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1.
Arch. endocrinol. metab. (Online) ; 65(4): 411-420, July-Aug. 2021. tab, graf
Article in English | LILACS | ID: biblio-1339098

ABSTRACT

ABSTRACT Objective: The aim of this study was to describe the real-world experience multikinase inhibitors (MKI) in the treatment advanced differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAIR) therapy. Subjects and methods: We reviewed the records of all patients with MKI-treated DTC from 2010 to 2018. Progression free survival (PFS), response rates (RR) and adverse events (AE) profiles were assessed. Clinical parameters were compared between groups with different outcomes (disease progression and death) to identify possible prognostic factors and benefit from treatment. Results: Forty-four patients received MKI for progressive RAIR DTC. Median PFS was 24 months (10.2-37.7) and median overall survival (OS) was 31 months. Best overall response was complete response in one patient (4.5%), partial response in nine (20.4%), stable disease in twenty-two (50%), and progressive disease (PD) in twelve (27.3%). Seventy-two point 7 percent patients had clinical benefit and AE were mild in most cases (82.7%). Progressive patients were more likely to have FDG positive target lesion than those who did not progress (p = 0.033) and higher maximum SUV on target lesions (p = 0.042). Presence of lung-only metastasis and lower thyroglobulin (Tg) during treatment was associated with stable disease (p = 0.015 and 0,049, respectively). Patients with shorter survival had larger primary tumor size (p = 0.015) and higher maximum SUV on target lesions (p = 0.023). Conclusion: Our findings demonstrate safety and effectiveness of MKI in patients with advanced RAIR DTC. We were able to identify as possible prognostic markers of better outcomes: absence of FDG uptake on target lesions, lower maximum SUV on PET-CT, presence of lung-only metastasis and lower Tg during treatment.


Subject(s)
Humans , Thyroid Neoplasms/drug therapy , Protein Kinase Inhibitors/therapeutic use , Antineoplastic Agents/therapeutic use , Prognosis , Positron Emission Tomography Computed Tomography , Iodine Radioisotopes
2.
Article in Chinese | WPRIM | ID: wpr-908607

ABSTRACT

Medication treatment is the most common measure for lowering intraocular pressure in glaucoma, and prostaglandin analogues have been unanimously recommended as the first choice for the treatment of glaucoma in multiple guidelines or consensus.Real-world studies (RWS) are observational studies in which diverse data are obtained in clinical environment, community or home settings to evaluate the real impact of some treatment on patients’ health.RWS have shown that tafluprost has a good effect on lowering intraocular pressure in patients with primary open angle glaucoma, ocular hypertension, normal tension glaucoma and other types of glaucoma, and it has mild ocular adverse effects in monotherapy for treatment-naive patients, alternative therapy and combination therapy.However, there are limiting factors for RWS such as the absence of the control group, and further studies are needed to evaluate the drug efficacy.In this article, the RWS of patients with different types of glaucoma and high intraocular pressure treated by tafluprost and the efficacy of tafluprost under different treatment modes as well as the safety of tafluprost and medication compliance in RWS were reviewed, so as to provide certain guidance for the practical clinical application of tafluprost.

