中华肾病研究电子杂志
中華腎病研究電子雜誌
중화신병연구전자잡지
2013年
5期
254-259
,共6页
陈万佳%邓跃毅%倪兆慧%汪年松%王怡%邓伟
陳萬佳%鄧躍毅%倪兆慧%汪年鬆%王怡%鄧偉
진만가%산약의%예조혜%왕년송%왕이%산위
IgA肾病%中西医结合治疗%脾肾阳虚证%健脾补肾通络颗粒
IgA腎病%中西醫結閤治療%脾腎暘虛證%健脾補腎通絡顆粒
IgA신병%중서의결합치료%비신양허증%건비보신통락과립
Immunoglobulin A nephropathy%Treatment of integrative traditional Chinese and western medicine%Pishenyangxu syndrome%Jianpibushentongluo granules
目的:探讨健脾补肾通络颗粒配合糖皮质激素治疗脾肾阳虚型Lee Ⅲ级及以上IgA肾病患者的有效性及安全性。方法采用多中心、随机、双盲、对照的研究方法。入选病例来自2011年1月至2012年2月在上海4个中心就诊的120例病理表现为Lee Ⅲ级及以上、中医辨证为脾肾阳虚证的IgA肾病患者。随机分为试验组和对照组,试验组用健脾补肾通络颗粒联合泼尼松;对照组用中药安慰剂颗粒联合泼尼松;两者病例数为1∶1。根据患者体重、肾功能状况,口服泼尼松的起始剂量为40~60 mg/d,共服用8~12周;其后每两周减5 mg,减至30 mg/d;再改为每月减5 mg,约治疗9个月停服。健脾补肾通络颗粒由黄芪、制黄精、杜仲、夏枯草、炒蒺藜、仙灵脾、茯苓、炒僵蚕、丹参等成分组成,疗程共48周。分别在0、4、12、24、36、48周进行随访,主要观察指标为估算的肾小球滤过率(eGFR),次要观察指标为中医证候变化、血肌酐、24 h尿蛋白定量。同时观察不良事件的发生情况。运用混合模型进行重复测量资料分析方法比较各疗效指标变化趋势的差别,P值<0.05被认为差异有统计学意义。结果最终完成病例数103例,试验组55例,对照组48例。48周时,主要疗效指标:eGFR试验组及对照组较基线均呈升高趋势(t=4.84,2.37;P<0.05),治疗至24周时试验组eGFR即大于对照组,至48周时eGFR较基线升高差值,试验组明显高于对照组,差异有统计学意义(F=14.39,P<0.05)。次要疗效指标,中医证候积分、24 h尿蛋白量,试验组及对照组均较基线水平下降(t=-12.1,-8.6;P<0.05);中医证候积分较基线水平下降差值,试验组高于对照组,差异有统计学意义(F=106.76,P<0.05);24 h尿蛋白量较基线水平下降差值,对照组高于试验组,差异有统计学意义(F=46.24,P<0.05)。试验组血清肌酐水平较基线明显下降,差异有统计学意义(t=-4.34,P<0.05),对照组血清肌酐较基线下降幅度较小,差异无统计学意义(t=-1.12,P>0.05)。中医证候治疗总有效率试验组为83.33%(50/60),对照组为63.33%(38/60),差异有统计学意义(χ2=17.85,P<0.05)。共出现不良事件14例,试验组5例(5/60,8.3%),对照组9例(9/60,15%),两组比较差异无统计学意义(χ2=1.294,P=0.255)。结论对脾肾阳虚型LeeⅢ级及以上IgA肾病患者,健脾补肾通络颗粒联合糖皮质激素治疗在改善肾功能及减轻临床症状方面较单独使用糖皮质激素治疗疗效更佳,且有更好的安全性。
目的:探討健脾補腎通絡顆粒配閤糖皮質激素治療脾腎暘虛型Lee Ⅲ級及以上IgA腎病患者的有效性及安全性。方法採用多中心、隨機、雙盲、對照的研究方法。入選病例來自2011年1月至2012年2月在上海4箇中心就診的120例病理錶現為Lee Ⅲ級及以上、中醫辨證為脾腎暘虛證的IgA腎病患者。隨機分為試驗組和對照組,試驗組用健脾補腎通絡顆粒聯閤潑尼鬆;對照組用中藥安慰劑顆粒聯閤潑尼鬆;兩者病例數為1∶1。根據患者體重、腎功能狀況,口服潑尼鬆的起始劑量為40~60 mg/d,共服用8~12週;其後每兩週減5 mg,減至30 mg/d;再改為每月減5 mg,約治療9箇月停服。健脾補腎通絡顆粒由黃芪、製黃精、杜仲、夏枯草、炒蒺藜、仙靈脾、茯苓、炒僵蠶、丹參等成分組成,療程共48週。分彆在0、4、12、24、36、48週進行隨訪,主要觀察指標為估算的腎小毬濾過率(eGFR),次要觀察指標為中醫證候變化、血肌酐、24 h尿蛋白定量。同時觀察不良事件的髮生情況。運用混閤模型進行重複測量資料分析方法比較各療效指標變化趨勢的差彆,P值<0.05被認為差異有統計學意義。結果最終完成病例數103例,試驗組55例,對照組48例。48週時,主要療效指標:eGFR試驗組及對照組較基線均呈升高趨勢(t=4.84,2.37;P<0.05),治療至24週時試驗組eGFR即大于對照組,至48週時eGFR較基線升高差值,試驗組明顯高于對照組,差異有統計學意義(F=14.39,P<0.05)。次要療效指標,中醫證候積分、24 h尿蛋白量,試驗組及對照組均較基線水平下降(t=-12.1,-8.6;P<0.05);中醫證候積分較基線水平下降差值,試驗組高于對照組,差異有統計學意義(F=106.76,P<0.05);24 h尿蛋白量較基線水平下降差值,對照組高于試驗組,差異有統計學意義(F=46.24,P<0.05)。