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1.广州中医药大学第二附属医院药学部,广州 510120
2.广东省中医院珠海医院药剂科,广东 珠海 519000
主管药师。研究方向:中药药效、合理用药及药学管理。电话:0756-33255046。E-mail:3330888888@163.com
主管药师。研究方向:中药药效、合理用药及药学管理。电话:0756-3325063。E-mail:chenjuliang2006@163.com
纸质出版日期:2024-12-15,
收稿日期:2024-06-20,
修回日期:2024-10-18,
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詹亚坤,曾瑾,胡紫微等.复方丹参制剂联合化学药治疗消化性溃疡有效性和安全性的Meta分析 Δ[J].中国药房,2024,35(23):2915-2922.
ZHAN Yakun,ZENG Jin,HU Ziwei,et al.Efficacy and safety of Compound danshen preparations combined with chemical drugs for peptic ulcer: a meta-analysis[J].ZHONGGUO YAOFANG,2024,35(23):2915-2922.
詹亚坤,曾瑾,胡紫微等.复方丹参制剂联合化学药治疗消化性溃疡有效性和安全性的Meta分析 Δ[J].中国药房,2024,35(23):2915-2922. DOI: 10.6039/j.issn.1001-0408.2024.23.13.
ZHAN Yakun,ZENG Jin,HU Ziwei,et al.Efficacy and safety of Compound danshen preparations combined with chemical drugs for peptic ulcer: a meta-analysis[J].ZHONGGUO YAOFANG,2024,35(23):2915-2922. DOI: 10.6039/j.issn.1001-0408.2024.23.13.
目的
2
系统评价复方丹参制剂联合化学药常规治疗消化性溃疡(PU)的有效性及安全性,为临床治疗PU提供循证参考。
方法
2
计算机检索中国知网、维普中文科技期刊数据、万方数据库、中国生物医学文献数据库、PubMed、Embase、Web of Science中相关临床随机对照试验,检索时间均为建库起至2023年9月30日。对纳入的文献采用Cochrane系统评价员手册5.1.0进行质量评价,采用RevMan 5.3软件进行Meta分析、敏感性分析以及发表偏倚分析。
结果
2
纳入26篇文献,合计患者2 451例,其中试验组(复方丹参制剂+化学药常规治疗)1 243例、对照组(化学药常规治疗)1 208例。有效性方面,试验组患者的溃疡愈合率[OR=4.66,95%CI(3.53,6.15),
P
<0.000 01
]
、幽门螺杆菌(HP)根除率[OR=1.90,95%CI(1.12,3.22),
P
=0.02
]
、疼痛缓解率[OR=3.91,95%CI(2.31,6.61),
P
<0.000 01
]
均显著高于对照组,溃疡复发率[OR=0.22,95%CI(0.15,0.32),
P
<0.000 01
]
和血清胃蛋白酶原Ⅰ(PGⅠ)水平[SMD=-1.92,95%CI(-2.
25,-1.58),
P
<0.000 01
]
、PGⅡ水平[SMD=-3.88,95%CI(-4.35,-3.41),
P
<0.000 01
]
、G-17水平[SMD=-3.44,95%CI(-3.87,-3.00),
P
<0.000 01
]
均显著低于对照组。安全性方面,两组患者的不良反应症状主要为腹部不适、头痛头晕、口干、面色潮红等;两组患者不良反应发生率比较,差异无统计学意义[OR=1.08,95%CI(0.75,1.54),
P
=0.69
]
。按照不同剂型对溃疡愈合率和HP根除率2个指标进行亚组分析,结果显示,复方丹参滴丸的HP根除率与对照组相比无明显改善,其余结果与上述相同。敏感性分析结果显示,本研究所得结果较稳健。发表偏倚结果显示,本研究存在发表偏倚的可能性较小。
结论
2
与单纯使用化学药常规治疗相比,联用复方丹参制剂能有效改善PU患者临床症状并且安全性相当。
OBJECTIVE
2
To systematically evaluate the efficacy and safety of compound danshen preparations combined with conventional chemical drug treatment for peptic ulcer (PU), providing evidence-based guidance for clinical treatment of PU.
