Review Article

Combined Therapy of Hypertensive Nephropathy with Breviscapine Injection and Antihypertensive Drugs: A Systematic Review and a Meta-Analysis

Table 1

Characteristics of 14 studies fulfilling the inclusion criteria.

StudySample size (T/C)Sex M/FAge (years) range, meanDiagnosis standardsInterventionControlCourse of treatmentClinical standardsOutcomesAdverse reactions

Zhang et al. 2004[29]94(47/47)T: 18/16,
C: 17/13
T: 60±8,
C: 60±8
GMY (1999WHO-ISH)Breviscapine injection (20 ml, ivgtt, qd) + controlLisinopril (5-10 mg, po, tid), 25 mg, tid2 weeksGuiding principles (2002)24UAER, SBP, DBP, B2M, TC, TG, LDL, LDH -C, Hct, PAGT, FibT: 2 cases of dry cough
C: 3 cases of dry cough

Wei and Tan 2005[30]76(40/36)T: 30/10,
C: 28/8
T: 63.5,
C: 64.3
GMY (1999WHO-ISH)Breviscapine injection (20 ml, ivgtt, qd) + controlAmlodipine (5 mg, po, qd)+ Captopril (25 mg, po, tid)4 weeksGuiding principles (2002)24 h UTP, BUN, Scr, blood B2M, Urine B2MT: 1 showed mild facial flushing
during infusion
C: None

Ren and Wu 2006[31]60(30/30)T: 21/9,
C: 22/8
T: 44-75,
C: 43-74
CGMY (2004)Breviscapine injection (30 ml, ivgtt, qd) + controlCaptopril (25-75 mg, po, qd) or Nifedipine (20-60 mg, po, qd)4 weeksGuiding principles (2002)Clinical efficacy, 24 h UTP, BUN, Scr,T: 2 cases of dry cough
C: 1 case of mild head inflation

Zheng 2006[32]72(37/35)T: 22/13,
C: 23/14
T: 41-73,
C: 42-71
GMY (1999WHO-ISH)Breviscapine injection (30 ml, ivgtt, qd) + controlCaptopril (25-75 mg, po, bid or tid) or Nifedipine (10-60 mg, po, bid or tid)4 weeksGuiding principles (2002)24 h UTP, BUN, Scr,T: 2 cases of cough
C: 1 case of mild head inflation

Chen et al. 2008[33]57(28/29)T: 19/9,
C: 20/9
T: 45.6±20.3,
C: 46.4±21.1
CGMY (2004)Breviscapine injection (20 ml, ivgtt, qd) + controlBenazepril (no details)4 weeksGuiding principles (2002)Clinical efficacy, 24 h UTP, BUN, Scr,, CcrT: 2 cases of head swelling,
dizziness during infusion
C: 1 case of cough

Ye 2009[34]75(40/35)T: 24/16,
C: 20/15
T: 47.3±18.2,
C: 46.9±16.1
GMY (1999WHO-ISH) and CGMY (2005)Breviscapine injection (5 ml, ivgtt, qd) + controlLosartan Potassium (100 mg, po, qd)4 weeksGuiding principles (2002)24 h UTP, Scr,, Ccr, Urine B2M, SBP, DBPT: 1 case of dizziness
C: None

He and Gen 2010[35]168(84/84)T: 49/35,
C: 48/36
T: 69±11,
C: 68±11
CGMY (2005)Breviscapine injection (20 ml, ivgtt, qd) + controlCaptopril (12.5-50 mg, po, tid)30 daysGuiding principles (2002)Clinical efficacy, SBP, DBP, 24 h UTP, Scr, BUNT: 5 cases of dry cough
C: 3 cases of dry cough

Wang and Lan 2012[36]103(52/51)UnclearT: 62.4±4.8,
C: 62.4±4.8
GMY (1999WHO-ISH) and Nephrology (Haiyan Wang)Breviscapine injection (10 ml, ivgtt, qd) + controlLisinopril (20 mg, po, qd)30 daysGuiding principles (2002)Clinical efficacy, SBP, DBP, 24 h UTP, Scr, BUNT: 1 case of dry cough
C: 2 cases of dry cough

