1.Study on patients’medicine instruction regulatory system in the European Union and the enlightenment
Sihan YUAN ; Rong JIANG ; Yujie ZHENG ; Haiqi LI ; Yixuan CHEN ; Rong SHAO
China Pharmacy 2025;36(3):269-274
OBJECTIVE To provide reference for the establishment and improvement of the regulatory system of patients’ medicine instructions in China. METHODS Through searching the official website of the European Medicines Agency (EMA) and related literature, the definition, basic nature, and content of patients’ medicine instructions in the European Union were introduced, and the characteristics of the management system of patients’ medicine instructions in the European Union were analyzed in terms of the management department, approval and change procedures, readability requirements and information accessibility requirements. At the same time, the pilot situation of patients’ medicine instructions in China, as well as problems in the paths of classification and management, readability of content, and information timeliness were analyzed to put forward suggestions. RESULTS & CONCLUSIONS European Union had a dedicated department for the management of medicine instructions; the approval and change procedures for patients’ medicine instructions were clear, the readability requirements were detailed, the readability verification program with patient participation was established, and multi-channel and timely information disclosure was adopted. It is recommended that China establish a mechanism to categorize and manage professionals’ and patients’ medicine instructions, guide multiple parties to participate in the design of patients’ medicine instructions and refine the readability requirements, and improve the mechanism for disclosure of medicine instructions to enhance the timeliness of medication information.
2.International practice and experience insights of electronic drug instructions
Yujie ZHENG ; Rong JIANG ; Yixuan CHEN ; Haiqi LI ; Sihan YUAN ; Rong SHAO
China Pharmacy 2024;35(17):2061-2067
OBJECTIVE To analyze the practices of electronic drug instructions in the European Union (EU), the United States (US) and Japan, so as to provide references for promoting electronic drug instructions under Chinese existing regulatory systems. METHODS By searching the official websites of FDA, European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA), as well as relevant literature, the practice and system of electronic drug instructions in different countries/regions were compared and analyzed. The problems of regulatory system, accessibility form and management system of electronic drug instructions in China were analyzed to put forward the suggestions. RESULT && CONCLUSIONS The EU, the US and Japan had established relevant laws for the implementation of electronic drug instructions, issued guidance to specify management requirements and work processes, and set up information platforms to standardize data requirements and enrich search channels. In contrast, the practice of electronic drug instructions in China is still in its infancy, the implementation of electronic drug instructions in China still lacks legislative support, and its accessibility form and future regulatory system need to be further explored. It is suggested to take the opportunity to carry out the pilot reforms of the age-friendly and barrier-free environment for drug instructions in China, improve the regulatory system of electronic drug instructions, promote the readability of drug instructions by exploring the accessibility form of electronic drug instructions in stages, establish and improve the regulatory system of electronic drug instructions, actively build an electronic information platform for it, and promote the development and implementation of electronic drug instructions.