METHODS
2
Related clinical randomized controlled trials were collected from CNKI, VIP, Wangfang data, CBM, PubMed, Embase and Web of Science from their establishment date to September 30, 2023. The qualities of included literature were evaluated by Cochrane Systematically Evaluator Manual 5.1.0. Meta-analysis, sensitivity analysis and publication bias analysis were conducted with RevMan 5.3 software.
RESULTS
2
Totally 26 pieces of literature were included with total of 2 451 cases, including 1 243 cases in trial group (compound danshen preparations+conventional chemical drug treatment) and 1 208 cases in the control group (conventional chemical drug treatment). In terms of effectiveness, trial group had significant advantages in ulcer healing rate [OR=4.66, 95%CI (3.53, 6.15),
P
<0.000 01
]
, HP eradication rate [OR=1.90, 95%CI (1.12, 3.22),
P
=0.02
]
,and pain relief rate [OR=3.91, 95%CI (2.31, 6.61),
P
<0.000 01
]
than control group, while ulcer recurrence rate [OR=0.22, 95%CI (0.15, 0.32),
P
<0.000 01
]
and serum levels of pepsinogen (PG)Ⅰ [SMD=-1.92, 95%CI (-2.25, -1.58),
P
<0.000 0
1
]
, PGⅡ [SMD=-3.88, 95%CI (-4.35, -3.41),
P
<0.000 01
]
and G-17 [SMD=-3.44, 95%CI (-3.87, -3.00),
P
<0.000 01
]
were significantly lower than control group. In terms of safety, the main adverse reactions were abdominal discomfort, headache, dizziness, dry mouth, facial flushing, etc. There was no significant difference in the incidence of adverse reactions between the two groups [OR=1.08, 95%CI (0.75, 1.54),
P
=0.69
]
. Subgroup analysis of ulcer healing rate and HP eradication rate based on dosage form showed that HP eradication rate in the compound danshen pellet group was not significantly improved compared to the control group, with consistent results for the remaining outcomes. The sensitivity analysis showed that above results were stable. There was less possibility of publication bias in this study.
CONCLUSIONS
2
Compared with conventional chemical drug treatment alone, the combination of compound danshen preparations can effectively improve the clinical symptoms of PU patients with similar safety.
复方丹参制剂消化性溃疡有效性安全性
peptic ulcerefficacysafety
中华消化杂志编辑委员会.消化性溃疡诊断与治疗共识意见:2022年:上海[J].中华消化杂志,2023,43(3):176-192.
Editorial Board of Chinese Journal of Digestion. Consensus on the diagnosis and therapy of peptic ulcer:2022:Shanghai[J]. Chin J Dig,2023,43(3):176-192.
张万岱,李军祥,陈治水,等.消化性溃疡中西医结合诊疗共识意见:2011年:天津[J].现代消化及介入诊疗,2012,17(3):177-180.
ZHANG W D,LI J X,CHEN Z S,et al. Consensus opi- nion on diagnosis and treatment of peptic ulcer with integrated traditional Chinese and western medicine:Tianjin:2011[J]. Mod Dig Interv,2012,17(3):177-180.
ANGEL L,FRANCIS KA LEUNG C.Peptic ulcer disease[J]. Lancet,2017,390(10094),613-624.
邱淑炜,梁广和.中医治疗消化性溃疡研究进展[J].中医临床研究,2022,14(21):108-112.
QIU S W,LIANG G H. A review on treating peptic ulcer in traditional Chinese medicine[J]. Clin J Chin Med,2022,14(21):108-112.
王垂杰,郝微微,唐旭东,等.消化系统常见病消化性溃疡中医诊疗指南:基层医生版[J].中华中医药杂志,2019,34(10):4721-4726.
WANG C J,HAO W W,TANG X D,et al. Clinical practice guideline of TCM for common digestive system di- seases:peptic ulcer:edition for primary physician[J]. China J Tradit Chin Med Pharm,2019,34(10):4721-4726.
周福生,胡玲,崔琦珍,等.中医药抗消化性溃疡复发的机理研究进展[J].中国中西医结合杂志,2001,21(3):232-234,225.
