A Clinical Study on the Treatment of Chronic Pelvic Inflammation of Qi-stagnation with Blood Stasis Syndrome by Penyanqing Capsule (盆炎清胶囊)

Objective: To observe the clinical efficacy of Penyanqing Capsule (盆炎清胶囊, PYQC) in treating pelvic inflammation of Qi-stagnation with blood stasis syndrome. Methods: The randomized, single blinded, parallel positive drug controlled method was adopted, with 82 patients assigned into two groups by envelop method. The 42 patients in the treated group received PYQC 3 times a day, 4 capsules each time taken orally; the 40 patients in the control group were given orally Fuyankang tablets (妇炎康片, FYKT) 3 times a day, 6 tablets each time. The therapeutic course for both groups was 2 months, and 2 courses of treatment were given successively to observe the comprehensive effect, changes of symptoms and signs before and after treatment. The effects of PYQC on hemorrheological character in part of the patients and on the pathogenetic chlamydia and mycoplasma were also observed. Results: The total effective rate in the treated group was 83.3 %, which was insignificantly different from that in the control group ( 77.5 %, P ＞ 0.05 ).However, PYQC could significantly lower the hemorrheologic indexes in patients and showed definite influence on the pathogenetic chlamydia and mycoplasma. Conclusion: PYQC has good therapeutic effect in treating chronic pelvic inflammation of Qi-stagnation with blood stasis syndrome, and showed definite effect on chlamydia and mycoplasma.     

Clinical Study of Puerarin in Treatment of Patients with Unstable Angina

Clinical Study of Puerarin in Treatment of Patients with Unstable Angina@赵志明@杨晓英@张永珍@肖正益     

Clinical Study of Effect of Yinji Capsule(银蒺胶囊)on Left Ventricular Systolic Function of Angina Pectoris Patients With Blood Stasis Syndrome

Ｃｌｉｎｉｃａｌ　Ｓｔｕｄｙ　ｏｆ　Ｅｆｆｅｃｔ　ｏｆ　Ｙｉｎｊｉ　Ｃａｐｓｕｌｅ（银蒺胶囊）ｏｎ　Ｌｅｆｔ　Ｖｅｎｔｒｉｃｕｌａｒ　Ｓｙｓｔｏｌｉｃ　Ｆｕｎｃｔｉｏｎ　ｏｆ　Ａｎｇｉｎａ　Ｐｅｃｔｏｒｉｓ　Ｐａｔｉｅｎｔｓ　ｗｉｔｈ　Ｂｌｏｏｄ　Ｓ...     

Effect and Safety of Hydroxysafflor Yellow A for Injection in Patients with Acute Ischemic Stroke of Blood Stasis Syndrome: A Phase Ⅱ , Multicenter, Randomized, Double-Blind, Multiple-Dose, Active-Controlled Clinical Trial

Objective: To assess the effect and safety of Hydroxysafflor Yellow A for Injection(HSYAI) in treating patients with acute ischemic stroke(AIS) and blood stasis syndrome(BSS). Methods: A multicenter, randomized, double-blind, multiple-dose, active-controlled phase Ⅱ trial was conducted at 9 centers in China from July 2013 to September 2015. Patients with moderate or severe AIS and BSS were randomly assigned to low-, medium-, high-dose HSYAI groups(25, 50 and 70 mg/d HSYAI by intravenous infusion, respectively), and a control group(Dengzhan Xixin Injection(灯盏细辛注射液, DZXXI) 30 mL/d by intravenous infusion), for 14 consecutive days. The primary outcome was the Modified Rankin Scale(mRS) score 1 at days 90 after treatment. The secondary outcomes included the National Institute of Health Stroke Scale(NIHSS) score 1, Barthel Index(BI) score 95, and BSS score reduced 30% from baseline at days 14, 30, 60, and 90 after treatment. The safety outcomes included any adverse events during 90 days after treatment. Results: Of the 266 patients included in the effectiveness analysis, 66, 67, 65 and 68 cases were in the low-, medium-, and high-dose HSYAI and control groups, respectively. The proportions of patients in the medium-and high-dose HSYAI groups with m RS score 1 at days 90 after treatment were significantly larger than the control group(P0.05). The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium-and high-dose HSYAI groups were all significantly higher than the control group(P0.05). No significant difference was reported among the 4 groups in any specific adverse events(P0.05). Conclusions: HSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS. The medium(50 mg/d) or high dose(75 mg/d) might be the optimal dose for a phase Ⅲ trial.(Registration No. ChiCTR-2000029608)     

