Objective To evaluate the efficacy and safety of Polyunsaturated phosphatidylcholine (PPC) for chronic hepatitis. Methods We searched EMBASE (1980May,2003), MEDLINE(1966May,2003), CBM (1979May,2003), The Cochrane Library Issue 2, 2003 and handsearched 8 related Chinese journals. Randomized controlled trials(RCT) comparing PPC versus placebo/no treatment for chronic hepatitis were included with no restrictions of blinding, language and publication. Two reviewers independently performed data extraction and assessed the quality . Data were entered and analyzed by RevMan 4.2 software supplied by the Cochrane Collaboration .Results Six high quality trials involving 568 patients were included. Four studies involving 451 patients showed the clinical effective rate of PPC for chronic hepatitis was 52.5% while the control group was 37.5% with statistical difference [RR1.81,95%CI(1.41,2.33),Z=4.69, Plt;0.00001].A meta-analysis involving three studies with 100 patients showed the PPC can statically improve histopathology of chronic hepatitis comparing with control group [RR 2.58,95%CI (1.61,4.15),Z=3.91,Plt;0.0001].No serious adverse events were reported.Conclusions PPC is a safe medicine used for treating chronic viral hepatitis and may relieve clinical symptoms and signs.At the same time ,it has positive effect on hepatic histopathology for patients .However ,more high quality clinical trials are required.
Objective To assess the effectiveness and safety of Jiuweirougan granule in the treatment of chronic hepatitis with hepatic fibrosis. Methods A double-blind, double dummy and randomized controlled method was adopted. Forty-six patients were selected by using the inclusion and exclusion criteria and were randomizedly allocated to the treatment group (n=23, Jiuweirougan 10 g, twice a day) and the control group (n=23, treated with Biejiaruangan 4 pills, three times a day). The duration of treatment for both groups lasted for 6 months. Results Two patients in the treatment group dropped out halfway through the study, while one patient in the control group was withdrawal for irregular treatment. Analysis according to intention-to-treat (ITT) and per-protocol (PP) was conducted. In the treatment group, the effective rates of TCM (Traditional Chinese Medicine) on the syndrome were 82.61% (19/23) (ITT) and 90.48% (19/21) (PP), while in the control group, there were 86.96% (20/23) (ITT) and 86.36% (19/20) (PP). There was no significant difference between the two groups (P＞0.05). The improvement rate of serum parameters in the treatment group such as hyaluronic acid (HA), type Ⅲ procollagen (PCⅢ), type Ⅳ collagewn (CⅣ) and laminin (LN) were 28.57% (6/21), 23.81% (5/21), 28.57% (6/21) and 4.76% (1/21), respectively, while in control group, the rates were 36.37% (8/22),13.64% (3/22), 36.37% (8/22) and 9.09% (2/22), respectively. No significant difference was seen between the two groups (P＞0.05). ITT and PP analysis revealed similar results. No obvious adverse effects were noted. Conclusion Jiuweirougan granule may improve chronic hepatitis with fibrosis, and its effect is equal to that of Biejiaruangan. No obvious toxic-adverse effects were seen.
【摘要】 目的 评价九味柔肝颗粒治疗慢性乙肝肝纤维化的疗效和安全性。 方法 根据纳入与排除标准，选取2007年2-8月入院的慢性乙肝肝纤维化（气滞血瘀兼湿热未净证）患者96例，按3∶1随机分为两组进行随机双盲双模拟对照试验。试验组72例，口服九味柔肝颗粒， 2次/d，每次10 g；阳性对照药鳖甲软肝片组（对照组）24例，口服鳖甲软肝片，4片/次，3次/d；两组疗程均为6个月。 结果 试验组完成治疗66例，对照组完成21例。符合方案数据分析（PPS）结果显示，试验组治疗后中医证侯积分及B超积分分别下降了0.50±1.04和8.61±3.62，对照组分别下降了0.32±1.01和8.63±3.15，均较治疗前显著下降（Plt;0.05），两组比较无统计学意义（Pgt;0.05）。在血清肝纤维化四项指标方面，试验组除LN外，其余指标治疗后均较治疗前明显下降（Plt;0.05），对照组中仅PⅢP有显著下降（Plt;0.05），其余指标下降不明显，两组比较无统计学意义（Pgt;0.05）。两组患者治疗期间均未观察到明显不良反应，不良反应发生率分别为5.56%和4.17%。 结论 九味柔肝颗粒能明显改善慢性肝炎肝纤维化患者的症状和部分肝纤维化指标，其疗效与鳖甲软肝片相当，安全性良好。【Abstract】 Objective To assess the safety and therapeutic effect of Jiuweirougan grandule on chronic hepatitis B with hepatic fibrosis. Methods A double-blind, double dummy and randomized controlled method was adopted. Ninety-six patients from February to August 2007 selected by including and excluding criteria were distributed randomly in accordance with the 3∶1 ratio into the test group (n=72, treated with Jiuweirougan 10 g, two times per day) and the control group (n=24, treated with Biejiaruangan 4 tablets, three times per day). The period of treatment for both groups lasted for half a year. Results A total of 66 cases in the test group and 21 cases in the control group completed the experiment. The results of per-protocol population (PPS) suggested that the accumulated score of B