A real-world study on the influence of Qishi Tongguan Prescription on the pregnancy outcome of patients with tubal factor infertility after interventional recanalization / 国际中医中药杂志

Objective:To evaluate the effect of Qishi Tongguan Prescription on pregnancy outcomes after interventional recanalisation in patients with tubal infertility (TFI).Methods:This was a retrospective study based on real-world and propensity score matching. Totally 260 patients with TFI from January 2020 to October 2021 in Shuguang Hospital of Shanghai University of Traditional Chinese Medicine and Maternal and Child Health Hospital of Pudong New Area were selected as observation subjects, and were divided into 123 cases in the TCM combination group and 137 cases in the control group based on whether they were treated with Qishi Tongguan Prescription in combination with interventional revascularization. Propensity score matching (PSM) was used as a covariate to obtain a new sample of inter group covariate equilibrium, and confounding factors that may affect the pregnancy outcome of TFI patients undergoing interventional recanalization surgery were used as covariates. The intrauterine pregnancy rate, ectopic pregnancy rate, biochemical pregnancy rate, early abortion rate and adverse reactions of the two groups of patients within 12 months of follow-up were compared, and the influence of TFI intervention and recanalization combined with Qishi Tongguan Prescription on intrauterine pregnancy rate was evaluated.Results:Age, years of infertility, type of infertility, history of miscarriage, history of ectopic pregnancy, history of biochemical pregnancy, history of uterine surgery, history of pelvic laparotomy, and degree of tubal patency had an effect on whether intrauterine pregnancy was achieved after interventional reversal in patients with TFI ( P<0.05), with age [ OR (95% CI) was 0.843 (0.769, 0.926)], history of pelvic laparotomy [ OR (95% CI) was 0.477 (0.248, 0.920)] and the degree of tubal obstruction [ OR (95% CI) was 0.152 (0.046, 0.500)] were independent factors ( P<0.01 or P<0.05). 81 patients were seen in each of the 2 groups after PSM, of whom the intrauterine pregnancy rates in the combined herbal group at 9 and 12 months after recanalisation were 48.1% (39/81) and 58.0% (47/81) respectively, compared with 32.1% (26/81) and 35.8% (29/81) in the control group, with statistical significance between the 2 groups ( χ2 values of 4.34 and 8.03, respectively, P<0.01); there was no statistical significance in the ectopic pregnancy rate, biochemical pregnancy rate and early abortion rate between the 2 groups ( P>0.05). There were no significant adverse reactions during the treatment. Conclusion:Qishi Tongguan Prescription combined with interventional recanalization can effectively improve the intrauterine pregnancy rate and shorten the waiting time for pregnancy in patients with TFI with higher safety.

A real-world retrospective study of pelvic floor muscle training efficacy using an APP-based home device / 复旦学报（医学版）

Objective To retrospectively investigate the efficacy of pelvic floor muscle training(PFMT)using APP-based home device in the real-world scenario.Methods A retrospective survey was conducted among 171 000 Chinese female users over 18 years old who freely registered APP and performed PFMT using a domestic manufactured home device from Oct 1,2019 to Mar 31,2021.The Patient Global Impression of Improvement(PGI-I)questionnaires concerning pelvic floor general condition,sexual satisfaction and other three major symptoms related to pelvic floor muscle laxity such as stress urinary incontinence(SUI),pelvic organ prolapse(POP),and vaginal laxity(VL)were broadcast public online for users to self-assess the improvement.The vaginal muscle strength values prior and post training recorded by APP were also reported.All data were collected anonymously for further stratified analysis.Results A total of 984 valid questionnaires were collected by systematic sampling.The PGI-I scores of pelvic floor general condition(P=0.000 1),sexual satisfaction(P=0.009),SUI(P=0.000 1),POP(P=0.044)and VL(P=0.034)were statistically significant in users who reported to use the device for 3 months or more compared with those less than 3 months.In addition,the increase of vaginal muscle strength was related to the improvement of PGI-I scores in SUI and POP with statistical significance.There were no significant difference in subgroups such as age,education,parity,and delivery mode.Conclusion The subjective benefit of pelvic floor function-related symptoms and the improvement of vaginal muscle strength could be observed after PFMT for three months or more using APP-based home device in Chinese women in the real-world scenario.

