ObjectiveTo evaluate the reporting quality of clinical randomized controlled trials (RCTs) published in five Chinese psychiatric journals from 2016 to 2020 and to compare the reporting quality with that from 2004 to 2008. MethodsRCTs in five Chinese psychiatric journals were collected through a computerized search of the CNKI, WanFang Data, and CBM databases and manual searches of paper journals, all with a search timeframe from 2016 to 2020. The CONSORT 2010 statement and two extensions (CONSORT extension for abstracts and CONSORT harms extension) were used to evaluate the RCTs. The criteria for reporting quality were the evaluation score, reporting proportion, and compliance proportion. The reporting quality of RCTs in the past 5 years was compared by year group. In addition, the RCT reporting quality from 2004 to 2008 was compared with that from 2016 to 2020. ResultsIn total, 226 RCTs were included. There was no statistically significant difference in the total evaluation score or abstract score from 2016 to 2020 (F=0.54, P=0.71; H=1.49, P=0.83). However, there were statistically significant differences in the harm scores from 2016 to 2020 (H=10.78, P=0.03). Further analysis of the items revealed statistically significant differences in the reporting proportion of items 16 and 19 (Fisher’s=8.61, P=0.04; χ2=11.63, P=0.02) and no significant differences in the other items (P>0.05). The reporting proportion of defined primary and secondary outcome indicators, allocation concealment, randomization implementation, outcomes and estimation, generalization, trial registration, and flow chart was <10% in each year. There was a statistically significant difference in the compliance proportion of RCT reporting quality from 2016 to 2020 versus 2004 to 2008 (39.54%±8.92% vs. 34.76%±9.16%, t=6.60, P<0.001). ConclusionThe reporting quality of RCTs in five Chinese psychiatric journals from 2016 to 2020 is better than that from 2004 to 2008. However, the reporting quality of RCTs within the latter 5 years still have reporting deficiencies in important items, and many aspects still are needed to be improved and enhanced.
目的 了解婦幼保健院住院患者抗菌藥物應用情況。 方法 采用橫斷面調查法，對2012年2月份患者的抗菌藥物使用情況進行調查。 結果 抗菌藥物橫斷面使用率為71.14%，其中單用率為79.27%，二聯使用率為20.73%；住院患者使用頻率排行前10位的抗菌藥物中應用最多的是頭孢硫脒；兒科抗菌藥物使用率最高為93.27%；產科抗菌藥物使用頻率強度最高為77.37，婦科為67.19；所有患者臨床微生物檢驗樣本送檢率僅為39.3%。 結論 抗菌藥物使用率及抗菌藥物使用強度不符合相關規定，需要加強其抗菌藥物臨床應用的管理。
【摘要】 目的 觀察激素加霉酚酸酯（mycophenolate mofetil，MMF）和他克莫司（tacrolimus，FK506）的多靶點方案治療難治性腎小球疾病的療效及安全性。 方法 2008年5月-2010年3月收治的15例狼瘡性腎炎（lupus nephritis，LN）、3例膜增生性腎小球腎炎（membranoproliferative glomerulonephritis，MPGN）及3例膜性腎病（membranous nephropathy，MN）患者，因多種免疫抑制劑治療無效或復發而改用多靶點療法。潑尼松以30~40 mg/d起始，逐漸減量。MMF 和FK506起始劑量分別為0.5 g/d或1 mg/d，目標血藥濃度分別為20~40 mg/（h·L）或5~8 ng/mL。定期隨訪觀察肝腎功能、尿蛋白定量、不良反應等指標。 結果 治療6個月時15例LN中7例（46.7%）完全緩解（complete remission，CR），5例（33.3%）部分緩解（partial remission，PR），3例（20%）無效（no response，NR）。3例MPGN均表現為NR。3例MN中2例（66.7%）PR，1例（33.3%）NR。治療過程中呼吸道感染及脫發各1例，胃腸不適2例，肌酐逐步升高3例，無死亡或退出者。 結論 多靶點療法對難治性LN安全、有效，可作為其他免疫抑制劑治療無效或復發時的選擇方案，但對MPGN和MN療效欠佳，需進一步研究。【Abstract】 Objective To investigate the efficacy and safety of multitarget therapy with steroid, mycophenolate mofetil (MMF) and tacrolimus (FK506) in the treatment of refractory glomerular diseases. Methods Fifteen patients with lupus nephritis (LN), 3 patients with membranoproliferative glomerulonephritis (MPGN) and 3 patients with membranous nephropathy (MN) who failed the previous immunosuppressive therapy from May 2008 to March 2010 in our hospital were treated with multitarget therapy. The initial dose of prednisone was 30-40 mg/d and then tapered gradually. MMF and FK506 were started at 0.5 g/d or 1 mg/d, and the target blood concentration of the two drugs was 20-40 mg/(h·L) and 5-8 ng/mL respectively. Clinical parameters such as liver and renal function, urine protein, and side effects were recorded and analyzed in the regular follow-up. Results After 6 months of treatment, 7 (46.7%) of the 15 LN patients achieved complete remission (CR), 5 (33.3%) achieved partial remission (PR), while 3 (20%) failed this treatment and had no response (NR). All of the three MPGN patents had NR to this combined therapy. Two (66.7%) of the 3 MN patents achieved PR while 1 (33.3%) had NR. No patient withdrew or died because of side effects. One patient developed upper respiratory infection, one experienced alopecia, two developed gastrointestinal syndrome and three experienced gradual increasing in the serum creatinine. Conclusion Multitarget therapy with FK506, MMF and steroid is an effective and safe therapy for refractory lupus nephritis and it can be used in patients who are resistant to the conventional immunosuppressive therapy. However, this combined therapy does not meet a satisfactory result in patients with MN and MPGN, which entails further study.