sunitinib, and the health utility value in progression-free survival status had a greater impact on the ICER of the model. Probabilistic sensitivity analysis suggested that the results of the study were stable, and the probability of the cost-effectiveness advantage of ripretinib was always much lower than that of sunitinib with the increase of WTP threshold, and showed a decreasing trend. CONCLUSIONS In the current economic context of China, ripretinib does not have a cost-effectiveness advantage over sunitinib as a second-line treatment for advanced GIST.
2.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.
3.LI Haisong's Experience in Treating Spermatorrhea based on the View of "Spirit Controlling Essence and Qi"
Runze WANG ; Kecheng LI ; Jisheng WANG ; Liang HAN ; Yexin CHEN ; Sheng HUANG ; Bin WANG
Journal of Traditional Chinese Medicine 2024;65(11):1109-1114
This paper summarized Professor LI Haisong's clinical experience in treating spermatorrhea based on the view of "spirit controlling essence and qi". It is emphasized that the heart spirit has the function of controlling the essence and qi of the human body, believing the frenetic stirring of heart spirit and the insecurity of essence gate are the core pathogenesis of spermatorrhea, LI advocates to regulate the heart spirit first and take into account of the zang-fu organs, essence and qi simultaneously for the treatment. Treatment should be performed according the clinical syndromes differentiatied. For those with heart spirit failing to nourish syndrome, it is recommended to supplement heart qi, nourish spirit and consolidate essence with self-made Yangxin Mijing Formula (养心秘精方). In case of heart fire hyperactivity, the method of clearing heart heat and draining fire, calming spirit and consolidating essence should be used, and self-made Xiexin Gujing Formula (泻心固精方) is recommended. For heart-liver qi constraint, it is advised to soothe the liver and calm heart, calm the mind and regulate essence with self-made Jieyu Anshen Tiaojing Formula (解郁安神调精方) which is a modifcation to Chaihu Shugan Powder (柴胡疏肝散). In terms of deficiency of both heart and liver, the treatment principle is supplementing spleen and nourishing heart, calming the mind and controlling essence, for which self-made Xinpi Tongtiao Shejing Formula (心脾同调摄精方) modified from Guipi Decoction (归脾汤) can be used. For deficiency of both heart and kidney, it is better to nourish the kidney and calm heart, calm the mind and consolidate essence with self-made Xinshen Liangzi Tianjing Formula (心肾两滋填精方) that modified from Shuilu Erxian Elixir (水陆二仙丹) and Wuzi Yanzong Pill (五子衍宗丸). Prescriptions are used to treat the root by harmonizing the zang-fu organs, nourish the spirit by regulating qi and blood, and calm the mind by taking special medi-cinals, and they should be flexibly modified according to the disease.
4.Promoting Reform of Talent Evaluation Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Yong ZHU ; Jisheng WANG ; Liangzhen YOU ; Weijun HUANG ; Jie YANG ; Candong LI ; Genping LEI ; Chuan ZHENG ; Shuzhen GUO ; Longtao LIU ; Zhining TIAN ; Xinping QIU ; Wenli SU ; Zuo LI ; Wei YAN ; Hongcai SHANG ; Xiaoxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(17):220-226
Talents are the main force for the development of traditional Chinese medicine(TCM), and the construction of TCM talents and the reformation of talent evaluation system are essential to promote the inheritance and innovation of TCM. At present, we are still exploring and developing in the fields of the formulation, implementation and evaluation indicators of TCM talent evaluation system. However, there are shortcomings and difficulties. For instance, insufficient stratification in the evaluation, excessive emphasis on the quantity of achievements, neglecting the quality of the achievements and the actual contribution, imperfect assessment indicators, and the weak characteristics of TCM. Therefore, national ministries and commissions have jointly issued a document requesting to break the four only and set a new standard, in order to promote the construction of a scientific and technological talent evaluation system oriented by innovation value, ability and contribution. For the evaluation of TCM clinical talents, China Association for Science and Technology commissioned China Association of Chinese Medicine to build the China Clinical Cases Library of TCM(CCCL-TCM), which aims at collecting the most authoritative and representative TCM clinical cases and exploring the advantages of applying clinical cases as masterpiece of achievement in TCM clinical talents evaluation. CCCL-TCM can promote the construction of a talent evaluation system that is more in line with the development characteristics of TCM industry, and to carry out relevant pilot in TCM colleges and institutions across the country in order to promote the reformation of TCM talent evaluation system.
