Objectives of Study:
|
This study intends to carry out a prospective, randomized, double-blind, and controlled clinical study to evaluate the integrative strategy of Qingre Shuji Decoction combined with Western medicine standard treatment : ( 1 ) to evaluate the clinical efficacy of “ Qingre Shuji Decoction ” on AS by using the internationally recognized efficacy evaluation system ; ( 2 ) Improving the quality of life of AS patients ; ( 3 ) Preliminary exploration on the improvement of bone marrow edema in AS patients with whole spine and sacroiliac MRI.
|
Description for medicine or protocol of treatment in detail:
|
1. Chinese medicine treatment
①Treatment group : Qingre Shuji Fang oral treatment, prescription composition : Dog ridge (hot), Anemarrhena, Cortex Phellodendri (salt), Gentiana, etc., one dose a day, concentrated decoction, 30 ml, Bid.
②Control group : Chinese medicine placebo oral, 30ml, Bid, prepared by China-Japan Friendship Hospital Pharmacy Department.
2. Western medicine treatment
The treatment group and the control group were treated with western medicine standard treatment :
①A non-steroidal anti-inflammatory drug was used in full for 2 weeks to evaluate the condition, and the ineffective drug could be replaced by another non-steroidal anti-inflammatory drug. After 4 weeks of full application, drug safety indicators were detected and the condition was evaluated.
Recommended scheme : Meloxicam (Shanghai Bolin Yingehan Pharmaceutical Co., Ltd.), 150 mg, Qd. After 2 weeks of treatment, if the effect is not good (ASDAS ≥ 2.1 or BASDAI ≥ 4 or opinions of rheumatism experts), it can be replaced by another non-steroidal anti-inflammatory drug. It is recommended that diclofenac sodium (produced by Beijing Novartis Pharmaceutical Co., Ltd.), 75 mg Bid. After 4 weeks of treatment, drug safety indicators and disease assessment were performed.
②Two non-steroidal anti-inflammatory drugs were determined by rheumatologists after 4 weeks of treatment :
If the effect is good (ASDAS < 2.1 or BASDAI < 4 or advice from rheumatologists), the current treatment can be continued and follow-up evaluations are conducted at weeks 6, 10 and 16, respectively. According to rheumatism experts, non-steroidal anti-inflammatory drugs can be reduced and used on demand. Patients need to record the dosage of non-steroidal anti-inflammatory drugs daily.
If the effect is not good (ASDAS ≥ 2.1 or BASDAI ≥ 4 or the opinion of rheumatism experts), it can be
|
Inclusion criteria
|
①18–75 years old ;
②Patients met the diagnostic criteria of Western medicine and disease activity, and the VAS score of spinal pain (the second item of BASDAI) was ≥ 40 mm.
③Patients who met the diagnostic criteria of kidney deficiency and dampness-heat syndrome in TCM ;
④voluntary signing of informed consent ;
⑤Drug cleaning : SASP, methotrexate (MTX), leflunomide (LEF) and other antirheumatic drugs, hormones, biological agents or small molecule targeted drugs were not used more than 1 month before randomization.
|
Exclusion criteria:
|
①pregnant or lactating women and mental patients with severe malnutrition or severe damage to the heart, brain, kidney and hematopoietic system ;
②patients with other rheumatic diseases ;
③Patients with severe spinal and hip joint dysfunction who needed surgery during this study ;
④Concurrent NSAIDs use contraindications ;
⑤contraindications for combined use of biological agents.
|