Subjects: Medicine, Pharmacy >> Clinical Medicine submitted time 2023-05-05 Cooperative journals: 《中国全科医学》
Abstract： Background Traditional Chinese medicine（TCM） is effective in the treatment of sepsis-induced acute lung injury（ALI）/acute respiratory distress syndrome（ARDS）. However，the lack of standard and uniform outcome indicators in the design of most published clinical trials makes it difficult to combine and compare the results of similar studies，causing the impossibility of generating high-quality evidence to guide clinical decision-making. Objective To analyze the use of outcome indicators in randomized controlled trials（RCTs） on TCM for sepsis-induced ALI/ARDS from 2017 to 2022. Methods CNKI，Wanfang Data，SinoMed，PubMed，Embase，Web of Science and Cochrane Library were searched for RCTs on sepsis-induced ALI/ARDS，with the intervention group treated with TCM combined with other drugs or conventional treatment，and no restrictions in the control group. The ROB.2 tool of the Cochrane Review Group was used to assess the quality of literature and the classification of outcome indicators was summarized. Results 39 papers were included after screening，including 1（2.56%）with low risk of bias，3 （7.69%） with high risk of bias and 35（89.74%） with concerns of bias. The outcome indicators in 5 RCTs were reported with a quality score of ≥ 5，indicating the complete reporting of outcome indicators. A total of 106 outcome indicators were reported and used for 443 times，including physicochemical testing outcome （55 types，51.89%），TCM syndrome/sign outcome（2 types，1.89%），symptom and syndrome outcome（13 types，12.26%），long#2;term prognosis outcome（19 types，17.92%），quality of life outcome（7 types，6.60%），safety event outcome（8 types，7.55%） and economic evaluation outcome（2 types，1.89%）. There were four outcome indicators with utilization rate>50%，including oxygenation index（82.05%），Acute Physiology and Chronic Health Evaluation Scoring System（58.97%），mechanical ventilation duration（51.28%） and interleukin-6（51.28%）. The composite outcome indicators of effective rate or TCM syndrome efficacy were used in 21 RCTs，involving a total of 12 times of effective rate，TCM syndrome score of 8 times and TCM symptom efficacy of 6 times. The total 106 outcome indicators were summarized and categorized sequentially including overall evaluation indicators（36 types，33.96%），common indicators（36 types，33.96%） and different focus indicators（34 types，32.08%）. Conclusion At present，the selection of outcome indicators in RCTs on TCM for sepsis-induced ALI/ARDS is still nonstandard，mainly manifests in unclear differentiation between primary and secondary outcome indicators，trivialization of endpoint indicators，lack of follow-up data and characteristic indicators of TCM. A core outcome set（COS） of TCM outcome indicators for septic induced ALI/ARDS should be constructed to promote the high-quality development of TCM in the future.
Subjects: Medicine, Pharmacy >> Clinical Medicine submitted time 2022-07-20 Cooperative journals: 《中国全科医学》
Abstract： Background Diabetes and osteoporosis are common diseases of middle-aged and elderly people. Diabetes can lead to a variety of acute and chronic complications, but diabetic skeletal changes are often the most overlooked. Osteoporosis is more common in postmenopausal women, and postmenopausal women with type 2 diabetes have multiple risk factors for osteoporosis and are at higher risk. Therefore, early identification and timely intervention are particularly important. Objective To explore the risk factors of osteoporosis in postmenopausal type 2 diabetic mellitus patients in China through Meta analysis. Methods CNKI, VIP, WanFang Data, CBM, PubMed, Embase, The Cochrane Library database were searched to collect clinical studies on the risk factors of osteoporosis in postmenopausal type 2 diabetic patients in China from inception to July 2021.Two researchers independently screened the literature, extracted data, and analyzed the data results using RevMan 5.4.1 software and Stata 15.0 software. Results 21 articles were finally included and 11 relevant influencing factors were extracted. Meta analysis results showed that there were significant difference in age(MD=6.56,95%CI:5.24～7.88),menopausal years(MD=5.93,95%CI:4.23～7.62),duration of diabetes(MD=1.94,95%CI:0.89～2.98),serum calcium(MD=0.03,95%CI:0.01～0.06),serum creatinine(MD=5.57,95%CI:0.70～10.44),Fasting blood glucose(MD=0.49,95%CI:0.09～0.90), glycosylated hemoglobin(MD=0.37,95%CI:0.02～0.71), fasting insulin(MD=3.65,95%CI:1.24～6.06) is a risk factor for osteoporosis in postmenopausal type 2 diabetic patients；BMI(MD=-1.99,95%CI:-2.63～-1.36) were associated with decreased risk of osteoporosis in postmenopausal type 2 diabetic patients. The combined analysis results of serum phosphorus (MD=0.00, 95%CI:-0.05～0.05) and alkaline phosphatase (MD=1.26, 95%CI:-0.06～2.57) were insignificant. The results of sensitivity analysis showed that, except for serum creatinine, the results of other risk factors were stable and reliable, and there was no publication bias. Conclusion BMI is a protective factor for osteoporosis in postmenopausal type 2 diabetic patients in China, while age, menopausal years, duration of diabetes, serum calcium, serum creatinine, fasting insulin, fasting blood glucose, and glycosylated hemoglobin are risk factors. The effects of serum phosphorus and alkaline phosphatase on osteoporosis in postmenopausal type 2 diabetic patients in China need to be further verified.
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