Liu 2012[37]50(26/24)T: 12/14,
C: 10/14
T: 55±4,
C: 53±5
GMY (1999WHO-ISH) and CGMY (2005)Breviscapine injection (10 ml, ivgtt, qd) + controlBenazepril (10 mg, po, bid)2 weeksGuiding principles (2002)SBP, DBP, Urinary microalbuminNot reported

Huang et al. 2013[38]63(33/30)T: 24/9,
C: 19/11
UnclearCGMY (2004)Breviscapine injection (20 ml, ivgtt, qd) + controlFelodipine (5 mg, po, qd)+ Aspirin (100 mg, po, qd)4 weeksGuiding principles (2002)Clinical efficacy, SBP, DBP, 24 h UTP, Scr, BUN, TC, TG, blood glucoseT: 2 cases of limb skin redness
C: None

Ye 2013[39]48(24/24)T: 16/8,
C: 14/10
T: 53.0±9.3,
C: 49.0±11.6
CGMY (2010)Breviscapine injection (12 ml, ivgtt, qd) + controlAntihypertensive Drugs (no details) + Prostaglandin E injection (2 ml, ivgtt, qd)30 daysGuiding principles (2002)Clinical efficacy, 24 h UTP, TC, TG, Scr, BUN,Not reported

Qiao 2015[40]158(79/79)UnclearT: 48.01±3.15,
C: 48.01±3.15
GMY (1999WHO-ISH) and CGMY (2005)Breviscapine injection (5 ml, ivgtt, qd) + controlCaptopril (25-75 mg, po, tid) or Nifedipine (10-60 mg, po, tid)4 weeksGuiding principles (2002)Clinical efficacy, SBP, DBP, 224 h UTP, Scr, BUNNot reported

Zhao and Dong 2016[41]80(40/40)UnclearT: 52.5±7.1,
C: 52.5±7.1
CGMY (2010)Breviscapine injection (5 ml, ivgtt, qd) + controlBenazepril (5mg, po, qd)4 weeksGuiding principles (2002)Col-IV, LN, P III P, ET-1, MMP-9, NO, EILA, EISA, VOI, SBP, DBPNone

Ma 2018[41]66(33/33)T: 19/14,
C: 20/13
T: 48.00±3.14,
C: 48.99±2.98
GMY (1999WHO-ISH) and CGMY (2005)Breviscapine injection (5 ml, ivgtt, qd) + controlLosartan Potassium (100mg, po, qd)4 weeksGuiding principles (2002)Urine B2M, SBP, DBP, 24 h UTP, Scr, CcrNot reported

T: treatment group; C: control group; GMY (1999 WHO-ISH): The 1999 WHO-ISH Guidelines for the Management of Hypertension; CGMY (2004): 2004 Chinese Guidelines for the Management of Hypertension; CGMY (2010): 2010 Chinese Guidelines for the Management of Hypertension; CGMY (2014): 2014 Chinese Guidelines for the Management of Hypertension; Guiding Principles (2002): Guiding Principles of Clinical Research on New Drugs of Chinese Medicines (2002); Scr: serum creatinine; BUN: blood urea nitrogen; Ccr: creatinine clearance rate; 24 h UTP: 24-hour urinary total protein; B2M: beta-2-microglobulin; SBP: systolic blood pressure; DBP: diastolic blood pressure; TC: total cholesterol; TG: total triglycerides. PAGT: platelet aggregation rate; Fib: fibrinogen; Hct: hematocrit; LDL: low-density lipoprotein; LDH-C: lactate dehydrogenase C; Col-IV: collagen IV, LN: laminin; P III P: procollagen-III-peptide; ET-1: endothelin 1; MMP-9: matrix metalloproteinase-9; EILA: elasticity index of large artery; EISA: elasticity index of small artery; VOI: vascular overload index.