Clinical Study on Treatment of Chronic Renal Failure with Shenshuailing

The therapeutic effects of Shenshuailing Kou Fu Ye (SKFY 肾衰灵口服液,the Oral Liquid for RenalFailure) and Shenshuailing Guan Chang Ye (SGCY 肾衰灵灌肠液,the Enema for Renal Failure) wereevaluated in treatment of chronic renal failure,with coateg aldehyde oxystarch as the controls.Thechanges in the clinical symptoms,serum creatinine,blood urea nitrogen and creatinine clearance ratewere observed.The total effective rate in the former was 90.46%,and the latter 60.43%.     

Clinical Study of Shuizhi-Dahuang Mixture(水蛭大黄合剂) in Treating Schizophrenics with Blood Stasis Syndrome

ＣｌｉｎｉｃａｌＳｔｕｄｙｏｆＳｈｕｉｚｈｉ－ＤａｈｕａｎｇＭｉｘｔｕｒｅｉｎＴｒｅａｔｉｎｇＳｃｈｉｚｏｐｈｒｅｎｉｃｓｗｉｔｈＢｌｏｏｄＳｔａｓｉｓＳｙｎｄｒｏｍｅ￥ＺＨＵＹｕｎ－ｚｈａｉ；ＫＡＮＧＢｉｎｇ；ＺＨＵＱｉｎｇ－ｑｉａｎｄＨＵＡＮＧＭ...     

Clinical Study of Pai-Neng-Da Capsule(派能达胶囊) in the Treatment of Chronic Aplastic Anemia

Objective:To evaluate the efficacy and safety of Pai-Neng-Da Capsule(派能达胶囊t panaxadiol saponins component,PND),a new Chinese patent medicine,on patients with chronic aplastic anemia(CAA)and to explore the optimal therapeutic regimen for CAA.Method:A total of 36 patients with CAA were enrolled and divided into three groups:the AP group(20 cases,andriol 120 mg/day + PND 240 mg/day),the ACP group(13 cases,andriol 120 mg/day + cyclosporine 3-6 mg·kd~(-1)·day~(-1) + PND 240 mg/day),and the PND group(3cases,PND 240 mg/day).All patients were treated and followed up for 6 months.Peripheral blood counts,renal and hepatic function and Chinese medical(CM) symptoms of patients were assessed and all indices were gathered at the beginning and end of the study.Result:In the AP group,no significant hematologic difference was observed at the end of 6-month treatment comparing with the beginning.In the ACP group,the blood counts were maintained at the same level after the 6-month treatment.In the PND group,trilineage hematologic improvement was displayed at the end of 6-month treatment comparing with the beginning.No significant difference was showed in renal and hepatic function in all patients.All patients' clinical symptom improved according to CM symptom score.The effective rates were 95%,73%and 100%,respectively.Conclusion:PND improved the efficacy and decreased side effects by cutting down the dosage of andriol,and it could also improve patients' clinical symptom and quality of life.PND were effective and safe in the treatment of CAA,it could be used alone or in combination with pharmacological agents such as andriol and cyclosporine.     

A Multicentral Randomized Control Study on Clinical Acupuncture Treatment of Bell's Palsy

To confirm the clinical therapeutic effects of acupuncture and moxibustion on Bell's palsy.Methods:480 cases from 4 hospitals were enrolled for this study,among whom 439 cases completed thewhole course of the study.The patients were randomly divided into the following 3 groups,a controlgroup(treated with prednisone,vitamin Bl,vitamin B_(12)and dibazol),an acu-moxibustion group(treatedwith filiform needle plus moxibustion),and a basic treatment plus acu-moxibustion group(treated withoral medicine like those in the control group plus acupuncture,and with moxibustion like in theacu-moxibustion group).The whole treatment course lasted 4 weeks.The therapeutic effects wereevaluated according to the symptoms and signs,House-Brackmann grading scale and facial disabilityindexes(FDI).Results:All the 4 centers(hospitals)completed this study well,with no statisticallysignificant difference found among the 4 centers in therapeutic effects.The patients with differentconditions were well distributed in the 3 groups,thus the basic general,data were comparable(P>0.05).The therapeutic effects of the two treatment groups were better than the control group(respectivelyP<0.05 and P<0.01),and it was the best in the acu-moxibustion group(P<0.01).Conclusion:Acupuncture and moxibustion may exert definite therapeutic effects on Bell's palsy,better than that ofthe basic treatment group or the basic treatment plus acu-moxibustion group.     

