1.A Preliminary Study on Risk and Benefit Assessment in Ethical Review of Clinical Trials
Pingping DONG ; Zhimin ZHANG ; Shukui QIN
Chinese Medical Ethics 2016;29(4):639-641
The risk and benefit assessment is an important part of ethical review in clinical trials, of which the significance is to minimize the risk and maximize the benefit, thus to protect the rights of the subject. Begin with introducing the nature of the risk and benefit of clinical trial, this paper analyzed the way of ethical review based on risk consideration and discussed some key points of risk and benefit assessment including the minimum risk, the risk and benefit of vulnerable groups, risk informing, benefit of clinical trials, the fairness of recruitment and the importance of strengthening follow-up review. Ethical review should play a role as the balance, which neither-hinder the development of clinical trial to protect the rights of the subjects nor damage the rights and interests of subject to develop clinical trials.
2.Selection of data mart in the application of medical data warehouse to hospital
Zhimin LIU ; Jun DONG ; Xiutang CAO
Chinese Medical Equipment Journal 2004;0(08):-
With the application of HIS in hospital,a great deal of data accumulate in database.It's very important to take advantage of these data for IT and managerial staffs.It is suggested that data mart be selected to process the data at the initial stage.
3.Case analysis of hospital merger and acquisition
Ruiwen HAO ; Zhimin MIAO ; Ming DONG
Chinese Journal of Hospital Administration 2009;25(3):206-208
It presented in detail the acquisition of Qingdao Wan Jie Hospital by the Affiliated Hospital of Medical College Qingdao University, describing the operational mechanisms in organizational setup, specialty setup, personnel management, logistic management, hospital culture and branding of the newly acquired section. It also summarized the achievements in medical resources reorganization and advantages complementary without government investment in a fast and low-cost manner. It is demonstrated that hospital acquisitions are in line with the medical reform, as they expand the service coverage of public hospitals, and extend medical service to the communities and lower levels, thus enhancing hospitals' impact and reach to integrate medical resources in a short timeframe.
4.Ureteral calculi treated with transureteroscopic Holmium:YAG laser lithotripsy (report of 105 cases)
Tiebing ZENG ; Xiaodong DENG ; Zhimin DONG
Chinese Journal of Rehabilitation Theory and Practice 2005;11(2):151-151
ObjectiveTo evaluate the effect of transureteroscopic Holmium:YAG laser lithotripsy on ureteral calculi.Methods105 cases of ureteral stones were treated by transureteroscopic Holmium:YAG laser lithotripsy. The transverses of stones were 4~15 mm and the vertical lengths were 5~25 mm.ResultsSuccessful lithotripsy was achieved on one session in 98 cases (95%), with the stones completely expelled within 2~6 weeks. Complications occurred in 4 cases and stones moved up in 3 cases.ConclusionThe transureteroscopic Holmium:YAG laser lithotripsy is an effective and safe method for ureteral calculi.
5.Space occupying lesion of the spleen
Fusheng WU ; Xiuzhi DONG ; Lisong TENG ; Zhimin MA
Chinese Journal of General Surgery 2001;0(09):-
Objective To summarize the experience in diagnosis and management for the space occupying lesion of spleen. Method The clinical data of 29 cases treated by surgery were retrospectively analyzed. Results There were 15 patients with benign masses including 7 hamartomas, 5 hemangiomas, 1 pseudocyst, 2 tuberculoses of the spleen, and 14 with malignant tumors including 9 lymphomas, 3 angiosarcomas, 2 metastatic tumors in the spleen. Splenectomy was performed in all patients. All patients with benign masses survived except 2 patients lost follow up and 1 coexisting with hepataocellular carcinoma died half a year after the operation. Twelve of 14 patients with malignant tumor were followed up.Of them, 5 patients survived more than 5 years and 2 were alive 1 and 3 years after the operation respectively; 5 patients died 6 months to 4 years after the operation. Conclusions Ultrasonography and CT or MRI are the main means of diagnosis for the space occupying lesion of spleen.It is difficalt to make diagnosis of the splenic tuberculosis before operation.Splenectomy is a primary procedure of surgery.
6.Clinical observation of metformin in treatment of endocrine resistance and postmenopausal hormone receptor positive advanced breast cancer
Yaqi WANG ; Meijian WANG ; Hanzhi DONG ; Zhimin QIU
The Journal of Practical Medicine 2017;33(9):1377-1380
Objective To evaluate the efficacy and security of metformin in the treatment of endocrine resistance and postmenopausal hormone receptor positive advanced breast cancer. Methods 60 cases of postmenopausal HR+advanced breast cancer whose first-line or second-line endocrine therapy failed were randomly divided into study group(n=30),treated with metformin combined with AI and control group(n=30),treated with placebo combined with AI. Standard RECIST guidelines were used to evaluate the clinical response. The objective response rate(ORR),clinical benefit rate(CBR),progression-free survival,and adverse reactions of two groups were compared. Results The ORR of two groups were 16.7%and 10%respectively and the difference was not statistically significant(P > 0.05). But CBR in study group was significantly higher than that in control group (63.3%vs 36.7%),and the difference was statistically significant(P<0.05). The median PFS in study group was slightly longer than that in control group (3.7 m vs 4.2 m),but there was no statistical difference. Multivariate regression analysis showed that PFS was only associated with the previous endocrine therapy. No serious adverse reactions occurred in two groups. Conclusion Metformin is expected to improve secondary endocrine resistance in breast cancer,but large prospective clinical studies are needed to confirm it.