Comparison of effectiveness,safety,and economy of generic and original levetiracetam concentrated solution for injection:a real-world study / 药物流行病学杂志

Objective To evaluate the effectiveness,safety and economy of the clinical application of levetiracetam(LEV)concentrated solution for injection generic drug and the original drug in the national centralized volume-based procurement.Methods The information of inpatients using original LEV concentrated solution for injection in the Xuanwu Hospital of Capital Medical University(original drug group)and inpatients using generic LEV concentrated solution for injection in the First Affiliated Hospital of Wannan Medical College(generic drug group)was retrospectively analyzed after the implementation of the procurement policy(from November 2021 to March 2022).To compare the effectiveness,safety and economy of the two in the prevention and treatment of epilepsy.Results In the original drug group and the generic drug group,18 and 17 patients were enrolled in the treatment of epilepsy respectively,the effective rates were 50.00％and 58.82％,the incidence of adverse reactions were both 0％,and the median daily cost was 255.00(255.00,510.00)yuan and 131.78(131.78,131.78)yuan.After propensity score matching,both the original drug group and the generic drug group had 76 patients each received preventive medication,the effective rates were 97.37％and 100％(P＞0.05),and the incidence of adverse reactions were both 0％.The median daily fee for the original the generic drug group was 170.00(170.00,170.00)yuan and 131.78(131.78,131.78)yuan,there were significant difference(P＜0.01).Conclusion The clinical effect of generic and original LEV concentrated solution for injection in preventing epilepsy is basically the same,the clinical safety are equivalent,the generic has better economy than the original.The effective rate of the treatment of epilepsy is similar,while the sample size needs to be further expanded to verify the results.

Real-World Study on Hematological Toxicities of Cyclin-dependent Kinase 4/6 Inhibitors Based on FAERS Database / 医药导报

Objective To evaluate adverse events(AEs)of hematological toxicities in cyclin-dependent kinase 4/6(CDK4/6)inhibitors based on the FDA adverse event reporting system(FAERS)database,and to provide a reference for rational drug use in the clinic.Methods A total of 29 quarterly AEs were extracted from the FAERS database from January 2015 to March 2022.Reported odds ratio(ROR)and proportional reported ratio(PRR)were used for data mining of CDK4/6 inhibitor AEs.Results A total of 7 872 AEs related to CDK4/6 inhibitors were reported,and the proportion of hematological AEs of each inhibitor was palbociclib(80.31%),ribociclib(15.36%),and abemaciclib(4.33%).Neutropenia and anemia were common in hematological toxicities.Palbociclib(2 982/6 322,47.17%)and ribociclib(613/1 209,50.70%)caused more neutropenia than abemaciclib(117/341,34.31%).Hematological toxicities mainly occurred 60 days after drug initiation(1 630,61.86%).Palbociclib had the longest median onset time,and 32.9%of patients still had hematological toxicities after 90 days of treatment.The clinical features and intensity were different among CDK4/6 inhibitors.Conclusions Palbociclib,abemaciclib,and ribociclib all cause significant hematological toxicities,among which abemaciclib has fewest reports of hematological toxicities.Still,the risk of death after anemia caused by abemaciclib should be noted.Complete blood cell count should be closely monitored within the first two months after treatment to monitor the patient's neutrophils and hemoglobin.The occurrence of hematological AEs associated with CDK4/6 inhibitors should be noted in the clinic.

A Practical Randomized Controlled Study on Effectiveness of TCM Syndrome Differentiation Treatment for Subsolid Pulmonary Nodules / 肿瘤防治研究

Objective To explore the therapeutic effect of traditional Chinese medicine (TCM) on subsolid nodule (SSN). Methods A practical randomized controlled study method, including 254 SSN patients was adopted. The patients were divided into the TCM (102 cases) and follow-up (152 cases) groups. The follow-up group received regular check-ups in accordance with the guidelines, and the TCM group received TCM syndrome differentiation treatment for 24 weeks. The two groups were compared in terms of the changes in their SSN diameter, SSN number, TCM symptom score, and overall therapeutic effect before and after treatment. Adverse reactions and safety indicators were also recorded. Results The TCM group showed a significantly higher effective rate of treatment (16.7%) than the follow-up group (2.6%) (P<0.01). Compared with their condition before treatment, the TCM group showed no significant changes in their SSN diameter and number but presented considerably reduced fatigue, yellow and red urine symptoms, and overall TCM symptom score (P<0.05). The follow-up group exhibited significantly increased diameter and number of SSN (P<0.01). The follow-up group showed the significantly higher increase in SSN diameter after treatment than the TCM group (P<0.05). Moreover, the follow-up group showed significantly higher fatigue, depression, yellow and red urine symptom scores, and overall TCM symptom score than the TCM group (P<0.05 or P<0.01). Conclusion TCM treatment for SSN has a distinct clinical efficacy, reduces the malignant risk of SSN and improves clinical symptoms of SSN patients, and is safe and feasible.

