1.Observation on the Therapeutic Effect of Yiqi Huoxue Huazhuo Therapy on Hepatic Fibrosis in Wilson's Disease
Lu-Qin ZHANG ; Yong-Zhu HAN ; Nan CHENG ; Jian-Jian DONG
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(4):822-828
Objective To assess the clinical effect of the Yiqi Huoxue Huazhuo therapy(the therapy for replenishing qi,activating blood and resolving turbidity)for the treatment of hepatic fibrosis in Wilson's disease(WD,also known as hepatolenticular degeneration).Methods Using retrospective research method,52 patients with liver fibrosis in WD of qi deficiency and blood stasis type were divided into 24 cases in the control group and 28 cases in the treatment group according to the treatment method.The control group was treated with conventional decopper therapy with western medicines,and the treatment group was treated with Chinese herbal decoction based on Yiqi Huoxue Huazhuo therapy together with conventional decopper therapy.Both groups were treated for a total of 4 weeks.Before and after the treatment,the two groups were observed in the changes of traditional Chinese medicine(TCM)syndrome scores,Unified Wilson's Disease Rating Scale(UWDRS)hepatic symptom scores,serum levels of liver fibrosis indicators of pre-collagen typeⅢ(PCⅢ),hyaluronic acid(HA),collagenⅣ(CⅣ),and laminin(LN),C-X-C motif chemokine ligand 10(CXCL10)level,and the point shear-wave elastography(pSWE)values of hepatic ultrasound based on acoustic radiation force impulse imaging(ARFI).After treatment,the clinical efficacy of the two groups was evaluated.Results(1)After 4 weeks of treatment,the total effective rate of the treatment group was 85.71%(24/28),while that of the control group was 54.17%(13/24),and the intergroup comparison(tested by chi-square test)showed that the therapeutic efficacy of the treatment group was significantly superior to that of the control group(P<0.05).(2)After treatment,the TCM syndrome scores in both groups were decreased compared with those before treatment(P<0.01),and the decrease of TCM syndrome scores in the treatment group was significantly superior to that in the control group(P<0.05).(3)After treatment,the UWDRS liver symptom scores in the two groups were decreased compared with those before treatment(P<0.01),but the difference was not statistically significant when comparing between the two groups after treatment(P>0.05).(4)After treatment,serum levels of liver fibrosis indicators of HA,LN,CⅣ and PCⅢ in the treatment group were all decreased compared with those before treatment(P<0.01),while in the control group only serum LN and PCⅢlevels were decreased(P<0.05).The intergroup comparison showed that the decrease of serum HA,LN,and PCⅢlevels in the treatment group was superior to that in the control group(P<0.05 or P<0.01),while the decrease of serum CⅣlevel tended to be superior to that in the control group,but the difference was not statistically significant(P>0.05).(5)After treatment,the serum chemokine CXCL10 level in the treatment group was significantly decreased compared with that before treatment(P<0.01),while the level tended to decrease in the control group,but the difference was not statistically significant(P>0.05).The intergroup comparison showed that the reduction of serum CXCL10 level in the treatment group was significantly superior to that in the control group(P<0.05).(6)After treatment,the pSWE values of hepatic ultrasound in the two groups were lower than those before treatment(P<0.01),and the reduction of pSWE values in treatment group was significantly superior to that of the control group(P<0.01).Conclusion Yiqi Huoxue Huazhuo therapy can effectively reduce the TCM syndrome scores of WD patients,improve the UWDRS hepatic symptom scores,down-regulate the liver fibrosis indicator level and serum CXCL10 expression level,reduce the pSWE values of hepatic ultrasound,and enhance the clinical efficacy.
2.The trend, problems discovered, and enlightenment to hospital management of medical insurance fund unannounced inspection
Chen XIE ; Yutong WANG ; Weiguo ZHU ; Xueqin SUN ; Rui DONG ; Ding HAN
Chinese Journal of Hospital Administration 2024;40(1):42-46
The rational use of medical insurance fund(MIF) plays an important role in promoting the high-quality development of public hospitals, and the supervision of MIF is in a trend of under the rule of law, normalization, professionalization and standardization, and unannounced inspection will become the norm. The authors systematically analyzed three main trends of MIF unannounced inspections, namely, gradually increasing intensity, constantly innovating methods, and increasingly serious consequences. The problems exposed in unannounced inspections were sorted out from five dimensions: form of results, severity, scope of attribution, subjective intention, and regulatory screening ideas. The enlightenment of MIF unannounced inspections to hospital management was explored from four aspects: compliance awareness, organizational system, fine management, and daily supervision. It was proposed that public hospitals should transform their roles and positions, improve the working mechanism of departmental collaboration, and achieve fine management in policy understanding, system formulation, process design, information support, data governance, regulatory implementation, personnel training, and performance matching. At the same time, internal simulated unannounced inspections in hospitals should be regarded as a routine work.