7.The application of data warehouse to the usage of medical quality information
Lei XIA ; Zhimin LIU ; Yongyong XU ; Jun DONG
Chinese Medical Equipment Journal 1989;0(04):-
Objective To set up the medical quality information statistics resource database of No.1 Military Medical Project by data warehouse technology. Method The front-end display tool of OLAP is applied to the setup of the database. Result OLAP platform is established and convenient query, statistics can be realized. Conclusion A great deal of aid decision making information can be got. Thus, the hospital resource utilization and medical quality management are improved.
8.Application of Aiyishu injection in adjuvant treatment of breast cancer after operation and curative effect evaluation
Tong FU ; Sijie LI ; Dong SONG ; Zhimin FAN
Journal of Jilin University(Medicine Edition) 2006;0(04):-
Objective To evaluate the effect of Aiyishu injection on the cellular immunity state of body and toxic and side reaction in post-operation patients with breast cancer after chemotherapy .Methods Seventy patients with breast carcinoma at stage Ⅰ-ⅢA were randomly divided into treatment group (Aiyishu associated CAF regimen) (n=36) and control group (CAF regimen) (n=34).The activities of T cells and NK cells were examined in two groups before and after treatment,and the toxic, side reaction and living quality were also compared.Results The levels of CD3,CD4,CD8 and the ratio of CD4/CD8 and the activity of NK cells in treatment group were higher than those in control group (P
9.Expressions of progesterone receptor A and B in breast cancer and adjacent non-malignant tissues and significances
Bing HAN ; Sijie LI ; Tong FU ; Zhimin FAN ; Dong SONG
Journal of Jilin University(Medicine Edition) 2006;0(06):-
Objective To study the expressions of progesterone receptor A (PRA) and B (PRB) in breast cancer and adjacent non-malignant tissues and the correlations between their expressions and the clinical characteristics. Methods The expressions of PRA and PRB in 50 specimens of female human breast cancer and adjacent non-malignant tissues were detected by immunohistochemistry. The correlations between the expressions of PRA and PRB and the clinical characteristics were analyzed.Results PRA and PRB expressed in both the nuclei and the cytoplasma of tumor cells and epithelial cells of the acini and ducts.The percentages of PRA and PRB positive cells were 42%,42% and 52%,36% in the cancer and the adjacent non-malignant tissues,respectively,there was no significant difference.The expression of PRA was significantly correlated with the age of patient(r=-0.316 8,P
10.Expression and significance of HIF-1α, HIF-2αand MT in human papillary thy-roid carcinoma
Ni WANG ; Chaoran DONG ; Cui TANG ; Lei YANG ; Zhimin LIU
Chinese Journal of Immunology 2014;(5):662-665,676
Objective:To investigate the expression of HIF-1α, HIF-2αand MT in human papillary thyroid carcinoma ( PTC) and the association of their expression with clinicopathological indicators .Methods:Immunohistochemistry was used to analyze the ex-pression of HIF-1α, HIF-2αand MT in 70 PTC samples .The correlations of HIF-1α, HIF-2αand MT expression with one another , and with several clinicopathological indicators were statistically analyzed .Results:In 70 PTC samples, the positive expression rates of HIF-1α, HIF-2αand MT were 52.86%(37/70), 50.00%(35/70) and 44.29%(31/70), respectively.HIF-1α, HIF-2αand MT expression had significant correlations with cervical lymph node metastasis (P=0.034, P=0.022, and P=0.032, respectively). Meanwhile, HIF-1αexpression had a positive correlation with HIF-2α(rs =0.258, P=0.031) and MT (rs =0.266, P=0.026). HIF-2αand MT expression were positively correlated (rs=0.259, P=0.030).Concomitant expression of any two or all of the three molecules had stronger correlation with lymph node metastasis than did each alone ( P=0.004 for HIF-1α/HIF-2α, P=0.024 for HIF-1α/MT, P=0.029 for HIF-2α/MT, P=0.017 for HIF-1α/HIF-2α/MT).Conclusion:HIF-1α, HIF-2αand MT expression in PTC samples have a closely correlation , which are related to cervical lymph node metastasis .Therefore, the expression of HIF-1α, HIF-2αand MT might be used as biomarkers for cervical lymph node metastasis of PTC .