Study on Traditional Chinese Medicine Syndrome Characteristics of 1676 Heart Failure Inpatients： A Cross-Sectional Survey Based on Real-World Electronic Medical Record Information / 中医杂志

ObjectiveTo analyse the clinical characteristics of different traditional Chinese medicine （TCM） syndromes in patients with heart failure based on information from electronic medical record. MethodsA cross-sectional study was conducted to collect clinical data of all inpatients with heart failure in the Department of Cardiology， Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from January 1， 2019 to December 31， 2020. A database of clinical TCM data was established to explore the characteristics of clinical data of basic information， syndromes and syndrome element types， and biochemical indexes. The distribution of TCM syndromes and syndrome elements in heart failure patients were also analysed， and the basic information and biochemical indexes of the patients with top 7 different TCM syndrome types were compared. ResultsA total of 1676 inpatients with heart fai-lure were included. The top 7 TCM syndromes of heart failure were syndrome of phlegm turbidity and blood stasis （477 cases， 28.46%）， syndrome of qi deficiency and blood stasis （439 cases， 26.19%）， syndrome of qi deficiency and blood stasis with water retention （274 cases， 16.35%）， syndrome of yang deficiency with water retention （145 cases， 8.65%）， syndrome of qi and yin deficiency （104 cases， 6.21%）， syndrome of qi and yin deficiency with blood stasis （80 cases， 4.77%）， syndrome of heart yang deficiency （59 cases， 3.52%）. Among the 1676 patients， 6 syndrome elements accounted for more than 5%. Blood stasis accounted for the highest proportion of TCM syndrome element type （1292 cases， 77.09%）， followed by qi deficiency （919 cases， 54.83%）， phlegm （498 cases， 29.71%）， water retention （434 cases， 25.89%）， yang deficiency （215 cases， 12.82%） and yin deficiency （191 cases， 11.40%）. Among the 1676 patients， 1308 cases of acute heart failure mainly showed syndrome of phlegm turbidity and blood stasis （386 cases， 29.51%）， and 368 of chronic heart fai-lure mainly showed syndrome of qi deficiency and blood stasis （118 cases， 32.07%）. Patients with syndrome of phlegm turbidity and blood stasis had the shortest disease duration of 0.3 months， while those with syndrome of heart yang deficiency had the longest disease duration of 15 months. The proportion of syndrome of phlegm turbidity and blood stasis was the highest in patients with heart failure combined with coronary artery disease， the proportion of syndrome of qi deficiency and blood stasis with water retention was the highest in patients with heart failure combined with atrial fibrillation， and the proportion of patients with syndrome of qi deficiency and blood stasis with water retention and syndrome of yang deficiency with water retention in those applying diuretics during the hospital stay was the highest with more than 86%. The different 7 TCM syndromes showed statistically difference in patients with complications including coronary artery disease， old myocardial infarction， atrial fibrillation， pre and post-admission medication usage including intravenous vasodilators， cardiac stimulants， diuretics， and level of blood chloride， blood urea， blood creatinine， blood bicarbonate， blood albumin， and blood total bilirubin （P＜0.05）. ConclusionThe most common TCM syndromes in patients with heart failure are syndrome of phlegm turbidity and blood stasis and syndrome of qi deficiency and blood stasis. Different TCM syndromes have different characteristics in gender， disease complications， medication before and after admission， and blood indexes.

Clinical Efficacy of Medication of Xibining Ⅱ Prescription in Treatment of Knee Osteoarthritis with Cold-dampness Blockage Syndrome： A Retrospective Cohort Study / 中国实验方剂学杂志

ObjectiveTo retrospectively analyze the clinical efficacy of Xibining Ⅱ prescription in the treatment of knee osteoarthritis with cold-dampness blockage syndrome by oral medication and to explore the influencing factors of endpoint events. MethodA real-world retrospective cohort design was adopted， and medical records of knee osteoarthritis patients with cold-dampness blockage syndrome treated with oral medication from the orthopedics outpatient department of Jiangsu Province Hospital of Chinese Medicine were collected. All patients received conventional Western medicine treatment and were divided into non-exposure group （573 cases） and exposure group （427 cases） according to whether or not they received treatment with Xibining Ⅱ prescription. Descriptive analysis of the baseline data of the 1 000 screened cases was performed using IBM SPSS 27.0. According to the baseline data， 334 pairs were matched using the propensity score matching method， resulting in a total of 668 cases in both groups. The changes in visual analogous scale （VAS）， Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC） total score， Japanese Knee Osteoarthritis Measure （JKOM） score， and traditional Chinese medicine （TCM） syndrome score before treatment and at 2， 6， 12 weeks after treatment， as well as the incidence of adverse reactions， were compared between the two groups. A multivariate logistic regression analysis was conducted to analyze the influencing factors of endpoint events， with clinical cure judged based on the improvement rate of WOMAC total score before and after treatment. ResultAfter 12 weeks of treatment， compared to the results before treatment， the VAS， WOMAC total score， JKOM score， and TCM syndrome score of patients in both groups significantly decreased （P<0.01）. Compared to the non-exposure group， the exposure group showed a more significant reduction in VAS， WOMAC total score， JKOM score， and TCM syndrome score （P<0.01）. After 12 weeks of treatment， the clinical cure rate and significant efficiency were higher in the exposure group than in the non-exposure group （P<0.05）. Compared to the results before treatment within each group， VAS， WOMAC pain， stiffness， function scores， JKOM score， and TCM syndrome score significantly decreased at 2， 6， 12 weeks after treatment in both groups （P<0.01）. Compared to the non-exposure group at the same time points， the exposure group showed a reduction in VAS at 2， 12 weeks， WOMAC pain at 6， 12 weeks， and function scores at 12 weeks （P<0.05， P<0.01）. The JKOM score decreased at 6， 12 weeks， and the TCM syndrome score significantly decreased at 2， 6， 12 weeks in the exposure group （P<0.05， P<0.01）. Multivariate logistic regression analysis at 12 weeks showed that factors affecting clinical cure included the course of disease， history of alcohol consumption， hypertension， coronary heart disease， and the use of Xibining Ⅱ prescription （P<0.05， P<0.01）. Compared to the non-exposure group at the same time points， the incidence of epigastric discomfort in the exposure group was lower at 2， 12 weeks （P<0.01）， the incidence of diarrhea and vomiting was slightly higher than that in the non-exposure group， but the difference was not statistically significant. ConclusionThe clinical application of Xibining Ⅱ prescription combined with conventional Western medicine treatment in the treatment of knee osteoarthritis with cold-dampness blockage syndrome is more effective than conventional Western medicine treatment alone. It can significantly reduce VAS， WOMAC total score， JKOM score， and TCM syndrome score， with more pronounced long-term effects and a low incidence of adverse reactions.