ultrasound and symptom decreased 0.50±1.04 and 8.61±3.62 in the test group and 0.32±1.01 and 8.63±3.15 in the control group, respectively. The score decreased remarkably compared with pre-treatment(Plt;0.05). There was no significant difference between the two groups (Pgt;0.05). For serum liver fibrotic parameters, all parameters except laminin (LN) in the test group decreased remarkably compared with pre-treatment(Plt;0.05). But in the control group, besides type Ⅲ procollagen (PCⅢ) decreased remarkably(Plt;0.05), other parameters showed no obvious changes. There was no significant difference between the two groups (Pgt;0.05). At the same time, no obvious adverse effect was found in the two groups. The incidence of adverse reactions was 5.56% and 4.17% respectively. Conclusion Jiuweirougan granule may improve the syndrome and part of fibrotic index of chronic hepatitis B with fibrosis, and the effect is equal to that of Biejiaruangan with good security.
ObjectiveTo investigate the ultrasonic changes of liver during various immune periods with different number of CD4+ T lymphocytes in HIV/AIDS patients with chronic viral hepatitis. MethodsThe clinical data of 100 patients with chronic viral hepatitis diagnosed between January 2010 and December 2012 were selected. Among them, 50 simple chronic viral hepatitis patients were designated as the control group, and the other 50 HIV/AIDS patients with chronic viral hepatitis were regarded as the experimental group. Ultrasonographic observation was applied on patients of the experimental group according to different immune period based on the number of CD4+ T lymphocytes. Indexes observed included liver size, the edge of liver, capsule of liver and hepatic parenchymal echo. The cross-check analysis was employed between observed results and clinical laboratory results. ResultsAbnormal changes of the experimental group were shown on the ultrasound observation of liver in different CD4+ T lymphocyte count immune periods, including enlargement of the liver, slightly blunt liver margin, slightly thick capsule, dense and uniform, slightly rough and not so uniform, or rough and not uniform hepatic parenchymal echo. There was no significant difference in ultrasonic changes of liver between the two groups when the CD4+ T cell number was over 300/mm3. However, the difference was significant when the CD4+ T cell number was below 100/mm3. ConclusionLiver abnormalities become more obvious as CD4+ T cell count decreases in HIV/AIDS patients with chronic viral hepatitis. Comprehensive considerations of various liver ultrasound indicators are helpful in clinical evaluation of HIV/AIDS patients with chronic viral hepatitis.
ObjectiveTo investigate the ultrasonic changes of hepatic veins and splenic veins during various immune stages with different CD4+T lymphocyte count. MethodsFifty AIDS/HIV patients with chronic viral hepatitis treated between January 2010 and October 2013 were designated as the case group, and another 50 patients with simple chronic viral hepatitis were regarded as the controls. For patients in the case group, we observed their ultrasonic changes of hepatic and splenic veins during various immune stages with different CD4+T lymphocyte count. The results of observation and clinical laboratory analysis were compared. ResultsAbnormal ultrasonic changes were detected in the liver in various immune stages based on the CD4+T lymphocyte count, and the main manifestations of these changes included unclear portal and splenic vein distal direction, wide diameter, slowed blood flow velocity, and disappearance of fluctuations of blood flow spectrum; and unclear hepatic vein distal direction, low and three-phase, and negative blood flow spectrum with the disappearance of windows were also detected. There were no statistical differences between the case group and the control group when the CD4+T cell count was over 300/mm3, and a few indexes were significantly different when the CD4+T cell count was between 100 and 200/mm3. However, the differences of almost all indexes were significant when the CD4+T cell count was below 100/mm3. ConclusionPatients with HIV/AIDS combined with chronic viral hepatitis have ultrasonographic abnormalities of intrahepatic and splenic veins, which is more obvious as the CD4+T cell count declines. Overall consideration of intrahepatic vein and splenic vein ultrasonic indicators helps clinical assessment of disease development in patients with HIV/AIDS combined with chronic viral hepatitis.