rongsheng cai md quotation

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Systematic review and meta-analysis were performed using RevMan 5.2. Dichotomous variables were expressed as pooled risk ratios (RR) with 95% confidence interval (CI) and continuous variables were expressed as the weighted mean difference (MD) with 95% CI. Heterogeneity across the RCTs was assessed by Chi-squared test and I2 statistic. If p < 0.05 or I2 > 50%, it suggested that there was significant statistical heterogeneity and the random-effect model was used to calculate the outcomes; otherwise, the fixed-effect model was considered. The Z-test was employed to verify the overall effects of ligustrazine injection as adjunctive therapy over using Western medicine alone in the treatment of ACI. Significant statistical difference was considered in this meta-analysis when p < 0.05.

Five RCTs reported the NDS as their secondary outcome measure for ACI patients. As shown in Figure 4, ligustrazine injection as adjunctive therapy significantly reduced the NDS in ACI patients (MD = −3.88; 95% CI, −4.15 to −3.61; Z = 28.35, p < 0.00001) with moderate heterogeneity (I2 = 41%; χ2 = 6.80; df = 4, p = 0.15). As shown in Supplementary Table S3, results from the sensitivity analysis and subgroup analysis showed that no significant difference was found in the overall mean differences (MDs) of NDS. Results of Begg’s test (Z = −0.24, p = 1.00) and Egger’s test (t = 0.37, p = 0.739) suggested that there were no significant publication biases among the five RCTs.

Seven RCTs mentioned fibrinogen as the secondary outcome measure. As shown in Figure 5, results indicated that ligustrazine injection combined with Western medicine was superior to Western medicine alone in reducing the fibrinogen in ACI patients (MD = −0.59; 95% CI, −0.76 to −0.42; Z = 6.77, p < 0.00001) with high heterogeneity (I2 = 93%; χ2 = 86.28; df = 6, p < 0.00001). As shown in Supplementary Table S4, sensitivity analysis and subgroup analysis showed that there were little changes in the overall MDs of fibrinogen. Results from Begg’s test (Z = 0.30, p = 0.764) and Egger’s test (t = 1.24, p = 0.269) indicated that no significant publication biases were found among the included seven RCTs.

LBV was reported as the outcome measure in four RCTs. As shown in Figure 6, results suggested that ligustrazine injection as adjunctive therapy was better than Western medicine alone in reducing LBV for ACI patients (MD = −2.11; 95% CI, −3.16 to −1.06; Z = 3.95, p < 0.0001) with high heterogeneity (I2 = 86%; χ2 = 21.17; df = 3, p < 0.0001). Sensitivity analysis and subgroup analysis were performed to evaluate the overall MDs influenced by the factors of low quality RCTs, sample size and publication date. Results showed that little differences were found in the overall MDs of LBV (Supplementary Table S5). Results of Begg’s test (Z = 0.34, p = 0.734) and Egger’s test (t = −0.64, p = 0.585) demonstrated that there were no significant publication biases among the four RCTs.

HBV was reported in six RCTs and it was selected for one of the outcome measures. As shown in Figure 7, results demonstrated that ligustrazine injection as adjunctive therapy was more effective than Western medicine alone to reduce HBV in the treatment of ACI patients (MD = −0.88; 95% CI, −1.20 to −0.55; Z = 5.27, p < 0.00001) with high heterogeneity (I2 = 98%; χ2 = 304.24; df = 5, p < 0.00001). In this meta-analysis, sensitivity analysis and subgroup analysis were conducted to verify if the overall MDs were affected by the low quality of RCTs, sample size and publication date and results suggested that little differences were found in the overall MDs of HBV (Supplementary Table S6). Results of Begg’s test (Z = 0, p = 1.00) and Egger’s test (t = −0.41, p = 0.70) indicated that no significant publication biases were found among the six RCTs.

