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新癀片治疗带状疱疹有效性和安全性的系统评价
丁志明1,2, 张宸玥3, 王辉4
1.天津中医药大学第一附属医院疮疡及血管外科, 天津 300193;2.国家中医针灸临床医学研究中心, 天津 300193;3.南开大学统计与数据科学学院, 天津 300071;4.天津中医药大学循证医学中心, 天津 301617
摘要:
[目的] 系统评价新癀片治疗带状疱疹的有效性和安全性。[方法] 双人计算机检索中文数据库包括中国知网、万方数据库、维普数据库、中国生物医学文献数据库,外文数据库包括PubMed、Embase、Cochrane library,共7个中英文数据库。检索新癀片治疗带状疱疹有效性与安全性的随机对照试验(RCT)相关文献,各数据库检索时限为建库至2023年2月7日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.4软件进行Meta分析。[结果] 共纳入10个RCTs,包括820例患者。Meta分析结果显示,新癀片联合西医常规与单用西医常规治疗相比可降低带状疱疹患者视觉模拟评分法(VAS)评分[MD=-0.93,95% CI(-1.57,-0.28),P=0.005],显著提升总有效率[RR=1.24,95% CI(1.12,1.37),P<0.000 1]和治愈率[RR=1.68,95% CI(1.43,1.96),P<0.000 01],缩短止痛时间[MD=-2.13,95% CI(-3.02,-1.23),P<0.000 01],止疱时间[MD=-1.50,95% CI(-2.70,-0.29),P=0.02],结痂时间[MD=-2.03,95% CI(-2.94,-1.11),P<0.000 1]和痊愈时间[MD=-2.27,95% CI(-3.27,-1.27),P<0.000 01]。新癀片联合组对比常规组不良反应发生率无明显差异。[结论] 现有证据表明,新癀片联合西医常规治疗使用可降低VAS评分,提高治疗的有效率和治愈率,缩短带状疱疹止痛、止疱、结痂和痊愈时间,安全性方面较好。由于受到纳入研究数量和质量的限制,上述结论仍有待于高质量研究进一步验证。
关键词:  带状疱疹  新癀片  系统评价  Meta分析  随机对照试验
DOI:10.11656/j.issn.1672-1519.2023.11.15
分类号:R752.12
基金项目:
Clinical efficacy and safety of Xinhuang Tablet for herpes zoster: a system evaluation
DING Zhiming1,2, ZHANG Chenyue3, WANG Hui4
1.Ulcers and Peripheral Vascular Surgery Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;2.National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China;3.School of Statistics and Data Science, Nankai University, Tianjin, 300071, China;4.Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Abstract:
[Objective] To systematically evaluate the efficacy and safety of Xinhuang Tablets in the treatment of herpes zoster. [Methods] A computer search was conducted on PubMed, EMbase, the Cochrane, Library, CNKI, WanFang Data, CBM, and VIP databases to search for randomized controlled trials(RCTs) on the efficacy and safety of Xinhuang Tablets in the treatment of herpes zoster. The search period was from the establishment of the database to February 7, 2023. After two researchers independently screened the literature, extracted data, and evaluated the risk of bias included in the study, a Meta-analysis was conducted using RevMan 5.4 software. [Results] A total of 10 RCTs were included, including 820 patients. Meta-analysis results showed that Xinhuang Tablet combined with conventional Western therapy compared with conventional Western therapy alone can reduce the VAS score of patients with herpes zoster [MD=-0.93, 95%CI(-1.57, -0.28), P=0.005], significantly improve the total effective rate [RR=1.24, 95%CI(1.12, 1.37), P<0.0001] and the cure rate [RR=1.68, 95%CI(1.43, 1.96), P<0.000 01], shorten the pain relief time [MD=-2.13, 95%CI(-3.02, -1.23), P<0.000 01], the blister arrest time [MD=-1.50, 95%CI(-2.70, -0.29), P=0.02], the scab formation time [MD=-2.03, 95%CI (-2.94, -1.11), P<0.000 1], and the recovery time [MD=-2.27, 95%CI(-3.27, -1.27), P<0.000 1]. There was no significant difference in the incidence of adverse reactions between the Xinhuang Tablet combined group and the conventional group. [Conclusion] The existing evidence indicates that Xinhuang Tablet combined with routine Western treatment can reduce VAS pain score, improve the effective rate and cure rate of treatment, shorten the time for pain relief, blister arrest, scab formation, and recovery of herpes zoster, and has good safety. Due to the limitations of the number and quality of included studies, the above conclusions need to be verified by more high-quality studies.
Key words:  herpes zoster  Xinhuang Tablet  system evaluation  Meta-analysis  randomized controlled trial
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