1. Clinical efficacy and safety of thrombolytic treatment with reteplase in patients with intermediate-risk acute pulmonary embolism
Haige ZHAO ; Shuxian WANG ; Zhinan LU ; Xinxin YAN ; Zichao LYU ; Fuhua PENG ; Yan WU ; Xin GAO ; Lu HUA ; Zhicheng JING ; Xiqi XU
Chinese Journal of Cardiology 2017;45(4):314-317
Objective:
To assess the efficacy and safety of thrombolytic treatment with reteplase in patients with intermediate-risk acute pulmonary embolism.
Methods:
Ten consecutive patients with intermediate-risk acute pulmonary embolism who received thrombolytic treatment with reteplase at Thrombosis and Vascular Medicine Center, Fuwai Hospital from March to November in 2016 were included.Vital signs, right ventricular diameter, systolic pulmonary artery pressure, and biochemical markers were assessed before and after thrombolytic therapy with reteplase, and bleeding complications were also observed during 3 months follow up.
Results:
(1) For the efficacy outcomes: at 48 hours after thrombolytic treatment with reteplase, echocardiography-derived diameter of right ventricular was significant reduced from (27.9±3.8) mm to (24.8±2.6) mm (
2.Efficacy and safety of tolvaptan for hyponatremia:an overview of systematic reviews/meta-analysis
Xiaoxiao LIANG ; Shuxian LYU ; Shixian CHEN ; Xiao LI ; Ling LI ; Xin HUANG
China Pharmacy 2023;34(8):983-987
OBJECTIVE To reevaluate systematic reviews/meta-analysis of efficacy and safety of tolvaptan for hyponatremia. METHODS Retrieved from CNKI, Wanfang Data, VIP, CBM, PubMed, Embase and the Cochrane Library database, systematic reviews/meta-analysis about tolvaptan for the treatment of hyponatremia were included from the inception to June 15, 2022. After screening literature and extracting data, the PRISMA statement, AMSTAR 2 scale and GRADE method were used to evaluate the reporting quality, methodological quality and evidence quality of the included literature, respectively. RESULTS A total of 6 articles were included, of which 1 was systematic review and 5 were meta-analysis, including 56 outcome indicators. All of the 6 studies had PRISMA scores ranging from 15.0 to 20.5, and the quality of them was moderate. Results of the AMSTAR 2 scale showed that the methodological quality of 5 literatures were very low, and the quality of 1 literature was low. The quality of GRADE evidence showed that there were 6 moderate-quality indicators, 13 low-quality indicators, 35 very low-quality indicators, and 2 indicators that could not be assessed due to missing data. The main factors causing degradation were limitations, inconsistency, imprecision and publication bias. In terms of efficacy, tolvaptan could effectively increase the level of serum sodium, increase urine volume, reduce body weight, reduce abdominal circumference, relieve edema, and reduce alaninetransaminase level. In terms of safety, the incidence of total adverse drug reaction induced by tolvaptan was controversial; it may increase the risk of dry mouth, thirst, frequent urination or excessive correction of serum sodium. CONCLUSIONS Tolvaptan has great efficacy in the treatment of hyponatremia, but serum sodium overcorrection should be avoided in terms of safety. Relevant systematic reviews/meta-analysis have shortcomings of low reporting quality, methodological quality and evidence quality, which may reduce the reliability of the results, so the results should be treated with caution.
3.Effectiveness and safety of generic and original drugs of atorvastatin :a systematic review
Shuxian LYU ; Xiaoxiao LIANG ; Rui YANG ; Xiao LI ; Yan LI ; Yi HAN ; Xin HUANG
China Pharmacy 2022;33(3):358-365
OBJECTIVE To systema tically evaluate the effectiveness and safety of gen eric and original drugs of atorvastatin , and to provide the latest evidence-based reference for drug selection in clinic. METHODS Retrieved from PubMed ,Cochrane Library,Embase,CNKI,VIP and Wanfang database ,intervention trials and observational studies about generic and original drugs of atorvastatin were collected during the inception to Apr. 2021. After data extraction of literatures met inclusion criteria ,the Cochrane risk bias evaluation tool 5.1.0 was used to evaluate the quality of intervention trials ;Newcastle-Ottawa Scale (NOS)was used to evaluate the quality of observational studies. RevMan 5.4 software was used to conduct meta-analysis ,and descrptive analysis was performed at the same time. RESULTS A total of 24 studies were included ,involving 21 randomized controlled trials (RCTs)and 3 retrospective cohort studies (RCSs),with 20 001 patients involved. Meta-analysis results of RCT showed there was no statistically significant difference between the two groups in reducing low-density lipoprotein cholesterol (LDL-C)levels [MD = - 0.05,95% CI(- 0.12,0.02),P=0.16] and increasing Δ 基金项目:国家重点研发计划项目(No.2017YFC0910004);山 东省重点研发计划项目(No.2020RKB14165) high-density lipoprotein cholesterol (HDL-C)levels [MD = *硕士研究生 。研究方向:临床药学。E-mail:1677032023@qq. - 0.00,95% CI(- 0.02,0.01),P=0.52];the degree of com reducing total cholesterol (TC)level [MD =-0.11,95%CI # 通信作者:主任药师,硕士生导师。研究方向:临床药学、药事 ( - 0.17,- 0.06),P<0.000 1] and triglyceride (TG) 管理。电话:0351-89268349。E-mail:13791120711@126.com level [MD =-0.05,95%CI(-0.09, -0.01),P=0.02] in ·358· China Pharmacy 2022Vol. 33 No. 3 中国药房 2022年第33卷第3期 generic drug group was lower than orig inal drug group ,with statistical significance difference. There was no statistical significance difference in total incidence of adverse drug reaction (ADR)[OR=1.08,95% CI(0.85,1.37),P=0.55] and the incidence of other ADR(P>0.05). The results of subgroup analysis showed that the reductions of TC and TG of generic drugs produced by Beijing Jialin Pharmaceutical Enterprise (hereinafter refer to Jialin generic drugs )were less than those of the original drug ,and the difference was statistically significant ;compared with original drugs ,there was no significant difference in other indexes or all indexes of the generic drugs from other manufacturers. Compared with original drugs ,the reductions of TC and TG in 20 mg/d group of Jialin generic drugs were less than original drug group ;the degree of TC reduction at 12 and 24 weeks of follow-up and TG reduction at 24 weeks of follow-up were less than those of the original drugs ,the difference was statistically significant ;there was no significant difference in other indexes. The qualitative description of RCS showed that for elderly patients with death/acute coronary syndrome ,there was no statistical difference between the two groups in terms of cardiovascular events or serious side effects. For the adult patients who switched from original drugs to generic drugs ,the effect of generic drugs instead of original drugs would not be reduced ,but the increase of HDL-C was less than that of original drug. CONCLUSIONS In terms of effectiveness,generic drugs of atorvastatin can replace original drugs and caution should be taken on the levels of HDL-C ,TC and TG for long time use ;in terms of safety ,generic drugs are similar to the original drugs.