ZHOU F S,HU L,CUI Q Z,et al. Research progress on mechanism of traditional Chinese medicine against recurrence of peptic ulcer[J]. Chin J Integr Tradit West Med,2001,21(3):232-234,225.
阴瑞瑞,陈海亮,武鑫,等.荆花胃康胶丸联合三联疗法治疗HP相关性慢性胃炎或消化性溃疡有效性和安全性的Meta分析[J].中国药房,2018,29(16):2256-2260.
YIN R R,CHEN H L,WU X,et al. Efficacy and safety of Jinghua weikang capsules combined with triple therapy in the treatment of HP related chronic gastritis or peptic ulcer:a meta-analysis[J]. China Pharm,2018,29(16):2256-2260.
刘武超男,魏堰翀,管雪,等.胃苏颗粒联合质子泵抑制剂治疗消化性溃疡疗效的Meta分析[J].中国民族民间医药,2023,32(4):96-102.
LIU W C N,WEI Y C,GUAN X,et al. Meta-analysis on Weisu granules with proton pump inhibitor in treatment of peptic ulcer[J]. Chin J Ethnomed Ethnopharmacy,2023,32(4):96-102.
李倩.复方丹参滴丸研究进展及临床应用[J].中华中医药杂志,2018,33(7):2989-2991.
LI Q. Research progress and clinical application of compound Danshen dripping pills[J]. China J Tradit Chin Med Pharm,2018,33(7):2989-2991.
张敏娜,钟鸣,吴景龙,等.复方丹参注射液对未分化型PC12细胞株的诱导作用[J].时珍国医国药,2019,30(2):298-300.
ZHANG M N,ZHONG M,WU J L,et al. Induction effect of compound Danshen injection on undifferentiated PC12 cell line[J]. Lishizhen Med Mater Med Res,2019,30(2):298-300.
葛均波,徐永健,王辰.内科学[M]. 9版.北京:人民卫生出版社,2018:358-363.
GE J B,XU Y J,WANG C,Internal medicine[M]. 9th ed. Beijing:The People’s Health Press,2018:358-363.
陈荣皇.泮托拉唑联合复方丹参治疗胃溃疡的临床分析[J].现代诊断治疗,2013,24(15):3439-3440.
CHEN R H. Clinical analysis of pantoprazole combined with compound Salvia miltiorrhiza in the treatment of gastric ulcer[J]. Mod Diagn Treat,2013,24(15):3439-3440.
陈雪芳.雷贝拉唑联合复方丹参滴丸治疗老年胃溃疡的疗效观察[J].中外医疗,2012,31(27):120-121.
CHEN X F. Clinical observation of rabeprazole combined with compound Danshen dripping pills in the treatment of elderly gastric ulcer[J]. China Foreign Medical Treatment,2012,31(27):120-121.
陈元鸿,伍灵达,王婉梅,等.复方丹参滴丸与雷尼替丁治疗老年胃溃疡的观察[J].中国基层医药,2005,12(5):548-549.
CHEN Y H,WU L D,WANG W M,et al. Clinical observation on treatment of gastric ulcer in the aged by compound Danshen dripping pills and ranitidine[J]. Chin J Prim Med Pharm,2005,12(5):548-549.
程冬娇.复方丹参滴丸联合奥美拉唑治疗老年胃溃疡40例临床观察[J].中国民族民间医药,2014,23(15):89.
CHENG D J. Clinical observation on compound Danshen dripping pills combined with omeprazole in the treatment of 40 cases of elderly gastric ulcer[J]. Chin J Ethnomed Ethnopharmacy,2014,23(15):89.
高玉芳.复方丹参滴丸联合奥美拉唑治疗老年胃溃疡疗效观察[J].基层医学论坛,2016,20(5):613-614.
GAO Y F. Clinical observation of compound Danshen dripping pills combined with omeprazole in the treatment of elderly gastric ulcer[J]. Med Forum,2016,20(5):613-614.
胡向军.奥美拉唑联合复方丹参滴丸治疗77例胃溃疡患者的疗效分析[J].中外妇儿健康,2011,19(7):265.
HU X J. Efficacy analysis of omeprazole combined with compound Danshen dripping pills in the treatment of 77 patients with gastric ulcer[J]. Chin Foreign Women Health,2011,19(7):265.
