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【Objective:】 To analyze and explore the key points of the ethical review of real-world research in pediatric population, and to provide reference for ethical review of real-world research in pediatric population. 【Methods:】 According to the characteristics of real-world research and pediatric clinical trials, the review points of real-world research in pediatric population were analyzed and discussed in comparison with the principles and focus of ethical review in general clinical research. 【Results:】 The ethics committee should pay particular attention to the review of informed consent, privacy protection, risk benefit assessment, cost and compensation, and should also take into account the research design, data governance, research conflicts of interest, research registration and publication, etc., and conduct scientific and reasonable ethical review of real-world research in pediatric population. 【Conclusion:】 Clinical trials in pediatric population should have stricter and scientific ethical review, which can not only protect the interests of vulnerable groups of minors, but also standardize real-world research in pediatric population and promote the healthy development of pediatric clinical research, so as to better protect children and promote their health.
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ObjectiveTo explore the clinical efficacy of Osteoking combined with non-steroidal anti-inflammatory drugs in the treatment of knee osteoarthritis based on real-world data and provide a basis for clinical medication. MethodFrom May 2020 to December 2021， the data of a total of 1 002 patients with knee osteoarthritis who did not undergo knee joint replacement surgery was collected through the registration method. 952 patients were ultimately included， including 133 cases orally taking Osteoking combined with non-steroidal anti-inflammatory drugs as the observation group and 73 cases orally taking non-steroidal anti-inflammatory drugs alone as the control group. Statistical analysis was conducted on the baseline data， VAS scores， WOMAC scores， and other items. The visit point is the 4th and 8th weeks after registration. In order to further elucidate the clinical efficacy of Osteoking combined with non-steroidal anti-inflammatory drugs in the treatment of knee osteoarthritis， the effective components of Osteoking and the relevant gene sets of non-steroidal anti-inflammatory drugs and knee osteoarthritis were obtained through network pharmacology methods and retrieval in bone injury cross database， TCMSP， and other databases. Venn analysis was performed on the relevant gene sets， and a PPI network diagram was constructed. Then key core targets were screened out， and enrichment GO and KEGG enrichment analyses were conducted. ResultThe VAS score of the observation group decreases by an average of （-2.79±1.206） scores in the 4th week， which is better than the control group ［（-2.73±1.575） scores， P<0.05］. The VAS score of the observation group decreases by an average of （-3.97±1.308） scores in the 8th week， which is better than the control group ［（-3.89±1.822） scores， P<0.05］. The total WOMAC score of the observation group decreases by an average of （-52.07±21.677） scores points in the 8th week， which is significantly better than the control group ［（-46.75±25.368） scores， P<0.05］. The observation group has an average decrease of （-10.99±4.229） scores in WOMAC （pain） score in the 8th week， which is better than the control group ［（-10.03±5.535） scores， P<0.05］. The observation group has an average decrease of （-1.49±2.901） in WOMAC （stiffness） score in the 4th week， which is better than the control group ［（-0.92±1.998） scores， P<0.05］， and the observation group has an average decrease of （-1.90±3.200） scores in WOMAC （stiffness） score in the 8th week， which is better than the control group ［（-1.26±2.230） scores， P<0.05］. The observation group shows an average decrease of （-39.17±16.562） scores in WOMAC （joint function） score in the 8th week， which is significantly better than the control group ［（-35.47±20.098） scores， P<0.05］. According to network pharmacology analysis， the core network target of Osteoking in treating knee osteoarthritis is manifested as regulating signal pathways such as signal transduction transcription activator 3（STAT3）， vascular endothelial growth factor A（VEGFA）， tumor necrosis factor （TNF） to regulate cell signaling， angiogenesis， chondrocyte proliferation and migration， and inflammatory cells， thereby inhibiting inflammatory reactions， reducing damage， and delaying the development of the disease. ConclusionAfter a 4-week and 8-week course of treatment for knee osteoarthritis with Osteoking combined with non-steroidal anti-inflammatory drugs， there is a significant therapeutic effect on relieving pain and joint stiffness and improving joint function. In network pharmacology， Osteoking is involved in regulating inflammatory factors， metabolic response-related biological processes， the proliferation and apoptosis of chondrocytes， etc. in the treatment of knee osteoarthritis， resulting in anti-inflammatory and analgesic effects and improving joint mobility and joint stiffness. Therefore， it is worthy of clinical promotion and application.