5.Thoughts and diagnostic strategies of traditional Chinese medicine in diagnosing and treating male infertility
Nianwen HUANG ; Bin WANG ; Jisheng WANG ; Yong YANG ; Juanlong FENG ; Longji SUN ; Zixiang GAO ; Zhechao LIN ; Haisong LI
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1490-1494
The pathogenesis of male infertility is intricate and complex,and now,Western medicine is primarily based on empirical drug treatment.Male infertility is one of the advantageous diseases of traditional Chinese medicine,and traditional Chinese medicine has obvious effect in improving male reproductive function,which is one of the important means of clinical treatment of this disease.Based on the classical ancient books and modern research,and based on the traditional tonifying kidney method,we have innovatively put forward the concept of treating male infertility with the principle of"deficiency of kidney essence as the root,tonifying kidney and benefiting essence as the method,and regulating yin and yang mildly as the rule",which has achieved good clinical efficacy.At the same time,combined with the long-term clinical practice of our team,we have proposed five major diagnosis and treatment strategies for male infertility,i.e.,combining disease identification with syndrome identification,combining macroscopic with microscopic approaches,combining holistic with localized treatments,combining traditional Chinese medicine with surgery,and combining treatment of the disease and treatment of the person.In addition,we have summarized some of the current problems in the treatment of male infertility with traditional Chinese medicine and put forward corresponding suggestions,with a view to promoting the development and application of traditional Chinese medicine in the treatment of male infertility.
6.Exploring the differentiation and treatment of varicocele infertility based on the theory of deficiency and stasis
Nianwen HUANG ; Haisong LI ; Bin WANG ; Jisheng WANG ; Haohao WANG ; Yong YANG
Journal of Beijing University of Traditional Chinese Medicine 2024;47(3):297-301
The pathogenesis of varicocele infertility is complex, and currently, there is no specific drug for clinical treatment, traditional Chinese medicine (TCM) has certain advantages in improving clinical symptoms of patients and improving sperm quality. Based on the theory of deficiency and stasis in TCM and modern related research, we believe that static blood blocking collaterals is the initiating factor of this disease, and kidney essence deficiency is the immanent trend of this disease. The pathogenesis and treatment method of this disease are studied on the basis of "soil theory". Guilu Tongqu Decoction is a formula developed by our team based on "soil theory" for the treatment of varicocele infertility. It is a modified version of the classic formula Zuogui Pill , which has the effects of tonifying the kidney, nourishing essence, and promoting blood circulation for removing blood stasis. Its clinical efficacy is good. At the same time, based on our team's extensive clinical practice, we propose three treatment strategies for varicocele infertility, namely, the combination of systemic and local treatment, the combination of radial and symptomatic treatment, and the combination of TCM and surgical procedures. These methods can effectively improve the overall therapeutic effect and provide a reference for the treatment of varicocele infertility with TCM.
7.Clinical Diseases Responding Specifically to Traditional Chinese Medicine:Chronic Prostatitis
Zhan QIN ; Mei MO ; Chaoba HE ; Liguo GENG ; Bin WANG ; Jisheng WANG ; Kecheng LI ; Nianwen HUANG ; Zhiming HONG ; Shaoying YUAN ; Xiaoxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):152-158
Chronic prostatitis is a common and frequently occurring disease in male clinics. Due to the diverse symptoms, complex etiology, unclear mechanisms, and recurrent episodes of chronic prostatitis, Western medicine often faces the challenge of limited treatment options and unsatisfactory outcomes. In order to fully leverage the unique advantages of traditional Chinese medicine (TCM) in the treatment of chronic prostatitis, the China Association of Chinese Medicine organized a discussion among experts from the fields of TCM urology, Western urology, and related pharmacy. The experts focused on the advancements in the understanding of chronic prostatitis in modern medicine, various theories on the etiology, pathogenesis, and treatment of chronic prostatitis in TCM, entry points from interdisciplinary fields, the role and advantages of TCM in the comprehensive management of chronic prostatitis, and research into mechanisms related to chronic prostatitis. After discussions, the experts concluded that chronic prostatitis is one of the diseases where TCM has a distinct advantage. TCM can effectively improve the clinical syndromes of chronic prostatitis, including urinary issues, social psychology, organ specificity, infection, nervous system problems, pain and discomfort, sexual dysfunction, etc., and can enhance the quality of life. For patients with chronic prostatitis who cannot tolerate or may not accept the adverse effects of Western medicine, as well as for those with non-inflammatory chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), those with pain as the primary symptom, those with urinary tract symptoms, those with coexisting anxiety and depression, and those with abnormal semen liquefaction, TCM-based treatment can be the main approach. Currently, the optimal diagnosis and treatment strategy for chronic prostatitis has not yet been established, and further research from perspectives such as clinical epidemiology, evidence-based medicine, and molecular biology is needed. Both TCM and Western medicine should integrate their respective strengths, clarify the role and advantages of TCM interventions based on mutual reference, and improve the diagnosis and treatment standards for chronic prostatitis in China.