Many RCTs on ligustrazine injection combined with Western medicine for the treatment of ACI. However, the clinical efficacy of ligustrazine injection is not yet well confirmed. Although a former meta-analysis published in 2016 had evaluated the efficacy and safety of ligustrazine in the treatment of cerebral infarction, the poor methodological quality (the Jadad score of all the studies was 1 point) prevented the author from making firm conclusions (Yu et al., 2016). The lack of a subgroup and sensitive analysis also resulted in its result being more unreliable. Moreover, the former meta-analysis was not conducted according to the PRISMA guidelines. This study aims to provide a PRISMA-compliant systematic review (PRISMA Checklist was provided in Supplementary Table S7) and meta-analysis for evaluating the efficacy of ligustrazine injection as adjunctive therapy in treating ACI. Meta-analysis results of the primary outcome measure (clinical effective rate) showed that ligustrazine injection combined with Western medicine appeared to be more effective than Western medicine alone (RR = 1.24; 95% CI, 1.19–1.29). Results of the secondary outcome measures including NDS (MD = −3.88; 95% CI, −4.15 to −3.61), fibrinogen (MD = −0.59; 95% CI, −0.76 to −0.42), LBV (MD = −2.11; 95% CI, −3.16 to −1.06), and HBV (MD = −0.88; 95% CI, −1.20 to −0.55) confirmed that the therapeutic effect of ligustrazine injection as adjunctive therapy surpassed the Western medicine alone in the treatment of ACI. Moreover, the combination of ligustrazine injection did not result in adverse reactions for ACI patients.

ACI is the ischemic necrosis or cerebral softening of local brain tissues caused by the obstruction of acute local blood supply in brain tissues, ischemia, and hypoxia (Regenhardt et al., 2018). The decrease or interruption of cerebral blood flow is the main reason of ACI, which seriously damages the function of the nervous system. Clinical efficacy of ligustrazine in the remediation of neurological deficits and reduction of the fibrinogen, LBV, and HBV has been demonstrated by many pharmacological experiments. Kong et al. found that ligustrazine could promote neural progenitor cells move to the damaged area by activating the phosphatidylinositol 3-kinase pathway to achieve the protective effect on the brain (Kong et al., 2016). Whole-blood viscosity and platelet aggregation are usually used as the prognostic indicators of ischemic cerebral and myocardial diseases. Cai et al. confirmed that ligustrazine could significantly decrease whole-blood viscosity and inhibit platelet aggregation through down-regulate the expression of CXCR4 in platelets, lymphocytes, and blood red cells (Cai et al., 2014). These available evidences also consistently supported the adjunctive use of ligustrazine injection in the treatment of ACI.

ACI, acute cerebral infarction; CI, confidence interval; CNKI, China national knowledge infrastructure; HBV, high shear blood viscosity; LBV, low shear blood viscosity; LSI, ligustrazine injection; MD, mean difference; NDS, neurological deficit score; RCTs, randomized controlled trials; RR, relative risk; rt-PA, recombinant tissue plasminogen activator; TCM, traditional Chinese medicine; UK, urokinase; VIP, China Science and Technology Journal Database; WM, western medicine.

Cai, X., Chen, Z., Pan, X., Xia, L., Chen, P., Yang, Y., et al. (2014). Inhibition of Angiogenesis, Fibrosis and Thrombosis by Tetramethylpyrazine: Mechanisms Contributing to the SDF-1/CXCR4 Axis. Plos One 9, e88176. doi:10.1371/journal.pone.0088176

Zhang, Y. H., Cai, X. Z., and Guo, M. H. (2013). Effects of Ligustrazine Injection on Serum High-Sensitivity C-Reactive Protein, Interleukin-6 and Matrix Metalloproteinases-9 in Treating Acute Cerebral Infarction. J. Clin. Med. Pract. 17, 78–80. (In Chinese). doi:10.7619/jcmp.201317026

After serum starvation for 24 h, cells were treated with inflammatory mediator or rapamycin (containing 100 nmol/L insulin or not) at 37 °C for 24 h. For analysis of glucose concentrations before and after the 24-hour treatment, the medium was spun down in a centrifuge column and subjected to glucose analysis in a GOPOD kit (Rongsheng Biotech, Shanghai, China) according to the manufacturer’s instructions.

