Analysis of outcome indexes in randomized controlled trials of traditional Chinese medicine for rheumatic heart disease / 中国中药杂志

The present study analyzed the efficacy evaluation indexes of the randomized controlled trials(RCTs) of Chinese medi-cine in the treatment of rheumatic heart disease to lay the foundation for the construction of the corresponding core outcome index set. Clinical RCTs with a definite diagnosis of rheumatic heart disease were retrieved from CNKI, Wanfang, VIP, Sino Med, Pub Med, EMbase, and Cochrane Library from January 1, 2010, to December 31, 2020. Thirty-five RCTs were included, involving 3 314 patients and 41 efficacy evaluation indexes, which covered seven domains [traditional Chinese medicine(TCM) symptoms/syndromes, symp-toms/signs, physical and chemical examination, quality of life, long-term prognosis, economic evaluation, and safety events]. Physi-cal and chemical examination(56. 91%) and symptoms/signs(29. 27%) were the more frequently applied. The number of indexes used in a single trial ranged from 1 to 15, with an average of 4. The measurement time points of the top five indexes in the frequency of use were as follows: total response rate was reported at five measurement time points, ranging from 14 days to 6 months; left ventri-cular ejection fraction was measured at eight time points ranging from 5 days to 6 months; left ventricular end systolic diameter was measured at six time points, ranging from 5 days to 6 months; interleukin-2(IL-2) and tumor necrosis factor-α(TNF-α) were repor-ted 28 days after treatment. At present, there are many problems in the efficacy outcome indexes of RCTs in the treatment of rheumatic heart disease with TCM, such as large difference in quantity, unclear primary and secondary indexes, unreasonable selection of " surro-gate indexes", insufficient attention to long-term prognostic indexes and safety event indexes, non-standard application of composite in-dexes, long measurement period, and lack of TCM characteristics. It is urgent to establish the core outcome set for TCM treatment of rheumatic heart disease.

Effect of single intraoperative dose of amiodarone in patients with rheumatic valvular heart disease and atrial fibrillation undergoing valve replacement surgery.

Maintenance of sinus rhythm (SR) is superior to rate control in atrial fibrillation (AF). In order to achieve SR, we administered single-dose intravenous amiodarone intraoperatively and evaluated its effect on conversion of rheumatic AF to SR in patients undergoing valvular heart surgery. Patients were randomly assigned to amiodarone (n = 42) or control (n = 40) group in a double blind manner. The amiodarone group received amiodarone (3 mg/kg) intravenously prior to the institution of cardiopulmonary bypass and the control group received the same volume of normal saline. In the amiodarone group, the initial rhythm after the release of aortic cross clamp was noted to be AF in 14.3% (n = 6) and remained so in 9.5% (n = 4) of patients till the end of surgery. In the control group, the rhythm soon after the release of aortic cross clamp was AF in 37.5% (n = 15) (p = 0.035) and remained so in 32.5% (n = 13) of patients till the end of surgery (p = 0.01). At the end of first post-operative day 21.4% (n = 9) of patients in amiodarone group and 55% (n = 22) of patients in control group were in AF (p = 0.002). The requirement of cardioversion/defibrillation was 1.5 (+/-0.54) in amiodarone group and 2.26 (+/-0.73) in the control group (p = 0.014), and the energy needed was 22.5 (+/-8.86) joules in the amiodarone group and 40.53 (+/-16.5) in the control group (p = 0.008). A single intraoperative dose of intravenous amiodarone increased the conversion rate of AF to normal sinus rhythm, reduced the need and energy required for cardioversion/defibrillation and reduced the recurrence of AF within one day.

Consensus guidelines on pediatric acute rheumatic fever and rheumatic heart disease.