Clinical Study on the Piweiping Capsule (脾胃平胶囊) in Treating Patients with Metaplasia of Gastric Mucosa

Intestinalmetaplasiaofgastricmucosaiscloselyrelatedtotheoccuranceofgastriccan-cerandistheprecancerouslesionofgastriccancer(l'2).Secondarypreventivemeasuresf0rgastriccanceraredesignedtost0pthedevelop-mentofitsprecancerouschange.TheauthorsusedPiweipingCapsule(PWPC)orSanji-uweitai(SJWT,-Agr$)totreatl43pa-tientssufferingfromchronicgastritisofgastricantrumwithintestinalmetaplasia(IM),andtakingpathology,cyclicadem0sinemon0phos-phate(cAMP),deoxyribonucleicacid(DNA)ofgastricmuc0saandlymphocyte…     

Clinical Assessment on Treatment of Hyperlipidemia with Pushen Capsule (蒲参胶囊)

Objective: To explore the therapeutic effect of Pushen capsule (PSC, 蒲参胶囊) in treating primary hyperlipidemia. Methods: Two hundred and forty patients with primary hyperlipidemia were randomly divided into two groups, the 120 patients in the treated group treated with PSC (4 capsules, tid) and the 120 patients in the control group treated with Zhibituo tablet (脂必妥, 3 tablets, tid), and they were administered at the same time with Zhibituo placebo. The therapeutic course for both groups was 4 weeks. The therapeutic effect and the effects on blood lipids and viscosity were observed. Results: The effective rate in thetreated group was 76. 3%, which was significantly higher than that in the control group (48. 7% , P< 0. 01). PSC showed a significant lowering effect on TC, TG and LDL-C and raising effect on HDL-C, and the effect in lowering TG was significantly better than that of Zhibituo (P<0.01). PSC also showed a certain effect in decreasing whole blood viscosity of both high-sheared and low-shear     

Xinfeng Capsule(新风胶囊)for the Treatment of Rheumatoid Arthritis Patients with Decreased Pulmonary Function—A Randomized Controlled Clinical Trial

Objective:To determine the effectiveness and safety of Xinfeng Capsules(新风胶囊,XFC) for the treatment of rheumatoid arthritis(RA) patients with decreased pulmonary function.Methods:This was a randomized controlled clinical trial of 80 RA patients.Participants were assigned to the trial group(40 cases) and the control group(40 cases) by block randomization.The trial group was treated with XFC,three pills each time three times daily for 2 months.The control group was treated with tripterygium glycoside(TPT),two pills each time three times daily for 2 months.Both groups were followed up after 2 months.The clinical effects,changes in joint and pulmonary function,and quality of life before and after treatment were observed;safety indices were also evaluated.Results:Pain,swelling,tenderness,and duration of morning stiffness of joints were obviously decreased after treatment in both the trial and the control groups compared with baseline(P0.01).Compared with before treatment,hand grip strength increased significantly after treatment in the trial group(P=0.0000);pulmonary function parameters such as forced expiratory volume in the first second of expiration/forced vital capacity(FEV_1/FVC),50%of the expiratory flow of forced vital capacity(FEF_(50)),carbon monoxide diffusing capacity(DLco) were increased(P0.01 or P0.05);measures of quality of life such as role-physical,body pain,vitality and mental health were also improved after treatment in the trial group(all P0.05).Joint swelling in the trial group decreased compared with the control group(P=0.0043),while hand grip strength was increased after treatment(P=0.0000).The increase in FEF_(50),DLco,and the dimensions of quality of life such as vitality and mental health were all significantly greater in the trial group than the control group(P0.05 or P0.01).Conclusions:XFC not only relieved joint pain in RA patients,but also significantly improved the ventilation and diffusion function of the lungs.Therefore,XFC could improve the whole body function and enhance the quality of life of RA patients.     

