Data_Sheet_1_The Effects of Aspirin With Combined Compound Danshen Dropping Pills on Hemorheology and Blood Lipids in Middle-Aged and Elderly Patients With CHD: A Systematic Review and Meta-Analysis.pdf

Background: Coronary heart disease (CHD) is one of the most common diseases in clinical cardiovascular practice, mainly afflicting the middle-aged and elderly. It will greatly affect elderly quality of life, and even affect their psychological and physical health. At present, CHD is treated with western drugs alone, but this can produce drug dependency. In recent years, Traditional Chinese Medicine (TCM) combine western drugs has been used as a complementary and alternative therapy, and its effectiveness and safety have been proven, attracting the attention of numerous researchers.
Objective: Our study aimed to compare the efficacy of Aspirin with Combined Compound Danshen Dropping Pills had a superior effect on the treatment of Hemorheology and Blood Lipids in Middle-aged and Elderly Patients with CHD. Determine the effectiveness and safety of Aspirin with Combined Compound Danshen Dropping Pills in the treatment of CHD, and obtain high quality clinical evidence.
Methods: Based on the PRISMA Statement, inclusion and exclusion criteria were formulated. Randomized controlled trials (RCTs) on the Effects of Aspirin with Combined Compound Danshen Dropping Pills on Hemorheology and Blood Lipids in Middle-aged and Elderly Patients with CHD were found following a search of 4 mainstream medical databases. RCTs found to meet the study's requirement were included; data information was then extracted, and the quality assessed using the Cochrane bias risk assessment tool. Through RevMan software, Meta analysis was carried out for overall TC, TG, HDL-C, LDL-C hematocrit, high shear viscosity, low shear viscosity, plasma viscosity, PAGM, and TXB2 effective rate. The relative risk (RR) and 95% confidence interval (95% CI) were calculated; heterogeneity was tested and its source found; publication bias was assessed through the Egger and Begg tests, and by means of funnel plots.
Result: 22 RCTs were found, involving 1,987 cases. The results of the Meta analysis showed that, compared to drug therapy alone, Aspirin with Combined Compound Danshen Dropping Pills had a superior effect on the treatment of Hemorheology and Blood Lipids in Middle-aged and Elderly Patients with CHD. The meta analysis results show the effects on TC [MD = −0.91, 95% CI (−1.09, −0.73)], on TG [MD = −0.94, 95% CI (−1.22, −0.66)], on HDL-C [MD = 0.40, 95% CI (0.27, 0.53)], on LDL-C [MD = −0.99, 95% CI (−1.24, −0.74)], on hematocrit [MD = −2.69, 95% CI (−3.73, −1.65)], on high shear blood viscosity [MD = −1.11, 95% CI (−2.18, −0.05)], on low shear viscosity [MD = −0.79, 95% CI (−0.89, −0.68)], on plasma viscosity [MD = −0.26, 95% CI (−0.52, 0.01)], on PAMG [MD = −10.75, 95% CI (−16.84, −4.67)], and on TXB2 [MD = −11.84, 95% CI (−14.75, −8.92)]. The source of heterogeneity might be related to the state of patient, efficacy of drugs in the control group and difference in judgment criteria for efficacy. The Egger test and Begg test showed that publication bias did not occur in our study.
Conclusions: The combination of compound dropping pill DSP with aspirin has some therapeutic effect on blood lipids and hemorheology in patients with CHD, ince some of the RCTs featured a very small sample size, the reliability and validity of our study's conclusion may have been affected as well; therefore, the explanation should be treated with some caution. In the future, a large number of higher-quality RCTs are still needed to confirm the results of our study.

背景：冠状动脉粥样硬化性心脏病（Coronary Heart Disease, CHD）是临床心血管领域最常见的疾病之一，多发于中老年人群。该疾病会严重降低老年人的生活质量，甚至损害其身心健康。目前临床多采用单一西药治疗冠心病，但该疗法可能引发药物依赖性。近年来，中西医联合疗法作为补充替代治疗手段应用于临床，其有效性与安全性已得到证实，受到了众多研究者的关注。
目的：本研究旨在对比阿司匹林联合复方丹参滴丸与单用西药治疗中老年冠心病患者的疗效，前者在改善血液流变学与血脂指标方面更具优势；明确阿司匹林联合复方丹参滴丸治疗冠心病的有效性与安全性，以期获取高质量临床证据。
方法：本研究遵循PRISMA声明（PRISMA Statement）制定纳入与排除标准。通过检索4个主流医学数据库，筛选关于阿司匹林联合复方丹参滴丸对中老年冠心病患者血液流变学及血脂影响的随机对照试验（Randomized Controlled Trials, RCTs）。纳入符合研究要求的随机对照试验，随后提取相关数据信息，并采用Cochrane偏倚风险评估工具（Cochrane bias risk assessment tool）对研究质量进行评价。采用RevMan软件对总胆固醇（Total Cholesterol, TC）、甘油三酯（Triglyceride, TG）、高密度脂蛋白胆固醇（High-Density Lipoprotein Cholesterol, HDL-C）、低密度脂蛋白胆固醇（Low-Density Lipoprotein Cholesterol, LDL-C）、血细胞比容、高切黏度、低切黏度、血浆黏度、PAGM及血栓烷B2（Thromboxane B2, TXB2）的有效率进行Meta分析（Meta-analysis）。计算相对危险度（Relative Risk, RR）与95%置信区间（95% Confidence Interval, 95% CI），检验异质性并明确其来源；通过Egger检验、Begg检验及漏斗图评估发表偏倚。
结果：共纳入22项随机对照试验，涉及1987例患者。Meta分析结果显示，相较于单一西药治疗，阿司匹林联合复方丹参滴丸治疗中老年冠心病患者在改善血液流变学与血脂指标方面更具优势。具体结果如下：对总胆固醇的均数差（Mean Difference, MD）为-0.91，95%置信区间为(-1.09, -0.73)；对甘油三酯的MD为-0.94，95%置信区间为(-1.22, -0.66)；对高密度脂蛋白胆固醇的MD为0.40，95%置信区间为(0.27, 0.53)；对低密度脂蛋白胆固醇的MD为-0.99，95%置信区间为(-1.24, -0.74)；对血细胞比容的MD为-2.69，95%置信区间为(-3.73, -1.65)；对高切血液黏度的MD为-1.11，95%置信区间为(-2.18, -0.05)；对低切黏度的MD为-0.79，95%置信区间为(-0.89, -0.68)；对血浆黏度的MD为-0.26，95%置信区间为(-0.52, 0.01)；对PAGM的MD为-10.75，95%置信区间为(-16.84, -4.67)；对血栓烷B2的MD为-11.84，95%置信区间为(-14.75, -8.92)。异质性来源可能与患者基线状态、对照组药物疗效及疗效判定标准的差异有关。Egger检验与Begg检验结果显示，本研究不存在发表偏倚。
结论：阿司匹林联合复方丹参滴丸可改善冠心病患者的血脂水平与血液流变学指标，但由于部分纳入的随机对照试验样本量较小，本研究结论的可靠性与有效性可能受到一定影响，因此对该结果的解读需谨慎。未来仍需开展更多高质量的随机对照试验以验证本研究结果。