Effectiveness of Acupoint Application in Patients with Pharyngeal Pain: Evidence from CHUNBO, A Prospective Real-World Study / 中国结合医学杂志

OBJECTIVE@#To assess the outcomes after acupoint application in patients with pharyngeal pain in a real-world settings, and analyze the characteristics of effective population and prescription characteristics of acupoint application.@*METHODS@#Based on CHUNBO platform, patients with pharyngeal pain who were candidates for acupoint application on the basis of physician-evaluation, were enrolled in a nationwide, prospective, 69-week multicenter observational study from August 2020 to February 2022. Propensity score matching (PSM) was used to match the confounding factors and the association rules were used to analyze the characteristics of effective population and prescription characteristics of acupoint application. Outcome assessments included the disappearance rate of pharyngeal pain (within 3, 7, and 14 days), disappearance time of pharyngeal pain, as well as adverse events.@*RESULTS@#Of 7,699 enrolled participants, 6,693 (86.9%) received acupoint application and 1,450 (21.7%) with non-acupoint application. After PSM, there were 1,004 patients each in the application group (AG) and non-application group (NAG). The disappearance rate of pharyngeal pain in the AG at 3, 7, and 14 days were all higher than those in the NAG (P<0.05). The disappearance time of pharyngeal pain in the AG were shorter than that in the NAG (logrank P<0.001, hazard ratio=1.51, 95% confidence interval: 1.41-1.63). The median age of effective cases was 4 years, mainly 3-6 years old (40.21%). The disappearance rate of pharyngeal pain in the application group with tonsil diseases was 2.19 times higher than that in the NAG (P<0.05). The commonly used acupoints for the effective cases were Tiantu (RN 22), Shenque (RN 8) and Dazhui (DU 14). The commonly used herbs for the effective cases were Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae. Among them, Natrii sulfas was applied to RN 8 most frequently (support 84.39%). A total of 1,324 (17.2%) patients experienced AEs, and mainly occurred in the AG, with significant difference in the incidence of AEs between goups (P<0.05). All AEs reported were the first grade, and the average regression days of AEs was 2.8 days.@*CONCLUSIONS@#Acupoint application in patients with pharyngeal pain resulted in improved effective rate and shortened duration, especially children aged 3-6 years old, and those with tonsil diseases. Acupoint of RN 22, RN 8 and DU 14, Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae were the most commonly used herbs in the treatment of pharyngeal pain.

Tenghuang Jiangu Tablets Combined with Non-steroidal Anti-inflammatory Drugs for Osteoarthritis of Knee： A Real-world Study / 中国实验方剂学杂志