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ObjectiveTo investigate the clinical efficacy and mechanisms of Osteoking in the treatment of knee osteoarthritis （KOA） in real-world practice， so as to provide a basis for the rational clinical use of Osteoking. MethodFrom the Osteoking for knee osteoarthritis case registration system， 638 KOA cases treated with Osteoking were selected and analyzed in SPSS 26.0. The clinical data were collected from 20 hospitals in China from May 2020 to December 2021. Descriptive analyses of patient age， gender， body mass index， course of treatment and other parameters were performed. The Mann-Whitney U test was performed to compare the visual analogue scale （VAS） and Western Ontario and McMaster universities arthritis index （WOMAC） scores before and after treatment. The integrative pharmacology-based research platform of traditional Chinese medicine （TCMIP） v2.0 was used for network analysis of the core targets of Osteoking in treating knee osteoarthritis. Furthermore， 20 KOA patients treated with Osteoking in the Third Affiliated Hospital of Beijing University of Chinese Medicine from October to December in 2022 were enrolled in the treatment group， and 20 healthy volunteers in the control group. The enzyme-linked immunosorbent assay was employed to measure the serum levels of related indicators to verify the prediction results. ResultA total of 638 KOA patients were treated with Osteoking， including 429 （67.24%） receiving Osteoking alone and 209 （32.76%） receiving Osteoking combined with other therapies. The female patients （415， 65.05%） were more than the male patients （223， 34.95%）. The patients showed the mean age of （63.48±13.51） years， mean body mass index of （24.09±2.98） kg·m-2， and mean course of treatment of （15.78±9.66） days. Most of the patients were rated as grades Ⅱ （46.24%） and Ⅲ （34.64%） in Kellgren-Lawrence （K-L） grading and in the relief stage （82.45%） in clinical staging. There was no significant correlation between clinical staging and K-L grading results. The cluster analysis identified three TCM syndromes： Qi stagnation and blood stasis， cold-dampness obstruction， and liver-kidney deficiency. The overall clinical efficacy evaluation showed that VAS score decreased from （6.01±0.85） scores before treatment to （2.54±1.73） scores after treatment （P<0.05）， and the WOMAC score decreased from （93.25±25.91） scores before treatment to （50.73±25.14） scores after treatment （P<0.05）. The network analysis predicted that Osteoking might regulate the transforming growth factor-beta （TGF-β）， tumor necrosis factor-alpha （TNF-α）， and nuclear factor-kappa B （NF-κB） signaling pathways to exert the therapeutic effect. The clinical trial showed elevated TGF-β1 level （P<0.01） and lowered NF-κB subunit RELA and tumor necrosis factor receptor superfamily， member 1A （TNFRSF1A） levels （P<0.05） after treatment. The synergistic effects of these changes provide a multidimensional and comprehensive therapeutic efficacy for KOA， alleviating the joint pain and limited mobility in patients. ConclusionOsteoking showed significant therapeutic efficacy in treating KOA. Osteoking may act on multiple pathways involved in cartilage metabolism and inflammation. The findings provide experimental evidence and theoretical support for elucidating the multi-target mechanism of Osteoking in treating KOA.
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Objective:Considering the large amount and poor quality of clinical data, this study aims to explore the establishment of high-quality research database and its role in real-world research by taking the establishment of lymphoma research database as an example.Methods:The expert opinions in the field of lymphoma were collected, and the relevant guidelines and standards were referenced to establish a standard medical knowledge dataset. The electronic diagnosis and treatment data of lymphoma patients treated in Peking University Cancer Hospital from February 2005 to December 2020 were retrospectively extracted, the deep Learning, natural language processing were adopted to build a dynamic intelligent information integration and processing system of " lymphoma database based on electronic medical record system - biological sample information database - extended genetic information database" .Results:The research database not only meets the research needs of clinical researchers, but also realizes the management of traces in the whole process of application, approval, traceability and analysis of hospital medical record data and biological sample data. The total number of research variables in the database was 668, and the structured variables accounted for 46.0%. On December 25, 2021, there were 68 687 lymphoma patients in the database, the ratio of male to female patients was 8/9, and the proportion of patients with ≥3 visits accounted for 23.0%. In addition, researchers can superimpose searches in the database according to the target conditions, display the targeted medical records according to research hypothesis, and then establish a research cohort, conducting statistical modeling, and mining data information.Conclusions:By integrating management processes and using new natural language artificial intelligence technology to establish a high-level evidence-based database, it is helpful for the interconnection and resource sharing of hospital information systems, so as to achieve the purpose of providing reliable and detailed data for real-world research.
