1.Varieties and Prescription Characteristics of Chinese Patent Medicines for Stroke in China
Jingdan ZHANG ; Wanping SUN ; Xiaoxia LIN ; Shuo ZHANG ; Xue ZHANG ; Jiahui YAO ; Yiming LIU ; Ming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):270-274
ObjectiveTo explore the listed varieties and prescription characteristics of Chinese patent medicines for stroke in China, explore the medication rules of Chinese medicine for stroke, and provide guidance for further clinical research and development of Chinese patent medicines. MethodsExcel 2021 and the Ancient and Modern Medical Record Cloud Platform (V2.3.5) were used to systematically mine and analyze the varieties and prescriptions of Chinese patent medicines for stroke in China. ResultsA total of 244 Chinese patent medicines (two for different dosage forms of the same prescription), 1 736 approval documents for Chinese patent medicines, 792 manufacturers, and 83 varieties of protected Chinese patent medicines were finally included in the database. The top three dosage forms were capsules (75), pills (53), and tablets (42). There were 28 Chinese patent medicines for stroke in the National Essential Drug Catalogue (2018), 129 in the National Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalogue (2023), and 4 in the National Non-prescription Drug Catalogue. Among the 138 prescriptions screened out, Chinese patent medicines mainly treated stroke patients with the syndrome of Qi deficiency and blood stasis. The top three most frequent medicinal herbs were Chuanxiong Rhizoma (63), Pheretima (47), and Salviae Miltiorrhizae Radix et Rhizoma (47). The medicinal herbs used were mainly warm, pungent, with the meridian tropism to the liver meridian. The correlation analysis showed that the herb pair with the highest support was Astragali Radix-Chuanxiong Rhizoma, and that with the highest confidence was Carthami Flos-Chuanxiong Rhizoma. Five herb combinations were identified based on the cluster analysis. ConclusionThe Chinese patent medicines for stroke mainly treat patients with the syndrome of Qi deficiency and blood stasis. The medicinal herbs used in the prescriptions mainly have the functions of activating blood and resolving stasis, extinguishing wind and stopping convulsions. Drug compatibility usually focuses on activating blood and resolving stasis, as well as expelling phlegm and opening orifices. This review of the varieties and prescription characteristics of Chinese patent medicines for stroke helps optimize clinical decision-making, guide drug research and development, promote medical research and scientific progress, and provide more effective support and guarantee for the treatment of stroke patients.
2.Comparison between sinking and floating fresh Rehmanniae Radix samples by UHPLC-Q-Orbitrap HRMS, fingerprinting, and chemometrics.
Shi-Long LIU ; Hong-Wei ZHANG ; Zhen-Ling ZHANG ; Han-Ting JIA ; Zhi-Jun GUO ; Rui-Sheng WANG ; Hong-Wei ZHANG ; Shuo WANG ; Yi-Jian ZHONG
China Journal of Chinese Materia Medica 2025;50(14):3918-3929
This study aims to explore the scientific connotation of sinking Rehmanniae Radix has the best quality and compare the quality between floating and sinking fresh Rehmanniae Radix samples. Ultra-performance liquid chromatography tandem quadrupole electrostatic field Orbitrap high-resolution mass spectrometry(UHPLC-Q-Orbitrap HRMS) was employed to detect the chemical components in floating and sinking fresh Rehmanniae Radix samples. The fingerprint of fresh Rehmanniae Radix was established by high performance liquid chromatography(HPLC), and four index components were determined simultaneously. The cluster analysis, principal component analysis(PCA), and orthogonal partial least squares-discriminant analysis(OPLS-DA) were conducted to compare the quality of floating and sinking fresh Rehmanniae Radix samples. An evaporative light-scattering detector was used to compare the content of five sugars. The extract yield and drying rate were determined, and the quality connotation of sinking Rehmanniae Radix has the best quality was explained by multiple indicators. A total of 41 components were preliminarily identified from fresh Rehmanniae Radix by UHPLC-Q-Orbitrap HRMS, including 7 iridoid glycosides, 9 phenylethanol glycosides, 6 amino acids, 4 sugars, 3 phenolic acids, 5 nucleosides, 3 organic acids, 1 ionone, 1 furan, 1 coumarin, and 1 phenylpropanoid. The results showed that the main chemical components were consistent between floating and sinking fresh Rehmanniae Radix. Nine common peaks were identified in the fingerprints of 15 batches of floating and sinking fresh Rehmanniae Radix samples, and the similarity of fingerprints was greater than 0.9. The cluster analysis, PCA, and OPLS-DA classified floating and sinking fresh Rehmanniae Radix sasmples into two categories, indicating differences in the quality between them. The total content of catalpol, rehmannioside D, ajugol, and verbascoside in sinking fresh Rehmanniae Radix samples was higher than that in floating samples of the same batch and specification, and the main differential component was catalpol. The total content of fructose, glucose, sucrose, raffinose, and stachyose in sinking fresh Rehmanniae Radix samples was higher than that in floating samples of the same batch and specification, and the main differential component was stachyose. The extract yield and drying rate of the sinking samples were higher than those of floating samples. This study preliminarily showed that floating and sinking fresh Rehmanniae Radix samples had the same components but great differences in the content of medicinal substance basis. The total content of four glycosides and five sugars, extract yield, and drying rate of sinking fresh Rehmanniae Radix samples is higher than that of floating samples of the same batch and specification. These findings, to a certain extent, explains the scientificity of sinking Rehmanniae Radix has the best quality recorded in ancient books and provide a reference for the quality control and clinical application of fresh Rehmanniae Radix.