試驗組血清肌酐水平較基線明顯下降,差異有統計學意義(t=-4.34,P<0.05),對照組血清肌酐較基線下降幅度較小,差異無統計學意義(t=-1.12,P>0.05)。中醫證候治療總有效率試驗組為83.33%(50/60),對照組為63.33%(38/60),差異有統計學意義(χ2=17.85,P<0.05)。共齣現不良事件14例,試驗組5例(5/60,8.3%),對照組9例(9/60,15%),兩組比較差異無統計學意義(χ2=1.294,P=0.255)。結論對脾腎暘虛型LeeⅢ級及以上IgA腎病患者,健脾補腎通絡顆粒聯閤糖皮質激素治療在改善腎功能及減輕臨床癥狀方麵較單獨使用糖皮質激素治療療效更佳,且有更好的安全性。
목적:탐토건비보신통락과립배합당피질격소치료비신양허형Lee Ⅲ급급이상IgA신병환자적유효성급안전성。방법채용다중심、수궤、쌍맹、대조적연구방법。입선병례래자2011년1월지2012년2월재상해4개중심취진적120례병리표현위Lee Ⅲ급급이상、중의변증위비신양허증적IgA신병환자。수궤분위시험조화대조조,시험조용건비보신통락과립연합발니송;대조조용중약안위제과립연합발니송;량자병례수위1∶1。근거환자체중、신공능상황,구복발니송적기시제량위40~60 mg/d,공복용8~12주;기후매량주감5 mg,감지30 mg/d;재개위매월감5 mg,약치료9개월정복。건비보신통락과립유황기、제황정、두중、하고초、초질려、선령비、복령、초강잠、단삼등성분조성,료정공48주。분별재0、4、12、24、36、48주진행수방,주요관찰지표위고산적신소구려과솔(eGFR),차요관찰지표위중의증후변화、혈기항、24 h뇨단백정량。동시관찰불량사건적발생정황。운용혼합모형진행중복측량자료분석방법비교각료효지표변화추세적차별,P치<0.05피인위차이유통계학의의。결과최종완성병례수103례,시험조55례,대조조48례。48주시,주요료효지표:eGFR시험조급대조조교기선균정승고추세(t=4.84,2.37;P<0.05),치료지24주시시험조eGFR즉대우대조조,지48주시eGFR교기선승고차치,시험조명현고우대조조,차이유통계학의의(F=14.39,P<0.05)。차요료효지표,중의증후적분、24 h뇨단백량,시험조급대조조균교기선수평하강(t=-12.1,-8.6;P<0.05);중의증후적분교기선수평하강차치,시험조고우대조조,차이유통계학의의(F=106.76,P<0.05);24 h뇨단백량교기선수평하강차치,대조조고우시험조,차이유통계학의의(F=46.24,P<0.05)。시험조혈청기항수평교기선명현하강,차이유통계학의의(t=-4.34,P<0.05),대조조혈청기항교기선하강폭도교소,차이무통계학의의(t=-1.12,P>0.05)。중의증후치료총유효솔시험조위83.33%(50/60),대조조위63.33%(38/60),차이유통계학의의(χ2=17.85,P<0.05)。공출현불량사건14례,시험조5례(5/60,8.3%),대조조9례(9/60,15%),량조비교차이무통계학의의(χ2=1.294,P=0.255)。결론대비신양허형LeeⅢ급급이상IgA신병환자,건비보신통락과립연합당피질격소치료재개선신공능급감경림상증상방면교단독사용당피질격소치료료효경가,차유경호적안전성。
Objective To observe the safety and efficacy of Jianpibushentongluo granules plus prednisone in treating immunoglobulin A nephropathy (IgAN ) patients staging Lee Ⅲ and above (Pishenyangxu pattern).Methods A randomized,controlled,and double-blind multicentre clinical trial was conducted.From January 201 1 to February 201 2,a total of 1 20 IgAN patients (LeeⅢand above)from 4 hospitals in Shanghai were recruited.All of the patients presented with Pishenyangxu syndrome.The patients were randomly divided into two groups:test group (Jianpibushentongluo granules plus prednisone) and control group (placebo granules plus prednisone).According to the patient′s weight and renal function, the starting dose of oral