JUSTIFICATION: Acute rheumatic fever and rheumatic chronic valvular heart disease is an important preventable cause of morbidity and mortality in suburban and rural India. Its diagnosis is based on clinical criteria. These criteria need verification and revision in the Indian context. Furthermore, there are glaring differences in management protocols available in literature. These facts prompted Indian Academy of Pediatrics to review the management of rheumatic fever. PROCESS: Management of Rheumatic fever was reviewed and recommendation was formulated at national consultative meeting on 20th May 2007 at New Delhi. OBJECTIVES: To formulate uniform guidelines on management of acute rheumatic fever and rheumatic heart disease in the Indian context. Guidelines were formulated for the management of streptococcal pharyngitis, acute rheumatic fever and its cardiac complication as well as secondary prophylaxis for recurrent episodes. RECOMMENDATIONS: (1) Streptococcal eradication with appropriate antibiotics (Benzathine penicillin single dose or penicillin V oral or azithromycin). (2) Diagnosis of rheumatic fever based on Jones criteria. (3) Control inflammatory process with aspirin with or without steroids (total duration of treatment of 12 weeks). (4) Treatment of chorea according to severity (therapy to continue for 2-3 weeks after clinical improvement). (5) Protocol for managing cardiac complication like valvular heart disease, congestive heart failure and atrial fibrillation. (6) Secondary prophylaxis with benzathine penicillin and management of anaphylaxis.

Prevalence of left atrial thrombus in rheumatic mitral stenosis with atrial fibrillation and its response to anticoagulation: a transesophageal echocardiographic study.

BACKGROUND: The frequency of occurrence of left atrial thrombi, and the effect of anticoagulation in patients with rheumatic mitral stenosis and atrial fibrillation is not well established. This study was conducted to evaluate the occurrence of left atrial body and left atrial appendage clots in patients with rheumatic mitral stenosis and atrial fibrillation, and to document the effect of long-term anticoagulation on clot dissolution. METHODS AND RESULTS: Consecutive patients with severe rheumatic mitral stenosis and atrial fibrillation were assessed by transesophageal echocardiography. Those with left atrial body or left atrial appendage clots were anticoagulated with oral nicoumalone. Transesophageal echocardiography was then repeated in patients on anticoagulation who were on regular follow-up, and in whom percutaneous transvenous mitral commissurotomy could be considered. Of the 490 patients studied, 163 had left atrial body or left atrial appendage clots. A repeat transesophageal echocardiographic examination was done in 50 patients who had optimal anticoagulation for a period of 6 months. Only 2 of the 17 patients who had left atrial body clots had successful clot dissolution after long-term anticoagulation, while the left atrial appendage clots disappeared in 31 of 33 patients (p<0.001). CONCLUSIONS: Left atrial clots are present in a third of patients with severe rheumatic mitral stenosis and atrial fibrillation. Isolated left atrial appendage clots in patients with rheumatic mitral stenosis and atrial fibrillation can disappear with long-term anticoagulation, while thrombi that extend into the left atrial body may persist despite optimal anticoagulation.

Treatment of rheumatic carditis.

Rheumatic fever and rheumatic heart disease continue unabated in most of the developing nations, affecting young individuals. Focal outbreaks of smaller magnitude have also been reported since mid 1980s from industrialized western nations, where this disease had almost disappeared. Introduction of penicillin in mid 1940s had markedly changed the natural history of rheumatic fever, although the incidence of rheumatic fever declined in developed nations before that, due to better living conditions. Treatment of rheumatic fever chiefly involves use of antibiotics (penicillin) to eradicate streptococci, and anti-inflammatory drugs like salicylates or corticosteroids. Patients with severe carditis, congestive heart failure and/or pericarditis are best treated with corticosteroids as these are more potent anti-inflammatory agents than salicylates. Salicylates may be sufficient for cases with mild or no carditis. The treatment must be continued for 12 weeks. Several studies have shown that valvular regurgitation, and not myocarditis, is the cause of congestive heart failure in active rheumatic carditis. Therefore surgery with mitral valve replacement or repair is indicated in cases with intractable hemodynamics due to mitral regurgitation. Development of chronic valvular lesion after an episode of rheumatic fever is dependent upon presence or absence of carditis in the previous attack and compliance with secondary prophylaxis. Recurrences due to inadequate penicillin prophylaxis are responsible for hemodynamically significant chronic valvular lesions requiring surgery.