3.
Article in Chinese | WPRIM | ID: wpr-907761

ABSTRACT

Objective:To summarize the clinical characteristics of patients with coronavirus disease 2019 (COVID-19) infected with Delta variant, so as to provide further references for clinical diagnosis and treatment.Methods:A real-world study was conducted to analyze the characteristics of 166 COVID-19 patients infected with Delta variant at Guangzhou Eighth People’s Hospital, Guangzhou Medical University.Results:The study enrolled 5 asymptomatic cases, 123 non-severe cases (mild and moderate type), and 38 severe cases (severe and critical type). Among these patients, 69 (41.6%) were male and 97 (58.4%) were female, with a mean age of 47.0±23.5 years. Thirty-nine cases (23.5%) had received 1 or 2 doses of inactivated vaccine. The incidence of severe COVID-19 cases was 7.7% in 2-doses vaccinated patients, which was lower than that of 11.5% in 1-dose and 26.8% in unvaccinated patients. The proportion of severe cases in 2 dose-vaccinated patients was 7.7%, which was lower than that of 11.5% in 1-dose vaccinated patients and 26.8% in unvaccinated patients, but the difference was not significant ( P>0.05). The most common clinical symptom was fever (134 cases, 83.2%), and 39.1% of cases presented with high-grade fever (≥39 °C); other symptoms were cough, sputum, fatigue, and xerostomia. The proportion of fever in severe cases was significantly higher than that of non-severe cases (97.4% vs. 76.4%, P<0.01). Similarly, the proportion of severe cases with high peak temperature (≥39 ℃) () was also higher than that of non-severe cases (65.8% vs. 30.9%, P<0.01). The median minimal Cycle threshold (Ct) values of viral nucleic acid N gene and ORFlab gene were 20.3 and 21.5, respectively, and the minimum Ct values were 11.9 and 13.5, respectively. Within 48 h of admission, 9.0% of cases presented with decreased white blood cell counts, and 52.4% with decreased lymphocyte counts. The proportions of increased C-reactive protein, serum amyloid A, interleukin 6, and interleukin 10 were 32.5%, 57.4%, 65.3%, and 35.7%, respectively. The proportions of elevated C-reactive protein, serum amyloid A and interleukin-6 in severe cases were significantly higher than those in non-severe cases ( P<0.01). Logistic regression analysis showed that older age and higher peak temperature were associated with a higher likelihood of severe cases ( OR>3, 95% CI: 2-7, P<0.01). In terms of treatment, traditional Chinese medicine (TCM) was used in 97.6% of non-severe cases and 100% in severe cases. Other treatments included respiratory and nutritional support, immunotherapy (such as neutralizing antibodies and plasma of recovered patients). The median times from admission to progression to severe cases, of fever clearance, and of nucleic acid conversion were 5 days, 6 days and 19 days, respectively. No deaths were reported within 28 days. Conclusions:The symptoms of Delta variant infection in Guangzhou are characterized by a high proportion of fever, high peak temperature, long duration of fever, high viral load, a long time to nucleic acid conversion, and a high incidence of severe cases. The severe cases exhibit a higher percentage of elderly patients, a longer duration of fever and have a higher fever rate and a higher hyperthermia rate than non-severe cases. Age and hyperthermia are independent risk factors for progression to severe disease. The combination of TCM and Western medicine can control the progression of the disease effectively.

4.
Article in Chinese | WPRIM | ID: wpr-906377

ABSTRACT

Objective:To explore the clinical diagnosis and treatment characteristics as well as the optimal schemes of Lianhua Qingwen Capsule in the treatment of upper respiratory tract infection (URTI) in the real world. Method:The information of 454 patients receiving Lianhua Qingwen Capsule for URTI was collected from the electronic medical data warehouse constructed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, which covered 16 large-scale tertiary Class A hospital information systems (HISs). The harvested information was subjected to descriptive analysis, Apriori algorithm-based analysis and Louvain (BGLL) algorithm-based complex network analysis to explore the clinical medication schemes. Result:The commonly adopted medication schemes were heat-clearing and detoxicating Chinese medicinal injections combined with expectorants, analgesic-antipyretic drugs, or antibacterial agents in western medicine. Besides, the combination with heat-clearing and phlegm-resolving Chinese medicinals, vitamins, or hypotensive, lipid-lowering, hypoglycemic, coronary circulation-improving, or antiplatelet aggregation drugs targeting the underlying diseases was also detectable. Conclusion:The complex network analysis based on BGLL clustering method can be used to find out the medication rules of Lianhua Qingwen Capsule for URTI. The traditional Chinese medicine has been widely employed for resolving phlegm and relieving cough due to its good efficacy. The combination with antibiotics follows the guidelines for the use of antimicrobial agents. Drug safety is one of the most concerned aspects in clinical drug combination. The uncovering of these rules has provided a direction for exploring the optimal treatments.