3.Analysis of utilization and influencing factors of preconception healthcare services among women expecting additional childbirth in Jiading District, Shanghai
Li CHENG ; Lifeng ZHANG ; Liandi SHEN ; Haiqi WANG ; Xianli GUO ; Bing LIU ; Shengrong FAN ; Hong JIANG
Shanghai Journal of Preventive Medicine 2024;36(8):783-788
ObjectiveTo understand the utilization of preconception healthcare services and the influencing factors among the women expecting additional childbirth in Jiading District, Shanghai, and to provide references for promoting the utilization of preconception healthcare services under the new population policy. MethodsA questionnaire survey on the utilization of preconception healthcare services and related influencing factors was carried out among 682 women expecting additional childbirth across six subdistricts in Jiading District, Shanghai. The results were statistically analyzed. ResultsThe average age of the women was (31.7±4.5) years, 30.2% of whom were ≥35 years old. The proportion of women having their third or subsequent children was low, at 16.4%. A significant majority, 92.4%, were found to have various risk factors during initial pregnancy screening. The utilization rate of preconception healthcare services among women seeking additional childbirth was relatively low at 26.7%. Awareness of the free preconception check-up program in Jiading District was also low at 28.6%, and the utilization rate for these services was even lower at 7.69%. Unplanned pregnancies were the primary reason for not utilizing preconception healthcare services, accounting for 63.6%. The results of multifactorial binary logistic regression analysis showed that the utilization rate of preconception healthcare services before the current pregnancy was higher for women aged between 35 and 39 compared to women aged ≤29 years old (OR=1.789, 95%CI: 1.033‒3.099). Women with planned pregnancies had a higher utilization of preconception healthcare services prior to this pregnancy (OR=4.164, 95%CI: 2.627‒6.602). Women who had received preconception care prior to their first birth had a higher utilization rate of preconception care prior to the current pregnancy (OR=7.534, 95%CI: 4.954‒11.456). Women without a family history of chronic diseases had a higher utilization rate of preconception healthcare services (OR=1.903, 95%CI: 1.083‒3.345). ConclusionUnder the context of three-child policy, the proportion of women seeking three or more children in Jiading District is low. Most of these women have risk factors identified during initial pregnancy screenings. The utilization rate of preconception healthcare services and the awareness of the free preconception screening program in Jiading District are both low. Unplanned pregnancies remain the primary reason for failing to receive timely preconception healthcare services. Age, whether the pregnancy was planned, whether the women had received preconception healthcare services before their first baby and family history of chronic diseases are the main factors affecting the utilization of preconception healthcare services. Relevant departments should enhance the promotion of preconception healthcare service programs, especially for women of childbearing age who have not yet given birth, so as to improve the utilization rate of preconception health care services.
4.Clinical features and prognostic analysis of adrenal metastasis tumor
Xiaofeng GUAN ; Xing LUO ; Haiqi LIANG ; Chengyang LI ; Deyun LIU
Chinese Journal of Urology 2024;45(4):314-319
Objective:To discuss the clinical features and prognostic factors of adrenal metastases.Methods:The clinical data of 37 patients with adrenal metastases admitted to the First Affiliated Hospital of Guangxi Medical University from May 2015 to August 2022 were retrospectively analyzed. There were 30 males and 7 females. The median age was 54 (43, 62) years old, including 13 cases aged ≥60 years old and 24 cases aged < 60 years old. There were 22 cases of right metastasis, 12 cases of left metastasis and 3 cases of bilateral metastasis. The maximum diameter of metastatic carcinoma was <3 cm in 10 cases, 3-6 cm in 18 cases, and >6 cm in 9 cases. There were 20 cases of synchronous metastasis (diagnosed with adrenal metastasis at the same time as the primary tumor) and 17 cases of metachronous metastasis (found after the diagnosis of primary tumor). There were 20 cases of adrenal metastasis alone and 17 cases of adrenal metastasis combined with other distant metastasis. 16 cases underwent adrenalectomy, 15 cases underwent adrenalectomy combined with other organ resection, and 6 cases underwent ultrasound-guided needle biopsy. 