Objective To evaluate the efficacy and safety of Shengmai injection for hypoxic-ischemic encephalopathy (HIE). Methods We searched MEDLINE (1966 to February 2007), EMBASE (1980 to February 2007), CBM (1978 to 2006), CNKI (1979 to February 2007), VIP (1989 to February 2007), and handsearched five Journals on Pediatrics. We evaluated features of quality of included studies, including randomization, blinding, allocation concealment and loss of follow-up. Meta-analyses were performed using The Cochrane Collaboration’s RevMan 4.2.8. Results Seven randomized controlled trials were included. The cure rate on day 5 in the Shengmai injection group was higher than in the control group (RR 1.55, 95%CI 1.25 to 1.93), but this rate was similar on day 10 (RR 0.74, 95%CI 0.43 to 1.29). No significant difference in cure rate was noted between the Shengmai injection group and naloxone group (RR 0.88, 95%CI 0.53 to 1.46). No significant differences were observed in mortality (RR0.44, 95%CI 0.16 to 1.19) and mutilation rate (RR 0.58, 95%CI 0.21 to 1.56) between the Shengmai injection group and the control group. For those babies suffering from HIE combined with myocardial damage, Shengmai injection could speed up the recovery of ECG (WMD=–2.02, 95%CI –2.76 to –1.28) and myocardial enzymogram (CK-MB: WMD= –4.78, 95%CI –6.77 to –2.79; CK-BB: WMD=–2.68, 95%CI –4.58 to –0.78). Significant differences in NBNA score were noted between the Shengmai injection group and the control group on day 5 (WMD=4.05, 95%CI 2.47 to 5.63) and day 10 (WMD=3.50, 95%CI 2.26 to 4.74). No fatal side effects were reported. Conclusions Shengmai injection has certain therapeutic values in treating HIE. Shengmai injection can speed up the recovery ECG, CK-BM and CK-BB of HIE patients, especially in those who have myocardial damage. Shengmai injection can also improve the NBNA score. However, because of the low statistical power and high risks for selection bias, performance bias and measurement bias in the included trials, these conclusions need to be interpreted cautiously.
Objective To assess the tolerability and safety of Yinhuang injection in Chinese healthy volunteers. Methods Thirty-two healthy subjects were enrolled in the single-dose study. Each subject was administered one of the seven doses of 40, 120, 240, 320, 400, 480, and 560 mg, respectively, by intravenous injection. The sample sizes were 2, 4, 6, 6, 6, 4 and 4, respectively, for each dose group. Twelve healthy subjects were enrolled in the multi-dose study. The subjects in the lower dose group were administered 240 mg and the subjects in the higher dose group were administered 400 mg Yinhuang by intravenous injection once a day for consecutive 7 days. The sample sizes for both groups were 6. The safety was evaluated based on clinical symptoms, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests and adverse events. All analyses were performed by using the software package SAS version 9.1. T-test and analysis of variance were used for continuous variables. Chi-square test and Fisher’s exact test were used for categorical variables.Results A total of 44 healthy volunteers completed the tolerance test. No serious adverse event and clinically significant changes in vital signs, ECG and laboratory tests were found in both single-dose groups and multi-dose groups. Among two mild adverse events, dizziness occurred in one subject in 480 mg dose group in the single-dose trial, which was probably related to the experimental drug. Conclusion Yinhuang injection is safe and well-tolerated in Chinese healthy subjects after administration of single-doses (40-560 mg) and multi-doses (240-400 mg once a day for consecutive 7 days). The maximum-tolerated dose of Yinhuang injection is at 560 mg in the single-dose trial. The dose regimen of 240-400 mg a day is recommended for phase II study.
【摘要】 目的 評價麻敏維C緩釋膠囊（每粒含鹽酸偽麻黃堿90 mg和馬來酸氯苯那敏4 mg）在人體的生物等效性。 方法 于2006年6月采用隨機交叉自身前后對照試驗設計，26例受試者分別單次和多次空腹口服麻敏維C緩釋膠囊（試驗制劑）和復方鹽酸偽麻黃堿緩釋膠囊（參比制劑），與不同時間點取血樣，采用液-質聯用（HPLC/MS）法測定人血漿中鹽酸偽麻黃堿和馬來酸氯苯那敏的濃度，以DAS軟件計算藥物代謝動力學參數，并進行生物等效性評價。 結果 單次給藥后，兩組分的主要藥物代謝動力學參數無統計學意義（Pgt;0.05）。試驗制劑中馬來酸氯苯那敏和鹽酸偽麻黃堿生物利用度分別為104.31%和109.19%。多次給藥后，兩組分的主要藥物代謝動力學參數無統計學意義（Pgt;0.05）。試驗制劑的馬來酸氯苯那敏和鹽酸偽麻黃堿的生物利用度分別為103.58%和99.37%。 結論 麻敏維C緩釋膠囊和復方鹽酸偽麻黃堿緩釋膠囊具有生物等效性。【Abstract】 Objective To investigate the bioequivalence of delayed-release capsule of ephedrine-chlorphenamine-vitamin C. Methods In June 2006, 26 healthy volunteers were administrated with delayed-release capsule of ephedrine-chlorphenamine-vitamin C or delayed-release capsule of ephedrine-chlorphenamine in a randomized and two-way crossover design with single or multiple dosage. The plasma concentrations were determined by HPLC/MS method. The pharmacokinetic parameters and bioequivalence were calculated by DAS software. Results After single dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 104.31% in chlorphenamine and 109.19% in ephedrine, respectively. After multiple dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 103.58% in chlorphenamine and 99.37% in ephedrine, respectively. Conclusion Delayed-release capsule of ephedrine-chlophenamine-vitamin C is equivalent to the reference preparation.