A community-based rheumatic fever/rheumatic heart disease cohort: twelve-year experience.

BACKGROUND: A pilot rheumatic fever and rheumatic heart disease control porject was started in 1988 in blocks of district Ambala (Haryana) to test the feasibility of early detection, treatment and secondary prophylaxis for rheumatic fever/rheumatic heart disease cases. School teachers, students and health workers were trained to identify and refer suspected cases of rheumatic fever/rheumatic heart disease to the community health center where physicians examined the suspected cases and monthly secondary prophylaxis was provided to the confirmed cases. METHODS AND RESULTS: A survey of registered cases was done in 1999 to determine the compliance rate of secondary prophylaxis and to describe clinical and epidemiologic features of the registered cohort of rheumatic fever/rheumatic heart disease patients. A total of 257 patients had been registered till the end of 1999 with 1263 person-years of follow-up. Out of these registered patients, 132 were receiving secondary prophylaxis, 52 had died, 17 had migrated, 8 were lost to follow-up, 18 had stopped prophylaxis and 30 completed the prophylaxis course. The mean age at registration was 18 years. Half of the cases were in the 6-15 years age group at registration. Over half of the patients were registered with a history of rheumatic fever. Fever was the most common symptom (75.9%). Carditis was more common among cases with recurrent attacks of rheumatic fever than after a first attack. The mortality in rheumatic fever/rheumatic heart cases was 32.5/1000 person-years. The mean age at death was 24.4 years. Compliance with secondary prophylaxis was 92% during the past 12 years. CONCLUSIONS: A rheumatic fever/rheumatic heart disease control program can be sustained within the primary health care system and the case registry can be utilized not only for monitoring the program but also to gain insight into the epidemiology of the disease.

Cardite reumática tratada com altas doses de metilprednisolona venosa (pulsoterapia): resultados em 70 crianças durante 12 anos / Rheumatic carditis treated with high doses of pulsetherapy methylprednisolone: results in 70 children over 12 years

Purpose - To report the result of patients treated with IV methylprednisolone divided into three groups and compare their follow-up during the last 12 years. Methods - Seventy children with active rheumatic carditis (76 episodes) in heart failure Class III and IV (NYHA) were studied. The diagnosis was based on modified Jones' criteria. After rulling out infections and stronglyoidiasis, treatment with IV methylprednisolone bolus was started three times a week until the laboratory tests became negative. Patients were divided into 3 groups, according to the time of hospital admittance: Groups 1,2 and 3, comprising of 40, 18 and 12 children, respectively. Results - Eighteen children in Group 1 (45 per cent) were in their 1st attack: 2 series of pulsetherapy were used in 10 (25 per cent), 3 in 9 (23 per cent) and 4 in 21 (52 per cent). In Group 2, 14 cases (77 per cent) were in their 1st attack: 2 series were used in 7 (39 per cent), 4 in 9 (50 per cent) and 5 in 2 (11 per cent). The echocardiogram showed a flail mitral valve in 12 (66 per cent) of these patients (1 death occurred after mitral valvoplasty). In Group 3,6 patients needed 5 or more series of pulsetherapy and a flail mitral valve was present in 5 (41 per cent). One child underwent mitral valve replacement while still in the active phase, after 8 series of pulsetherapy, and another died. The number of patients who needed 5 or more series was significantly higher in Group 3. Conclusion - There were variations in the presentation and evolution of the cases during these 12 year. The established pulsetherapy protocol continues to be useful to treat severe cases.