况余金,王秀颀.复方丹参滴丸联合奥美拉唑治疗胃溃疡疗效及复发率的临床观察[J].内蒙古中医药,2014,33(27):62.
KUANG Y J,WANG X Q. Clinical observation on the curative effect and recurrence rate of compound Danshen dripping pills combined with omeprazole in the treatment of gastric ulcer[J]. Nei Mongol J Tradit Chin Med,2014,33(27):62.
刘克勤. 复方丹参滴丸联合奥美拉唑治疗老年胃溃疡疗效观察[J]. 临床医药文献电子杂志,2014,1(12):2096,2098.
LIU K Q. Clinical observation of compound Danshen dripping pills combined with omeprazole in the treatment of elderly gastric ulcer[J]. Electron J Clin Med Lit,2014,1(12):2096,2098.
潘伟杰.泮托拉唑联合复方丹参治疗胃溃疡的临床分析[J].当代医学,2013,19(9):63-64.
PAN W J. Clinical analysis of pantoprazole combined with compound Salvia miltiorrhiza in the treatment of gastric ulcer[J]. Contemp Med,2013,19(9):63-64.
庞玲.雷贝拉唑联合复方丹参滴丸治疗老年胃溃疡的效果研究[J].医学信息,2015,28(51):24-25.
PANG L. The effect research of rabeprazole combined with compound Danshen dropping pill in the treatment of elderly gastric ulcer[J]. J Med Inf,2015,28(51):24-25.
荣家慧.泮托拉唑联合复方丹参(滴丸)治疗胃溃疡的疗效观察[J].现代预防医学,2007,34(12):2392,2397.
RONG J H. Clinical observation of pantoprazole combined with compound Danshen (dropping pills) in the treatment of gastric ulcer[J]. Mod Prev Med,2007,34(12):2392,2397.
阮元鸿,伍灵达,王婉梅,等.复方丹参(滴丸)联合雷尼替丁治疗老年胃溃疡的近期疗效观察[J].现代消化及介入诊疗杂志,1999(3):48-49.
RUAN Y H,WU L D,WANG W M,et al. The short-term clinical observation of ranitidine combined with compound Danshen (dropping pills) in the treatment of elderly gastric ulcer[J]. Mod Digestion Inte,1999(3):48-49.
王庆周,牛慧佳,徐立,等.复方丹参滴丸联合丽珠胃三联、奥美拉唑治疗老年胃溃疡临床研究[J].中国老年学杂志,2007,27(21):2135-2136.
WANG Q Z,NIU H J,XU L,et al. Clinical study of compound Danshen dripping pills combined with Livzon-stomach triple therapy and omeprazole in the treatment of elderly gastric ulcer[J]. Chin J Gerontol,2007,27(21):2135-2136.
吴世洪.复方丹参滴丸联合奥美拉唑治疗老年胃溃疡的临床疗效[J].心理医生,2017,23(29):159-160.
WU S H. Clinical efficacy of compound Danshen dripping pills combined with omeprazole in the treatment of elderly gastric ulcer[J]. Psychol Doct,2017,23(29):159-160.
吴文林.复方丹参滴丸联合奥美拉唑治疗老年胃溃疡的临床疗效[J].临床合理用药杂志,2018,11(15):76-77.
WU W L. Clinical efficacy of compound Danshen dripping pills combined with omeprazole in the treatment of elderly gastric ulcer[J]. Chin J Clin Ration Drug Use,2018,11(15):76-77.
吴永根.复方丹参滴丸联合奥美拉唑治疗老年胃溃疡的疗效[J].中国卫生产业,2012,9(31):74.
WU Y G. Efficacy of compound Danshen dripping pills combined with omeprazole in the treatment of elderly gastric ulcer[J]. China Health Ind,2012,9(31):74.
姚洁.复方丹参滴丸联合奥美拉唑治疗老年胃溃疡95例疗效观察[J].重庆医学,2008,37(23):2733-2734.
YAO J. Clinical observation on compound Danshen dripping pills combined with omeprazole in the treatment of 95 cases of elderly gastric ulcer[J]. Chongqing Med,2008,37(23):2733-2734.