5.
Article in Chinese | WPRIM | ID: wpr-906065

ABSTRACT

Objective:To explore the group modules of Chinese medicine and western medicine for the treatment of bronchitis patients with Xiyanping injection based on the real world to provide references for the clinical treatment of bronchitis with Chinese medicine and western medicine. Method:Medical records of 13 874 patients with bronchitis treated by Xiyanping injection were extracted from 29 hospital information systems (HISs) in China,and complex network analysis was carried out using Tabu Search algorithm to obtain the substructure and associated information of core drug combination of Xiyanping injection for the treatment of bronchitis and to analyze clinical medication protocols. Result:Medication protocols for the pathogens of bronchitis are listed below: Xiyanping injection + cefuroxime for bacterial infection. Xiyanping injection + interferon for viral infection. Xiyanping injection + azithromycin for mycoplasma infection. According to the clinical symptoms and complications of bronchitis, the appropriate medication protocols were as follows: Xiyanping injection + ambroxol + Feilike mixture + ibuprofen for uncomplicated bronchitis. Xiyanping injection + ipratropium bromide + budesonide + salbutamol for asthmatic bronchitis. Xiyanping injection + mannitol + furosemide + phenobarbital + gangliosides + immunoglobulin for bronchitis complicated with viral encephalitis. Xiyanping injection + creatine phosphate sodium + vitamin C for bronchitis complicated with viral myocarditis. The combined medication of Chinese medicine for the treatment of bronchitis was adopted based on its characteristics of traditional Chinese medicine. Conclusion:The data of this study were derived from the real world. The combined medications protocols of Xiyanping injection targeting the clinical symptoms and complications of bronchitis were extracted and summarized. However, it is necessary to formulate an individualized medication protocol according to the specific condition.

6.
Article in Chinese | WPRIM | ID: wpr-906057

ABSTRACT

Objective:To explore the long-term effect of Zhenzhu Tiaozhi capsule(FTZ) on hemoglobin A1c(HbA1c)in patients with type 2 diabetes mellitus (T2DM) based on real-world data. Method:T2DM patients who were provided with FTZ (FTZ group) and those receiving conventional hypoglycemic drugs (control group) were extracted from the hospital information system (HIS) of the First Affiliated Hospital of Guangdong Pharmaceutical University, followed by propensity score matching (PSM) for balancing the confounding factors between groups. With HbA1c as the efficacy evaluation index, the difference in efficacy between the two groups was compared using <italic>t</italic>-test and <italic>χ</italic><sup>2</sup> test. For repeated measurement data of the same patient, the difference in efficacy and the stability of FTZ against HbA1c were analyzed by generalized estimating equation (GEE). The factors that might affect the efficacy of FTZ against HbA1c were subjected to multivariate linear regression analysis (MLRA), and the subgroup analyses were then conducted after the stratification of relevant factors. Result:There were 46 patients included in the FTZ group and 1 208 patients in the control group. PSM yielded 42 pairs of samples with balanced covariates between groups. As revealed by one-year observation, ① HbA1c in the FTZ group after treatment was 6.51%±1.09%. No significant difference was observed either in pre- and post-treatment comparison in the FTZ group or in its comparison with the control group. At the same time, the HbA1c compliance rate in the FTZ group was 73.8% after treatment. No significant difference was observed either in pre- and post-treatment comparison in the FTZ group or in its comparison with the control group. ② The GEE results showed that the post-treatment HbA1c levels in the two groups were not significantly different from each other. Moreover, the HbA1c level remained stable over treatment time. ③ MLRA and subgroup analyses results demonstrated that FTZ was more effective in patients with high baseline HbA1c [<italic>β</italic>=-0.530,95% confidence interval(CI) -0.850~-0.209,<italic>P</italic><0.01] or those who were complicated with hypertension (<italic>β</italic>=-0.918,95%CI -1.614~-0.222,<italic>P</italic><0.05). Conclusion:In the real world, FTZ is able to control the blood sugar, and its effect is similar to those of conventional hypoglycemic drugs. Besides, it is capable of stabilizing the blood sugar for a long time.

