1.Analysis on approval and declaration of new Chinese medicines from 2016 to 2022
Xuezhen LI ; Lishi CHEN ; Xiating PING ; Xiang ZHOU
International Journal of Traditional Chinese Medicine 2024;46(4):519-525
Objective:To discuss and analyze the current situation of the application and approval of new Chinese medicine in China; To provide a reference for the research and development of new Chinese medicines in the future.Methods:The drug registration data were retrieved from Xanda database from January 1, 2016 to December 31, 2022, and the information of new approval and application of new Chinese medicines during this periods was systematically organized from the aspects of the number of registered varieties, registration categories, therapeutic areas, prescription sources, dosage form distribution, development cycle, clinical research and control drugs.Results:From 2016 to 2022, the total number of application for new Chinese medicines was 265. The number of registration classification 1.1 of new compound drugs was the largest. The dosage forms of new drugs were mainly granules, capsules, and tablets. Indications mainly focused on respiratory, neuropsychiatric, digestion and cardio-cerebrovascular diseases, etc. From 2016 to 2022, the total number of approval for new Chinese medicines was 29, of these, 19 from 2021 to 2022. The number of registration classification 1.1 of new Chinese medicines was the largest. The treatment fields are mainly respiratory system, gynecology and neuropsychiatric diseases, etc. The dosage forms of new drugs were mainly granules, capsules, and tablets. The number of drugs in prescriptions was 6-15. High-frequency drugs included Glycyrrhizae Radix et Rhizoma, Ephedrae Herba, Scutellariae Radix, Pinelliae Rhizoma, Poria and Gypsum Fibrosum. Phase Ⅱ and phase Ⅲ of the clinical trials had the largest number. The development period was approximately between 10-20 years. The most prescription source of new drugs was clinical experienced prescriptions and hospital pharmaceutics.Conclusion:The results show that China has been gradually building-up a relatively complete ecosystem for research and development of new Chinese medicines, helping to develop more high-quality Chinese medicines.
2.Study on the application value of fecal SDC2 gene methylation detection in colorectal cancer screening of urban residents in Zengcheng District in Guangzhou City
Yan HE ; Fangfang XU ; Haijun ZUO ; Wei CHEN ; Zhibin LIU ; Zebang LIU ; Xuezhen CHEN ; Qingshen HUI ; Gengwen ZOU ; Zhenbin CAI ; Yang LIU ; Haoshun TAN ; Hongfeng ZHOU ; Jianping WANG
Chinese Journal of Preventive Medicine 2024;58(7):1020-1028
Objective:To investigate the application value of fecal Syndecan-2 (SDC2) gene methylated SDC2 (m SDC2) detection in colorectal cancer (CRC) screening among urban residents in Guangzhou City. Methods:A cross-sectional study was conducted in Shitan Town, Zengcheng District, Guangzhou City from July to December 2022. A community-based screening program for CRC was conducted among residents aged 40-74 years old. m SDC2 detection was employed in the participants, and those with positive results should be recommended to receive colonoscopy examination. The positive rate of m SDC2 detection, colonoscopy compliance rate, detection rate of intestinal lesions and clinicopathological characteristics were observed. The relationship between cycle threshold (CT) value of m SDC2 and intestinal lesions was explored. Further, the cost-effectiveness of screening was evaluated. Results:A total of 8 189 fecal samples were collected from 8 877 participants with the recovery rate of 92.25%. 8 048 qualified samples were enrolled in this study, consisted of 3 182 males (39.54%) and 4 866 females (60.46%), with the average age of 56 years old (40-74 years). The positive rate of m SDC2 detection was 7.99% (643/8 048), and the compliance rate of colonoscopy was 73.10% (470/643). 20 cases (4.25%) of colorectal cancer, 109 cases (23.19%) of advanced adenoma, 145 cases (30.85%) of non-advanced adenoma, 79 cases (16.81%) of polyps were detected. The detection rate of intestinal lesions was 75.11% and indicated significant differences in gender and age. 20 CRCs included 15 of stage 0-I, 4 of stage Ⅱ-Ⅲ and 1 of unknown stage. The CT value of m SDC2 was negatively correlated with the proportion of advanced colorectal neoplasms ( χ2=16.063, P<0.001). The total cost of the screening was 4.339 5 million yuan, the screening benefit was 28.506 2 million yuan, and the benefit-cost ratio was 6.57. Conclusion:The CRC screening strategy of fecal m SDC2 detection combined with colonoscopy has high colonoscopy compliance and detection rate of intestinal lesions, which is conducive to the detection of early CRCs, and has good cost-effectiveness. This study suggests that this method may be applied to the general CRC screening in China and contribute to the prevention of CRC. The CT value of m SDC2 may have a certain suggestion on the malignant degree of intestinal tumors.