张辉.泮托拉唑联合复方丹参(滴丸)治疗胃溃疡的疗效观察[J].大家健康,2014(5):176.
ZHANG H. Clinical observation of pantoprazole combined with compound Danshen (dropping pills) in the treatment of gastric ulcer[J]. Well-being,2014(5):176.
张辉.泮托拉唑联合复方丹参滴丸治疗胃溃疡临床观察[J].临床医学,2014,34(8):126-127.
ZHANG H. Clinical observation of pantoprazole combined with compound Danshen dripping pills in the treatment of gastric ulcer[J]. Clin Med,2014,34(8):126-127.
张杰.复方丹参滴丸联合奥美拉唑治疗老年胃溃疡的疗效观察[J].医学理论与实践,2016,29(13):1735-1736.
ZHANG J. Clinical observation of compound Danshen dripping pills combined with omeprazole in the treatment of elderly gastric ulcer[J]. J Med Theory Pract,2016,29(13):1735-1736.
张玲玲,余毅,何惠平.复方丹参滴丸联用奥美拉唑、阿莫西林、灭滴灵治疗老年性胃溃疡的疗效研究[J].中国医药指南,2010,8(13):31,47.
ZHANG L L,YU Y,HE H P. The clinical effect exploration on compound Dansen (dropping pills) combined with omeprazole,amoxicillin and metronidazole used in senile gastric ulcer[J]. Guide China Med,2010,8(13):31,47.
邹静.老年胃溃疡患者应用复方丹参滴丸联合奥美拉唑治疗方案的有效性评价[J].医药论坛,2021(9):117-119.
ZOU J. Efficacy evaluation of compound Danshen dripping pills combined with omeprazole in elderly patients with gastric ulcer[J]. J Med Forum,2021(9):117-119.
蔡朝敏,汪传臻.复方丹参注射液治疗消化性溃疡的临床疗效分析[J].内蒙古中医药,2017,36(5):68-69.
CAI C M,WANG C Z. Clinical effect analysis of Compound Danshen injection in the treatment of peptic ulcer[J]. Nei Mongol J Tradit Chin Med,2017,36(5):68-69.
何悠,朱栋才. 复方丹参注射液治疗消化性溃疡40例疗效观察[J]. 广西医学,2001,23(3):560-561.
HE Y,ZHU D C. Observation on therapeutic effect of compound Danshen injection on 40 cases of peptic ulcer[J]. Guangxi Med J,2001,23(3):560-561.
肖桂珍.复方丹参注射液佐治消化性溃疡的疗效观察[J].中国临床研究,2011,24(7):631-632.
XIAO G Z. Curative effect observation of compound Danshen injection in adjuvant treatment of peptic ulcer[J]. Chin J Clin Res,2011,24(7):631-632.
叶纪纲.注射用泮托拉唑钠复合复方丹参注射液治疗消化性溃疡并出血的临床疗效观察[J].吉林医学,2014,35(36):8046-8047.
YE J G. Clinical observation of Pantoprazole sodium for injection combined with compound Danshen injection in the treatment of peptic ulcer complicated with bleeding[J]. Jilin Med J,2014,35(36):8046-8047.
单晓晓,洪帮振,刘洁,等.丹参化学成分、药理作用、临床应用的研究进展及质量标志物的预测分析[J].中国中药杂志,2021,46(21):5496-5511.
SHAN X X,HONG B Z,LIU J,et al. Review of chemical composition,pharmacological effects,and clinical application of Salviae Miltiorrhizae Radix Et Rhizoma and prediction of its Q-markers[J]. China J Chin Mater Med,2021,46(21):5496-5511.
李倩倩,陈霞,夏晨梅,等.复方丹参滴丸联合奥美拉唑治疗糖尿病并消化性溃疡的疗效分析及对患者血液相关指标的影响[J].中华全科医学,2018,16(2):250-252.
LI Q Q,CHEN X,XIA C M,et al. Effects of compound Danshen dripping pills combined omeprazole on peptic ulcer with diabetes mellitus and its impact on the hemorheo- logy[J]. Chin J Gen Pract,2018,16(2):250-252.
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