目的 评价参附注射液治疗老年人心力衰竭疗效和安全性。 方法 计算机检索Cochrane图书馆，Medline（1950年－2013年10月），Embase（1980年－2013年10月），中国知网（1979年1月－2013年10月）、万方（1986年1月－2013年10月）、维普（1989年1月－2013年10月）数据库，全面收集参附注射液联用西药常规治疗（试验组）与西药常规治疗疗效（对照组）比较的随机对照试验（RCT），分别由2名研究者根据纳入与排除标准，独立筛选文献、提取资料并评价文献质量，采用Revman 5.1软件进行Meta分析。 结果 共纳入8个研究559例患者，研究质量均为C级。Meta分析结果显示：与对照组比较，试验组临床疗效明显提高、症状改善[RR=1.20，95%CI（1.11，1.29），P＜0.000 01]，左室舒张末期内径减小明显[MD=5.90，95%CI（3.97，7.84），P＜0.000 01]、6 min步行试验距离增加[MD=62.48，95%CI（43.12，81.84），P＜0.000 01]，但左室射血分数两组差异无统计学意义[MD=4.79，95%CI（－0.07，9.65），P=0.05]。 结论 参附注射液与西药常规治疗联用能进一步提高老年心力衰竭患者的临床疗效，且安全性较好。
【摘要】 目的 探讨抗氧化应激是否参与参附注射液预处理诱导的肾脏保护作用。 方法 健康成年雄性SD大鼠21只随机分为假手术对照组（Sham组）、肾脏缺血再灌注组（I/R组）和参附注射液组（SF组）；SF组给予参附注射液10 mL/kg腹腔注射，每日1次，连续给药7d。麻醉下行右肾切除后，用无损伤动脉夹钳夹左侧肾蒂60min，再灌注24 h，制备肾缺血再灌注损伤动物模型。比较各组SD大鼠再灌注24 h肾脏组织中超氧化物歧化酶（superonidedismutase，SOD）水平、过氧化氢酶（catalese，CAT）和丙二醛（malonicalaldehyed，MDA）含量。 结果 与Sham组相比，I/R和SF组肾脏组织SOD和CAT显著降低，而MDA明显升高（Plt;0.05）；与I/R组比，参附注射液能明显增加SOD和CAT水平（Plt;0.05），降低MDA含量（Plt;0.05）。 结论 参附注射液预处理可增强缺血再灌注损伤肾脏组织抗氧化应激，其表现为增强SOD和CAT的活力，减少MDA的生成。【Abstract】 Objective To explore the protective effect of Shenfu injection combined with antioxidant system on rats’ kidney after ischemia-reperfusion injury. Methods Twenty-one male Sprague Dawley (SD) rats were randomly divided into 3 groups: sham operation group (Sham group), ischemia-reperfusion group (IR group), and shenfu injection treated group (SF group). The rats were anesthetized with valebarbitone. Bilateral kidneys were exposed through midline incision. The right kidney underwent the nephrectomy and left renal pedicels were occluded for 60 minutes with a traumatic mini-clamp and then unclamped for 24 hours. Animals in SF group received Shenfu injection (10 mL/kg) through intraperitoneal injection every day for 7 days. About 24 hours after reperfusion, superoxide dismutase (SOD), CAT and malonical aldehyde (MDA) were measured. Results The levels of MDA were lower in SF group than those in IR group (Plt;0.05). The level of SOD and CAT in SF group increased more significantly than which did in IR group (Plt;0.05). Conclusion Our finding suggests that antioxidant system in SF group works more efficiently than IR group to overcome oxidative stress in renal ischemia-reperfusion injury.
Objective To evaluate the clinical therapeutic effect and safety of western medicine plus Shenfu Injection versus simple western medicine in heart failure (HF) patients. Methods Such databases as CNKI (January 1979 to 2009), VIP (January 1989 to December 2009), CBM (1978 to 2009), PubMed (1978 to December 2009), The Cochrane Library (Issue 4, 2009) and relevant journals were searched, and the literature of randomized controlled trials comparing the combination of western medicine and Shenfu Injection with simple western medicine in HF patients was included. The quality of studies was evaluated according to the methods of the Cochrane Collaboration, the data were extracted; and meta-analyses were performed with RevMan5.0.2 software. Results Sixteen trials involving 1 117 patients were included. The results of meta-analyses showed that compared with the simple western medicine treatment, the combination of western medicine and Shenfu Injection therapy significantly improved the symptoms, clinical comprehensive effect (RR=3.30, 95%CI 2.22 to 4.92, Plt;0.000 01), TCM syndrome and patient’s quality of life (RR=6.85, 95%CI 2.90 to 16.17, Plt;0.000 01), increased left ventricular ejection fraction (WMD=3.54, 95%CI 2.78 to 4.30, Plt;0.000 01), and reduced LVSD (WMD=2.43, 95%CI 1.04 to 3.82, P=0.000 6). Meanwhile, only one trail indicated that the combination of western medicine and Shenfu Injection might increase the six-minute walking distance, reduce the level of IL-6 and TNF-α, and eliminate the Lee’s HF and LVD-36 questionnaire integral. Conclusion The therapeutic effect of combining western medicine with Shenfu Injection therapy on HF patients is better than that of simple western medicine treatment.
