Objective: This research aims to evaluate the efficacy and safety of the Fuke Qianjin capsule combined with antibiotics in the treatment of chronic pelvic inflammatory disease, including the associated complications (endometritis and adnexitis). Methodology: We searched 4 Chinese and 3 English databases from their establishment to May, 2023. A randomized controlled trial (RCT) of the Fuke Qianjin capsule combined with antibiotics was included in the trial group. The meta-analysis used the RevMan 5.4 software provided by the Cochrane collaboration network. Results: A total of 103 RCTs were included, specifically 58 on chronic pelvic inflammatory disease, 6 on endometritis, and 39 on adnexitis (n= 9820, trial group n = 4925, control group n = 4895). The results of the meta-analysis demonstrated that the total effective rate of the Fuke Qianjin capsule combined with antibiotics in the treatment of chronic pelvic inflammatory disease (RR=1.21, 95%CI [1.18, 1.25], Z=14.86, p < 0.00001), endometritis (RR=1.22, 95%CI [1.13, 1.31], Z=5.31, p < 0.00001), and adnexitis (RR=1.26, 95%CI [1.23, 1.30], Z=16.49, p < 0.00001) was significantly better than that of antibiotics alone. Equally important, the relief time of clinical symptoms, the incidence of adverse reactions, and the recurrence rate (p < 0.05) were significantly lower than those of antibiotics alone. Conclusion: The Fuke Qianjin capsule combined with antibiotics was found to be superior to those in the antibiotic group alone. However, this conclusion necessitates further improvements, such as being supported by a greater number of high-quality and substantive research samples.

目的 系统评价妇科千金胶囊联合抗菌药治疗慢性宫颈炎的有效性和安全性.方法 计算机检索中文学术期刊全文数据库(CNKI)、维普中文期刊全文数据库(VIP)、万方数据库(Wanfang Data)、中国生物医学文献数据库(CBM)、PubMed、Cochrane Library、Embase和Web of Science数据库中妇科千金胶囊联合抗菌药治疗慢性宫颈炎的临床随机对照试验(RCT),检索时间从各数据库建库至2023年1月.采用Cochrane协作网提供的RevMan 5.4软件进行Meta分析.结果 共纳入18项RCTs,共计1 946例患者(试验组972例、对照组974例).Meta分析结果显示,妇科千金胶囊联合抗菌药治疗慢性宫颈炎的临床总有效率明显高于单独使用抗菌药[RR=1.23,95％CI(1.18,1.27),P＜0.000 01];白细胞介素-6水平[MD=-2.60,95％CI(-3.32,-1.88)]、超敏C反应蛋白(hs-CRP)水平[MD=-3.78,95％CI(-4.46,-3.09)]均明显低于单独使用抗菌药(P＜0.000 01);分泌物评分[MD=-0.74,95％CI(-1.05,-0.43)]、宫颈病变评分[MD=-0.89,95％CI(-1.07,-0.72)]均明显低于单独使用抗菌药物(P＜0.000 01);不良反应发生率与单独使用抗菌药物相比,组间差异无统计学意义[RR=0.78,95％CI(0.34,1.77),P=0.55].结论 妇科千金胶囊联合抗菌药物治疗慢性宫颈炎的临床疗效较好,在血清学指标、治疗后评分方面也有较好表现,亚组分析认为该结果稳健.但纳入文献较少,其中血清学指标、治疗后评分结局指标存在显著异质性,尚需要更多高质量、大样本、多中心RCT进一步验证.

Purpose To measure health-related quality of life in the Chinese population using three universal health utility scales (CQ-11D, EQ-5D-5L, and SF-6D) and to compare the differences in the results obtained by the different scales to provide a reference for future utility on health-related quality of life in the Chinese population. Methods According to the Chinese population's distribution area, gender, and age, quota sampling was conducted. Three scales, CQ-11D, EQ-5D-5L, and SF-6D, whose results were self-reported, were collected in succession after collecting respondents' demographic information. The health utility value and floor/ceiling effect were explained. Bland–Altman was used to evaluate the consistency, the intraclass correlation coefficient was used to evaluate the correlation, and the receiver operating characteristic curve was used to evaluate the discriminative validity of the scale. Results The mean utility values of the CQ-11D, EQ-5D-5L, and SF-6D scales, respectively, were 0.891, 0.927, and 0.841. The floor effect did not appear in any of the three scales, but the ceiling effect did, and the EQ-5D-5L ceiling effect was the most severe. The limits of the agreement interval for CQ-11D versus EQ-5D-5L in the total sample population were (-0.245,0.172); for CQ-11D versus SF-6D, they were (− 0.256,0.354); and for EQ-5D-5L versus SF-6D, they were (-0.199,0.371). The consistency of the three scales is satisfactory overall. In the total population, the intraclass correlation coefficient between CQ-11D and EQ-5D-5L was 0.709, while EQ-5D-5L and SF-6D were 0.0.565 and that between EQ-5D-5L and SF-6D was 0.472. According to the subject operation curve results, the area under the curve for the total sample population of CQ-11D was 0.746, EQ-5D-5L was 0.669, and SF-6D was 0.734. Conclusion The CQ-11D is inferior to the EQ-5D-5L, but superior to the SF-6D. There is a strong correlation between the health utility values of the total population as measured by the three scales and those of the healthy population. The CQ-11D scale is the most sensitive to differences between populations and diseases.