Clinical Observation on Treatment of PostcardiotomicComplications with Chinese Herbal Medicine BasedOn Syndrome Differentiation in 58Patients with Angiocardiopathy

Objective:TostudytheeffectofChineseherbalmedicine(CHM)basedonSyndromeDifferentiationonpostcardiotomiccomplicationsinpatientswithangiocardiopathy.Methods:Aimedattreatingthefrequentlyencounteredpostcardiotomiccomplications,includingfever,coughandexpectoration,belching,abdominaldistension,palpitation,shortbreath,etc.CHMtreatmentwasappliedincombinationwithroutinewesterndrugtreatment(cardiactonic,diuretics,vasculardilatorandanticoagulant).Results:Twentyoutof22patientswithprotractedfeverandirres…     

Clinical Study on the Superoxide Dismutase Activity of Erythrocytes in Circulating Blood of Patients with Carcinoma of Lung

ＣｌｉｎｉｃａｌＳｔｕｄｙｏｎｔｈｅＳｕｐｅｒｏｘｉｄｅＤｉｓｍｕｔａｓｅＡｃｔｉｖｉｔｙｏｆＥｒｙｔｈｒｏｃｙｔｅｓｉｎＣｉｒｃｕｌａｔｉｎｇＢｌｏｏｄｏｆＰａｔｉｅｎｔｓｗｉｔｈＣａｒｃｉｎｏｍａｏｆＬｕｎｇＹｕａｎＨａｎｑｕａｎ，ｅｔａｌ．ＡＣ...     

Clinical Pathologic Study on Effect of Qianggan Capsule (强肝胶囊) in Treating Patients of Chronic Hepatitis B with Liver Cirrhosis

Objective: To explore the clinical therapeutic effect of Qianggan Capsule (QGC) in treating chronic hepatitis B with liver fibrosis from the pathological aspect. Methods: Sixty-three patients of chronic hepatitis B with liver fibrosis were randomly divided into the treated group (n=45) and the control group (n=18). Both groups were treated with general liver protective drugs, such as Glucurone and vitamins B complex for 6 months. To the treated group, QGC was used additionally. The levels of serum alanine transaminase and liver fibrosis indexes including hyaluronic acid (HA), collagen type Ⅳ (C-Ⅳ) and laminin (LN) as well as the pathological examination of liver biopsy were observed before and after treatment. Results: The liver cirrhosis indexes, HA, C-Ⅳ and LN, were improved significantly in the treated group after treatment, P<0.05. The liver function improvement rate in the treated group and the control group was 90.3% and 66.7% respectively, comparison of the two groups showed insignificant difference, P>0.05. Pathological examination showed that the effective rate of treatment on liver inflammatory necrosis activity grade in the treated group was 57.8% and that on liver fibrosis stage was 75.6%, which were significantly improved as compared with those before treatment (P<0.05 and P<0.01), while in the control group, no significant improvement was found after treatment (P>0.05). Conclusion: QGC has marked effects in reversing liver fibrosis and alleviating hepatic inflammatory necrosis in patients of chronic hepatitis B with liver fibrosis, and could lower the serum liver fibrosis related indexes effectively.     

Clinical Study of the Treatment Based Mainly on Syndrome Differentiation for the Complications of Bone Marrow Transplantation in 22 Patients with Leukemia

Bonemarrowtransplantation(BMT)isnowthemosteffectivetreatmentforleukemia;itisusedastheroutinetreatmentforleukemiainmanyco..t.ies(l).Butitspretreatmentofradiotherapyorchemotherapyinultra--largedosagewhichisusedinadditiontoBMTtoremoveleukemiccellsbringaboutin..Juriesoftheorgansandweakensthehematopoieticandimmunologicfunctionsofthepatient;moreover,evenaftertherestorationofhematopoiesis('),thedamagedorgansandtheimpairedimmunologicfunctionmightbeunabletonormalizeforalongperiodoftime,complicationsr…     

