The Clinical Effect Of Self-designed Six-herb Decoction Of Elevating Blood Pressure Compared With Midodrine Hydrochloride Tablets In The Treatment Of Primary Hypotension

Objectives: 1.To observe the clinical improvement characteristics and the effect of conventional dose of Self-designed six-herb decoction of elevating blood pressure in patients with both of Yin and Yang deficiency of primary hypotension;2.To compare and evaluate the clinical efficacy,office blood pressure and indexes of ambulatory blood pressure of conventional dose of Self-designed six-herb decoction of elevating blood pressure compared with conventional dose Midodrine hydrochlori de tablets in the treatment of patients with primary hypotension;3.To explore the characteristics and safety of Chinese and western medicine in the treatment of primary hypotension,and to provide ideas for the combination of Chinese and western medicine.Methods: Randomly selected untreated patients of primary hypotension with both of Yin and Yang deficiency syndrome,TCM syndrome differentiation,CBP,ABPM,auxiliary examination for exclusion of secondary hypotension were carried out and in conformity with tentative diagnosis standard of SBP ≤ 100 or DBP≤60 in each period or present of multi-period regularity of BP ≤90/60 mm Hg throughout the day with load values of low blood pressure ≥25% / 25%;A total of 94 patients were selected and randomly divided into two groups.In the group of traditional Chinese medicine,48 patients took a routine dose of Self-designed six-herb decoction of elevating blood pressure(150ml,tid;100ml,qn)every day.In the group of western medicine,46 patients took a routine dose of Midodrine hydrochloride tablets(2.5mg bid)every day.The symptoms,CBP,24 h SBP,24 h DBP,d SBP,d DBP,n SBP,n DBP,BPV and HR were assessed in the differences at baseline and after treatment for 4 weeks for intra or intergroup in the relevant indicators.Results: 1.Curative effect of TCM syndrome: The score of syndrome were significantly lower after treatment than before in both of the TCM group(19.46±1.45vs5.38±1.61,P<0.01)and group of western medicine(20.31±2.56vs9.46±1.85,P<0.01).The score of syndrome was significantly lower in the TCM group than in that of group of western medicine(5.38±1.61vs9.46 ±1.85,P<0.01).After treatment,the effective rate was significantly higher in the TCM group than in that of group of western medicine(WM group)(93.7% vs 80.0%,P<0.01).2.The changes of CBP: The CBP of the TCM group was increased obviously after treatment(116 ± 16.25/67.17 ± 8.88vs120.10 ± 14.54/70.67 ± 7.17,P<0.01)and similarly the WM group was increased after treatment(114.03 ± 17.02/65.61 ± 9.71 vs 125.56±18.95/67.81±10.63,P<0.05);The effect of increasing of SBP in the WM group was better than TCM group(125.56 ± 18.95vs120.10 ± 14.54,P<0.05);the effective rate was obviously higher in the TCM group than in WM group(80.0% vs 52.1%,P<0.05).3.The comparisons of mean ABP: After treatment,the 24 h BP、d BP and n BP in the TCM and WM group were significantly higher than that before treatment(106.21±9.72/60.00±4.65vs113.44±9.35/66.54±5.90、108.33±10.14/61.56±4.95vs115.40±9.78/67.98 ±6.32 、99.73 ±10.21/55.10 ±5.11vs106.90 ±10.05/62.00 ±6.05,P<0.01)、(107.39±8.51/59.08±4.20vs114.31±8.16/66.39±6.47、109.28±9.55/60.39±4.66vs115.89±8.08/67.19±6.50、101.94±7.35/55.28±5.33vs109.41±10.41/62.64±7.43,P<0.01);There was no significant difference between the two groups in the increase of 24 h BP、d BP and n BP after treatment(113.44±9.35/66.54±5.90vs114.31±8.16/66.39±6.47、115.40±9.78/67.98±6.32vs115.89±8.08/67.19±6.50、106.90±10.05/62.00±6.05vs109.41±10.41/62.64±7.43,P>0.05);The total effective rate were 79.2% in TCM group and 73.3% in WM group(P>0.05).4.The comparisons of MAP: After treatment,the 