This study was conducted to evaluate the efficacy and safety of Simotang Oral Liquid in the treatment of functional dyspepsia in adults. "Simotang Oral Liquid" "Simotang" "Si Mo Tang" "Si Mo Tang Oral Liquid" were used for retrieval of the relevant papers from CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, Springer Link, and Web of Science from database inception to June 2021. Randomized controlled trial(RCT) of Simotang Oral Liquid in the treatment of functional dyspepsia in adults was screened out for Meta-analysis which was conducted in RevMan 5.3. A total of 16 RCTs were included. Meta-analysis showed that compared with the control group, Simotang Oral Liquid increased the total response rate and lowered the traditional Chinese medicine syndrome scores, serum cholecystokinin(CCK), serum nitric oxide(NO), and incidence of adverse reactions. However, the serum substance P(SP) had no statistical difference between the two groups. Simotang Oral Liquid is effective and safe in the treatment of functional dyspepsia in adults. However, this study has evidence and limitations, so the conclusions need to be further verified by large sample and multicenter clinical studies.

目的 基于Meta分析评价四磨汤口服液治疗小儿功能性消化不良、早产儿喂养不耐受和新生儿黄疸的有效性和经济性.方法 根据纳排标准进行文献筛选,通过适应证进行归类整理;利用RevMan 5.3软件进行Meta分析,采用成本-效果分析和最小成本分析法进行经济学评价.结果 共纳入18篇随机对照试验(RCT)文献;Meta分析结果显示,相对于对照组,四磨汤口服液组治疗小儿功能性消化不良、新生儿黄疸的临床效果更优;相对于常规治疗,四磨汤口服液联合常规治疗早产儿喂养不耐受的呕吐停止或缓解时间更短,住院时间更短,体重增长更优,差异均有统计学意义(P<0.05).经济性评价结果显示,与多潘立酮混悬液比较,四磨汤口服液治疗小儿功能性消化不良总有效率的增量成本-效果比(ICER)为0.35元;与常规治疗联合茵栀黄口服液比较,四磨汤口服液联合常规治疗联合茵栀黄口服液治疗新生儿黄疸总有效率的ICER为1.70元;与常规治疗相比,四磨汤口服液联合常规治疗早产儿喂养不耐受呕吐停止或缓解时间、住院时间的ICER分别为15.07元、2.70元.结论 四磨汤口服液治疗小儿功能性消化不良、早产儿喂养不耐受和新生儿黄疸有较好的有效性和经济性.

目的 探讨降脂通络软胶囊治疗原发性高脂血症气滞血瘀证患者的有效性、安全性及经济性.方法 收集2016年7月—2017年3月期间9所医院的441例原发性高脂血症(气滞血瘀证)的患者,根据用药不同分为试验组(降脂通络软胶囊)332例,对照组(蒲参胶囊)109例,观察两组患者血脂指标[低密度脂蛋白胆固醇(Low Density Lipoprotein-Cholesterol,LDL-C)、高密度脂蛋白胆固醇(High Density Lipoprotein Cholesterol,HDL-C)、血清总胆固醇(Serum Total Cholesterol,TC)、甘油三酯(Triglyceride,TG)]的变化、中医证候总有效率及安全性,采用成本-效果法分析经济性.结果 两组均可降低患者的LDL-C、TG和TC值,且试验组在降低LDL-C和TG值方面优于对照组(P<0.05);但两组对HDL-C的影响均不明显.试验组中医证候总有效率优于对照组(P<0.05).两组均未发现明显的不良反应.经济性方面,试验组的成本效果比(C/E)低于对照组,且两组相比的IC-ER为-1345.43元,试验组为成本效果优势方案,敏感性分析显示该结论较为稳定.结论 相比蒲参胶囊,降脂通络软胶囊治疗原发性高脂血症(气滞血瘀证)更为有效、经济.

