1.Current Situation of Health Technology Assessment in Traditional Chinese Medicine Hospitals
Simin XU ; Hui ZHAO ; Jing HU ; Zhaolan LIU ; Weiwei SUN ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(4):190-197
ObjectiveThis study aims to understand the recognition of practitioners in traditional Chinese medicine (TCM) hospitals on hospital-based health technology assessment (HB-HTA), assessment needs, challenges, and suggestions, so as to provide references for the future work. MethodThe convenient sampling method was adopted to survey the relevant practitioners in TCM hospitals. The questionnaire included 39 questions in 4 dimensions and was distributed through the online platform Weijuanxing. ResultA total of 244 questionnaires were recovered, and the obtained data were analyzed in SPSS. The results showed that 137 practitioners were very familiar with HB-HTA and there was no significant difference in the recognition of practitioners in different occupations (F=0.251; P=0.778). The practitioners in Hong Kong, Macao, and Taiwan had lower recognition than those in other regions. In terms of the assessment needs, 127 practitioners believed that it was very necessary to carry out HB-HTA in TCM hospitals in the future. Chinese patent medicines/Chinese herbal medicine decoction pieces (5.91) and TCM appropriate technology (5.57) had higher assessment priority scores. The assessment needs were high for the effectiveness (235 practitioners) and safety (224 practitioners) of health technology. The lack of specialized organization and standardized evaluation process system and the shortage of talents were considered to be the major challenges for the future development in this field. ConclusionThe stakeholders carrying out the health technology assessment in TCM hospitals had certain awareness of HB-HTA. Most practitioners believed that it was necessary to carry out HB-HTA in TCM hospitals in the future, while the work might face challenges such as the lack of organizations and system and the shortage of talents, which requires policy support.
2.Drug Selection and Evaluation in Medical Institutions: A Scoping Review
Simin XU ; Zeqi DAI ; Junling CAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):154-162
ObjectiveBy analyzing the current situation of drug selection and evaluation in medical institutions in the world,we aim to understand the development of relevant selection methods and tools,provide reference basis for drug selection in traditional Chinese medicine (TCM) medical institutions,and promote the optimization of drug catalogs in TCM medical institutions. MethodBased on the method of scoping review,the eight databases were systematically searched,the included documents were screened,extracted and analyzed,and the research results were graphically displayed. ResultA total of 23 articles were included in this study,including 13 in Chinese and 10 in English,involving 23 methods or tools related to drug selection. Of the 14 methods or tools from Chinese medical institutions,the earliest one was published in 2012,and five were published in 2022. The published methods or tools involved different levels of hospitals,different drug varieties,different evaluation angles,etc.,such as the drug selection methods of one county hospital and one township hospital, methods and tools for different types of drugs such as antibacterial drugs,ibuprofen preparations,proton pump inhibitors and hypoglycemic drugs used in pediatric intensive care units, Chinese patent medicine selection tools, tools for evaluation from the perspective of pharmacoeconomics, and universal tools for selecting domestic medical institutions. The nine drug selection tools of foreign medical institutions were from the European,American,Asian and African countries. It was first published in 1955. The contents included the formulation standards that medical institutions should follow for drug prescription sets,the management formulation and update of hospital prescription sets,and drug evaluation tools. ConclusionOn the whole,the drug selection methods and institutional methods of foreign medical institutions developed earlier than those in China. In recent years,Chinese medical institutions have paid high attention to drug selection and released various types of drug selection tools. However,the standardization should be further improved in the future.