7.
Journal of Clinical Hepatology ; (12): 2595-2599, 2021.
Article in Chinese | WPRIM | ID: wpr-904999

ABSTRACT

Objective To investigate the use of hepatoprotective drugs in China in recent years, and to put forward related suggestions. Methods The outpatient prescription data of hepatoprotective drugs were collected from 85 hospitals in 6 cities of China from 2015 to 2019, and a real-world data analysis was performed to analyze the payment method, issuing department, drug category, and use of hepatoprotective drugs. Results A total of 1 113 575 prescriptions were extracted, involving 38 hepatoprotective drugs such as compound glycyrrhizin, polyene phosphatidylcholine, and bicyclol. Hepatoprotective drugs were mainly in tertiary hospitals, and the highest number of prescriptions containing hepatoprotective drugs were observed in department of infectious diseases, department of gastroenterology, and department of tuberculosis. Anti-inflammatory hepatoprotective drugs accounted for the highest proportion of all prescriptions, mainly compound glycyrrhizin, polyene phosphatidylcholine, and bicyclol. Of all prescriptions, 253 429 (22.76%) had the combination of multiple hepatoprotective drugs, with the highest number of 6 drugs, among which polyene phosphatidylcholine combined with bicyclol accounted for the highest proportion. Conclusion There are large quantities of hepatoprotective drugs used by outpatients in China. At present, the hepatoprotective drugs are clinically applied rationally, but there are still some problems to be solved, such as the combination of drugs.

8.
Article in Chinese | WPRIM | ID: wpr-921721

ABSTRACT

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.


Subject(s)
Drugs, Chinese Herbal/adverse effects , Humans , Medicine, Chinese Traditional , Prescriptions , Reproducibility of Results , Research
9.
Article in Chinese | WPRIM | ID: wpr-912844

ABSTRACT

Clinical data is one of the key sources of real-world data, while the reliability of such data is often hindered by unscientific and irregular data management. Based on various problems found in the application of clinical data to scientific research, this study formulated a standard operation procedure(SOP) for real-world data management, and organized the data in terms of content and logic consistency, completeness and standardization. The clinical data of syphilis at a tertiary hospital were used as an example for verification. The clinical data of syphilis patients in the dermatology department from January 1, 2008 to January 1, 2018 were derived from the basic information database, diagnosis database, laboratory information database, and treatment information database of its hospital information system, and a total of 71 705 pieces of relevant information were extracted. SOP analysis showed that 6 816 articles were completely repeated. There were content or logical inconsistencies in name, medical identification number, resident ID number, age and gender, being 152, 360, 88, 107 and 457 respectively. There were many missing entries for marital status, ethnicity, gender, birthday, and ID number, being 1 711, 1 077, 457, 496 and 355 respectively. The standardization situation was generally good, and the number of irregularities in filling out occupational items was 1 884. The standardized and collated data could effectively count the proportion of patients in different stages of syphilis and the cost of diagnosis and treatment, indicating that the real-world data management and analysis SOP proposed in this study could be used to build a clinical-research oriented dual-functional database based on medical practice data.