3.Break the domestic public hospital clinical research evaluation system under the background of"five only"
Xiaowen CHEN ; Yongkai ZHU ; Yingyan ZHENG ; Yuhui LIN ; Peng SHI ; Liyuan HAN ; Pin JIA ; Rui DONG
Modern Hospital 2024;24(3):465-468,492
Objective The purpose of this article is to summarize and review the current status of the construction of clinical research evaluation systems in domestic public hospitals,identify existing problems in the evaluation system,and propose development strategies and suggestions.Methods Retrieved relevant articles,dissertations and policies from the past five years(2018-2022),screened the titles,viewed the full texts of 52 selected papers and their references,and summarized them.Results The"five-only"indicators have long been an important indicator for evaluating clinical research in public hospitals,but in today's scientific research environment and policy environment,the"five-only"evaluation system has revealed its utilitarian draw-backs and gradually evolved into a hindrance to scientific research.It is urgent to break through the"five-only"orientation and establish a clinical research evaluation system oriented towards"transforming and applying transformation of scientific research achievements".Conclusion The evaluation system for clinical research should break the previous"five-only"evaluation model based on quantity-oriented scientific research evaluation.We can draw on the framework of the research output,influence,and environment indicators in the UK's REF Excellence Framework model,combine the American APT system and the Chinese STEM indicator dimensions,explore multi-outcome evaluation,integrate developmental indicators,and continuously improve the indica-tor system and application methods in practice to promote the development of clinical research in public hospitals.
4.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
5.Cloning and functional characterization of α 7 nicotinic acetylcholine receptor molecular chaperone Tmem35a
Zi-han WANG ; Jin-peng YU ; Dong-ting ZHANGSUN ; Xiao-peng ZHU ; Su-lan LUO
Acta Pharmaceutica Sinica 2024;59(7):1993-2001
Nicotinic acetylcholine receptors (nAChRs) belong to ligand-gated ion channel receptors, of which
6.Factors Influencing Inpatient Costs for Patients Undergoing Surgery for Intrauterine Lesions under DRG Payment
Yutong WANG ; Weiguo ZHU ; Xueqin SUN ; Jiali TONG ; Jingya ZHOU ; Qing ZHAO ; Bocheng LI ; Wei ZHANG ; Xiaokun LIU ; Rui DONG ; Chen XIE ; Ding HAN
Medical Journal of Peking Union Medical College Hospital 2024;15(5):1069-1076
To analyze the factors affecting the cost of hospitalization for patients and provide insights using the intrauterine lesion surgery group (DRG code NE19) as an example. This study was a retrospective cross-sectional study, with data from the first page of medical records of patients enrolled under NE19 at a comprehensive tertiary hospital in Beijing from March 15, 2022 to November 30, 2023. Influence factor selection and multifactorial linear regression analysis were conducted with hospitalization cost as the dependent variable, and patient's basic information, treatment information and key concern factors as independent variables. The profit and loss of medical records containing key factors and differences in indicators of hospitalization cost structure were analyzed in the context of clinical practice. A total of 2213 valid medical records (all female patients) were included, with patients predominantly young and middle-aged women under 45 years of age (72.12%), and with 931 day surgery medical records (42.07%). The diagnosis records included 334(15.09%) multiple uterine leiomyomas, and 246(11.12%) pelvic adhesions. A total of 150(6.78%) medical records involved ovary- and tubal-related surgeries or manipulations, with 160(7.23%) main operations being laparoscopic hysterectomy of diseased uterine lesions and 38(1.72%) mechanical rotational excision of abnormal uterine tissue using transhysteroscopy. Linear regression analysis showed that whether or not ovarian and tubal surgical operations were involved ( The NE19 group of hospitals in the study had a high loss rate, and factors such as the severity of the patient's condition and the use of new technologies affected hospitalization costs, suggesting that there is room for further optimization of the existing grouping scheme. Tiered payment standards can be set up for different tiers of healthcare institutions, and a sound and optimized exclusion mechanism can be used to promote the development of new technologies. The internal management of hospitals should encourage the development of daytime surgery to improve the efficiency of medical services.