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Objective:To compare and analyze the application of anti-vascular endothelial growth factor (VEGF) drugs for intravitreal injection in the real world before and after the establishment of one-stop intravitreal injection center, as well as the advantages and disadvantages of different management modes.Methods:A retrospective clinical study. A total of 4 015 patients (4 659 eyes) who received anti-VEGF drugs for ocular fundus diseases at the Tianjin Medical University Eye Hospital from July, 2018 to June, 2022 were included in the study. There were 2 146 males and 1 869 females. The ocular fundus diseases in this study were as follows: 1 090 eyes of 968 patients with wet age-related macular degeneration (wAMD); 855 eyes of 654 patients with diabetic macular edema (DME); 1 158 eyes of 980 patients with diabetic retinopathy (DR); 930 eyes of 916 patients with macular edema secondary to retinal vein occlusion (RVO-ME). A total of 294 eyes of 275 patients with choroidal neovascularization secondary to pathological myopia (PM-CNV); 332 eyes of 222 patients with other fundus diseases. A total of 13 796 anti-VEGF needles were injected. A total of 1 252 patients (1 403 eyes) from July 2018 to June 2020 were regarded as the control group. From July 2020 to June 2022, 2 763 patients (3 256 eyes) who received anti-VEGF treatment in the intravitreal injection center were regarded as the observation group. The total number of intravitreal injection needles, the distribution of anti-VEGF therapy in each disease according to disease classification, the proportion of patients who chose the 3+ on-demand treatment (PRN) regimen and the distribution of clinical application of different anti-VEGF drugs were compared between the control group and the observation group. The waiting time and medical experience of patients were investigated by questionnaire. χ2 test was used to compare the count data between the two groups, and t test was used to compare the measurement data. Results:Among the 13 796 anti-VEGF injections in 4 659 eyes, the total number of anti-VEGF drugs used in the control and observation groups were 4 762 and 9 034, respectively, with an average of (3.39±3.78) and (2.78±2.27) injections per eye ( t=6.900, P<0.001), respectively. In the control and observation groups, a total of 1 728 and 2 705 injections of anti-VEGF drugs were used for wAMD with an average of (5.14±4.56) and (3.59±2.45) injections per eye, respectively; a total of 982 and 2 038 injections of anti-VEGF drugs were used for DME with an average of (4.36±4.91) and (3.24±2.77) needles per eye, respectively. Additionally, a total of 942 and 2 179 injections of anti-VEGF drugs were injected for RVO-ME with an average of (3.98±3.71) and (3.14±2.15) injections per eye, respectively; a total of 291 and 615 injections of anti-VEGF drugs were injected for PM-CNV with an average of (3.31±2.63) and (2.99±1.69) injections per eye, respectively. A total of 683 and 1 029 injections of anti-VEGF drugs were injected for DR with an average of (1.60±1.26) and (1.41±1.05) injections per eye, respectively. The clinical application and implementation of "3+PRN" treatment were as follows: 223 (66.4%, 223/336) and 431 eyes (57.2%, 431/754) in the wAMD ( χ2=8.210, P=0.004), 75 (33.3%, 75/225) and 236 (37.5%, 236/630) eyes in the DME ( χ2=1.220, P>0.05), and 97 (40.9%, 97/237) and 355 eyes (51.2%, 355/693) in the RVO-ME ( χ2=7.498, P=0.006), 39 (44.3%, 39/88) and 111 eyes (53.9%, 111/206) in the PM-CNV ( χ2=2.258, P>0.05), respectively. In addition, the results of the questionnaire survey showed that there were significant differences between the control and observation groups regarding the time of appointment waiting for surgery ( t=1.340), time from admission to entering the operating room on the day of injection ( t=2.780), time from completing preoperative treatment preparation to waiting for entering the operating room ( t=8.390), and time from admission to discharge ( t=6.060) ( P<0.05). Conclusions:The establishment of a one-stop intravitreal injection mode greatly improved work efficiency and increased the number of injections. At the same time, the compliance, waiting time, and overall medical experience of patients significantly improved under centralized management.