8. Application and progress of pharmacodynamics study in bioequivalence evaluation of orally inhaled drug products
Yifei GU ; Jisheng ZHANG ; Xuemei XIANG ; Nannan CHU ; Kai HUANG ; Linling QUE ; Qing HE
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(7):822-833
Orally inhaled drug products (OIDPs) play a great role in the pharmacological treatment of chronic obstructive pulmonary disease (COPD) and asthma. There is an unmet clinical need for OIDPs. Pharmacodynamics-Bioequivalence studies (PD-BE) are recommended by several national guidelines as important research methods for bioequivalence study of OIDPs. It can effectively bridge the gap between in vitro studies and PK-BE studies in evaluating the efficacy and safety consistency of generic drugs with the original drugs. There are two research methods for PD-BE, using a diastolic model or an excitation model. The different methods use different metrics to evaluate efficacy. The more commonly used metrics include Forced Expiratory Volume in the First Second (FEV1), Specific Airway Conductance (sGaw), Peripheral Airway Resistance (R5-20), and stimulant concentration/dose (PC20/PD20). PD-BE studies using FEV1 as an efficacy metric is also recommended by the FDA (Food and Drug Administration), EMA (European Medicines Agency) and NMPA (National Medical Products Administration) guidelines and is widely accepted by investigators. In such PD-BE studies, the trial protocols for different OIDPs drugs are relatively consistent in terms of trial design, trial data processing, and equivalence evaluation criteria, while there are detailed differences in terms of target population, single/multiple dosing, dose administration, and collection site design. This paper reviews the progress of PD-BE studies in the bioequivalence evaluation of OIDPs by combining national guidelines and PD-BE-related studies of OIDPs published in the last five years, with a view to providing important theoretical information for PD-BE studies of OIDPs.
9.Efficacy and safety of BeEAM regimen in pretreatment of autologous hematopoietic stem cell transplantation for patients with lymphoma
Qingfen LI ; Qike ZHANG ; Jisheng ZHAO ; Xiaofang WEI ; Youfan FENG ; Xiujuan HUANG ; Yuan FU
Journal of Leukemia & Lymphoma 2022;31(5):278-281
Objective:To investigate the efficacy and safety of BeEAM (bendamustine+cytarabine+etoposide+melphalan) regimen in pretreatment of autologous hematopoietic stem cell transplantation for patients with lymphoma.Methods:The clinical data of 15 patients with lymphoma who underwent autologous hematopoietic stem cell transplantation after pretreatment with BeEAM regimen from January 2020 to February 2021 in Gansu Provincial Hospital were retrospectively analyzed. The transplant-related adverse reactions and hematopoietic reconstitution were evaluated.Results:During the pretreatment process of 15 patients, 13 patients had gastrointestinal adverse reactions such as nausea, vomiting and diarrhea, 2 patients had hypokalemia, and 1 patient had abnormal liver function, but all of them were grade 1-2, and no grade 3-4 adverse reactions occurred. One patient had poor platelet implantation, and the remaining 14 patients all achieved hematopoietic reconstruction. After transplantation, the median time of peripheral blood neutrophils and platelets good implantation in patients was 10 d (9-14 d) and 11 d (9-17 d), respectively. Until March 2021, all patients were alive during follow-up.Conclusions:The efficacy of BeEAM regimen in pretreatment of autologous hematopoietic stem cell transplantation for patients with lymphoma is good, and the adverse reactions are tolerable.
10.Efficacy of low-dose rituximab combined with glucocorticoids in a case of childhood pemphigus foliaceus: a clinical observation
Zhong LIU ; Jisheng HU ; Meng HUANG ; Liuqing CHEN ; Li QIN ; Xiaoyong ZHOU
Chinese Journal of Dermatology 2021;54(5):436-437
A 9-year-old boy presented with pruritic erythema and erosions of the scalp for 1 month, which spread all over the body for 1 week. Histopathological examination of the skin lesions showed blisters forming under the granular layer of the epidermis, a large number of acantholytic cells in the blisters, and perivascular infiltration of lymphocytes and eosinophils in the superficial dermis. Direct immunofluorescence study showed reticular deposition of IgG and complement C3 between epidermal cells, and negative staining for IgM and IgA. Enzyme-linked immunosorbent assay showed the presence of serum anti-Dsg1 antibody (157.00 U/ml) . The patient was diagnosed with pemphigus foliaceus. After admission, the patient showed poor response to the treatment with prednisone at a dose of 40 mg/d. After the treatment with low-dose rituximab (100 mg per week, 4 weeks) combined with prednisone (20 mg/d) , her condition was well controlled. The dosage of prednisone gradually decreased to 7.5 mg/d for maintenance treatment, and no recurrence was observed during 24-month follow-up.

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