prednisone was 40-60 mg/d for a total of 8 to 1 2 weeks;Thereafter,the oral prednisone dose was reduced by 5 mg every two weeks until the dose reached 30 mg/d,and then by 5 mg every month.Oral prednisone was stopped after 9 months of treatment.The Jianpibushentongluo granules were made from astragalus,sealwort,eucommia,prunella,fried caltrop,epimedium,poria,fried silkworm, and salvia,which were administered to patients for 48 weeks.Follow-up was performed at the 0,4,1 2,24, 36,and 48 week,monitoring estimated glomerular filtration rate (eGFR),symptoms of traditional Chinese medicine,serum creatinine,and 24-hour urinary protein excretion.Mixed model was used for analysis of repeated measuring data to compare efficacy difference between the two groups.P value less than 0.05 was considered statistically significant.Results 1 03 patients (test group 55 cases,control group 48 cases) completed the study.eGFR in both test and control group showed an increasing trend compared with baseline (t=4.84,2.37;P<0.05);eGFR level became higher at 24-week of treatment (P<0.05),and increased more from baseline in test group than in control group at 48-week of treatment (F=1 4.39,P<0.05).The syndrome scoring and 24 h urinary protein in both groups were lower than baseline (t=-1 2.1 ,-8.6;P<0.05).The syndrome scoring decreased more in test group than in control group (F=1 06.76,P<0.05), but the 24 h urinary protein decreased more in control group than in test group (F=46.24,P<0.05 ). Serum creatinine level decreased significantly than baseline in test group (t=-4.34,P<0.05),but not in control group (t =-1 .1 2,P>0.05 ).The total effective rate of syndromes treatment was higher in test group (83.33%,50/60)than in control group (63.33%,38/60)(χ2 =17.85,P<0.05).Adverse events occurred in 1 4 cases:test group 5 cases (5/60,8.3%),and control group 9 cases (9/60,1 5%) with no statistically significant difference between the two groups (χ2 =1 .294,P=0.255 ).Conclusion For IgAN patients staging Lee Ⅲ and above (Pishenyangxu pattern ),Jianpibushentongluo granules plus prednisone showed better efficacy and safety than prednisone alone in improving renal function and reducing clinical symptoms.