目的:评估降脂通络软胶囊纳入《国家基本医疗保险、工伤保险和生育保险药品目录》(以下简称"药品目录")报销对医保基金支出可能产生的影响.方法:基于国际药物经济学与结果研究协会公布的预算影响分析《预算影响分析指南》,采用Excel软件构建降脂通络软胶囊治疗原发性高脂血症的预算影响分析模型,模型模拟时间范围设定为5年(2021～2025年),对降脂通络软胶囊纳入药品目录报销对医保基金支出进行估算.结果:假设降脂通络软胶囊进入药品目录乙类后,在现有市场份额基础上,平均每年分别替代血脂康胶囊4％、降脂通脉胶囊4％、蒲参胶囊10％的市场份额,预计2021～2025年在治疗原发性高脂血症中,因降脂通络软胶囊纳入药品目录乙类而增加的医保基金支出分别为-176万元、-1 732万元、-3 297万元、-4 871万元、-6 457万元,增加的医保基金支出分别占原发性高脂血症治疗中的医保基金支出的-0.16％,-1.55％,-2.97％,-4.43％和-5.92％.敏感性分析显示预算影响分析结果较稳定,当降脂通络软胶囊价格上调至约36.66元/盒(规格:50 mg×36粒/盒)时,可增加医保基金支出,但在此价格下2022年及以后仍可节约医保基金.结论:在本研究假定参数下,若降脂通络软胶囊进入药品目录乙类,平均每年分别替代血脂康胶囊4％、降脂通脉胶囊4％、蒲参胶囊10％的市场份额,以当前中标价格作为2021～2025年药品价格,将能够减少医保基金的支出,并且随着降脂通络软胶囊市场份额的增大,将会节约更多的医保基金.

目的:运用灰色GM(1,1)预测模型对我国中药上市企业主营业务收入和净利润进行预测分析.方法:以北京同仁堂股份有限公司、云南白药集团股份有限公司等10家中药上市企业为样本,分析各企业2011—2020年的主营业务收入和净利润发展现状,采用Matlab 7.0软件构建和拟合灰色GM(1,1)预测模型,预测各企业2021—2025年主营业务收入和净利润发展趋势.结果:基于各企业2011—2020年的主营业务收入和净利润构建预测模型,结果显示,预测模型的发展系数(a)均满足–a小于0.3,后验差比值(C)均小于0.35,且P值均为1.000,模型预测精确度均为好.预测结果显示,各企业2021—2025年主营业务收入将整体呈增长趋势,净利润则出现不同的发展趋势.结论:灰色GM(1,1)模型预测中药上市企业财务指标主营业务收入和净利润的拟合效果好,可应用于财务指标的中长期预测.各企业的主营业务收入将不断增加,但净利润波动较大,企业应根据财务指标的发展趋势,适当调整发展战略方向,以提高企业获利能力和盈利运营能力.

目的 探讨康妇炎胶囊联合抗生素治疗盆腔炎(PID)的有效性、安全性及经济性.方法 收集2009年12月至2011年9月就诊于北京大学人民医院、北京医院、北京中医药大学东直门医院、中国中医科学院望京医院、北京市海淀医院、北京市垂杨柳医院、北京中医药大学第三附属医院等7个中心的442例盆腔炎患者,取其中采用口服药物治疗的205例患者,其中康妇炎胶囊联合抗生素组(观察组)64例、抗生素组(对照1组)73例、妇科清热剂中成药联合抗生素组(对照2组)68例.观察3组的PID症状、体征评分、总有效率以及安全性,并采用成本-效果分析、成本-效用分析等方法分析其经济性.结果 观察组第4周、第8周总有效率均优效于对照1组和对照2组(第4周总有效率,观察组68.75％ vs.对照1组6.85％ vs.对照2组20.59％;第8周总有效率,观察组76.56％ vs.对照1组8.22％ vs.对照2组20.59％)(均P＜0.05).3组均未发现明显的不良反应.经济性方面,第4周、8周总有效率采用成本-效果分析,观察组相较于对照1组每提高一单位总有效率需多花3.48～3.84元,相较于对照2组每提高一单位总有效率少花0.19～0.22元,观察组为成本-效果优势方案.决策树模型分析显示,观察组治疗成本为1412.96元,健康效用值为0.35质量调整生命年(QALYs),对照1组治疗成本为1493.42元,健康效用值为0.33 QALYs,观察组为成本-效用优势方案.敏感性分析显示该结论较为稳定.结论 在治疗盆腔炎方面,康妇炎胶囊联合抗生素组治疗为具有药物经济学优势的治疗方案.