3.Efficacy of rituximab therapy for 10 patients suffering from systemic lupus erythematosus with intestinal involvement
Yurong ZHAO ; Zheng ZHAO ; Jie ZHANG ; Kunpeng LI ; Jinshui YANG ; Fei SUN ; Simin LIAO ; Jianglin ZHANG ; Feng HUANG ; Jian ZHU
Chinese Journal of Internal Medicine 2024;63(2):198-202
We retrospectively analyzed therapy efficacy and the adverse reactions of 10 patients suffering from systemic lupus erythematosus (SLE) with intestinal involvement treated with rituximab (RTX). Patients were hospitalized in the Department of Rheumatology and Immunology of the First Medical Center of PLA General Hospital from January 2015 to January 2023. Among the 10 patients, two were men and eight were women. The age of the cohort was (41.9±8.8) years. The age at disease onset was (28.8±9.2) years. The total course of the SLE diagnosis was(109.6±59.9) months. The course of the diagnosis of SLE with intestinal involvement was (89.3±50.2) months. The time from the appearance of intestinal symptoms to the diagnosis of SLE with intestinal involvement was 1.5 (1.0,8.0) months. The time from the diagnosis of SLE with intestinal involvement to RTX use was 13.0 (1.0,46.3) months. Follow-up duration after application of RTX treatment was (55.3±28.4) months. There were five cases of abdominal pain, four cases of abdominal distension, nine cases of diarrhea, three cases of nervous-system involvement, nine cases of lupus nephritis, and seven cases of serositis. All 10 patients underwent computed tomography and radiology of the abdomen. Eight patients had intestinal-wall edema, seven suffered intestinal dilation, four had target signs, three suffered congestion of mesenteric blood vessels, eight had increased mesenteric-fat density, and six had false intestinal obstruction. All 10 patients showed a low level of complement C3 (250-750 mg/L). Nine cases showed a low level of complement C4 (10-90 mg/L). The SLE disease activity index 2000 (SLEDAI-2K) at baseline in 10 patients was 20.5 (17.8, 30.0). After receiving RTX (0.5 g: day 1, day 14, or 375 mg/m 2: day 1, day 14) induction treatment, the intestinal symptoms of 10 cases were relieved completely. Four patients had adverse reactions, of which three received a high-dose glucocorticoid combined with RTX treatment simultaneously. Adverse reactions manifested mainly as a reduced level of IgG and infection with herpes simplex virus in one case, reduced level of IgG and lung infection in one patient, lung infection in one case, and reduced IgG level in one patient. RTX may an efficacious treatment strategy for patients suffering from refractory SLE with intestinal involvement.
4.Construction and characterization of monoclonal antibodies against the native H11 protein of Haemonchus contortus
Feng LIU ; Simin WU ; Yao ZHANG ; Shusen LIAO ; Liurong FANG ; Min HU ; Chunqun WANG
Chinese Journal of Veterinary Science 2024;44(6):1204-1212
To construct monoclonal antibodies against Haemonchus contortus native H11 protein.In this study,five 4-6 weeks female BALB/c mice were immunized with native H11 protein extrac-ted from adult worms by Concanavalin A lectin.Spleen cells were isolated and fused with SP2/0 cells after 3 times of immunization.Two hybridoma cell lines,named A1E3 and A10E1,which could stably secrete monoclonal antibodies against H11 protein were obtained.The subtype identi-fication and immunological analysis showed that the heavy chain of the two monoclonal antibodies belonged to IgG1 and the light chain was κ type,and both monoclonal antibodies recognized the natural antigen H11.Immunohistochemical localization and larval developmental inhibition test in vitro showed that the mAb A1E3 could be localized to the intestinal microvilli of the adult worm,and that the antibody can inhibit the growth of the fourth-stage larvae.The successful production of two monoclonal antibodies not only lays the foundation for the study of protective antigenic epitopes of the H11 protein and the development of epitope vaccines,but also provides a potential application of the monoclonal antibody for the treatment of haemonchusis in animals.
5.Relationship between social exclusion and relapse tendency in female drug rehabilitation patients
Lihao LAI ; Ruonan SUN ; Yuyao TANG ; Xihui JI ; Simin HOU ; Lushi JING ; Linhui WANG ; Chen YI ; Chuanyou LIAO
Chinese Mental Health Journal 2024;38(10):880-885
Objective:To explore the influence of social exclusion on the relapse tendency of female drug re-hab patients,and the mediating role of self-esteem and the moderating role of positive psychological capital.Method:A total of 288 female drug rehabilitation patients were selected,and the Social Exclusion Question-naire(SEQ)was used to assess the degree of social exclusion experienced by the patients.The Relapse Tendency Questionnaire(RPQ)was used to evaluate the current tendency of drug relapse.The Rosenberg Self-Esteem Scale(RSES)was used to evaluate the self-esteem level of the patients,and the Positive Psychological Capital Question-naire(PPCQ)was used to evaluate their level of positive psychological capital.Results:The SEQ scores of female drug rehab patients were positively correlated with the RPQ scores(β=0.41,P<0.001),The RSES scores had a mediating effect between the scores of SEQ and RPQ,with a mediation effect size of 0.09(95%CI:0.04-0.15,accounting for 20.6%of the total effect).The PPCQ scores had a moderating effect between the scores of RSES and RPQ(β=-0.08,P<0.05)and between the scores of SEQ and RPQ(β=0.10,P<0.05).Conclusion:So-cial exclusion could not only directly affect but also indirectly affect the relapse tendency through self-esteem of fe-male drug rehab patients.Positive psychological capital could moderate the relationship between social exclusion,self-esteem,and relapse tendency.