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Objective:To evaluate the efficacy and safety of Rezūm Water Vapor Thermal Therapy system in the treatment of patients with benign prostatic hyperplasia (BPH).Methods:The clinical data of 22 patients with benign prostatic hyperplasia treated with Rezūm Water Vapor Thermal Therapy system in Boao Yiling Life Care Center in Hainan from December 2020 to January 2021 were retrospectively analyzed, with age of (61.0±5.9) years, prostate volume of (43.7±8.4) ml. international prostate symptom score (IPSS) of (19.3±3.7), quality of life (QOL) score of (4.2±0.8), maximum urinary flow rate (Q max) of (11.9±3.4) ml ml/s, and residual urine volume (PVR) of (14.0±19.0). For 19 patients with sexual life, the International Index of Erectile Function Questionnaire-5 (IIEF-5) were 17.0±5.5, the Men's Sexual Health Questionnaire-Ejaculatory Dysfunction Score (MSHQ-EjD) ejaculatory function score were 10.0±3.2, and the ejaculatory satisfaction score were 1.5±1.0. Twenty-two patients underwent Rezūm Water Vapor Thermal Therapy under intravenous anesthesia (general anesthesia without intubation) in the dorsal lithotomy position. The Rezūm system consisted of reusable thermal steam treatment device and disposable prostate thermal steam treatment instrument. The thermal steam treatment device used radiofrequency energy to heat sterile distilled water, generating high-temperature steam at 103℃. In a 9-second timeframe, the tissue temperature within each treatment area was raised approximately 70℃, causing cell death and resulting in a shrink in prostate tissue volume. The disposable prostate thermal steam treatment instrument could be inserted through a cystoscope and had a retractable needle tip that extends to a length of 10.25 mm. The needle tip had 12 evenly distributed holes arranged in three rows of four holes each, with a spacing of 120° between rows, allowing for even diffusion of thermal steam along the circumference. The patient was placed in a lithotomy position, and the disposable prostate thermal steam treatment instrument was used to examine the prostate, urethra, and bladder via cystoscopy, assessing the lateral lobes and median lobe of the prostate. The tissue spacing within each field of view of the treatment instrument is 0.5 cm, and the distance from the bladder neck to the verumontanum is calculated. The first needle was injected at 3 o’clock along the left lobe, withdrawing 2 fields of view each time. During the release of thermal steam, the needle tip was positioned perpendicular to the prostate urethral mucosa, and each needle injection delivered 0.42 ml of sterile distilled water-formed thermal steam into the prostate tissue. The thermal steam injection lasted for 9 seconds, followed by a 2-3 seconds waiting period before retracting the needle tip. One needle was injected per 2 fields of view, progressing towards the proximal urethra of the verumontanum. The same method was used to treat the right lobe. For cases with significant median lobe enlargement, two fields of view were retracted at the bladder neck, and the needle was inserted at a 45° angle. The second needle was injected at intervals determined by the extent of median lobe enlargement. Each puncture point was observed for no significant bleeding, and the instrument was then removed, with an F16/F18 silicone catheter left in place. The operative time as well as indwelling catheter time were recorded. The clinical parameters such as IPSS, QOL, prostate volume, Qmax, PVR, QOL, IIEF-5 and MSHQ-EjD at preoperative and 12 to 22 weeks post operation were compared. Adverse events from the Rezūm procedure to 12-22 weeks postoperatively were recorded. Results:All the operations were successfully completed. The operation time of Rezūm system was 3.9±1.6 min, and the indwelling catheter time after operation was 4.8±1.1 days. The IPSS scores of 22 patients at 12-22 weeks after operation were 4.4±3.3, whose reduction was 14.9±4.4 compared with these at baseline( P<0.01). The PV was (37.7±8.4)ml, Qmax was (25.5±9.6)ml/s, PVR was (6.2±8.1)ml, and QOL was 1.6±0.9, all demonstrating statistically significant differences compared to preoperative values ( P<0.05). Among the 19 cases with sexual activity, the IIEF-5 score was 20.4±3.2, and the ejaculatory function score of MSHQ-EjD was 13.1±3.1, both showing statistically significant differences compared to preoperative scores ( P<0.05). The ejaculatory satisfaction score of MSHQ-EjD was 1.1±0.5, and there was no