This research was to evaluate the economics of Shexiang Tongxin Dropping Pills combined with conventional therapy for patients with coronary heart disease(CHD) in Chinese medical environment. From the perspective of medical insurance, a Markov model was established in this study based on the results of Meta-analysis comparing the effectiveness and safety of Shexiang Tongxin Dripping Pills combined with conventional treatment and conventional treatment alone. The experimental group was treated with She-xiang Tongxin Dropping Pills combined with conventional Western medicine treatment, while the control group was treated with conventional Western medicine treatment alone. The cost-utility analysis and sensitivity analysis were performed for the two regimens using Treeage pro. After 30 cycles of model simulation, according to the results of Markov model, the total cost and health output were CNY 237 795.73 and 16.36 QALYs(the quality adjusted life years, QALYs), respectively for Shexiang Tongxin Dropping Pills combined with conventional Western medicine treatment, CNY 247 396.55 and 16.36 QALYs respectively for the conventional Western medicine treatment alone. Compared with the conventional treatment alone, the Shexiang Tongxin Dropping Pills combined with conventional treatment had lower long-term cost and higher health output, with advantages of cost-utility and pharmacoeconomic advantages. The sensitivity analysis results showed that the conclusion was relatively stable. Based on the above results, it is considered that compared with the conventional Western medicine alone, Shexiang Tongxin Dropping Pill combined with conventional Western medicine is a treatment regimen with pharmacoeconomic advantages for the treatment of CHD.

目的 在中国的医疗环境下评估蛭蛇通络胶囊与脑安胶囊治疗中风(气虚血瘀证)恢复期患者的经济性.方法 基于蛭蛇通络胶囊治疗中风病(气虚血瘀证)的Ⅲ期临床试验和已发表的临床研究数据,从医保角度出发,构建Markov模型模拟Ⅲ期临床试验结束后蛭蛇通络胶囊与脑安胶囊治疗中风(气虚血瘀证)患者的疾病进展情况,评价2种治疗方案的经济性.结果 模型结果显示,在模拟长期(30年)的治疗中,蛭蛇通络胶囊平均治疗成本为130193.70元,质量调整生命年(quality adjusted life year,QALY)为6.62年;脑安胶囊平均治疗成本为130204.41元,QALY为6.52年.与脑安胶囊相比,蛭蛇通络胶囊可节约10.71元,可多获得0.10个QALY,增量成本-效果比(incremental cost effectiveness ratio,ICER)为-102.52元/QALY.结论 与脑安胶囊相比,蛭蛇通络胶囊治疗中风(气虚血瘀证)的长期成本较低、产出略高,具有一定的药物经济学优势.

The aim of the research was to evaluate the efficacy and safety associated with Shexiang Tongxin Dropping Pills combined with conventional therapy for patients with coronary heart disease(CHD). We searched 8 electronic databases up to November 2020, including PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, VIP and SinoMed. Eligible studies were clinical trials of Shexiang Tongxin Dropping Pills combined with conventional therapy used in the treatment of coronary heart disease(CHD). The Meta-analysis was performed using STATA 15 software. A total of 21 RCTs(n=2 186) were shortlisted for the Meta-analysis. The results of efficacy evaluation showed that the total effective rate of Shexiang Tongxin Dropping Pills combined with conventional therapy was higher than that of conventional therapy of coronary heart disease(RR=1.20, 95%CI[1.15, 1.26], Z=8.63, P<0.001). Furthermore, Shexiang Tongxin Dripping Pills combined with conventional therapy had better effect on electrocardiogram efficacy(RR=1.24, 95%CI[1.16, 1.34], Z=5.98, P<0.001) and the number of angina attacks(SMD=-2.30, 95%CI[-3.47,-1.14], Z=3.88, P<0.001), the duration of angina attack(SMD=-2.31, 95%CI[-3.07,-1.55], Z=5.97, P<0.001), with lower levels of LDL-C(SMD=-0.73, 95%CI[-1.32,-0.14], Z=2.42, P=0.016), TC(SMD=-1.16, 95%CI[-1.35,-0.96], Z=11.56, P<0.001) and TG(SMD=-0.87, 95%CI[-1.06,-0.68], Z=8.97, P<0.001), and higher levels of HDL-C(SMD=0.87, 95%CI[0.02, 1.71], Z=2.00, P=0.045). The results of safety evaluation showed that the incidence of adverse reactions of Shexiang Tongxin Dropping Pills combined with conventional therapy was lower than that of conventional therapy of coronary heart disease(RR=0.45, 95%CI[0.22, 0.91], Z=2.23, P=0.026). There were significant differences in the above outcome indexes between the two groups. After the Harbord method test, the total effective rate outcome index has publication bias, but the sensitivity analysis of the cut-and-fill method suggested that the result was stable. In general, limited by the quantity and quality of included literature, more high-quality studies are needed to further verify the conclusions of this study.