ObjectiveTo investigate the clinical efficacy of Tenghuang Jiangu tablets （THJGT） combined with oral non-steroidal anti-inflammatory drugs （NSAIDs） in the treatment of osteoarthritis of the knee and its applicable stage based on real-world data， and provide a basis for the rational clinical use of THJGT. MethodA total of 218 cases treated with THJGT combined with oral NSAIDs included in the "THJGT for knee osteoarthritis case registry" from September 2019 to January 2021 were selected as the observation group， and 126 cases treated with oral NSAIDs alone as the control group （CG）. The data of gender， age， body mass index， Kellgren-Lawrence grading scale （K-L scale） score， visual analogue score （VAS score）， Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC） score， swelling grade， joint fear of cold score， back pain and weakness score， and occurrence of adverse events/reactions of the patients in both groups were used for the evaluation of efficacy with full analysis set. The propensity score matching method was used to exclude the influence of confounding factors between groups， and the sub-data sets were established， with which the repeated measures analysis of variance （ANOVA） was carried out to evaluate the efficacy. Visit points were at registration， 4 weeks and 8 weeks after registration. The data were statistically analyzed in Excel 2019 and SPSS 23.0. ResultThe proportion of females in the observation group was 66.06% （144/218）， which was higher than that （58.73%， 74/126） in the control group （χ2=1.846）. The average age in the observation group was （61.12±7.01） years， which was higher than that ［（59.38±5.99） years］ in the control group （W=19 918.50， P<0.05）. The remission rate in the observation group was 98.17% （214/218）. In the observation group， the proportions of the patients at K-L grades Ⅱ and Ⅲ were 64.22% （144/218） and 25.23% （55/218）， respectively. The effect analysis of the whole data set for enrollment and treatment for 8 weeks showed that the VAS score of the experimental group decreased by （3.27±1.24） points on average， which was better than that of the control group [（2.75±1.20）， W=34 179.00， P<0.05]. The average WOMAC score decreased （23.43±11.46） points， which was better than that of the control group [（16.71±8.86）， W=32 387.00， P<0.05]. The average swelling grade decreased （0.63±0.64）， which was better than the control group [（0.33±0.59）， W=33 847.50， P<0.05]. The average score of joint chills decreased （1.90±1.84）， points， which was better than that of control group [（1.40±1.28）， W=35 165.00， P<0.05]. The average lumbar acid fatigue score decreased by （2.02±1.64） points, which was better than that of the control group [（1.10±1.28）， W=32 986.50， P<0.05]. Efficacy analysis of subdata sets for enrollment， 4 weeks of medication and 8 weeks of medication showed that VAS scores of both groups showed a downward trend after treatment， and the improvement of experimental group was more significant than that of control group at 4 weeks， with statistical significance （P<0.05）. After treatment， the total WOMAC score of both groups showed a downward trend， and the improvement of experimental groups was more significant at 4 weeks and 8 weeks （P<0.05）. After treatment， swelling， cold fear grade and lumbar acid fatigue score of both groups showed a decreasing trend,， and the improvement of experimental group was more significant at 8 weeks （P<0.05）. The therapeutic effect analysis of patients in the attack stage and remission stage of the experimental group showed that the total WOMAC score of the two groups showed a downward trend after treatment， and the trend was basically the same， and there was no statistical difference between the two groups at enrollment， 4 weeks after treatment， and 8 weeks after treatment （t=1.675， t=2.068， t=2.364）. The total WOMAC score of the patients in remission stage in the experimental group with K-L grading between grade 0 and grade Ⅲ had statistical significance at 4 weeks after treatment compared with the time of entry （P<0.05， P<0.01）. Group of adverse event rate was 4.13% （9/218）， lower than the control group 10.32% （13/126） （χ2= 5.109， P<0.05）. ConclusionThe population receiving THJGT combined with oral NSAIDs is mostly female， old， in remission， and with K-L grades Ⅱ and Ⅲ. THJGT can enhance the anti-inflammatory and analgesic effects of oral NSAIDs and keep the drug effect in improving joint function and alleviating fear of cold， swelling， and back pain and weakness. The drug combination can be applied to patients in both attack and remission， and the clinical application should take patient's disease stage and degree of osteoarthritis into account. Furthermore， the combination has the potential to reduce the incidence of adverse events caused by NSAIDs.

Effects of acupuncture on hemorrhagic transformation and motor function in stroke patients after intravenous thrombolysis with rt-PA: a prospective cohort study / 中国针灸

OBJECTIVE@#To observe the effects of the Xingnao Kaiqiao (regaining consciousness and opening orifices) acupuncture on hemorrhagic transformation and limb motor function after intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) in stroke patients.@*METHODS@#A total of 130 stroke patients after rt-PA thrombolytic were divided into an acupuncture group (58 cases, 1 case dropped off) and a non-acupuncture group (72 cases, 7 cases dropped off) according to whether they received acupuncture treatment. Propensity score matching (PSM) was used to match each group, with 38 patients in each group. The patients in the non-acupuncture group received rt-PA thrombolytic therapy and western medical basic treatment. In addition to the basic treatment, the patients in the acupuncture group received Xingnao Kaiqiao acupuncture at Shuigou (GV 26), bilateral Neiguan (PC 6), and ipsilateral Sanyinjiao (SP 6), Chize (LU 5), once a day for 14 days. The incidence of hemorrhagic transformation within 30 days after onset was compared between the two groups. The Fugl-Meyer assessment (FMA) score and activities of daily living (ADL) score were observed at baseline and 30 days, 6 months, 1 year after onset in the two groups. The disability rate at 6 months and 1 year after onset was recorded, and safety was evaluated in both groups.@*RESULTS@#The incidence of hemorrhagic transformation in the acupuncture group was 5.3% (2/38), which was lower than 21.1% (8/38) in the non-acupuncture group (P<0.05). At 30 days, 6 month, and 1 year after onset, the FMA and ADL scores of both groups were higher than those at baseline (P<0.01), and the scores in the acupuncture group were higher than those in the non-acupuncture group (P<0.01). The disability rate in the acupuncture group at 1 year after onset was 10.5% (4/38), which was lower than 28.9% (11/38) in the non-acupuncture group (P<0.05). There was no significant difference in the incidence of adverse events between the two groups (P>0.05).@*CONCLUSION@#The Xingnao Kaiqiao acupuncture method could reduce the incidence of hemorrhagic transformation in stroke patients after intravenous thrombolysis with rt-PA, improve their motor function and daily living ability, and reduce the long-term disability rate.

