1.Clinical Efficacy of Medication of Xibining Ⅱ Prescription in Treatment of Knee Osteoarthritis with Cold-dampness Blockage Syndrome: A Retrospective Cohort Study
Zifeng CAO ; Wei MEI ; Li ZHANG ; Wendi PAN ; Xiaochen LI ; Jun MAO ; Guojun LI ; Peimin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):122-129
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.
2.Analysis of red blood cells supply before and after the outbreak of COVID-19 from 2018 to 2021 in 18 domestic blood centers
Dongyan ZHAO ; Hongwei MA ; Dingjie TANG ; Xiaorong FENG ; Hao TIAN ; Mengzhuo LUO ; Nan WU ; Yan LIN ; Xia DU ; Qi FU ; Junlei HUANG ; Changchun LU ; Xiaoli CAO ; Yi YANG ; Lin WANG ; Ying LI ; Hai QI ; Dongtai WANG ; Yan QIU
Chinese Journal of Blood Transfusion 2023;36(10):892-898
【Objective】 To compare the supply data of red blood cells(RBCs) from 18 blood centers in China before and after the outbreak of COVID-19 during 2018 to 2021. 【Methods】 Eight indicators related to RBCs supply from 18 blood centers in China during 2018-2021 were collected retrospectively, including the storage of total amount of qualified RBCs (referred to as the total amount of storage), the distribution of total amount of RBCs (referred to as the total amount of distribution), the distribution amount of RBCs per 1 000 population (referred to as the amount of distribution per 1 000 population), the distribution amount of RBCs from 400 mL original blood per 1 000 population [referred to as the amount of distribution per 1 000 population (400 mL)], the average daily distribution amount of RBCs (referred to as the average daily distribution amount), the average daily storage amount of RBCs (referred to as the average daily storage amount), the average storage days of RBCs when distribute (referred to as the RBC storage days), and the expired amount of RBCs (referred to as the expired amount). Based on the outbreak time of COVID-19, the data of 2018 and 2019 were the pre-pandemic group, and the data of 2020 and 2021 were the post-pandemic group. 【Results】 Data on RBCs supply in 18 blood centers from 2018 to 2021(comparison of the pre-pandemic group and the post-pandemic group): the amount of distribution per 1 000 population (median 14.68 U>13.92 U) decreased, the amount of distribution per 1 000 population (400 mL) (median 10.16 U>9.21 U) decreased, and the difference was statistically significant (P<0.05); data comparison between 2019 and 2020:the total amount of distribution (median 117 770.38 U>99 084.08 U) decreased, the amount of distribution per 1 000 population (median 15.04 U>12.19 U) decreased, the amount of distribution per 1000 population (400 mL) (median 10.11 U>8.94 U), the average daily distribution amount(322.66 U>270.73 U) decreased and RBC storage days (median 10.50 d<11.45 d) increased, the difference has statistical significance (P<0.05); data comparison between 2020 and 2021:the total amount of storage (median 101 920.25 U<120 328.63 U), the total amount of distribution (median 99 084.08 U<118 428.62 U), the amount of distribution per 1 000 population (median 12.19 U<15.00 U), the amount of distribution per 1 000 population (400 mL) (median 8.94 U<9.46 U), the average daily distribution amount (270.73 U>324.46 U), the average daily inventory (median 3 222.00 U<4 328.00 U) increased, the expired amount (median 1.50 U>0.00 U) decreased, the difference has statistical significance (P<0.05). The results of ANOVA showed that there were significant differences on the data related to RBCs supply (except expired amount) in different blood centers (P<0.05). The ratio of average daily stock to average daily distribution in the post-outbreak group (median 12.36 d) was higher than that in the pre-outbreak group (median 10.92 d), the difference has statistical significance (P<0.05), with significant difference among different blood centers (P <0.05). 【Conclusion】 The COVID-19 pandemic has a significant impact on RBCs supply in different blood centers. In the second year of the pandemic, the supply capability had recovered to some extent, and there were differences in RBCs supply in different blood centers.
3. Post-marketing multi-center safety surveillance of inactivated enterovirus A71 vaccine (Vero cell)
Ji ZENG ; Tian TANG ; Yijun WANG ; Huakun LYU ; Jianhua HUANG ; Xiuqun LI ; Ningning JIA ; Gang ZENG ; Zhiping CHEN
Chinese Journal of Preventive Medicine 2019;53(3):252-257
Objective:
To evaluate the post-marketing safety profiles of the inactivated enterovirus type 71 (EV-A71) vaccine (Vero cell) after routine inoculation.
Methods:
Eleven cities of Zhejiang Province, Fengtai district of Beijing, Qinnan district, two counties as Pingle and Pingguo of Guangxi Zhuang Autonomous Region, and Dongtai city of Jiangsu Province were selected as the field sites. A total of 45 239 subjects were enrolled in this study from children who seeked the vaccination of EV-A71 vaccine during the period from July, 2016 to June, 2018. Different sampling method were adopted in different sites. All vaccinated children were invited to participate in the study in Fengtai and Dongtai, however, systematic sampling method were adopted in other sites. Active surveillance was conducted and information about adverse reactions (ARs) occurred in 30 min, 3 d and 30 d following each dose of EV-A71 immunization was collected by field observation, phone-call or face-to-face interview. The incidence of ARs in different types, symptoms and grades were described.
Results:
In total, there were 45 239 children who received 71 243 doses EV-A71 vaccine. The overall incidence of ARs was 1.079% (769 doses), with the highest incidence of 1.182% (177/14 973) in 5-11 month group and the lowest incidence of 0.849% (18/2 119) in ≥ 36 month group among different age groups. There was a higher incidence in solicited ARs, which was 1.047% (746 doses). The incidences of grade 1 and grade 2 ARs were also higher, which were 0.404% (288 doses) and 0.554% (395 doses), respectively. No grade 4 ARs occurred. The doses of the first and the second vaccination was 40 736 and 30 507, respectively, and the incidences of ARs were 1.281% (522 doses) and 0.810% (247 doses). Also, the incidences of ARs were 0.091% (37 doses) and 0.043% (13 doses) in local, and 1.168% (476 doses) and 0.760% (232 doses) in system. The symptoms of ARs after the two doses of vaccination were basically the same. Redness at the injection site was the most common local ARs after each dose vaccination, with doses of 24 and 11, while fever was the most common systemic ARs, with doses of 362 and 190. Moreover, ARs mainly occurred in 30 min to 3 d after each dose vaccination, with incidence of 1.016% (414 doses) and 0.698% (213 doses) in the first and second dose, respectively.
Conclusion
The ARs had a low incidence after vaccination in children and most were mild or moderate. EV-A71 vaccine with good safety is suitable for inoculation in a large scale.