10.
Chinese Journal of Urology ; (12): 449-454, 2021.
Article in Chinese | WPRIM | ID: wpr-911048

ABSTRACT

Objective:Evaluate the influence of different pressure transmission media of urodynamic water filled catheter(WFC) and air charged catheter(ACC) on the pressure measurement results to determine whether they can be used interchangeably.Methods:The results of 2 147 patients who underwent urodynamic examination in our hospital from January 2014 to December 2020 were retrospectively analyzed. A total of 2 538 times of bladder manometry data were obtained, including 1 299 times in WFC group, 856 times in male and 443 times in female, aged 37(24, 50)years, course of disease 1.2(0.4, 5.0) years, 1 130 times in neurogenic bladder(NB)and 169 times in non-neurogenic bladder(N-NB); In ACC group, there were 1 239 times, 773 times for male and 466 times for female, with age of 37(24, 55)years, course of disease of 1.5(0.5, 6.0)years, 1 040 times for Nb and 199 times for N-NB. There was no significant difference in baseline data of general clinical data between the two groups. The intravesical pressure(Pves), intra-abdominal pressure(Pabd)and detrusor pressure(Pdet) of WFC and ACC patients during filling and urination were analyzed. For traumatic spinal cord injury(SCI) and idiopathic patients, the two sets of pressure measurement data were analyzed separately. Nonparametric test and Chi-square test were used to compare the Pves, Pabd, and Pdet recorded by the two manometry catheters before, at the end and after urination, the maximum detrusor pressure at DO(Pdet.max-DO), and the maximum detrusor pressure during spontaneous urination (Pdet. max) and the detrusor pressure (Pdet.Qmax) corresponding to the maximum urine flow rate, the maximum urethral pressure (MUP) and the maximum urethral closure pressure (MUCP) during resting urethral pressure profile, and the initial cough Pdet signal pattern (typeⅠ, typeⅡand typeⅢ).Results:Regardless of the cause, the Pabd values measured by ACC were significantly higher than WFC before filling, end filling and after voiding[18(10, 26)cmH 2O vs.15(11, 21)cmH 2O; 23(16, 31)cmH 2O vs. 20(14, 26)cmH 2O; 23(15, 31)cmH 2O vs.18(12, 24)cmH 2O], and Pdet were significantly lower than WFC[0(0, 0) cmH 2O vs. 0(0, 1)cmH 2O; 5(1, 13)cmH 2O vs. 9(4, 17)cmH 2O; 6(1, 12)cmH 2O vs. 7(3, 14)cmH 2O]. In the initial cough state, Pves and Pabd increase value were also significantly lower than that of WFC [22(12, 36)cmH 2O vs. 23(14, 38)cmH 2O; 20(10, 33)cmH 2O vs. 21(12, 36)cmH 2O]. The Pves measured by ACC was also significantly higher than WFC before filling and after voiding[18(10, 27)cmH 2O vs. 16(11, 21)cmH 2O; 30(22, 39)cmH 2O vs. 26(20, 36)cmH 2O]. Maximum urethral pressure (MUP) and maximum urethral closure pressure (MUCP) measured by ACC were significantly higher than WFC [91(69, 118)cmH 2O vs.81(64, 106)cmH 2O; 77(55, 103)cmH 2O vs. 68(48, 91)cmH 2O], and there were no significant differences in Pdet.max-DO、Pdet.max和Pdet.Qmax. For patients with traumatic SCI, the Pves measured by ACC was significantly higher than WFC before filling[15(10, 24)cmH 2O vs. 14(10, 20)cmH 2O], and only MUP was significantly higher than WFC in the measurement of urethral pressure[95(71, 119)cmH 2O vs. 85(65, 112)cmH 2O], and there were no significant differences in Pdet.max-DO, Pdet.max, Pdet.Qmax and MUCP. For idiopathic patients, Pves measured by ACC before filling and after urination were significantly higher than WFC[25(20, 29)cmH 2O vs. 18(11, 23)cmH 2O; 35(29, 44)cmH 2O vs. 28(20, 38)cmH 2O], while Pdet.max-DO, Pdet.max, Pdet.Q max, MUP and MUCP were not significantly different in different pressure measurement systems. For the comparison of the initial cough Pdet signal pattern, ACC is easier to detect type Ⅰ, and WFC is easier to detect type Ⅱ and type Ⅲ. Conclusions:Compared with WFC, ACC measured higher Pves and Pabd and lower Pdet in resting state, and lower Pves and Pabd in initial cough state. The pressure values and signal pattern measured by WFC and ACC are not completely consistent, so they cannot be used interchangeably.