Discuss Application of Real-world Data from the Boao Lecheng Pilot Zone to Support Premarket Clinical Evaluation of Medical Device / 中国医疗器械杂志

The real-world data of Hainan Boao Lecheng International Tourism Pilot Zone has the advantage of supporting pre-market clinical evaluation of medical devices. Based on the relevant requirements of clinical evaluation of medical devices and based on the practical experience of pilot devices in the early stage, the application of Boao Lecheng real-world data in the pre-market clinical evaluation path of medical devices from the perspective of review is discussed. At the same time, the elements that should be considered in real-world study design and the way of data quality evaluation are proposed. Expect to provide a reference in order to allow registration applicants to use real world data wisely to help declare device registration for marketing.

Clinicodemographic profile and outcomes of type 2 diabetes mellitus in the Indonesian cohort of DISCOVER: A 3-year prospective cohort study / Journal of the ASEAN Federation of Endocrine Societies

Background@#Indonesia is amongst the top 10 countries with the highest prevalence of Type 2 Diabetes Mellitus (T2DM) at 10.8%. However, the distinguishable features of T2DM in Indonesia remain obscure. Therefore, the DISCOVER study aimed to describe the characteristics of T2DM patients, associated vascular complications and treatment in Indonesia.@*Methodology@#DISCOVER study is a multi-country, multicenter, prospective, cohort study over 3 years. In the present study, the data were collected from 13 sites from clinical practice, hospitals and public health facilities in Indonesia.@*Results@#A total of 221 subjects were recruited with a mean age of 55.6 ± 9.8 years and body mass index (BMI) of 26.4 ± 4.4 kg/m2. Over 40% of patients had hypertension and/or hyperlipidemia. The mean duration of T2DM was 58.3 ± 62.0 months while the mean HbA1c levels was 9.2 ± 2%. In total, 82.4% completed the study within a 36-month follow-up period. BMI remained elevated i.e., >25 kg/m2. A significant reduction was observed in HbA1c levels as compared to baseline (9.2 ± 2% to 8.1 ± 1.8%). T2DM-associated microvascular complications such as peripheral neuropathy, albuminuria and chronic kidney disease were observed in 17.2%. Macrovascular complications including coronary artery disease and heart failure were seen in 26.2% of patients. We also found that more than 70% of patients were on metformin and/or sulfonylurea.@*Conclusion@#The features of patients with T2DM in Indonesia were high BMI, with hypertension and hyperlipidemia as co-morbidities. Metformin and sulfonylureas were the most common treatment. HbA1c reduction during follow-up did not reach recommended target. Thus, early detection and intervention using available glucose-lowering medications and aggressive management of risk factors and complications are essential to improve outcomes of diabetes management in Indonesia.

Progress in A Real-world Study of Abiraterone Acetate Versus Docetaxel in Patients with Metastatic Hormone-sensitive Prostate Cancer / 肿瘤防治研究

The safety and survival benefits of abiraterone acetate and docetaxel in the treatment of patients with metastatic hormone-sensitive prostate cancer have been confirmed by randomized controlled trials and clinical studies abroad. However, real-world studies remain lacking. In this article, we review the progress of real-world studies of abiraterone acetate and docetaxel in the treatment of patients with metastatic hormone-sensitive prostate cancer and the problems faced in clinical practice against the background of differentiated real-world studies. Further research is needed to address clinically important issues, such as individualized dosing, combination dosing, and monitoring of adverse effects.