A total of 17 RCTs involving 1,459 patients were included in this meta-analysis. Results indicated that puerarin injection as adjunctive therapy was more superior than conventional Western medicine alone in reducing angina symptoms [risk ratio (RR) = 1.22, 95% CI 1.16 to 1.28, Z = 8.11, p < 0.00001] and improving ECG (RR = 1.32, 95% CI 1.20 to 1.44, Z = 6.00, p < 0.00001), meanwhile reducing the frequency of angina attack [mean difference (MD) = −2.22, 95% CI −2.53 to −1.90, Z = 13.97, p < 0.00001] and the duration of angina attack (MD = −2.00, 95% CI −2.39 to −1.61, Z = 9.99, p < 0.00001) for the treatment of UAP. Results from the GRADE assessment suggested that the comprehensive quality of this evidence was low.

RevMan version 5.3 was used for the statistical analysis. The dichotomous variable was represented as the pooled risk ratios (RRs) with 95%CI. The continuous variable was represented as the weighted mean difference (MD) with 95%CI. I2 statistic and the chi-squared test were employed to evaluate the heterogeneity between the included RCTs. If I2 > 50% or p < 0.05, it suggested that a significant statistical heterogeneity was observed and the random-effect model should be employed to evaluate the outcome measures. Otherwise, the fixed-effect model was adopted. To evaluate whether the overall effects of puerarin injection as adjunctive therapy were superior to Western medicine alone for UAP, Z-test was employed. If p < 0.05, it suggested that there was a significant statistical difference in this meta-analysis.

Treatment groupControl groupTreatment groupControl groupTreatment groupControl groupCai and Liu (19)Puerarin injection 60 mg, isosorbide nitrate 10 mg, nifedipine 15–30 mg, aspirin 50 mg, nitroglycerin 0.3–0.6 mgIsosorbide dinitrate 10 mg, nifedipine 15–30 mg, aspirin 50 mg, nitroglycerin 0.3–0.6 mg40382020Symptoms

Three included RCTs reported the frequency of angina attacks (time/week). The random-effect model was used to analyze the data since there was significant heterogeneity (I2 = 77%, p = 0.01). As shown in Figure 6, results suggested that the adjunctive use of puerarin injection was better than Western medicine alone in reducing the frequency of angina attacks (MD = −2.58; 95% CI −3.35 to −1.81; Z = 6.55, p < 0.00001). To evaluate if the overall effect in reducing the frequency of angina attack was influenced by low-quality RCTs, sensitivity analysis was performed. As shown in Table 5, there was a significant difference when the low-quality RCTs were gradually excluded based on the M scale. Big changes (2.46 in magnitude) were found for the included RCTs with high quality (M scale > 3) and low quality (M scale ≤ 3). To assess if the overall effect was influenced by sample size and publication date among the three RCTs, subgroup analysis was introduced in this meta-analysis (Supplementary Table 4). A significant difference was observed in the overall MDs. After carefully reading the original RCT (23), it was found that the 26 patients with initial onset angina pectoris could be the important reason leading to heterogeneity. Hence, we removed this RCT and pooled other two RCTs alone (MD = −2.22, 95% CI −2.53 to −1.90, Z = 13.97, I2 = 0%, p < 0.00001).

Duration of angina attacks (minutes for each attack) was reported in three included RCTs in this meta-analysis. There was significant heterogeneity (I2 = 87%, p = 0.0004) and random effect model was adopted. As shown in Figure 7, results indicated that puerarin injection as adjunctive therapy had a better therapeutical effect in reducing the duration of angina attacks than Western medicine alone (MD = −2.56, 95% CI −3.45 to −1.66, Z = 5.62, p < 0.00001). To evaluate if the overall effect of MDs in reducing the duration of angina attack was influenced by low-quality RCTs, sensitivity analysis was performed. As shown in Table 6, a significant difference was observed when the low-quality RCTs were gradually excluded. Significant changes (2.67 in magnitude) were found for the included three RCTs with high quality (M scale > 3) and low quality (M scale ≤ 3). To assess if the overall effect of MDs was influenced by sample size and publication date among the three RCTs, subgroup analysis was introduced in this meta-analysis (Supplementary Table 5). A significant difference was observed in the overall MDs. For the same reason, the heterogeneity was attributed to the patients with initial onset angina pectoris in the RCT (23). Finally, this RCT was removed and other two RCTs were pooled alone (MD = −2.00, 95% CI −2.39 to −1.61, Z = 9.99, I2 = 50%, p < 0.00001).

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