7.Expert consensus on surgical treatment of oropharyngeal cancer
China Anti-Cancer Association Head and Neck Oncology Committee ; China Anti-Cancer Association Holistic Integrative Oral Cancer on Preventing and Screen-ing Committee ; Min RUAN ; Nannan HAN ; Changming AN ; Chao CHEN ; Chuanjun CHEN ; Minjun DONG ; Wei HAN ; Jinsong HOU ; Jun HOU ; Zhiquan HUANG ; Chao LI ; Siyi LI ; Bing LIU ; Fayu LIU ; Xiaozhi LV ; Zheng-Hua LV ; Guoxin REN ; Xiaofeng SHAN ; Zhengjun SHANG ; Shuyang SUN ; Tong JI ; Chuanzheng SUN ; Guowen SUN ; Hao TIAN ; Yuanyin WANG ; Yueping WANG ; Shuxin WEN ; Wei WU ; Jinhai YE ; Di YU ; Chunye ZHANG ; Kai ZHANG ; Ming ZHANG ; Sheng ZHANG ; Jiawei ZHENG ; Xuan ZHOU ; Yu ZHOU ; Guopei ZHU ; Ling ZHU ; Susheng MIAO ; Yue HE ; Jugao FANG ; Chenping ZHANG ; Zhiyuan ZHANG
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(11):821-833
With the increasing proportion of human papilloma virus(HPV)infection in the pathogenic factors of oro-pharyngeal cancer,a series of changes have occurred in the surgical treatment.While the treatment mode has been im-proved,there are still many problems,including the inconsistency between diagnosis and treatment modes,the lack of popularization of reconstruction technology,the imperfect post-treatment rehabilitation system,and the lack of effective preventive measures.Especially in terms of treatment mode for early oropharyngeal cancer,there is no unified conclu-sion whether it is surgery alone or radiotherapy alone,and whether robotic minimally invasive surgery has better func-tional protection than radiotherapy.For advanced oropharyngeal cancer,there is greater controversy over the treatment mode.It is still unclear whether to adopt a non-surgical treatment mode of synchronous chemoradiotherapy or induction chemotherapy combined with synchronous chemoradiotherapy,or a treatment mode of surgery combined with postopera-tive chemoradiotherapy.In order to standardize the surgical treatment of oropharyngeal cancer in China and clarify the indications for surgical treatment of oropharyngeal cancer,this expert consensus,based on the characteristics and treat-ment status of oropharyngeal cancer in China and combined with the international latest theories and practices,forms consensus opinions in multiple aspects of preoperative evaluation,surgical indication determination,primary tumor re-section,neck lymph node dissection,postoperative defect repair,postoperative complication management prognosis and follow-up of oropharyngeal cancer patients.The key points include:① Before the treatment of oropharyngeal cancer,the expression of P16 protein should be detected to clarify HPV status;② Perform enhanced magnetic resonance imaging of the maxillofacial region before surgery to evaluate the invasion of oropharyngeal cancer and guide precise surgical resec-tion of oropharyngeal cancer.Evaluating mouth opening and airway status is crucial for surgical approach decisions and postoperative risk prediction;③ For oropharyngeal cancer patients who have to undergo major surgery and cannot eat for one to two months,it is recommended to undergo percutaneous endoscopic gastrostomy before surgery to effectively improve their nutritional intake during treatment;④ Early-stage oropharyngeal cancer patients may opt for either sur-gery alone or radiation therapy alone.For intermediate and advanced stages,HPV-related oropharyngeal cancer general-ly prioritizes radiation therapy,with concurrent chemotherapy considered based on tumor staging.Surgical treatment is recommended as the first choice for HPV unrelated oropharyngeal squamous cell carcinoma(including primary and re-current)and recurrent HPV related oropharyngeal squamous cell carcinoma after radiotherapy and chemotherapy;⑤ For primary exogenous T1-2 oropharyngeal cancer,direct surgery through the oral approach or da Vinci robotic sur-gery is preferred.For T3-4 patients with advanced oropharyngeal cancer,it is recommended to use temporary mandibu-lectomy approach and lateral pharyngotomy approach for surgery as appropriate;⑥ For cT1-2N0 oropharyngeal cancer patients with tumor invasion depth>3 mm and cT3-4N0 HPV unrelated oropharyngeal cancer patients,selective neck dissection of levels ⅠB to Ⅳ is recommended.For cN+HPV unrelated oropharyngeal cancer patients,therapeutic neck dissection in regions Ⅰ-Ⅴ is advised;⑦ If PET-CT scan at 12 or more weeks after completion of radiation shows intense FDG uptake in any node,or imaging suggests continuous enlargement of lymph nodes,the patient should undergo neck dissection;⑧ For patients with suspected extracapsular invasion preoperatively,lymph node dissection should include removal of surrounding muscle and adipose connective tissue;⑨ The reconstruction of oropharyngeal cancer defects should follow the principle of reconstruction steps,with priority given to adjacent flaps,followed by distal pedicled flaps,and finally free flaps.The anterolateral thigh flap with abundant tissue can be used as the preferred flap for large-scale postoperative defects.
