Xingyue Huang1, Xiaojiao Duan2, Kaihuan Wang3, Jiarui Wu4, Xiaomeng Zhang5. 1. Department of Clinical Chinese Pharmacy, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, 100102, China. Electronic address: 2043773492@qq.com. 2. Department of Clinical Chinese Pharmacy, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, 100102, China. Electronic address: duanxiaojiaodgh@163.com. 3. Department of Clinical Chinese Pharmacy, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, 100102, China. Electronic address: wkhlinda@163.com. 4. Department of Clinical Chinese Pharmacy, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, 100102, China. Electronic address: exogamy@163.com. 5. Department of Clinical Chinese Pharmacy, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, 100102, China. Electronic address: MDmengziq_2525jy@126.com.
Abstract
OBJECTIVE: To evaluate the clinical efficacy of Shengmai injection for the treatment of chronic obstructive pulmonary disease (COPD) through an evidence-based approach. METHODS: Randomized controlled trials (RCTs) investigating the effect of Shengmai injection on COPD were included in this study. Seven electronic databases were searched to obtain eligible studies. The quality of the included RCTs was evaluated according to the Cochrane Risk of Bias Assessment Tool. When appropriate, meta-analysis of the data was conducted by RevMan 5.3 software and Stata 13.0 software. The relative risk (RR) or mean difference (MD) and 95% confidence interval (CIs) were reported for dichotomous or continuous outcomes, respectively. Sensitivity analysis was performed to verify the independence of the results. Funnel plots and the Begg and Egger tests were implemented to determine the potential publication bias. RESULTS: Ultimately, 23 RCTs were included, involving 1804 participants. Meta-analysis showed that the combination of Shengmai injection and western medicine (WM) could achieve a better effect than WM alone in terms of improving the clinical total effective rate (RR = 1.20, 95% CIs: 1.15-1.24), pulmonary function (FEV1(L): MD = 0.41, 95% CIs 0.32 to 0.49; FEV1(%): MD = 6.21, 95% CIs: 2.72-9.71), blood gas index (PaO2: MD = 6.13, 95% CIs: 2.93-9.32; PaCO2: MD=-6.2, 95% CIs: -11.63 to -0.77), immunoglobulin levels (IgG: MD = 3.55, 95% CIs: 3.10-3.99; IgA: MD = 0.34, 95% CIs: 0.31to 0.38; IgM: MD = 0.35, 95% CIs: 0.27 to 0.42), C-reactive protein levels (MD = -8.05, 95% CIs: -10.11 to -6.00) and the lung rale disappearance time (MD = -2.57, 95% CIs: -3.19 to -1.95). Additionally, the CAT score, mMRC and average hospitalization time were also reduced significantly by Shengmai injection plus WM. Among 11 RCTs that mentioned safety issues, 6 RCTs found no adverse events, and the other 5 RCTs reported the details of adverse events. CONCLUSION: Shengmai injection may positively influence COPD in combination with WM. However, firm conclusions could not be draw due to the low quality of the evidence. Further high-quality studies are still required to test the efficacy of Shengmai injection for this condition.
OBJECTIVE: To evaluate the clinical efficacy of Shengmai injection for the treatment of chronic obstructive pulmonary disease (COPD) through an evidence-based approach. METHODS: Randomized controlled trials (RCTs) investigating the effect of Shengmai injection on COPD were included in this study. Seven electronic databases were searched to obtain eligible studies. The quality of the included RCTs was evaluated according to the Cochrane Risk of Bias Assessment Tool. When appropriate, meta-analysis of the data was conducted by RevMan 5.3 software and Stata 13.0 software. The relative risk (RR) or mean difference (MD) and 95% confidence interval (CIs) were reported for dichotomous or continuous outcomes, respectively. Sensitivity analysis was performed to verify the independence of the results. Funnel plots and the Begg and Egger tests were implemented to determine the potential publication bias. RESULTS: Ultimately, 23 RCTs were included, involving 1804 participants. Meta-analysis showed that the combination of Shengmai injection and western medicine (WM) could achieve a better effect than WM alone in terms of improving the clinical total effective rate (RR = 1.20, 95% CIs: 1.15-1.24), pulmonary function (FEV1(L): MD = 0.41, 95% CIs 0.32 to 0.49; FEV1(%): MD = 6.21, 95% CIs: 2.72-9.71), blood gas index (PaO2: MD = 6.13, 95% CIs: 2.93-9.32; PaCO2: MD=-6.2, 95% CIs: -11.63 to -0.77), immunoglobulin levels (IgG: MD = 3.55, 95% CIs: 3.10-3.99; IgA: MD = 0.34, 95% CIs: 0.31to 0.38; IgM: MD = 0.35, 95% CIs: 0.27 to 0.42), C-reactive protein levels (MD = -8.05, 95% CIs: -10.11 to -6.00) and the lung rale disappearance time (MD = -2.57, 95% CIs: -3.19 to -1.95). Additionally, the CAT score, mMRC and average hospitalization time were also reduced significantly by Shengmai injection plus WM. Among 11 RCTs that mentioned safety issues, 6 RCTs found no adverse events, and the other 5 RCTs reported the details of adverse events. CONCLUSION: Shengmai injection may positively influence COPD in combination with WM. However, firm conclusions could not be draw due to the low quality of the evidence. Further high-quality studies are still required to test the efficacy of Shengmai injection for this condition.