Chromatography, High Pressure Liquid/methods*
;
Drugs, Chinese Herbal/chemistry*
;
Rehmannia/chemistry*
;
Chemometrics
;
Mass Spectrometry/methods*
;
Quality Control
;
Principal Component Analysis
;
Plant Extracts
3.Identification of critical quality attributes related to property and flavor of Jianwei Xiaoshi Tablets based on T1R2/T1R3/TRPV1-HEMT biosensor.
Dong-Hong LIU ; Yan-Yu HAN ; Jing WANG ; Hai-Yang LI ; Xin-Yu GUO ; Hui-Min FENG ; Han HE ; Shuo-Shuo XU ; Zhi-Jian ZHONG ; Zhi-Sheng WU
China Journal of Chinese Materia Medica 2025;50(14):3930-3937
The quality of traditional Chinese medicine(TCM) is a critical foundation for ensuring the stability of its efficacy, as well as the safety and effectiveness of its clinical use. The identification of critical quality attributes(CQAs) is one of the core components of TCM preparation quality control. This study focuses on Jianwei Xiaoshi Tablets and explores their CQAs related to property and flavor from the perspective of taste receptor proteins. Three taste receptor proteins, T1R2, T1R3, and TRPV1, were selected, and a biosensor based on high-electron-mobility transistor(HEMT) was constructed to detect the interactions between Jianwei Xiaoshi Tablets and taste receptor proteins. Simultaneously, liquid chromatography-mass spectrometry(LC-MS) technology was used to analyze the chemical composition of Jianwei Xiaoshi Tablets. In examining the interaction strength, the results indicated that the interaction between Jianwei Xiaoshi Tablets and TRPV1 protein was the strongest, followed by T1R3, with the interaction with T1R2 being relatively weaker. By combining biosensing technology with LC-MS, 16 chemical components were identified from Jianwei Xiaoshi Tablets, among which six were selected as CQAs for sweetness and seven for pungency. Further validation experiments demonstrated that CQAs such as hesperidin and hesperetin had strong interactions with their corresponding taste receptor proteins. Through the combined use of multiple technological approaches, this study successfully determined the property and flavor-related CQAs of Jianwei Xiaoshi Tablets. It provides novel ideas and approach for the identification of CQAs in TCM preparations and offers comprehensive theoretical support for TCM quality control, contributing to the improvement and development of TCM preparation quality control systems.
Drugs, Chinese Herbal/chemistry*
;
Biosensing Techniques/methods*
;
TRPV Cation Channels/chemistry*
;
Tablets/chemistry*
;
Receptors, G-Protein-Coupled/genetics*
;
Quality Control
;
Taste
;
Humans
;
Mass Spectrometry
4.Analysis of unhealthy listening habits and related factors on hearing impairment among primary and middle school students in Jilin Province
YANG Shuo, LIU Bing, ZHANG Yuting, WU Xiaogang, MEI Songli
Chinese Journal of School Health 2025;46(2):215-218
Objective:
To understand the unhealthy listening habits and related factors hearing on impairment among primary and middle school students in Jilin Province, so as to provide a scientific basis for the prevention of hearing impairment in children and adolescents.