6.Efficacy and safety of half-dose rituximab in the treatment of 23 cases with lupus nephritis
Yurong ZHAO ; Kunpeng LI ; Xiaohu DENG ; Xiaofei LIU ; Simin LIAO ; Jinshui YANG ; Xi ZHENG ; Jianglin ZHANG ; Feng HUANG ; Jian ZHU
Chinese Journal of Internal Medicine 2023;62(1):84-87
The study aimed to analyze the efficacy and safety of rituximab in the treatment of 23 cases of lupus nephritis and explore the prospect of half-dose rituximab in lupus nephritis treatment. Twenty-three patients with lupus nephritis hospitalized in the Department of Rheumatology and Immunology at the First Medical Center of the PLA General Hospital from May 2013 to December 2021 were selected. Eighteen patients received rituximab 375 mg/m 2 on the first and 14th days, 5 patients received 500 mg of rituximab on the first and 14th days, and rituximab was used as needed 6 months later. Methylprednisolone (80-120 mg) was given together with rituximab. Afterward, 1 mg/kg prednisone was used for 4 weeks, which was progressively tapered to maintenance doses or discontinued. B lymphocyte level, renal function, 24-h urine protein level, and systemic lupus erythematosus (SLE) disease activity index 2000 (SLEDAI2K) score before and after treatment were recorded. The efficacy and adverse reactions were analyzed. The results showed that 11 patients suffered from renal insufficiency [creatinine (162.7±58.6) μmol/L ] at baseline, while the creatinine level of 9 patients returned to normal 12 months after the treatment [ (66.3±10.1)μmol/L ]. Normal renal function of the other 12 patients was maintained during treatment. After 12 months, the 24-h urine protein level decreased from 4.00 (2.00,6.80) g in the baseline period to 0.10 (0.08,0.40) g. SLEDAI2K score decreased from 22 (18,26) in the baseline period to 3 (0,6) 12 months after the treatment. The B lymphocyte level reached 0.00 (0.00,0.01)% at 3 months. Of 23 patients, 13 patients achieved complete remission, and 7 patients achieved partial remission after 6 months of rituximab treatment. Five patients experienced adverse reactions related to rituximab, including 1 case of transfusion reaction, 1 case of perioral herpes with pulmonary infection, and 3 cases of decreased IgG levels. Therefore, rituximab regimen used in this study can be an effective treatment strategy for lupus nephritis.
7.A pilot study of late-onset neuromyelitis optica spectrum disorder disease based on brain three-dimensional structural MRI
Li ZHANG ; Mingqin ZHU ; Simin YANG ; Dan LIAO ; Jie ZHU ; Dan TONG ; Chunjie GUO
Chinese Journal of Radiology 2023;57(6):617-624
Objective:To explore the different patterns of brain structural abnormalities in patients with delayed neuromyelitis optica pedigree disease (LO-NMOSD) and its relationship with clinical neuropsychological scale score based on the quantitative analysis of three-dimensional (3D) brain structure MRI.Methods:Patients with neuromyelitis optica pedigree disease in remission (NMOSD group) who received treatment at Jilin University First Hospital from January 2016 to December 2018 were prospectively included and divided into LO-NMOSD subgroup and early-onset NMOSD (EO-NMOSD) subgroup according to whether the age of first onset was>50 years. Another age-and sex-matched healthy volunteers with NMOSD patients were recruited as the control group. 3D brain T 1WI and T 2 fluid-attenuated inversion recovery sequence imaging were acquired, and clinical data, neuropsychological scores of all subjects were analyzed. Total gray matter volume (GMV), cerebral gray matter fraction (GMF), cerebral white matter fraction (WMF), and cerebral white matter high signal fraction (WMHF) were obtained by quantitative analysis of MRI data using voxel-based morphology and lesion segmentation tool techniques. Analysis of covariance was used to compare the differences in brain structure between LO-NMOSD subgroup and EO-NMOSD subgroup, NMOSD group and control group. Partial correlation analysis was used to analyze the correlation between GMF, WMHF and patient clinical data, neuropsychological scale scores, and the correlation between WMHF and GMF, WMF. Results:There were 47 cases in