statistically significant difference compared to preoperative scores ( P>0.05). None of the 22 cases required medication or further surgical treatment for BPH after surgery. There were no urethral injuries, rectal or bladder perforations during the surgeries, and no severe complications such as rectal fistula or bladder neck contracture occurred postoperatively. There were no deaths reported. Postoperative discomfort in the urethra occurred in 19 cases, urethral pain in 8 cases, hematuria in 15 cases, poor sleep quality in 2 cases, and constipation in 1 case, all of which resolved within 7 to 10 days after surgery. Erectile dysfunction and retrograde ejaculation occurred in one case each at 4 to 5 weeks postoperatively but did not reoccur thereafter. Prostatitis and nodular hyperplasia of the middle lobe of the prostate occurred in one case each at 21 weeks and 25 weeks postoperatively, respectively, and no treatment was administered. Conclusions:In the real world, the short-term overall effect of Rezūm Water Vapor Thermal Therapy system in the treatment of benign prostatic hyperplasia is satisfactory, which shows good efficacy and safety.
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Objective:To evaluate the efficacy and side effects of PD-1 monoclonal antibody in the treatment of advanced metastatic renal cell carcinoma in China.Methods:The clinical data of 117 patients with advanced metastatic renal cell carcinoma (mRCC) treated with PD-1 monoclonal antibody from October 2016 to February 2022 were retrospectively analyzed. There were 87 males (74.4%) and 30 females (25.6%), with an average age of (57.9±10.9) years old, BMI of (23.6±3.4) kg/m 2and smoking history of 79 (67.5%). There were 44 cases (37.6%) with hypertension, 19 (16.2%) cases of diabetes. The ECOG score of 59.8% (70/117) patients was 0, 33.3% (39/117) was 1, 4.3% (5/117) was 2, and 2.5% (3/117) was 3. The pathological type of 104 cases were renal clear cell carcinoma (ccRCC), 8 cases of papillary renal cell carcinoma, 2 cases of chromophobe cell carcinoma, 2 cases of collecting duct carcinoma and 1 case of eosinophilic cell carcinoma. The general condition of the overall population and the overall survival (OS) of relevant subgroups were analyzed. Secondary goals included progression free survival (PFS), objective response rate (ORR), adverse reactions, overall survival (OS), and progression free survival (PFS). Results:65.8% (77 / 117) of the patients chose targeted combined with PD-1 monoclonal antibody in the first-line treatment. The main targeted drugs were acitinib (81.8%, 63 / 77), tirelizumab (37.6%, 29 / 77) and cindilimab (25.9%, 20 / 77). After first-line treatment, 19.6.1% (23 / 117) patients needed to be converted to second-line treatment, and 15 patients changed the type of PD-1 antibody during treatment. In addition, the targeted drug of combined therapy was replaced by acitinib in 8 patients. The main causes of drug withdrawal were disease progression (70.7%, 29 / 41) and death (29.2%, 12 / 41). The median OS of the overall population was 35.6 (19-60) months and PFS was 12.1 (1-60) months. The ORR of the overall population was 47.8% (56 / 117). 4.2% (5/117) patients had complete remission, another 17.0% (20/117) patients were in stable condition, and 43.5% (51 / 117) patients were in partial remission. In the first-line treatment, the median PFS time of targeted combined with PD-1 monoclonal antibody was 12.6 (1-30) months, the median PFS time of PD-1 single drug immunotherapy was 10.5 (1-60) months. In the second-line treatment, the PFS of patients treated with PD-1 monoclonal antibody was 10.1 (4-19) months, and that of patients treated with PD-1 monoclonal antibody combined with targeted therapy was 11.7 (1-25) months. The most common adverse reactions were elevated blood pressure (18.5%, 23 / 124), followed by hypothyroidism (15.3%%, 19/124), rash (14.5%, 18 / 124), elevated transaminase (10.5%, 13 / 124) and bone marrow suppression (9.7%, 12/124). 9.4% (11 / 117) patients needed to reduce the related adverse reactions by interrupting the treatment control of PD-1 monoclonal antibody.Conclusions:The safety and efficacy of PD-1 monoclonal antibody in domestic patients are better, and the side effects are less. The efficacy and safety of PD-1 monoclonal antibody combined with targeted therapy in the real world population are consistent with many key clinical trials abroad. PD-1 monoclonal antibody combined with targeted drugs can be popularized in the domestic MRCC population.