3.Study on the application value of fecal SDC2 gene methylation detection in colorectal cancer screening of urban residents in Zengcheng District in Guangzhou City
Yan HE ; Fangfang XU ; Haijun ZUO ; Wei CHEN ; Zhibin LIU ; Zebang LIU ; Xuezhen CHEN ; Qingshen HUI ; Gengwen ZOU ; Zhenbin CAI ; Yang LIU ; Haoshun TAN ; Hongfeng ZHOU ; Jianping WANG
Chinese Journal of Preventive Medicine 2024;58(7):1020-1028
Objective:To investigate the application value of fecal Syndecan-2 (SDC2) gene methylated SDC2 (m SDC2) detection in colorectal cancer (CRC) screening among urban residents in Guangzhou City. Methods:A cross-sectional study was conducted in Shitan Town, Zengcheng District, Guangzhou City from July to December 2022. A community-based screening program for CRC was conducted among residents aged 40-74 years old. m SDC2 detection was employed in the participants, and those with positive results should be recommended to receive colonoscopy examination. The positive rate of m SDC2 detection, colonoscopy compliance rate, detection rate of intestinal lesions and clinicopathological characteristics were observed. The relationship between cycle threshold (CT) value of m SDC2 and intestinal lesions was explored. Further, the cost-effectiveness of screening was evaluated. Results:A total of 8 189 fecal samples were collected from 8 877 participants with the recovery rate of 92.25%. 8 048 qualified samples were enrolled in this study, consisted of 3 182 males (39.54%) and 4 866 females (60.46%), with the average age of 56 years old (40-74 years). The positive rate of m SDC2 detection was 7.99% (643/8 048), and the compliance rate of colonoscopy was 73.10% (470/643). 20 cases (4.25%) of colorectal cancer, 109 cases (23.19%) of advanced adenoma, 145 cases (30.85%) of non-advanced adenoma, 79 cases (16.81%) of polyps were detected. The detection rate of intestinal lesions was 75.11% and indicated significant differences in gender and age. 20 CRCs included 15 of stage 0-I, 4 of stage Ⅱ-Ⅲ and 1 of unknown stage. The CT value of m SDC2 was negatively correlated with the proportion of advanced colorectal neoplasms ( χ2=16.063, P<0.001). The total cost of the screening was 4.339 5 million yuan, the screening benefit was 28.506 2 million yuan, and the benefit-cost ratio was 6.57. Conclusion:The CRC screening strategy of fecal m SDC2 detection combined with colonoscopy has high colonoscopy compliance and detection rate of intestinal lesions, which is conducive to the detection of early CRCs, and has good cost-effectiveness. This study suggests that this method may be applied to the general CRC screening in China and contribute to the prevention of CRC. The CT value of m SDC2 may have a certain suggestion on the malignant degree of intestinal tumors.