18 patients were treated with surgery alone, and 19 patients were treated with combined treatment (surgery, chemotherapy, radiotherapy, immunotherapy, targeted therapy, interventional therapy and seed implantation). There were 12 cases of hepatocellular carcinoma, 8 cases of renal clear cell carcinoma, 5 cases of lung adenocarcinoma, 2 cases of colon adenocarcinoma, 2 cases of neuroblastoma, 1 case of renal pelvis carcinoma, 1 case of gastric adenocarcinoma, 1 case of cholangiocarcinoma, 1 case of renal papillary cell carcinoma, 1 case of colon adenosquamous carcinoma, 1 case of thymic small cell carcinoma, 1 case of endometrial carcinoma, and 1 case of diffuse large B-cell lymphoma. The Kaplan-Meier method was used to draw the survival curve, the log-rank test was used to analyze the relationship between the clinical characteristics of patients and overall survival (OS) and progression-free survival (PFS), and the Cox proportional hazards regression model was used to analyze the factors affecting OS.Results:The median follow-up time of the 37 patients was 10 (4, 18.5) months.The overall survival rates at 6 months, 1 year and 2 years were 59.5% (22/37), 43.2% (16/37) and 32.4% (12/37), respectively. The 6-month, 1-year and 2-year overall survival rates of 18 patients who underwent surgery alone were 66.7% (12/18), 44.4% (8/18) and 27.8% (5/18), respectively. The 6 months, 1 year and 2 years overall survival rates of 19 patients with comprehensive treatment were 52.6% (10/19), 42.1% (8/19) and 36.8% (7/19), respectively. There was no significant difference in overall survival rate between the two groups ( P=0.773). Kaplan-Meier survival curve analysis showed that the side of metastatic cancer was a risk factor for OS ( P=0.012) and PFS ( P=0.013), and the time of diagnosis of metastatic cancer was a risk factor for OS ( P=0.021). Univariate Cox regression analysis showed that, time to diagnosis of metastases ( HR=2.5, 95% CI 1.1-5.4, P=0.021), side of metastases ( HR=3.6, 95% CI 1.5-8.5, P=0.004), pulmonary metastases ( HR=3.6, 95% CI 1.1-11.0, P=0.032) and adenocarcinoma of the primary tumor ( HR=3.2, 95% CI 1.2-8.8, P=0.025) were risk factors for OS. Multivariate Cox regression analysis showed that simultaneous presence of metastases ( HR=2.6, 95% CI 1.1-6.2, P=0.033) and metastases located on the left side ( HR=3.6, 95% CI 1.5-8.6, P=0.005) were independent risk factors for OS. Conclusions:Hepatocellular carcinoma is the most common pathological type of adrenal metastases in this study. Patients may benefit from combined therapy based on surgery. The time of diagnosis, side, tumor origin and pathological type of primary tumor are the prognostic factors of adrenal metastases. Simultaneous presence of metastases and left-sided metastases are independent risk factors for OS in patients with adrenal metastases.
5.Initial study on a comprehensive strategy for female patients with bladder pain syndrome
Haiqi WU ; Hai XU ; Yalikun YIERFAN ; Batur JESUR ; Yingguo GAN ; Zhenyu TAN ; Li LU
Journal of Modern Urology 2023;28(2):149-152
【Objective】 To explore the efficacy of a comprehensive treatment strategy of bladder hydrodistension, transurethral resection of bladder lesions and triple drug instillation in patients with painful bladder syndrome (BPS). 【Methods】 A total of 15 female BPS patients treated during Jan.2020 and Oct.2021 were enrolled. All patients received bladder hydrodistension and transurethral resection. After operation, intravesical instillation of a triple-drug mixture (2% lidocaine hydrochloride 20 mL, heparin sodium 25 000 U, and dexamethasone 10 mg) was administered once a day for 5 days, and then once per week for 4 weeks. The Visual Analogue Scale (VAS) score, quality of sexual life, health-related quality of life, and self-rating anxiety scale score were compared before treatment and 1, 4 and 12 weeks after treatment. The complications were recorded. 【Results】 All patients completed the treatment. Of 14 patients, the VAS score and self-rating anxiety scale score were lower in week 1, 4 and 12 after treatment, while the health-related quality of life score increased. One patient’s symptoms remained unchanged. The VAS score decreased from (5.47±1.81) to (1.87±1.51) (P<0.05), and the self-rating anxiety scale score decreased from (18.13±8.64) to (6.33±8.22) (P<0.05). The score of health-related quality of life increased from (24.47±5.41) to (31.53±6.49) (P<0.05). 【Conclusion】 The comprehensive strategy is effective in the treatment of bladder pain syndrome, which can relieve pain symptoms and improve patients’ quality of life.