Safety and antithrombotic effects of fixed low-dose warfarin-aspirin combination in rheumatic mitral stenosis associated with atrial fibrillation

The incidence of thromboembolic complications in cases of mitral stenosis [MS] associated with atrial fibrillation [AF] is around 20%. To prevent this complication, warfarin and aspirin is administered to keep the INR between 2 and 3. However, this treatment is associated with increased risk of hemorrhagic episodes. Fifty-five patients with both rheumatic MS and AF, were randomly divided into two groups; Twenty-five patients received 2.5-mg of warfarin and 100 mg of aspirin daily, and thirty patients served as control. The mean +/- SD INR in the treatment group [1.58 +/- 0.45] was significantly higher than that of the control group [1.175 +/- 0.21] [p < 0.001]. Twenty per cent of the control group developed thromboembolic complications. However, none of the patients in the treatment group had any thromboembolic or hemorrhagic events. No inter - or intra-patient INR variability was seen. Therefore the use of low-dose warfarin - aspirin combination for the prevention of thromboembolic complications in patients with MS associated with AF is effective and safe, and thus, is strongly suggested

Pulsoterapia (altas doses de metil-prednisolona venosa) em crianças com cardite reumática. Estudo prospectivo de 40 episódios / Pulse Therapy (High Dosis of Intravenous Methyl-Prednisolone) in Children with Rheumatic Carditis. Prospective Study of 40 Episodes

PURPOSE--To use corticosteroids in a shorter period to treat rheumatic carditis, keeping the patient in the hospital; and verify the time interval of normalization of rheumatic activity tests with this method. METHODS--In 36 patients (40 episodes) intravenous methyl-prednisolone (1g/day) was administered. The number of series ranged from two to four, according to severity of the disease. The ages ranged from 6 to 17 years old, all of them fulfilled the criteria of Jones for diagnosis of rheumatic fever. They were submitted to treatment to eradicate the streptococcus, worms, PPD and dental focus extraction, before use of corticosteroids. RESULTS--In all patients the signals and symptoms of heart failure improved. In six cases occurred complications during pulse therapy that were easily controlled with clinical measures. Two series of methylprednisolone were used in 10 children, three in nine and four in 21 episodes. Eight patients were sent to valve replacement. The interval of time that laboratory tests of rheumatic activity became negative was 41.2 +/- 13.3 days. CONCLUSION--Using this IV corticotherapy it was possible decrease the amount of days of this medication, keeping the patient in the hospital. In this way we eliminate the problem of interruption of the treatment. There was not significative difference between oral and IV corticotherapy in order to the laboratory tests become negative.

Cardites rhumatismales de l'enfant: etude clinique et evolutive a propos de 45 cas

les auteurs etudient 45 cas de cardites rhumatismales colliges entre janvier 1989 et decembre 1992 dans le service de pediatrie du CHU de Brazzaville et repondant aux criteres de Jones revises. La frequence etait de 0;78 pour cent; l'age moyen de 10 ans et 4 mois. Il y avait 26 filles et 19 garcons. L'insuffisance cardiaque presente dans 32 cas; l'index cardiothoracique superieur a 0;60 dans 33 cas temoignent de la gravite de cette affection

Pulsoterapia com metilprednisolona em cardite reumática ativa / Pulsetherapy with methylprednisolone in active rheumatic fever

Setenta pacientes com diagnóstico clínico e laboratorial de febre reumática ativa, todos com cardite, e a maioria em franca insuficiência cardíaca, foram tratados com esquema de pulsoterapia, utilizando-se como corticoesteróide a metilprednisolona, em ciclos de 1g intravenoso, em infusäo contínua por duas a três dias consecutivos nas duas primeiras semanas, dois dias na 3ª semana e um dia na 4ª semana. Em alguns casos, esta terapêutica foi instituida após a corticoterapia oral ter falhado. Antes do tratamento pela pulsoterapia todos eram submetidos à medicaçäo antiestrongiloidíase, afastado tuberculose ou outra infeccäo, com rigor