4.Analysis of DRG policy implementation dilemma and countermeasures of China based on Smith policy implementation process model
Manchen LYU ; Dian ZHOU ; Di TIAN ; Yuan ZHOU ; Yu ZHANG ; Tongbin XUE ; Xuezhen LIU ; Ye WU
Chinese Journal of Hospital Administration 2024;40(9):662-665
DRG payment reform is an important means to control the unreasonable growth of medical expenses, improve the quality of medical services and achieve a win-win situation among three sides of hospitals, medical insurance and patients. This study adopted the Smith policy implementation process model to analyze the difficulties in the DRG policy implementation process from four aspects(idealized policies, policy implementation institutions, target groups, and policy environment), including the deviation between policy connotations and actual needs; the interest objectives of all parties were not completely aligned, the target group lacked a sense of identity, and the social impact and technological support needed to be improved. It was suggested that optimization should be carried out from four dimensions: policy supply coordination and precision, performance evaluation and personnel literacy, target group cognitive level and participation willingness, and policy implementation environment and atmosphere, in order to synergistically promote the effective implementation of DRG policies.
5.Clinical efficacy and influencing factor of Remote Ischemic Postconditioning in Patients with Post Stroke Fatigue
Suzhen YE ; Xiaoyang WANG ; Hongzhao BAI ; Xuezhen ZHOU ; Haiyan LI
The Journal of Practical Medicine 2023;39(21):2812-2816
Objective To investigate the clinical effects and influencing factors of remote ischemic post-conditioning RIPostC in the patients with post stroke fatigue(PSF).Methods Eighty patients with PSF were ran-domly divided into experimental group(n = 40)and control group(n = 40).Patients in both groups received routine drug therapy and rehabilitation training for stroke.The experimental group were additionally given RIPostC for four weeks.They were evaluated with National Institute of Health Stroke Scale(NIHSS),Barthel Index(BI),Mini-mental State Examination(MMSE),fatigue severity scale(FSS),Hamilton Anxiety Scale(HAMA),and Hamilton Depression Scale(HAMD).Results The score of NIHSS,FSS,HAMA and HAMD in the both groups were decreased,while the score of BI and MMSE were increased(P<0.01).The difference in the score of NIHSS,BI,MMSE,FSS,HAMA and HAMD between the two groups before and after treatment showed statistical significance(P<0.01)and the difference in the score was more significant in the experimental group.The risk factors of FSS were MMSE and HAMA.Conclusion RIPostC can effectively improve the neurological deficits,daily activity ability and cog-nitive function,alleviate fatigue,anxiety and depression in the patients of PSF.The influencing factors of PSF are cognitive function and anxiety.
6.Effect of Kinesio taping on salivation for stroke patients with dysphagia
Xuezhen ZHOU ; Wenxiu WU ; Zuchen LIN ; Haiyan LI ; Suzhen YE
Chinese Journal of Rehabilitation Theory and Practice 2022;28(5):530-533
ObjectiveTo observe the effect of Kinesio taping on salivation after stroke. MethodsFrom October, 2019 to January, 2021, 40 patients with salivation after stroke were randomly divided into control group (n = 20) and experimental group (n = 20). Both groups received routine medicine, routine rehabilitation for dysphagia and rehabilitation nursing, while the experimental group received Kinesio taping in addition, for three weeks. They were assessed with Functional Oral Intake Scale (FOIS), Water Swallow Test (WST) and Teacher Drooling Scale (TDS) before and after treatment. ResultsOne case dropped in the experimental group. The scores of FOIS, TDS and WST improved in both groups after treatment (|Z| > 2.000, P < 0.05), and improved more in the experimental group than in the control group (|Z| > 3.045, P < 0.01). ConclusionKinesio taping may relieve the salivation of patients with dysphagia after stroke.
7. Discussion on the effect of comprehensive nursing in endoscopic treatment of esophageal and gastric varicose bleeding
Xian LU ; Xuezhen ZHOU ; Jing WANG ; Yan SHAO ; Yuhong XU
Chinese Journal of Practical Nursing 2020;36(6):415-418
Objective:
To explore and analyze the effect of comprehensive nursing care in endoscopic treatment of esophageal and gastric varicose bleeding.
Methods:
A retrospective analysis of 60 cases of patients with esophageal and gastric varicose hemorrhage admitted to the hospital was conducted. The patients were randomly divided into 30 cases of control group and 30 cases of observation group. Routine nursing and comprehensive nursing were adopted respectively to evaluate different nursing effects.