11.
Article in Chinese | WPRIM | ID: wpr-887500

ABSTRACT

OBJECTIVE@#To observe the clinical therapeutic effect on mild and moderate postpartum depression treated with acupuncture of @*METHODS@#A total of 116 patients with mild and moderate postpartum depression were divided into an acupuncture group (103 cases) and a non-acupuncture group (13 cases) according to treatment regimen provided. In the acupuncture group, acupuncture of @*RESULTS@#The total effective rate of the acupuncture A group was 100.0% (31/31), better than 76.9% (10/13) in the non-acupuncture group and 58.1% in the acupuncture B group (18/31) (@*CONCLUSION@#Acupuncture of


Subject(s)
Acupuncture Points , Acupuncture Therapy , Depression/therapy , Depression, Postpartum/therapy , Female , Humans , Needles , Treatment Outcome
12.
Article in Japanese | WPRIM | ID: wpr-887175

ABSTRACT

Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan; however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.

13.
Article in Japanese | WPRIM | ID: wpr-887116

ABSTRACT

Objective:To assess the risk for hyperkalemia caused by treatment with angiotensin Ⅱ Type 1 receptor blockers (ARB) in clinical practice with Japanese medical database.Design:A cohort study in patients treated with ARB alone and those treated with calcium channel blockers (CCB) alone as control.Methods:The Diagnosis Procedure Combination (DPC) database provided by Medical Data Vision Co., Ltd. was used to identify patients who received a diagnosis of hypertension (ICD-10 codes, I10 to I15) and were treated with ARB or CCB from April 2008 to June 2017. A logistic regression model was applied to estimate adjusted odds ratios (OR) and their 95% confidence intervals (CI) in these patients. The outcome in the logistic model was hyperkalemia (serum potassium≧5.5 mEq/L) and the covariates were sex, age, renal insufficiency, hepatic insufficiency, and baseline serum potassium levels. And, subgroup analysis was also performed in patients with and without renal insufficiency.Results:The incidence of hyperkalemia (per 1000 person-years) with ARB was 39.4 and that with CCB was 32.6. And, median periods from the index date to the date of occurrence of hyperkalemia for both exposure and control groups were 36 days (Min-Max:12-85) and 51.5 days(Min-Max:8-88)respectively. However, treatment with ARB was not associated with occurrence of hyperkalemia (OR 1.26, 95%CI: 0.58-2.75). The risk for hyperkalemia among those with renal insufficiency was higher (OR 3.31, 95%CI: 1.39-7.88)and as baseline serum potassium increased, the risk increased as well (OR 9.20, 95%CI: 3.52-24.10). And, the subgroup analysis also showed that rare occurrence of hyperkalemia by ARB and elevation risk for hyperkalemia by baseline serum potassium.Conclusion:The clinical data showed rare occurrence of hyperkalemia caused by ARB, indicating that renal insufficiency and baseline serum potassium levels affected the onset of the disease in clinical practice. Previous studies also reported the effects of renal insufficiency and other factors on the onset of hyperkalemia. ARB should be prescribed carefully in patients with these factors, as is conventionally done.

14.
Article in Chinese | WPRIM | ID: wpr-881232

ABSTRACT

@#Objective    To compare the 5-year survival rates between two different follow-up patterns of postoperative stage Ⅰ-ⅢA non-small cell lung cancer (NSCLC) patients. Methods    Pathological stage Ⅰ-ⅢA NSCLC 11 958 patients who underwent surgical resection and received follow-up within 6 months after initial diagnosis through telephone follow-up system were included in nine hospitals from July 2014 to July 2020. The patients were divided into two groups including a proactive follow-up group (n=3 825) and a passive follow-up group (n=8 133) according to the way of following-up. There were 6 939 males and 5 019 females aged 59.8±9.5 years. The Kaplan-Meier and Cox proportional hazards regression model were used. Results    The median follow-up frequency was 8.0 times in the proactive follow-up group and 7.0 times in the passive follow-up group. The median call duration was 3.77 minutes in the proactive follow-up group and 3.58 minutes in the passive follow-up group. The 5-year survival rate was 81.8% and 74.2% (HR=0.60, 95CI 0.53-0.67, P<0.001) in the proactive follow-up group and the passive follow-up group, respectively. Multivariate analysis showed that follow-up pattern, age, gender and operation mode were independent prognostic factors, and the results were consistent in all subgroups stratified by clinical stages. Conclusion    The proactive follow-up leads to better overall survival for resected stage Ⅰ-ⅢA NSCLC patients, especially in the stage ⅢA.