Methods:
From September to November 2021, a stratified cluster random sampling method was employed to select 12 847 primary and middle school students in nine cities of Jilin Province who use headphones for more than 0.5 hours daily for a questionnaire survey. Data on unhealthy listening habits, lifestyle habits and hearing impairment were collected. The data were analyzed using the χ 2 test and Logistic regression.
Results:
Totally 1 702 students(13.25%) experienced hearing impairment within the last month. There were statistical differences between the sexes with the average daily headphone use, the times of using headphones ≥1 h every day for one week use in all environment or noisy environment ( χ 2=47.86, 57.60, 66.31, P <0.01). Logistic regression analysis results showed that factors related to the occurrence of hearing impairment among primary and secondary school students included:average daily headphone use of 1-2 h and more than 2 h ( OR=1.74, 95%CI =1.60-1.90; OR=1.73, 95%CI =1.59-1.90), times of using headphones ≥1 h every day for one week were 1-2 times and >2 times ( OR=1.71, 95%CI =1.59- 1.84 ; OR=1.83, 95%CI =1.71-1.97), the times of using headphones≥1 h every day for one week being 1-2 times and >2 times in noisy environment per week ( OR=1.48, 95%CI =1.40-1.56; OR=1.72, 95%CI =1.61-1.86), economic underdevelopment ( OR=1.85, 95%CI =1.76-1.96), boarding (OR=1.78, 95%CI =1.69-1.89), single parent family ( OR=1.72, 95%CI =1.60- 1.87 ), daily activity duration less than 1 h ( OR=1.71, 95%CI =1.63-1.81), sedentary behavior duration more than 6 h per day ( OR=1.88, 95%CI =1.79-1.98) ( P <0.05).
Conclusions
The behavior of ear protection among primary and middle school students in Jilin Province needs to be enhanced, focusing on students in economically underdeveloped areas, boarding schools and single parent families. It is necessary to guide primary and middle school students to improve their bad ear habits, increase outdoor activities and reduce the time of sitting.
5.Treatment Strategy of Fire Acupuncture by Repeated Shallow Needling Method for Refractory Facial Paralysis Based on the Pathogenesis of "Channel Sinews Deficiency and Stasis"
Bing HONG ; Chao YANG ; Zijing WANG ; Jing LIU ; Shuo DU ; Wenhui WANG ; Jiping ZHAO
Journal of Traditional Chinese Medicine 2025;66(7):741-745
It is regarded that the disease location of refractory facial paralysis is in the channel sinews of the face, with its primary pathogenesis characterized by a combination of deficiency and stasis of the channel sinews. The integration of repeated shallow needling method and fire acupuncture can first remove stagnation within the channel sinews, and second utilize the warming effect of fire to reinforce yang, stimulate meridian qi, and nourish the channel sinews. This approach balances both supplementation and drainage manipulation, aligning with the underlying pathogenesis of deficiency and stasis combination. In clinical practice, diagnostic methods should be applied flexibly to accurately identify the affected channel sinews. The severity of facial symptoms, the size and mobility of the paralyzed facial muscles, as well as the depth and size of the reactive points identified through palpation, should be considered when determining the extent of the condition. By adjusting the appropriate level of stimulation, the fire acupuncture with repeated shallow needling method could effectively improve facial muscle morphology and function, promoting recovery from the disease.
6.Fu′s academic thoughts of promoting conception based on the "qi cycle in round" theory
Yan LIU ; Haoxian WANG ; Xiangyu LI ; Shuo SUN ; Jiuxian LI
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):336-342
FU Qingzhu Nyuke·Zhongzi is a concentrated manifestation of Fu′s academic thoughts of promoting conception (Zhongzi), which affects the treatment of infertility in later generations. However, the Zhongzi chapter is named after "symptoms" and is not divided into chapters according to "syndromes, "limiting the clinical application of Fu′s thoughts of Zhongzi. The "qi circle in round" theory is the crystallization of HUANG Yuanyu′s academic thinking, advocating for qi transformation, emphasizing middle qi, and considering the four phenomena. This theory highlights the role of middle qi in the rise, fall, and circulation of disease development. The "qi cycle in round" theory, a comprehensive view of Fu′s Zhongzi chapter, reveals that FU Qingzhu emphasizes the transformation of visceral qi in diagnosing and treating infertility, focusing on the spleen, liver, and kidneys. His prescription aims to restore the overall qi mechanism of the body, highlighting the circulation of middle earth and the dredging of meridians, aligning perfectly with the theory of the "qi cycle in round." Therefore, this article argues from the perspective of the "qi cycle in round, "deconstructing the pathogenesis of Fu′s infertility based on the dereliction of spleen earth, stagnation of liver wood, and kidney yin and yang deficiency. It reorganizes Fu′s formula system of Zhongzi by mediating middle earth, soothing liver depression, and regulating kidney function, summarizing the characteristics of Fu′s thoughts of Zhongzi with the aid of qi around the waist and navel, simultaneous treatment of conqenital and acquired essence, and restriction and generation of five phases. Based on the "qi cycle in round" theory, this study explores Fu′s academic thoughts of Zhongzi to strengthen the organic integration of Fu′s academic thoughts of Zhongzi with the theory of "qi cycle in round, "providing new perspectives for the study and inheritance of Fu′s academic thoughts of Zhongzi.