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Rich experience of clinical diagnosis and treatment has been accumulated in the developmental history of Chinese medicine, and the efficacy has been increasingly accepted by the public. However, the evaluation of clinical efficacy is currently based more on scientific evidence instead of merely the changes of patient symptoms. In Chinese medicine, the changes of major disease indicators, patient symptoms, and pathogenesis are the major criteria for the evaluation of clinical efficacy. The lack of well-accepted and uniform criteria and the uncertainty of subjective evaluation limit the development of clinical Chinese medicine. Evidence-based medicine combines clinical skills with the current best evidence. Narrative medicine, utilizing people's narratives in clinical practice, emphasizes patient feelings, willingness, and value orientation. The introduction of both evidence-based medicine and narrative medicine into the evaluation of clinical efficacy refers to the construction of the clinical efficacy evaluation system in a paradigm of participatory diagnosis and treatment. It can fully reflect the characteristics of Chinese medicine, respect the values of patients, and achieve universal clinical evidence. Therefore, it helps to improve the diagnosis and treatment, the relationship between doctors and patients, patients' life quality and decision-making awareness, and finally the new evaluation model of clinical efficacy of Chinese medicine.
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Humans , Evidence-Based Medicine , Medicine, Chinese Traditional , Narrative Medicine , Physicians , Treatment OutcomeABSTRACT
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.
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Bibliometrics , China , Databases, Factual , PublicationsABSTRACT
As early as in the 1960s, China has begun to conduct exploratory clinical researches on gastric cancer. In the past 10 years, the research projects have increased significantly. Among them, the minimally invasive surgery represented by laparoscopy (CLASS Trial), the hot spot of the esophagogastric junction cancer (5010 Trial), the perioperative adjuvant treatment of advanced gastric cancer (CGOG1001 and RESOLVE Trials), the conversion treatment of late gastric cancer (DRAGON Trial) and high quality clinical research such as real-world research based on large database have made great progress. But there are still many deficiencies, such as few multi-center prospective research, limited research return, and the quality and innovation of scientific research data need to be further improved. However, it should also be noted that the clinical researches of gastric cancer in China have greater advantages and development space. The characteristics of large population base, rich cases and large proportion of advanced gastric cancer are conducive to real-world research. In the future, we should follow the international frontier and combine with national conditions to deepen clinical research, so that more "Chinese elements" can be introduced into the international guidelines for gastric cancer, and promote the overall level of diagnosis and treatment of gastric cancer in China.
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Objective@#To evaluate the real-world safety and curative effect of ombitasvir combined with dasabuvir for the treatment of chronic hepatitis C 1b genotype infection in non-cirrhotic or compensated cirrhotic patients.@*Methods@#A real-world research method was adopted, and the research was conducted at three medical centers of mainland China. Non- cirrhotic or compensated cirrhotic patients with HCV genotype 1b infection who were initially treated with IFN/PEG-IFN-alpha combined with ribavirin, and ombitasvir combined with dasabuvir for 8 or 12 weeks were taken. Sustained virological response (SVR) and the incidence of adverse events during treatment and follow-up were evaluated after 12 weeks of drug withdrawal at OBV/PTV/r 25/150/100mg once daily and DSV 250mg, twice daily. Median and range were used for description of non-normally distributed data.@*Results@#80 cases of GT1b were included in this study. Of these 88.8% (71/80) were newly diagnosed, 12.5% (10/80) were compensated cirrhotic, 97.5% (78/80) received 12 weeks treatment, and 2.5% (2/80) received 8 weeks treatment. The rate of HCV RNA negative at EOT (end of treatment) was 100% (64/64). A total of 67 patients completed the treatment within 12 weeks, and 43 patients returned to the hospital for further consultations, and SVR12 was 100%(43/43). No patient discontinued the drugs because of an adverse event during treatment.@*Conclusion@#In the real world, Ombitasvir combined with dasabuvir for the treatment of chronic hepatitis C 1b genotype infection in China has 100% rates of EOT and SVR12 with well- tolerability and safety.