24 h MAP 、d MAP and n MAP in the TCM and WM group were significantly higher than that before treatment(78.38±6.31vs84.08±6.23、80.17±6.47vs85.65±6.71、72.83±6.73vs78.75±6.69,P<0.05;77.44±5.67vs83.25±6.38、79.72±6.38vs84.17±5.94、72.84±5.59vs78.94±7.69,P<0.05);There was no significant difference between groups in each parameter(84.08±6.23vs83.25±6.38、85.65±6.71vs84.17±5.94、78.75±6.69vs78.94±7.69,P>0.05).5.The comparisons of PP: After treatment,the 24 h PP 、d PP and n PP in the TCM and WM group were significantly higher than that before treatment(44.25±9.25 vs 48.12±10.10、44.71±9.45 vs 48.44±10.13、42.83±9.01 vs 45.98±8.70,P<0.01;47.22±7.91 vs 50.47±7.63、47.69±8.47 vs 50.50±7.81、45.50±7.11 vs 48.69±7.44,P<0.01).There was no significant difference between the two groups in each parameter(P>0.05).6.The comparisons of BPV: After treatment,the BPV in the TCM and WM group had no significant respectively(11.49±2.57/7.63±2.06vs11.23±2.91/7.56±1.67、9.45±3.65/6.95±1.98vs10.65±3.22/7.85±1.75,P>0.05;11.93±3.08/8.16±2.36 vs11.74±3.07/8.09±1.99、10.18±3.32/7.10±2.17vs10.63±2.78/7.91±2.53,P>0.05);There was no significant difference between the two groups for each parameter(P>0.05).7.Blood pressure drop rate: There were no significant change in nocturnal blood pressure drop rate after treatment in the two groups respectively(TCM group 7.61±6.05/10.10±7.10vs6.73±6.24/8.74±7.78,P>0.05、WM group 6.45±6.61/7.75±9.08 vs5.81±6.04/6.63±8.23,P>0.05);There was no significant difference between the two groups in each parameter(P>0.05).8.The comparings of average HR: After treatment,there were no significant change in the HR during daytime and nighttime in two groups respectivey(TCMgroup 72.38±8.52/63.33±6.64vs72.52±9.29/62.04±6.72,P>0.05、WMgroup 73.06±10.30/63.94±8.20vs73.61±8.04/62.22±6.30,P>0.05),There was no significant difference in HR between the two groups after treatment(P>0.05).9.Adverse reactions: In TCM group,transient diarrhea occurred in 1 case and transient abdominal pain occurred in 1 case during the treatment,and blood pressure increased to about 140/90 in the fourth week of treatment in 1 case.All symptoms were mild and did not affect the completion of the study.The incidence of adverse reactions was 6.25%(3/48).In WM group,1 patient presented progressive aggravation of pilli muscle contraction accompanied by sweating,which was not tolerated by the patient.After 2 weeks,the drug was discontinued(46 cases in this group were eventually analyzed for efficacy by 45 cases),and 2 cases had mild gastrointestinal discomfort and abdominal distension,the incidence of adverse reactions was 6.67%(3/45).10.Observation of safety index: No abnormal cases were found in the parameters of three routine tests,liver and kidney function and myocardial enzyme etc.before and after treatment in the two groups.Conclusions:1.Two groups can improve the symptoms of dizziness,shortness of breath,fatigue and other symptoms in patients with primary hypotension,and the Selfdesigned six-herb decoction of elevating blood pressure is better and quicker than Midodrine hydrochloride tablets.2.Two groups could significantly increase CBP,24 h BP,d BP,n BP.The amplitude of elevated blood pressure in the daytime is greater than the nighttime and no difference in two groups.3.It should be jointly evaluated with the CBPM and ABPM for the "white coat effect" that may appear in patients with primary hypotension.4.BPV,nocturnal blood pressure drop rate and HR were not affected by the two groups after treatment.5.Adverse drug reactions in both groups were mild with low incidence,and most patients had no adverse reactions with good safety.6.The study of combination of clinical symptoms,OBPM and ABPM can more effectively evaluate the efficacy of elevated blood pressure.