7.Study on Brain Functional Network Characteristics of Parkinson’s Disease Patients Based on Beta Burst Period
Yu-Jie HAO ; Shuo YANG ; Shuo LIU ; Xu LOU ; Lei WANG
Progress in Biochemistry and Biophysics 2025;52(5):1279-1289
ObjectiveThe central symptom of Parkinson’s disease (PD) is impaired motor function. Beta-band electrical activity in the motor network of the basal ganglia is closely related to motor function. In this study, we combined scalp electroencephalography (EEG), brain functional network, and clinical scales to investigate the effects of beta burst-period neural electrical activity on brain functional network characteristics, which may serve as a reference for clinical diagnosis and treatment. MethodsThirteen PD patients were included in the PD group, and 13 healthy subjects were included in the healthy control group. Resting-state EEG data were collected from both groups, and beta burst and non-burst periods were extracted. A phase synchronization network was constructed using weighted phase lag indices, and the topological feature parameters of phase synchronization network were compared between the two groups across different periods and four frequency bands. Additionally, the correlation between changes in network characteristics and clinical symptoms was analyzed. ResultsDuring the beta burst period, the topological characteristic parameters of phase synchronization network in all four frequency bands were significantly higher in PD patients compared to healthy controls. The average clustering coefficient of the phase synchronization network in the beta band during the beta burst period was negatively correlated with UPDRS-III scores. In the low gamma band during the non-burst period, the average clustering coefficient of phase synchronization network was positively correlated with UPDRS and UPDRS-III scores, while UPDRS-III scores were positively correlated with global efficiency and average degree. ConclusionThe brain functional network features of PD patients were significantly enhanced during the beta burst period. Moreover, the beta-band brain functional network characteristics during the beta burst period were negatively correlated with clinical scale scores, whereas low gamma-band functional network features during the non-burst period were positively correlated with clinical scale scores. These findings indicate that motor function impairment in PD patients is associated with the beta burst period. This study provides valuable insights for the diagnosis of PD.
8.Mechanism of Kidney-tonifying and Liver-regulating Cyclical Therapy and Formula in Improving Endometrial Receptivity during "Implantation Window" in Rats with Polycystic Ovary Syndrome via miR-140-5p/VEGF Pathway
Quan LIU ; Yiqing HE ; Ying ZHANG ; Xi WANG ; Shuo YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):100-109
ObjectiveTo investigate the mechanism of kidney-tonifying and liver-regulating cyclical therapy and its formula in regulating endometrial receptivity during the "implantation window" in rats with polycystic ovary syndrome (PCOS). MethodsSix rats were randomly selected from 36 SPF SD female rats as the normal group, and the remaining rats were administered letrozole to induce a PCOS model. By using a random number method, the rats were divided into the following groups: normal group, model group, Xiaoyaosan group (11.97 g·kg-1), Sanzi Yangmo decoction group (28.35 g·kg-1), cyclical therapy group (11.97/28.35 g·kg-1), and aspirin group (8 × 10-3 mg·kg-1). After 12 days of continuous administration by gavage (equivalent to three estrous cycles), female and male rats were co-housed. On the fifth day of pregnancy, the number of blastocyst implantation in each group was counted. Hematoxylin-eosin (HE) staining was used to observe the pathological morphology of rat endometrial tissue. Enzyme-linked immunosorbent assay (ELISA) was used to measure the levels of estradiol (E2) and progesterone (P) in rat serum. Western blot was used to detect the protein expression of vascular endothelial growth factor (VEGF), progesterone receptor (PR), estrogen receptor (ER), androgen receptor (AR), and integrin(ITG) αvβ3 in rat endometrial blood vessels. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of miR-140-5 P, VEGF, vascular endothelial growth factor receptor 2 (VEGFR2), PR, ER, AR, and ITGαvβ3 in rat endometrium. ResultsCompared with normal group, the estrous cycle of the rats in model group continued to be in the estrus interval and the estrous cycle lost regular changes. The endometrium was significantly thinner, the number of uterine glands and blood vessels were significantly reduced (P<0.01), and the pregnancy rate was significantly reduced. Compared with the model group, each drug group restored the regular estrous cycle to varying degrees, and the endometrial thickness and the number of blood vessels were significantly improved (P<0.01). The pregnancy rate of each drug group increased, and the effect of the cycle therapy group could reach the normal level. The results of molecular biology experiments showed that compared with the normal group, the levels of serum E2 and P in the model group were significantly decreased (P<0.01), the expression of VEGF, ER, PR and ITGαvβ3 protein was significantly decreased (P<0.05,P<0.01), the expression of AR protein was significantly increased (P<0.01), the expression of miR-140-5P and AR mRNA was significantly increased (P<0.01), and the expression of VEGF, VEGFR2, ER, PR and ITGαvβ3 mRNA was significantly decreased (P<0.01). Compared with model group, the serum E2 level in the Xiaoyaosan group was significantly increased (P<0.01).The levels of E2 and P in serum of rats in Sanzi Yangmo decoction group, cycle therapy group and aspirin group were significantly increased (P<0.01). The expression of AR protein in each drug group was significantly decreased (P<0.01). The expression of VEGF and ITGαvβ3 protein in Xiaoyaosan group was significantly increased (P<0.01). The expression of VEGF, ER and PR protein in Sanzi Yangmo decoction group was increased to varying degrees (P<0.05,P<0.01). The expression of VEGF, PR, ER and ITGαvβ3 protein in the cycle therapy group and the aspirin group increased to varying degrees (P<0.05,P<0.01). The expression of miR-140-5P and AR mRNA in each drug group was significantly decreased (P<0.01). The expression of VEGF, VEGFR2, ER, PR and ITGαvβ3 mRNA in each drug group increased to varying degrees (P<0.05,P<0.01). Compared with Xiaoyaosan group and Sanzi Yangmo decoction group, the expression of miR-140-5P, VEGFR2, ER, PR, AR and ITGαvβ3 mRNA in the cycle therapy group were significantly different (P<0.05,P<0.01). ConclusionThe kidney-tonifying and liver-regulating cyclical therapy may reduce the activity of miR-140-5P, target the upregulation of VEGF expression, mediate angiogenesis, and promote endometrial angiogenesis, thereby playing a synergistic role in improving endometrial receptivity in PCOS-induced infertility. Its efficacy in increasing pregnancy rates surpasses that of Xiaoyaosan or Sanzi Yangmo decoction used alone.
9.Mechanism of Kidney-tonifying and Liver-regulating Cyclical Therapy and Formula in Improving Endometrial Receptivity during "Implantation Window" in Rats with Polycystic Ovary Syndrome via miR-140-5p/VEGF Pathway
Quan LIU ; Yiqing HE ; Ying ZHANG ; Xi WANG ; Shuo YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):100-109
ObjectiveTo investigate the mechanism of kidney-tonifying and liver-regulating cyclical therapy and its formula in regulating endometrial receptivity during the "implantation window" in rats with polycystic ovary syndrome (PCOS). MethodsSix rats were randomly selected from 36 SPF SD female rats as the normal group, and the remaining rats were administered letrozole to induce a PCOS model. By using a random number method, the rats were divided into the following groups: normal group, model group, Xiaoyaosan group (11.97 g·kg-1), Sanzi Yangmo decoction group (28.35 g·kg-1), cyclical therapy group (11.97/28.35 g·kg-1), and aspirin group (8 × 10-3 mg·kg-1). After 12 days of continuous administration by gavage (equivalent to three estrous cycles), female and male rats were co-housed. On the fifth day of pregnancy, the number of blastocyst implantation in each group was counted. Hematoxylin-eosin (HE) staining was used to observe the pathological morphology of rat endometrial tissue. Enzyme-linked immunosorbent assay (ELISA) was used to measure the levels of estradiol (E2) and progesterone (P) in rat serum. Western blot was used to detect the protein expression of vascular endothelial growth factor (VEGF), progesterone receptor (PR), estrogen receptor (ER), androgen receptor (AR), and integrin(ITG) αvβ3 in rat endometrial blood vessels. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of miR-140-5 P, VEGF, vascular endothelial growth factor receptor 2 (VEGFR2), PR, ER, AR, and ITGαvβ3 in rat endometrium. ResultsCompared with normal group, the estrous cycle of the rats in model group continued to be in the estrus interval and the estrous cycle lost regular changes. The endometrium was significantly thinner, the number of uterine glands and blood vessels were significantly reduced (P<0.01), and the pregnancy rate was significantly reduced. Compared with the model group, each drug group restored the regular estrous cycle to varying degrees, and the endometrial thickness and the number of blood vessels were significantly improved (P<0.01). The pregnancy rate of each drug group increased, and the effect of the cycle therapy group could reach the normal level. The results of molecular biology experiments showed that compared with the normal group, the levels of serum E2 and P in the model group were significantly decreased (P<0.01), the expression of VEGF, ER, PR and ITGαvβ3 protein was significantly decreased (P<0.05,P<0.01), the expression of AR protein was significantly increased (P<0.01), the expression of miR-140-5P and AR mRNA was significantly increased (P<0.01), and the expression of VEGF, VEGFR2, ER, PR and ITGαvβ3 mRNA was significantly decreased (P<0.01). Compared with model group, the serum E2 level in the Xiaoyaosan group was significantly increased (P<0.01).The levels of E2 and P in serum of rats in Sanzi Yangmo decoction group, cycle therapy group and aspirin group were significantly increased (P<0.01). The expression of AR protein in each drug group was significantly decreased (P<0.01). The expression of VEGF and ITGαvβ3 protein in Xiaoyaosan group was significantly increased (P<0.01). The expression of VEGF, ER and PR protein in Sanzi Yangmo decoction group was increased to varying degrees (P<0.05,P<0.01). The expression of VEGF, PR, ER and ITGαvβ3 protein in the cycle therapy group and the aspirin group increased to varying degrees (P<0.05,P<0.01). The expression of miR-140-5P and AR mRNA in each drug group was significantly decreased (P<0.01). The expression of VEGF, VEGFR2, ER, PR and ITGαvβ3 mRNA in each drug group increased to varying degrees (P<0.05,P<0.01). Compared with Xiaoyaosan group and Sanzi Yangmo decoction group, the expression of miR-140-5P, VEGFR2, ER, PR, AR and ITGαvβ3 mRNA in the cycle therapy group were significantly different (P<0.05,P<0.01). ConclusionThe kidney-tonifying and liver-regulating cyclical therapy may reduce the activity of miR-140-5P, target the upregulation of VEGF expression, mediate angiogenesis, and promote endometrial angiogenesis, thereby playing a synergistic role in improving endometrial receptivity in PCOS-induced infertility. Its efficacy in increasing pregnancy rates surpasses that of Xiaoyaosan or Sanzi Yangmo decoction used alone.
10.Rapid health technology assessment of serplulimab in the first-line treatment of small-cell lung cancer
Yibing HOU ; Shuo KANG ; Yuan GONG ; Xiaohui WANG ; Ying NIE ; Huanlong LIU
China Pharmacy 2025;36(11):1405-1410
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of serplulimab as a first-line treatment of small- cell lung cancer (SCLC), and provide an evidence-based basis for drug selection in hospitals. METHODS Rapid health technology assessment was adopted; PubMed, Cochrane Library, Embase, CNKI, Wanfang, VIP and official websites of domestic and international health technology assessment agencies were systematically searched from the inception to Oct. 2024. Two reviewers independently screened the literature, assessed the quality of included studies and carried out the qualitative analysis according to the inclusion and exclusion criteria. RESULTS A total of 13 systematic reviews/meta-analyses and 9 economic studies were included, and the literature quality was generally good. In terms of effectiveness, compared with chemotherapy alone, serplulimab combined with chemotherapy significantly improved progression-free survival, overall survival, and objective response rate in patients with SCLC. In terms of safety, serplulimab combined with chemotherapy showed no significant difference in the incidence of ≥3 grade adverse events compared with chemotherapy alone in the treatment of SCLC, indicating a good safety profile; compared with combination therapies involving other immunosuppressive agents, the incidence rate of adverse events was also lower. In terms of cost-effectiveness, compared with chemotherapy alone, serplulimab combined with chemotherapy is not cost- effective, which may be related to the high price of serplulimab. CONCLUSIONS Serplulimab is effective and safe in the treatment of SCLC, but has no obvious advantage in terms of cost-effectiveness.


Result Analysis
Print
Save
E-mail