Trajectories of glucose and lipid metabolism of schizophrenic patients in long-term hospitalization： a real-world study / 四川精神卫生

ObjectiveTo picture the trajectory of changes in glucose and lipid metabolism among schizophrenic patients in long-term hospitalization. MethodsA total of 109 inpatients of Shenzhen Kangning Hospital from 2014 to 2022， who were diagnosed with schizophrenia based on the International Classification of Diseases， tenth edition （ICD-10） criteria， were recruited as subjects. Real-world follow-up data on longitudinal glucose metabolism （fasting blood glucose， glycosylated hemoglobin， C-peptide） and lipid metabolism （triglycerides， low density lipoprotein， high density lipoprotein， total cholesterol） were observed. The frequency of visit was once a year， with a total of 9 visits over 8 years. ResultsIn terms of glucose metabolism parameters， fasting blood glucose level decreased to 4.87 mmol/L at the 7th visit， lower than the baseline level （P<0.01）. Glycated hemoglobin level was 6.08% at the 9th visit， higher than the baseline level （P<0.05）. C-peptide level was 3.14 ng/mL at the 7th visit， higher than the baseline level （P<0.01）. As for the trajectory of lipid metabolism parameters， high-density lipoprotein level were significantly lower than baseline level at the second visit （P<0.01） and stayed basically stable thereafter. Total cholesterol levels at the last three visits were 4.06， 4.07 and 3.95 mmol/L， respectively， all lower than the baseline level （P<0.01）. ConclusionThe changes of glycolipid metabolism parameters in long-term inpatients with schizophrenia were generally smooth during the 8-year follow-up period.

Effectiveness of HPV vaccines in real-world study / 中华微生物学和免疫学杂志

Human papillomavirus (HPV) is an epitheliotropic virus. High-risk HPV infections lead to precancerous lesions which may progress to cancer in the cervix, vagina and vulva, while low-risk HPV infections cause benign lesions such as genital warts and recurrent respiratory papillomas. HPV infection remains one of the major public health problems threatening human health. To date, six prophylactic preventive HPV vaccines have been licensed, and the effectiveness of HPV vaccination has gradually appeared in some countries with earlier vaccination. HPV vaccination has been proved to be effective in protecting against diseases related to HPV infection, which leads to significant reductions in the incidence of vaccine-type HPV-related infection, high cervical lesions, anogenital warts, recurrent respiratory papillomatosis and other relevant diseases. The herd protection effect of the vaccines is outstanding. Meanwhile, a bivalent HPV vaccine has been demonstrated for the cross-protection against HPV infections of non-vaccine types (HPV31/33/45) in real-world vaccination practice.

Efficacy and safety of HIFU lesion combined with endometrial ablation in treatment of adenomyosis with excessive menstruation / 实用医学杂志

Objective To evaluate the efficacy and safety of high intensity focused ultrasound(HFIU)combined with endometrial ablation in the treatment of adenomyosis(AM)patients with heavy menstrual bleeding(HMB).Method A total of 199 patients with AM combined with HMB who underwent HIFU treatment at the Obstetrics and Gynecology Center of Affiliated Hospital of Chengdu University of TCM from July 2020 to September 2022 were selected and divided into two groups according to the ablation range.The combined ablation group included 80 cases with lesion and endometrial ablation(endometrial ablation rate≥30%),while the lesion ablation group 119 cases with simple lesion ablation.A 1∶1 propensity score matching was performed on the two groups,resulting in 59 patients in each group.A 6-month follow-up was conducted.The clinical manifestations(menstrual volume,degree of dysmenorrhea,uterine and lesion volume),quality of life(MS-QOL,UFS-QOL),and postoperative adverse reactions between the two groups before and 6 months after surgery was compared.Results Menstrual volume,degree of dysmenorrhea,uterine and lesion volume,MS-QOL score,and UFS-QOL score of the both groups were improved 6 months after surgery,when compared to those before surgery(P<0.05).Significantly reduced menstrual volume,degree of dysmenorrhea,and lower MS-QOL score were observed in the combined ablation group when compared with the lesion ablation group(P<0.05),but there was no statistical significance in uterine and lesion volume and UFS-QOL score(P>0.05).There was no difference in the incidence of adverse reactions between the two groups(P>0.05),but the combined ablation group had longer vaginal bleeding and fluid flow time(P<0.05).Conclusion The combined HIFU and endometrial ablation can effectively reduce menstrual flow,alleviate dysmenorrhea,and improve quality of life in patients with AM combined with HMB.Although it increases vaginal bleeding and fluid flow time,reasonable symptomatic management can effectively prevent the occurrence of adverse consequences such as infection.

Advancing neonatal clinical scientific research through regional collaboration network / 中国小儿急救医学

Healthcare Big Data and its driven real-world study (RWS) have increasingly become important sources of evidence for medical decision-making.Drawing on successful international experiences, China′s neonatal-perinatal field has established national or regional neonatal collaboration networks to conduct various forms of clinical scientific researches, continuously improving the treatment and care level for preterm infants.How to construct a scientific clinical research methodology system based on clinical issues in China′s neonatal field and reliable real-world data is currently a pressing issue that needs to be addressed.This article discussed the methodological exploration for advancing neonatal clinical scientific research through regional collaboration networks.