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Evidence-based medicine remains the best paradigm for medical practice.However,evidence alone is not decisions;decisions must also consider resources available and the values of people.Evidence shows that most of those treated with blood pressure-lowering,cholesterol-lowering,glucose-lowering and anti-cancer drugs do not benefit from preventing severe complications such as cardiovascular events and deaths.This implies that diagnosis and treatment in modem medicine in many circumstances is imprecise.It has become a dream to identify and treat only those few who can respond to the treatment.Precision medicine has thus come into being.Precision medicine is however not a new idea and cannot rely solely on gene sequencing as it was initially proposed.Neither is the large cohort and multi-factorial approach a new idea;in fact it has been used widely since 1950s.Since its very beginning,medicine has never stopped in searching for more precise diagnostic and therapeutic methods and already made achievements at various levels of our understanding and knowledge,such as vaccine,blood transfusion,imaging,and cataract surgery.Genetic biotechnology is not the only path to precision but merely a new method.Most genes are found only weakly associated with disease and are thus unlikely to lead to great improvement in diagnostic and therapeutic precision.The traditional multi-factorial approach by embracing big data and incorporating genetic factors is probably the most realistic way ahead for precision medicine.Big data boasts of possession of the total population and large sample size and claims correlation can displace causation.They are serious misleading concepts.Science has never had to observe the totality in order to draw a valid conclusion;a large sample size is required only when the anticipated effect is small and clinically less meaningful;emphasis on correlation over causation is equivalent to rejection of the scientific principles and methods in epidemiology and a call to give up the assurance for validity in scientific research,which will inevitably lead to futile interventions.Furthermore,in proving the effectiveness of intervention,analyses of real-world big data cannot displace the role of randomized controlled trial.We expressed doubts and critiques in this article on precision medicine and big data,merely hoping to stimulate discussing on the true potentials of precision medicine and big data.
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Evidence-based medicine remains the best paradigm for medical practice.However,evidence alone is not decisions;decisions must also consider resources available and the values of people.Evidence shows that most of those treated with blood pressure-lowering,cholesterol-lowering,glucose-lowering and anti-cancer drugs do not benefit from preventing severe complications such as cardiovascular events and deaths.This implies that diagnosis and treatment in modem medicine in many circumstances is imprecise.It has become a dream to identify and treat only those few who can respond to the treatment.Precision medicine has thus come into being.Precision medicine is however not a new idea and cannot rely solely on gene sequencing as it was initially proposed.Neither is the large cohort and multi-factorial approach a new idea;in fact it has been used widely since 1950s.Since its very beginning,medicine has never stopped in searching for more precise diagnostic and therapeutic methods and already made achievements at various levels of our understanding and knowledge,such as vaccine,blood transfusion,imaging,and cataract surgery.Genetic biotechnology is not the only path to precision but merely a new method.Most genes are found only weakly associated with disease and are thus unlikely to lead to great improvement in diagnostic and therapeutic precision.The traditional multi-factorial approach by embracing big data and incorporating genetic factors is probably the most realistic way ahead for precision medicine.Big data boasts of possession of the total population and large sample size and claims correlation can displace causation.They are serious misleading concepts.Science has never had to observe the totality in order to draw a valid conclusion;a large sample size is required only when the anticipated effect is small and clinically less meaningful;emphasis on correlation over causation is equivalent to rejection of the scientific principles and methods in epidemiology and a call to give up the assurance for validity in scientific research,which will inevitably lead to futile interventions.Furthermore,in proving the effectiveness of intervention,analyses of real-world big data cannot displace the role of randomized controlled trial.We expressed doubts and critiques in this article on precision medicine and big data,merely hoping to stimulate discussing on the true potentials of precision medicine and big data.