6.Construction and verification of a nomogram model for predicting pain after transcatheter arterial chemoembolization in patients with hepatocellular carcinoma
Huijie YANG ; Huimin ZHAI ; Hailan LI ; Sijing LIANG ; Juan LIU ; Haiqi MA
Chinese Journal of Practical Nursing 2022;38(24):1885-1891
Objective:To establish a predictive model of moderate to severe pain in patients with hepatocellular carcinoma (HCC) undergoing transcatheter arterial chemoembolization (TACE).Methods:264 patients with HCC who underwent TACE operation in Southern Medical University from January 2017 to April 2018 were selected as the modeling set. The pain was assessed by numeric rating scales. The patients were divided into pain group ( n=96) and non-pain group ( n=168) according to whether moderate to severe pain occurred within 24 hours after the operation. Binary Logistic regression analysis were performed for variables that were statistically significant in the univariate analyses. The predictive nomogram was constructed and the internal validation was performed. In addition, 87 patients with HCC who underwent TACE operation from January 2020 to June 2020 were selected as the validation set for external validation. Results:In the modeling set, 96 patients (36.36%) had moderate to severe pain within 24 hours after TACE operation in 264 patients with HCC, and the dosage of morphine intramuscularly injected within 24 hours was 1015 mg, with an average of 10.57 mg per patient. Multivariate Logistic regression analysis showed that preoperative pain, the distance between the tumor and capsule ≤2 cm, high prothrombin activity, dosage of lipiodol>10 ml, and several thromboembolic tumors were independent risk factors for moderate to severe pain after TACE ( P<0.05). Age>50 was the protective factor of moderate to severe pain after TACE ( P<0.05). The area under ROC curve was 0.799 (95% CI: 0.745-0.853) in the modeling set. The area under Roc curve for internal validation and external validation were 0.780 and 0.788, respectively. The calibration curves showed satisfactory agreements between the model predicted probability and the actually observed probability. Conclusion:The predictive model of moderate to severe pain after TACE was established in this study has good differentiation and accuracy, it has certain guiding significance for predicting the high-risk group of moderate to severe pain after TACE operation and formulating the targeted prevention strategy.
7.Influencing factors of intention to utilize preconception health care services among women with future pregnancy plan
Shengrong FAN ; Liandi SHEN ; Lifeng ZHANG ; Hang LI ; Hong JIANG ; Haiqi WANG
Shanghai Journal of Preventive Medicine 2022;34(6):577-582
ObjectiveTo understand the influencing factors of women’s intention to utilize preconception health care services, so as to promote the utilization of preconception care among women with future pregnancy plan. MethodsThe study was conducted at 8 outpatient health clinics of medical institutions providing perinatal health care in Jiading District of Shanghai. Women who had fertility intention for another child were invited to complete an electronic questionnaire from November 2020 to February 2021. ResultsWomen with better pregnancy and birth care behaviors during the last periconception were more likely to utilize preconception care service before the next conception than those with previous poorer behaviors (OR=1.980, 95%CI= 1.061‒3.694, P=0.032). Women with higher preconception care knowledge scores had better pregnancy and birth care behaviors during the last periconception than those with lower knowledge scores (OR=1.362, 95%C1= 1.004‒1.846, P=0.047). ConclusionsIn order to improve the utilization of preconception care among the population with future pregnancy plan, it is necessary to further strengthen health education and social mobilization to promote the preconception eugenic knowledge, planned pregnancy and pregnancy and birth care behaviors.
8.Application of a recombinant replicase to localize the
Sunjian LYU ; Xuemei YUAN ; Li LIU ; Haiqi ZHANG ; Zhe YU ; Xiaoying HANG ; Weida SHI ; Yinglei WU
Journal of Zhejiang University. Science. B 2021;22(4):295-304

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