Objective To investigate the status of clinical practices and side effects related to Shenfu injection.Method We searched the China National Knowledge Infrastructure (CNKI) database using the key word “Shenfuinjection”. Original clinical studies of Shenfu injection which were published from January 1993 to December 2008 inChinese magazines were included. Results A total of 576 relevant clinical studies were identified. There were 21 496 cases in the study group and excluding the control group patients. We investigated and analyzed the side effects of Shenfu injection. For cases with side effects, the medication dosage, the diseases for treatment, the method of medication, the menstruum, and course of treatment for the side effects were evaluated. All the side effects were mild except one case of anaphylactic shock. Conclusion Shenfu injection has been widely used in clinical patients since it came into the market in 1993. However, systematic evaluation of its clinical application is lacking, and there are some unsolved problems and deficiency in selecting and expanding diseases for treatment, evaluating the dosage and treatment method, and investigating the side effects of the drug. Therefore, it is imperative to enhance the evaluation drugs and good clinical application after the drugs come into the market with evidence-based medicine.
【摘要】 目的 探讨中成药参附注射液对大鼠深Ⅱ度烧伤创面愈合的影响。 方法 选用16只Sprague-Dawley（SD）大鼠，随机分为实验组、对照组，每组各8只，建立20%体表面积深Ⅱ度烫伤模型。烫伤后即刻及此后每天，实验组大鼠以参附注射液20 mL/kg腹腔注射给药，1次/d，连续给药5 d；对照组给予注射等剂量的生理盐水。分别于致伤后的7、14 d取创面组织块，光学显微镜观察成纤维细胞及胶原纤维生长情况，电子显微镜观察致伤后14 d成纤维细胞细胞器情况，分别计算烧伤后第7、14天两组的创面愈合率，并观察比较两组创面愈合的时间。 结果 所有选入实验的SD大鼠均存活至实验结束。实验组、对照组术后第7天创面愈合率分别为（36.34±2.55）%及（33.13±2.62）%，两组差异有统计学意义（t=2.486，P=0.027）；实验组、对照组术后第14天创面愈合率分别为（75.71±2.29）%及（72.36±2.85）%，两组差异有统计学意义（t=2.590，P=0.022）；实验组、对照组创面愈合时间分别为（20.88±1.36）、（22.94±2.16） d，两组差异有统计学意义（t=-2.286，P=0.0395）。伤后7、14 d创面组织块切片光学显微镜观察发现，实验组肉芽组织及胶原纤维较多，排列更有序，表皮基底细胞增殖活跃，炎症反应较轻；伤后14 d时电子显微镜观察发现，实验组成纤维细胞的细胞器更丰富，分泌胶原更多，实验组创面愈合情况优于对照组。 结论 腹腔注射参附注射液可以促进烧伤创面的愈合，其可能的机制为清除氧自由基，抗脂质过氧化。【Abstract】 Objective To explore the effect of Shenfu injection on promoting healing of deep partial-thickness burn wound in rats. Methods Sixteen Sprague-Dawley (SD) rats were randomly selected, and deep partial-thickness burn with 20% of the body surface was inflicted. The rats were randomly divided into experimental group and control group with eight in each group. Rats in the experimental group were treated with abdominal injection of Shenfu injection at a dose of 20 mL/(kg•d) for five days continually, and rats in the control group were treated with the same dose of 0.9% saline solution. The growth of granulation tissue and collagen fibers were evaluated under light microscope at the seventh and the fourteenth day. The growth of fibroblast was observed under transmission electron microscope at the fourteenth day. The cure rate of both groups of rats at the seventh and fourteenth day was calculated. Then we compared their healing time and the cure rate of the traumatic wound respectively. Results All rats had survived until wound healing. The cure rate at the seventh day for the experimental group and the control group was (36.34±2.55)% and (33.13±2.62)%, and their difference was statistical (t=2.486, P=0.027); At the fourteenth day, the cure rate was respectively (75.71±2.29)% and (72.36±2.85)% with a significant difference between each other (t=2.590, P=0.022). The healing time of the experimental group (20.88±1.36) was significantly shorter than that of the control group (22.9±2.16) (t=-2.286, P=0.040). At the seventh and fourteenth day, light microscope observation showed that the growth of granulation tissue and collagen fibers for rats in the experimental group were much more than that in the control group, the basale cell proliferation was more active, and inflammation was slighter. Through transmission electron microscope, we observed more fibroblast and collagen in the experimental group, which showed a better cure than the control group. Conclusion Shenfu injection can significantly promote wound healing of deep partial-thickness burn. It may possibly get this effect through anti-oxidation.
ObjectiveTo evaluate the clinical efficacy of shenfu injection in reducing the side effects of chemotherapy in patients with cancer. MethodsWe searched Medline, PubMed, EMbase, VIP, Chinese science and technology periodical database full text database, China journal full database, Chinese biomedical literature database, and WANFANG database the durationi was from January 1994 to May 2013 for controlled trials about the use of shenfu injection to reduce the side effects of chemotherapy, without any language limitations. The quality of literature was evaluated by Jadad rating scale, and the included trials were analyze for systematic review. ResultsA total of 30 articles were included, and all of them were from Chinese literature. There were altogether 2039 cases. Compared with single chemotherapy group, the normal rate of white blood cells [RR=1.54, 95%CI (1.28, 1.84), P<0.0000 1], hemoglobin [RR=1.30, 95%CI (1.14, 1.48), P<0.000 1], platelet [RR=1.39, 95%CI (1.19, 1.62), P<0.000 1], and the number of patients without vomiting or sickness [RR=1.54, 95%CI (1.30, 1.81), P<0.0000 1] in the shenfu treatment group were all significantly higher. The life quality of the shenfu treatment group was also obviously better than the single chemotherapy group. ConclusionCompared with single chemotherapy, shenfu injection can reduce the peripheral blood cell reduction, gastrointestinal reaction and improve the patients' quality of life. Because the quality of included studies in this research is generally low, it is necessary to design a more reasonable and strict experiment with a large sample to get an exact conclusion.