the NMOSD group, including 7 males and 40 females aged 18-66 years. Among them, there were 20 cases in the LO-NMOSD subgroup and 27 cases in the EO-NMODS subgroup. The control group consisted of 50 individuals (13 males and 37 females, aged 18 to 77 years). Compared with the control group, the GMV of the right caudate nucleus in the LO-NMOSD group was reduced ( t=3.33, P<0.05), and the GMV of multiple brain regions in the bilateral frontal and temporal lobes in the EO-NMOSD group was reduced considerably (FDR corrected, P<0.05), which was consistent with the NMOSD group. After adjusting for age, there was no statistically significant difference in WMHF between the LO-NMOSD and EO-NMOSD groups ( F=0.22, P=0.644). The LO-NMOSD subgroup showed a negative correlation between global GMF and the extended disability status scale (EDSS) score ( r=-0.53, P=0.025). WMHF in the NMOSD group was positively correlated with annual recurrence rate and EDSS ( r=0.35 and 0.35, respectively, and P=0.017 and 0.018, respectively), while other indicators were not correlated ( P>0.05). The EO-NMOSD subgroup WMHF showed a negative correlation with GMF and WMF ( r=-0.76, -0.70, respectively, P<0.001). The NMOSD group showed a negative correlation between WMHF and GMF, WMF ( r=-0.38, -0.55, respectively, P<0.05). There was no correlation between WMHF and GMF, WMF in the LO-NMOSD subgroup ( P>0.05). Conclusions:The extent and location of gray matter atrophy in patients with LO-NMOSD are different from those of EO-NMOSD. The correlation between WMHF and brain structural changes and clinical data is different between the two groups of patients. These suggest that LO-NMOSD patients may have different patterns of brain structural damage.
8.Oral Chinese Patent Medicines for Adult Functional Dyspepsia:A Scoping Review of Clinical Evidence and Drug Package Inserts
Miaomiao LI ; Hui ZHAO ; Yue WU ; Zeqi DAI ; Simin XU ; Xudong TANG ; Xing LIAO
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(8):2840-2850
Objective To systematically review the present status of oral Chinese patent medicines(CPMs)for treating functional dyspepsia(FD),explore the formation rules of CPMs,and reveal the potential problems by referring to the methods and procedures of Scoping review.Methods First,we screened all CPMs from the domestic-related drug catalogs which are generally accepted and own the force of law,then we sorted the CPMs based on the drug instructions while carrying out Chinese and English database document retrieval to review the clinical studies.Descriptive analysis of the basic feature and clinical research evidence of CPMs was performed combined with visual charts.Results This study included 42 CPMs for treating FD.Among the formulas of CPMs,Tangerine peel,Radices saussureae,Poria cocos,Glycyrrhiza,Atractylodes macrocephala,and Six Divine Qu appeared frequently.In addition,96 studies involving 21 CPMs were included,among which Zhizhu Kuanzhong Capsule,Liuwei Anxiao capsule,and Dalitong granules had more clinical literature.By analyzing the included 96 clinical studies,we found that the combination of Chinese and Western medicine was the main intervention,and the effective rate,clinical symptom score,and adverse reactions were the main outcomes that were concerned.In addition,8 studies had off-label use of diseases,involving the Wuling capsule to treat the FD whether the disease was accompanied by depression and anxiety symptoms or not,and Zhizhu Kuanzhong Capsule to treat the FD with anxiety and depression.Although the Wuling capsule and Zhizhu Kuanzhong capsule were off-label used in clinical practice,there was no beyond the scope of the guideline.Conclusion The qi-regulating drug,spleen-strengthening drug and digestant drugs are the usual Chinese medicines used for treating adult FD.In recent years,research on CPMs for treating adult FD has increased rapidly.But there is insufficient reflection of CPMs treatment characteristics,ambiguous differences from the primary and secondary outcomes,multiple composite outcomes,and not explicit information on FD or its symptoms in drug package insert,which needs to be improved in the future.
