Feng Malong, Ding Qunli, Zhong Cheng, Li Jingjie, Wang Qun, Yuan Zhi, Dong Yishan
Pharmazie. 2016 Sep 1;71(9):499-503. doi: 10.1691/ph.2016.6051.
To evaluate the effectiveness and safety of V-5 immunitor (V5) added to chemotherapy of tuberculosis (TB) patients.
The databases Medline, Embase, Biosis, Cochrane Central Register of Controlled Trials, SCI, CBM, VIP and CNKI were searched. Randomized controlled trials (RCT) and controlled clinical trials (CCT) of V5 immunitor with or without a placebo-control as adjuvant therapy in the chemotherapy of TB patients were included. Two reviewers independently performed data extraction and quality assessment. Data were analyzed using RevMan 5.3 software by The Cochrane Collaboration.
Four studies were included. At the end of the follow-up period, pooled RR (Risk Ratio) and its 95% CI of sputum smear conversion rate were 4.91 (3.32, 7.28) in drug-sensitive, drug-resistant TB patients or HIV-TB co-infection patients. When analyzing inflammation biomarkers including ESR and leukocyte accounts, pooled mean difference and its 95% CI of ESR and leukocyte accounts were -7.62 (-9.55, -5.68) and -2.13 (-2.58, -1.68), respectively. As to body weight, pooled mean difference and its 95% CI were 0.96 (-1.13, 3.05) in TB patients. Two clinical trials were included for analyzing temperature after using V5 immunitor, pooled mean difference and its 95% CI were -0.34 (-0.46, -0.22) in TB patients. These results suggested that V5 immunitor holds important promise in improving sputum conversion to AFB- and inhibiting inflammatory reaction in TB patients, but showed no significant promotion to the increase in body weight based on this meta-analysis. Compared with the control group, V5 immunitor may have some potential in decreasing the temperature of TB patients. No systemic adverse events were reported.
Added to chemotherapy, V5 immunitor seems to be helpful in the treatment of TB patients in terms of improving sputum conversion and reducing inflammatory reactions.
评估V - 5免疫调节剂（V5）联合化疗用于结核病（TB）患者的有效性和安全性。
检索Medline、Embase、Biosis、Cochrane对照试验中央注册库、SCI、中国生物医学文献数据库（CBM）、中文科技期刊数据库（VIP）和中国知网（CNKI）。纳入以V5免疫调节剂联合或不联合安慰剂对照作为辅助治疗用于TB患者化疗的随机对照试验（RCT）和对照临床试验（CCT）。两名评价员独立进行数据提取和质量评估。采用Cochrane协作网的RevMan 5.3软件进行数据分析。
纳入4项研究。在随访期末，药物敏感、耐药TB患者或HIV - TB合并感染患者痰涂片转阴率的合并风险比（RR）及其95%置信区间（CI）为4.91（3.32，7.28）。在分析包括红细胞沉降率（ESR）和白细胞计数在内的炎症生物标志物时，ESR和白细胞计数的合并平均差及其95%CI分别为 - 7.62（ - 9.55， - 5.68）和 - 2.13（ - 2.58， - 1.68）。对于体重，TB患者的合并平均差及其95%CI为0.96（ - 1.13，3.05）。纳入两项临床试验分析使用V5免疫调节剂后的体温，TB患者的合并平均差及其95%CI为 - 0.34（ - 0.46， - 0.22）。这些结果表明，基于该荟萃分析，V5免疫调节剂在提高TB患者痰涂片抗酸杆菌转阴率和抑制炎症反应方面具有重要前景，但对体重增加无显著促进作用。与对照组相比，V5免疫调节剂在降低TB患者体温方面可能具有一定潜力。未报告全身性不良事件。
联合化疗时，V5免疫调节剂在改善痰涂片转阴和减轻炎症反应方面似乎有助于TB患者的治疗。