8.Expert consensus on clinical application of 177Lu-prostate specific membrane antigen radio-ligand therapy in prostate cancer
Guobing LIU ; Weihai ZHUO ; Yushen GU ; Zhi YANG ; Yue CHEN ; Wei FAN ; Jianming GUO ; Jian TAN ; Xiaohua ZHU ; Li HUO ; Xiaoli LAN ; Biao LI ; Weibing MIAO ; Shaoli SONG ; Hao XU ; Rong TIAN ; Quanyong LUO ; Feng WANG ; Xuemei WANG ; Aimin YANG ; Dong DAI ; Zhiyong DENG ; Jinhua ZHAO ; Xiaoliang CHEN ; Yan FAN ; Zairong GAO ; Xingmin HAN ; Ningyi JIANG ; Anren KUANG ; Yansong LIN ; Fugeng LIU ; Cen LOU ; Xinhui SU ; Lijun TANG ; Hui WANG ; Xinlu WANG ; Fuzhou YANG ; Hui YANG ; Xinming ZHAO ; Bo YANG ; Xiaodong HUANG ; Jiliang CHEN ; Sijin LI ; Jing WANG ; Yaming LI ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2024;31(5):844-850,封3
177Lu-prostate specific membrane antigen(PSMA)radio-ligand therapy has been approved abroad for advanced prostate cancer and has been in several clinical trials in China.Based on domestic clinical practice and experimental data and referred to international experience and viewpoints,the expert group forms a consensus on the clinical application of 177Lu-PSMA radio-ligand therapy in prostate cancer to guide clinical practice.
9.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
10.Simultaneous determination of gefitinib,erlotinib,nilotinib and imatinib concentrations in plasma by HPLC-MS/MS
Tian-Lun ZHENG ; Jing-Pu XU ; Zhu-Hang HAN ; Wen-Li LI ; Wei-Chong DONG ; Zhi-Qing ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):899-903
Objective To establish a high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)for the simultaneous determination of gefitinib,erlotinib,nillotinib and imatinib plasma concentrations and analyze the results.Methods The plasma samples were treated with acetonitrile precipitation and separated by Diamonsil C18 column(150 mm ×4.6 mm,3.5 μm)with mobile phase of 0.1%formic acid water(A)-0.1%formic acid acetonitrile(B).The flow rate of gradient elution was 0.7 mL·min-1,and the column temperature was 40 ℃ and the injection volume was 3 μL.Using arotinib as the internal standard,the scanning was carried out by using electrospray ionization source in positive ionization mode with multi-reaction monitoring.The specificity,standard curve,lower limit of quantitation,precision,accuracy,recovery rate,matrix effect and stability of the method were investigated.The concentrations of imatinib and erlotinib in 20 patients with chronic myelogenous leukemia(CML)and gefitinib and erlotinib in 3 patients with non-small cell lung cancer were measured.Results The standard curves of the four drugs were as follows,gefitinib:y=2.536 × 10-3x+9.362 × 10-3(linear range 20-2 000 ng·mL-1,R2=0.996 6);erlotinib:y=3.575× 10-3x+7.406 × 10-3(linear range 50-5 000 ng·mL-1,R2=0.994 9);nilotinib:y=1.945 x 10-3x+0.015 643(linear range 50-5 000 ng·mL-1,R2=0.990 6);imatinib:y=4.56 x 10-3x+0.010 451(linear range 100~104 ng·mL-1,R2=0.9963).RSD of intra-day and inter-day were less than 10%,and the accuracy ranged from 90%to 110%,and the recovery rates were 91.35%to 98.93%(RSD<10%);the matrix effect ranged from 91.64%to 107.50%(RSD<10%).Determination of 23 patients showed that the blood concentration of nilotinib ranged from 623.76 to 2 934.13 ng·mL-1,and the blood concentration of imatinib ranged from 757.77 to 2 637.71 ng·mL-1,and the blood concentration of gefitinib ranged from 214.76 to 387.40 ng·mL-1.The serum concentration of erlotinib was 569.57 ng·mL-1.Conclusion The method of this research is simple,fast,sensitive and dedicated,which can be monitored by the concentration of clinical blood.


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