Results:
Intraoperative and postoperative heart rate of the observation group (91.0 ± 4.0) times/min, (89.2 ± 4.2) times/min, which were lower than (98.0 ± 4.2) times/min, (94.7 ± 4.5) times/min of the control group. There was statistically significant difference (
8.Conservative therapy with metformin plus megestrol acetate for endometrial atypical hyperplasia.
Weiwei SHAN ; Chao WANG ; Zhenbo ZHANG ; Chao GU ; Chengcheng NING ; Xuezhen LUO ; Qiongjie ZHOU ; Xiaojun CHEN
Journal of Gynecologic Oncology 2014;25(3):214-220
OBJECTIVE: To compare the efficacy of metformin plus megestrol acetate (MA) with that of MA alone for treating endometrial atypical hyperplasia (EAH). METHODS: This pilot study included 16 EAH patients who met at least one metabolic syndrome (MS) criterion and received either adjunctive metformin plus MA (MET group) or MA monotherapy (MA group). Each patient in the MA group received 160 mg of MA daily, whereas patients in the MET group received the same dose of MA plus 0.5 g of metformin thrice daily. Treatment response was assessed by histological examination of dilation and curettage specimens obtained after 12 weeks of therapy. RESULTS: Each group had eight patients, and half of the patients in each group were diagnosed with MS. The complete response (CR) rate was 75% (6/8) in the MET group and 25% (2/8) in the MA group (p=0.105). Complications of MS did not affect the response rates in either group. In the MET group, 75% (3/4) of the patients had CR in the presence or absence of MS. In the MA group, 50% (2/4) of the patients with MS had CR, whereas no patient without MS had CR. No irreversible toxicities were observed. CONCLUSION: Metformin plus MA may be a potential alternative therapy for treating EAH, and the MS status of patients may have no effect on the efficacy of metformin plus MA therapy.
Adult
;
Antineoplastic Agents, Hormonal/*therapeutic use
;
Drug Therapy, Combination
;
Endometrial Hyperplasia/complications/*drug therapy/metabolism
;
Female
;
Humans
;
Hypoglycemic Agents/*therapeutic use
;
Megestrol Acetate/*therapeutic use
;
Metabolic Syndrome X/complications/metabolism
;
Metformin/*therapeutic use
;
Pilot Projects
;
Receptors, Estrogen/metabolism
;
Receptors, Progesterone/metabolism
;
Single-Blind Method
;
Treatment Outcome
9.Observation of hydrocolloid dressing in preventing iatrogenic phlebitis
Ya CHEN ; Xuezhen ZHOU ; Ping YU
Journal of Clinical Medicine in Practice 2014;(12):147-148
Objective To observe the effect of hydrocolloid dressing in treatment of iatro-genic phlebitis (IP).Methods 120 patients treated with intravenous infusion of hypertonic fluid were equally divided into experimental group (preventively treated with hydrocolloid dressing named Kang Huier transparent stickers)and control group (treated with conventional transfusion stickers).The incidence rate,onset time and severity of IP were compared between the two groups.Results Incidence rate of IP in the experimental group was significantly lower than that in the control group,and the onset time of IP in the experimental group was later than that in the control group(P <0.05).Conclusion Kang Huier transparent stickers are worthy of populariza-tion and application.
10.Observation of hydrocolloid dressing in preventing iatrogenic phlebitis
Ya CHEN ; Xuezhen ZHOU ; Ping YU
Journal of Clinical Medicine in Practice 2014;(12):147-148
Objective To observe the effect of hydrocolloid dressing in treatment of iatro-genic phlebitis (IP).Methods 120 patients treated with intravenous infusion of hypertonic fluid were equally divided into experimental group (preventively treated with hydrocolloid dressing named Kang Huier transparent stickers)and control group (treated with conventional transfusion stickers).The incidence rate,onset time and severity of IP were compared between the two groups.Results Incidence rate of IP in the experimental group was significantly lower than that in the control group,and the onset time of IP in the experimental group was later than that in the control group(P <0.05).Conclusion Kang Huier transparent stickers are worthy of populariza-tion and application.

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