Effect and Safety of Guanxinning Tablet(冠心宁片) for Stable Angina Pectoris Patients with Xin(Heart)-Blood Stagnation Syndrome:A Randomized,Multicenter,Placebo-Controlled Trial

Objective: To investigate the effect and safety of Guanxinning Tablet(冠心宁片, GXN) for the treatment of stable angina pectoris patients with Xin(Heart)-blood stagnation syndrome(XBSS). Methods: One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN(80 cases) or placebo(80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets(0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test(treadmill protocol), Chinese medicine(CM) syndrome score, electrocardiogram(ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events(AEs) were evaluated during the whole clinical trial. Results: Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28±17.67 s after treatment(P0.05); moreover, the change of exercise duration in the GXN group increased 63.10±96.96 s in subgroup analysis(P0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group(40.58%, 75.36%, 26.92%, 28.21%, respectively, P0.05). Conclusion: GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.     

Clinical Observation on Influence of Chinese Medicines for Promoting Blood Circulation to Remove Blood Stasis on FIB and DD in Plasma of Patients with Cerebral Thrombosis

to study the influence of Chinese medicines for promoting blood circulation to removeblood stasis on fibrinogen(FIB)and D-dimer(DD)in plasma of patients with cerebral thrombosis.Method:73 inpatients with acute cerebral thrombosis were randomly divided into a control group of34 cases and a treatment group of 39 cases.The content of FIB and DD in plasma was detectedbefore treatment and on the 7th and 14th days after treatment.Result:FIB content in plasma aftertreatment was lower than that before treatment in the control group(P<0.01)and more remarkablein the treatment group(P<0.001).There was an obvious difference in DD content before and aftertreatment in both groups.DD content on the 7th and 14th days after treatment in the treatmentgroup was obviously higher than that in the control group(P<0.01 and P<0.05 respectively).Conclusion:Chinese medicines for promoting blood circulation to remove blood stasis can reducethe FIB content in plasma of patients with cerebral thrombosis,raise the DD content in plasma,cause the peak of DD content appear earlier and obviously improve hypercoagulability of blood inpatients with cerebral thrombosis.     

A Multicentral Randomized Control Study on Clinical Acupuncture Treatment of Bell＇s Palsy

To confirm the clinical therapeutic effects of acupuncture and moxibustion on Bell＇s palsy. Methods： 480 cases from 4 hospitals were enrolled for this study, among whom 439 cases completed the whole course of the study. The patients were randomly divided into the following 3 groups, a control group（treated with prednisone, vitamin B 1, vitamin B 12 and dibazol）, an acu-moxibustion group （treated with filiform needle plus moxibustion）, and a basic treatment plus acu-moxibustion group （treated with oral medicine like those in the control group plus acupuncture, and with moxibustion like in the acu-moxibustion group）. The whole treatment course lasted 4 weeks. The therapeutic effects were evaluated according to the symptoms and signs, House-Brackmann grading scale and facial disability indexes（FDI）. Results： All the 4 centers （hospitals） completed this study well, with no statistically significant difference found among the 4 centers in therapeutic effects. The patients with different conditions were well distributed in the 3 groups, thus the basic general data were comparable （P〉0.05）. The therapeutic effects of the two treatment groups were better than the control group （respectively P〈0.05 and P〈0.01）, and it was the best in the acu-moxibustion group （P〈0.01）. Conclusion： Acupuncture and moxibustion may exert definite therapeutic effects on Bell＇s palsy, better than that of the basic treatment group or the basic treatment plus acu-moxibustion group.     

Observation on Clinical Effects of Herba Andrographidis in Patients with Chronic Cor Pulmonale

ＯｂｓｅｒｖａｔｉｏｎｏｎＣｌｉｎｉｃａｌＥｆｆｅｃｔｓｏｔＨｅｒｂａＡｎｄｒｏｇｒａｐｈｉｄｉｓｉｎＰａｔｉｅｎｔｓｗｉｔｈＣｈｒｏｎｉｃＣｏｒＰｕｌｍｏｎａｌｅｚｈｕＹｉｎｇ－ｃｈｕｎ（朱迎春）；ＺｈａｎｇＹａｏ－ｚｈｅｎ（张瑶珍）；ＮｉｕＲｕ－...