9.Clinical Evidence of Treatment of Constipation with Oral Chinese Patent Medicine: A Scoping Review
Simin XU ; Zeqi DAI ; Miaomiao LI ; Xue WU ; Xudong TANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):144-153
This study systematically and comprehensively sorted out the application status of Chinese patent medicines for the treatment of constipation in the clinic, to provide scientific evidence for future research directions and clinical drug use in this field. Based on the method of scoping review, the Chinese patent medicines for the treatment of constipation were retrieved from three drug lists to obtain the medicines that needed to be evaluated. A comprehensive and systematic search was carried out on the included studies on the treatment of constipation by Chinese patent medicines through eight Chinese and English databases, and the included studies were integrated and analyzed. The results were displayed in combination with charts. Thirty-four Chinese patent medicines and 118 studies were included in this study. According to the efficacies, Chinese patent medicines were divided into 4 categories, namely eliminating accumulation, purging fire, promoting Qi, and moistening bowels, involving 125 Chinese medicines. The overall attention of constipation research is on the rise. Marenwan (granules or soft capsules) gained the highest attention, with 42 studies, followed by Qirong Runchang oral liquid, with 21 studies, and Biantong tablets (capsules), with 19 studies. There are 10 studies on Congrong Tongbian oral liquid. Seventeen Chinese patent medicines had no corresponding clinical research. There were 8 study design types, and all drugs were mainly randomized controlled trials except Danggui Longhui pill. Among the intervention types, the comparison between Chinese patent medicines and western medicines was the most. The highest outcome indicators were efficacy, safety evaluation, and main symptoms or scores, and there was a lack of a unified core outcome indicator set. There were few studies on adverse reactions and the economy. Only 11.86% of the studies were funded. Clinically, Chinese patent medicines are widely used in the treatment of constipation, and the amount of related research shows an increasing trend. However, some Chinese patent medicines lack corresponding clinical evidence, and the published research has problems such as unrigorous design, ununified criteria for efficacy evaluation, lack of comprehensive evidence studies, and insufficient funds. It is hoped that more investment will be made in this field in the future, and more attention will be paid to drugs with relatively blank research and constipation syndromes with few treatments. Comprehensive evidence studies such as systematic reviews should be carried out actively. And the study design should be standardized to provide reliable evidence for the treatment of constipation with Chinese patent medicines.
10.Four Oral Chinese Patent Medicines for Treatment of Functional Dyspepsia: A Rapid Health Technology Assessment
Miaomiao LI ; Hui ZHAO ; Zeqi DAI ; Xue WU ; Simin XU ; Xudong TANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):161-169
ObjectiveTo evaluate the safety, efficacy, and economy of the four Chinese patent medicines (CPMs), including Simotang oral liquid, Liuwei Anxiao capsule, Baohe pill, and Jianwei Xiaoshi oral liquid in the treatment of functional dyspepsia (FD) by a rapid health technology assessment (RHTA), thus providing evidence support for clinical decision making. MethodChina National Knowledge Infrastructure (CNKI), WanFang Database, VIP Chinese Technology Periodical Database (VIP), China Biology Medicine disc (CBMdisc), PubMed, EMBASE, Cochrane Library, and Web of Science were searched by computer from inception to March 2022. After literature screening, data extraction, and quality evaluation, the descriptive analysis of the results combined with visual charts was performed. Nineteen studies were included, involving 18 randomized controlled trials (RCTs) and 1 Meta-analysis. Neither economic studies nor health technology assessment (HTA) reports were retrieved. ResultThe four CPMs were safe and effective in the treatment of FD, but economic research was lacking. Among them, Simotang oral liquid could be used for children with FD and FD caused by qi and food stagnation, liver and spleen disharmony, and liver and spleen stagnation. Liuwei Anxiao capsule could be used for adult patients with FD caused by food stagnation. Baohe pill could be used for the elderly with FD. Jianwei Xiaoshi oral liquid could be used for children with FD caused by spleen and stomach weakness. ConclusionThe four CPMs have their advantages in the treatment of FD. Among them, the clinical universality of Simotang oral liquid is higher. However, the quality of clinical evidence is generally low, and comparative analysis among drug dosage forms is lacking. In the future, it is necessary to improve, apply, and promote RHTA for rapid evidence production while carrying out a more standardized and scientific evidence-based demonstration of the comprehensive clinical efficacy of CPMs.

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