15.
Acta Pharmaceutica Sinica B ; (6): 300-303, 2021.
Article in English | WPRIM | ID: wpr-881090

ABSTRACT

In order to understand this disparity between human use and drugs approved by regulatory agencies, we analyzed botanical drug clinical trials registered at ClinicalTrial.gov to detect trends in current trials and guide future trials. A total of 195 botanical drug clinical trials were registered from 2016 to 2019, of which 81 are phase II or phase II/III. 95% of all phase II and II/III studies were designed with 100 or less participants per arm, indicating a more observational nature due to the limited power to detect differences in outcomes between treatment and control groups. Due to the limited number of participants, efficacy outcome from results may be highly subjective. 14% of the total trials were phase I studies. For botanical drugs with well-documented or extensive history of human use, phase I may not provide significant additional information, and may, therefore, not be necessary. For the trial design, we suggest added-on studies when botanical drugs are used as part of a combination treatment. Additionally, we believe standardized data collection methods and criteria are critical to utilizing the vast collection of human experience as quality evidence to support regulatory approval.

16.
Article in Chinese | WPRIM | ID: wpr-879280

ABSTRACT

To explore the focus and trends in real-world studies in Chinese through knowledge mapping method, databases CNKI, VIP, Wanfang and Sinomed were retrieved, with 1 757 relevant articles published before September 30rd, 2020 finally included, whose bibliographical records were imported into NoteExpress to avoid duplication and check relativity. VOSviewer, a bibliometric analysis tool, was used to analyze their development. It was found that real-world studies have mainly taken shape after 2010, in which traditional Chinese medicine research plays an important role.


Subject(s)
Bibliometrics , China , Databases, Factual , Publications
17.
Article in Chinese | WPRIM | ID: wpr-879072

ABSTRACT

The physical properties of powder and granules are the critical quality attributes for the process control of Suhuang Zhike Capsules, a big brand traditional Chinese medicine. This paper took the production of 25 batches of real-world Suhuang Zhike Capsules dry extract powder and granules intermediates as the research object. Firstly, a method for testing the physical properties of Suhuang Zhike Capsules powder and granules with 19 physical indicators was established. The results showed that the granules of dry extract powder after granulation had a smaller particle size, wider particle size distribution range and poor fluidity, which easily caused the problem of over-limit capsule loading. Secondly, correlation analysis, principal component analysis and cluster analysis were used for mathematical statistics. The correlation analysis showed that the density of dry extract powder could affect the chroma and fluidity. At the same time, the particle size in the granules had a stronger effect on the chroma and fluidity than the density. The study also found that the particle size and hygroscopicity of dry extract powder were potentially key physical properties that affected the physical properties of granules. Furthermore, the results of principal component analysis and cluster analysis showed that the consistency of the physical properties between the dry extract powder and intermediate granules was relatively poor. To this end, similarity analysis was carried out, and the quality control method of powder and granules based on physical fingerprint was established. The results showed that the physical fingerprint similarity of 25 batches of dry extract powder was 0.639-0.976, and the physical fingerprint similarity of the gra-nules was 0.716-0.983. With the similarity of 0.85 as the threshold, the batches with abnormal physical properties could be identified. In this study, the process quality control method of Suhuang Zhike Capsules based on the physical properties of powder and granules was established finally, which realized the identification of abnormal batches, and provided a reference for the process quality control of Suhuang Zhike Capsules.