Real-world Study on the Efficacy,Safety and Economics of Vancomycin Hydrochloride for Injection from Two Manufacturers / 医药导报

Objective To evaluate the differences in efficacy,safety and economics of vancomycin hydrochloride for injection between two manufacturers based on real-world data.Methods A total of 6 757 cases of intravenous use of vancomycin hydrochloride for injection from different manufacturers between January 1,2013 and December 31,2019 in the Affiliated Drum Tower Hospital of Nanjing University Medical School were retrospectively analyzed,and 5308 cases were matched by 1∶1 propensity score method,including 2 654 cases in the group A(domestic drug group)and 2 654 cases in group B(the innovator drug group).The differences in efficacy and safety between the two groups were compared.Cost-effectiveness analysis was used to compare the drug economics of the two groups.Results There were no significant differences in clinical cure rate,bacterial clearance rate,and incidence of adverse events between the two groups(P>0.05).In terms of economics,the average cost of vancomycin per capita,average daily cost of vancomycin and average cost of antibiotics per capita were significantly different between the two groups(P<0.05),and the cost of group B was higher than that of group A.Conclusion The efficacy and safety of vancomycin hydrochloride for injection were consistent between the two manufacturers.

Effectiveness and safety of PD-1 inhibitors for immunotherapy in patients with advanced cancer:a real-world study in a Chinese cohort / 肿瘤

Objective:To study the effectiveness and safety of PD-1(programmed cell death protein-1,PD-1)inhibitors for the treatment of patients with advanced cancer in real-world in a Chinese cohort. Methods:Data of patients with advanced cancer who were admitted to the Department of Oncology,Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine between May 2018 and September 2019 and received PD-1 inhibitor alone orcombined with otheranti-cancer therapies were collected.The clinical characteristics,therapeutic efficacy and adverse events were analyzed retrospectively. Results:A total of 75 patients with advanced cancer were included in this study.The cohort consisted of 53 males and 22 females with an average age of 60 years,among whom 60 patients had metastasis.Lung cancer(27 cases)and gastric cancer(12 cases)accounted for the largest proportion.Other cancer types included cancers of the digestive system(colorectal,liver,pancreatic,esophageal,and bile duct cancer),urinary system(kidney,pelvis,ureter,and bladder cancer)and female reproductive system(breast,cervical,and ovarian cancer),malignant melanoma,and head and neck cancer(nasopharyngeal and laryngeal cancer).Among all the patients studied,55 patients(73.3％)received PD-1 inhibitors as first-line and(or)second-line therapy,and 62 patients(82.7％)received PD-1 inhibitors in combination with other anti-cancer therapies.The objective response rate was 1 4.5％,disease control rate was 65.2％,the median progression-free survival was 6.1 months[95％confidence interval(C/):4.356-7.844],and the median overall survival was 1 8.0 months(95％CI:9.565-26.435).Adverse events,mainly grade 1 or grade 2,accured in 5 5 patients.The progression-free survival was 6.3 months in patients treated with PD-1 inhibitors as first-line and(or)second-line therapy,significantly longer than the 3.0-month-long progression-free survival of the patients treated with PD-1 inhibitors as third-line or multiline therapy[hazard ratio(HR)=0.492,95％Cl:0.244-0.992,P=0.048]. Conclusions:Immunotherapy with PD-1 inhibitors was effective and safe for patients with advanced cancer in real-world,especially in those who received PD-1 inhibitor treatment as first-or second-line therapy.

Research Ideas and Challenge of Real World Study and Artificial Intelligence Based On Clinical Diagnosis and Treatment Data of Traditional Chinese Medicine / 中医杂志

With the continuous progress of research methodology in the real world and the growing maturity of artificial intelligence technology， a method for conducting “quantitative” research to guide clinical practice based on traditional Chinese medicine （TCM） diagnosis and treatment data was gradually developed. However， there is still a need for further improvements in the overall design of studies and the transformation of findings into clinical practice. Based on this， we put forward a comprehensive overall design concept and application approach for real-world study and artificial intelligence research based on clinical diagnosis and treatment data of TCM. This approach consists of five steps： Constructing a research-based database with a large sample size and high data quality； Mining and classification of core prescriptions； Conducting cohort studies to evaluate the effectiveness of core prescriptions； Utilizing case-control studies to clarify the dominant population； Establishing predictive models to achieve precision medicine. Additionally， it is imperative for researchers to establish a standardized system for collecting TCM variables and processing data， optimize the determination and measurement methods of confounding factors， further improve and promote methodologies， and strengthen the training of interdisciplinary talents. By following this research method， we anticipate that the clinical translation of research findings will be facilitated， leading to advancements in TCM precision medicine. Real-world study and artificial intelligence research share similar research foundations， and clinical applications complement each other. In the future， the two will merge together.