Objective To assess the efficacy and safety of human urinary kallidinogenase injection (HUK) in treating patients with acute ischemic stroke. Methods Through adopting Cochrane systematic review methods, the relevant materials were retrieved by electronically and manually searching databases and claimed from pharmaceutical factories, so as to collect the randomized controlled trials (RCTs) about HUK for the patients with acute ischemic stroke, which were searched by the end of October 2010. The quality of each trial was assessed by two reviewers independently, and meta-analysis was conducted by using RevMan 5.0.2 software. Results Twenty-four trials involving 2 433 patients were included, of which 2 were multi-center placebo controlled trials, and the other 22 were all non-placebo trials. Only 2 trials (459 cases) reported the death or dependence at the end of 3-month follow-up. In those trials, HUK reduced death or dependency comparing to the control group (RR=0.69, 95%CI 0.55 to 0.86). Twenty trials (2 117 patients) reported the proportion of patients with marked neurological improvement after finishing the 7 to 21 days treatment. Meta-analysis showed the HUK group had more neurological improvement than the control group, with significant differences (RR=1.56, 95%CI 1.44 to 1.70). Fifteen trials reported adverse events, of which the transient hypotension was commonly seen (1.5%-5.1%). Non-fatal intracerebral hemorrhage was detected in 7 patients in 3 trials, but the difference between the HUK group (6 patients, 1.2%) and the control group (1 patient, 0.4%) was not significant (RR=1.82, 95%CI 0.34 to 9.61). Deaths occurred in both HUK group (2 patients, 0.4%) and the control group (1 patient, 1.1%) in 2 trials, without significant differences (RR=0.6, 95%CI 0.09 to 3.92). No trial assessed quality of life. Conclusion Available evidence suggests that HUK injection reduces neurological impairment after acute ischemic stroke and improves long-term outcomes, though a few patients suffer from transient hypotension. Further high-quality, large-scale RCTs are needed to confirm these results.
Objective To assess the effects and safety of Tongxinluo (TXL) Capsule for patients with acute ischemic stroke. Methods PubMed (1966 to 2011.12.23), EMbase (1966 to 2011.12.23), Ovid CENTRAL (2011.10), CBM (1978 to 2011.12.23), VIP (1989 to 2011.12.23), CNKI (1980 to 2011.12.23), CDFD (1999 to 2011.12.23), and CDFD (1999 to 2011.12.23) were electronically searched for randomized controlled trials (RCTs) on TXL Capsule for patients with acute ischemic stroke. Meanwhile, relevant data were retrieved by hand search and data from pharmaceutical factories were collected. Two reviewers independently screened literature, extracted data, and assessed the methodological quality. Then, meta-analysis was performed using RevMan 5.1 software. Results Thirty nine RCTs (non-placebo-controlled trials) involving 3 906 patients were included. The quality of the included studies was generally low. The follow-up time started from the end of treatment (minimum: 7 days) to 6 months. The result of meta-analysis (16 trials, 1 445 patients) showed that the TXL group was better than the control group in improving neurological function (SMD= −1.09, 95%CI −1.68 to −0.49). The result of meta-analysis (21 trials, 2 500 patients) showed that, the effectiveness rate (91.3%) of the TXL group was significantly higher than that of the control group (RR=1.22, 95%CI 1.14 to 1.30). Eight trials reported adverse reactions such as nausea and gastric discomfort. Four trials reported that 5 patients in the control group died during the treatment. No studies reported the data of mortality, dependency rate during 3-month follow up, or quality of life. Conclusion Current studies show that, TXL Capsule improves neurological impairment of patients with acute ischemic stroke which has less adverse reactions. Further studies are still needed to verify the effects of TXL on long-term mortality and disability. It is necessary to conduct more high quality RCTs especially with placebo-controlled trials to confirm the efficacy of Tongxinluo for acute ischemic stroke.
Objectives To assess the efficacy and safety of dl-3-butylphthalide for patients with acute ischemic stroke. Methods We collected randomized controlled trials, which compared dl-3-butylphthalide agents with placebo or open control in patients with acute ischaemic stroke, by searching the electronic bibliographic databases, scanning references listed in articles and handsearching journals. Meta-analysis was conducted based on the methods recommended by the Cochrane Collaboration. Results Twenty-one trials involving 2 123 patients were included, of which 2 were placebo-controlled and 19 were open-label controlled. Meta-analysis of 10 trials (n=958), in which neurological deficits were assessed by CSS, suggested that there were significant differences favoring butylphthalide in the mean change of neurological deficits’ score during the treatment period [MD=2.30, 95%CI (1.57, 3.03)]. Meta-analysis of 6 trials (n=590), in which neurological deficits were assessed by NIHSS, also favored butylphthalide [MD=2.06, 95%CI (0.65, 3.46)]. Adverse events (AEs) were reported in 13 trials. Gastrointestinal discomfort (1.7%~8%) and abnormal liver function including abnormal ALT (1.4%~17.5%) and abnormal AST (1.9%~8.82%) were the two most common AEs. However, no severe adverse events (SAEs) were reported. Numbers of dead and dependent patients at the end of followup (at least three months) were not reported in the 21 included trials. Quality of life was not assessed in any of the trials. Conclusion Dl-3-butylphthalide can improve the neurological function after acute ischemic stroke and appears to be safe. However, further study is needed to confirm its effects for lowering rates of death and dependency.