Subject(s)
Capsules , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Powders , Quality Control
18.
Article in Chinese | WPRIM | ID: wpr-879070

ABSTRACT

The physical properties of ginkgo leaves extract(GLE) are the critical quality attributes for the control of the manufacturing process of ginkgo leaves preparations. In this study, 53 batches of GLE with different sources from the real world were used as the objects to carry out the research from 3 levels. First, based on micromeritics evaluation method, a total of 29 physical attribute quality parameters in five dimensions were comprehensively characterized, with a total of 1 537 data points. Further, with use of physical fingerprinting technology combined with similarity evaluation, the powder physical properties of 53 batches of GLE showed obvious differences from an overall perspective, and the similarity of the physical fingerprints was 0.876 to 1.000. Secondly, hierarchical clustering analysis(HCA) and principal component analysis(PCA) models were constructed to realize the reliable identification and differentiation of real-world materials produced by GLE from different sources. Multivariate statistical process control(MSPC) model was used to create GLE material Hotelling T~2 and squared prediction error(SPE) control charts. It was found that the SPE score of B_(21) powder exceeded the 99% confidence control limit by 22.495 9, and the SPE scores of A_1 and C_(10) powder exceeded the 95% confidence control limit by 16.099 2, realizing the determination of abnormal samples in the materials of GLE from the production in real world. Finally, the physical quality control method of GLE in the production process of ginkgo leaves preparations was established in this study, providing a reference for the quality control methods of ginkgo leaves preparations in their manufacturing process.


Subject(s)
Drugs, Chinese Herbal , Ginkgo biloba , Medicine, Chinese Traditional , Plant Extracts , Plant Leaves , Powders , Quality Control
19.
Article in Chinese | WPRIM | ID: wpr-879065

ABSTRACT

The spatial distribution uniformity of valuable medicines is the critical quality attribute in the process control of Tongren Niuhuang Qingxin Pills. With the real world sample of the mixed end-point powder of Tongren Niuhuang Qingxin Pills as the research object, hyperspectral imaging technology was used to collect a total of 32 400 data points with a size of 180 pix×180 pix. Spectral angle matching(SAM), classical least squares and mixed tuned matched filtering(MTMF) were used to identify the spatial distribution of rare medicines. MTMF model showed higher identification accuracy, therefore the spatial distribution of the blended intermediates was identified based on the MTMF model. The histogram method was also used to evaluate the spatial distribution uniformity of rare medicines. The results showed that the standard deviation was 4.78, 6.5, 3.48, 1.96, and 3.00 respectively for artificial bezoar, artificial musk, Borneol, Antelope horn and Buffalo horn; the variance was 22.8, 42.3, 12.1, 3.82, and 9.00, and the skewness was 1.26, 1.71, 0.06,-0.86, and 1.04, respectively. The final results showed that the most even blending was achieved in concentrated powder of Borneol, Antelope horn and Buffalo horn, followed by artificial bezoar, and last artificial musk. A visualization method was established for quality attributes of distribution uniformity in blending process of Tongren Niuhuang Qingxin Pills. It could provide evidences of quality control methods in the mixing process of big brand traditional Chinese medicine.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Powders , Quality Control
20.
China Pharmacy ; (12): 1165-1172, 2021.
Article in Chinese | WPRIM | ID: wpr-876882

ABSTRACT

OBJECTIVE:To provid e reference for promoting the application of real-world evidence in pediatric medical product R&D. METHODS :The progress of real-world evidence in pediatrics in the United States and Europe was introduced. The obstacles of real-world evidence in pediatric drug R&D were analyzed ,and a series of feasibility suggestions were put forward. RESULTS & CONCLUSIONS:Real world evidence had been widely used in pediatric medical product R&D ,including evaluation and validation of biomarkers and prognostic indicators ,clinical trial design and optimization ,support for extended indications , post-marketing safety monitoring/pharmacovigilance ,etc. There were still many obstacles ,such as data fragmentation and access restrictions,lack of standardized analysis methods for real-world evidence ,lack of key pediatric variables ,and difficulties in obtaining informed consent from pediatric patients. In order to promote the application of real-world evidence in pediatrics ,it is suggested to strengthen the construction of data infrastructure ,expand the application of general data model ,develop methods for collecting longitudinal data of pediatric patients ,and carry out reasonable research design.

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